DEFM14A
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

(Amendment No. )

 

 

Filed by the Registrant ☒

Filed by a Party other than the Registrant ☐

Check the appropriate box:

 

Preliminary Proxy Statement

 

Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))

 

Definitive Proxy Statement

 

Definitive Additional Materials

 

Soliciting Material under §240.14a-12

ELIEM THERAPEUTICS, INC.

(Name of Registrant as Specified in its Charter)

(Name of Person(s) Filing Proxy Statement, if Other Than the Registrant)

Payment of Filing Fee (Check all boxes that apply):

 

No fee required

 

Fee paid previously with preliminary materials

 

Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11

 

 

 


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LOGO

Eliem Therapeutics, Inc.

PMB #117

2801 Centerville Road, 1st Floor

Wilmington, DE 19808-1609

NOTICE OF 2024 ANNUAL MEETING OF STOCKHOLDERS

 

 

To be held on June 26, 2024

Dear Stockholders of Eliem Therapeutics, Inc.,

You are cordially invited to attend the 2024 annual meeting of stockholders (the “Meeting”) of Eliem Therapeutics, Inc. (“Eliem”), which will be held on Wednesday, June 26, 2024 at 9:00 a.m., Eastern Time. The Meeting will be held by a virtual-only format, solely by means of remote communication at www.proxydocs.com/ELYM.

On April 10, 2024, Eliem entered into an Agreement and Plan of Merger and Reorganization (as it may be amended from time to time, the “Acquisition Agreement”), with Tenet Medicines, Inc. (“Tenet”), a privately held development-stage biotechnology company focused on advancing TNT119, an anti-CD19 antibody designed for a broad range of autoimmune disorders, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy. The Acquisition Agreement provides for the acquisition of Tenet by Eliem through the merger of a wholly owned subsidiary of Eliem into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem (the “Acquisition”).

The aggregate consideration payable by Eliem to the former equityholders of Tenet in the Acquisition will be a number of shares of Eliem common stock (the “Aggregate Consideration”) (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement (as defined below)), calculated on a fully diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem). The Acquisition and the Acquisition Agreement are more fully described in the accompanying proxy statement.

In connection with the Acquisition, on April 10, 2024, Eliem entered into a securities purchase agreement (as it may be amended from time to time, the “Securities Purchase Agreement”) with several accredited institutional investors (the “PIPE Investors”) pursuant to which Eliem agreed to issue and sell to the PIPE Investors in a private placement (the “Private Placement”) an aggregate of 31,238,282 shares of Eliem common stock, at a price per share of $3.84. Eliem expects to receive aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting estimated offering expenses payable by Eliem. The Private Placement is expected to close immediately following the closing of the Acquisition, subject to the satisfaction of specified customary closing conditions, including approval from the stockholders of Eliem of the Share Issuance Proposal (as defined below), and contingent upon, among other things, the closing of the Acquisition. The Private Placement and the Securities Purchase Agreement are more fully described in the accompanying proxy statement.


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At the Meeting, you will be asked to consider and vote upon the following proposals:

 

  (1)

To approve, for purposes of Nasdaq Listing Rule 5635 and the satisfaction of the related condition contained in the Acquisition Agreement, the issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement (the “Share Issuance Proposal”);

 

  (2)

To adjourn the Meeting from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the Meeting to be necessary or appropriate;

 

  (3)

To elect each of Andrew Levin, M.D., Ph.D., and Liam Ratcliffe, M.D., Ph.D., to the Eliem Board of Directors to hold office until the 2027 annual meeting of stockholders;

 

  (4)

To ratify the selection by the audit committee of the Eliem Board of Directors of PricewaterhouseCoopers LLP as the independent registered public accounting firm of Eliem for its fiscal year ending December 31, 2024; and

 

  (5)

To transact any other business that may properly come before the Meeting or any adjournment or postponement of the Meeting by or at the direction of the Eliem Board of Directors.

Eliem will transact no other business at the Meeting, except such business as may properly be brought before the Meeting or any adjournments or postponements thereof by or at the direction of the Eliem Board of Directors in accordance with Eliem’s bylaws.

Please refer to the attached proxy statement for further information about the proposals. Eliem is seeking approval to issue shares of Eliem common stock in connection with the Acquisition equal to the Aggregate Consideration, as described above, and 31,238,282 shares of Eliem common stock in the Private Placement. Because Eliem is seeking your approval to issue its shares of common stock in the Acquisition and the Private Placement, the accompanying proxy statement includes certain material information regarding Eliem, Tenet, the Acquisition, the Acquisition Agreement, the Private Placement and the Securities Purchase Agreement.

As described in the accompanying proxy statement, RA Capital Management, L.P. and certain of its affiliated funds (“RA Capital Management”) entered into a support agreement with Eliem and Tenet to vote all of their respective shares of Eliem common stock in favor of the Share Issuance Proposal and against any alternative acquisition proposals, subject to the terms and conditions set forth therein. However, as described in the accompanying proxy statement, the Share Issuance Proposal is conditioned upon the affirmative vote of a majority of the aggregate voting power of the outstanding shares of Eliem common stock excluding, among other shares, shares beneficially owned by RA Capital Management. Accordingly, your vote on the Share Issuance Proposal is very important.

Stockholders will not be able to attend the Meeting in person and will be able to attend the Meeting only via the webcast. Eliem believes that hosting a “virtual meeting” will enable greater stockholder attendance and participation from any location around the world. Eliem has designed the format of the Meeting to provide stockholders substantially the same rights and opportunities to participate as they would have at an in-person meeting.

The Eliem Board of Directors has fixed the close of business on May 30, 2024 as the record date for the purpose of determining the stockholders who are entitled to receive notice of, and to vote at, the Meeting and any adjournment or postponement thereof. Only stockholders of record at the close of business on the record date are entitled to notice of, and to vote at, the Meeting and at any adjournment of that meeting. Stockholders of record at the close of business on the record date can attend the Meeting online, including to vote their shares and ask questions, by accessing www.proxydocs.com/ELYM. To participate in the Meeting, stockholders will need to enter the 16-digit control number included on their proxy card or in the voting instructions that accompanied their voting materials.


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The rules and procedures applicable to the Meeting, together with a list of stockholders of record for inspection for any purpose germane to the Meeting, will be available for the stockholders of record from investorrelations@eliemtx.com during regular business hours for a period of ten days ending on the day before the Meeting.

On or about June 4, 2024, Eliem is mailing to its stockholders a paper copy of the proxy materials, including a proxy card. The proxy card contains instructions on how to cast your vote via the Internet or by telephone.

Your vote is very important. Whether or not you plan to attend the Meeting online, please vote your shares by proxy as promptly as possible to ensure your representation and the presence of a quorum at the Meeting. You may vote electronically at the Meeting, by telephone, online, or by completing and returning the enclosed proxy card. Eliem recommends you vote by proxy even if you plan to participate in the virtual meeting. You can always change your vote by voting electronically at the virtual meeting.

Eliem is excited about the opportunities that the Acquisition and the Private Placement bring to its stockholders, and thanks you for your consideration and continued support.

 

BY ORDER OF THE BOARD OF DIRECTORS

LOGO

Andrew Levin, M.D., Ph.D.
Executive Chairman of the Board of Directors
Wilmington, Delaware
June 4, 2024


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IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 26, 2024:

This proxy statement and the accompanying proxy card are available for viewing, printing and downloading at: www.proxydocs.com/ELYM. These documents are also available to any stockholder who wishes to receive a paper copy free of charge by calling (877) 354-3689 or emailing investorrelations@eliemtx.com. This proxy statement is also available on the Securities and Exchange Commission’s website at http://www.sec.gov.


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Eliem Therapeutics, Inc.

Proxy Statement

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     Page No.  

INFORMATION CONCERNING SOLICITATION AND VOTING

     1  

QUESTIONS AND ANSWERS ABOUT THE MEETING, THE ACQUISITION, THE PRIVATE PLACEMENT AND THE PROPOSALS

     2  

MARKET PRICE AND DIVIDEND INFORMATION

     12  

RISK FACTORS

     13  

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

     50  

THE MEETING OF ELIEM STOCKHOLDERS

     52  

THE ACQUISITION

     57  

THE ACQUISITION AGREEMENT

     83  

AGREEMENTS RELATED TO THE ACQUISITION AND THE PRIVATE PLACEMENT

     95  

MATTERS BEING SUBMITTED TO A VOTE OF ELIEM STOCKHOLDERS

     99  

PROPOSAL NO. 1: APPROVAL, FOR PURPOSES OF NASDAQ LISTING RULE 5635 AND THE CONDITIONS OF THE ACQUISITION AGREEMENT, OF THE ISSUANCE OF SHARES OF ELIEM’S COMMON STOCK PURSUANT TO THE TERMS OF THE ACQUISITION AGREEMENT AND THE SECURITIES PURCHASE AGREEMENT

     99  

PROPOSAL NO. 2: APPROVAL OF POSSIBLE ADJOURNMENT OF THE MEETING

     102  

PROPOSAL NO. 3: ELECTION OF DIRECTORS

     103  

NOMINEES FOR ELECTION FOR A THREE-YEAR TERM EXPIRING AT THE 2027 ANNUAL MEETING OF STOCKHOLDERS

     105  

PROPOSAL NO. 4: RATIFICATION OF SELECTION OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     106  

REPORT OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS

     108  

ELIEM’S BUSINESS

     109  

ELIEM’S PROPERTY

     109  

TENET’S BUSINESS

     110  

ELIEM’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     129  

TENET’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     130  

MANAGEMENT FOLLOWING THE ACQUISITION

     143  

EXECUTIVE COMPENSATION OF ELIEM

     152  

PRINCIPAL STOCKHOLDERS OF ELIEM

     160  

PRINCIPAL STOCKHOLDERS OF POST-CLOSING ELIEM

     163  

CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

     166  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

     170  

NOTES TO UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

     176  

HOUSEHOLDING

     181  

STOCKHOLDER PROPOSALS

     182  

INFORMATION INCORPORATED BY REFERENCE

     183  

COMMUNICATIONS WITH THE ELIEM BOARD

     184  

WHERE YOU CAN FIND MORE INFORMATION

     184  

OTHER MATTERS

     184  

CONSOLIDATED FINANCIAL STATEMENTS OF ELIEM

     185  

INDEX TO FINANCIAL STATEMENTS OF TENET

     F-1  

 

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ANNEX A – AGREEMENT AND PLAN OF MERGER AND REORGANIZATION

ANNEX B – OPINION OF LEERINK PARTNERS LLC

ANNEX C – FORM OF SAFE CANCELLATION AGREEMENT

ANNEX D – FORM OF ELIEM SUPPORT AGREEMENT

ANNEX E – FORM OF TENET JOINDER AND SUPPORT AGREEMENT

ANNEX F – FORM OF LOCK-UP AGREEMENT

ANNEX G – SECURITIES PURCHASE AGREEMENT

ANNEX H – REGISTRATION RIGHTS AGREEMENT

 

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INFORMATION CONCERNING SOLICITATION AND VOTING

This proxy statement contains information about the 2024 annual meeting of stockholders (the “Meeting”) of Eliem Therapeutics, Inc. (the “Company” or “Eliem”) to be held on Wednesday, June 26, 2024 at 9:00 a.m., Eastern Time.

Eliem’s Board of Directors (the “Eliem Board”) has furnished this proxy statement and the enclosed proxy card in connection with the solicitation of proxies by the Eliem Board for the Meeting, and any adjournment or postponement of the Meeting.

This proxy statement, together with the enclosed form of proxy card, is first being mailed to Eliem stockholders on or about June 4, 2024.

All properly submitted proxies will be voted in accordance with the instructions contained in those proxies. If no instructions are specified, the shares represented by the proxies will be voted in accordance with the recommendation of the Eliem Board with respect to each of the matters set forth in the proxy card.

IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 26, 2024:

This proxy statement and the accompanying proxy card are available at: www.proxydocs.com/ELYM.

In this proxy statement, the terms “we,” “us,” “our,” “the Company” or “Eliem” refer to Eliem Therapeutics, Inc. unless the context indicates otherwise. In this proxy statement, the term “Tenet” refers to Tenet Medicines, Inc., unless the context indicates otherwise. The surviving corporation following the Acquisition (as defined below) is referred to herein as “Post-Closing Eliem.”

Eliem has supplied all information contained in this proxy statement relating to Eliem, and Tenet has supplied all information contained in this proxy statement relating to Tenet. Eliem and Tenet have both contributed to the information related to the Acquisition contained in this proxy statement.

 

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QUESTIONS AND ANSWERS ABOUT THE MEETING, THE ACQUISITION, THE PRIVATE PLACEMENT AND THE PROPOSALS

The following are some questions that you, as a holder of Eliem common stock, may have regarding the Meeting, the Acquisition, the Private Placement (as defined below) and the Proposals (as defined below) and brief answers to such questions. Eliem urges you to carefully read this entire proxy statement and the documents referred to in this proxy statement because the information in this section does not provide all of the information that may be important to you as a stockholder of Eliem with respect to the Proposals.

Why am I receiving this proxy statement?

You are receiving this proxy statement because you have been identified as a holder of Eliem common stock as of the close of business on May 30, 2024 (the “Record Date”), and you are entitled to notice of, and to vote at, the Meeting. This proxy statement contains important information about the Meeting, the Acquisition, the Acquisition Agreement, the Private Placement, the Securities Purchase Agreement and the other business to be considered by Eliem stockholders at the Meeting, and you should read it carefully and in its entirety.

What proposals are the stockholders being asked to consider at the Meeting?

At the Meeting, you will be asked to vote upon:

 

  (1)

To approve, for purposes of Nasdaq Listing Rule 5635 and the satisfaction of the related condition contained in the Acquisition Agreement, the issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement (the “Share Issuance Proposal” or “Proposal No. 1”);

 

  (2)

To adjourn the Meeting from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the Meeting to be necessary or appropriate (the “Adjournment Proposal” or “Proposal No. 2”);

 

  (3)

To elect each of Andrew Levin, M.D., Ph.D., and Liam Ratcliffe, M.D., Ph.D., to the Eliem Board to hold office until the 2027 annual meeting of stockholders (the “Election Proposal” or “Proposal No. 3”);

 

  (4)

To ratify the selection by the audit committee of the Eliem Board of PricewaterhouseCoopers LLP as independent registered public accounting firm of Eliem for its fiscal year ending December 31, 2024 (the “Ratification Proposal” or “Proposal No. 4” and, collectively with the Share Issuance Proposal, Adjournment Proposal and Election Proposal, the “Proposals”); and

 

  (5)

To transact any other business that may properly come before the Meeting or any adjournment or postponement of the Meeting by or at the direction of the Eliem Board.

The Eliem Board is not aware of any other business to be conducted at the Meeting.

When and where will the Meeting take place?

The Meeting will be held on June 26, 2024 at 9:00 a.m., Eastern Time. The Meeting will be held via the Internet at a webcast at www.proxydocs.com/ELYM. As always, Eliem encourages you to vote your shares prior to the Meeting regardless of whether you intend to attend virtually via the webcast.

Where can we get technical assistance if we are having trouble accessing the Meeting or during the Meeting?

If you have difficulty accessing the Meeting or during the Meeting, please refer to the technical support telephone number posted on the virtual meeting website login page, where technicians will be available to help you.

 

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What is the Acquisition?

On April 10, 2024, Eliem entered into an Agreement and Plan of Merger and Reorganization (as it may be amended from time to time, the “Acquisition Agreement”) with Tango Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Eliem (“Transitory Subsidiary”), Tenet Medicines, Inc. (“Tenet”), a privately held development-stage biotechnology company, and, solely in his capacity as equityholder representative, Stephen Thomas (the “Company Equityholder Representative”), a copy of which is attached as Annex A. The Acquisition Agreement contains the terms and conditions of the proposed acquisition by Eliem of Tenet. The Acquisition Agreement provides for the acquisition of Tenet by Eliem through the merger of Transitory Subsidiary into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem (the “Acquisition”).

The aggregate consideration payable to the former equityholders of Tenet by Eliem in the Acquisition will be a number of shares of Eliem common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement), calculated on a fully diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem) (the “Aggregate Consideration”). For more information about the Acquisition, please see the sections titled “The Acquisition” beginning on page 57 of this proxy statement.

Why is Eliem proposing to acquire Tenet pursuant to the Acquisition Agreement?

Eliem believes that the acquisition of Tenet provides an opportunity to strengthen Eliem’s pipeline of development assets and, together with the Private Placement, strengthen its capital resources, positioning it to become a leading immunology and inflammation company focused on developing novel treatments for a broad range of autoimmune diseases. Following the Acquisition, Post-Closing Eliem plans to focus primarily on advancing TNT119, an anti-CD19 antibody, designed for a broad range of autoimmune diseases, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy. For a discussion of Eliem’s reasons for the Acquisition, please see the section titled “The Acquisition—Eliem’s Reasons for the Acquisition and the Private Placement” beginning on page 66 of this proxy statement.

What is the Private Placement?

On April 10, 2024, concurrently with the execution of the Acquisition Agreement, Eliem entered into the securities purchase agreement (as it may be amended from time to time, the “Securities Purchase Agreement”) with several accredited institutional investors (the “PIPE Investors”), pursuant to which Eliem agreed to issue and sell to such PIPE Investors in a private placement an aggregate of 31,238,282 shares of Eliem common stock, at a price of $3.84 per share (the “Private Placement”). Eliem expects to receive aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting estimated offering expenses payable by Eliem.

The Private Placement is expected to close immediately following the closing of the Acquisition, subject to the satisfaction of specified customary closing conditions, including approval from the stockholders of Eliem of the Share Issuance Proposal (as defined below), and contingent upon, among other things, the closing of the Acquisition. For more detail on the Securities Purchase Agreement and the Private Placement, see the section titled “Agreements Related to the Acquisition and the Private Placement—Securities Purchase Agreement and Registration Rights Agreement—Securities Purchase Agreement” beginning on page 96 of this proxy statement.

What is the Registration Rights Agreement?

On April 10, 2024, in connection with the entry into the Securities Purchase Agreement, Eliem entered into a registration rights agreement (as it may be amended from time to time, the “Registration Rights Agreement”)

 

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with the PIPE Investors in the Private Placement, pursuant to which Eliem agreed to register for resale the shares of Eliem common stock to be issued in the Private Placement. On or prior to the closing of the Acquisition, each Tenet equityholder entitled to receive shares of Eliem common stock in the Acquisition may elect to become party to the Registration Rights Agreement, in which case Eliem will also register for resale the shares of Eliem common stock to be issued in the Acquisition. Under the Registration Rights Agreement, Eliem has agreed to file a registration statement covering the resale of the shares of Eliem common stock to be issued in the Private Placement and in the Acquisition within 45 days following the closing of the Private Placement. Post-Closing Eliem has agreed to use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable and to keep such registration statement effective until the date the shares of Eliem common stock covered by such registration statement have been sold or cease to be registrable securities under the Registration Rights Agreement. For more detail on the Registration Rights Agreement, see the section titled “Agreements Related to the Acquisition and the Private Placement—Securities Purchase Agreement and Registration Rights Agreement—Registration Rights Agreement” beginning on page 98 of this proxy statement.

What will happen to Eliem if, for any reason, the Acquisition is not consummated?

If, for any reason, the Acquisition is not consummated, Eliem will not complete the share issuance pursuant to the Acquisition Agreement and, as a result, the Private Placement, which is conditioned on the closing of the Acquisition, will also not be consummated. Under certain specified circumstances, Eliem may be obligated to pay Tenet a termination fee of $1,000,000 and reimburse certain expenses of Tenet up to a maximum of $500,000, as more fully described in the section titled “The Acquisition Agreement—Termination and Termination Fees.”

Why am I being asked to consider other proposals unrelated to the Acquisition?

The timing of a special meeting to consider the Share Issuance Proposal required for the completion of the Acquisition would have occurred around the time Eliem would regularly hold its annual meeting of stockholders. Eliem determined to combine the two meetings in an effort to significantly reduce proxy statement printing and other meeting costs and administrative burdens and to reduce the burden on Eliem stockholders who would otherwise receive two sets of proxy materials around the same time to consider and vote on two separate sets of stockholder proposals. The approval of the Election Proposal and the Ratification Proposal is not a condition to the closing of the Acquisition and the Private Placement.

What are the recommendations of the Board?

After consideration and consultation with management and its financial and legal advisors, and after recommendation by the Special Committee composed entirely of disinterested directors of the Eliem Board (the “Special Committee”), the Eliem Board unanimously recommends that the stockholders vote (1) “FOR” the Share Issuance Proposal, (2) “FOR” the Adjournment Proposal, (3) “FOR” the two nominees in the Election Proposal and (4) “FOR” the Ratification Proposal. For more information on the Special Committee’s and the Eliem Board’s recommendations to Eliem stockholders regarding the Proposals to be voted on at the Meeting, see the section titled “The Meeting of Eliem Stockholders” beginning on page 52 of this proxy statement.

What proposal will be voted on at the Meeting the approval of which is a condition to the closing of the Acquisition and the Private Placement?

As a condition to the closing of the Acquisition and the Private Placement, Proposal No. 1, which is the Share Issuance Proposal, must be approved by the affirmative vote of (i) a majority in voting power of the votes cast by holders of the outstanding shares of Eliem common stock entitled to vote in accordance with the Delaware General Corporation Law (“DGCL”) (the vote contemplated by this clause (i), the “Baseline Vote”) and (ii) a majority of the aggregate voting power of the outstanding shares of Eliem common stock entitled to vote thereon other than any outstanding shares of Eliem common stock beneficially owned, directly or indirectly, by

 

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(1) Tenet, (2) any stockholder of Tenet, including RA Capital Management, L.P. (together with certain of its affiliated funds, “RA Capital Management”), (3) any individual that Eliem has determined to be an “officer” of Eliem within the meaning of Rule 16a-1(f) of the Exchange Act, (4) any PIPE Investor, (5) any “immediate family member” (as defined in Item 404 of Regulation S-K) of any individual listed in the foregoing clauses (1)-(4), and (6) any “affiliate” or “associate” (as defined in Section 12b-2 of the Exchange Act) of any person listed in the foregoing clauses (1)-(5) (holders of Eliem common stock other than the persons listed in this clause (ii), the “Disinterested Stockholders” and, the vote contemplated by this clause (ii), the “Disinterested Stockholder Approval” and, collectively with the Baseline Vote, the “Required Eliem Stockholder Vote”).

Concurrently with the execution of the Acquisition Agreement, RA Capital Management entered into a support agreement with Eliem and Tenet to vote all of its shares of Eliem common stock (a) in favor of the Share Issuance Proposal and (b) against any alternative acquisition proposals. Such vote will not have any impact on the Disinterested Stockholder Approval.

In addition to the requirement of obtaining the Required Eliem Stockholder Vote, the closing of the Acquisition is subject to the satisfaction or waiver of each of the other closing conditions set forth in the Acquisition Agreement, and the closing of the Private Placement is subject to the closing of the Acquisition and the satisfaction or waiver of each of the other closing conditions set forth in the Securities Purchase Agreement. For a complete description of the closing conditions under the Acquisition Agreement, we urge you to read the section titled “The Acquisition Agreement—Conditions to the Completion of the Acquisition” beginning on page 90 of this proxy statement. For a complete description of the closing conditions under the Securities Purchase Agreement, we urge you to read the section titled “Agreements Related to the Acquisition and the Private Placement—Securities Purchase Agreement and Registration Rights Agreement—Securities Purchase Agreement” beginning on page 96 of this proxy statement.

What risks should I consider in deciding whether to vote in favor of the Share Issuance Proposal?

You should carefully review the section titled “Risk Factors” beginning on page 13 of this proxy statement, which sets forth certain risks and uncertainties related to the Acquisition and the Private Placement, risks and uncertainties to which Post-Closing Eliem’s business will be subject, and risks and uncertainties to which each of Eliem and Tenet, as independent companies, are subject.

Who will be the directors of Post-Closing Eliem following the Acquisition?

Assuming that both of the director nominees referenced in the section titled, “Matters Being Submitted to a Vote of Eliem Stockholders—Proposal No. 3: Election of Directors” beginning on page 103 of this proxy statement are elected by the Eliem stockholders at the Meeting, the Eliem Board will be composed, as of immediately prior to the closing of the Acquisition, of the following directors: Andrew Levin, M.D., Ph.D., Judith Dunn, Ph.D., Liam Ratcliffe, M.D., Ph.D., Adam Rosenberg and Simon Tate. In the event that the two director nominees are elected at the Meeting but the Acquisition is not completed, the Eliem Board will continue as described in the immediately preceding sentence, including that both Dr. Levin and Dr. Ratcliffe will continue in office until the 2027 annual meeting of stockholders.

In the event that the Acquisition is completed and the two director nominees are elected at the Meeting, the Post-Closing Eliem board of directors (the “Post-Closing Eliem Board”) will be composed of seven board members consisting of the following:

 

   

the five existing members of the Eliem Board;

 

   

Stephen Thomas, Ph.D., the expected interim Chief Executive Officer of Post-Closing Eliem; and

 

   

one director to be designated by Tenet prior to the closing of the Acquisition.

 

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Who will be the executive officers of Post-Closing Eliem following the Acquisition?

Immediately following the closing of the Acquisition, the executive management team of Post-Closing Eliem is expected to be composed of the following:

 

Name

  

Position

Stephen Thomas, Ph.D.    Interim Chief Executive Officer
Andrew Levin, M.D., Ph.D.    Executive Chairman of the Board of Directors
Valerie Morisset, Ph.D.    Executive Vice President, Research and Development and Chief Scientific Officer

When do you expect the Acquisition to be consummated?

Eliem currently anticipates that the Acquisition will close in the middle of 2024, soon after the Meeting to be held on June 26, 2024, but Eliem cannot predict the exact timing. For more information about the conditions to the consummation of the Acquisition, please see the section titled “The Acquisition Agreement—Conditions to the Completion of the Acquisition” beginning on page 90 of this proxy statement.

What are the material U.S. federal income tax consequences of the Acquisition to Eliem and its stockholders?

Eliem will not recognize any gain or loss for U.S. federal income tax purposes upon consummation of the Acquisition. In addition, because the stockholders of Eliem immediately prior to the consummation of the Acquisition will not sell, exchange or dispose of any shares of Eliem common stock in the Acquisition, such stockholders will not recognize any gain or loss upon consummation of the Acquisition.

Am I entitled to dissenters’ or appraisal rights?

No, Eliem stockholders are not entitled to dissenters’ or appraisal rights in connection with the Acquisition. Tenet stockholders are entitled to dissenters’ rights in connection with the Acquisition. For more information about dissenters’ rights, please see the section titled “The Acquisition—Appraisal Rights and Dissenters’ Rights” beginning on page 82 of this proxy statement.

Have Tenet stockholders adopted the Acquisition Agreement?

Yes, Tenet stockholders have adopted the Acquisition Agreement and approved the Acquisition via a written consent delivered by Tenet stockholders. For more information on the matters approved by Tenet stockholders in connection with the Acquisition please see the sections titled “The Acquisition Agreement—Conditions to the Completion of the Acquisition” beginning on page 90 of this proxy statement and “The Acquisition Agreement—Meeting of Eliem Stockholders and Written Consent of Tenet Stockholders” beginning on page 89 of this proxy statement.

Who can vote at the Meeting?

Stockholders of record who owned shares of Eliem common stock on the Record Date may attend and vote at the Meeting. There were 29,752,317 shares of Eliem common stock outstanding on the Record Date. All shares of Eliem common stock have one vote per share and vote together as a single class.

What is the proxy card?

The proxy card enables you to appoint Liam Ratcliffe, M.D., Ph.D., and Simon Tate, individually, as your proxies at the Meeting. By completing and returning or submitting the proxy card as described herein or therein,

 

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you are authorizing these individuals to vote your shares at the Meeting in accordance with your instructions on the proxy card. This way, your shares will be voted whether or not you attend the Meeting. Even if you plan to attend the Meeting online, Eliem recommends completing and returning or submitting your proxy card before the Meeting date in the event your plans change. If no instructions are specified on your proxy card, the shares represented by the proxies will be voted in accordance with the recommendation of the Eliem Board with respect to each of the matters set forth in the proxy card. If a proposal comes up for vote at the Meeting that is not on the proxy card, the proxies will vote your shares, under your proxy, according to their best judgment.

What is the difference between holding shares as a stockholder of record and as a beneficial owner?

Most Eliem stockholders hold their shares through a bank, broker or other nominee, rather than holding share certificates in their own name. As summarized below, there are some distinctions between voting shares held of record and voting those owned beneficially.

 

   

Stockholders of Record. If you are a stockholder of record and do not vote over the Internet, by phone or by mailing your proxy card, your shares will not be voted unless you attend the Meeting and vote your shares electronically at the Meeting.

 

   

Beneficial Owners of Shares Held in Street Name. If your shares are held through a bank, broker or other nominee, you are considered the beneficial owner of shares held in “street name.” If your shares of Eliem common stock are held in “street name”, you should provide the record holder of your shares with instructions on how to vote your shares. Please follow the voting instructions provided by your bank, broker or other nominee to provide your instruction on how to vote at the Meeting.

How do I virtually attend the Meeting?

Eliem will host the Meeting live online via webcast. You may attend the Meeting live online by visiting www.proxydocs.com/ELYM. The live audio webcast will start at 9:00 a.m., Eastern time on Wednesday, June 26, 2024. Online access to the audio webcast will open 15 minutes prior to the start of the Meeting to allow time for you to log-in and test your device’s audio system. To be admitted to the virtual meeting, you will need the 16-digit control number, which is included on your proxy card if you are a stockholder of record, or is included with your voting instruction card or voting instructions received from your broker, bank or other nominee if you hold your shares in “street name”.

You are entitled to participate in the Meeting only if you were a stockholder as of the close of business on the Record Date.

Beginning 15 minutes prior to, and during, the Meeting, Eliem will have support available to assist with any technical difficulties that you may have accessing or hearing the virtual meeting. If you encounter any difficulty accessing, or during, the Meeting, please call the support team at the numbers listed on the web portal at the time of the Meeting.

How do I submit a question at the Meeting?

You will be able to submit your questions prior to and during the Meeting by visiting www.proxydocs.com/ELYM.

What is the quorum required for the Meeting?

The representation online or by proxy of holders of a majority of the voting power of the shares of Eliem common stock entitled to vote at the Meeting is necessary to constitute a quorum for the transaction of business at the Meeting. For purposes of determining the presence of a quorum, abstentions (meaning, for purposes of this proxy statement, an Eliem stockholder who attends the Meeting in person via the Internet and does not vote or

 

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returns a proxy with “abstain” instructions) and broker non-votes will be counted as present at the Meeting. Shares present virtually during the Meeting will be considered shares of common stock represented online at the Meeting.

Assuming that a quorum is present, what vote is required to approve each Proposal to be voted upon at the Meeting?

The Share Issuance Proposal requires that Eliem obtain both the Baseline Vote and the Disinterested Stockholder Approval.

 

   

The Baseline Vote requires the affirmative vote of a majority in voting power of the votes cast by holders of the outstanding shares of Eliem common stock entitled to vote in accordance with the DGCL.

 

   

The Disinterested Stockholder Approval requires the affirmative vote of a majority of the aggregate voting power of the outstanding shares of Eliem common stock entitled to vote thereon other than any outstanding shares of Eliem common stock beneficially owned, directly or indirectly, by (1) Tenet, (2) any stockholder of Tenet, including RA Capital Management, (3) any individual that Eliem has determined to be an “officer” of Eliem within the meaning of Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), (4) any PIPE Investor, (5) any “immediate family member” (as defined in Item 404 of Regulation S-K) of any individual listed in the foregoing clauses (1)-(4), and (6) any “affiliate” or “associate” (as defined in Section 12b-2 of the Exchange Act) of any person listed in the foregoing clauses (1)-(5).

The Adjournment Proposal requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote thereon.

The Ratification Proposal requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and voting affirmatively or negatively on such matter.

For the Election Proposal, the election of each director nominee requires the plurality of votes of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote generally on the election of directors.

Who will count the vote?

Representatives of Mediant Communications, Inc. will tabulate the votes and act as inspectors of election.

May I see a list of stockholders entitled to vote as of the record date?

A complete list of stockholders of record will be available for the stockholders of record from investorrelations@eliemtx.com during regular business hours for a period of ten days ending on the day before the Meeting.

How do I vote?

Stockholders of Record

If you are a stockholder of record of Eliem on the Record Date, you may vote in person via the Internet during the Meeting by visiting www.proxydocs.com/ELYM. You will need to enter the 16-digit control number included on your proxy card. Even if you plan to attend the Meeting online, Eliem urges you to vote your shares by proxy in advance of the Meeting so that if you should become unable to attend the Meeting in person via the

 

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Internet your shares will be voted as directed by you. You may submit your proxy before the Meeting in one of the following ways:

 

  1.

Internet. To submit your proxy by Internet, visit the website shown on your proxy card.

 

  2.

Telephone. To submit your proxy by telephone, please call 1-866-506-2806 using a touch-tone phone and follow the recorded instructions.

 

  3.

Mail. Simply complete, sign and date the enclosed proxy card and return it before the Meeting in the envelope provided.

Telephone and Internet voting for stockholders of record will be available up until 11:59 p.m., Eastern Time, on June 25, 2024. If the Meeting is adjourned or postponed, these deadlines may be extended.

Beneficial Owners of Shares Held in Street Name

If you are a beneficial owner of shares registered in the name of your bank, broker or other nominee, you should have received a voting instruction card and voting instructions with these proxy materials from that organization rather than from us. Please follow the voting instructions provided by your bank, broker or other nominee to provide your instruction on how to vote at the Meeting.

What are the effects of not voting, withholding or abstaining?

If you are a stockholder of record and do not vote by virtue of not being present virtually or by proxy at the Meeting, your shares will not be counted for purposes of determining the existence of a quorum. Assuming a quorum is present, this will have no effect on the Baseline Vote, the Adjournment Proposal, the Election Proposal or the Ratification Proposal. If you are a Disinterested Stockholder, this will have the effect of a vote “AGAINST” the Disinterested Stockholder Approval.

Abstentions (meaning an Eliem stockholder who attends the Meeting in person via the Internet and does not vote or returns a proxy with “abstain” instructions) will be counted for the purpose of determining the existence of a quorum. Abstentions will have the effect of a vote “AGAINST” the Adjournment Proposal and, if you are a Disinterested Stockholder, “AGAINST” the Disinterested Stockholder Approval. Assuming a quorum is present, abstentions will have no effect on the Baseline Vote or Ratification Proposal.

With respect to the Election Proposal, you may either vote “FOR” each nominee to the Eliem Board or you may “WITHHOLD” your vote. A properly executed proxy marked “WITHHOLD” with respect to the election of a director will not be voted with respect to such director. Assuming a quorum is present and at least one share votes in favor of the election of such director, this will have no effect on the outcome of the Election Proposal.

What are the effects of broker non-votes?

Banks, brokers or other nominees are not permitted to vote on “non-routine” matters without instruction from the beneficial owner. Broker non-votes occur on a matter when a bank, broker or other nominee is not permitted to vote on that matter because it is a “non-routine” matter and instructions are not given. The Share Issuance Proposal, the Adjournment Proposal and the Election Proposal are “non-routine” matters.

The Ratification Proposal is a “routine” matter and brokers, banks or other securities intermediaries may therefore vote on that proposal even if you do not instruct your bank, broker or other nominee how to vote with respect to the Ratification Proposal. Because of this, even if you do not instruct your bank, broker or other nominee how to vote on any matter at the Meeting, assuming your bank, broker or other nominee votes on the Ratification Proposal, the shares of Eliem common stock you beneficially own will be counted as present for purposes of determining a quorum.

 

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If you hold your shares in “street name” and do not instruct your bank, broker or other nominee how to vote with respect to the Share Issuance Proposal, the Adjournment Proposal or the Election Proposal, your bank, broker or other nominee may not vote with respect to such proposal and those votes will be counted as broker non-votes. Such broker non-votes will have no impact on the Baseline Vote, the Adjournment Proposal or the Election Proposal. If you are a Disinterested Stockholder, such broker non-votes will have the effect of a vote “AGAINST” the Disinterested Stockholder Approval, regardless of whether a quorum is present.

What does it mean if I received more than one proxy card?

If your shares are registered differently or in more than one account, you will receive more than one proxy card. To make certain that all of your shares are voted, please vote each proxy card either by Internet, telephone or mail before the Meeting or in person via the Internet during the Meeting.

What happens if I do not indicate how to vote my proxy?

If you just sign or submit your proxy card without providing further instructions, your shares will be counted as a vote “FOR” the Proposals.

What if I change my mind after I return my proxy?

Stockholders of Record

If you are a stockholder of record of Eliem and you have not executed a support agreement, you can revoke your proxy vote at any time before the final vote at the Meeting in any one of the following ways:

 

   

You may submit another properly completed proxy card with a later date or submit a new vote by telephone or through the Internet.

 

   

You may send a timely written notice that you are revoking your proxy to Eliem’s Executive Chairman at Eliem’s corporate mailing address located at PMB #117, 2801 Centerville Road 1st Floor Wilmington, DE 19808-1609.

 

   

You may attend the Meeting and vote online at the Meeting. Simply attending the Meeting will not, by itself, revoke your proxy.

Beneficial Owners of Shares Held in Street Name

Please note, however, that if your shares are held of record by a bank, broker or other nominee, you must instruct your bank, broker or other nominee that you wish to revoke or resubmit your vote by following the procedures on the voting card provided to you by the bank, broker or other nominee.

When are stockholder proposals and director nominations due for next year’s annual meeting?

To be considered for inclusion in Eliem’s 2025 annual meeting proxy materials, your proposal must be submitted in writing by February 4, 2025, to Eliem’s Executive Chairman at PMB #117, 2801 Centerville Road 1st Floor, Wilmington, DE 19808-1609, and must comply with all applicable requirements of Rule 14a-8 promulgated under the Exchange Act, provided, however, that if the date of Eliem’s 2025 annual meeting of stockholders is changed by more than 30 days from the anniversary of the Meeting, then the deadline is a reasonable amount of time prior to the date Eliem begins to print and mail the proxy statement for the 2025 annual meeting of stockholders.

If you wish to submit a proposal (including a director nomination) at the 2025 annual meeting of stockholders that is not to be included in the 2025 annual meeting proxy materials, Eliem’s bylaws establish that the proposal must be received by Eliem’s Executive Chairman not later than the close of business on March 28, 2025 nor

 

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earlier than the close of business on February 26, 2025; provided, however, that if the date of Eliem’s 2025 annual meeting of stockholders is changed by more than 30 days from the anniversary of the Meeting, then the proposal must be received no earlier than the close of business on the 120th day prior to such annual meeting and no later than the close of business on the later of the 90th day prior to such annual meeting or the tenth day following the day on which public announcement of the date of such meeting is first made.

In addition to satisfying the advance notice provisions in Eliem’s bylaws, stockholders who intend to solicit proxies in support of director nominees other than Eliem’s nominees must also comply with the additional requirements of Rule 14a-19(b). In addition, to comply with the universal proxy rules, stockholders who intend to solicit proxies in support of director nominees other than Eliem’s nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act no later than April 27, 2025. If the date of the 2025 annual meeting of stockholders changes by more than 30 days from the anniversary of the Meeting, such notice must instead be provided by the later of 60 days prior to the date of the 2025 annual meeting of stockholders or the 10th day following public announcement by Eliem of the date of the 2025 annual meeting of stockholders.

You are also advised to review Eliem’s bylaws, which contain additional requirements about advance notice of stockholder proposals and director nominations.

Who will bear the costs of the proxy solicitation?

Eliem will bear the costs of soliciting proxies. In addition to solicitations by mail, Eliem’s directors, officers and regular employees, without additional remuneration, may solicit proxies by telephone, facsimile, email, personal interviews and other means.

Will a representative of PricewaterhouseCoopers LLP be present at the Meeting?

A representative of PricewaterhouseCoopers LLP, Eliem’s independent registered public accounting firm, is expected to be present at the Meeting and will have an opportunity to make a statement if he or she desires to do so and to respond to appropriate questions from Eliem stockholders.

Who can help answer my questions?

If you are a holder of Eliem common stock as of the Record Date and would like additional copies, without charge, of this proxy statement or if you have questions about the Proposals, the Acquisition or the Private Placement, including the procedures for voting your shares, you should contact:

Eliem Therapeutics, Inc.

PMB #117

2801 Centerville Road 1st Floor

Wilmington, DE 19808-1609

Attn: Emily Pimblett

Email: investorrelations@eliemtx.com

When will the voting results of the Meeting be announced?

Eliem plans to announce preliminary voting results at the Meeting and will publish final results in a Current Report on Form 8-K to be filed with the SEC within four business days following the Meeting.

 

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MARKET PRICE AND DIVIDEND INFORMATION

Eliem common stock is currently listed on the Nasdaq Global Market under the symbol “ELYM.” Tenet is a private company, and the shares of Tenet are not publicly traded. Upon the closing of the Acquisition, Eliem’s common stock will continue to be listed under the symbol “ELYM.”

Eliem Common Stock

The closing price of Eliem common stock on April 10, 2024, the trading day immediately prior to the public announcement of the Acquisition on April 11, 2024, as reported on the Nasdaq Global Market, was $2.67 per share. The closing price of Eliem’s common stock on May 31, 2024, as reported on the Nasdaq Global Market, was $7.71 per share.

Because the market price of Eliem common stock is subject to fluctuation, the market value of the shares of Eliem common stock that Tenet stockholders will be entitled to receive in the Acquisition may increase or decrease.

As of May 30, 2024, the Record Date for the Meeting, Eliem had approximately 14 holders of record of Eliem common stock. This number does not include beneficial owners whose shares were held in street name. The actual number of holders of Eliem common stock is greater than this number of record holders and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers or held by other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.

Tenet Common Stock

As of May 30, 2024, the Record Date for the Meeting, Tenet had approximately four holders of record of Tenet common stock.

Dividends

Eliem has never declared or paid any cash dividends on Eliem’s capital stock and does not anticipate paying cash dividends on Eliem common stock for the foreseeable future. Eliem currently intends to retain all of its available funds and future earnings, if any, to support its operations and finance the growth and development of its business. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Acquisition (in which Tenet will become a wholly owned subsidiary of Eliem) will be at the discretion of the Post-Closing Eliem Board and will depend upon a number of factors, including Post-Closing Eliem’s results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the then-current board of directors deems relevant.

Tenet has never declared or paid any cash dividends on shares of Tenet’s capital stock. Pursuant to the Acquisition Agreement, Tenet cannot, without the written consent of Eliem, declare or pay dividends on Tenet’s capital stock during the period prior to the closing of the Acquisition. If the Acquisition is not consummated, Tenet does not anticipate paying cash dividends on the Tenet’s capital stock for the foreseeable future, and any future determination to pay cash dividends will be at the discretion of Tenet’s then-current board of directors and will depend upon a number of factors, including Tenet’s results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the then-current board of directors deems relevant.

 

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RISK FACTORS

Post-Closing Eliem will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement, you should carefully consider the material risks described below before deciding how to vote your shares of Eliem common stock. You should also read and consider the other information included or incorporated by reference in this proxy statement. Please see the section titled “Where You Can Find More Information.”

Summary of Risk Factors

Risks Related to the Acquisition and the Private Placement

 

   

Failure to complete the Acquisition could adversely impact Eliem, including resulting in Eliem paying a termination fee to Tenet and a decline in the price of Eliem common stock and an adverse impact on the future business and operations of Eliem.

 

   

If the conditions to the Acquisition are not satisfied or waived, the Acquisition may not be consummated and the Private Placement will likely not close.

 

   

Some Eliem and Tenet directors, executive officers and principal stockholders, including RA Capital Management, have interests in the Acquisition that are different from yours and that may influence them to support or approve the Acquisition without regard to your interests.

 

   

Eliem stockholders may not realize a benefit from the Acquisition and the Private Placement commensurate with the ownership dilution they will experience in connection with the Acquisition and the Private Placement.

 

   

If the Acquisition and the Private Placement are not completed, the price of Eliem common stock may decline or fluctuate significantly.

 

   

The number of shares of Eliem common stock that Eliem will issue to former Tenet stockholders in the Acquisition is based on a formula and is uncertain.

Risks Related to Tenet

 

   

Tenet is highly dependent on the success of TNT119. If Tenet is unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, TNT119, or if Tenet experiences delays in doing so, it will be materially harmed.

 

   

Tenet will need significant additional capital to proceed with development and commercialization of TNT119. Tenet may not be able to access sufficient capital on acceptable terms, if at all, and, as a result, it may be required to delay, scale back or discontinue development of TNT119.

 

   

There may be substantial delays in future clinical trials of TNT119 or TNT119 may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

 

   

Preliminary, initial, or interim results from clinical trials that Tenet announces, presents, or publishes from time to time may change as more data and information become available (or are updated based upon audit, validation and verification procedures of the data/information commonly performed for clinical trials) that could result in material changes in the final trial results.

 

   

Tenet has a limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of its business to date and to assess its future viability.

 

   

Tenet’s success depends on its ability to protect its intellectual property and TNT119.

 

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Tenet relies heavily on certain in-licensed patents and other intellectual property rights in connection with its development of TNT119 and may be required to acquire or license additional patents or other intellectual property rights to continue to develop and commercialize TNT119.

 

   

Tenet’s losses from operations and financial conditions raise substantial doubt about its ability to continue as a going concern.

Risks Related to Post-Closing Eliem

 

   

Post-Closing Eliem will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

 

   

The market price of Post-Closing Eliem common stock may be volatile, and the market price of the common stock may drop following the Acquisition.

 

   

After completion of the Acquisition, Post-Closing Eliem’s executive officers, directors and principal stockholders, including RA Capital Management, will have the ability to control or significantly influence all matters submitted to Post-Closing Eliem stockholders for approval.

 

   

Post-Closing Eliem will have broad discretion in the use of the cash and cash equivalents of Post-Closing Eliem and the proceeds from the Private Placement, and Post-Closing Eliem may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

Risks Related to the Acquisition and the Private Placement

Failure to complete the Acquisition could adversely impact Eliem, including resulting in Eliem paying a termination fee to Tenet and a decline in the price of Eliem common stock and an adverse impact on the future business and operations of Eliem.

If the Acquisition is not completed, Eliem is subject to the following risks, among others:

 

   

if the Acquisition Agreement is terminated under specified circumstances, Eliem will be required to pay Tenet a termination fee of $1,000,000 and reimburse Tenet’s transaction-related expenses up to a maximum of $500,000;

 

   

the price of Eliem common stock may decline and could fluctuate significantly; and

 

   

Eliem may be required to pay certain costs related to the Acquisition, such as legal and accounting fees, whether or not the Acquisition is consummated.

If the Acquisition Agreement is terminated and the Eliem Board determines to seek another strategic or financial transaction, there can be no assurance that Eliem will be able to identify and/or consummate such a transaction that would yield greater benefits than the benefits to be provided under the Acquisition Agreement.

If the conditions to the Acquisition are not satisfied or waived, the Acquisition may not be consummated.

The closing of the Acquisition is subject to a number of conditions as set forth in the Acquisition Agreement that must be satisfied or waived, including, among others, the approval of the Share Issuance Proposal by Eliem stockholders at the Meeting and the other conditions described in the section titled “The Acquisition Agreement—Conditions to the Completion of the Acquisition” beginning on page 90 of this proxy statement.

There can be no assurance as to whether or when the conditions to the closing of the Acquisition will be satisfied or waived or as to whether or when the Acquisition will be consummated. If the conditions are not satisfied or waived, the Acquisition may not be consummated or the closing of the Acquisition may be delayed, and Eliem and Tenet each may lose some or all of the intended benefits of the Acquisition.

 

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If the Acquisition is not consummated, the Private Placement will likely not close.

In connection with the Acquisition, on April 10, 2024, Eliem entered into the Securities Purchase Agreement with the PIPE Investors, pursuant to which the PIPE Investors agreed to purchase 31,238,282 shares of Eliem common stock upon the closing of the Private Placement, which is expected to occur immediately following the closing of the Acquisition. The expected gross proceeds from the Private Placement are approximately $120.0 million, before deducting estimated offering expenses. The closing of the Private Placement is subject to a number of conditions as set forth in the Securities Purchase Agreement that must be satisfied or waived, including, among others, the approval of the Share Issuance Proposal at the Meeting by Eliem stockholders, the closing of the Acquisition and the other conditions described in the section titled “Agreements Related to the Acquisition and the Private Placement—Securities Purchase Agreement and Registration Rights Agreement—Securities Purchase Agreement” beginning on page 96 of this proxy statement. In the event of any such failure to meet the conditions precedent, if the PIPE Investors in the Private Placement do not waive Eliem’s requirement to satisfy such conditions (to the extent applicable), then the Private Placement will not close.

The Acquisition may be completed even though a material adverse effect may result from the announcement of the Acquisition, industry-wide changes or other causes.

In general, neither Eliem nor Tenet is obligated to complete the Acquisition if there is a “material adverse effect” affecting the other party between April 10, 2024, the date of the Acquisition Agreement, and the closing of the Acquisition. However, certain types of changes are excluded from the concept of a “material adverse effect.” Such exclusions include, but are not limited to, changes in general business or economic conditions affecting the industry in which Eliem and/or Tenet, as applicable, operates, changes in the generally accepted accounting principles in the United States (“GAAP”), change in, or compliance with or action taken for the purpose of complying with any laws, rules, regulations of general applicability or GAAP or interpretations thereof, natural disasters, pandemics and related or associated epidemics, acts of war, outbreak or escalation of hostilities or acts of terrorism, changes in financial, banking, securities markets, or general economic, regulatory, legislative or political conditions, changes resulting from the announcement or pendency of the Acquisition, and failures to meet internal expectations or projections of results of operations. Therefore, if any of these events were to occur impacting Eliem or Tenet, the other party would still be obliged to consummate the closing of the Acquisition. If any such adverse changes occur and Eliem and Tenet consummate the Acquisition, the price of Eliem common stock following the closing of the Acquisition may suffer. This in turn may reduce the value of the Acquisition to the stockholders of Eliem, Tenet or both.

Some Eliem and Tenet directors, executive officers and principal stockholders, including RA Capital Management, have interests in the Acquisition that are different from yours and that may influence them to support or approve the Acquisition without regard to your interests.

Directors, executive officers and principal stockholders, such as RA Capital Management, of Eliem and Tenet have interests in the Acquisition that are different from, or in addition to, the interests of Eliem stockholders generally. These interests with respect to Eliem’s directors and executive officers may include, among others, that Eliem’s directors and certain of Eliem’s executive officers are expected to continue to serve as directors and executive officers, respectively, of Post-Closing Eliem after the closing of the Acquisition; that certain of Tenet’s current executive officers are expected to enter into employment agreements with Eliem on or prior to the closing of the Acquisition; and that Eliem’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Acquisition Agreement. These interests with respect to Tenet’s directors and executive officers may include, among others, transaction bonus payments, discretionary annual performance bonuses and the payment of base salaries or consulting compensation, as applicable. Additionally, certain directors of Eliem and Tenet and/or their respective affiliated funds will receive additional shares of Eliem common stock in the Acquisition, and RA Capital Management, which is affiliated with a director of Eliem, has agreed to participate in the Private Placement. Certain of Tenet’s executive officers are expected to serve as interim employees of Post-Closing Eliem after the closing of the Acquisition, including that

 

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William Bonificio, Chief Business Officer of Tenet, is expected to serve as interim Chief Business Officer of Post-Closing Eliem and Stephen Thomas, Chief Executive Officer of Tenet, is expected to serve as interim Chief Executive Officer of Post-Closing Eliem and on the Post-Closing Eliem Board as of, and contingent upon, the closing of the Acquisition.

The Eliem Board and Tenet’s board of directors (the “Tenet Board”), including the Eliem Special Committee, were aware of and considered those interests, among other matters, in reaching their respective decisions to approve and adopt the Acquisition Agreement, approve the Acquisition and the Private Placement, and recommend the approval of the Acquisition Agreement and related matters to Eliem and Tenet stockholders. These interests, among other factors, may have influenced the directors and executive officers of Eliem and Tenet to support or approve the Acquisition.

For more information regarding the interests of Eliem’s and Tenet’s directors and executive officers in the Acquisition, please see the sections titled “The Acquisition—Interests of Eliem’s Directors and Executive Officers in the Acquisition” beginning on page 69 and “The Acquisition—Interests of Tenet’s Directors, Executive Officers and Certain Other Persons in the Acquisition” beginning on page 70 of this proxy statement.

The number of shares of Eliem common stock that Eliem will issue to former Tenet equityholders in the Acquisition is based on a formula and is uncertain.

Pursuant to the Acquisition Agreement, the Aggregate Consideration payable by Eliem to the former equityholders of Tenet in the Acquisition will be a number of shares of Eliem common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement), calculated on a fully diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem).

Because the Aggregate Consideration depends on a formula determined at the closing of the Acquisition, which is based on the number of shares of Eliem’s common stock then outstanding, Eliem stockholders will not know or be able to determine at the time of the Meeting the exact number of shares of Eliem common stock that Tenet stockholders will receive as the Aggregate Consideration or the market value of such shares.

The market price of Eliem common stock fluctuated prior to and after the date of the announcement of the Acquisition Agreement and has and will continue to fluctuate from the date of this proxy statement to the date of the Meeting, and through the date the Acquisition is completed. It is impossible to accurately predict the market price of Eliem common stock and, therefore, impossible to accurately predict the value of the shares of Eliem common stock that Eliem will issue to former Tenet stockholders in the Acquisition. Stock price changes may result from a variety of factors, including, among others, general market and economic conditions, changes in Eliem’s business, results of operations, financial condition and prospects, market assessments of the likelihood that the Acquisition will be completed, interest rates and other factors generally affecting the price of Eliem’s common stock and the timing of the Acquisition. Many of these factors are beyond the control of Eliem.

Eliem stockholders may not realize a benefit from the Acquisition and the Private Placement commensurate with the ownership dilution they will experience in connection with the Acquisition and the Private Placement.

If Post-Closing Eliem is unable to realize the full strategic and financial benefits currently anticipated from the Acquisition and the Private Placement, Eliem stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent Post-Closing Eliem is able to realize only part of the benefits currently anticipated from the Acquisition and the Private Placement.

 

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The obligations and liabilities of Tenet, some of which may be unanticipated or unknown, may be greater than Eliem has anticipated, which may diminish the value of Tenet to Eliem.

Tenet’s obligations and liabilities, some of which may not have been disclosed to Eliem or may not be reflected or reserved for in Tenet’s financial statements, may be greater than Eliem has anticipated. The obligations and liabilities of Tenet could have a material adverse effect on Tenet’s business or Tenet’s value to Eliem or on Eliem’s business, results of operations or financial condition. Eliem is not entitled to indemnification by Tenet under the Acquisition Agreement with respect to obligations or liabilities of Tenet, whether known or unknown. In the event that Eliem is responsible for liabilities substantially in excess of any amounts recovered through any applicable insurance or alternative remedies that might be available to Eliem, Eliem could suffer severe consequences that materially and adversely affect Eliem’s business, results of operations, or financial conditions.

If the Acquisition and the Private Placement are not completed, the price of Eliem’s common stock may decline or fluctuate significantly.

Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. The market price of Eliem common stock will likely be volatile based on whether stockholders and other investors believe that Eliem can complete the Acquisition and the Private Placement or otherwise raise additional capital to support Eliem’s operations if the Acquisition is not consummated and another strategic or financial transaction cannot be identified, negotiated and consummated in a timely manner, if at all. In addition, Eliem common stock may remain subject to such fluctuations even if the Acquisition and the Private Placement are completed.

The volatility of the market price of Eliem common stock may be exacerbated by low trading volume or other factors. Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Eliem common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

The market price of Eliem common stock following the Acquisition may decline as a result of the Acquisition.

 

   

The market price of Eliem common stock may decline as a result of the Acquisition for a number of reasons, including if:

 

   

investors react negatively to the prospects of Post-Closing Eliem’s business and prospects following the closing of the Acquisition;

 

   

the effect of the Acquisition on Post-Closing Eliem’s business and prospects following the closing of the Acquisition is not consistent with the expectations of financial or industry analysts; or

 

   

Post-Closing Eliem does not achieve the perceived benefits of the Acquisition as rapidly or to the extent anticipated by stockholders or financial or industry analysts.

During the pendency of the Acquisition, Eliem and Tenet may not be able to enter into a strategic transaction with another party on more favorable terms because of restrictions in the Acquisition Agreement, which could adversely affect their respective business prospects.

Covenants in the Acquisition Agreement impede the ability of Eliem and Tenet to make acquisitions during the pendency of the Acquisition, subject to specified exceptions. As a result, if the Acquisition is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Acquisition Agreement is in effect, each party is generally prohibited from soliciting, initiating or knowingly encouraging, inducing or facilitating the communication, making, submitting or announcing any acquisition proposal or acquisition inquiry or taking any action that could reasonably be expected to lead to an acquisition proposal or

 

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acquisition inquiry, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “The Acquisition Agreement—Non-Solicitation” beginning on page 87 of this proxy statement.

Certain provisions of the Acquisition Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Acquisition Agreement.

The terms of the Acquisition Agreement prohibit each of Eliem and Tenet from soliciting competing proposals or cooperating with persons making unsolicited acquisition proposals, except, in the case of Eliem, in limited circumstances as described in further detail in the section titled “The Acquisition Agreement—Non-Solicitation” beginning on page 87 of this proxy statement. In addition, if the Acquisition Agreement is terminated under specified circumstances, Eliem would be required to pay Tenet a termination fee of $1,000,000 and reimburse Tenet’s transaction-related expenses up to a maximum of $500,000. These payments may discourage third parties from submitting competing proposals to Eliem or its stockholders and may cause the Eliem Board to be less inclined to recommend a competing proposal.

Because the lack of a public market for Tenet common stock makes it difficult to evaluate the fair market value of Tenet’s common stock, the value of Eliem common stock to be issued to Tenet stockholders in connection with the Acquisition may be more or less than the fair market value of Tenet common stock.

The outstanding common stock of Tenet is privately held and is not traded in any public market. The lack of a public market makes it difficult to determine the fair market value of Tenet common stock. Because the percentage of Eliem’s equity to be issued to Tenet stockholders in the Acquisition was determined based on negotiations between the parties, it is possible that the value of Eliem common stock to be issued to Tenet stockholders in connection with the Acquisition will be more or less than the fair market value of Tenet common stock.

Eliem and Tenet may become involved in securities litigation or stockholder derivative litigation in connection with the Acquisition, the Private Placement and the other transactions contemplated by the Acquisition Agreement, and this could divert the attention of Eliem’s and Tenet’s management and harm Post-Closing Eliem’s business.

Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or announcement of an acquisition or a business combination transaction. Eliem and Tenet may become involved in this type of litigation in connection with the Acquisition, the Private Placement and the other transactions contemplated by the Acquisition Agreement, and Post-Closing Eliem may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect the business of Eliem, Tenet and Post-Closing Eliem.

Risks Related to Eliem

For risks related to the business of Eliem, please refer to the section titled “Item 1A. Risk Factors” set forth in Eliem’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 28, 2024 (the “2023 Annual Report”), and the section titled “Item 1A. Risk Factors” set forth in Eliem’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 (the “Q1 Quarterly Report”), as filed with the SEC on May 15, 2024, which sections are incorporated by reference herein.

 

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Risks Related to Tenet

Risks Related to Tenet’s Development of TNT119

There may be substantial delays in conducting future clinical trials of TNT119 in Tenet’s intended indications or TNT119 may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining marketing approval from regulatory authorities for the sale of TNT119, Tenet must collect sufficient safety and efficacy data from preclinical studies and conduct extensive clinical trials of TNT119 for its intended indications. Clinical testing is expensive, time-consuming and uncertain as to outcome. Tenet cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

 

   

inadequacy of or changes in Tenet’s manufacturing process or formulation of TNT119;

 

   

delays in reaching a consensus with regulatory authorities on trial design, including the planned investigational new drug application (“IND”) submission for TNT119 for systemic lupus erythematosus (“SLE”) and immune thrombocytopenia (“ITP”) and the potential for a delay in initiation of the related Phase 2 studies of TNT119 for SLE and ITP and any preclinical or nonclinical studies required in support of an IND submission for TNT119;

 

   

delays in enrolling patients in clinical trials;

 

   

delays in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites;

 

   

delays in opening clinical trial sites or obtaining required institutional review board (“IRB”) or independent ethics committee approval at each clinical trial site;

 

   

delays in recruiting suitable subjects to participate in Tenet’s clinical trials, including because such trials have restrictive eligibility criteria or may be controlled trials and patients are not guaranteed to receive TNT119, or as a result of alternative therapies or competing trials;

 

   

failure by Tenet, any CROs it engages or any other third parties to adhere to clinical trial requirements;

 

   

failure to perform in accordance with good clinical practices (“GCPs”), or applicable regulatory guidelines in other countries;

 

   

delays in the testing, validation, manufacturing and delivery of TNT119 to the clinical sites, including delays by third parties with whom Tenet has contracted to perform certain of those functions;

 

   

delays in subjects completing participation in a trial or returning for post-treatment follow-up;

 

   

clinical trial sites or subjects dropping out of a trial;

 

   

selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data;

 

   

imposition of a clinical hold by regulatory authorities as a result of a serious adverse event, or after an inspection of Tenet’s clinical trial operations, trial sites or manufacturing facilities or otherwise;

 

   

occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors;

 

   

delays as a result of public health crises, or from the outbreak of another pandemic or contagious disease or other global instability could delay the initiation or rate of completion of any clinical trial; or

 

   

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

 

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In addition, the U.S. Food and Drug Administration’s (“FDA”) and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. If Tenet is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, its development plans may be impacted. Tenet’s product development costs will increase if it experiences delays in testing or marketing approvals. In addition, if Tenet makes manufacturing or other changes to TNT119, Tenet may need to conduct additional studies to bridge such new formulation of TNT119 to earlier versions. For example, Tenet expects it will need to conduct additional non-clinical studies of TNT119 to bridge its new planned formulation of TNT119 to its earlier formulation. Tenet does not know whether any of its clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Tenet may also determine to change the design or protocol of one or more of its clinical trials, which could result in delays. Significant clinical trial delays with respect to TNT119 could also shorten any periods during which Tenet may have the exclusive right to commercialize TNT119 or allow its competitors to bring products to market before Tenet does and impairs its ability to successfully commercialize TNT119.

Tenet may find it difficult to enroll and/or retain patients in its future clinical trials, which could delay or prevent Tenet from proceeding with clinical trials and its clinical development activities.

Tenet may not be able to initiate or continue its planned clinical trials on a timely basis or at all if it is unable to recruit and enroll a sufficient number of eligible patients to participate in these trials through completion of such trials as required by the FDA or other comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. Tenet’s ability to enroll eligible patients may be limited or may result in slower enrollment than it anticipates. There may be limited patient pools from which to draw for clinical studies. Patient enrollment for Tenet’s current or any future clinical trials may be affected by other factors, including:

 

   

the patient eligibility criteria defined in the protocol;

 

   

the size of the patient population required for analysis of the trial’s primary endpoints;

 

   

the proximity of patients to trial sites;

 

   

the design of the trial;

 

   

the availability and efficacy of approved drugs for the disease under investigation;

 

   

perceived risks and benefits of the product candidate under study;

 

   

Tenet’s ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

   

competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications that Tenet is investigating;

 

   

Tenet’s ability to obtain and maintain patient consents;

 

   

patient referral practices of physicians;

 

   

the ability to monitor patients adequately during and after treatment;

 

   

proximity and availability of clinical trial sites for prospective patients; and

 

   

the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion.

In addition, Tenet’s clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as TNT119, and this competition would reduce the number and types of patients available to Tenet because some patients who might have opted to enroll in Tenet’s clinical trials may instead opt to enroll in a clinical trial being conducted by one of its competitors. Since the number of qualified clinical investigators is limited, Tenet expects to conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which will reduce the number of patients who are available for Tenet’s clinical trials in such clinical trial site.

 

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Tenet’s inability to enroll a sufficient number of patients for its clinical trials would result in significant delays or might require it to abandon one or more clinical trials altogether. Delays in patient enrollment may result in increased costs, affect the timing or outcome of the planned clinical trials, product candidate development and approval process and jeopardize Tenet’s ability to seek and obtain the regulatory approval required to commence product sales and generate revenue, which could prevent completion of these trials, adversely affect Tenet’s ability to advance the development of TNT119, cause the value of its company to decline and limit its ability to obtain additional financing if needed. Furthermore, even if Tenet is able to enroll a sufficient number of patients for its clinical trials, it may have difficulty maintaining participation in its clinical trials through the treatment and any follow-up periods.

Tenet is also required to register certain clinical trials and post the results of completed clinical trials on a government-sponsored database, such as www.ClinicalTrials.gov in the United States, within certain time frames. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Preliminary, initial, or interim results from clinical trials that Tenet announces, presents, or publishes from time to time may change as more data and information become available (or are updated based upon audit, validation and verification procedures of the data/information commonly performed for clinical trials) that could result in material changes in the final trial results.

From time to time, Tenet may announce, present or publish preliminary, initial, or interim data or other information from its clinical trials, such as the preliminary data from the Phase 1b clinical trial of TNT119 for the treatment of membranous nephropathy (“MN”). Any such data and other results from Tenet’s clinical trials may materially change as more patient data and information become available. Such data and information may also undergo significant change following subsequent auditing, validation and/or verification procedures that are commonly conducted in clinical trials. Thus, any preliminary, initial, or interim data or other information may not be predictive of final results from the clinical trial and should be viewed with caution until the final data are available. Tenet may also arrive at different conclusions, or other determinations that may qualify such results, once it has received and fully evaluated the additional data. Differences between preliminary, initial or interim results and final results could lead to significantly different interpretations or conclusions of the trial outcomes.

Further, others, including regulatory authorities and collaboration or regional partners, may not accept or agree with Tenet’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of TNT119, the approvability or commercialization of TNT119, and Tenet, in general. In addition, the information Tenet chooses to publicly disclose regarding a particular clinical trial is based on what is typically extensive information, and investors may not agree with what Tenet determines is material or otherwise appropriate information to publicly disclose.

If the preliminary, initial or interim data that Tenet reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Tenet’s ability to obtain approval for, and commercialize TNT119 may be harmed, which could significantly harm Tenet’s reputation, business, results of operations, financial condition and prospects.

TNT119 may cause adverse events and/or undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit its commercial potential or result in significant negative consequences following any potential marketing approval.

Certain adverse events and undesirable side effects caused by TNT119 could cause Tenet or regulatory authorities to interrupt, delay or pause clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. If undesirable side effects do occur in Tenet’s clinical trials, they could cause delay or even discontinuance of further development of TNT119, which would impair Tenet’s ability to generate revenues and would have a material adverse effect on its business, results of operations, financial condition and cash flows and future prospects.

 

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As a result of undesirable side effects or further safety issues that Tenet may experience in its clinical trials in the future, it may not receive approval to market TNT119, which could prevent it from ever generating revenues or achieving profitability. Results of trials could reveal an unacceptably high severity and prevalence of side effects. In such an event, clinical trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order Tenet to cease further development of, or deny approval of, TNT119 for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any of these occurrences may have a material adverse effect on Tenet’s business, results of operations, financial condition and cash flows and future prospects.

Additionally, even if TNT119 receives marketing approval, if Tenet or others later identify undesirable side effects caused by TNT119, a number of potentially significant negative consequences could result, including:

 

   

Tenet may suspend or be forced to suspend marketing of TNT119;

 

   

regulatory authorities may suspend, vary or withdraw their approvals of TNT119;

 

   

Tenet may be obliged to conduct a product recall or product withdrawal;

 

   

regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of TNT119;

 

   

the FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about TNT119;

 

   

the FDA may require the establishment or modification of a Risk Evaluation and Mitigation Strategy (“REMS”) or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, restrict distribution of TNT119 and impose burdensome implementation requirements on Tenet;

 

   

Tenet may be required to change the way TNT119 is administered or conduct additional post-marketing clinical trials;

 

   

Tenet could be sued and held liable for harm caused to subjects or patients;

 

   

Tenet could be required to pay fines and face other administrative, civil and criminal penalties;

 

   

Tenet may be subject to litigation or product liability claims; and

 

   

Tenet’s reputation may suffer.

Any of these events could prevent Tenet from achieving or maintaining market acceptance of the particular product candidate, if approved.

Tenet faces significant competition in an environment of rapid technological change, and there is a possibility that its competitors may achieve regulatory approval before it or develop therapies that are safer, less expensive or more advanced or effective than Tenet, which may harm its financial condition and its ability to successfully market or commercialize TNT119.

The development and commercialization of new drug products is highly competitive. Moreover, the immunology and inflammation field is characterized by rapidly changing technologies, significant competition, and a strong emphasis on intellectual property. Tenet will face competition with respect to TNT119 from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for development, manufacturing, and commercialization.

 

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There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which Tenet is developing TNT119. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to Tenet’s approach, and others are based on entirely different approaches.

Companies developing biologics and other modalities include Roche Holding AG (currently markets Rituxan (rituximab), which is used for a broad number of autoimmune diseases), Amgen (UPLINZA (inebilizumab) for the treatment of neuromyelitis optica spectrum disorder) and Ocrevus (ocrelizumab for the treatment of multiple sclerosis), each of which target CD20 on B cells), and others who have biologics aimed at other targets relevant to autoimmune diseases, including, for example, AbbVie, Johnson & Johnson, Bristol Myers Squibb and Novartis.

If Tenet successfully develops and commercializes TNT119, it will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which Tenet may obtain approval for TNT119. This may include other types of therapies, such as small molecule, chimeric antigen receptor T cells (“CAR-T”), antibody, and/or protein therapies.

Many of Tenet’s current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise than it does in research and development, manufacturing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products. Mergers and acquisitions in the pharmaceutical, biotechnology, and gene therapy industries may result in even more resources being concentrated among a smaller number of Tenet’s competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Tenet in recruiting and retaining qualified scientific and management consultants and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Tenet’s programs. Tenet’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than TNT119 or that would render TNT119 obsolete or non-competitive. Tenet’s competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than Tenet may obtain approval for TNT119, which could result in its competitors establishing a strong market position before Tenet is able to enter the market. Additionally, technologies developed by Tenet’s competitors may render TNT119 uneconomical or obsolete, and Tenet may not be successful in marketing TNT119 against competitors.

In addition, as a result of the expiration or successful challenge of Tenet’s patent rights, Tenet could face more litigation with respect to the validity and/or scope of patents relating to its competitors’ products. The availability of Tenet’s competitors’ products could limit the demand, and the price Tenet is able to charge, for TNT119.

Tenet’s estimates of market opportunity and forecasts of market growth for TNT119 may prove to be inaccurate, and even if the markets in which Tenet compete achieve the forecasted growth, its business may not grow at similar rates, or at all.

Tenet’s market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates which may not prove to be accurate. Tenet currently focuses its research and product development on TNT119 for the treatment of MN, ITP and SLE. Tenet’s understanding of the patient populations with these diseases is based on estimates in published literature. These estimates, and Tenet’s estimates and forecasts relating to size and expected growth based on these estimates, may prove to be incorrect and new studies may reduce the estimated incidence or prevalence of these diseases. The number of patients in the United States and elsewhere may turn out to be lower than expected, patients may not be otherwise amenable to treatment with TNT119 or patients may become increasingly difficult to identify and access. Even if the patient populations meet Tenet’s size estimates and growth forecasts, its business may not grow at similar rates, or at all. Tenet’s growth is subject to many factors, including its success in implementing its business strategy, which is subject to many risks and uncertainties.

 

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Tenet’s revenue will be dependent, in part, upon the size of the markets in the territories for which Tenet gains regulatory approval, the accepted price for TNT119, the ability to obtain coverage and reimbursement, the ability to gain market share and whether Tenet owns the commercial rights for that territory. If the number of its addressable patients is not as significant as Tenet estimates, the indication approved by regulatory authorities is narrower than Tenet expects or the treatment population is narrowed by competition, physician choice or treatment guidelines, Tenet may not generate significant revenue from sales of TNT119, even if approved.

Further, there are several factors that could contribute to making the actual number of patients who receive TNT119 less than the potentially addressable market. These include the lack of widespread availability of, and limited reimbursement for, new therapies in many underdeveloped markets.

Tenet has no experience in sales, marketing and distribution and may have to enter into agreements with third parties to perform these functions, which could prevent it from successfully commercializing TNT119.

Tenet currently has no sales, marketing or distribution capabilities. To commercialize TNT119, Tenet must either develop its own sales, marketing and distribution capabilities or make arrangements with third parties to perform these services for it. If Tenet decides to market or distribute TNT119 on its own, it will have to commit significant resources to developing a marketing and sales force and supporting distribution capabilities. If Tenet decides to enter into arrangements with third parties for performance of these services, it may find that they are not available on terms acceptable to it, or at all. If Tenet is not able to establish and maintain successful arrangements with third parties or build its own sales and marketing infrastructure, it may not be able to commercialize TNT119, which would adversely affect its business, results of operations, financial condition and cash flows and prospects.

Tenet expects to expand its clinical development, manufacturing and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, it may encounter difficulties in managing its growth, which could disrupt its operations.

As of the date of this proxy statement, Tenet had no full-time employees. Tenet’s research and development and professional services functions, including the services of Tenet’s executive officers, are currently performed pursuant to a services agreement with Sera Services, Inc. (“Sera Services”). For more information about Tenet’s relationship with Sera Services, see the section titled “Certain Relationships and Related Party Transactions–Certain Relationships of Tenet–Relationship with Sera Services, Inc.” beginning on page 169 of this proxy statement. As Tenet’s development progresses, it expects to experience significant growth in the number of its employees and consultants and the scope of its operations, particularly in the areas of clinical product development, regulatory affairs and, if TNT119 receives marketing approval, sales, marketing and distribution. To manage Tenet’s anticipated future growth, it must continue to implement and improve its managerial, operational and financial systems, expand its facilities and continue to recruit and train additional qualified personnel. There is intense competition for qualified personnel in the technical fields in which Tenet operates and Tenet may not be able to attract and retain qualified personnel necessary for the successful development and future commercialization, if any, of TNT119.

Due to Tenet’s limited financial resources and the limited experience of its management team in managing a company with such anticipated growth, Tenet may not be able to effectively manage the expansion of its operations or recruit and train additional qualified personnel. Tenet’s choice to focus on multiple therapeutic areas may negatively affect its ability to develop adequately the specialized capability and expertise necessary for operations. The expansion of Tenet’s operations may lead to significant costs and may divert its management and business development resources. Any inability to manage growth could delay the execution of Tenet’s business plans or disrupt its operations.

 

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Risks Related to Regulatory Matters

Tenet has received orphan drug designation for TNT119 for the treatment of MN, but it may be unable to realize the benefits associated with orphan drug designation, including market exclusivity.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. In order to obtain orphan drug designation, the request must be made before submitting a biologics license application (“BLA”). In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval of that particular product for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic (meaning, a product with the same principal molecular structural features) for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if TNT119 receives orphan exclusivity, the FDA can still approve other biologics that do not have the same principal molecular structural features for use in treating the same indication or disease or the same biologic for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity if Tenet is unable to manufacture sufficient supply of TNT119 or if a subsequent applicant demonstrates clinical superiority over TNT119.

The FDA granted orphan drug designation to TNT119 for the treatment of MN. Tenet may seek orphan drug designation for TNT119 in other specific orphan indications in which there is a medically plausible basis for the use of TNT119 but may never receive such designations. In addition, even with orphan drug designation, exclusive marketing rights in the United States may be limited if Tenet seeks approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if Tenet is unable to assure sufficient quantities of TNT119 to meet the needs of patients with the rare disease or condition, or if a subsequent applicant demonstrates clinical superiority over TNT119, if approved.

Tenet plans to conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject Tenet to additional delays and expense.

Tenet plans to conduct one or more clinical trials with one or more trial sites that are located outside the United States. The acceptance by the FDA or other regulatory authorities of trial data from clinical trials conducted outside their jurisdiction may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.

 

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In addition, even where the foreign trial data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the trial is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the trial through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that Tenet may develop not receiving approval for commercialization in the applicable jurisdiction.

Conducting clinical trials outside the U.S. will also expose Tenet to additional risks, including risks associated with:

 

   

additional foreign regulatory requirements;

 

   

foreign exchange fluctuations;

 

   

compliance with foreign manufacturing, customs, shipment and storage requirements;

 

   

cultural differences in medical practice and clinical research;

 

   

diminished protection of intellectual property in some countries; and

 

   

interruptions or delays in Tenet’s trials resulting from geopolitical events, such as war or terrorism.

Tenet’s failure to obtain regulatory approval in foreign jurisdictions would prevent Tenet from marketing TNT119 or any potential future product candidates outside the U.S.

If Tenet succeeds in developing TNT119, it intends to market TNT119 in foreign jurisdictions in addition to the U.S. In order to market and sell products in other jurisdictions, Tenet must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the U.S. generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the U.S., Tenet must secure product pricing and reimbursement approvals before regulatory authorities will approve the product for sale in that country. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Tenet and could delay or prevent the introduction of TNT119 in certain countries. Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries and regulatory approval in one country does not ensure approval in any other country, while a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory approval process in others. If Tenet fails to obtain approval of TNT119 or any potential future product candidates by regulatory authorities in another country, Tenet will be unable to commercialize its products in that country, and the commercial prospects of that product candidate and Tenet business prospects could decline. In addition, failure to obtain regulatory approval in one country or region could adversely affect future regulatory approvals in other countries.

Risks Related to Tenet’s Dependence on Third Parties

Tenet relies on third parties to conduct its clinical trials and development activities and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

Tenet relies on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, and Tenet expects to rely on third parties to help conduct its Phase 2 clinical trials of TNT119 for the treatment of SLE and ITP. Any of these third parties may terminate their engagements with Tenet at any time under certain criteria. If Tenet needs to enter into alternative arrangements, it may delay its product development activities for TNT119.

 

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Tenet’s reliance on these third parties to conduct its future clinical trials will reduce its control over these activities but will not relieve Tenet of its responsibilities. For example, Tenet will remain responsible for ensuring that each of its clinical trials is conducted in accordance with the general investigational plan and protocols for the clinical trial. Moreover, the FDA and other regulatory authorities require Tenet to comply with GCPs for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Moreover, Tenet’s business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Although Tenet may design potential clinical trials for TNT119, CROs will conduct some or all of the clinical trials. As a result, many important aspects of its development program for TNT119, including its conduct and timing, will be outside of Tenet’s direct control. Tenet’s reliance on third parties to conduct future clinical trials for TNT119 will also result in less direct control over the management of data developed through such clinical trials than would be the case if Tenet was relying entirely upon its own staff. Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

Third parties may:

 

   

have staffing difficulties;

 

   

fail to comply with contractual obligations;

 

   

experience regulatory compliance issues;

 

   

undergo changes in priorities or become financially distressed; or

 

   

form relationships with other entities, some of which may be Tenet’s competitors.

These factors may materially and adversely affect the willingness or ability of third parties to conduct future clinical trials for Tenet and may subject Tenet to unexpected cost increases that are beyond Tenet’s control. If CROs and other third parties that Tenet contracts with do not perform future clinical trials in a satisfactory manner, breach their obligations to Tenet or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of TNT119 may be delayed, Tenet may not be able to obtain regulatory approval and commercialize TNT119. If Tenet is unable to rely on clinical data collected by its CROs and other third parties, Tenet could be required to repeat, extend the duration of, or increase the size of its clinical trials and this could significantly delay commercialization and require greater expenditures, which could have a material adverse effect on its business, result of operations, financial condition and cash flows, and future prospects.

Tenet also expects to rely on third parties to store and distribute drug supplies for its clinical trials. Any performance failure on the part of its distributors could delay any potential clinical development or marketing approval of TNT119 or commercialization, producing additional losses and depriving Tenet of potential product revenue.

Tenet contracts with third parties for the manufacture of materials and expects to continue to do so for its clinical trials and for commercialization of TNT119. This reliance on third parties increases the risk that Tenet will not have sufficient quantities of such materials or that such supply will not be available to Tenet at an acceptable cost or timelines, which could delay, prevent, or impair its development or commercialization efforts.

Tenet does not have any manufacturing facilities. Tenet currently relies and expects to continue to rely on third party manufacturers for the manufacture of TNT119 for nonclinical and clinical testing and for commercial supply of TNT119, if approved.

 

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Tenet may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms for one or more of its material needs. Even if Tenet is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 

   

the possible failure of the third party to manufacture TNT119 according to Tenet’s schedule, or at all, including if the third party gives greater priority to the supply of other products over TNT119 or otherwise do not satisfactorily perform according to the terms of the agreements between Tenet and them;

 

   

the possible breach of the manufacturing agreement by the third party;

 

   

the possible misappropriation of Tenet’s proprietary information, including Tenet’s trade secrets and know-how;

 

   

the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for Tenet; and

 

   

reliance on the third party for regulatory compliance, quality assurance, safety, and pharmacovigilance and related reporting.

Although Tenet plans to design the clinical trials for TNT119, Tenet anticipates that third parties will conduct all of its clinical trials. As a result, many important aspects of Tenet’s clinical development will be outside of its direct control. Tenet’s reliance on third parties to conduct clinical trials will also result in less direct control over the management of data developed through clinical trials than would be the case if it were relying entirely upon its own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may have staffing difficulties, fail to comply with contractual obligations, experience regulatory compliance issues, and form relationships with other entities, some of which may be Tenet’s competitors. These factors may materially adversely affect the willingness or ability of third parties to conduct Tenet’s clinical trials and may subject it to unexpected cost increases that are beyond its control.

Any performance failure on the part of Tenet’s existing or future manufacturers could delay any potential clinical development or marketing approval. Tenet does not currently have arrangements in place for redundant supply for bulk drug substances. If any one of its current contract manufacturers cannot perform as agreed, Tenet may be required to replace that manufacturer, or Tenet may be forced to manufacture the materials itself, for which it may not have the capabilities or resources, or enter into an agreement with a different third-party manufacturer, which Tenet may not be able to do on reasonable terms, if at all. In either scenario, Tenet’s clinical trials supply could be delayed significantly as it establishes alternative supply sources. In some cases, the technical skills required to manufacture TNT119 may be unique or proprietary to the original third-party manufacturer and Tenet may have difficulty, or there may be contractual restrictions prohibiting Tenet from, transferring such skills to a back-up or alternate supplier, or Tenet may be unable to transfer such skills at all. In addition, if Tenet is required to change third-party manufacturers for any reason, Tenet will be required to verify that the new third-party manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations. Tenet will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce TNT119 according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new third-party manufacturer could negatively affect its ability to develop or commercialize TNT119 in a timely manner or within budget. Furthermore, a third-party manufacturer may possess technology related to the manufacture of TNT119 that such third-party manufacturer owns independently. This would increase Tenet’s reliance on such third-party manufacturer or require Tenet to obtain a license from such third-party manufacturer in order to have another third-party manufacturer manufacture TNT119. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that Tenet conduct bridging studies between its prior clinical supply used in its clinical trials and that of any new manufacturer. Tenet may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.

 

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Tenet’s current and anticipated future dependence upon others for the manufacture of TNT119 may adversely affect its future expenses and its ability to commercialize TNT119, if it receives marketing approval, on a timely and competitive basis.

Tenet plans to rely on third parties to conduct certain clinical trials for TNT119. If these third parties do not successfully comply with regulatory requirements, Tenet’s development program may be delayed or subject to increased costs and Tenet may not be able to obtain regulatory approval for, or commercialize, TNT119, which would have an adverse effect on Tenet’s business and prospects.

Tenet has relied upon and plans to continue to rely upon third parties, including independent investigators, medical institutions, CROs, and strategic partners, to help conduct certain of Tenet’s clinical trials, including its upcoming Phase 2 clinical trials of TNT119 for the treatment of SLE and ITP. Tenet expects to rely on these parties for execution of its clinical trials, and only control certain aspects of their activities. Nevertheless, Tenet is responsible for ensuring that each of its clinical trials are conducted in accordance with the applicable protocol, legal and regulatory requirements, and scientific standards, and its reliance on these third parties will not relieve Tenet of its regulatory responsibilities. For any violations of laws and regulations during the conduct of its clinical trials, Tenet could be subject to untitled and warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.

Tenet, and any third parties that Tenet contracts with, is required to comply with regulations and requirements, including good laboratory practices (“GLP”), GCP, for conducting, monitoring, recording, and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the patients in the trials are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the European Medicines Agency, and comparable foreign regulatory authorities for any drugs in clinical development. The FDA and other foreign regulatory authorities enforce GLP and GCP requirements through periodic inspections of laboratories conducting GLP studies, clinical trial sponsors, principal investigators, and trial sites. If Tenet or the third parties Tenet contracts with fail to comply with applicable GLP and GCP requirements, the data generated in Tenet’s clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Tenet to perform additional clinical trials before approving its marketing applications. Despite oversight of Tenet’s vendors and clinical trial sites, regulatory authorities may still find issues of compliancy with applicable GLP or GCP regulations. In addition, Tenet’s clinical trials must be conducted with product candidates produced under good manufacturing practice (“cGMP”) regulations or similar regulatory requirements outside the United States. Tenet’s failure, or the failure of its third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on Tenet, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocations, seizures or recalls of product candidates, operating restrictions, and criminal prosecutions, any of which could significantly and adversely affect supplies of Tenet’s products and harm its business, results of operations, financial condition and prospects. Any products that Tenet may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of suppliers or manufacturers that operate under cGMP regulations and that might be capable of manufacturing for Tenet.

If Tenet’s CROs fail to comply with regulatory requirements, the development, regulatory approval, and commercialization of TNT119 may be delayed, Tenet may not be able to obtain regulatory approval and commercialize TNT119, or Tenet’s development program may be materially and irreversibly harmed. Additionally, if any of Tenet’s relationships with these third party CRO’s terminate, it may not be able to enter into arrangements with alternative CROs on commercially reasonable terms, or at all.

In addition, principal investigators for Tenet’s clinical trials may serve as scientific advisors or consultants to Tenet from time to time and receive compensation in connection with such services. Under certain circumstances, Tenet may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities may conclude that a financial relationship between Tenet and a principal investigator has created a conflict of interest or otherwise affected

 

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interpretation of the clinical trial. The FDA or comparable foreign regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of Tenet’s marketing applications by the FDA or comparable foreign regulatory authorities and may ultimately prevent Tenet from commercializing TNT119.

If Tenet or any contract manufacturers and suppliers it engages fail to comply with environmental, health, and safety laws and regulations, Tenet could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.

Tenet and any contract manufacturers and suppliers it engages are subject to numerous federal, state, and local environmental, health, and safety laws, regulations, and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment, and disposal of hazardous and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air, and water; and workplace health and safety. Under certain environmental laws, Tenet could be held responsible for costs relating to any contamination at third-party facilities. Tenet also could incur significant costs associated with civil or criminal fines and penalties.

Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair its research and product development efforts. Tenet does not carry specific biological or hazardous waste insurance coverage, and its property, casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, Tenet could be held liable for damages or be penalized with fines in an amount exceeding its resources, and its clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on its business, results of operations, financial condition, and prospects.

In addition, Tenet may incur substantial costs in order to comply with current or future environmental, health, and safety laws, regulations, and permitting requirements. These current or future laws, regulations, and permitting requirements may impair its development, or production efforts. Failure to comply with these laws, regulations, and permitting requirements also may result in substantial fines, penalties, or other sanctions or business disruption, which could have a material adverse effect on its business, results of operations, financial condition, and prospects.

Any third-party contract manufacturers and suppliers Tenet engages will also be subject to these and other environmental, health, and safety laws and regulations. Liabilities they incur pursuant to these laws and regulations could result in significant costs or an interruption in operations, which could have a material adverse effect on Tenet’s business, results of operations, financial condition, and prospects.

Tenet may not have access to the raw materials and other components necessary for the manufacturing of TNT119.

Tenet is dependent on third parties for the supply of various materials that are necessary to produce TNT119 for its clinical trials and does not have any supply agreements currently in place. Even when Tenet has supply agreements, it is possible that the supply may be reduced or interrupted at any time. In such case, Tenet may not be able to find other suppliers of acceptable materials in appropriate quantities at an acceptable cost. If Tenet loses key suppliers or the supply of materials is diminished or discontinued, it may not be able to continue to develop, manufacture and market TNT119 in a timely and competitive manner. In addition, these materials are subject to stringent manufacturing processes and rigorous testing. Delays in the completion and validation of facilities and manufacturing processes of these materials could adversely affect Tenet’s ability to complete trials and commercialize Tenet’s products in a cost-effective and timely manner. If Tenet encounters difficulties in the supply of these materials or other necessary products, or if it is not able to maintain its supply agreements or establish new supply agreements in the future or incur increased production costs as a result of any of the foregoing, Tenet’s product development and business prospects could be significantly compromised.

 

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Tenet relies heavily on certain in-licensed patents and other intellectual property rights in connection with its development of TNT119 and may be required to acquire or license additional patents or other intellectual property rights to continue to develop and commercialize TNT119.

Tenet relies heavily on patents, know-how and other intellectual property licensed from others. Tenet is party to a license agreement with Cancer Research Technology Limited (“CRH”), under which it is granted rights to intellectual property that are important to its business. Additionally, Tenet may need to acquire or license intellectual property rights from additional third parties in order to continue to develop or commercialize TNT119. Any future license agreements where Tenet in-licenses intellectual property may impose on it various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations. If Tenet fails to comply with any of the obligations under such license agreements, including payment terms and diligence terms, the licensors may have the right to terminate its agreements, in which case Tenet may lose important intellectual property rights and it may not be able to develop, manufacture, market or sell TNT119 or may face other penalties under such agreements or be subject to litigation for breach of these agreements. In addition, such a termination could result in the licensor reacquiring the intellectual property rights and subsequently enabling a competitor to access the technology. Any such occurrence could materially adversely affect the value of TNT119. Termination of license agreements or reduction or elimination of Tenet’s rights under them may result in Tenet having to negotiate a new or reinstated agreement, which may not be available on equally favorable terms, or at all, which may mean Tenet is unable to develop or commercialize TNT119. For instance, these licenses may not provide exclusive rights to use the subject intellectual property and technology in all relevant fields of use and in all territories in which Tenet may wish to develop or commercialize Tenet’s technology and TNT119 in the future, such as provisions under the license agreement with CRH prohibiting Tenet from developing TNT119 for oncology indications. In that event, Tenet may be required to expend significant time and resources to redesign its technology or the methods for manufacturing or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

Further, the agreements under which Tenet currently licenses, and may license in the future, intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. Accordingly, material disputes may arise between Tenet and its licensor, regarding intellectual property subject to such license agreement, including those relating to:

 

   

the scope of rights, if any, granted under the license agreement and other interpretation-related issues;

 

   

the scope and practice of any rights reserved by its licensors;

 

   

whether its licensor had the right to grant the license agreement;

 

   

whether third parties are entitled to compensation or equitable relief, such as an injunction, for Tenet’s use of the intellectual property without their authorization;

 

   

its right to sublicense patent and other rights to third parties under collaborative development relationships;

 

   

whether Tenet is complying with its obligations with respect to the use of the licensed technology in relation to Tenet’s development and commercialization of TNT119;

 

   

its involvement in the prosecution of the licensed patents and its licensors’ overall patent enforcement strategy;

 

   

the allocation of ownership of inventions and know-how resulting from the creation or use of intellectual property by Tenet’s licensors and by Tenet and its partners, including jointly developed intellectual property; and

 

   

the amounts of royalties, milestones or other payments due under the license agreement.

The resolution of any contract interpretation disagreement that may arise could narrow what Tenet believes to be the scope of its rights to the relevant intellectual property or technology, increase what it believes to be its financial or other obligations under the relevant agreement, or decrease the financial or other benefits it might

 

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otherwise receive under the relevant agreement. If material disputes over intellectual property that Tenet has licensed prevent or impair its ability to maintain licensing arrangements on acceptable terms or are insufficient to provide it the necessary rights to use the intellectual property, it may be unable to successfully develop and commercialize TNT119. If Tenet or any such licensors fail to adequately protect the relevant in-licensed intellectual property, Tenet’s ability to commercialize TNT119 could suffer. Any material disputes with licensors or any termination of the licenses on which Tenet depends could have a material adverse effect on its business, results of operations, financial condition and prospects.

Tent relies on third parties from whom Tenet licenses proprietary technology to file and prosecute patent applications and maintain patents and otherwise protect the intellectual property it licenses from them. For example, under the license agreement with CRH, CRH is responsible for prosecuting and maintaining intellectual property protection for TNT119 in consultation with Tenet. Tenet has limited control over these activities or any other intellectual property that may be related to Tenet’s in-licensed intellectual property. For example, Tenet cannot be certain that such activities by CRH or other licensors will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights. Tenet has limited control over the manner in which CRH or Tenet’s other licensors may initiate an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual property that may be licensed to Tenet. It is possible that CRH or Tenet’s other licensors infringement proceeding or defense activities may be less vigorous than if Tenet conducts them itself.

Risks Related to Tenet’s Intellectual Property

Tenet’s success depends on its ability to protect its intellectual property for TNT119.

Tenet’s commercial success depends in part on its ability to obtain and maintain patent protection and trade secret protection for TNT119, its proprietary technologies and their uses, its ability to operate without infringing the proprietary rights of others, and its and its licensors’ ability to successfully defend its patents, including those that it has in-licensed, against third-party challenges. If Tenet or its licensors are unable to protect its intellectual property rights or if its intellectual property rights are inadequate for its technology or TNT119, its competitive position could be harmed.

Tenet and its licensors generally seek to protect its proprietary position by filing patent applications in the United States and outside of the United States related to TNT119, its proprietary technologies and their uses that are important to its business. Tenet’s or its licensors’ patent applications, including those that Tenet has in-licensed, cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. There can be no assurance that Tenet’s or its licensors’ patent applications will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents, if issued, will be infringed or will not be designed around, invalidated or rendered unenforceable by third parties. Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for Tenet’s proprietary rights is uncertain. Only limited protection may be available and may not adequately protect Tenet’s rights or permit Tenet to gain or keep any competitive advantage. These uncertainties and/or limitations in Tenet’s and its licensors’ ability to properly protect the intellectual property rights relating to TNT119 could have a material adverse effect on its results of operations and financial condition.

Although Tenet licenses issued patents in the United States and ex-U.S. countries, it cannot be certain that the claims in its other U.S. pending patent applications, corresponding international patent applications and patent applications in certain ex-U.S. countries will be considered patentable by the United States Patent and Trademark Office (“USPTO”) courts in the United States or by the patent offices and courts in ex-U.S. countries, nor can it be certain that the claims in its issued patents will not be found invalid or unenforceable if challenged.

 

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The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that Tenet or its licensors or any of its potential future collaborators will be successful in TNT119 by obtaining and defending patents. These risks and uncertainties include the following:

 

   

the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;

 

   

patent applications may not result in any patents being issued;

 

   

patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

 

   

Tenet’s competitors, many of whom have substantially greater resources than Tenet or its licensors do and many of whom have made significant investments in competing technologies, may seek, may have filed patent applications, or may have already obtained patents that will limit, interfere with or block its ability to make, use and sell TNT119;

 

   

there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and

 

   

countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing ex-U.S. competitors a better opportunity to create, develop and market competing products.

The patent prosecution process is also expensive and time-consuming, and Tenet or its licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that Tenet or its licensors may not identify patentable aspects of its research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, Tenet does not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, directed to technology that it licenses, including those from its licensors. Tenet also may require the cooperation of its licensors in order to enforce the licensed patent rights, and such cooperation may not be provided. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of Tenet’s business. Tenet cannot be certain that patent prosecution and maintenance activities by its licensors have been or will be conducted in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such applications. If they fail to do so, this could cause Tenet to lose rights in any applicable intellectual property that it in-licenses, and as a result its ability to develop and commercialize TNT119 may be adversely affected and it may be unable to prevent competitors from making, using and selling competing products.

In addition, although Tenet enters into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of its research and development output, such as outside scientific collaborators, CROs, contract manufacturing organizations, consultants, advisors, licensors, and other third parties, any of these parties may breach such agreements and publicly disclose such output before a patent application is filed, thereby jeopardizing its ability to seek patent protection.

If Tenet fails to comply with its obligations in the agreements under which it licenses intellectual property rights from its licensors or otherwise experiences disruptions to its business relationships with its licensors, it could lose license rights that are important to its business.

Tenet is a party to a number of license agreements under which it is granted rights to intellectual property that are important to its business and it may enter into additional license agreements in the future.

 

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Tenet’s existing license agreements impose on it, and Tenet expects that any future license agreements where Tenet in-licenses intellectual property will impose on it, various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations. If Tenet fails to comply with its obligations under these agreements, or it is subject to bankruptcy-related proceedings, the licensors may have the right to terminate the licenses, in which event it would not be able to market products covered by the licenses.

Tenet obtained its right to a number of existing license agreements pursuant to its asset purchase agreement with Acelyrin, Inc. (“Acelyrin”) which imposes on Tenet various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations. If Tenet fails to comply with its obligations under the asset purchase agreement, Acelyrin may have the right to re-purchase the obtained asset, including Tenet’s rights to the licenses subject to the asset purchase agreement, in which event Tenet may not be able to market or develop TNT119.

Tenet may need to obtain licenses from third parties to advance its research or commercialize TNT119, and it cannot provide any assurances that third-party patents do not exist that might be enforced against TNT119 in the absence of such a license. Tenet may fail to obtain any of these licenses on commercially reasonable terms, if at all. Even if Tenet is able to obtain a license, it may be non-exclusive, thereby giving its competitors access to the same technologies licensed to it. In that event, Tenet may be required to expend significant time and resources to develop or license replacement technology. If Tenet is unable to do so, it may be unable to develop or commercialize TNT119, which could materially harm its business and the third parties owning such intellectual property rights could seek either an injunction prohibiting its sales, or, with respect to its sales, an obligation on its part to pay royalties and/or other forms of compensation. Licensing of intellectual property is of critical importance to Tenet’s business and involves complex legal, business and scientific issues. Disputes may arise between Tenet and its licensors regarding intellectual property subject to a license agreement, including:

 

   

the scope of rights granted under the license agreement and other interpretation-related issues;

 

   

whether and the extent to which Tenet’s technology and processes infringe intellectual property of the licensor that is not subject to the licensing agreement;

 

   

Tenet’s right to sublicense patents and other rights to third parties;

 

   

Tenet’s diligence obligations with respect to the use of the licensed technology in relation to its development and commercialization of TNT119, and what activities satisfy those diligence obligations;

 

   

Tenet’s right to transfer or assign the license; and

 

   

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Tenet’s licensors and its affiliates and sublicensees and by Tenet and its partners and sublicensees.

If disputes over intellectual property that Tenet has licensed prevent or impair Tenet’s ability to maintain its current licensing arrangements on acceptable terms, it may not be able to successfully develop and commercialize TNT119, which would have a material adverse effect on its business.

If the scope of any patent protection Tenet’s licensors obtain is not sufficiently broad, or if its licensors lose any of the patent protection it licenses, its ability to prevent its competitors from commercializing similar or identical product candidates to TNT119 would be adversely affected.

The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the existence, issuance, scope, validity, enforceability and commercial value of Tenet’s patent rights are highly uncertain. Tenet’s or its licensors’ pending and future patent applications may not result in patents being issued that protect TNT119 or that effectively prevent others from commercializing competitive product candidates.

 

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Moreover, the scope of claims in a patent application can be significantly reduced before any claims in a patent issue, and claim scope can be reinterpreted after issuance. Even if patent applications Tenet licenses currently or in the future issue as patents, they may not issue in a form that will provide it with any meaningful protection, prevent competitors or other third parties from competing with it, or otherwise provide it with any competitive advantage. Any patents that Tenet licenses may be challenged or circumvented by third parties or may be narrowed or invalidated as a result of challenges by third parties. Consequently, Tenet does not know whether TNT119 will be protectable or remain protected by valid and enforceable patents. Tenet’s competitors or other third parties may be able to circumvent its patents by developing similar or alternative technologies or products in a non-infringing manner, which could materially adversely affect its business, results of operations, financial condition and prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and Tenet’s or its licensors’ patents, including those that Tenet has in-licensed, may not cover TNT119 or may be challenged in the courts or patent offices in the United States and abroad. Tenet and its licensors may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review (“PGR”), and inter partes review (“IPR”), or other similar proceedings in the USPTO or ex-U.S. patent offices challenging its patent rights. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to validity of Tenet’s or its licensors’ patents, for example, it cannot be certain that there is no invalidating prior art, of which it or its licensors and the patent examiner were unaware during prosecution. There is no assurance that all potentially relevant prior art relating to Tenet’s or its licensors’ patents and patent applications or those of its licensors has been found. There is also no assurance that there is not prior art of which Tenet or its licensors were or are aware of, but which it does not believe affects the validity or enforceability of a claim in its patents and patent applications or those of its licensors, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, Tenet’s patent rights or in-licensed patent right, and could allow third parties to commercialize TNT119 and compete directly with Tenet, without payment to it. Such loss of in-licensed patent rights, loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable could limit Tenet’s ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of TNT119. Such proceedings also may result in substantial cost and require significant time from Tenet’s scientists and management, even if the eventual outcome is favorable to it. In addition, if the breadth or strength of protection provided by Tenet’s or its licensors’ patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with Tenet to license, develop or commercialize TNT119.

The patent protection and patent prosecution for TNT119 may be dependent on its licensors and third parties.

Tenet or its licensors may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, Tenet may miss potential opportunities to strengthen its patent position. It is possible that defects as to form in the preparation or filing of Tenet’s or its licensors’ patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If Tenet or its licensors, whether current or future, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If Tenet’s licensors are not fully cooperative or disagree with Tenet as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of Tenet’s or its licensors’ patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair Tenet’s ability to prevent competition from third parties, which may have an adverse impact on its business.

As a licensee, Tenet relies on third parties to file and prosecute patent applications and maintain patents and otherwise protect the licensed intellectual property under some of its license agreements. Tenet has not had and

 

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does not have primary control over these activities for certain of its in-licensed patents or patent applications and other intellectual property rights. Tenet cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights. Pursuant to the terms of the license agreements with some of Tenet’s licensors, the licensors may have the right to control enforcement of Tenet’s licensed patents or defense of any claims asserting the invalidity of these patents and even if Tenet is permitted to pursue such enforcement or defense, it will require the cooperation of its licensors. Tenet cannot be certain that its licensors will allocate sufficient resources or prioritize their or Tenet’s enforcement of such patents or defense of such claims to protect its interests in the licensed patents. Even if Tenet is not a party to these legal actions, an adverse outcome could harm its business because it might prevent Tenet from continuing to license intellectual property that it may need to operate its business. If any of Tenet’s licensors or any of Tenet’s future licensors or future collaborators fails to appropriately prosecute and maintain patent protection for patents covering TNT119, its ability to develop and commercialize TNT119 may be adversely affected and it may not be able to prevent competitors from making, using and selling competing products.

In addition, even where Tenet has the right to control patent prosecution of patents and patent applications it has acquired or licensed from third parties, it may still be adversely affected or prejudiced by actions or inactions of its licensors and their counsel that took place prior to it assuming control over patent prosecution.

Tenet’s technology acquired or licensed from various third parties, including its licensors, may be subject to retained rights. Tenet’s licensors often retain certain rights under their agreements with it, including the right to use the underlying technology for use in fields other than the fields licensed to it or for use in noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether Tenet’s licensors limit their use of the technology to these uses, and Tenet could incur substantial expenses to enforce its rights to its licensed technology in the event of misuse by the licensor.

If Tenet is limited in its ability to utilize acquired or licensed technologies, or if it loses its rights to critical licensed technology, it may be unable to successfully develop and commercialize TNT119, which could prevent or delay new product introductions. Tenet’s business strategy depends on the successful development of licensed and acquired technologies into commercial products. Therefore, any limitations on its ability to utilize these technologies may impair its ability to develop and commercialize TNT119.

Intellectual property rights do not necessarily address all potential threats to Tenet’s competitive advantage.

The degree of future protection afforded by Tenet’s intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect Tenet’s business or permit it to maintain its competitive advantage. For example:

 

   

others may be able to develop products that are similar to TNT119 but that are not covered by the claims of the patents that Tenet owns or licenses;

 

   

Tenet or its licensors might not have been the first to make the inventions covered by the issued patents or patent application that Tenet owns or licenses;

 

   

Tenet or its licensors might not have been the first to file patent applications covering certain of its inventions;

 

   

others may independently develop similar or alternative technologies or duplicate any of Tenet’s technologies without infringing its intellectual property rights;

 

   

it is possible that Tenet’s licensors’ pending patent applications will not lead to issued patents;

 

   

issued patents that Tenet owns or licenses may be held invalid or unenforceable, as a result of legal challenges by its competitors;

 

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Tenet’s competitors might conduct research and development activities in countries where it does not have patent rights and then use the information learned from such activities to develop competitive products for sale in its major commercial markets;

 

   

Tenet may not develop additional proprietary technologies that are patentable; and

 

   

the patents of others may have an adverse effect on Tenet’s business.

 

   

Should any of these events occur, it could significantly harm Tenet’s business, results of operations, financial condition and prospects.

Tenet’s commercial success depends significantly on its ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that Tenet infringes their proprietary rights may result in liability for damages or prevent or delay its development and commercialization efforts.

Tenet’s commercial success depends in part on avoiding infringement of the patents and other proprietary rights of third parties. However, Tenet’s development and commercialization activities may be subject to claims that it infringes or otherwise violates patents or other intellectual property rights owned or controlled by third parties. Other entities may have or obtain patents or other proprietary rights that could limit Tenet’s ability to make, use, sell, offer for sale, or import TNT119 or impair its competitive position. There is a substantial amount of litigation and administrative proceedings, both within and outside the United States, involving patent and other intellectual property rights in the biopharmaceutical industry, including patent invalidity and infringement lawsuits, oppositions, reexaminations, IPR proceedings and PGR proceedings before the USPTO, ex-U.S. patent offices and/or in a court of law. Numerous third-party U.S. and ex-U.S. issued patents and pending patent applications exist in the fields in which Tenet is developing TNT119. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of TNT119.

As the biopharmaceutical industry expands and more patents are issued, the risk increases that TNT119 may be subject to claims of infringement of the patent rights of third parties. Because patent applications are maintained as confidential for a certain period of time, until the relevant application is published Tenet may be unaware of third-party patents that may be infringed by the development or commercialization of TNT119, and it cannot be certain that it was the first to file a patent application related to TNT119. Moreover, because patent applications can take many years to issue, there may currently be pending patent applications that may later result in issued patents that TNT119 may infringe. In addition, identification of third-party patent rights that may be relevant to Tenet’s technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims. In addition, third parties may obtain patents in the future and claim that use of Tenet’s technologies infringes these patents. Any claims of patent infringement asserted by third parties would be time consuming and could:

 

   

result in costly litigation that may cause negative publicity;

 

   

divert the time and attention of Tenet’s technical personnel and management;

 

   

cause development delays;

 

   

prevent Tenet from commercializing TNT119 until the asserted patent expires or is held finally invalid or unenforceable or not infringed in a court of law;

 

   

require Tenet to develop non-infringing technology, which may not be possible or may not be done on a cost-effective basis;

 

   

subject Tenet to significant liability to third parties; or

 

   

require Tenet to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in its competitors gaining access to the same technology.

 

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Third parties may hold proprietary rights that could prevent TNT119 from being developed or commercialized. Any patent-related legal action against Tenet claiming damages and seeking to enjoin activities relating to TNT119 or its processes could subject it to potential liability for damages, including treble damages if Tenet was determined to have willfully infringed, and require Tenet to obtain a license to develop, manufacture or commercialize TNT119. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management resources from Tenet’s business. Tenet cannot predict whether it would prevail in any such actions or that any license required under any of these patents would be made available on commercially acceptable terms, if at all. Moreover, even if Tenet or its future strategic partners were able to obtain a license, the rights may be nonexclusive, which could result in its competitors gaining access to the same intellectual property. In addition, Tenet cannot be certain that it could redesign TNT119 or its processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent Tenet from developing and commercializing TNT119, which could harm its business, results of operations, financial condition and prospects.

Parties making claims against Tenet may be able to sustain the costs of complex patent litigation more effectively than Tenet can because they have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of Tenet’s confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation or administrative proceeding could have a material adverse effect on Tenet’s ability to raise additional funds or otherwise have a material adverse effect on its business, results of operations, financial condition and prospects.

Tenet may be involved in lawsuits or other proceedings to protect or enforce its patents or the patents of its licensors, which could be expensive, time-consuming and unsuccessful. Further, Tenet’s or its licensors’ issued patents could be found invalid or unenforceable if challenged in court.

Competitors may infringe Tenet’s intellectual property rights or those of its licensors. To prevent infringement or unauthorized use, Tenet and/or its licensors may be required to file infringement claims, which can be expensive and time-consuming. Further, Tenet’s licensors may need to file infringement claims, but they may elect not file such claims. In addition, in a patent infringement proceeding, a court may decide that a patent Tenet owns or licenses is not valid, is unenforceable and/or is not infringed. If Tenet or any of its licensors or potential future collaborators were to initiate legal proceedings against a third party to enforce a patent directed at TNT119, the defendant could assert that Tenet’s patent is invalid and/or unenforceable in whole or in part. In patent litigation, defendant allegations of invalidity and/or unenforceability of asserted patents are commonplace. Grounds for a validity challenge include an alleged failure to meet any of several statutory requirements, including lack of novelty or written description, obviousness or non-enablement. Grounds for an unenforceability assertion could include an allegation that someone connected with prosecution of the patent intentionally withheld material information from the USPTO or made a misleading statement during prosecution.

If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, Tenet would lose at least part, and perhaps all, of the patent protection on TNT119. In addition, if the breadth or strength of protection provided by Tenet’s or its licensors’ patents and patent applications is threatened, it could dissuade companies from collaborating with Tenet to license, develop or commercialize TNT119. Such a loss of patent protection would have a material adverse impact on Tenet’s business.

Even if resolved in Tenet’s favor, litigation or other proceedings relating to Tenet’s intellectual property rights may cause it to incur significant expenses and could distract its technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase Tenet’s operating losses and reduce the resources available for development activities or any future sales, marketing, distribution or other commercialization activities. Tenet may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of Tenet’s competitors may be able to sustain the costs of such litigation or

 

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proceedings more effectively than Tenet can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise Tenet’s ability to compete in the marketplace.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to Tenet’s intellectual property rights, there is a risk that some of Tenet’s confidential information could be compromised by disclosure during this type of litigation or other proceedings.

Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing Tenet’s ability to protect its intellectual property for TNT119.

Tenet’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves a high degree of technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of Tenet’s intellectual property rights and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Tenet cannot predict the breadth of claims that may be allowed or enforced in its patents or in third-party patents. In addition, Congress or other ex-U.S. legislative bodies may pass patent reform legislation that is unfavorable to Tenet.

For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Tenet’s or its licensors’ ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the U.S. federal courts, the USPTO, or similar authorities in ex-U.S. jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken Tenet’s or its licensors’ ability to obtain new patents or to enforce Tenet’s existing patents and patents it might obtain in the future.

In September 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted and also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first inventor to file” system in which, assuming that other requirements of patentability are met, the first inventor to file a patent application will be entitled to the patent regardless of whether a third party was first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013 but before Tenet could therefore be awarded a patent covering an invention of Tenet even if Tenet had made the invention before it was made by such third party. This requires Tenet to be cognizant going forward of the time from invention to filing of a patent application. Furthermore, Tenet’s ability to obtain and maintain valid and enforceable patents depends on whether the differences between its technology and the prior art allow its technology to be patentable over the prior art. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, Tenet cannot be certain that it was the first to either (i) file any patent application related to TNT119 or (ii) invent any of the inventions claimed in its patents or patent applications.

The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications are prosecuted and also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including PGR proceedings, IPR proceedings, and derivation proceedings. An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, Tenet’s patent rights, which could adversely affect its competitive position.

 

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Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate Tenet’s patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of Tenet’s or its licensors’ patent applications and the enforcement or defense of Tenet’s or its licensors’ issued patents, all of which could have a material adverse effect on Tenet’s business, results of operations, financial condition and prospects.

Tenet or its licensors may be subject to claims challenging the inventorship or ownership of Tenet’s or its licensors’ patents and other intellectual property.

Tenet or its licensors may be subject to claims that third parties have an ownership interest in Tenet’s or its licensors’ patents or other intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If Tenet or its licensors fail in defending any such claims, in addition to paying monetary damages, Tenet may lose valuable intellectual property rights. Such an outcome could have a material adverse effect on Tenet’s business. Even if Tenet or its licensors are successful in defending against such claims, litigation could result in substantial costs and distraction to management.

Patent terms may be inadequate to protect Tenet’s competitive position on TNT119 for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the term of a patent, and the protection it affords, is limited. Even if patents directed to TNT119 are obtained, once the patent term has expired, Tenet may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of product candidates, patents directed to TNT119 might expire before or shortly after such candidates are commercialized. Tenet intends, or understands that its licensors intend, to pursue additional patent protection covering, when possible, compositions, methods of use, methods of manufacture, and dosing and formulations of TNT119. The issued patents, or patents that may be issued from the pending patent applications that Tenet exclusively in-licenses from CRH are expected to expire in 2026, excluding any patent term adjustment that might be available following the grant of the patent and any patent term extensions that might be available following the grant of marketing authorizations. As a result, Tenet’s patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to TNT119.

If Tenet or its licensors do not obtain patent term extension(s) for TNT119, Tenet’s business may be materially harmed.

Depending upon the timing, duration and specifics of FDA marketing approval of TNT119, one or more of its U.S. patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Amendments”). The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA-approved product as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term extension may also be available in certain ex-U.S. countries upon regulatory approval of TNT119. However, Tenet or its licensors may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded

 

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could be less than Tenet requests. If Tenet or its licensors are unable to obtain patent term extension or restoration or the term of any such extension is less than Tenet requests, Tenet’s competitors may obtain approval of competing products following its patent expiration, and its revenue could be reduced, possibly materially. Further, if this occurs, Tenet’s competitors may take advantage of Tenet’s investment in development and trials by referencing Tenet’s clinical and preclinical data and launch their product earlier than might otherwise be the case.

Tenet may not be able to protect its intellectual property rights throughout the world.

Although Tenet has issued patents and pending patent applications in the United States and certain other countries, filing, prosecuting and defending patents in all countries throughout the world would be prohibitively expensive, and its intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some ex-U.S. countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, Tenet may not be able to prevent third parties from practicing its inventions in all countries outside the United States or from selling or importing products made using its inventions in and into the United States or other jurisdictions. Competitors may use Tenet’s technologies in jurisdictions where it has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Tenet or its licensors have patent protection but enforcement is not as strong as that in the United States. These products may compete with TNT119, and Tenet’s or its licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in ex-U.S. jurisdictions. The legal systems of many ex-U.S. countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for Tenet to stop the infringement of its or its licensors’ patents or marketing of competing products in violation of its proprietary rights. Proceedings to enforce Tenet’s patent rights in ex-U.S. jurisdictions could result in substantial costs and divert Tenet’s efforts and attention from other aspects of its business, could put Tenet’s or its licensors’ patents at risk of being invalidated or interpreted narrowly and Tenet’s or its licensors’ patent applications at risk of not issuing and could provoke third parties to assert claims against Tenet. Tenet or its licensors may not prevail in any lawsuits that Tenet or its licensors initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Tenet’s or its licensors’ efforts to enforce Tenet’s intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Tenet develops or licenses.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If Tenet or its licensors are forced to grant a license to third parties with respect to any patents relevant to Tenet’s business, its competitive position may be impaired, and its business, results of operations, financial condition and prospects may be adversely affected.

Obtaining and maintaining Tenet’s patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and Tenet’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and patent applications will be due to the USPTO and various ex-U.S. patent offices at various points over the lifetime of Tenet’s or its licensors’ patents and patent applications. Tenet has systems in place to remind it to pay these fees, and it relies on third parties to pay these fees when due. Additionally, the USPTO and various ex-U.S. patent offices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Tenet employs reputable law firms and other professionals to help it

 

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comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to the particular jurisdiction. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, it could have a material adverse effect on Tenet’s business.

If Tenet is unable to protect the confidentiality of its trade secrets, its business and competitive position would be harmed.

In addition, Tenet relies on the protection of its trade secrets, including unpatented know-how, technology and other proprietary information to maintain its competitive position. Although Tenet has taken steps to protect its trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with consultants, licensors and advisors, it cannot provide any assurances that all such agreements have been duly executed, and any of these parties may breach the agreements and disclose its proprietary information, including its trade secrets, and it may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

Moreover, third parties may still obtain this information or may come upon this or similar information independently, and Tenet would have no right to prevent them from using such information to compete with Tenet. If any of these events occurs or if Tenet otherwise loses protection for its trade secrets, the value of this information may be greatly reduced and its competitive position would be harmed. If Tenet or its licensors do not apply for patent protection prior to such publication or if Tenet cannot otherwise maintain the confidentiality of its proprietary technology and other confidential information, then its ability to obtain patent protection or to protect its trade secret information may be jeopardized.

As is common in the biopharmaceutical industry, Tenet engages the services of consultants to assist it in the development of TNT119. Many of these consultants were previously employed at, or may have previously provided or may be currently providing consulting services to, other biopharmaceutical companies including Tenet’s competitors or potential competitors. Tenet may become subject to claims that it or its consultants inadvertently or otherwise used or disclosed trade secrets or other information proprietary to its consultants’ former employers or their former or current clients. Litigation may be necessary to defend against these claims. If Tenet fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights or personnel, which could adversely affect its business. Even if Tenet is successful in defending against these claims, litigation could result in substantial costs and be a distraction to its management team.

Risks Related to Tenet’s Financial Condition and Need for Additional Capital

Tenet has incurred net losses since inception and Tenet anticipates that it will continue to incur net losses for the foreseeable future and may never achieve or maintain profitability.

Since inception, Tenet has incurred net losses. Tenet’s net loss was approximately $9.0 million and $0.6 million for the three months ended March 31, 2024 and the year ended December 31, 2023, respectively. As of March 31, 2024 and December 31, 2023, Tenet had an accumulated deficit of $9.5 million and $0.6 million, respectively. To date, Tenet has devoted substantially all of its efforts to organizing its company, business planning, raising capital, acquiring intellectual property related to TNT119 and developing TNT119. Tenet expects that it could be several years, if ever, before it has a commercialized product. Tenet expects to continue to incur significant expenses and increasing operating losses for the foreseeable future.

To become and remain profitable, Tenet must develop and eventually commercialize TNT119. This will require Tenet to be successful in a range of challenging activities, and Tenet’s expenses will increase substantially as it

 

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prepares to initiate planned and future clinical trials of TNT119, prepares for and potentially obtains marketing approval for TNT119, develops and validates commercial-scale manufacturing processes, manufactures, markets and sells TNT119 and satisfies any post-marketing requirements. Moreover, the manufacturing process requires materials which may fluctuate in cost or be limited or unavailable to Tenet, as well as relationships with contract development and manufacturing organizations to facilitate the manufacturing process. Tenet may never succeed in any or all of these activities and, even if it does, Tenet may never generate revenue that is significant or large enough to achieve profitability.

Conducting clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and Tenet may never generate the necessary data or results required to submit a BLA or obtain marketing approval and achieve product sales. In addition, TNT119, if approved, may not achieve commercial success. Tenet’s product revenue, if any, will be derived from or based on sales of TNT119 that may not be commercially available for many years, if at all.

Tenet’s business is highly dependent on the success of TNT119. If Tenet is unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, TNT119, or if Tenet experiences delays in doing so, its business will be materially harmed.

Tenet’s future success and ability to generate revenue from TNT119, which Tenet does not expect will occur for several years, if ever, is dependent on Tenet’s ability to successfully develop, obtain regulatory approval for and commercialize TNT119. If TNT119 encounters undesirable safety signals, insufficient efficacy results, development delays, regulatory issues or other problems, Tenet’s development plans and business would be significantly harmed.

Tenet will need significant additional capital to proceed with development and commercialization of TNT119 and to conduct its other operations. Tenet may not be able to access sufficient capital on acceptable terms, if at all, and, as a result, it may be required to delay, scale back or discontinue development of TNT119 or other operations.

To date, Tenet has funded its operations primarily with proceeds from the issuance of simple agreements for future equity. Tenet expects its expenses to increase in connection with its ongoing activities, particularly as Tenet initiates Phase 2 clinical trials of TNT119. In addition, if Tenet successfully completes development through Phase 3 and obtains regulatory approval for TNT119, Tenet expects to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Tenet may also need to raise additional funds sooner if Tenet chooses to pursue additional indications. Accordingly, Tenet will need to obtain substantial additional funding in connection with its continuing operations. If Tenet is unable to raise capital when needed or on attractive terms, Tenet could be forced to delay, scale back or discontinue development of TNT119 or its other operations.

Tenet’s future capital requirements for TNT119 will depend on and could increase significantly as a result of many factors, including:

 

   

the progress, timing and completion clinical trials for TNT119, as well as the associated costs, including any unforeseen costs Tenet may incur as a result of clinical trial delays due to disease outbreaks, epidemics and pandemics or other causes;

 

   

the initiation, enrollment and completion of clinical trials that exhibit satisfactory safety, tolerability and efficacy profiles;

 

   

the timing and amount of milestone and royalty payments Tenet is required to make under its license agreement with CRH, its asset purchase agreement with Acelyrin and other licensing or collaboration agreements, as applicable;

 

   

the need for additional or expanded clinical trials beyond those that Tenet plans to conduct with respect to TNT119;

 

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the costs involved in growing the organization to the size needed to allow for the development and potential commercialization of TNT119;

 

   

the costs involved in filing patent applications, maintaining and enforcing patents or defending against infringement or other claims raised by third parties;

 

   

the maintenance of Tenet’s existing license and collaboration agreements and the entry into new license and collaboration agreements;

 

   

the time and costs involved in obtaining regulatory approval for TNT119 and any delays Tenet may encounter as a result of evolving regulatory requirements or adverse results with respect to TNT119;

 

   

the effect of competing technological and market developments;

 

   

the cost and timing of completion of commercial-scale outsourced manufacturing activities;

 

   

the cost of establishing sales, marketing and distribution capabilities for TNT119 if Tenet receives regulatory approval in regions where Tenet chooses to commercialize TNT119 on its own;

 

   

the amount of revenues, if any, Tenet may derive from future sales of TNT119, if approved; and

 

   

market acceptance of TNT119, if approved.

Tenet does not have any committed external source of funds or other support for its development efforts, and Tenet cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available on commercially acceptable terms when needed, Tenet may be forced to delay, scale back or discontinue development of TNT119 or other operations.

Tenet’s losses from operations and financial conditions raise substantial doubt about its ability to continue as a going concern.

Tenet’s losses from operations and its financial condition raise substantial doubt about its ability to continue as a going concern. In Tenet’s financial statements for the year ended December 31, 2023 and the three months ended March 31, 2024, Tenet concluded that its losses from operations and need for additional financing to fund future operations raise substantial doubt about Tenet’s ability to continue as a going concern. Similarly, Tenet’s independent registered public accounting firm included an explanatory paragraph in its report on Tenet’s financial statements for the year ended December 31, 2023, with respect to this uncertainty. Tenet’s ability to continue as a going concern will require it to obtain additional funding. If Tenet is unable to obtain sufficient funding, its business, results of operations, financial condition and prospects will be materially and adversely affected, and Tenet may be unable to continue as a going concern. If Tenet is unable to raise capital when needed or on acceptable terms, it would be forced to delay, limit, reduce or terminate its product development or future commercialization efforts for TNT119, or may be forced to reduce or terminate its operations. If Tenet is unable to continue as a going concern, Tenet may have to liquidate its assets and may receive less than the value at which those assets are carried on its audited financial statements, and it is likely that investors will lose all or part of their investment.

Tenet has a very limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of its business to date and to assess its future viability.

Tenet is a clinical-stage biotechnology company with a very limited operating history and a single product candidate in development. Tenet was formed and commenced operations in November 2023. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Tenet’s limited operations to date have been largely focused on organizing its company, business planning, raising capital, acquiring intellectual property rights to TNT119 and developing TNT119. To date, Tenet has not yet demonstrated its ability to successfully complete any clinical trials, obtain regulatory approvals, manufacture a product on a commercial scale or arrange for a third-party to do so on its behalf, or conduct sales and marketing

 

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activities necessary for successful product commercialization, and it may not be successful in doing so in the future. Consequently, any predictions about Tenet’s future success or viability may not be as accurate as they could be if Tenet had a longer operating history or a history of successfully developing and commercializing products.

In addition, as a business with a limited operating history, Tenet may encounter unforeseen expenses, technical or regulatory challenges, unanticipated delays in development timelines or other known and unknown factors. Tenet will eventually need to transition from a development-stage company to a company capable of supporting late-stage clinical development and, if TNT119 is approved, commercial activities. Tenet may not be successful in such a transition.

Risks Related to Post-Closing Eliem

Post-Closing Eliem will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

Eliem expects that Post-Closing Eliem will have approximately $210.0 million in cash and cash equivalents at the closing of the Acquisition and the Private Placement, which Eliem expects will be sufficient to fund Post-Closing Eliem’s planned operations into 2027 and to enable the potential attainment of key clinical and development milestones for TNT119. Following such period of time (or during that period of time, if Post-Closing Eliem depletes it capital resources sooner than expected), Post-Closing Eliem will require additional funds to continue the development and potential commercialization of TNT119 and any other product candidates it develops. Post-Closing Eliem’s future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture adequate supply of its product candidates to complete preclinical studies and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance.

Raising additional capital may be costly or difficult to obtain and could significantly dilute stockholders’ ownership interests or inhibit Post-Closing Eliem’s ability to achieve its business objectives. It is also possible that the terms of any new equity securities may have preferences over Post-Closing Eliem common stock. Any debt financing Post-Closing Eliem enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of Post-Closing Eliem’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if Post-Closing Eliem raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to Post-Closing Eliem. Even if Post-Closing Eliem were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to Post-Closing Eliem or its stockholders.

The market price of Post-Closing Eliem common stock may be volatile, and the market price of the common stock may drop following the Acquisition.

The market price of Post-Closing Eliem common stock following the Acquisition could be subject to significant fluctuations and may drop following the Acquisition. Some of the factors that may cause the market price of Post-Closing Eliem common stock to fluctuate include:

 

   

results of clinical trials and preclinical studies of Post-Closing Eliem’s product candidates, including TNT119, or those of Post-Closing Eliem’s competitors or Post-Closing Eliem’s existing or future collaborators;

 

   

failure of any of Post-Closing Eliem’s product candidates, if approved, to achieve commercial success;

 

   

the level of expenses related to any of Post-Closing Eliem’s product candidates, its development programs and any future commercialization efforts;

 

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failure to meet or exceed financial and development projections Post-Closing Eliem may provide to the public;

 

   

failure to meet or exceed the financial and development projections of the investment community;

 

   

if Post-Closing Eliem does not achieve the perceived benefits of the Acquisition as rapidly or to the extent anticipated, or at all, by financial or industry analysts;

 

   

announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by Post-Closing Eliem or its competitors;

 

   

actions taken by regulatory agencies with respect to Post-Closing Eliem’s product candidates, preclinical studies, clinical trials, manufacturing process or sales and marketing terms;

 

   

disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain patent protection for its technologies;

 

   

additions or departures of key personnel;

 

   

significant lawsuits, including patent or stockholder litigation;

 

   

if securities or industry analysts do not publish research or reports about Post-Closing Eliem’s business, or if they issue adverse or misleading opinions regarding its business and stock;

 

   

changes in the market valuations of similar companies;

 

   

general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors;

 

   

sales of securities by Post-Closing Eliem or its securityholders in the future;

 

   

if Post-Closing Eliem fails to raise an adequate amount of capital to fund its operations and continued development of its product candidates;

 

   

trading volume of Post-Closing Eliem common stock;

 

   

announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

 

   

adverse publicity relating to anti-CD19 antibody product candidates, including with respect to other products in such markets;

 

   

the introduction of technological innovations or new therapies that compete with the product candidates and services of Post-Closing Eliem;

 

   

Post-Closing Eliem’s ability to maintain its listing on the Nasdaq Global Market; and

 

   

period-to-period fluctuations in Post-Closing Eliem’s financial results.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Post-Closing Eliem common stock. In addition, a recession, depression or other sustained adverse market event could materially and adversely affect Post-Closing Eliem’s business and the value of its common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies. Furthermore, market volatility may lead to increased shareholder activism if Post-Closing Eliem experiences a market valuation that activists believe is not reflective of its intrinsic value. Activist campaigns that contest or conflict with Post-Closing Eliem’s strategic direction or seek changes in the composition of the Post-Closing Eliem Board could have an adverse effect on its operating results and financial condition.

 

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Following the Acquisition, Post-Closing Eliem may be unable to successfully integrate the businesses of Eliem and Tenet and realize the anticipated benefits of the Acquisition.

The Acquisition involves the combination of two companies which currently operate as independent companies. Following the Acquisition, Post-Closing Eliem will focus on developing TNT119 for a broad range of autoimmune diseases, including SLE, ITP and MN. Post-Closing Eliem will be required to devote significant management attention and resources to integrating its business practices and operations. Post-Closing Eliem may fail to realize some or all of the anticipated benefits of the Acquisition, including if the integration process takes longer than expected or is more costly than expected. Potential difficulties Post-Closing Eliem may encounter in the integration process include the following:

 

   

the inability to successfully combine the businesses of Eliem and Tenet in a manner that permits Post-Closing Eliem to achieve the anticipated benefits from the Acquisition, which would result in the anticipated benefits of the Acquisition not being realized partly or wholly in the time frame currently anticipated or at all;

 

   

creation of uniform standards, controls, procedures, policies and information systems; and

 

   

potential unknown liabilities and unforeseen increased expenses, delays or regulatory conditions associated with the Acquisition.

In addition, Eliem and Tenet have operated and, until the completion of the Acquisition, will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined company’s ability to maintain its relationships with third parties or the ability to achieve the anticipated benefits of the Acquisition, or could otherwise adversely affect the business and financial results of Post-Closing Eliem.

Post-Closing Eliem may never commercialize a product candidate or generate revenue.

Neither Eliem nor Tenet have commercialized a product or generated revenue from the sale of any products. Post-Closing Eliem is expected to incur significant net losses for the foreseeable future and may never achieve or maintain profitability. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete. Post-Closing Eliem may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any products for which Post-Closing Eliem may obtain marketing approval. Eliem and Tenet cannot predict when, or if, Post-Closing Eliem will obtain regulatory approval to TNT119 or other future product candidates.

The unaudited pro forma condensed combined financial data for Eliem and Tenet included in this proxy statement are preliminary, and Post-Closing Eliem’s actual financial position and operations after the Acquisition may differ materially from the unaudited pro forma condensed combined financial data included in this proxy statement.

The unaudited pro forma condensed combined financial data for Eliem and Tenet included in this proxy statement are presented for illustrative purposes only and are not necessarily indicative of Post-Closing Eliem’s actual financial condition or results of operations of future periods, or the financial condition or results of operations that would have been realized had the entities been combined during the periods presented. Post-Closing Eliem’s actual results and financial position after the Acquisition and the Private Placement may differ materially and adversely from the unaudited pro forma condensed combined financial data included in this proxy statement. The unaudited pro forma condensed combined financial statements have been derived from the historical financial statements of Eliem and Tenet and adjustments and assumptions have been made regarding Post-Closing Eliem after giving effect to the Acquisition and the Private Placement. The information upon which

 

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these adjustments and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with accuracy. Moreover, the unaudited pro forma condensed combined financial statements do not reflect all costs that are expected to be incurred by Post-Closing Eliem in connection with the Acquisition and the Private Placement or that have been incurred since the date of such unaudited pro forma condensed combined financial statements. The assumptions used in preparing the unaudited pro forma condensed combined financial data may not prove to be accurate, and other factors may affect Post-Closing Eliem’s financial condition following the Acquisition and the Private Placement. For more information see the section titled “Unaudited Pro Forma Condensed Combined Financial Statements” beginning on page 170 of this proxy statement.

Eliem and Tenet do not anticipate that Post-Closing Eliem will pay any cash dividends in the foreseeable future.

The current expectation is that Post-Closing Eliem will retain its future earnings, if any, to finance the growth and development of Post-Closing Eliem’s business as opposed to paying dividends. As a result, capital appreciation, if any, of the common stock of Post-Closing Eliem will be your sole source of gain, if any, for the foreseeable future.

Post-Closing Eliem may be exposed to increased litigation, including stockholder litigation, which could have an adverse effect on Post-Closing Eliem’s business and operations.

Post-Closing Eliem may be exposed to increased litigation from stockholders, suppliers and other third parties due to the combination of Eliem’s and Tenet’s businesses following the Acquisition. Such litigation may have an adverse impact on Post-Closing Eliem’s business and results of operations or may cause disruptions to Post-Closing Eliem’s operations. In addition, in the past, stockholders have initiated class action lawsuits against biotechnology companies following periods of volatility in the market prices of these companies’ stock. Such litigation, if instituted against Post-Closing Eliem, could cause Post-Closing Eliem to incur substantial costs and divert management’s attention and resources, which could have a material adverse effect on Post-Closing Eliem’s business, results of operations and financial condition.

Future sales of shares by existing stockholders could cause Post-Closing Eliem’s stock price to decline.

If existing securityholders of Eliem and Tenet sell, or indicate an intention to sell, substantial amounts of Post-Closing Eliem common stock in the public market after legal restrictions on resale discussed in this proxy statement lapse, the trading price of the common stock of Post-Closing Eliem could decline. Based on shares of common stock outstanding as of May 10, 2024, and after giving effect the shares of common stock to be issued in the Private Placement and the shares of common stock expected to be issued upon completion of the Acquisition, Post-Closing Eliem is expected to have outstanding a total of approximately 65,916,502 shares of common stock immediately following the completion of the Acquisition and the Private Placement. Post-Closing Eliem has agreed to file a registration statement covering the resale of the shares issued in the Acquisition and the Private Placement within 45 days of the closing of the Private Placement. Post-Closing Eliem has agreed to keep such registration statement effective until the date the shares covered by such registration statement have been sold or can be resold without restriction under Rule 144 of the Securities Act. If outstanding shares of common stock are sold, the trading price of Post-Closing Eliem common stock could decline.

After completion of the Acquisition and the Private Placement, Post-Closing Eliem’s executive officers, directors and principal stockholders, including RA Capital Management, will have the ability to control or significantly influence all matters submitted to Post-Closing Eliem stockholders for approval.

Upon the completion of the Acquisition and the Private Placement, it is anticipated that Post-Closing Eliem’s executive officers, directors and principal stockholders, including RA Capital Management, will, in the aggregate, beneficially own approximately 70.4% of Post-Closing Eliem’s outstanding shares of common stock,

 

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including 47.6% of Post-Closing Eliem’s outstanding common stock beneficially owned by RA Capital Management and its affiliates as of May 10, 2024. As a result, if these stockholders were to choose to act together (or, in the case of RA Capital Management, alone), they would be able to control or significantly influence all matters submitted to Post-Closing Eliem stockholders for approval, as well as Post-Closing Eliem’s management and affairs. For example, these persons, if they choose to act together (or, in the case of RA Capital Management, alone), would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of Post-Closing Eliem’s assets. This concentration of voting power could delay or prevent an acquisition of Post-Closing Eliem on terms that other stockholders may desire.

Post-Closing Eliem will have broad discretion in the use of the cash and cash equivalents of Post-Closing Eliem and the proceeds from the Private Placement, and Post-Closing Eliem may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment.

Post-Closing Eliem will have broad discretion over the use of the cash and cash equivalents of Post-Closing Eliem and the proceeds from the Private Placement. You may not agree with Post-Closing Eliem’s decisions, and its use of the proceeds may not yield any return on your investment. Post-Closing Eliem’s failure to apply these resources effectively could compromise its ability to pursue its growth strategy and Post-Closing Eliem might not be able to yield a significant return, if any, on its investment of these net proceeds. You will not have the opportunity to influence its decisions on how to use Post-Closing Eliem’s cash resources.

If Post-Closing Eliem fails to attract and retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.

Post-Closing Eliem’s ability to compete in the highly competitive pharmaceuticals industry depends on its ability to attract and retain highly qualified managerial, scientific, medical, legal, sales and marketing and other personnel. Post-Closing Eliem will be highly dependent on recruiting and retaining its management and scientific personnel. The loss of the services of any of these individuals could impede, delay or prevent the successful development of Post-Closing Eliem’s product candidates, completion of its planned clinical trials, commercialization of its product candidates or in-licensing or acquisition of new assets and could negatively impact its ability to implement successfully its business plan. If Post-Closing Eliem loses the services of any of these individuals, it might not be able to find suitable replacements on a timely basis or at all, and its business could be harmed as a result. Post-Closing Eliem might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This proxy statement, and the documents incorporated by reference into this proxy statement, contain forward-looking statements relating to Eliem, Tenet, the Acquisition, the Private Placement and the other proposed transactions contemplated thereby.

These forward-looking statements include, without limitation, statements regarding: future expectations, plans and prospects for Eliem, Tenet and Post-Closing Eliem following the anticipated consummation of the Acquisition; the anticipated benefits of the Acquisition; the anticipated timing of the closing the Acquisition and the Private Placement, the strategy, the anticipated milestones and key inflection points of Post-Closing Eliem; the anticipated use of proceeds of the Private Placement, the expected cash and cash equivalents of Post-Closing Eliem at closing of the Acquisition and the Private Placement and the anticipated cash runway of Post-Closing Eliem; the expected ownership, management team and Post-Closing Eliem Board; Tenet’s TNT119 product candidate, including expectations regarding TNT119’s therapeutic benefits, clinical potential and clinical development, and anticipated timelines for initiating clinical trials of TNT119, including initiating Phase 2 clinical trials for the treatment of systemic lupus erythematosus and immune thrombocytopenia in the second half of 2024. In addition, any statements that refer to projections, forecasts or other characterizations of future developments or circumstances, including any underlying assumptions, are forward-looking statements. The words “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “working,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on management’s current expectations and beliefs concerning future events and their potential effects. There can be no assurance that future developments affecting Eliem, Tenet or the proposed transactions will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Eliem’s or Tenet’s control) or other assumptions that could cause actual results or performance to differ materially and adversely from those set forth in, expressed or implied by, such forward-looking statements. Post-Closing Eliem may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: completion of the Acquisition and the Private Placement in a timely manner or on the anticipated terms or at all; the satisfaction (or waiver) of closing conditions to the consummation of the Acquisition and the Private Placement, including with respect to the approval of the Share Issuance Proposal by Eliem stockholders at the Meeting; risks related to Eliem’s and Tenet’s ability to estimate their respective operating expenses and expenses associated with the Acquisition and the Private Placement; uncertainties regarding the impact any delay in the closing would have on the anticipated cash and cash equivalents of Post-Closing Eliem upon closing and other events and unanticipated spending and costs that could reduce Post-Closing Eliem’s cash and cash equivalents; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Acquisition Agreement or the Private Placement; the effect of the announcement or pendency of the Acquisition on Eliem’s or Tenet’s business relationships, operating results and business generally; the ability of Post-Closing Eliem to timely and successfully achieve or recognize the anticipated benefits of the Acquisition; the outcome of any legal proceedings that may be instituted against Eliem or Tenet following any announcement of the Acquisition and related transactions; costs related to the Acquisition, including unexpected costs, charges or expenses resulting from the Acquisition; changes in applicable laws or regulation; the possibility that Eliem or Tenet may be adversely affected by other legislative, regulatory, political, economic, business and/or competitive factors and developments; competitive responses to the Acquisition and the Private Placement; Post-Closing Eliem’s ability to advance TNT119 and/or Post-Closing Eliem’s other product candidates on the timelines expected or at all and to obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring board; replicating in clinical trials positive results found in early-stage clinical trials of TNT119; competing successfully with other companies that are seeking to develop treatments for systemic lupus erythematosus, immune thrombocytopenia, membranous nephropathy and other autoimmune driven

 

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inflammatory diseases; maintaining or protecting intellectual property rights related to TNT119 and/or its other product candidates; managing expenses; raising the substantial additional capital needed, on the timeline necessary, to continue development of TNT119 and other product candidates Post-Closing Eliem may develop; achieving Eliem’s other business objectives. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. There may be additional risks that Eliem considers immaterial or which are unknown. It is not possible to predict or identify all such risks. The forward-looking statements only speak as of the date they are made, and Eliem does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

For a discussion of the factors that may cause Eliem, Tenet or Post-Closing Eliem’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risks associated with the ability of Eliem and Tenet to complete the Acquisition and the Private Placement and the effects of the Acquisition on the business of Eliem, Tenet and Post-Closing Eliem, please see the section titled “Risk Factors” beginning on page 13 of this proxy statement. Additional factors that could cause actual results to differ materially from those expressed in the forward-looking statements are discussed in reports filed with the SEC by Eliem. Please see the section titled “Where You Can Find More Information” beginning on page 184 of this proxy statement. There can be no assurance that the Acquisition and the Private Placement will be completed, or if completed, that such transactions will be completed within the anticipated time period or that the expected benefits of the Acquisition and the Private Placement will be realized.

If any of these risks or uncertainties materialize or any of these assumptions prove incorrect, the results of Eliem, Tenet or Post-Closing Eliem could differ materially from the forward-looking statements. All forward-looking statements in this proxy statement are current only as of the date on which the statements were made. Eliem and Tenet do not undertake any obligation (and expressly disclaim any such obligation) to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement is made or to reflect the occurrence of unanticipated events, except as required by applicable law.

 

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THE MEETING OF ELIEM STOCKHOLDERS

Date, Time and Place

The Meeting will be held on Wednesday, June 26, 2024, commencing at 9:00 a.m., Eastern Time, unless postponed or adjourned to a later date. The Meeting will be held virtually through a live webcast at www.proxydocs.com/ELYM. Eliem is sending this proxy statement to its stockholders in connection with the solicitation of proxies by the Eliem Board for use at the Meeting and any adjournments or postponements of the Meeting. This proxy statement is first being furnished to Eliem stockholders on or about June 4, 2024.

Purposes of the Meeting

The purposes of the Meeting are:

 

  1.

To approve, for purposes of Nasdaq Listing Rule 5635 and the satisfaction of the related condition contained in the Acquisition Agreement, the issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement (the “Share Issuance Proposal” or “Proposal No. 1”);

 

  2.

To adjourn the Meeting from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the Meeting to be necessary or appropriate (the “Adjournment Proposal” or “Proposal No. 2”);

 

  3.

To elect each of Andrew Levin, M.D., Ph.D., and Liam Ratcliffe, M.D., Ph.D., to the Eliem Board to hold office until the 2027 annual meeting of stockholders (the “Election Proposal” or “Proposal No. 3”);

 

  4.

To ratify the selection by the audit committee of the Eliem Board of PricewaterhouseCoopers LLP as the independent registered public accounting firm of Eliem for its fiscal year ending December 31, 2024 (the “Ratification Proposal” or “Proposal No. 4” and, collectively with the Share Issuance Proposal, Adjournment Proposal and Election Proposal, the “Proposals”); and

 

  5.

To transact any other business that may properly come before the Meeting or any adjournment or postponement of the Meeting by or at the direction of the Eliem Board.

Proposal No. 1 is a condition to the completion of the Acquisition. The issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement will not take place unless approved by the Required Eliem Stockholder Vote (including the Baseline Vote and the Disinterested Stockholder Approval) and the Acquisition is consummated. Therefore, the Acquisition cannot be consummated without the approval of Proposal No. 1.

At this time, the Eliem Board is unaware of any matters, other than the Proposals set forth above, that may properly come before the Meeting.

Recommendation of the Eliem Board

 

   

The Eliem Board and Special Committee has determined and believes that the issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and Securities Purchase Agreement is fair to, in the best interests of, and advisable to, Eliem and its stockholders and has approved such issuance. The Eliem Board and Special Committee each unanimously recommend that Eliem stockholders vote “FOR” Proposal No. 1 to approve the issuance of shares of Eliem common stock pursuant to the Acquisition Agreement and Securities Purchase Agreement.

 

   

The Eliem Board and Special Committee has determined and believes that adjourning the Meeting, from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are

 

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insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the Meeting to be necessary or appropriate is fair to, in the best interests of, and advisable to, Eliem and its stockholders and has approved and adopted the proposal. The Eliem Board and Special Committee each unanimously recommend that Eliem stockholders vote “FOR” Proposal No. 2 to adjourn the Meeting from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the meeting to be necessary or appropriate.

 

   

The Eliem Board unanimously recommends that Eliem stockholders vote “FOR” Proposal No. 3 to elect each of Andrew Levin, M.D., Ph.D., and Liam Ratcliffe M.D., Ph.D., to the Eliem Board to hold office until the 2027 annual meeting of stockholders.

 

   

The Eliem Board unanimously recommends that Eliem stockholders vote “FOR” Proposal No. 4 to ratify PricewaterhouseCoopers LLP as Eliem’s independent registered public accounting firm.

Record Date and Voting Power

Only holders of record of Eliem common stock at the close of business on May 30, 2024 (the “Record Date”), are entitled to notice of, and to vote at, the Meeting. At the close of business on the Record Date, there were 14 holders of record of Eliem common stock and there were 29,752,317 shares of Eliem common stock issued and outstanding. Each share of Eliem common stock entitles the holder thereof to one vote on each matter submitted for stockholder approval.

Voting of Proxies

The proxy accompanying this proxy statement is solicited on behalf of the Eliem Board for use at the Meeting.

The procedures for voting are as follows:

Stockholders of Record

If you are a stockholder of record of Eliem on the Record Date, you may vote in person via the Internet during the Meeting by visiting www.proxydocs.com/ELYM. You will need to enter the 16-digit control number included on your proxy card.

You may submit your proxy before the Meeting in one of the following ways:

 

  1.

Internet. To submit your proxy by Internet, visit the website shown on your proxy card.

 

  2.

Telephone. To submit your proxy by telephone, please call 1-866-506-2806 using a touch-tone phone and follow the recorded instructions.

 

  3.

Mail. Simply complete, sign and date the enclosed proxy card and return it before the Meeting in the envelope provided.

Telephone and Internet voting for stockholders of record will be available up until 11:59 p.m., Eastern Time, on June 25, 2024, and mailed proxy cards must be received by June 25, 2024 in order to be counted at the Meeting. If the Meeting is adjourned or postponed, these deadlines may be extended.

Eliem provides Internet proxy voting to allow you to vote your shares online, with procedures designed to ensure the authenticity and correctness of your proxy vote instructions. However, please be aware that you must bear any costs associated with your Internet access, such as usage charges from Internet access providers and telephone companies.

 

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All properly executed proxies that are not revoked will be voted at the Meeting and at any adjournments or postponements of the Meeting in accordance with the instructions contained in the proxy. If a holder of Eliem common stock executes and returns a proxy and does not specify otherwise, the shares represented by that proxy will be voted “FOR” all of the proposals in accordance with the recommendation of the Eliem Board.

Beneficial Owners of Shares Held in Street Name

If you are a beneficial owner of shares registered in the name of your bank, broker or other nominee, you should have received a voting instruction card and voting instructions with these proxy materials from that organization rather than from us. Please follow the voting instructions provided by your bank, broker or other nominee to provide your instruction on how to vote at the Meeting.

Banks, brokers or other nominees are not permitted to vote on “non-routine” matters without instruction from the beneficial owner. Broker non-votes occur on a matter when a bank, broker or other nominee is not permitted to vote on that matter because it is a “non-routine” matter and instructions are not given. The Share Issuance Proposal, the Adjournment Proposal and the Election Proposal are “non-routine” matters. The Ratification Proposal is a “routine” matter and brokers, banks or other securities intermediaries may therefore vote on that proposal even if you do not instruct your bank, broker or other nominee how to vote with respect to the Ratification Proposal. Because of this, even if you do not instruct your bank, broker or other nominee how to vote on any matter at the Meeting, assuming your bank, broker or other nominee votes on the Ratification Proposal, the shares of Eliem common stock you beneficially own will be counted as present for purposes of determining a quorum.

If you hold your shares in “street name” and do not instruct your bank, broker or other nominee how to vote with respect to the Share Issuance Proposal, the Adjournment Proposal or the Election Proposal, your bank, broker or other nominee may not vote with respect to such proposal and those votes will be counted as broker non-votes. Such broker non-votes will have no impact on the Baseline Vote, the Adjournment Proposal or the Election Proposal. If you are a Disinterested Stockholder, such broker non-votes will have the effect of a vote “AGAINST” the Disinterested Stockholder Approval, regardless of whether a quorum is present.

Revocation of Proxies

Stockholders of Record

If you are a stockholder of record of Eliem and you have not executed a support agreement, you can revoke your vote at any time before the final vote at the Meeting in any one of the following ways:

 

   

You may submit another properly completed proxy card with a later date or submit a new vote by telephone or through the Internet.

 

   

You may send a timely written notice that you are revoking your proxy to Eliem’s Executive Chairman at its corporate mailing address located at PMB #117, 2801 Centerville Road 1st Floor, Wilmington, DE 19808-1609.

 

   

You may attend the Meeting and vote online at the Meeting. Simply attending the Meeting will not, by itself, revoke your proxy.

Beneficial Owners of Shares Held in Street Name

Please note, however, that if your shares are held of record by a bank, broker, or other nominee, you must instruct your banker, broker or other nominee that you wish to revoke or resubmit your vote by following the procedures on the voting card provided to you by the bank, broker or other nominee.

 

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Quorum

The representation online or by proxy of holders of a majority of the voting power of the shares of Eliem common stock entitled to vote at the Meeting is necessary to constitute a quorum for the transaction of business at the Meeting. For purposes of determining the presence of a quorum, abstentions (meaning, for purposes of this proxy statement, an Eliem stockholder who attends the Meeting in person via the Internet and does not vote or returns a proxy with “abstain” instructions) will be counted as present at the Meeting. Shares present virtually during the Meeting will be considered shares of common stock represented online at the meeting.

Vote Required

Approval of Proposal No. 1 requires that Eliem obtain both the Baseline Vote and the Disinterested Stockholder Approval:

 

  i.

The Baseline Vote requires the affirmative vote of a majority in voting power of the votes cast by holders of the outstanding shares of Eliem common stock entitled to vote in accordance with the DGCL.

 

  ii.

The Disinterested Stockholder Approval requires the affirmative vote of a majority of the aggregate voting power of the outstanding shares of Eliem common stock entitled to vote thereon other than any outstanding shares of Eliem common stock beneficially owned, directly or indirectly, by (1) Tenet, (2) any stockholder of Tenet, including RA Capital Management, (3) any individual that Eliem has determined to be an “officer” of Eliem within the meaning of Rule 16a-1(f) of the Exchange Act, (4) any PIPE Investor, (5) any “immediate family member” (as defined in Item 404 of Regulation S-K) of any individual listed in the foregoing clauses (1)-(4), and (6) any “affiliate” or “associate” (as defined in Section 12b-2 of the Exchange Act) of any person listed in the foregoing clauses (1)-(5).

Approval of Proposal No. 2 requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote thereon.

For Proposal No. 3, the election of each director nominee requires the plurality of votes of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote generally on the election of directors.

Approval of Proposal No. 4 requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and voting affirmatively or negatively on such matter.

Proposal No. 1 is a condition to the completion of the Acquisition. Therefore, the Acquisition cannot be consummated without the approval of Proposal No. 1. The issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement, or Proposal No. 1, will not take place unless approved by the requisite Eliem stockholders and the Acquisition is consummated.

Votes will be counted by the inspector of election appointed for the meeting, who will separately count (i) with respect to all Proposals other than Proposal No. 3, “FOR” and “AGAINST” votes, abstentions and broker non-votes and (ii) with respect to the election of each director in Proposal No. 3 “FOR” votes, “WITHHOLDS” and broker non-votes.

If you are a stockholder of record and you do not vote by virtue of not being present virtually or by proxy at the Meeting, your shares will not be counted for purposes of determining the existence of a quorum. This will have no effect on the Adjournment Proposal. Assuming a quorum is present, this will have no effect on the Baseline Vote, the Election Proposal or the Ratification Proposal. If you are a Disinterested Stockholder, this will have the effect of a vote “AGAINST” the Disinterested Stockholder Approval.

 

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Abstentions (meaning an Eliem stockholder attends the Meeting in person via the Internet and does not vote or returns a proxy with “abstain” instructions) will be counted for the purpose of determining the existence of a quorum. Abstentions will have the effect of a vote “AGAINST” the Adjournment Proposal and, if you are a Disinterested Stockholder, “AGAINST” the Disinterested Stockholder Approval. Assuming a quorum is present, abstentions will have no effect on the Baseline Vote or Ratification Proposal.

With respect to the Election Proposal, you may either vote “FOR” the nominee to the Board of Directors or you may “WITHHOLD” your vote. A properly executed proxy marked “WITHHOLD” with respect to the election of a director will not be voted with respect to such director. Assuming a quorum is present and at least one share votes in favor of the election of such director, this will have no effect on the outcome of the Election Proposal.

Other Matters

As of the date of this proxy statement, the Eliem Board does not know of any business to be presented at the Meeting other than as set forth in the notice accompanying this proxy statement. If any other matters should properly come before the Meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.

 

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THE ACQUISITION

This section and the section titled “The Acquisition Agreement” beginning on page 83 of this proxy statement describe the material aspects of the Acquisition, including the Acquisition Agreement. While Eliem believes that this description covers the material terms of the Acquisition and the Acquisition Agreement, which is attached as Annex A to this proxy statement, and the other documents to which Eliem has referred to or incorporated by reference herein. For a more detailed description of where you can find those documents, please see the section titled “Where You Can Find More Information” beginning on page 184 of this proxy statement.

Background of the Acquisition

In an effort to enhance stockholder value, the Eliem Board and Eliem management regularly review and discuss Eliem’s near and long-term operating and strategic priorities. Among other things, these reviews and discussions focus on the opportunities and risks associated with Eliem’s development programs, financial condition and potential long-term strategic options.

In the fall of 2022, the Eliem Board and management performed a review of Eliem’s development pipeline, following its announcement in August 2022 of the discontinuation of further development of ETX-810, after ETX-810 did not achieve statistically significant separation from placebo on the primary endpoint of its Phase 2a clinical trial in lumbosacral radicular pain.

In connection with such review, on October 4, 2022, Eliem engaged Leerink Partners LLC (“Leerink Partners”) as exclusive financial adviser to assist with the Eliem Board’s evaluation of a range of strategic alternatives, including potential acquisitions, mergers, in-licenses of assets or other strategic transactions. The Eliem Board authorized the engagement of Leerink Partners based on Leerink Partners’ qualifications, reputation, experience and expertise in the biopharmaceutical industry, its knowledge of and involvement in recent transactions in the biopharmaceutical industry and its familiarity with Eliem and its business, as well as Leerink Partners’ familiarity with Eliem given that it had acted as an underwriter on Eliem’s initial public offering.

On October 6, 2022, the Eliem Board established a transaction committee (the “Transaction Committee”), composed of Dr. Andrew Levin, Dr. Liam Ratcliffe, and Simon Tate, to oversee Eliem’s review of its existing program and pipeline and the Eliem Board’s evaluation, with the assistance of Leerink Partners, of potential strategic alternatives.

From October 6, 2022 through January 8, 2023, the Transaction Committee oversaw the evaluation and engagement in exploratory discussions with a number of potential counterparties, including evaluating 40 potential counterparties for various forms of strategic transactions. During this time, the Eliem Board had discussed and agreed upon the proposed criteria that would be used to evaluate any potential strategic counterparty, consisting of: the inherent attractiveness of the counterparty’s technology and development pipeline, including likelihood of applicable regulatory and marketing authorization and success, potential value inflection milestones in the relative near term, including within the anticipated cash runway period following the closing of a transaction; quality of management, board and investor base, including an ability to attract additional investment in connection with a strategic transaction; competitive differentiation; ability to fund operations following closing; and proposed relative valuations and pro forma ownership splits of the combined company’s equity (the “Criteria”). At the direction of the Transaction Committee, Leerink Partners, on behalf of Eliem, engaged in preliminary discussions with eleven of these potential counterparties, selected based on the Criteria. Eight of those potential counterparties submitted non-binding indications of interest, and the Transaction Committee directed Eliem management and Leerink Partners to engage in exploratory discussions with two of such potential counterparties, selected based on a combination of the Criteria and the attractiveness of such parties’ proposals. However, following such exploratory discussions and continued evaluation of Eliem’s existing pipeline, the Eliem Board, at a meeting held on January 8, 2023, determined not to pursue any strategic transaction with any counterparty and instead determined to focus Eliem’s efforts on development of ETX-155 and its preclinical Kv7 program for epilepsy.

 

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On February 7, 2023, the Eliem Board determined to re-prioritize Eliem’s pipeline to focus on its Kv7 program, including ETX-123, and to pause all further development of ETX-155. In connection with such change in priorities, the Eliem Board approved a reorganization plan to conserve financial resources and better align Eliem’s workforce with its business needs. Eliem at this time also announced the departure of certain members of management, and the appointment of Dr. Andrew Levin, Chairman of the Eliem Board, as Executive Chairman of Eliem. Eliem publicly announced this reorganization plan on February 9, 2023.

On June 20, 2023, the Eliem Board held a meeting by videoconference, at which representatives of Eliem management were present. During the meeting, representatives of Eliem management reviewed with the Eliem Board the status of Eliem’s Kv7 program, including ETX-123. The Eliem Board and representatives of Eliem management discussed potentially pausing further development of its Kv7 program and reinitiating its process with Leerink Partners (under the October 2022 engagement letter, which remained in effect) to again explore and evaluate potential strategic alternatives. The Eliem Board directed the Transaction Committee and representatives of Eliem management to engage with Leerink Partners to discuss and begin outreach to potential counterparties, to be identified based on the Criteria, regarding a potential strategic transaction, as well as to finalize communications related to the Eliem Board’s determinations.

Between June 20, 2023 and July 21, 2023, members of the Transaction Committee and representatives of Eliem management and Leerink Partners identified and evaluated potential counterparties, and, pursuant to the Eliem Board’s prior direction, initiated outreach to such potential counterparties.

On July 19, 2023, the Eliem Board held a meeting by videoconference, at which representatives of Eliem management and Leerink Partners were present. During the meeting, the Eliem Board reviewed Eliem’s business results, strategy and outlook, including the status of ETX-123 and its Kv7 program. Following discussion, the Eliem Board determined to pause further development of its Kv7 program. Further, at the meeting, representatives of Leerink Partners reviewed potential strategic alternatives for Eliem, including reviewing with the Eliem Board potential counterparties to a strategic transaction, which represented parties identified by representatives of Eliem management and Leerink Partners that had previously been identified in the prior outreach as potentially meeting the Criteria identified by the Eliem Board. Representatives of Eliem management and Leerink Partners and members of the Eliem Board also discussed the competitive landscape in which Eliem operated, as well as current conditions in the capital markets and the economic environment more generally. Following discussion, the Eliem Board authorized and directed representatives of Eliem management and Leerink Partners to continue to, based on the previously identified Criteria, contact potential strategic counterparties to gauge their interest in a strategic transaction with Eliem.

On July 20, 2023, Eliem publicly announced that it had determined to halt further development of its Kv7 program and would conduct a comprehensive exploration of strategic alternatives focused on enhancing stockholder value, including potential acquisitions of other assets and product candidates and further evaluation of its existing development pipeline and assets. At the same time, Eliem publicly announced that it had retained Leerink Partners to act as its strategic adviser in that process.

During June and July of 2023, at the direction of the Eliem Board, the Transaction Committee and representatives of Eliem management and Leerink Partners evaluated a list of 115 potential counterparties, and, based on the Criteria, determined to contact 16 such potential counterparties, which included private companies who would be candidates to engage in a merger with Eliem.

From July 2023 through October 2023, members of the Transaction Committee and representatives of Eliem management and Leerink Partners engaged in exploratory discussions with 13 potential counterparties, six of which submitted non-binding proposals, and five of which made management presentations to Eliem. Each such potential counterparty proposed a merger transaction, and the valuations ascribed to Eliem in the proposed stock-for-stock merger transactions ranged from $85.0 million to $116.0 million, in each case with pre-closing Eliem equityholders owning a minority of the combined company. None of the non-disclosure agreements Eliem

 

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executed with any of these potential counterparties, or any other counterparty with whom Eliem engaged from October 2022 through January 2024, included any “don’t ask / don’t waive” provisions or standstills.

While the Transaction Committee determined to prioritize three of the six potential counterparties that submitted non-binding proposals to engage in exploratory discussions during this time, none of the discussions progressed to the exchange of definitive documentation, and each of the three engaged in exploratory discussions ultimately withdrew their respective proposals and terminated discussions with Eliem, in each case citing a preference for alternatives to a transaction with Eliem, including focusing on operating as stand-alone companies and raising capital independently.

From November 2023 to January 2024, the Eliem Board directed Leerink Partners to contact two potential counterparties that had previously expressed an interest in a strategic transaction with Eliem to determine if either would be interested in resuming discussions in respect of a potential transaction. One of these potential counterparties made a management presentation to representatives of Eliem and Leerink Partners in January 2024. Each of these two potential counterparties declined to resume discussions by the beginning of February 2024.

As a result, by the beginning of February 2024, Eliem was not in active discussions with any potential counterparty regarding any potential strategic transaction, as all such discussions had been terminated by the potential counterparties.

On February 2, 2024, Dr. Levin, acting on behalf of RA Capital Management, introduced Tenet, a privately held company majority owned and controlled by RA Capital Management and its affiliates, to Leerink Partners, as a potential counterparty for a strategic transaction for consideration by the Eliem Board. As noted further below, Dr. Levin is a partner and managing director at RA Capital Management, affiliates of which owned approximately 47.5% of the outstanding shares of Eliem. At the direction of Eliem, Leerink Partners arranged for the execution of a non-disclosure agreement between Eliem and Tenet on February 2, 2024. The non-disclosure agreement did not include any “don’t ask / don’t waive” provisions or standstill.

Between February 2, 2024 and February 19, 2024, representatives of Eliem management and Leerink Partners engaged in business and research and development due diligence of Tenet. During this period, representatives of Eliem management and Leerink Partners, Tenet management and Dr. Levin, acting on behalf of RA Capital Management, discussed various aspects of a potential acquisition of Tenet by Eliem, including potential transaction structures and timelines, as well as the view of Tenet management and RA Capital Management that a concurrent financing of the combined company would be a condition to support for a transaction. In the course of these discussions, Dr. Levin, on behalf of RA Capital Management, informed representatives of Eliem management and Leerink Partners that Tenet and RA Capital Management were likely to support a transaction which valued the combined company at $130.0 million, with $100.0 million ascribed to Eliem and $30.0 million ascribed to Tenet. The proposed valuation of Tenet was, according to Tenet and RA Capital Management, based on Tenet’s stage of development, assets, prospects, valuations of similarly- situated companies, as well as the valuations certain potential investors had indicated they would support in a private financing of Tenet. Tenet management and Dr. Levin, on behalf of RA Capital Management, also stated that it was Tenet’s and RA Capital Management’s expectation that the potential investors in a Tenet private financing, including RA Capital Management, would likely be supportive of investing in a financing of a combined Tenet and Eliem. Representatives of Eliem management and Leerink Partners stated they would discuss these terms with the Eliem Board, and further noted that the Eliem Board intended to create a special committee of independent, disinterested directors to oversee the process related to any potential transaction with Tenet.

On February 8, 2024, management of Tenet presented to the Eliem Board and representatives of Eliem management and Leerink Partners regarding Tenet’s pipeline, history, product candidates and business strategy.

On February 19, 2024, the members of the Eliem Board, other than Dr. Levin who had recused himself from Eliem deliberations regarding a potential transaction with Tenet, held a meeting by teleconference, at which

 

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representatives of Eliem management, Leerink Partners and Wilmer Cutler Pickering Hale and Dorr LLP, recently retained counsel for Eliem (“WilmerHale”), were present. The Eliem Board selected WilmerHale given its expertise and experience with similar transactions to the proposed transaction with Tenet, as well as its knowledge of the industry in which Eliem and Tenet operate. The members of the Eliem Board in attendance and representatives of Eliem management and Leerink Partners reviewed the status of Eliem’s strategic discussions and process to date, including with respect to initial discussions with, and due diligence with respect to, Tenet. Representatives of WilmerHale reviewed with the Eliem Board its fiduciary duties, including when potential conflicts are present. In particular, the Eliem Board observed that Dr. Andrew Levin, the Chairman of the Eliem Board and Executive Chairman of Eliem, is a partner and managing director at RA Capital Management, affiliates of which owned approximately 47.5% of the outstanding shares of Eliem, and, further, that affiliates of RA Capital Management owned a controlling majority of Tenet. At the meeting, the Eliem Board discussed the establishment of a special committee composed solely of independent and disinterested directors, to oversee and direct Eliem’s evaluation of strategic alternatives, including any potential transaction with Tenet and/or financing in which RA Capital Management or its affiliates participated. The members of the Eliem Board identified Dr. Liam Ratcliffe, Simon Tate and Dr. Judith Dunn as independent, disinterested directors who could serve on such a special committee. Finally, representatives of Leerink Partners reviewed with the Eliem Board the indicative, oral terms that had been raised by Dr. Levin and representatives of Tenet, namely proposed relative valuations of $100.0 million for Eliem and $30.0 million for Tenet, reflecting an implied exchange ratio of approximately 76.9% for pre-closing Eliem equityholders and 23.1% for pre-closing Tenet equityholders. Representatives of Eliem management and Leerink Partners reviewed with the Eliem Board Tenet’s assets, operations and business, including the status of its development program, and, following discussion, the Eliem Board directed representatives of Eliem management and Leerink Partners to seek improvement in the proposed terms with Tenet, including improvement in the relative valuations, and to negotiate for a limit of $70.0 million on the amount of any concurrent financing to be conducted in connection with the proposed acquisition.

Later on February 19, 2024, representatives of Leerink Partners met by teleconference with Dr. Levin, who provided perspective on behalf of RA Capital Management. During the meeting, representatives of Leerink Partners informed Dr. Levin of the Eliem Board’s determinations regarding the need to increase the valuation ascribed to Eliem as well as regarding the appropriate size of any concurrent financing. In the discussion, Dr. Levin indicated that a concurrent financing was, in the view of RA Capital Management, critical to successful execution of any transaction. Further, Dr. Levin expressed tentative support, on behalf of RA Capital Management, for revised valuations of $110.0 million ascribed to Eliem and $20.0 million ascribed to Tenet, but noted that investors in the concurrent financing, including RA Capital Management, were, he believed, unlikely to support an aggregate valuation of the combined company of more than $130.0 million. Dr. Levin also re-iterated the view of RA Capital Management that a substantial concurrent financing was a necessary condition to a transaction, and suggested to Leerink Partners that, when formed, the committee of independent, disinterested directors of the Eliem Board send a term sheet reflecting its proposal as soon as practicable.

On February 21, 2024, the full Eliem Board established, by written consent, a special committee, composed solely of independent, disinterested directors: Dr. Liam Ratcliffe, Dr. Judith Dunn, and Simon Tate, with Dr. Ratcliffe appointed chair (the “Special Committee”). The Eliem Board delegated authority to the Special Committee to, among other things: review, evaluate and negotiate the terms and conditions, and determine the advisability, of a potential strategic transaction, including any potential transaction with Tenet; establish, approve, monitor and direct the process and procedure related to the review, evaluation and negotiation of a potential transaction and any alternatives thereto, including to determine not to proceed with any such process, procedures or transaction; respond to any communications, inquiries or proposals regarding any potential transaction; make or accept, reject, negotiate or seek to modify the price, structure, form, terms and conditions of a potential transaction; retain advisors; and recommend to the full Eliem Board what action, if any, should be taken by the Elien Board and Eliem with respect to any potential strategic transaction. Further, the Eliem Board resolved not to approve a potential transaction, or recommend a potential transaction to Eliem stockholders, without the prior favorable recommendation of the Special Committee, and directed representatives of Eliem management, Leerink Partners and WilmerHale to evaluate structures for the transaction, including conditioning

 

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the transaction on a non-waivable condition that the transactions must be approved by holders of a majority of outstanding shares of Eliem common stock, other than RA Capital Management and its affiliates.

On February 22, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. Representatives of WilmerHale reviewed with the Special Committee its fiduciary duties, as well as its rights and powers as delegated by the full Eliem Board. Representatives of Eliem management and Leerink Partners reviewed with the Special Committee the status of discussions and Eliem’s strategic review process to date, including the potential counterparties contacted, the proposals previously received, and the fact that, other than Tenet, each party with whom Eliem had engaged in discussions had withdrawn all prior proposals and unilaterally terminated discussions with Eliem. Further, Leerink Partners confirmed to the Special Committee that it had recontacted the potential counterparties that had previously submitted proposals to Eliem, and each of them had reconfirmed they were not interested in resuming discussions regarding a potential strategic transaction, as such potential counterparties remained focused on other alternatives. Representatives of Eliem management and Leerink Partners then reviewed with the Special Committee the terms of a proposed non-binding term sheet to be sent by Eliem to Tenet. The draft term sheet reflected the proposed acquisition of Tenet by Eliem, with the aggregate consideration being a number of newly issued shares of Eliem common stock determined based on relative valuations which valued Tenet at $20.0 million and Eliem at $110.0 million, reflecting an anticipated pro forma ownership split of approximately 84.6% for pre-closing equityholders of Eliem and 15.4% for pre-closing equityholders of Tenet. The term sheet did not contemplate any adjustments to such implied exchange ratio, other than to account for the number of outstanding shares of Eliem as of the closing. The term sheet also contemplated a concurrent private placement of not more than $70.0 million into the combined company as of immediately after the closing. The term sheet also proposed that the post-closing board of directors of the combined company would consist of six directors, with five being the existing directors of Eliem and one director to be designated by Tenet. Representatives of Eliem management and Leerink Partners reviewed these terms with the Special Committee, including that the valuation of Eliem ascribed in the transaction reflected a significant premium to Eliem’s existing trading price and was at the highest end of the range of valuations any other party had ascribed to Eliem in prior discussions, while the potential transaction, as it represented an acquisition and not a merger and pre-closing Eliem stockholders would continue to own a substantial majority of the combined company, preserved flexibility to evaluate and potentially engage in additional strategic transactions in the future. Following discussion, the Special Committee directed Leerink Partners to distribute the term sheet to Tenet. Following the meeting, Leerink Partners distributed the non-binding term sheet to Tenet.

On February 23, 2024, representatives of Cooley LLP (“Cooley”), counsel to Tenet, sent to WilmerHale a revised draft of the non-binding term sheet. The term sheet accepted the proposed relative valuations of $110.0 million for Eliem and $20.0 million for Tenet, but proposed, among other things, an increase in the size of the concurrent financing to $100.0 million, and that the board of directors of the combined company would be composed of four current directors of Eliem, one director designated by Tenet (to be filled by Dr. Stephen Thomas, Tenet chief executive officer), one director designated by an investor in the concurrent financing, and one seat left vacant to be filled by the permanent chief executive officer of the combined company. The term sheet also proposed that Dr. Thomas would serve as interim chief executive officer of the combined company and other members of Tenet management would serve similar interim roles with the combined company.

On February 27, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Leerink Partners and representatives of Eliem management discussed with the Special Committee the terms of the revised non-binding term sheet from Tenet, including the relative valuations of the companies, Tenet’s pipeline, the fact that an acquisition of Tenet would preserve flexibility for Eliem to continue to add to its pipeline or engage in future strategic transactions, and the additional capital represented by the proposed concurrent private financing. The Special Committee also discussed with representatives of Eliem management and Leerink Partners the Tenet management team, their knowledge of Tenet’s assets, and the potential, through the transaction, to engage a knowledgeable interim management team while preserving flexibility to identify and

 

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hire a permanent chief executive officer. Representatives of Eliem management and Leerink Partners also reviewed with the Special Committee the due diligence findings to date regarding Tenet. Representatives of WilmerHale then reviewed with the Special Committee its fiduciary duties and certain legal considerations with respect to a potential transaction with Tenet, including as a result of RA Capital Management’s ownership positions in each of Tenet and Eliem and Dr. Levin’s roles with Eliem and RA Capital Management. The Special Committee determined that the approval of the Eliem Board of any transaction with Tenet must be conditioned on approval by a committee of the Eliem Board composed entirely of independent, disinterested directors, and a non-waivable condition requiring approval of Eliem stockholders holding at least a majority of all issued and outstanding shares of Eliem common stock not held by RA Capital Management or its affiliates. The Special Committee directed representatives of Leerink Partners, Eliem management, and WilmerHale to continue engaging with Tenet, including regarding the structure of, and conditions to, the transaction, the composition of the post-closing board and management, the proposed concurrent financing and the proposed aggregate amount of gross proceeds, and other aspects of the term sheet.

Later on February 27, 2024, Tenet communicated to representatives of Leerink Partners and Eliem management that it had delivered a notice to Acelyrin, the counterparty to its asset purchase agreement pursuant to which it obtained its license rights to TNT119, its lead asset, regarding the potential transaction with Eliem, including that the proposed transaction would not constitute a “right of first negotiation” transaction under such asset purchase agreement, though Tenet stated it would nonetheless comply with the required waiting period under that agreement.

On February 29, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Leerink Partners and Eliem management reviewed with the Special Committee the status of discussions with Tenet, including that Tenet had delivered a notice to Acelyrin under its asset purchase agreement and was complying with the required waiting period under that agreement, noting the impact of this notice on the timeline to potentially signing and announcing a transaction. Representatives of Eliem management reviewed with the Special Committee the due diligence findings to date regarding Tenet, including with respect to clinical, regulatory and licensing matters.

Later on February 29, 2024, the Special Committee and representatives of Eliem management and Leerink Partners held a meeting by videoconference with Tenet management to conduct additional due diligence on Tenet. During this meeting, Tenet management answered questions submitted by the Special Committee and members of Eliem management, focusing on business, strategic, financial, scientific, and clinical diligence as well as with respect to Tenet management’s initial financial projections for Tenet. Following this meeting, Tenet management shared its financial projections for Tenet.

On March 5, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management reviewed with the Special Committee the results of several due diligence calls held with representatives of Tenet, as well as updates regarding other due diligence findings. Representatives of Leerink Partners and representatives of Eliem management further discussed the terms of any revised non-binding term sheet from Eliem, including that the per share price in any concurrent financing would be determined based on the implied combined company valuation set forth in the term sheet, which implied a significant premium to the trading price of Eliem’s common stock.

On March 11, 2024, Acelyrin confirmed to Tenet that it agreed that a proposed transaction between Eliem and Tenet would not constitute a “right of first negotiation” transaction.

On March 13, 2024, WilmerHale sent to Cooley a draft non-binding term sheet reflecting the terms authorized by the Special Committee on March 5, 2024, which provided for, among other things: (1) the proposed implied exchange ratio for the transaction valuing Eliem at $110.0 million as of the closing, while Tenet would be valued at $20.0 million (and, as a result, (i) the pre-closing equityholders of Tenet would own 15.4% of the equity of the combined company on a fully diluted basis and (ii) the pre-closing equityholders of Eliem would own 84.6% of the equity of the combined company on a fully diluted basis (calculated via the treasury stock method); (2) in

 

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connection with the closing of the proposed transaction, a concurrent private placement of common stock of Eliem would be effected at or as of immediately after the closing, in an aggregate amount to be mutually determined by the parties; (3) the post-closing board of directors of Eliem would consist of seven directors, the composition of which would satisfy applicable U.S. Securities and Exchange Commission (“SEC”) and Nasdaq listing requirements, and that the specific composition of the board of directors would be determined by the parties during negotiation of a definitive agreement; and (4) conditions to approval of the transaction by the Eliem Board would include approval by a special committee of independent and disinterested directors of Eliem, and a non-waivable condition requiring approval of the stockholders holding at least a majority of all the issued and outstanding shares of Eliem common stock not held by the RA Capital Management or its affiliates.

On March 14, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management updated the Special Committee that Acelyrin had confirmed to Tenet that the proposed transaction with Eliem would not constitute a “right of first negotiation” transaction, and further that WilmerHale had sent to Tenet’s counsel a revised non-binding term sheet reflecting the terms previously authorized by the Special Committee. Representatives of Eliem management then further reviewed the status of due diligence with respect to Tenet. Representatives of Leerink Partners then confirmed to the Special Committee that Leerink Partners had not identified any conflicts of interest on the part of Leerink Partners with respect to either Tenet or RA Capital Management. Following discussion, the Special Committee determined that Leerink Partners was appropriately independent with respect to the proposed transaction with Tenet, and that it was not necessary to retain a second financial advisor to deliver a fairness opinion or otherwise act as financial advisor for the Special Committee and Eliem Board. Lastly, representatives of Eliem management advised the Special Committee that Tenet and its counsel had indicated that Tenet would be sending a non-binding term sheet to Eliem later that day, which Tenet had indicated would reflect substantial agreement with the term sheet previously sent by Eliem, and representatives of WilmerHale advised the Special Committee that internal counsel at RA Capital Management had indicated that RA Capital Management expected to file an amendment to RA Capital Management’s Schedule 13D filing in connection with the delivery of such non-binding term sheet. Following discussion, the Special Committee directed representatives of Eliem management, Leerink Partners and WilmerHale to, assuming the revised term sheet from Tenet reflected alignment between the parties, to prepare definitive documentation for the transaction and to work with representatives of Tenet to begin outreach to potential investors for the concurrent financing, including that the price per share in any concurrent financing would be based on the proposed combined company valuation of $130.0 million set forth in the term sheet, which implied a significant premium to the trading price of Eliem’s common stock.

Later on March 14, 2024, Cooley sent to WilmerHale a draft non-binding term sheet, which was substantially consistent with the non-binding term sheet sent by Eliem to Tenet on March 13, 2024, and which noted that the composition of the post-closing board of directors would be determined by the parties during the negotiation of the definitive documentation.

On March 15, 2024, representatives of Tenet, Cooley and WilmerHale initiated outreach to potential investors for the concurrent financing.

On March 18, 2024, RA Capital Management publicly filed an amendment to its Schedule 13D, which summarized the material terms of the non-binding term sheet sent by Tenet on March 14, 2024 (but which referred to Tenet by a codename, “Tango”) and included the term sheet as an exhibit. Later on March 18, 2024, Eliem filed a Current Report on Form 8-K which acknowledged the receipt of the non-binding term sheet from Tenet (also identified by the codename Tango), and further stating that there was no assurance any transaction with Tango or any other party would be consummated, and that any transaction with Tango would be subject to various conditions, including but not limited to, (i) the satisfactory completion of due diligence by both parties, (ii) the negotiation and execution of a definitive agreement and the satisfaction of the conditions negotiated therein, (iii) the approval and recommendation of any such transaction by the Special Committee, and (iv) a non-waivable condition requiring approval of the stockholders of Eliem holding a majority of the voting power of the outstanding shares of Eliem not held by RA Capital Management or its affiliates.

 

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During the period from March 14, 2024 to April 10, 2024 representatives of Eliem and representatives of Tenet completed confirmatory due diligence and representatives of WilmerHale and Cooley negotiated the terms of the Acquisition Agreement drafted by WilmerHale, including with respect to the calculation of the aggregate consideration, the representations and warranties and operating covenants of each party, the amount of the termination fees and expense reimbursement, non-solicitation provisions, the indemnification provisions, and the terms of the forms of support agreement, lock-up agreements and other ancillary agreements to the transactions. Also during this period, representatives of Eliem and Tenet engaged in discussions with potential investors for the concurrent private placement, including with respect to finalizing the securities purchase agreement and other relevant transaction documents.

On March 21, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management, Leerink Partners and WilmerHale reviewed with the Special Committee the terms of the proposed non-binding term sheet from Tenet. Following discussion, and on the basis of the term sheet, the Special Committee directed representatives of Eliem management, WilmerHale, and Leerink Partners to negotiate definitive documents for the proposed transaction. Representatives of Eliem management also reviewed with the Special Committee the status of discussions regarding the Private Placement, including that, based on initial feedback, demand for the concurrent financing was likely to exceed $100.0 million, as well as initial indications of allocations among potential investors. Representatives of Eliem management and the Special Committee further discussed the process for evaluating Dr. Thomas, as proposed interim chief executive officer for Eliem, and the other interim members of management. The Special Committee directed representatives of Eliem management to arrange meetings between Mr. Thomas and members of the Special Committee and Eliem’s nominating and corporate governance committee.

On March 24, 2024, representatives of Eliem management, Leerink Partners and Tenet management met by videoconference to review and discuss Tenet’s financial projections, including regarding the underlying assumptions and potential adjustments to such assumptions. Representatives of Eliem management, Leerink Partners and Tenet management met again on March 28, 2024 to discuss follow-up items from the March 24, 2024 meeting.

On March 29, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management and WilmerHale reviewed with the Special Committee updates regarding the status of discussions and negotiations, including with respect to the proposed concurrent financing and the proposed investor allocations among investors. Representatives of Eliem management and WilmerHale further reviewed with the Special Committee the anticipated timeline for the transaction. Representatives of Eliem management then reviewed with the Special Committee proposals from Tenet regarding the post-closing compensation for the interim chief executive officer and other interim members of management, and further noted that representatives of Eliem management was seeking input from Eliem’s compensation consultant regarding such proposals.

On April 1, 2024, representatives of Eliem management and Leerink Partners held a meeting by videoconference with Tenet management to discuss adjustments to Tenet’s financial projections, as initially prepared by Tenet management and as adjusted by representatives of Eliem management. From April 1, 2024 through April 5, 2024, representatives of Eliem management, with the assistance of Leerink Partners, reviewed and adjusted the financial projections provided by Tenet, and representatives of Eliem management circulated its adjusted Tenet financial projections to the Special Committee.

On April 5, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management, Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management, Leerink Partners and WilmerHale reviewed with the Special Committee the status of due diligence, discussions and negotiations regarding the draft Acquisition Agreement and regarding the Private Placement. In particular, representatives of Eliem management reviewed with the Special Committee the investor demand for the Private Placement, including that the demand would likely support aggregate gross proceeds of $120.0 million, and that investors had agreed that the per share price in the Private Placement would be

 

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determined based on an indicative $130.0 million valuation for the combined company, which implied a significant premium to the trading price of Eliem’s common stock. Further, representatives of Eliem management reviewed with the Special Committee proposed investor allocations for the Private Placement, noting that, following discussions, RA Capital Management would be investing an amount in the Private Placement which would result in its post-closing ownership percentage of Eliem to be approximately 48.5%, which would be substantially unchanged from its ownership percentage of Eliem prior to the closing. The Special Committee and representatives of Eliem management and Leerink Partners reviewed the Financial Projections, which had originally been prepared by Tenet and were adjusted by representatives of Eliem management, which, following discussion and further input from the Special Committee, the Eliem Special Committee believed were reasonable for transactions in the biotechnology industry, including in light of, among other things, the applicable projections period, the expected timelines to regulatory approval, the anticipated period of patent term exclusivity for the product candidates if approved, and the other assumptions underlying such Financial Projections. Further, representatives of Eliem management reviewed with the Special Committee information from Eliem’s compensation consultant regarding the requested salaries and compensation packages for Mr. Thomas and the other proposed interim members of management, determining they were above market for similarly situated persons. The Special Committee directed representatives of Eliem management to continue to engage with Eliem’s compensation consultant regarding the compensation proposals from Tenet, and to provide such feedback to Tenet management. Lastly, members of the Special Committee reviewed feedback from the one-on-one interviews of Mr. Thomas, and, following discussion, determined that Mr. Thomas was qualified to act as interim chief executive officer of Eliem following the closing given his knowledge and expertise with respect to the acquired assets and his effectiveness in the fundraising process for the Private Placement.

Later on April 5, 2024, representatives of Leerink Partners, on behalf of representatives of Eliem management and the Special Committee, circulated to the Special Committee the final version of the Financial Projections, reflecting the input and feedback from the Special Committee and representatives of Eliem management.

On April 9, 2024, the Special Committee held a meeting by videoconference in which representatives of Eliem management and representatives of Leerink Partners and WilmerHale were present. During the meeting, representatives of Eliem management, Leerink Partners and WilmerHale reviewed with the Special Committee the status of negotiations to date, including with respect to the definitive documentation for the transactions and the final allocations for the Private Placement. Among other things, representatives of Eliem management reviewed with the Special Committee the revised proposal from Tenet personnel regarding their respective post-closing compensation, including with respect to equity awards, noting that the revised proposal was within the ranges recommended by Eliem’s compensation consultant. Following discussion, the Special Committee directed representatives of Eliem management, Leerink Partners and WilmerHale to finalize the documentation for the Acquisition, Private Placement and related matters.

On April 10, 2024, the Special Committee and the Eliem Board held a joint meeting at which representatives of Eliem management, Leerink Partners, and representatives of WilmerHale were present. During the meeting, the representatives of WilmerHale reviewed the fiduciary duties of the Eliem Board and Special Committee in connection with the proposed transaction with Tenet, and the terms of the Acquisition Agreement, forms of support agreement and form of lock-up agreement, as well as the terms of the securities purchase agreement and registration rights agreement with respect to the Private Placement. Representatives of Leerink Partners then reviewed Leerink Partners’ financial analysis with respect to the proposed financial terms of the Acquisition. At the request of the Special Committee and the Eliem Board, Leerink Partners then rendered to the Special Committee and Eliem Board its oral opinion, which was subsequently confirmed by delivery of a written opinion dated April 10, 2024, that, as of such date and based upon and subject to the assumptions made, and the qualifications and limitations upon the review undertaken by Leerink Partners in preparing its opinion, the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement was fair, from a financial point of view, to Eliem. The Special Committee and the Eliem Board then discussed various considerations with respect to the proposed transaction, as summarized under “Eliem’s Reasons for the Acquisition and the Private Placement” in this proxy statement. The Acquisition Agreement, securities purchase

 

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agreement with respect to the Private Placement, and the other agreements contemplated thereby were each in final form as presented to the Special Committee and Eliem Board for approval. Following discussion and the presentations, the members of the Special Committee unanimously recommended to the Eliem Board that the Eliem Board approve the Acquisition Agreement and the transactions contemplated by the Acquisition Agreement, including the Private Placement. Thereafter, the Eliem Board unanimously approved the Acquisition Agreement and the transactions contemplated by the Acquisition Agreement and authorized Eliem management to execute the Acquisition Agreement on behalf of Eliem.

Subsequently on April 10, 2024, Eliem and Tenet executed the Acquisition Agreement and the parties executed the support agreements, lock-up agreements, as well as the securities purchase agreement with respect to the Private Placement. On April 11, 2024 in advance of the opening for trading on Nasdaq, Eliem and Tenet issued a joint press release announcing the execution of the Acquisition Agreement and the securities purchase agreement for the Private Placement, and Eliem filed a Current Report on Form 8-K with the SEC announcing the execution of the Acquisition Agreement and the securities purchase agreement for the Private Placement.

Eliem’s Reasons for the Acquisition and the Private Placement

During the course of its evaluation of the Acquisition Agreement and the transactions contemplated by the Acquisition Agreement, each of the Eliem Board and the Special Committee held numerous meetings, consulted with Eliem’s senior management and legal counsel, and reviewed and assessed a significant amount of information. In reaching its decision to approve the Acquisition Agreement and the other transactions contemplated by the Acquisition Agreement, including the Private Placement, the Special Committee, in connection with its determination and recommendation to the Eliem Board, and the Eliem Board, following such recommendation by the Special Committee, considered a number of factors that it viewed as supporting its decision to approve the Acquisition Agreement and the other transactions contemplated by the Acquisition Agreement, including the Private Placement, including:

 

   

the Acquisition can strengthen Eliem’s pipeline of development assets, including by the addition of Tenet’s TNT119, an anti-CD19 antibody, designed for a broad range of autoimmune diseases, including SLE, ITP and MN;

 

   

the financial condition and prospects of Eliem and the risks associated with continuing to operate Eliem on a stand-alone basis, particularly in light of Eliem’s July 2023 decision to halt further development of its Kv7 program;

 

   

the implied valuation of Eliem in the Acquisition and the Private Placement represented a significant premium to the market price of Eliem’s common stock;

 

   

the Special Committee, the Eliem Board and Eliem management undertook a comprehensive and thorough process of reviewing and analyzing potential strategic transactions as well as sources of

 

   

the Special Committee’s and, following the Special Committee’s recommendation, the Eliem Board’s belief, after a thorough review of strategic and capital raising alternatives and discussions with Eliem’s senior management and financial and legal advisors, that the Acquisition, together with the Private Placement, is more favorable to Eliem stockholders than other reasonably available alternative strategic and capital raising transactions, and further that Post-Closing Eliem may continue to evaluate other strategic and capital raising transactions following consummation of the Acquisition and the Private Placement;

 

   

the transactions provide access to capital to identify additional future opportunities that would, in the view of the Special Committee and the Eliem Board, be the most reasonably likely to create the most value for Eliem stockholders;

 

   

the Special Committee’s and, following the Special Committee’s recommendation, the Eliem Board’s belief that, as a result of arm’s length negotiations with Tenet, the terms of the Acquisition Agreement,

 

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including of the amount of the Aggregate Consideration, represents the most favorable terms to Eliem in the aggregate to which Tenet was willing to agree;

 

   

the Special Committee’s and the Eliem Board’s consideration of the expected cash balance of Post-Closing Eliem following the closing of the Acquisition and the Private Placement, and that as a result of such capital, Post-Closing Eliem would possess sufficient cash resources following the closing of the Acquisition to fund development of Post-Closing Eliem’s product candidates through upcoming value inflection points;

 

   

the market and commercial opportunity presented by Tenet’s TNT119 product candidate, including the Financial Projections (as defined below) prepared by Eliem management, which projections the Special Committee and the Eliem Board believed were reasonable given the underlying assumptions as further described under “The Acquisition—Certain Unaudited Financial Projections”;

 

   

the Special Committee’s and the Eliem Board’s view that Post-Closing Eliem will be led by an experienced board of directors and an interim management team with a deep understanding of Post-Closing Eliem’s product candidates, and that Post-Closing Eliem would be well positioned to identify and hire experienced permanent management;

 

   

the fact that the Eliem Board determined to follow, and did follow, a strategic review process whereby Eliem would only proceed with a transaction with Tenet or the Private Placement if the transactions were approved by the Special Committee (with the assistance of legal and financial advisors) and the consummation of such transactions were subject to a non-waivable condition requiring approval of at least a majority of the shares of Eliem common stock owned by stockholders other than RA Capital or its affiliates;

 

   

the current financial market conditions and historical market prices, volatility and trading information with respect to Eliem common stock; and

 

   

the opinion of Leerink Partners, rendered orally to the Special Committee and to the Eliem Board on April 10, 2024 (and subsequently confirmed by delivery of a written opinion dated April 10, 2024) that, as of such date and based upon and subject to the various assumptions made, and the qualifications and limitations upon the review undertaken by Leerink Partners in preparing its opinion, the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement was fair, from a financial point of view, to Eliem, as more fully described below under the caption “The Acquisition—Opinion of Leerink Partners LLC,” beginning on page 73 of this proxy statement.

The Special Committee and, following the Special Committee’s recommendation, the Eliem Board also reviewed the terms of the Acquisition Agreement and related transaction documents, including those described below, and concluded that the terms of the Acquisition Agreement and related transaction documents, in the aggregate, were reasonable under the circumstances:

 

   

the calculation of the Aggregate Consideration payable by Eliem, including the estimated number of shares of Eliem common stock to be issued in the Acquisition;

 

   

the number and nature of the conditions to Eliem’s and Tenet’s respective obligations to complete the Acquisition and the likelihood that the Acquisition will be completed on a timely basis;

 

   

the respective rights of, and limitations on, Eliem and Tenet under the Acquisition Agreement to consider and engage in discussions regarding unsolicited acquisition proposals under certain circumstances, and the limitations on the board of directors of each party to change its recommendation in favor of the Acquisition, as more fully described below under the caption “The Acquisition Agreement—Non-Solicitation,” beginning on page 87 of this proxy statement;

 

   

the potential termination fee of $1,000,000, in the case of the fee payable by Eliem, and related reimbursement of certain transaction expenses of up to $500,000, which could become payable by

 

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Eliem to Tenet if the Acquisition Agreement is terminated in certain circumstances, as more fully described below under the caption “The Acquisition Agreement—Termination and Termination Fees,” beginning on page 92 in this proxy statement;

 

   

the Lock-Up Agreements, pursuant to which certain stockholders of Eliem and Tenet, respectively, have, subject to certain exceptions, agreed not to transfer their shares of Eliem common stock during the period of 180 days following the completion of the Acquisition, as more fully described below under the caption “Agreements Related to the Acquisition and the Private Placement—Support Agreements and Lock-up Agreements—Lock-Up Agreements,” beginning on page 96 of this proxy statement; and

 

   

the support agreements, pursuant to which certain stockholders of Eliem and Tenet, respectively, have agreed, solely in their capacities as stockholders, to vote all of their shares of Eliem common stock or Tenet common stock in favor of the proposals submitted to them in connection with the Acquisition and against any alternative acquisition proposals, as more fully described below under the caption “Agreements Related to the Acquisition and the Private Placement—Support Agreements and Lock-up Agreements—Support Agreements,” beginning on page 95 in this proxy statement, and that Tenet stockholders would be required to deliver written consents representing adoption and approval of the Acquisition Agreement and the other transactions contemplated thereby within one business day of execution of the Acquisition Agreement.

In the course of its deliberations and in addition to the analyses and recommendation of the Special Committee, the Eliem Board also considered a variety of risks and other countervailing factors related to entering into the Acquisition and the Private Placement, including:

 

   

the potential effect of the $1,000,000 termination fee payable by Eliem and Eliem’s expense reimbursement obligations upon the occurrence of certain events in deterring other potential acquirors from proposing an alternative acquisition proposal that may be more advantageous to Eliem stockholders;

 

   

the prohibition on Eliem’s ability to solicit alternative acquisition proposals during the pendency of the Acquisition;

 

   

the substantial expenses to be incurred by Eliem in connection with the Acquisition and other contemplated transactions;

 

   

the possible volatility of the trading price of Eliem common stock resulting from the announcement, pendency or completion of the Acquisition;

 

   

the scientific, technical, regulatory and other risks and uncertainties associated with development and commercialization of Tenet’s TNT119 product candidate;

 

   

the risk that, even if Tenet’s product candidate is approved for sale, that the product fails to realize the benefits reflected in the Financial Projections, including because the numerous variables, estimates, and assumptions underlying the Financial Projections, which are by their nature difficult to predict and many of which are beyond the parties’ control, do not prove accurate; and

 

   

the various other risks associated with Post-Closing Eliem and the transaction, including those described in the sections titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in this proxy statement.

The foregoing information and factors considered by the Special Committee and, following the Special Committee’s recommendation, the Eliem Board are not intended to be exhaustive but are believed to include all of the material factors considered by the Special Committee and the Eliem Board. In view of the wide variety of factors considered in connection with its evaluation of the Acquisition and the complexity of these matters, the Special Committee and the Eliem Board did not find it useful, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of the Special Committee and the Eliem Board may have given different weight to different factors. The Special

 

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Committee and the Eliem Board conducted an overall analysis of the factors described above, including thorough discussions with, and questioning of, the Eliem management team and the legal advisors of Eliem, and considered the factors overall to be favorable to, and to support, its determination.

Interests of Eliem’s Directors and Executive Officers in the Acquisition

In considering the recommendation of the Eliem Board with respect to issuing shares of Eliem common stock in the Acquisition and the Private Placement and the other matters to be acted upon by Eliem stockholders at the Meeting, Eliem stockholders should be aware that Eliem’s directors and executive officers have interests in the Acquisition and the Private Placement that are different from, or in addition to, the interests of Eliem stockholders generally. These interests may present them with actual or potential conflicts of interest, and these interests, to the extent material, are described below.

The Eliem Board was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Acquisition Agreement, the Acquisition, the Securities Purchase Agreement and the Private Placement and to recommend that Eliem stockholders approve the proposals to be presented to Eliem stockholders for consideration at the Meeting as contemplated by this proxy statement.

Ownership Interests of Eliem’s Directors, Executive Officers and Affiliated Funds

As of May 10, 2024, Eliem’s non-employee directors and executive officers held, in the aggregate, approximately 683,407 shares of Eliem common stock.

As of May 10 2024, certain stockholders of Eliem affiliated with Eliem’s directors and executive officers also held shares of Eliem’s common stock. The table below sets forth the ownership of Eliem common stock by certain of these affiliated entities as of May 10, 2024.

 

Stockholder

   Number of Shares of
Common Stock Held
 

Entities affiliated with RA Capital Management (1)

     13,190,293  

 

 

(1)

Consists of: (i) 10,599,586 shares of common stock held by RA Capital Healthcare Fund, L.P. (“RA Healthcare”); (ii) 1,226,497 shares of common stock held by Nexus Fund, L.P. (“Nexus Fund”); (iii) 841,087 shares of common stock held directly by shares of common stock held directly by a separately managed account (the “Account”); (iv) 483,679 shares of common stock held by RA Capital Nexus Fund II, L.P. (“Nexus Fund II”) and (v) 39,444 shares issuable pursuant to stock options held by Andrew Levin for the benefit of RA Capital Management, L.P. (“RACM”) that are exercisable within 60 days of May 10, 2024. RACM is the investment manager for RA Healthcare, Nexus Fund, the Account, and Nexus Fund II. The general partner of RACM is RA Capital Management GP, LLC. The general partner of RA Healthcare is RA Capital Healthcare Fund GP, LLC. The general partner of Nexus Fund is RA Capital Nexus Fund GP, LLC. The general partner of Nexus Fund II is RA Capital Nexus Fund II GP, LLC. Peter Kolchinsky and Rajeev Shah are the managing members of RA Capital Management GP, LLC, RA Capital Healthcare Fund GP, LLC, RA Capital Nexus Fund GP, LLC, and RA Capital Nexus Fund II GP, LLC and have the power to vote or dispose of the shares held by RA Healthcare, Nexus Fund, the Account and Nexus Fund II.

Andrew Levin, Executive Chairman of the Eliem Board, is a Partner and Managing Director of RACM.

The Share Issuance Proposal requires that Eliem obtain the Required Eliem Stockholder Vote (including the Baseline Vote and the Disinterested Stockholder Approval). RA Capital Management has entered into a support agreement, pursuant to which it has agreed to vote in favor of the Share Issuance Proposal. Such vote will not, however, have any effect on the Disinterested Stockholder Approval, as shares held by RA Capital Management and its affiliates are excluded from such vote. For a more detailed discussion of the support agreement, please see the section titled “Agreements Related to the Acquisition and the Private Placement—Support Agreements and Lock-up Agreements—Support Agreements” beginning on page 95 of this proxy statement.

 

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Acquisition Consideration

Certain affiliates of RA Capital Management are also currently principal stockholders of Tenet and have executed support agreements in connection with, among other matters, approval of the Acquisition and adoption of the Acquisition Agreement. Upon the effective time of the Acquisition and pursuant to the Acquisition Agreement, RA Capital Management is expected to receive approximately 5,197,480 shares of Eliem common stock, in each case, in exchange for the shares then-held in Tenet as of May 10, 2024.

Participation in Private Placement

RA Capital Management has agreed to purchase in the Private Placement 13,008,546 shares of Eliem common stock for a total of $49,971,549. For more information about the ownership of Eliem common stock following the closing of the Acquisition and the Private Placement, see the section titled “Principal Stockholders of Post-Closing Eliem” beginning on page 163 of this proxy statement.

Treatment of Equity Awards Following the Closing of the Acquisition

All outstanding options to purchase shares of Eliem common stock will continue, on and after the closing of the Acquisition, in accordance with their terms as of immediately prior to the effective time of the Acquisition.

Director Positions Following the Acquisition

Each of the current directors of Eliem is expected to continue as a director of Post-Closing Eliem after the effective time of the Acquisition, assuming that both of the director nominees referenced in the section titled “Matters Being Submitted to a Vote of Eliem Stockholders—Proposal No. 3: Election of Directors” beginning on page 103 of this proxy statement are elected by the Eliem stockholders at the Meeting.

Indemnification for Directors and Officers

For a discussion of the indemnification provisions related to Eliem’s directors and officers under the Acquisition Agreement, please see the section titled “The Acquisition Agreement—Indemnification for Directors and Officers” beginning on page 90 of this proxy statement.

Director Compensation

Eliem compensates its non-employee directors for their service on the Eliem Board pursuant to its non-employee director compensation program. The chairperson of the Eliem Board is also entitled to an annual cash retainer of $30,000 in addition to the annual retainer received by non-employee directors for serving as Eliem’s lead director. For a description of the non-employee director compensation program, please see the section titled “Executive Compensation of Eliem—Director Compensation” beginning on page 156 of this proxy statement.

Executive Officer Positions Following the Acquisition

It is anticipated that Post-Closing Eliem’s executive officers will be Andrew Levin, M.D., Ph.D., as Executive Chairman of the Board of Directors, and Valerie Morisset, Ph.D., as Executive Vice President, Research and Development and Chief Scientific Officer.

Interests of Tenet’s Directors, Executive Officers and Certain Other Persons in the Acquisition

Positions with Post-Closing Eliem and New Employment Agreements

In connection with the closing of the Acquisition, Eliem will use commercially reasonable efforts to enter into employment agreements with each of Dr. Thomas, Tenet’s current Chief Executive Officer, Dr. Bonificio, Tenet’s current Chief Business Officer and Treasurer, and Dr. Daryani, Tenet’s current Vice President of

 

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Business Development, providing for employment with Post-Closing Eliem after the closing of the Acquisition on an interim basis. For a description of the interim positions each such officer will hold in Post-Closing Eliem following the closing of the Acquisition, please see the section titled “Management Following the Acquisition” beginning on page 143 of this proxy statement.

Subject to such changes as may be mutually agreed between Eliem and the individual service provider and approval of each arrangement by the Eliem Board (or a committee thereof), the material terms of the employment agreements with each of Dr. Thomas, Dr. Bonificio and Dr. Daryani are expected to be as described below, provided, in each case, that the closing of the Acquisition occurs and each such individual continues to provide services to Tenet through the closing date of the Acquisition.

As interim Chief Executive Officer of Post-Closing Eliem, Dr. Thomas will receive a base salary of $450,000. Dr. Thomas will be eligible to receive a discretionary annual performance bonus targeted at 50% of this annual base salary. For his assistance with respect to the closing of the Acquisition, Dr. Thomas will also receive a transaction bonus of $150,000, payable in a single lump-sum within 15 days following the closing date of the Acquisition.

As interim Chief Business Officer of Post-Closing Eliem, Dr. Bonificio will receive an annual base salary of $395,000. Dr. Bonificio will be eligible to receive a discretionary annual performance bonus targeted at 40% of this annual base salary. For his assistance with respect to the closing of the Acquisition, Dr. Bonificio will also receive a transaction bonus of $150,000, payable in a single lump-sum within 15 days following the closing date of the Acquisition.

As interim Vice President of Business Development of Post-Closing Eliem, Dr. Daryani will receive a base salary of $290,000. Dr. Daryani will be eligible to receive a discretionary annual performance bonus targeted at 30% of this annual base salary. For his assistance with respect to the closing of the Acquisition, Dr. Daryani will also receive a transaction bonus of $150,000, payable in a single lump-sum within 15 days following the closing date of Acquisition.

In addition, subject to the closing of the Acquisition occurring and Dr. Thomas, Dr. Bonificio, Dr. Daryani and Tatyana Touzova (the “Key Service Providers”) each remaining in service to Tenet through the closing date of the Acquisition, and subject to approval of the Post-Closing Eliem Board and the Special Committee, as soon as practicable following the closing, Post-Closing Eliem shall grant an aggregate of 803,000 restricted stock units (“RSUs”) to the Key Service Providers, each of which entitles the recipient thereof to receive one share of Post-Closing Eliem common stock per RSU upon vesting. The allocation of RSUs among the Key Service Providers shall be approved by the Post-Closing Eliem Board and the Special Committee, based on an allocation determined Dr. Thomas. Half of the RSUs to be allocated amongst the Key Service Providers, or 401,500 of the RSUs, shall vest quarterly over a 1-year period subject to a recipient thereof remaining in service to Tenet or Post-Closing Eliem through the applicable vesting date, provided, however, in the event that such recipient’s employment is terminated by Tenet or Post-Closing Eliem without Cause (as defined in Eliem’s 2021 Equity Incentive Plan), then the number of such RSUs held by such recipient that remain unvested at the time of such termination shall immediately vest, and half of the RSUs to be allocated amongst the Key Service Providers, or 401,500 of the RSUs, shall vest upon the certification of achievement of certain clinical and regulatory milestones set forth in the Acquisition Agreement. The definitive documentation in respect of the grants of the RSUs shall contain customary terms as agreed by the parties prior to the closing of the Acquisition. If, before the closing date of the Acquisition, Eliem effects a distribution, reclassification, stock split, reverse stock split, stock dividend or distribution, recapitalization, subdivision or other similar transaction, the number of RSUs to be granted to the Key Service Providers by Post-Closing Eliem shall be equitably adjusted to reflect such change in capitalization.

Dr. Thomas, Dr. Bonificio and Dr. Daryani are not presently entitled to severance benefits.

 

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Consulting Agreement

In connection with the closing, Eliem will use commercially reasonable efforts to enter into a consulting agreement with Tatyana Touzova for the provision of services to Post-Closing Eliem following the closing of the Acquisition. Pursuant to this new consulting agreement, Ms. Touzova will be paid $240,000 per year for the provision of chemistry, manufacturing and controls consulting services. In addition, for her assistance with respect to the closing of the Acquisition, Ms. Touzova is also eligible to receive a transaction bonus of $100,000, payable in a lump-sum within 15 days following the closing of the Acquisition. Entry into the consulting agreement on these terms is subject to such changes as may be mutually agreed between Ms. Touzova and Eliem and to approval by the Eliem Board (or a committee thereof) and to both the closing of the Acquisition occurring and Ms. Touzova’s continuing to provide services to Tenet through the closing date of the Acquisition.

Treatment of Common Stock

Under the Acquisition Agreement, Eliem will acquire Tenet for aggregate consideration of a number of shares of the Post-Closing Eliem common stock (rounded to the nearest whole share) equal to 15.4% of the outstanding shares of Eliem common stock as of immediately following the closing (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement, calculated on a fully diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem)). Based on the closing price of Eliem common stock on May 10, 2024, the aggregate value the Aggregate Consideration to be received by Tenet equityholders is approximately $46,480,035. As more fully described below in the section titled “Directors and Officers of Tenet Receiving Acquisition Consideration,” the Key Service Providers will be receiving shares of Eliem common stock as consideration for their shares of Tenet common stock under the Acquisition Agreement.

All of the holders of the issued and outstanding Tenet common stock have signed support and joinder agreements (the “Tenet Support and Joinder Agreements”) and have consented to the Acquisition.

Treatment of Tenet SAFEs

Pursuant to the SAFE Cancellation Agreements (the “SAFE Cancellation Agreements”) to be entered into prior to the closing of the Acquisition by each of RA Capital Healthcare Fund, L.P. and RA Capital Nexus Fund III, L.P. as holders of the simple agreements for future equity of Tenet (each such holder, a “SAFE Holder” and such agreements, the “Tenet SAFEs”) and Tenet, and in accordance with the Acquisition Agreement, immediately prior to the closing of the Acquisition, each Tenet SAFE that is then outstanding shall, without any action on the part of Eliem, Tenet, any SAFE Holder or any other person, terminate and be canceled, and be converted into the right to receive the applicable portion of the Aggregate Consideration as set forth on the Allocation Schedule to the Acquisition Agreement.

Directors and Officers of Tenet Receiving Acquisition Consideration

As holders of Tenet common stock, (i) Dr. Thomas will be receiving 102,674 shares of Eliem common stock, having a market value of approximately $868,622, (ii) Dr. Bonificio will be receiving 102,674 shares of Eliem common stock, having a market value of approximately $868,622 and (iii) Dr. Daryani will be receiving 91,266 shares of Eliem common stock, having a market value of approximately $772,110. All approximated market values are based on the closing price of Eliem common stock on May 10, 2024.

Upon the closing of the Acquisition, and subject to their continued provision of services to Tenet through the closing date of the Acquisition, Dr. Thomas will become the interim Chief Executive Officer and a director of Post-Closing Eliem, Dr. Bonificio will become the interim Chief Business Officer of Post-Closing Eliem and Dr. Daryani will become interim Vice President of Business Development of Post-Closing Eliem.

 

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Interests of Certain Significant Stockholders of Tenet

RA Capital Management is a principal stockholder of both Tenet and of Eliem. For information about RA Capital Management’s ownership in Eliem, see the section titled “Principal Stockholders of Eliem” beginning on page 160 of this proxy statement.

Sera Medicines, LLC (“Sera Medicines”), an affiliate of Sera Services and an affiliate of RA Capital Management, holds shares of Tenet common stock representing approximately 89.2% of the outstanding voting power, and will receive approximately 44.6% of the Aggregate Consideration in the Acquisition payable to Tenet stockholders. As a holder of Tenet common stock, Sera Medicines will be receiving 2,450,456 shares of Eliem common stock in connection with the Acquisition, having a market value of approximately $20,730,858 based on the closing price of Eliem common stock on May 10, 2024.

Sera Medicines was formed on October 30, 2023 and functions as a holding company for approximately 89.2% of Tenet’s outstanding equity interests. Approximately 81% of Sera Medicines’ equity interests are held by RA Capital Management and approximately 19% of Sera Medicines’ equity interests are held by members of Tenet’s management. In addition, Tenet’s research and development and professional services functions, including the services of Tenet’s executive officers, are currently performed through Sera Services pursuant to a services agreement (the “Sera Services Agreement”). For more information about the Sera Services Agreement, see the section entitled “Certain Relationships and Related Person TransactionsCertain Relationships of TenetRelationship with Sera Services, Inc.” beginning on page 169 of this proxy statement.

RA Capital Management holds Tenet SAFEs which convert into shares of Tenet common stock upon the occurrence of certain events. Immediately prior to the closing and pursuant to the SAFE Cancellation Agreements, such Tenet SAFEs shall terminate and be cancelled, and be converted into the right to receive the applicable portion of the Aggregate Consideration. As consideration for cancellation of the Tenet SAFEs, the SAFE Holders will receive approximately 2,747,024 shares of Eliem common stock in connection with the Acquisition, such shares having a market value of approximately $23,239,823 based on the closing price of Eliem common stock on May 10, 2024.

Eliem has also entered into a Securities Purchase Agreement with RA Capital Management, among other PIPE Investors in the Private Placement, pursuant to which Eliem agreed to issue and sell to the PIPE Investors in the Private Placement an aggregate of 31,238,282 shares of Eliem common stock, at a price of $3.84 per share. The Private Placement is expected to close immediately following the closing of the Acquisition. For more information about the Private Placement, the Securities Purchase Agreement and the PIPE Investors, see the sections titled “Agreements Related to the Acquisition and the Private Placement—Securities Purchase Agreement and Registration Rights Agreement” beginning on page 96 of this proxy statement and “The Acquisition—Interests of Eliem’s Directors and Executive Officers in the Acquisition” beginning on page 69 of this proxy statement.

Directors and Officers Affiliated with Significant Stockholders

Certain members of the Eliem Board are affiliated with RA Capital Management. On the Eliem Board, Andrew Levin, M.D., Ph.D., is a Partner and Managing Director at RA Capital Management. Dr. Levin will continue to serve on the Post-Closing Eliem Board following the Acquisition.

Opinion of Leerink Partners LLC

Introduction

Eliem retained Leerink Partners as its exclusive financial advisor in connection with the Acquisition. In connection with this engagement, the Special Committee and the Eliem Board requested that Leerink Partners evaluate the fairness, from a financial point of view, to Eliem of the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement. On April 10, 2024, Leerink Partners rendered to the Special Committee and the Eliem Board its oral opinion, which was subsequently confirmed by delivery of a

 

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written opinion dated April 10, 2024, that, as of such date and based upon and subject to the various assumptions made, and the qualifications and limitations upon the review undertaken by Leerink Partners in preparing its opinion, the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement was fair, from a financial point of view, to Eliem.

The full text of the written opinion of Leerink Partners, dated April 10, 2024, which describes the assumptions made and the qualifications and limitations upon the review undertaken by Leerink Partners in preparing its opinion, is attached as Annex B to this proxy statement and is incorporated herein by reference. The summary of the written opinion of Leerink Partners set forth below is qualified in its entirety by the full text of the written opinion attached hereto as Annex B. Leerink Partners’ financial advisory services and opinion were provided for the information and assistance of the Special Committee and the Eliem Board (in their capacity as directors and not in any other capacity) in connection with and for purposes of the Special Committee’s and the Eliem Board’s consideration of the Acquisition, and the opinion of Leerink Partners addressed only the fairness, from a financial point of view, as of the date thereof, to Eliem of the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement. The opinion of Leerink Partners did not address any other term or aspect of the Acquisition Agreement or the Acquisition and does not constitute a recommendation to any stockholder of Eliem or Tenet as to whether or how such holder should vote or otherwise act with respect to the Acquisition or any other matter.

The full text of the written opinion of Leerink Partners should be read carefully in its entirety for a description of the assumptions made and the qualifications and limitations upon the review undertaken by Leerink Partners in preparing its opinion.

In connection with rendering the opinion described above and performing its related financial analyses, Leerink Partners reviewed, among other things:

 

   

a draft of the Acquisition Agreement as provided to Leerink Partners by Eliem on April 10, 2024;

 

   

Eliem’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed by Eliem with the SEC;

 

   

certain Current Reports on Form 8-K, as filed by Eliem with, or furnished by Eliem to, the SEC;

 

   

certain internal information, primarily related to expense forecasts, relating to the business, operations, earnings, cash flow, assets, liabilities and prospects of Eliem, as furnished to Leerink Partners by the management of Eliem; and

 

   

certain internal information relating to the business, operations, earnings, cash flow, assets, liabilities and prospects of Tenet, including the Financial Projections prepared by management of Tenet and adjusted by Eliem, as furnished to, and approved for use by, Leerink Partners for purposes of Leerink Partners’ analysis, as described below under “The Acquisition–Certain Unaudited Financial Projections,” and which are collectively referred to in this summary of the opinion of Leerink Partners as the “Internal Data.”

Leerink Partners also conducted discussions with members of the senior management of Eliem and Tenet and their respective advisors and representatives regarding the Internal Data as well as the past and current business, operations, financial condition and prospects of each of Eliem and Tenet. In addition, Leerink Partners reviewed publicly available financial and stock market data for Eliem and conducted such other financial studies and analyses and took into account such other information as Leerink Partners deemed appropriate.

Leerink Partners assumed, without independent verification or any responsibility therefor, the accuracy and completeness of the financial, legal, regulatory, tax, accounting and other information supplied to, discussed with, or reviewed by Leerink Partners for purposes of its opinion and, with Eliem’s consent, relied upon such information as being complete and accurate. In that regard, Leerink Partners was advised by Eliem, and assumed, at Eliem’s direction, that the Internal Data (including, without limitation, the Financial Projections) were reasonably prepared on bases reflecting the best currently available estimates and judgments of the management

 

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of Eliem and Tenet as to the matters covered thereby and Leerink Partners relied, at Eliem’s direction, on the Internal Data for purposes of its analysis and its opinion. Leerink Partners expressed no view or opinion as to the Internal Data (including, without limitation, the Financial Projections) or the assumptions on which the Internal Data was based. The Special Committee and the Eliem Board were aware that the management of Eliem did not provide Leerink Partners with, and Leerink Partners did not otherwise have access to, financial forecasts regarding Eliem’s business, other than the expense forecasts described above. Accordingly, Leerink Partners did not perform a discounted cash flow analysis or any multiples-based analysis with respect to Eliem. In addition, at Eliem’s direction, Leerink Partners did not make any independent evaluation or appraisal of any of the assets or liabilities (contingent, derivative, off-balance-sheet or otherwise) of Eliem or Tenet, nor was Leerink Partners furnished with any such evaluation or appraisal, and Leerink Partners was not asked to conduct, and did not conduct, a physical inspection of the properties or assets of Eliem or Tenet.

Leerink Partners assumed, at Eliem’s direction, that the final executed Acquisition Agreement would not differ in any respect material to Leerink Partners’ analysis or its opinion from the last version of the Acquisition Agreement reviewed by Leerink Partners. Leerink Partners also assumed, at Eliem’s direction, that the representations and warranties made by Tenet, Eliem and Transitory Subsidiary in the Acquisition Agreement were and would continue to be true and correct in all respects material to Leerink Partners’ analysis. Furthermore, Leerink Partners assumed, at Eliem’s direction, that the Acquisition would be consummated on the terms set forth in the Acquisition Agreement and in accordance with all applicable laws and other relevant documents or requirements, without delay or the waiver, modification or amendment of any term, condition or agreement, the effect of which would be material to Leerink Partners’ analysis or its opinion and that, in the course of obtaining the necessary governmental, regulatory and other approvals, consents, releases and waivers for the Acquisition, no delay, limitation, restriction, condition or other change would be imposed, the effect of which would be material to Leerink Partners’ analysis or its opinion. Leerink Partners did not evaluate and did not express any opinion as to the solvency or fair value of Eliem or Tenet, or their respective abilities to pay their obligations when they come due, or as to the impact of the Acquisition on such matters, under any state, federal or other laws relating to bankruptcy, insolvency, or similar matters. Leerink Partners is not a legal, regulatory, tax or accounting advisor, and Leerink Partners expressed no opinion as to any legal, regulatory, tax or accounting matters. Leerink Partners expressed no view or opinion as to the price or range of prices at which the shares of stock or other securities or instruments of Eliem or any third party may trade at any time, including subsequent to the announcement or consummation of the Acquisition.

Leerink Partners expressed no view as to, and the opinion of Leerink Partners did not address, Eliem’s underlying business decision to proceed with or effect the Acquisition, or the relative merits of the Acquisition as compared to any alternative business strategies or transactions that might be available to Eliem or in which Eliem might engage. The opinion of Leerink Partners was limited to and addressed only the fairness, from a financial point of view, as of the date of the opinion, to Eliem of the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement. Leerink Partners was not asked to, and Leerink Partners did not, express any view on, and Leerink Partners’ opinion did not address, any other term or aspect of the Acquisition Agreement or the Acquisition, including, without limitation, the structure or form of the Acquisition, or any other agreements or arrangements contemplated by the Acquisition Agreement or entered into in connection with or otherwise contemplated by the Acquisition, including, without limitation, the fairness of the Acquisition or any other term or aspect of the Acquisition to, or any consideration to be received in connection therewith by, or the impact of the Acquisition on, the holders of any class of securities, creditors or other constituencies of Eliem, Tenet or any other party. In addition, Leerink Partners expressed no view or opinion as to the fairness (financial or otherwise) of the amount, nature or any other aspect of any compensation to be paid or payable to any of the officers, directors or employees of Eliem, Tenet or any other party, or class of such persons in connection with the Acquisition, whether relative to the Aggregate Consideration proposed to be paid by Eliem pursuant to the terms of the Acquisition Agreement or otherwise. The opinion of Leerink Partners was necessarily based on financial, economic, monetary, currency, market and other conditions and circumstances as in effect on, and the information made available to Leerink Partners as of, the date of its written opinion, and Leerink Partners does not have any obligation or responsibility to update, revise or reaffirm its

 

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opinion based on circumstances, developments or events occurring after the date of the opinion. Leerink Partners’ opinion does not constitute a recommendation to any stockholder of Eliem or Tenet as to whether or how such stockholder should vote or otherwise act with respect to the Acquisition or any other matter.

Leerink Partners’ financial advisory services and its opinion were provided for the information and assistance of the Special Committee and the Eliem Board (in their capacity as directors and not in any other capacity) in connection with and for purposes of their consideration of the Acquisition. Leerink Partners’ opinion was authorized by the Leerink Partners LLC Fairness Opinion Review Committee.

Summary of Financial Analyses

The following is a summary of the material financial analyses prepared by Leerink Partners and reviewed with the Special Committee and the Eliem Board in connection with its opinion, which was delivered orally to the Special Committee and the Eliem Board on April 10, 2024, and subsequently confirmed in its written opinion, dated April 10, 2024. For purposes of the analyses described below, Leerink Partners was directed to rely upon the Internal Data, including the Financial Projections. The summary set forth below does not purport to be a complete description of the financial analyses performed or factors considered by, and underlying the opinion of, Leerink Partners, nor does the order of the analyses described below represent the relative importance or weight given to those analyses by Leerink Partners. The preparation of a fairness opinion is a complex analytical process involving various determinations as to the most appropriate and relevant methods of financial analysis and the application of those methods to the particular circumstances and, therefore, a fairness opinion is not readily susceptible to summary description. In arriving at its opinion, Leerink Partners did not draw, in isolation, conclusions from or with regard to any factor or analysis that it considered. Accordingly, Leerink Partners believes that its analyses must be considered as a whole and that selecting portions of such analyses and factors without considering all analyses and factors, could create a misleading or incomplete view of the processes underlying Leerink Partners’ financial analyses and its opinion.

Leerink Partners may have deemed various assumptions more or less probable than other assumptions, so the reference ranges resulting from any particular portion of the analyses summarized below should not be taken to be the view of Leerink Partners as to the actual value of Eliem or Tenet. In its analyses, Leerink Partners made numerous assumptions with respect to industry performance, general business and economic conditions and other matters, many of which are beyond the control of Eliem, Tenet or any other parties to the Acquisition. None of Eliem, Tenet, Transitory Subsidiary, Leerink Partners or any other person assumes responsibility if future results are materially different from those discussed. Any estimates contained in these analyses are not necessarily indicative of actual values or predictive of future results or values, which may be significantly more or less favorable than as set forth below. In addition, analyses relating to the value of Eliem or Tenet do not purport to be appraisals or reflect the prices at which these companies may actually be sold. Accordingly, the assumptions and estimates used in, and the results derived from, the financial analyses are inherently subject to substantial uncertainty. Except as otherwise noted, the following quantitative information, to the extent that it is based on market data, is based on market data as it existed on or before April 10, 2024, and is not necessarily indicative of current market conditions.

Leerink Partners’ financial analyses and opinion were only one of many factors taken into consideration by the Special Committee and the Eliem Board in their evaluation of the Acquisition, as described under “The Acquisition—Eliem’s Reasons for the Acquisition and the Private Placement.” Consequently, the analyses described below should not be viewed as determinative of the views of the Special Committee, the Eliem Board or management of Eliem with respect to the Aggregate Consideration or as to whether the Special Committee or the Eliem Board would have been willing to determine that a different aggregate consideration was fair. The Aggregate Consideration, as well as the type of consideration payable in the Acquisition, were determined through arm’s-length negotiations between Eliem and Tenet and were approved by the Special Committee and the Eliem Board. Leerink Partners provided advice to Eliem during these negotiations. However, Leerink Partners did not recommend any specific consideration or other financial terms to Eliem, the Special Committee or the Eliem Board, or that any specific consideration or other financial terms constituted the only appropriate consideration for the Acquisition.

 

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In preparing its analyses, Leerink Partners took into account that the Aggregate Consideration is equal to the number of shares of Eliem common stock (rounded to the nearest whole share) equal to 15.4% of the outstanding shares of Eliem common stock as of immediately following the closing (and for the avoidance of doubt, before giving effect to the issuance of any securities in the Private Placement), calculated on a fully-diluted basis using the treasury stock method. For additional information, see “The Acquisition Agreement—Acquisition Consideration.” For purpose of its financial analysis, at the direction of management of Eliem and based on the capitalization of Eliem as of April 9, 2024, Leerink Partners assumed that 5,211,593 shares of Eliem common stock would be issued to Tenet stockholders in payment of the Aggregate Consideration pursuant to the Acquisition Agreement. Based upon the 30-day volume weighted average trading price of the Eliem common stock as of March 18, 2024, the unaffected date of Eliem’s Form 8-K filing publicly disclosing the term sheet delivered by Tenet to Eliem, Leerink Partners calculated that the implied value of the Aggregate Consideration payable pursuant to the Acquisition Agreement was approximately $14.3 million.

Discounted Cash Flow Analysis

A discounted cash flow analysis is a traditional valuation methodology used to derive a valuation of an asset or set of assets by calculating the “present value” of estimated future cash flows of the asset or set of assets. “Present value” refers to the current value of future cash flows or amounts and is obtained by discounting those future cash flows or amounts by a discount rate that takes into account assumptions and estimates of risk, the opportunity cost of capital, expected returns and other appropriate factors, and then adding the present value equivalent of the terminal value of the business at the end of the applicable projection period. A discounted cash flow analysis is a widely accepted valuation methodology for development stage biotechnology companies, including valuations of companies whose primary product candidate is still in development and for which regulatory authorization to market the applicable product candidate may not be obtained, if at all, until several years into the future. For purposes of its discounted cash flow analysis, at the direction of Eliem, Leerink Partners relied upon the Financial Projections. Leerink Partners was advised by Eliem, and assumed, at Eliem’s direction, that the Financial Projections were reasonably prepared on bases reflecting the best currently available estimates and judgments of the management of Eliem as to the matters covered thereby. The Financial Projections, which Eliem management directed Leerink Partners to use in deriving its financial analyses, include cash flows through 2041, which is the year that Eliem management assumed patent protections for TNT119 will expire. Eliem advised Leerink Partners that it believed it was reasonable to forecast revenues through the patent life of TNT119.

Leerink Partners’ discounted cash flow analysis calculated the estimated present value of the stand-alone, unlevered, after-tax free cash flows that Tenet was forecasted to generate from June 30, 2024, through December 31, 2041, which unlevered, after-tax free cash flows were derived from the Financial Projections. Leerink Partners estimated the net present value of unlevered, after-tax free cash flows after fiscal year 2041 by assuming an annual decline of 60% of such cash flows in perpetuity. These cash flows were discounted to present value as of June 30, 2024, using a discount rate ranging from 10% to 12%, derived from a weighted average cost of capital calculation for Tenet, which Leerink Partners performed utilizing the capital asset pricing model with inputs that Leerink Partners determined were relevant based on publicly available data and Leerink Partners’ professional judgment, including target capital structure, levered and unlevered betas for certain companies deemed by Leerink Partners to be comparable to Tenet, and the equity market risk premium and yields for U.S. treasury bonds, as provided by management of Tenet, in order to derive an implied equity value range for Tenet. This analysis resulted in an implied equity value for Tenet of approximately $30 million to $90 million, i.e., an implied equity value for Tenet that is substantially greater than the implied equity value of the Aggregate Consideration payable to Tenet stockholders pursuant to the Acquisition Agreement of approximately $14.3 million as calculated by Leerink Partners for purposes of its financial analyses.

General

Leerink Partners is a full-service securities firm engaged in securities trading and brokerage activities as well as investment banking and financial advisory services. Leerink Partners has provided certain investment banking services to Eliem from time to time, for which it has received compensation but other than compensation in

 

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connection with its services related to the Acquisition, no such compensation was received in the past two years. In the past two years, Leerink Partners has not provided investment banking services to Tenet or RA Capital Management or received compensation from them for the rendering of such services. In the ordinary course of business, Leerink Partners may in the future provide investment banking services to Eliem, Tenet or their respective affiliates and would expect to receive customary fees for the rendering of such services. In the ordinary course of its trading and brokerage activities, Leerink Partners has in the past held, and may in the future hold, positions for its own account or the accounts of its customers, in equity, debt or other securities of Eliem, Tenet or their respective affiliates.

Consistent with applicable legal and regulatory requirements, Leerink Partners has adopted policies and procedures to establish and maintain the independence of its research department and personnel. As a result, Leerink Partners’ research analysts may hold views, make statements or investment recommendations and/or publish research reports with respect to Eliem, Tenet and the Acquisition and other participants in the Acquisition that differ from the views of Leerink Partners’ investment banking personnel.

Eliem selected Leerink Partners as its exclusive financial advisor in connection with the Acquisition based on Leerink Partners’ qualifications, reputation, experience and expertise in the biopharmaceutical industry, its knowledge of and involvement in recent transactions in the biopharmaceutical industry and its familiarity with Eliem and its business. Leerink Partners is an internationally recognized investment banking firm that has substantial experience in transactions similar to the Acquisition.

In connection with Leerink Partners’ services as the exclusive financial advisor to Eliem, Eliem has agreed to pay Leerink Partners an aggregate fee of $2.5 million, $500,000 of which became payable upon the rendering by Leerink Partners of its opinion on April 10, 2024, and the remainder of which is payable contingent upon consummation of the Acquisition. In addition, Eliem has agreed to reimburse certain of Leerink Partners’ expenses arising, and to indemnify Leerink Partners against certain liabilities that may arise, out of Leerink Partners’ engagement. The terms of the fee arrangement between Leerink Partners and Eliem, which are customary in transactions of this nature, were negotiated at arm’s length between Leerink Partners and Eliem. The Special Committee and the Eliem Board were aware of the arrangement, including the fact that a significant portion of the fee payable to Leerink Partners is contingent upon the completion of the Acquisition.

Certain Unaudited Financial Projections

As a matter of course, Eliem does not publicly disclose long-term projections of future financial results due to the inherent unpredictability and subjectivity of underlying assumptions and estimates. However, in connection with the Special Committee’s and the Eliem Board’s evaluation of the Acquisition, preliminary internal financial projections for Tenet were prepared by the management of Tenet and provided to the management of Eliem, and then adjusted by the management of Eliem (such adjusted projections, the “Financial Projections”) for use by the Special Committee and the Eliem Board in connection with their evaluation of the Acquisition and for use by Leerink Partners in connection with its financial analysis as described below under “The Acquisition—Opinion of Leerink Partners LLC.” A summary of the Financial Projections is set forth below.

The inclusion of the Financial Projections should not be deemed an admission or representation by Eliem, Leerink Partners, Tenet or any of their respective officers, directors, affiliates, advisors, or other representatives with respect to such Financial Projections. The Financial Projections are not included to influence your views on the Acquisition and are summarized in this proxy statement solely to provide stockholders access to certain non-public information considered by the Special Committee and the Eliem Board in connection with their evaluation of the Acquisition and provided to Eliem’s financial advisor, Leerink Partners for purposes of its financial analysis. The information from the Financial Projections should be evaluated, if at all, in conjunction with the historical financial statements and other information regarding Tenet in this proxy statement.

The Financial Projections were not prepared with a view toward public disclosure, nor were they prepared with a view toward compliance with published guidelines of the SEC, the guidelines established by the American Institute of Certified Public Accountants for preparation and presentation of prospective financial information, or

 

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GAAP. The Financial Projections included in this document have been prepared by, and are the responsibility of Eliem’s management. PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled nor applied agreed-upon procedures with respect to the Financial Projections and, accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect thereto. The PricewaterhouseCoopers LLP report incorporated by reference in this proxy statement relates to the previously issued financial statements of Eliem. It does not extend to the Financial Projections and should not be read to do so. Further, neither Deloitte & Touche LLP, nor any other independent accountants, have compiled, examined, or performed any procedures with respect to the Financial Projections, nor have they expressed any opinion or any other form of assurance on such information or its achievability, and assume no responsibility for, and disclaim any association with, the Financial Projections.

The Financial Projections include unlevered free cash flow, total risk-adjusted revenues and risk-adjusted tax-effected operating income (loss), which are “non-GAAP financial measures” and which are financial performance measures that are not calculated in accordance with GAAP. Non-GAAP financial measures should not be viewed as a substitute for GAAP financial measures and may be different from non-GAAP financial measures used by other companies. Furthermore, there are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation. Accordingly, non-GAAP financial measures should be considered together with, and not as an alternative to, financial measures prepared in accordance with GAAP. The SEC rules, which otherwise would require a reconciliation of a non-GAAP financial measure to a GAAP financial measure, do not apply to non-GAAP financial measures provided to a board of directors or financial advisors in connection with a proposed business combination transaction such as the Acquisition if the disclosure is included in a document such as this proxy statement to comply with requirements under state laws, including case law. The Financial Projections were provided to the Special Committee and the Eliem Board in connection with their consideration of the Acquisition and to Leerink Partners for purposes of its financial analysis, and Eliem believes it has an obligation to disclose such projections under Delaware law, including applicable case law, because the Financial Projections were relied upon by the Special Committee and the Eliem Board in connection with their consideration of the Acquisition and furnished to Leerink Partners for purposes of its financial analysis. In addition, reconciliations of non-GAAP financial measures to GAAP financial measures were not provided to or relied upon by the Special Committee or the Eliem Board in connection with their consideration of the Acquisition or Leerink Partners for purposes of its financial analysis. Accordingly, Eliem has not provided a reconciliation of the financial measures included in the Financial Projections to the relevant GAAP financial measures.

The financial projections prepared by Tenet and supplied to Eliem were prepared solely for internal use as part of Tenet’s ongoing strategic planning processes and are subjective in many respects. As a result, the Financial Projections are susceptible to multiple interpretations and periodic revisions based on actual experience and business developments. Although Tenet and Eliem believe their respective assumptions to be reasonable, all financial projections are inherently uncertain, and Tenet and Eliem expect that differences will exist between actual and projected results. Although presented with numerical specificity, the Financial Projections reflect numerous variables, estimates, and assumptions made by Tenet’s and Eliem’s respective management at the time the initial financial projections were prepared by Tenet and adjusted by Eliem, and also reflect general business, economic, market, and financial conditions and other matters, all of which are difficult to predict and many of which are beyond Tenet’s and Eliem’s control. In addition, the Financial Projections cover multiple years, and this information by its nature becomes subject to greater uncertainty with each successive year. Accordingly, there can be no assurance that the estimates and assumptions made in preparing the Financial Projections will prove accurate or that any of the Financial Projections will be realized.

Eliem management, the Special Committee and the Eliem Board believed that, while only forming a part of the analysis involved with the approval of the Acquisition and the related transactions and the Special Committee’s and the Eliem Board’s recommendation of approval to Eliem stockholders, it was nonetheless helpful to the Special Committee’s and the Eliem Board’s process and determinations to review potential forecasted financial information given that Tenet is a clinical stage company and the performance of Post-Closing Eliem following

 

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the closing of the Acquisition would be contingent upon, in part, the market opportunity for Tenet and, as a result, Eliem management prepared the Financial Projections. As noted above, Tenet provided certain forecasted financial information to Eliem, but Eliem management desired to take a more conservative approach with respect to certain of the forecasted financial information, including with respect to various of the underlying assumptions, and therefore Eliem believed that a revised set of forecasts with adjusted assumptions would be more appropriate for the Special Committee and the Eliem Board to consider in connection with evaluating the Acquisition, including for Leerink Partners to use for purposes of its financial analysis. In particular, the Financial Projections included certain assumptions relating to, among other things, Tenet’s and Eliem’s respective expectations, which may not prove to be accurate, relating to the business, earnings, cash flow, assets, liabilities and prospects of Tenet, industry metrics and the regulatory and commercial probability of success and expenses adjusted on the basis thereof, including: (i) that the total risk-adjusted revenues will include net sales in the United States and royalties outside of the United States, (ii) that TNT119 will launch (a) in the United States for the treatment of MN and ITP in 2030 and the treatment of SLE in 2032 and (b) outside of the United States for the treatment of MN and ITP in 2032 and the treatment of SLE in 2033 (but the Financial Projections did not assume any acquisitions of additional product candidates or the approval of product candidates other than TNT119); (iii) forecasted financial information through 2041, which coincided with Tenet’s expectations regarding the expected period of patent term exclusivity for TNT119, which forecast period Eliem believed was reasonable given the other assumptions described herein; (iv) cumulative probabilities of success of 29%, 16% and 12% for TNT119 for the treatment of MN, ITP and SLE, respectively, which probabilities of success were based on industry benchmarks for probabilities of success for similarly situated product candidates and for which Eliem believed to be reasonable, based on a review of publicly available studies and industry practice; and (v) peak market penetration rate of 40% for MN and ITP and 30% for SLE in the United States, based on estimates for the addressable patient population in the United States across the three indications (which included adjustments made by Eliem management), which Eliem management believed were reasonable based on their experience and judgment, as well as a review of publicly available information for similarly situated products).

The Financial Projections are subject to many risks and uncertainties and you are urged to review the section titled “Risk Factors” for a description of risk factors relating to the Acquisition and Tenet’s business. You should also read the section titled “Cautionary Note Regarding Forward-Looking Statements” for additional information regarding the risks inherent in forward-looking information such as the Financial Projections.

The inclusion of the Financial Projections herein should not be regarded as an indication that Eliem, Leerink Partners, Tenet or any of their respective affiliates or representatives considered or consider the Financial Projections to be necessarily indicative of actual future events, and the Financial Projections should not be relied upon as such. The Financial Projections do not take into account any circumstances or events occurring after the date they were prepared. Eliem and Post-Closing Eliem do not intend to, and disclaim any obligation to, update, correct, or otherwise revise the Financial Projections to reflect circumstances existing or arising after the date the Financial Projections were generated or to reflect the occurrence of future events, even in the event that any or all of the assumptions or other information underlying the Financial Projections are shown to be in error. Furthermore, the Financial Projections do not take into account the effect of any failure of the Acquisition to be consummated and should not be viewed as accurate or continuing in that context.

 

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In light of the foregoing factors and the uncertainties inherent in financial projections, stockholders are cautioned not to place undue reliance, if any, on the Financial Projections.

The following table, which is subject to the financial projection statements above, presents (in millions) a summary of the Financial Projections, which represent the preliminary internal risk-adjusted financial projections for Tenet as such risk-adjusted financial projections were adjusted by the management of Eliem for use by the Special Committee and the Eliem Board in connection with their evaluation of the Acquisition and for use by Leerink Partners in connection with its financial analysis.

 

    2024E     2025E     2026E     2027E     2028E     2029E     2030E     2031E     2032E     2033E     2034E     2035E     2036E     2037E     2038E     2039E     2040E     2041E  

Total Revenues(1)

    —        —        —        —        —        —      $ 16     $ 32     $ 75     $ 121     $ 168     $ 218     $ 270     $ 305     $ 341     $ 351     $ 361     $ 371  

Tax-Effected Operating Income (Losses)(2)

  ($ 48   ($ 39   ($ 84   ($ 28   ($ 31   ($ 44   ($ 44   ($ 5   $ 10     $ 47     $ 72     $ 109     $ 139     $ 128     $ 144     $ 149     $ 154     $ 159  

Unlevered Free Cash Flow(3)

  ($ 48   ($ 39   ($ 84   ($ 28   ($ 31   ($ 44   ($ 45   ($ 7   $ 6     $ 42     $ 67     $ 104     $ 134     $ 124     $ 141     $ 148     $ 153     $ 158  

 

(1)

A non-GAAP financial measure defined as total risk-adjusted revenues.

(2)

A non-GAAP financial measure defined as total risk-adjusted revenues less cost of goods sold, royalty expenses, risk-adjusted research and development expenses, risk-adjusted general and administrative expenses, risk-adjusted sales and marketing expenses, risk-adjusted regulatory and sales milestones and taxes.

(3)

A non-GAAP financial measure defined as tax-effected operating income (loss) less change in net working capital.

Form of the Acquisition

Subject to the terms and conditions of the Acquisition Agreement, and in accordance with Delaware law, at the closing of the Acquisition, Transitory Subsidiary, a wholly owned subsidiary of Eliem formed by Eliem in connection with the Acquisition, will merge with and into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem.

Acquisition Consideration

The Aggregate Consideration payable by Eliem to the former equityholders of Tenet in the Acquisition will be a number of shares of Eliem common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement), calculated on a fully-diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem).

Procedures for Exchanging Tenet Stock Certificates

Promptly after the effective time of the Acquisition, Eliem will mail to each record holder of Tenet common stock that was issued and outstanding as of immediately prior to the effective time of the Acquisition (i) a letter of transmittal and (ii) instructions for surrendering the record holder’s stock certificates (to the extent the applicable shares of common stock are certificated) in exchange for the applicable portion of the Aggregate Consideration that is or may become payable with respect thereto pursuant to the terms of the Acquisition Agreement. Upon (A) (i) proper surrender of a certificate for cancellation to Eliem or (ii) confirmation by Tenet’s transfer agent of cancellation of such certificates(s) representing shares of Tenet common stock and (B) delivery of a duly completed and executed letter of transmittal, the holder of such stock certificates or book-entry shares, as applicable, will be entitled to receive in exchange therefor, book-entry shares representing the number of shares of Eliem common stock issuable to such holder pursuant to the Acquisition Agreement. The surrendered certificates representing shares of Tenet common stock (to the extent the applicable shares of common stock are certificated), will be canceled.

 

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After the effective time of the Acquisition, each certificate representing Tenet that has not been surrendered will represent only the right to receive shares of Eliem common stock issuable pursuant to the Acquisition Agreement to which the holder of any such certificate is entitled.

HOLDERS OF TENET COMMON STOCK SHOULD NOT SEND IN THEIR TENET STOCK CERTIFICATES UNTIL THEY RECEIVE A LETTER OF TRANSMITTAL FROM ELIEM WITH INSTRUCTIONS FOR THE SURRENDER OF TENET STOCK CERTIFICATES.

Effective Time of the Acquisition

The Acquisition Agreement requires each of the parties (other than the Company Equityholder Representative) to consummate the Acquisition as promptly as practicable, including using its reasonable best efforts to ensure that the conditions to the obligations of the other parties to consummate the Acquisition are satisfied or waived, including the approval by Eliem stockholders of the Share Issuance Proposal and the other transactions proposed under the Acquisition Agreement, other than those conditions that by their nature are to be satisfied at the closing of the Acquisition. The Acquisition will become effective upon the filing of a certificate of merger with the Secretary of State of the State of Delaware or at such later time as is agreed by Eliem and Tenet and specified in the certificate of merger. Neither Eliem nor Tenet can predict the exact timing of the consummation of the Acquisition.

Regulatory Approvals

In the United States, Eliem must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Eliem common stock to Tenet stockholders in connection with the transactions contemplated by the Acquisition Agreement and the filing of this proxy statement with the SEC. Eliem does not intend to seek any regulatory approval from antitrust authorities to consummate the transactions.

Material U.S. Federal Income Tax Consequences of the Acquisition to Eliem and its Stockholders

Eliem will not recognize any gain or loss for U.S. federal income tax purposes upon consummation of the Acquisition. In addition, because the stockholders of Eliem immediately prior to the consummation of the Acquisition will not sell, exchange or dispose of any shares of Eliem common stock in the Acquisition, such stockholders will not recognize any gain or loss upon consummation of the Acquisition.

Anticipated Accounting Treatment

It is anticipated that the Acquisition will be accounted for as an acquisition in which Eliem, as the accounting acquirer, will record the assets acquired and assumed liabilities of Tenet at their relative fair values as of the acquisition date. See the “Unaudited Pro Forma Condensed Combined Financial Statements” elsewhere in this proxy statement for additional information.

Appraisal Rights and Dissenters’ Rights

Under the DGCL, Eliem stockholders are not entitled to appraisal rights in connection with the Acquisition.

Tenet stockholders are entitled to statutory appraisal rights in connection with the Acquisition under Section 262 of the DGCL.

As of the date of the Acquisition Agreement, all of Tenet stockholders waived any statutory appraisal rights pursuant to Section 262 of the DGCL with respect to their shares of Tenet common stock.

 

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THE ACQUISITION AGREEMENT

The following is a summary of the material terms of the Acquisition Agreement. A copy of the Acquisition Agreement is attached to this proxy statement as Annex A and is incorporated by reference into this proxy statement. The Acquisition Agreement has been attached to this proxy statement to provide you with information regarding its terms. It is not intended to provide any other factual information about Eliem, Tenet or Transitory Subsidiary. The following description does not purport to be complete and is qualified in its entirety by reference to the Acquisition Agreement. You should refer to the full text of the Acquisition Agreement for details of the Acquisition and the terms and conditions of the Acquisition Agreement.

The Acquisition Agreement contains representations and warranties that Eliem and Transitory Subsidiary, on the one hand, and Tenet, on the other hand, have made to one another as of specific dates. These representations and warranties have been made for the benefit of the other parties to the Acquisition Agreement and may be intended not as statements of fact but rather as a way of allocating the risk to one of the parties if such representations and warranties prove to be incorrect. In addition, the assertions embodied in the representations and warranties are qualified by information in confidential disclosure schedules exchanged by the parties in connection with signing the Acquisition Agreement. While Eliem and Tenet do not believe that these disclosure schedules contain information required to be publicly disclosed under the applicable securities laws, other than information that has already been so disclosed, the disclosure schedules do contain information that modifies, qualifies and creates exceptions to the representations and warranties set forth in the attached Acquisition Agreement. Accordingly, you should not rely on the representations and warranties as current characterizations of factual information about Eliem, Tenet or Transitory Subsidiary, because they were made as of specific dates, may be intended merely as a risk allocation mechanism between Eliem, Transitory Subsidiary and Tenet and are modified by the disclosure schedules.

Structure

Subject to the terms and conditions of the Acquisition Agreement, and in accordance with Delaware law, at the closing of the Acquisition, Transitory Subsidiary, a wholly owned subsidiary of Eliem formed by Eliem in connection with the Acquisition, will merge with and into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem.

Completion and Effectiveness of the Acquisition

The Acquisition will be completed (i) no later than the second business day after all of the conditions to completion of the Acquisition are satisfied or waived, including the approval by Eliem stockholders of the Share Issuance Proposal and the other transactions proposed under the Acquisition Agreement, unless earlier terminated in accordance with the terms of the Acquisition Agreement, or (ii) such other date as may be mutually agreed between Eliem and Tenet. For more information on termination rights, see the section titled “The Acquisition Agreement—Termination and Termination Fees” beginning on page 92 in this proxy statement.

Eliem and Tenet are working to complete the Acquisition as quickly as practicable and currently anticipate that the Acquisition will close in the middle of 2024, after the Meeting. However, Eliem and Tenet cannot predict the completion of the Acquisition or the exact timing of the completion of the Acquisition because it is subject to various conditions.

Acquisition Consideration

At the effective time of the Acquisition, upon the terms and subject to the conditions set forth in the Acquisition Agreement: (i) each outstanding share of Tenet common stock will be automatically cancelled and shall be converted into the right to receive the applicable portion of the Aggregate Consideration as set forth on the Allocation Schedule to the Acquisition Agreement; and (ii) each Tenet SAFE that is then outstanding shall (in

 

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accordance with the SAFE Cancellation Agreement(s) and the Acquisition Agreement), terminate and be cancelled, and be converted into the right to receive the applicable portion of the Aggregate Consideration as set forth on the Allocation Schedule to the Acquisition Agreement.

Except as otherwise provided in the Acquisition Agreement, no fractional shares of Eliem common stock will be issued in exchange for any Tenet common stock or Tenet SAFE, and no holder of Tenet common stock or Tenet SAFE will be entitled to receive a fractional share of Eliem common stock. Any holder of Tenet common stock who would otherwise be entitled to receive a fraction of a share of Eliem common stock (after aggregating all fractional shares of Eliem common stock issuable to such holder) will receive from Eliem, in lieu of such fractional share and upon surrender by such holder of a letter of transmittal in accordance with the Acquisition Agreement and any accompanying documents as required therein: (i) one share of Eliem common stock if the aggregate amount of fractional shares of Eliem common stock such holder would otherwise be entitled to is equal to or exceeds 0.50; or (ii) no shares of Eliem common stock if the aggregate amount of fractional shares of Eliem common stock such holder would otherwise be entitled to is less than 0.50, with no cash being paid for any fractional share eliminated by such rounding.

Under the Acquisition Agreement, the Aggregate Consideration is defined as being equal to an aggregate of a number of shares of Eliem common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement), calculated on a fully-diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem).

Representations and Warranties

The Acquisition Agreement contains customary representations and warranties of the parties for a transaction of this type, relating to, among other matters:

 

   

Organization, Standing and Corporate Power;

 

   

Capitalization;

 

   

Subsidiaries;

 

   

Authority; No Conflict; Required Filings and Consents;

 

   

Financial Statements and with respect to Eliem, documents filed with the SEC and the accuracy of information contained in those documents;

 

   

Absence of Certain Changes;

 

   

Books and Records;

 

   

Tax Matters;

 

   

Assets;

 

   

Owned and Leased Real Property;

 

   

Intellectual Property;

 

   

Contracts;

 

   

Litigation;

 

   

Environmental Matters;

 

   

Labor and Employment;

 

   

Employee Benefit Plans;

 

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Compliance with Laws;

 

   

Unlawful Payments;

 

   

Permits and Regulatory Matters;

 

   

Insurance;

 

   

Certain Business Relationships With Affiliates;

 

   

Investor Questionnaires;

 

   

Brokers; Schedule of Fees and Expenses;

 

   

Powers of Attorney;

 

   

No Other Representations and Warranties;

 

   

Reliance; and

 

   

With respect to Eliem, the valid issuance in the Acquisition of Eliem common stock and the opinion of Leerink Partners.

The representations and warranties are, in many respects, qualified by materiality and knowledge, but their accuracy forms the basis of one of the conditions to the obligations of Eliem and Tenet to complete the Acquisition.

Covenants; Conduct of Business Pending the Acquisition

Eliem has agreed that, except as permitted by the Acquisition Agreement, as required by law, or unless Tenet has provided written consent, during the period commencing on the date of the Acquisition Agreement and continuing until the earlier to occur of the effective time and the termination of the Acquisition Agreement, Eliem shall use commercially reasonable efforts to, and shall cause each subsidiary to use commercially reasonable efforts to, conduct its operations only in the ordinary course of business and in compliance with all applicable laws in all material respects. Eliem has also agreed that, subject to certain limited exceptions, without the consent of Tenet, it will not, and will not cause or permit any of its subsidiaries to, during the period commencing on the date of the Acquisition Agreement and continuing until the earlier to occur of the effective time and the termination of the Acquisition Agreement:

 

   

issue or sell any stock or other securities of Eliem or any options, warrants or rights to acquire any such stock or other securities (except for shares of Eliem’s common stock issued upon settlement of employee awards existing on the date of the Acquisition Agreement), or amend any of the terms of any stock options or restricted stock agreements, declare, accrue, set aside or pay any dividend or make any other distribution in respect of any shares of its capital stock, or repurchase or redeem any stock or other securities of Eliem (except from former employees, directors or consultants in accordance with agreements in place on the date of the Acquisition Agreement and providing for the repurchase of shares at their original issuance price in connection with any termination of employment with or services to Eliem);

 

   

split, combine or reclassify any shares of its capital stock; or declare, set aside or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of its capital stock;

 

   

(i) create, incur or assume any Indebtedness (as defined in the Acquisition Agreement) (other than interest incurred with respect to Indebtedness outstanding as of the date of the Acquisition Agreement in accordance with its terms); (ii) assume, guarantee, endorse or otherwise agree to be liable (whether directly, contingently or otherwise) for the obligations of any other person; or (iii) make any loans, advances or capital contributions to, or investments in, any other person (other than investments of cash in cash equivalents in the ordinary course of business);

 

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hire any new officers or, except in the ordinary course of business, any new employees;

 

   

enter into a joint venture;

 

   

amend its organizational documents;

 

   

make or change any tax election, change an annual accounting period, file any amended income or other material tax return, enter into any closing agreement, waive or extend any statute of limitations with respect to taxes, settle or compromise any liability, claim or assessment in respect of material taxes or surrender any right to claim a material refund of taxes;

 

   

make or commit to make any capital expenditure in excess of $75,000 per item or $250,000 in the aggregate; or

 

   

agree in writing or otherwise to take any of the foregoing actions.

Tenet has agreed that, except as permitted by the Acquisition Agreement, as required by law, or unless Eliem shall have provided written consent, during the period commencing on the date of the Acquisition Agreement and continuing until the earlier to occur of the effective time and the termination of the Acquisition Agreement, Tenet shall use commercially reasonable efforts to, conduct its operations only in the ordinary course of business and in compliance with all applicable laws in all material respects and, to the extent consistent therewith, use its reasonable best efforts to preserve intact its current business organization, keep its physical assets in good working condition, and preserve its relationships with customers, suppliers and others having business dealings with it and to continue the timely payment of its accounts payable that are not subject to good faith dispute. Tenet has also agreed that, subject to certain limited exceptions, without the consent of Eliem, it will not, during the period commencing on the date of the Acquisition Agreement and continuing until the earlier to occur of the effective time and the termination of the Acquisition Agreement:

 

   

issue or sell any stock or other securities of Tenet or any options, warrants or rights to acquire any such stock or other securities, or amend any of the terms of any restricted stock agreements, declare, accrue, set aside or pay any dividend or make any other distribution in respect of any shares of its capital stock, or repurchase or redeem any stock or other securities of Tenet;

 

   

split, combine or reclassify any shares of its capital stock; or declare, set aside or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of its capital stock;

 

   

(i) create, incur or assume any Indebtedness (other than interest incurred with respect to Indebtedness outstanding as of the date hereof in accordance with its terms; (ii) assume, guarantee, endorse or otherwise become liable or responsible (whether directly, contingently or otherwise) for the obligations of any other person; or (iii) make any loans, advances or capital contributions to, or investments in, any other person;

 

   

hire any officers or any employees or consultants;

 

   

adopt or enter into any employment or severance plan, agreement or arrangement or any Company Plan (as defined in the Acquisition Agreement);

 

   

acquire, sell, lease, license or dispose of any assets or property (including any intellectual property or any shares or other equity interests in or securities of any other corporation, partnership, association or other business organization or division thereof);

 

   

mortgage or pledge any of its property or assets or subject any such property or assets to any lien;

 

   

discharge or satisfy any lien or pay any obligation or liability other than in the ordinary course of business;

 

   

form any subsidiary or acquire any equity interest or other interest in any other entity or enter into a joint venture with any other entity;

 

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amend its organizational documents;

 

   

forgive any loans to any person, including its employees, officers, directors or affiliates;

 

   

sell, assign, transfer, license or sublicense any intellectual property;

 

   

change the nature or scope of its business being carried on as of the date of the Acquisition Agreement or commence any new business not being ancillary or incidental to such business or take any action to alter its general organizational or management structure;

 

   

change its accounting methods, principles or practices, except insofar as may be required by a generally applicable change in GAAP or applicable law;

 

   

except as required by applicable law, make, or amend, any filings with the FDA or any other regulatory authority;

 

   

make or change any tax election, change an annual accounting period, file any amended income or other material tax return, enter into any closing agreement, waive or extend any statute of limitations with respect to taxes, settle or compromise any liability, claim or assessment in respect of material taxes, or surrender any right to claim a material refund of taxes;

 

   

enter into, amend, terminate, take or omit to take any action that would constitute a material violation of or default under, or waive any rights under, applicable law or any contract;

 

   

make or commit to make any capital expenditure in excess of $50,000 per item or $200,000 in the aggregate;

 

   

enter into any material transaction other than in the ordinary course of business;

 

   

institute or settle any legal proceeding;

 

   

take any action or fail to take any action permitted by the Acquisition Agreement with the knowledge that such action or failure to take action would have the result of causing any of the conditions to the Acquisition set forth in the Acquisition Agreement to not be satisfied;

 

   

take any action to adversely effect, or fail to take any action, in each case, reasonably necessary to preserve the validity, in each case as existing as of the date of the Acquisition Agreement, of, any Company Intellectual Property (as defined in the Acquisition Agreement) or permit; or

 

   

agree in writing or otherwise to take any of the foregoing actions.

Non-Solicitation

Each of Eliem and Tenet have agreed that, except as described below, Eliem and Tenet will not, nor will either party authorize any of its directors, officers, employees, agents, attorneys, accountants, investment bankers, advisors or representatives (and shall use its reasonable best efforts to cause such persons not to), directly or indirectly:

 

   

solicit, initiate or knowingly encourage, induce or facilitate the communication, making, submission or announcement of any acquisition proposal or acquisition inquiry (each, as defined in the Acquisition Agreement) or take any action that could reasonably be expected to lead to an acquisition proposal or acquisition inquiry;

 

   

furnish any non-public information with respect to it to any person for the purpose of encouraging, or in response to, an acquisition proposal or acquisition inquiry;

 

   

engage in discussions (other than to inform any person of the existence of these restrictions) or negotiations with any person with respect to any acquisition proposal or acquisition inquiry;

 

   

approve, endorse or recommend an acquisition proposal;

 

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execute or enter into any letter of intent or any contract contemplating or otherwise relating to any acquisition transaction (other than enter into a confidentiality agreement permitted under the Acquisition Agreement);

 

   

publicly propose to do any of the foregoing; or

 

   

agree, resolve or commit to do any of the foregoing.

Notwithstanding the foregoing, before obtaining the approval of the Eliem stockholders required to consummate the Acquisition, Eliem may furnish non-public information regarding such party to, and may enter into discussions or negotiations with, any third party in response to a bona fide written acquisition proposal, which the Eliem Board determines in good faith, after consultation with Eliem’s financial advisors and outside legal counsel, constitutes or is reasonably likely to result in a superior offer (and is not withdrawn), if:

 

   

neither Eliem nor any of its representatives has materially breached the non-solicitation provisions of the Acquisition Agreement described above;

 

   

the Eliem Board concludes in good faith, based on the advice of outside legal counsel, that the failure to take such action is reasonably likely to be inconsistent with the fiduciary duties of the Eliem Board under applicable legal requirements;

 

   

Eliem receives from the third party an executed confidentiality agreement containing provisions at least as favorable to Eliem as those contained in the confidentiality agreement between Eliem and Tenet; and

 

   

substantially contemporaneously with the furnishing of any non-public information to a third party, Eliem furnishes the same non-public information to Tenet to the extent not previously furnished.

Board Recommendation Change

Under the Acquisition Agreement, subject to certain exceptions described below, Eliem agreed that the Eliem Board and the Special Committee will recommend that the Eliem stockholders vote to approve the Share Issuance Proposal (the “Eliem Board recommendation”) and that such Eliem Board recommendation will not (each of the following are referred to in this proxy statement as an “Eliem Board recommendation change”):

 

   

be withheld, amended, withdraw or modified (and the Eliem Board nor the Special Committee will not publicly propose to withhold, amend, withdraw or modify) the Eliem Board recommendation in a manner adverse to Tenet; or

 

   

following the public disclosure of an acquisition inquiry or acquisition proposal, fail to publicly reaffirm, within five (5) business days of a written request therefor by Tenet, the Eliem Board recommendation (provided, that Tenet shall be limited to one such request with respect to any acquisition inquiry or acquisition proposal unless such acquisition proposal has been modified, and then one such request with respect to any such modification).

However, notwithstanding the foregoing, at any time prior to the approval of the Share Issuance Proposal by Eliem stockholders, the Eliem Board may make an Eliem Board recommendation change or terminate the Acquisition Agreement if, but only if, following the receipt of and on account of a bona fide superior offer or otherwise:

 

   

the Eliem Board determines in good faith, after consultation with Eliem’s outside legal counsel, that the failure to make an Eliem Board recommendation change would be reasonably likely to be inconsistent with the fiduciary duties of the Eliem Board to Eliem stockholders under applicable law;

 

   

Eliem has given Tenet prior written notice of its intention to consider making an Eliem Board recommendation change or to terminate the Acquisition Agreement at least three (3) business days prior to making such Eliem Board recommendation change;

 

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Eliem has provided Tenet a summary of the material terms and conditions of such acquisition proposal in accordance with the Acquisition Agreement;

 

   

Eliem has given Tenet three (3) business days after the applicable determination notice to propose revisions to the Acquisition Agreement or make another proposal and shall have made its representatives reasonably available to negotiate in good faith with Tenet (to the extent that Tenet desires to negotiate) with respect to such proposed revisions or other proposal; and

 

   

after considering the results of any such negotiations and giving effect to the proposals made by Tenet, if any, after consultation with outside legal counsel, the Eliem Board has determined, in good faith, that such acquisition proposal is a superior offer and that the failure to make the Eliem Board recommendation change or terminate the Acquisition Agreement would be reasonably likely to be inconsistent with the fiduciary duties of the Eliem Board to Eliem stockholders under applicable law.

Meeting of Eliem Stockholders and Written Consent of Tenet Stockholders

Eliem is obligated under the Acquisition Agreement to, as promptly as reasonably practicable after the filing of a definitive proxy statement, take all action reasonably necessary under applicable law to call, give notice of and hold a meeting of the holders of Eliem’s common stock for the purpose of considering and voting to approve the Share Issuance Proposal.

Following the execution and delivery of the Acquisition Agreement, Tenet obtained approval by written consent from Tenet stockholders sufficient to (i) adopt and approve the Acquisition Agreement and the contemplated transactions (including the Acquisition), (ii) acknowledging that the approval given thereby is irrevocable and that such stockholders are aware of their rights to demand appraisal for their shares pursuant to Section 262 of the DGCL, and that such stockholder has received and read a copy of Section 262 of the DGCL and (iii) acknowledging that by their approval of the Acquisition, they are not entitled to appraisal rights with respect to their shares in connection with the Acquisition and thereby waive any rights to receive payment of the fair value of their capital stock under the DGCL.

Completion and Effectiveness of the Acquisition

The Acquisition will be completed as promptly as practicable, after all of the conditions to completion of the Acquisition are satisfied or waived, including the approval by Eliem stockholders of the Share Issuance Proposal and the other transactions proposed under the Acquisition Agreement, unless earlier terminated in accordance with the terms of the Acquisition Agreement. For more information on termination rights, see the section titled “The Acquisition Agreement—Termination and Termination Fees” beginning on page 92 in this proxy statement.

Eliem and Tenet currently anticipate that the Acquisition will close in the middle of 2024, after the Meeting. However, Eliem and Tenet cannot predict the completion of the Acquisition or the exact timing of the completion of the Acquisition because it is subject to various conditions.

Directors and Officers of Post-Closing Eliem Following the Acquisition

Following the closing of the Acquisition, Stephen Thomas (Tenet’s Chief Executive Officer who will serve as interim Chief Executive Officer of Post-Closing Eliem following the Acquisition) and one director to be designated by Tenet will each join the Post-Closing Eliem Board. All of the current members of the Eliem Board will remain on the Post-Closing Eliem Board. The staggered structure of the Eliem Board will remain in place for Post-Closing Eliem following the completion of the Acquisition.

In addition, upon the closing of the Acquisition, (i) Stephen Thomas, Ph.D. will serve as interim Chief Executive Officer of Post-Closing Eliem, (ii) William Bonificio, Ph.D. will serve as the interim Chief Business Officer of Post-Closing Eliem, and (iii) Naveen Daryani, PharmD will serve as interim Vice President of Business Development.

 

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Indemnification for Directors and Officers

Under the Acquisition Agreement, for a period of six years after the closing date of the Acquisition, Post-Closing Eliem shall not amend, repeal or otherwise modify any provisions of its certificate of incorporation or bylaws concerning indemnification, exculpation or limitation of liability of directors, officers, fiduciaries or agents of Tenet in any manner that would affect adversely the rights thereunder of persons who, prior to the closing date of the Acquisition, were directors, officers, employees, fiduciaries or agents of Tenet, except to the extent required by applicable law and except for any such change that would not affect the application of such provisions to acts or omissions of such individuals prior to the closing of the Acquisition.

Notwithstanding anything to the contrary in the certificate of incorporation, bylaws of Tenet, Post-Closing Eliem or any provision in any indemnification or other agreement to which any of them is a party or by which any of them is bound, (a) no exculpation or other provision in the certificate of incorporation or bylaws of Tenet, Post-Closing Eliem or any such agreement shall be deemed to exculpate any such person from its obligations under the Acquisition Agreement and (b) no person shall be entitled to indemnification or reimbursement or advancement of expenses under any provision of the certificate of incorporation or bylaws of Tenet, Post-Closing Eliem or any such agreement for any matter for which any indemnified party of Eliem is entitled to indemnification pursuant to the Acquisition Agreement.

Additional Agreements

Each of Eliem and Tenet has agreed to use its reasonable best efforts to take all actions and to do all things necessary, proper or advisable to consummate the transactions contemplated by the Acquisition Agreement to be completed at the closing of the Acquisition, including using its reasonable best efforts to ensure that the conditions to the obligations of the other parties to consummate the Acquisition are satisfied.

Conditions to the Completion of the Acquisition

The following contains a description of all material conditions to the completion of the Acquisition. Each party’s obligation to complete the Acquisition is subject to the satisfaction or, to the extent permitted by applicable law, the written waiver by each of the parties, at or prior to the closing, of various conditions.

The conditions to Eliem’s and the Transitory Subsidiary’s obligation to complete the Acquisition include the following:

 

   

no judgment, order, decree, stipulation or injunction shall be in effect, and no legal proceeding shall be pending or shall have been threatened in writing by a governmental entity, that would reasonably be expected to (i) prevent consummation of the transactions contemplated by the Acquisition Agreement, or (ii) cause the transactions contemplated by the Acquisition Agreement to be rescinded following consummation of such transaction;

 

   

the representations and warranties of Tenet set forth in the Acquisition Agreement regarding organization, standing and corporate power, capitalization, authority, subsidiaries, and investor questionnaires shall have been true and correct in all material respects as of the date of the Acquisition Agreement and shall be true and correct in all material respects on and as of the closing date of the Acquisition with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties will be true and correct in all material respects as of such date);

 

   

the representations and warranties of Tenet contained in the Acquisition Agreement (other than the Tenet representations and warranties of Tenet regarding organization, standing and corporate power, capitalization, authority, subsidiaries and investor questionnaires) shall have been true and correct as of the date of the Acquisition Agreement and will be true and correct on and as of the closing date of the Acquisition with the same force and effect as if made on the closing date of the Acquisition except

 

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(i) in each case, or in the aggregate, where the failure to be true and correct would not reasonably be expected to have a material adverse effect on Tenet (without giving effect to any references therein to any material adverse effect on Tenet or other materiality qualifications), or (ii) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause, as of such particular date);

 

   

Tenet shall have performed or complied with, in all material respects, its agreements and covenants required to be performed or complied with under the Acquisition Agreement as of or prior to the closing of the Acquisition;

 

   

there will have occurred no change, event, circumstance or development since the date of the Acquisition Agreement that, individually or taken together with all other changes, events, circumstances or developments, has had, or would be reasonably expected to have, a material adverse effect on Tenet;

 

   

Eliem must have received copies of written consents of Tenet stockholders evidencing that the Acquisition Agreement and the Acquisition have been approved, in accordance with the Acquisition Agreement, by Tenet stockholders;

 

   

the number of shares of Tenet’s common stock dissenting from the Acquisition, together with the number of shares of Tenet’s common stock eligible to become dissenting shares, must not exceed eight percent (8%) of the number of outstanding shares of Tenet’s common stock as of the effective time of the Acquisition;

 

   

Eliem must have received evidence, in form and substance reasonably satisfactory to it, that Tenet has, at its own expense, obtained certain specified waivers, permits, consents, approvals or other authorizations, and effected such registrations, filings and notices;

 

   

each of the holders of Tenet’s stock receiving shares of Eliem’s common stock as part of the Aggregate Consideration must have executed and delivered (i) a support and joinder agreement and (ii) an investor questionnaire;

 

   

Eliem must have received the SAFE Cancellation Agreements;

 

   

Eliem must have received copies of the resignations, effective as of the closing of the Acquisition and in form and substance reasonably satisfactory to it, of each director of Tenet (other than any such resignations which Eliem designates, by written notice to Tenet, as unnecessary) from their director positions (but not employment, as applicable);

 

   

Eliem must have received a properly executed certification that shares of Tenet’s capital stock are not “U.S. real property interests” in accordance with the treasury regulations under Sections 897 and 1445 of the Code, together with a notice to the Internal Revenue Service in accordance with the provisions of treasury regulations section 1.897-2(h)(2);

 

   

Eliem must have received a certificate delivered from Tenet to the effect that certain conditions in the Acquisition Agreement are satisfied;

 

   

Eliem must have received certificates of good standing of Tenet in its jurisdictions of organization and the various foreign jurisdictions in which it is qualified, certified charter documents and certificates as to the incumbency of officers and the adoption of authorizing resolutions; and

 

   

Eliem shall have obtained stockholder approval of the Share Issuance Proposal.

 

   

The conditions to Tenet’s obligation to complete the Acquisition include the following:

 

   

the representations regarding Eliem’s and Transitory Subsidiary’s organization, standing and power, authority and capitalization shall have been true and correct in all material respects as of the date of the Acquisition Agreement and shall be true and correct in all material respects on and as of the closing

 

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date of the Acquisition with the same force and effect as if made on and as of such date (except to the extent such representations and warranties are specifically made as of a particular date, in which case such representations and warranties shall be true and correct in all material respects as of such date);

 

   

the representations and warranties of Eliem and the Transitory Subsidiary contained in the Acquisition Agreement (other than the representations regarding Eliem’s and Transitory Subsidiary’s organization, standing and power, authority and capitalization) shall have been true and correct as of the date of the Acquisition Agreement and shall be true and correct on and as of the closing date of the Acquisition with the same force and effect as if made on the closing date of the Acquisition except (a) in each case, or in the aggregate, where the failure to be true and correct would not reasonably be expected to have a material adverse effect on Eliem (without giving effect to any references therein to any material adverse effect on Eliem or other materiality qualifications), or (b) for those representations and warranties which address matters only as of a particular date (which representations shall have been true and correct, subject to the qualifications as set forth in the preceding clause, as of such particular date) (it being understood that, for purposes of determining the accuracy of such representations and warranties, any update of or modification to the disclosure schedules of Eliem made or purported to have been made after the date of the Acquisition Agreement shall be disregarded);

 

   

each of Eliem and Transitory Subsidiary must have performed or complied, in all material respects, with its agreements and covenants required to be performed or complied with under the Acquisition Agreement as of or prior to the closing of the Acquisition;

 

   

no judgment, order, decree, stipulation or injunction shall be in effect that would reasonably be expected to either prevent consummation of the transactions contemplated by the Acquisition Agreement or cause the transactions contemplated by the Acquisition Agreement to be rescinded following consummation of such transaction;

 

   

Tenet must have received a certificate delivered from Eliem to the effect that certain conditions in the Acquisition Agreement are satisfied; and

 

   

Eliem shall have obtained approval of the Share Issuance Proposal.

Termination and Termination Fees

Termination of the Acquisition Agreement

The Acquisition Agreement may be terminated at any time before the effective time of the Acquisition, whether before or, subject to the terms of the Acquisition Agreement, after receipt of the required stockholder approval of Tenet, as set forth below:

 

  a)

by mutual written consent of Eliem, Transitory Subsidiary and Tenet; or

 

  b)

by either Eliem or Tenet, if the Acquisition has not been consummated by October 10, 2024; provided, however, that this right to terminate the Acquisition Agreement shall not be available to a party if the failure of the Acquisition to have been consummated on or before October 10, 2024 was primarily due to the failure of such party to perform any of its material obligations under the Acquisition Agreement; or

 

  c)

by either Eliem or Tenet, if a governmental entity of competent jurisdiction has issued a nonappealable final order, decree or ruling or taken any other nonappealable final action, in each case having the effect of permanently restraining, enjoining or otherwise prohibiting the Acquisition; provided, however, that this right to terminate the Acquisition Agreement shall not be available to a party if the issuance of such order, decree, ruling or the taking of such action was primarily due to the failure of such party to perform any of its material obligations under the Acquisition Agreement; or

 

  d)

by Eliem, if there has been a breach of or failure to perform any representation, warranty, covenant or agreement on the part of Tenet set forth in the Acquisition Agreement, which breach or failure to

 

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  perform (i) would cause the conditions set forth in Section 6.1(b) or 6.1(c) of the Acquisition Agreement not to be satisfied and (ii) shall not have been cured or waived within 30 days following receipt by Tenet of written notice of such breach or failure to perform from Eliem; provided, however, that this right to terminate the Acquisition Agreement shall not be available to Eliem if Eliem or Transitory Subsidiary is then in material breach of any representation, warranty or covenant set forth in the Acquisition Agreement; or

 

  e)

by Tenet, if there has been a breach of or failure to perform any representation, warranty, covenant or agreement on the part of Eliem or Transitory Subsidiary set forth in the Acquisition Agreement, which breach or failure to perform (i) would cause the conditions set forth in Section 6.2(a) or 6.2(b) of the Acquisition Agreement not to be satisfied and (ii) shall not have been cured or waived within 30 days following receipt by Eliem of written notice of such breach or failure to perform from Tenet; provided, however, that this right to terminate the Acquisition Agreement shall not be available to Tenet if Tenet is then in material breach of any representation, warranty or covenant set forth in the Acquisition Agreement; or

 

  f)

by Eliem, at any time, if (i) Eliem has received a superior offer (ii) Eliem concurrently terminates the Acquisition Agreement and enters into a permitted alternative agreement with respect to a superior offer and (iii) within two business days of such termination, Eliem pays to Tenet the amount contemplated by the Acquisition Agreement; or

 

  g)

by either Eliem or Tenet if (i) the Eliem stockholders’ meeting (including any adjournments and postponements thereof) shall have been held and completed and Eliem stockholders shall have taken a final vote on the matters proposed at the Eliem stockholders’ meeting and (ii) the matters proposed at the Eliem stockholders’ meeting shall not have been approved at the Eliem stockholders’ meeting (or at any adjournment or postponement thereof) by the requisite vote of Eliem stockholders; or

 

  h)

by Eliem, if Tenet’s stockholder approval for the Acquisition shall not have been obtained prior to 5:00 p.m., New York time, on the first business day immediately following the date of the Acquisition Agreement.

Termination Fees Payable by Eliem

If (i) the Acquisition Agreement is terminated pursuant to clauses (b) or (g) above and an acquisition proposal with respect to Eliem shall have been publicly announced or disclosed to Eliem or the Eliem Board after the date of the Acquisition Agreement but prior to the termination of the Acquisition Agreement (which shall not have been withdrawn), and within twelve months after the date of such termination, Eliem consummates a transaction in respect of such acquisition proposal; or (ii) the Acquisition Agreement is terminated by Eliem pursuant to clause (f) above; then in the case of a termination pursuant to clause (i) or (ii), Eliem shall pay to Tenet an amount equal to $1,000,000 within three business days of termination of the Acquisition Agreement or, in the cause of clause (i) above, the date of the applicable triggering event, as applicable. If the Acquisition Agreement is terminated pursuant to clause (g) above, Eliem shall reimburse Tenet for all reasonable out of pocket fees and expenses incurred by Tenet in connection with the Acquisition Agreement and the other transactions contemplated by the Acquisition Agreement, up to a maximum of $500,000.

Amendment and Waiver

Prior to the effective time of the Acquisition, the Acquisition Agreement may be amended by Eliem and Tenet, by action taken or authorized by their respective boards of directors, at any time before or after receipt of approval of the Acquisition by Tenet stockholders. After receipt of approval of the Acquisition by Tenet stockholders, no amendment to the Acquisition Agreement shall be made which by law requires further approval by such stockholders without such further approval. The Acquisition Agreement may not be amended except by an instrument in writing signed (a) in the case of an amendment of any of Section 2.4 (Company Equityholder Representative), Section 2.5 (Allocation Schedule), Article VIII (Termination and Amendment), Article IX

 

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(Definitions), and Article X (Miscellaneous), on behalf of each of the parties to the Acquisition Agreement, and (b) in the case of an amendment of any other provision of the Acquisition Agreement, on behalf of Eliem and Tenet.

At any time prior to the effective time of the Acquisition, Eliem and Tenet, by action taken or authorized by their respective boards of directors, may, to the extent legally allowed, (i) extend the time for the performance of any of the obligations or other acts of the other parties to the Acquisition Agreement, (ii) waive any inaccuracies in the representations and warranties contained in the Acquisition Agreement or in any document delivered pursuant to the Acquisition Agreement and (iii) waive compliance with any of the agreements or conditions contained in the Acquisition Agreement; provided, however, the requirement that Eliem obtain the Required Eliem Stockholder Vote (including the Baseline Vote and the Disinterested Stockholder Approval) shall not be waivable by either party. Any agreement on the part of a party to the Acquisition Agreement to any such extension or waiver shall be valid only if set forth in a written instrument signed on behalf of such party. Such extension or waiver shall not be deemed to apply to any time for performance, inaccuracy in any representation or warranty, or noncompliance with any agreement or condition, as the case may be, other than that which is specified in the extension or waiver. The failure of any party to the Acquisition Agreement to assert any of its rights under the Acquisition Agreement or otherwise shall not constitute a waiver of such rights.

Fees and Expenses

Except as described above in the section titled “The Acquisition Agreement—Termination and Termination Fees” beginning on page 92 of this proxy statement, the Acquisition Agreement provides that Eliem shall pay all fees and expenses (including legal and accounting fees and expenses) incurred by it in connection with the transactions contemplated thereby and that the holders of Tenet stock shall pay the fees and expenses incurred in connection with the negotiation, preparation and execution of the Acquisition Agreement and the consummation of the transactions contemplated thereby, including any brokerage fees and commissions, finders’ fees or financial advisory fees and any fees and expenses of counsel or accountants payable by Tenet.

 

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AGREEMENTS RELATED TO THE ACQUISITION AND THE PRIVATE PLACEMENT

Support Agreements and Lock-up Agreements

Support Agreements

In order to induce Eliem to enter into the Acquisition Agreement, each Tenet stockholder is party to a Tenet Support and Joinder Agreement pursuant to which, among other things, each such stockholder, solely in his, her or its capacity as a Tenet stockholder, has agreed to vote all of such stockholder’s shares of Tenet common stock in favor of (i) the adoption of the Acquisition Agreement and (ii) the approval of the Acquisition and related transactions contemplated by the Acquisition Agreement. The Tenet stockholders also agreed to vote against any competing acquisition proposal with respect to Tenet.

The Tenet stockholders have also granted Eliem an irrevocable proxy to vote their respective shares of Tenet common stock in accordance with the Tenet Support and Joinder Agreement. The Tenet stockholders have also agreed not to solicit any acquisition proposals or acquisition inquiries and agreed to waive any appraisal or dissenters’ rights relating to the Acquisition.

As of May 10, 2024, the Tenet stockholders party to the Tenet Support and Joinder Agreement with Tenet and Eliem owned 100% of the outstanding shares of Tenet common stock. Subsequent to execution of the Tenet Support and Joinder Agreements and the Acquisition Agreement, holders of the requisite number of shares of Tenet common stock required by Tenet’s governing documents to adopt the Acquisition Agreement and approve the Acquisition and related transactions have adopted the Acquisition Agreement and approved the Acquisition via written consent, consisting of 100% of the outstanding shares of Tenet common stock.

Under the Tenet Support and Joinder Agreements, subject to certain exceptions, Tenet stockholders have also agreed not to sell or transfer their shares of Tenet common stock until the earlier of the termination of the Acquisition Agreement and the completion of the Acquisition. To the extent that any such sale or transfer is permitted pursuant to the exceptions included in the Tenet Support and Joinder Agreements, each person to which any shares of Tenet common stock are so sold or transferred must agree in writing to be bound by the terms and provisions of the Tenet Support and Joinder Agreement.

In addition, in order to induce Tenet to enter into the Acquisition Agreement, RA Capital Management entered into a support agreement with Eliem and Tenet pursuant to which, among other things, RA Capital Management agreed to vote all of its shares of Eliem common stock in favor of the Share Issuance Proposal and against any alternative acquisition proposals, subject to the terms and conditions set forth therein (the “Eliem Support Agreement”). RA Capital Management also agreed to vote against any competing acquisition proposal with respect to Eliem.

RA Capital Management also granted Tenet an irrevocable proxy to vote their respective shares of Eliem common stock in accordance with the Eliem Support Agreement. RA Capital Management also agreed not to solicit any acquisition proposals or acquisition inquiries and agreed to waive any appraisal or dissenters’ rights relating to the Acquisition.

As of May 10, 2024, RA Capital Management owned approximately 45.2% of the outstanding shares of Eliem common stock.

Under the Eliem Support Agreement, subject to certain exceptions, RA Capital Management also agreed not to sell or transfer its shares of Eliem common stock until the earlier of the termination of the Acquisition Agreement and the completion of the Acquisition, subject to certain exceptions. To the extent that any such sale or transfer is permitted pursuant to the exceptions included in the Eliem Support Agreement, each person to which any shares of Eliem common stock are so sold or transferred must agree in writing to be bound by the terms and provisions of the Eliem Support Agreement.

 

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The foregoing descriptions of the Tenet Support and Joinder Agreement and the Eliem Support Agreement do not purport to be complete and are qualified in their entirety by the full text of the forms of the Tenet Support and Joinder Agreement and the Eliem Support Agreement, which are attached hereto as Annex E and Annex D.

Lock-up Agreements

Concurrently with the execution of the Acquisition Agreement, certain executive officers, directors and stockholders of Tenet and Eliem (solely in their respective capacities as stockholders) entered into lock-up agreements (the “Lock- Up Agreements”) pursuant to which, subject to specified exceptions, they agreed not to transfer their shares of Eliem common stock issued in connection with the Acquisition for the 180-day period following the closing of the Acquisition.

Tenet stockholders and Eliem stockholders who have executed Lock-Up Agreements as of May 10, 2024, are expected to own in the aggregate, approximately 59.1% of the shares of Post-Closing Eliem’s outstanding common stock.

The foregoing description of the Lock-Up Agreements does not purport to be complete and is qualified in its entirety by the full text of the form of Lock-Up Agreement, which is attached hereto as Annex F.

SAFE Cancellation Agreements

Concurrently with the execution of the Acquisition Agreement, the SAFE Holders entered into the SAFE Cancellation Agreements. Pursuant to the SAFE Cancellation Agreements and in accordance with the Acquisition Agreement, immediately prior to the Acquisition, each Tenet SAFE that is then outstanding will, without any action on the part of Eliem, Tenet, any SAFE Holder or any other person, terminate and be cancelled, and be converted into the right to receive the applicable portion of the Aggregate Consideration as set forth on the allocation schedule to the Acquisition Agreement.

The foregoing description of the SAFE Cancellation Agreements does not purport to be complete and is qualified in its entirety by the full text of the form of SAFE Cancellation Agreement, which is attached hereto as Annex C.

Securities Purchase Agreement and Registration Rights Agreement

Securities Purchase Agreement

Concurrently with the execution and delivery of the Acquisition Agreement, Eliem entered into the Securities Purchase Agreement with the PIPE Investors, pursuant to which Eliem agreed to issue and sell to the PIPE Investors in the Private Placement an aggregate of 31,238,282 shares of Eliem common stock, at a price of $3.84 per share. Eliem expects to receive aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting estimated offering expenses payable by Eliem.

The Private Placement is expected to close immediately following the closing of the Acquisition, subject to the satisfaction of specified customary closing conditions, including approval from Eliem stockholders of the Share Issuance Proposal at the Meeting, and contingent upon, among other things, the closing of the Acquisition. The Securities Purchase Agreement contains customary representations and warranties of Eliem. The Securities Purchase Agreement also contains customary representations and warranties of PIPE Investors party thereto.

Each PIPE Investor’s obligation to purchase the shares of Eliem’s common stock pursuant to the Securities Purchase Agreement is subject to the satisfaction or waiver of certain conditions, including, among others:

 

   

the satisfaction or waiver of each of the conditions to the consummation of the Acquisition set forth in the Acquisition Agreement, including, without limitation, that Eliem obtain the Required Eliem Stockholder Vote (including the Baseline Vote and the Disinterested Stockholder Approval) of the Share Issuance Proposal under this proxy statement;

 

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all representations and warranties of Eliem contained in the Securities Purchase Agreement shall be true and correct in all material respects as of the date of the closing of the Private Placement (except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date);

 

   

Eliem shall have performed in all material respects all obligations and covenants required by the Securities Purchase Agreement to be performed by Eliem on or prior to the closing of the Private Placement;

 

   

Eliem shall have obtained all consents, permits, approvals, registrations and waivers necessary for the consummation of the Private Placement;

 

   

all conditions to the closing of the Acquisition set forth in the Acquisition Agreement shall have been satisfied or waived by the party entitled to the benefit thereof under the Acquisition Agreement;

 

   

Eliem shall have obtained the Required Eliem Stockholder Vote (including the Baseline Vote and the Disinterested Stockholder Approval);

 

   

no judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the Private Placement; and

 

   

no material adverse effect (as defined in the Securities Purchase Agreement) shall have occurred with respect to Eliem since the signing of the Securities Purchase Agreement.

 

   

Eliem’s obligation to sell shares of Eliem’s common stock to each PIPE Investor pursuant to the Securities Purchase Agreement is subject to the satisfaction or waiver of certain conditions, including:

 

   

all representations and warranties of the PIPE Investor contained in the Securities Purchase Agreement shall be true and correct in all material respects as of the date of the closing of the Private Placement (except to the extent any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date);

 

   

the PIPE Investor shall have performed in all material respects all obligations and covenants required by the Securities Purchase Agreement to be performed by the PIPE Investor on or prior to the closing of the Private Placement;

 

   

all conditions to the closing of the Acquisition set forth in the Acquisition Agreement shall have been satisfied or waived by the party entitled to the benefit thereof under the Acquisition Agreement; and

 

   

the PIPE Investor shall have paid in full to Eliem its aggregate purchase price for the shares acquired in the Private Placement.

The Securities Purchase Agreement terminates (i) upon the mutual written consent of Eliem and the PIPE Investors then committed to purchasing a majority of the shares to be purchased at the closing of the Private Placement by (or, if after the closing, then holding a majority of the shares held by) all PIPE Investors in the Private Placement; (ii) such date and time that the Acquisition Agreement is terminated in accordance with its terms; or (iii) by either Eliem or any PIPE Investor (with respect to itself only) if the closing of the Private Placement has not occurred on or prior to October 10, 2024.

Eliem has granted the PIPE Investors indemnification rights with respect to its representations, warranties, covenants and agreements under the Securities Purchase Agreement.

The foregoing description of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the Securities Purchase Agreement, which is attached hereto as Annex G.

 

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Registration Rights Agreement

Concurrently with the execution of the Securities Purchase Agreement, Eliem entered into the Registration Rights Agreement with the PIPE Investors, pursuant to which Eliem agreed to register for resale the shares sold in the Private Placement. On or prior to the closing of the Acquisition, each Tenet stockholder receiving a portion of the Aggregate Consideration in the Acquisition may elect to become party to the Registration Rights Agreement (each such stockholder, together with the investors in the Private Placement, the “Registrable Holders”), in which case Eliem will also register for resale the Aggregate Consideration. Under the Registration Rights Agreement, Eliem has agreed to file a registration statement covering the resale of the shares sold in the Private Placement and any Aggregate Consideration within 45 days following the closing of the Private Placement (the “Filing Deadline”). Eliem has agreed to use commercially reasonable efforts to cause such registration statement to become effective as promptly as practicable and to keep such registration statement effective until the date the shares of common stock sold in the Private Placement and any Aggregate Consideration covered by such registration statement have been sold or cease to be registrable securities under the Registration Rights Agreement.

If (i) the registration statement has not been filed by the Filing Deadline, (ii) the registration statement has not been declared effective by the SEC prior to the earlier of (A) five business days after the date on which Eliem is notified by the SEC that the registration statement will not be reviewed by the SEC staff or is not subject to further comment by the SEC staff, or (B) 45 days following the closing date of the Private Placement (or, in the event the SEC reviews and has written comments to the registration statement, 90 days following the Filing Deadline) or (iii) after the registration statement has been declared effective by the SEC, sales cannot be made pursuant to the registration statement for any reason (including by reason of a stop order or Eliem’s failure to update such registration statement), subject to certain limited exceptions, then Eliem has agreed to make pro rata payments to each Registrable Holder as liquidated damages in an amount equal to 1.0% of the aggregate amount invested by each such Registrable Holder in the registrable securities for the initial day of failure and for each subsequent 30-day period (or pro rata for any portion thereof) for each such month during which such event continues, subject to certain caps set forth in the Registration Rights Agreement.

Eliem has granted the Registrable Holders customary indemnification rights in connection with the registration statement. The Registrable Holders have also granted Eliem customary indemnification rights in connection with the registration statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by the full text of the Registration Rights Agreement, which is attached hereto as Annex H.

Senior Secured Promissory Note

On May 14, 2024, Eliem and Tenet entered into a Senior Secured Promissory Note (the “Note”) providing for Eliem to make short-term loans (the “Loan” or “Loans”) to Tenet up to an aggregate principal amount of $15.0 million. On or about the date of execution of the Note, Eliem made an initial Loan to Tenet of $5.0 million. Tenet requested the Loan in order to provide it with sufficient cash to fund its operations prior to the consummation of the Acquisition. Tenet’s ability to borrow the remaining $10.0 million under the Note is subject to certain conditions and restrictions on use.

The Loans will bear simple interest at a fixed rate per annum of 6%. All outstanding Loans, together with accrued interest, will become due and payable upon the earlier of (i) 12 months from the date of issuance the Note, (ii) the occurrence of specified corporate transactions, or (iii) Tenet’s receipt of at least $15.0 million in gross proceeds from the closing of a bona fide equity and/or debt financing.

Under the Note, Tenet granted Eliem a continuing, first-priority perfected security interest in all of Tenet’s present and future assets, properties and rights, whether tangible or intangible, including, without limitation, the intellectual property of Tenet. The Note contains certain customary representations and warranties and certain customary events of default.

 

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MATTERS BEING SUBMITTED TO A VOTE OF ELIEM STOCKHOLDERS

PROPOSAL NO. 1: APPROVAL, FOR PURPOSES OF NASDAQ LISTING RULE 5635 AND THE CONDITIONS OF THE ACQUISITION AGREEMENT, OF THE ISSUANCE OF SHARES OF ELIEM’S COMMON STOCK PURSUANT TO THE TERMS OF THE ACQUISITION AGREEMENT AND THE SECURITIES PURCHASE AGREEMENT

General

At the Meeting, Eliem stockholders will be asked to approve, in accordance with applicable rules of the Nasdaq Stock Market, the issuance of shares of Eliem’s common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement.

The Aggregate Consideration payable by Eliem to the former equityholders of Tenet in the Acquisition will be a number of shares of Eliem’s common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of outstanding shares of Eliem’s common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any shares of common stock pursuant to the Private Placement), calculated on a fully diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem).

Pursuant to the terms of the Securities Purchase Agreement, immediately following the effective time of the Acquisition, Eliem will issue to investors in the Private Placement an aggregate of 31,238,282 shares of Eliem’s common stock at a price per share of $3.84. Eliem expects to receive aggregate gross proceeds from the Private Placement of approximately $120.0 million, before deducting estimated offering expenses payable by Eliem.

The terms of, reasons for and other aspects of the Acquisition, the Acquisition Agreement, the Private Placement and the Securities Purchase Agreement are described in detail in the other sections in this proxy statement. A copy of the Acquisition Agreement is attached as Annex A to this proxy statement, and a copy of the Securities Purchase Agreement is attached as Annex G to this proxy statement.

Stockholder Approval Requirement for Purposes of Nasdaq Listing Rule 5635

Nasdaq Listing Rule 5635(a)(1)

Pursuant to Nasdaq Listing Rule 5635(a)(1), a company listed on Nasdaq is required to obtain stockholder approval prior to the issuance of common stock or other securities convertible into or exercisable for common stock, in connection with the acquisition of the stock or assets of another company, if such securities are not issued in a public offering and (i) the common stock has, or will have upon issuance, voting power equal to or in excess of 20% of the voting power outstanding before the issuance of such securities, or (ii) the number of shares of common stock to be issued is or will be equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of such securities.

In connection with the consummation of the Acquisition and the closing of the Private Placement, Eliem expects to issue (i) shares of Eliem’s common stock in connection with the Acquisition equal to the Aggregate Consideration, as described above and (ii) an aggregate of 31,238,282 shares of its common stock to investors in the Private Placement in accordance with the terms and subject to the conditions of the Securities Purchase Agreement. Accordingly, because the aggregate number of shares of Eliem’s common stock that Eliem will issue in connection with the Acquisition and the Private Placement will exceed 20% of both the voting power and the number of shares of Eliem’s common stock outstanding before such issuance, Eliem is seeking the approval of its stockholders for the issuance of shares of Eliem’s common stock pursuant to the Acquisition Agreement and the Private Placement pursuant to Nasdaq Listing Rule 5635(a)(1).

Nasdaq Listing Rule 5635(a)(2)

Pursuant to Nasdaq Listing Rule 5635(a)(2), a company listed on Nasdaq is required to obtain stockholder approval prior to the issuance of common stock or other securities convertible into or exercisable for common

 

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stock, in connection with the acquisition of the stock or assets of another company, if any director, officer or substantial shareholder of the listed company has a 5% or greater interest (or such persons collectively have a 10% or greater interest), directly or indirectly, in the listed company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding shares of common stock or voting power of 5% or more. Nasdaq Listing Rule 5635(e)(3) defines a substantial stockholder as the holder of an interest of 5% or more of either the number of shares of common stock or the voting power outstanding of a Nasdaq-listed company.

RA Capital Management is a greater than 5% stockholder of Eliem before the closing of the Acquisition and the Private Placement, and RA Capital Management has a representative on the Eliem Board, who is Andrew Levin, M.D., Ph.D. RA Capital Management is considered a substantial shareholder of Eliem pursuant to Nasdaq Listing Rule 5635(a)(2). For more information about RA Capital Management’s beneficial ownership in Eliem, please see the section titled “Principal Stockholders of Eliem.”

RA Capital Management is also a greater than 5% stockholder of Tenet before the closing of the Acquisition and the Private Placement and, as a result, upon the effective time of the Acquisition and pursuant to the Acquisition Agreement, RA Capital Management is expected to receive shares of Eliem’s common stock in exchange for the shares then-held in Tenet. In addition, RA Capital Management has agreed to purchase in the Private Placement 13,008,546 shares of Eliem’s common stock for approximately $49,971,549.

Because RA Capital Management has a 10% or greater interest in the shares of Eliem’s common stock to be issued in the Private Placement and the Acquisition and the Acquisition and the Private Placement will result in an increase in outstanding shares of common stock of Eliem of 5% or more, Eliem is seeking the approval of its stockholders for the issuance of shares of Eliem’s common stock pursuant to the Acquisition Agreement and the Private Placement pursuant to Nasdaq Listing Rule 5635(a)(2).

Reasons for the Transactions

After consideration and consultation with Eliem’s senior management and Eliem’s financial and legal advisors, the Eliem Board determined that the Acquisition Agreement, the Acquisition, the Securities Purchase Agreement and the Private Placement are advisable and in the best interests of Eliem and its stockholders. The Special Committee and the Eliem Board considered various reasons to reach its determination, as discussed elsewhere in this proxy statement, including, but not limited to, “The Acquisition—Eliem’s Reasons for the Acquisition and the Private Placement” beginning on page 66 of this proxy statement.

As previously disclosed in its Q1 Quarterly Report, Eliem estimates that its cash and cash equivalents as of March 31, 2024 will be sufficient to fund its planned operations through at least 12 months following the filing date of the Q1 Quarterly Report. Following the Acquisition, as Post-Closing Eliem seeks to develop and commercialize TNT119 and/or other Post-Closing Eliem product candidates, Eliem will need substantial additional funding to support its continuing operations. The net proceeds from the Private Placement are expected to be used to advance Post-Closing Eliem’s development pipeline, business development activities, working capital and other general corporate purposes. Immediately following the closing of the Acquisition and the Private Placement, the total cash and cash equivalents of Post-Closing Eliem is expected to be approximately $210.0 million, which Eliem believes will be sufficient to fund Post-Closing Eliem’s operations into 2027. Eliem believes the total cash and cash equivalents of Post-Closing Eliem following the closing will enable the potential attainment of key clinical and development milestones for TNT119.

The closing of the Acquisition is subject to the satisfaction or waiver of customary conditions to closing, including receipt of approval of this Proposal No. 1 by Eliem stockholders at the Meeting. The Private Placement is expected to close as of immediately following the closing of the Acquisition and is conditioned upon the satisfaction or waiver of the conditions to the closing of the Acquisition, receipt of approval of this Proposal No. 1 by Eliem stockholders at the Meeting, as well as certain other closing conditions.

 

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In the event that this Proposal No. 1 is not approved by Eliem stockholders, the Acquisition and the Private Placement cannot be consummated.

Required Vote

Approval of Proposal No. 1 requires the affirmative vote of both:

 

  i.

a majority in voting power of the votes cast by holders of the outstanding shares of Eliem common stock entitled to vote in accordance with the DGCL (the “Baseline Vote”); and

 

  ii.

a majority of the aggregate voting power of the outstanding shares of Eliem common stock entitled to vote thereon other than any outstanding shares of Eliem common stock beneficially owned, directly or indirectly, by (1) Tenet, (2) any stockholder of Tenet, including RA Capital Management, L.P. (together with certain of its affiliated funds, “RA Capital Management”), (3) any individual that Eliem has determined to be an “officer” of Eliem within the meaning of Rule 16a-1(f) of the Exchange Act, (4) any PIPE Investor, (5) any “immediate family member” (as defined in Item 404 of Regulation S-K) of any individual listed in the foregoing clauses (1)-(4), and (6) any “affiliate” or “associate” (as defined in Section 12b-2 of the Exchange Act) of any person listed in the foregoing clauses (1)-(5) (holders of Eliem common stock other than the persons listed in this clause (ii), the “Disinterested Stockholders” and, the vote contemplated by this clause (ii), the “Disinterested Stockholder Approval” and. collectively with the Baseline Vote, the “Required Eliem Stockholder Vote”).

Pursuant to a support agreement, RA Capital Management has agreed to vote in favor of this Proposal No. 1. As of May 10, 2024, RA Capital Management owned approximately 45.2% of the outstanding shares of Eliem’s common stock. Such vote will not, however, have any effect on the Disinterested Stockholder Approval.

THE ELIEM BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 1 TO APPROVE, FOR PURPOSES OF NASDAQ LISTING RULE 5635 AND THE CONDITIONS OF THE ACQUISITION AGREEMENT, THE ISSUANCE OF SHARES OF ELIEM’S COMMON STOCK PURSUANT TO THE TERMS OF THE ACQUISITION AGREEMENT AND THE SECURITIES PURCHASE AGREEMENT.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the approval, for purposes of Nasdaq Listing Rule 5635 and the conditions of the Acquisition Agreement, of the issuance of shares of Eliem common stock pursuant to the terms of the Acquisition Agreement and the Securities Purchase Agreement.

 

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PROPOSAL NO. 2: APPROVAL OF POSSIBLE ADJOURNMENT OF THE MEETING

General

If Eliem fails to receive a sufficient number of votes to approve Proposal No. 1, Eliem may propose to adjourn the Meeting for the purpose of soliciting additional proxies to approve Proposal No. 1. Eliem currently does not intend to propose adjournment at the Meeting if there are sufficient votes to approve Proposal No. 1.

Eliem may also propose adjourning the Meeting if otherwise determined by the chairperson of the meeting to be necessary or appropriate.

Required Vote

Approval of Proposal No. 2 requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote thereon.

THE ELIEM BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” THIS PROPOSAL NO. 2 TO ADJOURN THE MEETING FROM TIME TO TIME TO SOLICIT ADDITIONAL PROXIES IN FAVOR OF THE SHARE ISSUANCE PROPOSAL IF THERE ARE INSUFFICIENT VOTES AT THE TIME OF SUCH ADJOURNMENT TO APPROVE THE SHARE ISSUANCE PROPOSAL OR IF OTHERWISE DETERMINED BY THE CHAIRPERSON OF THE MEETING TO BE NECESSARY OR APPROPRIATE.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy to vote shares “FOR” the proposal to adjourn the Meeting from time to time to solicit additional proxies in favor of the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Share Issuance Proposal or if otherwise determined by the chairperson of the meeting to be necessary or appropriate.

 

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PROPOSAL NO. 3: ELECTION OF DIRECTORS

General

The Eliem Board is divided into three classes. Each class consists, as nearly as possible, of one-third of the total number of directors, and each class has a three-year term. Vacancies on the Eliem Board may be filled only by persons elected by a majority of the remaining directors. A director elected by the Eliem Board to fill a vacancy in a class, including vacancies created by an increase in the number of directors, shall serve for the remainder of the full term of that class and until the director’s successor is duly elected and qualified.

The Eliem Board presently has five members. There are two directors in the class whose term of office expires in 2024. If elected at the Meeting, these nominees would serve until the 2027 annual meeting of stockholders and until their successors have been duly elected and qualified, or, if sooner, until such director’s death, resignation or removal. It is Eliem’s policy to invite directors and nominees for director to attend the Meeting. Three members of the Eliem Board attended the 2023 annual meeting.

If the Acquisition is completed, the composition of the Eliem Board will change. For more information relating to the effect of the Acquisition on the Eliem Board, see the section titled “Management Following the Acquisition” beginning on page 143 of this proxy statement.

Required Vote

Directors are elected by a plurality of the votes of the shares present in person via the Internet or represented by proxy at the Meeting and entitled to vote generally on the election of directors. Accordingly, the nominee receiving the highest number of affirmative votes will be elected. Shares represented by executed proxies will be voted, if authority to do so is not withheld, for the election of the nominee named below. If the nominee becomes unavailable for election as a result of an unexpected occurrence, shares that would have been voted for that nominee will instead be voted for the election of a substitute nominee proposed by Eliem. The person nominated for election has agreed to serve if elected. Eliem has no reason to believe that any nominee will be unable to serve.

Andrew Levin, M.D., Ph.D. and Liam Ratcliffe, M.D., Ph.D. were recommended for election by the nominating and corporate governance committee of the Eliem Board (the “Nominating and Corporate Governance Committee”) and are currently directors of Eliem. Dr. Levin and Dr. Ratcliffe were each appointed to the Eliem Board prior to Eliem’s initial public offering by the then current members of the Eliem Board to fill a vacant seat. The Nominating and Corporate Governance Committee seeks to assemble a board that, as a whole, possesses the appropriate balance of professional and industry knowledge, financial expertise and high-level management experience necessary to oversee and direct Eliem’s business. To that end, the Nominating and Corporate Governance Committee has identified and evaluated nominees in the broader context of the Eliem Board’s overall composition, with the goal of recruiting members who complement and strengthen the skills of other members and who also exhibit integrity, collegiality, sound business judgment and other qualities that the Nominating and Corporate Governance Committee views as critical to effective functioning of the Eliem Board. To provide a mix of experience and perspective on the Eliem Board, the Nominating and Corporate Governance Committee also takes into account geographic, gender, age, racial and ethnic diversity. The brief biographies below include information, as of the date of this proxy statement, regarding the specific and particular experience, qualifications, attributes or skills of each director or nominee that led the Nominating and Corporate Governance Committee to believe that that nominee should continue to serve on the Eliem Board. However, each of the members of the Nominating and Corporate Governance Committee may have a variety of reasons why he or she believes a particular person would be an appropriate nominee for the Eliem Board, and these views may differ from the views of other members.

 

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NAME OF NOMINEE

   AGE   

PRINCIPAL OCCUPATION/

POSITION HELD WITH ELIEM

Andrew Levin, M.D., Ph.D.    47    Executive Chair of the Board of Directors of Eliem; Managing Director at RA Capital Management, L.P.
Liam Ratcliffe, M.D., Ph.D.    60    Lead Independent Director of Eliem; Head of Biotechnology at Access Industries, Inc.

 

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NOMINEES FOR ELECTION FOR A THREE-YEAR TERM EXPIRING AT THE 2027 ANNUAL MEETING OF STOCKHOLDERS

Andrew Levin, M.D., Ph.D. is a Co-Founder of Eliem, served as Eliem’s Chief Executive Officer from October 2018 to October 2020, and has served as the Chairman of the Eliem Board since February 2019 and as Executive Chairman of the Eliem Board since February 2023. Since 2015, Dr. Levin has served as a Managing Director on the Investment Team at RA Capital Management, L.P. Previously, Dr. Levin was a Vice President at H.I.G. BioVentures, and prior to that he served as the Director of Pharmaceutical Sciences for the Clinton Health Access Initiative. Dr. Levin holds a B.S. in mechanical engineering from Princeton University, a Ph.D. in biomedical engineering from the Massachusetts Institute of Technology and an M.D. from Harvard Medical School.

The Nominating and Corporate Governance Committee believes that Dr. Levin is qualified to serve on the Eliem Board due to his substantial experience as an investor in early-stage biopharmaceutical and life sciences companies, as well as his experience of serving on the boards of directors for several biopharmaceutical companies.

Liam Ratcliffe, M.D., Ph.D. has served as a member of the Eliem Board since October 2019 and as Eliem’s Lead Independent Director since March 2023. Dr. Ratcliffe has also served as the Head of Biotechnology at Access Industries, Inc. since April 2019. From September 2008 to April 2019, Dr. Ratcliffe served as Managing Director at New Leaf Venture Partners (“New Leaf”), where he focused on investing in therapeutics and therapeutic platform companies. Prior to joining New Leaf, Dr. Ratcliffe held various positions of increasing responsibility at Pfizer Inc., a multinational pharmaceutical corporation, including Senior Vice President and Development Head for Neuroscience, and Worldwide Head of Clinical Research and Development. Dr. Ratcliffe currently serves on the board of directors of Disc Medicines, a biopharmaceutical company, and several privately held biotechnology companies. Dr. Ratcliffe previously served on the boards of directors of several biotechnology and biopharmaceutical companies, including Deciphera Pharmaceuticals, Inc. and Arvinas, Inc, Unum Therapeutics, Inc., from March 2018 to April 2019, Edge Therapeutics, Inc., from October 2015 to November 2018, and Array Biopharmaceuticals, Inc., from April 2012 to April 2014. Dr. Ratcliffe holds an M.B.A. from the University of Michigan and an M.D. and Ph.D. in Immunology from the University of Cape Town, and he completed his internal medicine training and fellowship in Immunology at Groote Schuur Hospital and associated teaching hospitals in Cape Town, South Africa.

The Nominating and Corporate Governance Committee believes that Dr. Ratcliffe is qualified to serve on the Eliem Board due to his extensive experience in the venture capital industry, medical and scientific background and training, and leadership at various biopharmaceutical and biotechnology companies.

THE ELIEM BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” BOTH OF THE NOMINEES FOR ELECTION AS DIRECTORS.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the approval of the director nominees for election as directors.

 

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PROPOSAL NO. 4: RATIFICATION OF SELECTION OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

General

The audit committee of the Eliem Board has selected PricewaterhouseCoopers LLP as Eliem’s independent registered public accounting firm for the fiscal year ending December 31, 2024, and has further directed that management submit the selection of its independent registered public accounting firm for ratification by the stockholders at the Meeting. PricewaterhouseCoopers LLP has audited Eliem’s financial statements since 2020. Representatives of PricewaterhouseCoopers LLP are expected to be present at the Meeting. They will have an opportunity to make a statement if they so desire and will be available to respond to appropriate questions.

Neither Eliem’s bylaws nor other governing documents or law require stockholder ratification of the selection of PricewaterhouseCoopers LLP as Eliem’s independent registered public accounting firm. However, the audit committee of the Eliem Board is submitting the selection of PricewaterhouseCoopers LLP to the stockholders for ratification as a matter of good corporate practice. If the stockholders fail to ratify the selection, the audit committee of the Eliem Board will reconsider whether or not to retain that firm. Even if the selection is ratified, the audit committee of the Eliem Board in its discretion may direct the appointment of different independent auditors at any time during the year if they determine that such a change would be in the best interests of Eliem and its stockholders.

Required Vote

Approval of Proposal No. 4 requires the affirmative vote of the holders of a majority of the voting power of the shares present in person via the Internet or represented by proxy at the Meeting and voting affirmatively or negatively on such matter.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The following table represents aggregate fees billed to Eliem for the years ended December 31, 2022 and December 31, 2023 by PricewaterhouseCoopers LLP, Eliem’s principal accountant.

 

    

Year Ended

December 31,

 
     2022      2023  

Audit Fees (1)

   $ 929,500      $ 680,000  

Audit-related Fees

     —         —   

Tax Fees

     —         —   

All Other Fees (2)

   $ 6,650      $ 1,944  

Total Fees

   $ 936,150      $ 681,944  

 

(1)

This category includes fees for professional services provided in conjunction with the audit and quarterly review of Eliem’s financial statements and review of our registration statements and related issuances of consents, and related services that are normally provided in connection with statutory and regulatory filings or engagements.

(2)

All other fees relate to subscriptions for accounting-related research software.

All fees described above were pre-approved by the audit committee.

PRE-APPROVAL POLICIES AND PROCEDURES

The charter of the audit committee provides for the pre-approval of audit and non-audit services rendered by Eliem’s independent registered public accounting firm, PricewaterhouseCoopers LLP. The audit committee generally pre-approves specified services in the defined categories of audit services, audit-related services and

 

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tax services up to specified amounts. Pre-approval may also be given as part of the audit committee’s approval of the scope of the engagement of the independent auditor or on an individual, explicit, case-by-case basis before the independent auditor is engaged to provide each service. The pre-approval of services may be delegated to one or more of the audit committee’s members, but the decision must be reported to the full audit committee at its next scheduled meeting. The audit committee has determined that the rendering of services other than audit services by PricewaterhouseCoopers LLP is compatible with maintaining the principal accountant’s independence.

THE ELIEM BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” THE RATIFICATION OF THE APPOINTMENT OF THE INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM.

Unless otherwise instructed, it is the intention of the persons named in the accompanying proxy card to vote shares represented by properly executed proxy cards “FOR” the ratification of the appointment of the independent registered public accounting firm.

 

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REPORT OF THE AUDIT COMMITTEE OF THE BOARD OF DIRECTORS(1)

The audit committee has reviewed and discussed Eliem’s audited financial statements for the fiscal year ended December 31, 2023 with management of Eliem. The audit committee has discussed with the independent registered public accounting firm the matters required to be discussed by the applicable requirements of the Public Company Accounting Oversight Board (“PCAOB”) and the SEC. The audit committee has also received the written disclosures and the letter from the independent registered public accounting firm required by applicable requirements of the PCAOB regarding the independent accountants’ communications with the audit committee concerning independence, and has discussed with the independent registered public accounting firm the accounting firm’s independence. Based on the foregoing, the audit committee recommended to the Eliem Board that the audited financial statements be included in Eliem’s 2023 Annual Report.

 

Adam Rosenberg
Simon Tate
Judith Dunn

 

(1)

The material in this report is not “soliciting material,” is not deemed “filed” with the Commission and is not to be incorporated by reference in any filing of Eliem under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.

 

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ELIEM’S BUSINESS

For a description of Eliem’s business, please refer to the section titled “Item 1. Business” set forth in Eliem’s 2023 Annual Report as filed with the SEC on March 28, 2024, which section is incorporated by reference herein. For a description of legal proceedings Eliem is party to, please refer to the section titled “Item 3. Legal Proceedings” set forth Eliem’s 2023 Annual Report, as filed with the SEC on March 28, 2024, and the section titled “Item 1. Legal Proceedings” set forth in Eliem’s subsequent Q1 Quarterly Report, as filed with the SEC on May 15, 2024, which sections are incorporated by reference herein.

ELIEM’S PROPERTY

For a description of Eliem’s property, please refer to the section titled “Item 2. Properties” set forth in Eliem’s 2023 Annual Report as filed with the SEC on March 28, 2024, which section is incorporated by reference herein.

 

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TENET’S BUSINESS

Overview and Corporate History

Tenet is a clinical stage biotechnology company dedicated to developing its product candidate, TNT119. Also known as budoprutug, TNT119 is an anti-CD19 monoclonal antibody (“mAb”) designed for a broad range of autoimmune diseases, including systemic lupus erythematosus (“SLE”), immune thrombocytopenia (“ITP”) and membranous nephropathy (“MN”). Tenet was founded in November 2023 and entered into an asset purchase agreement with Acelyrin in January 2024, which granted Tenet worldwide licenses to develop, manufacture, use and commercialize TNT119 for any non-oncology indication. Approximately 81% of Tenet’s equity interests are held by Sera Medicines, which is majority owned by RA Capital Management L.P., and approximately 19% of its equity interests are held by Tenet’s management. The services of Tenet’s management team, including its Chief Executive Officer and Chief Business Officer, are provided pursuant to a services agreement with an affiliate of Sera Medicines, which, in connection the Closing of the Acquisition, will be terminated as such members of management become employees of Eliem.

TNT119 is an anti-CD19 mAb with a fragmented crystallizable region engineered to achieve effector function through low-fucosylation (“Fc+”). CD19 is expressed on B-lineage cells and plays a key role in B cell autoimmune diseases. TNT119, an anti-CD19 mAb, is designed to deplete CD19-positive B cells, including antibody secreting cells, in order to directly reduce pathogenic autoantibodies. This reduction of autoantibodies has the potential to be disease modifying in autoantibody driven diseases, such as SLE, ITP and MN. In a Phase 1b clinical trial of TNT119 in MN, 3 out of 5 (or 60%) of patients that received four doses of TNT119 achieved a complete remission of proteinuria, a primary symptom of MN.

In SLE, one of TNT119’s lead indications, the underlying pathology involves production of autoantibodies by autoreactive B cells that contribute to inflammation and tissue damage. CD19 is a protein expressed on the surface of these B-cells and plays a key role in B cell activation. Because TNT119 is designed to target and deplete CD19-expressing B cells known to produce autoantibodies, Tenet believes TNT119 has the potential to treat SLE. In ITP, Tenet believes targeting plasmablasts and plasma cells is likely to decrease the production of autoantibodies, increase platelet count and ameliorate disease. B-cell depletion with anti-CD20 targeting mAbs, whose expression initiates somewhat later and is lost somewhat earlier than anti-CD19, has demonstrated efficacy in ITP disease for some patients in clinical trials by third parties. For those patients who do not respond to anti-CD20 therapy, Tenet believes an anti-CD19 approach, such as TNT119, may have the ability to further deplete pathogenic CD20-/CD19+ cells.

Based on the preliminary results of the Phase 1b clinical trial of TNT119 in MN, Tenet aims to initiate two Phase 2 clinical trials of TNT119 in the second half of 2024, one in SLE and one in ITP, pending submission and clearance of investigational new drug applications (“INDs”) to the U.S. Food and Drug Administration (“FDA”) for these indications. By the end of 2024, Tenet also expects to have finalized a high concentration formulation of TNT119 to potentially support subcutaneous dosing. Tenet is also targeting publishing a more comprehensive set of preliminary MN data from the Phase 1b clinical trial at a medical conference in the fourth quarter of 2024.

 

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Tenet’s Pipeline

The following chart summarizes the lead indications for which Tenet plans to develop TNT119 and the current stage of development in each indication:

 

LOGO

Tenet’s Strategy

Tenet’s strategy since the asset acquisition of TNT119 has been to develop TNT119 across a range of autoimmune-mediated diseases, especially where targeted approaches have clear biological rationale, where Tenet can potentially achieve clinical proof-of-concept and where TNT119 can be meaningfully differentiated in the market.

The key elements of Tenet’s strategy for TNT119 include:

 

   

Advance TNT119 through clinical development for patients with SLE. Tenet is developing TNT119 for the treatment of SLE. Tenet expects to initiate a Phase 2 clinical trial of TNT119 for the treatment of SLE in the second half of 2024, pending submission and clearance of an IND to the FDA for this indication.

 

   

Advance TNT119 through clinical development for patients with ITP. Tenet is developing TNT119 for the treatment of ITP. Tenet expects to initiate a Phase 2 clinical trial of TNT119 for the treatment of ITP in the second half of 2024, pending submission and clearance of an IND to the FDA for this indication.

 

   

Advance subcutaneous formulation of TNT119. Tenet is developing a high concentration formulation of TNT119 to support subcutaneous administration, which is a convenient dose form that is designed to differentiate TNT119 from intravenous treatments for SLE, ITP, MN and other autoimmune diseases. Tenet expects to finalize its subcutaneous formulation by the end of 2024.

 

   

Continue to advance TNT119 through clinical development in patients with MN. Tenet believes preliminary data from the Phase 1b clinical trial of TNT119 in MN supports TNT119’s potential to provide a differentiated product profile for the treatment of MN. Tenet expects to report additional preliminary Phase 1b clinical data in the fourth quarter of 2024.

 

   

Explore opportunities to selectively expand the potential of TNT119. Tenet plans to strategically evaluate potential collaborations with external parties to maximize the potential of TNT119. Tenet also believes that there is an opportunity to develop TNT119 for other autoimmune diseases in addition to SLE, ITP and MN and plans to evaluate the development of TNT119 for additional indications.

Autoimmune Disease

Overview of Autoimmune Diseases

The immune system plays a vital role in nearly every aspect of human health, from protecting against external pathogens such as viruses, bacteria and fungi, to acting as a frontline surveillance and defense system that

 

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eliminates internal threats, such as pre-malignant and malignant lesions. Beyond providing protection, the immune system regulates key regenerative and homeostatic processes in healthy individuals on an ongoing basis.

In patients with autoimmune diseases, the immune system inappropriately recognizes and attacks normal healthy tissues, causing inflammation, organ damage, debilitating symptoms and, in severe cases, death. To date there are over 100 documented autoimmune diseases, each with a wide range of clinical manifestations, pathophysiology and severities. It is estimated that approximately 4% of the world’s population and nearly 50 million people in the United States are affected by an autoimmune disease, with evidence suggesting that this percentage will continue to rise in the future.

The standard-of-care for immune-related diseases has been immunosuppressive medications and anti-inflammatory agents that are intended to prevent and control immune system overactivity. Recently, improved research and development efforts have resulted in targeted therapies that have shown greater efficacy while reducing treatment-limiting side effects, including those associated with broad immunosuppression. However, despite these advances, many patients with autoimmune diseases continue to be underserved. Existing targeted therapies may not fully address underlying disease biology or have meaningful side effects.

SLE

Systemic lupus erythematosus, characterized by the presence of autoantibodies, is a multifactorial autoimmune disease in which the immune system attacks its own tissue, causing widespread inflammation and tissue damage in affected organs including joints, skin, brain, lungs, kidneys and blood vessels. In SLE, the underlying pathology involves the production of autoantibodies by autoreactive B cells that contribute to inflammation and tissue damage. Based on third-party research, we estimate that SLE affects over 240,000 people in the United States.

Current treatment options for SLE are steroids or immune-suppressive therapies, including AstraZeneca plc’s Saphnelo and GSK plc’s Benlysta. Recent studies conducted by third parties have indicated a potential for CD19-targeted therapies to address autoimmune diseases such as SLE.

ITP

Immune thrombocytopenia is an autoimmune disease characterized by abnormally low levels of platelets, which help prevent and control bleeding by accelerating clotting where needed. The low platelet levels can lead to severe internal bleeds and hemorrhaging. A major cause of ITP is a breakdown of immune tolerance to platelets, followed by production of autoantibodies that target and destroy platelets. In the United States, Tenet estimates there are approximately 65,000 people with ITP.

Current therapies for ITP include corticosteroids, intravenous immunoglobulin, thrombopoietin receptor agonists, spleen tyrosine kinase inhibitor and immunosuppressive agents. One leading medication in the market is rituximab, which is a monoclonal antibody medication used to treat ITP along with other forms of autoimmune diseases and various forms of cancer. While these current treatments have proven successful in improving platelet counts, some patients still have an inadequate response with current treatments and continue to struggle with low levels of platelets, thereby a need for improved therapies remains.

MN

Membranous nephropathy is an organ-specific autoimmune disease that largely affects the kidney’s ability to function due to autoantibody-mediated inflammation in the glomerular basement membrane, ultimately causing nephrotic syndrome. These patients often spill excess protein, known as proteinuria, which, if left untreated, can lead to kidney failure. Tenet estimates there are approximately 70,000 people in the United States with MN.

 

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Traditional treatments for patients with MN include alkylating agents or calcineurin inhibitors, which have undesirable side effects, including, among others, hypertension, neurotoxicity, metabolic abnormalities, a heightened risk of life-threatening bacterial, viral, and fungal infections, malignancies, hypoglycemia and gastrointestinal disturbances. Newer therapies like rituximab have been used with some success, however the majority of treated patients do not achieve complete remission of their disease. There are currently no drugs specifically approved for the treatment of MN in the United States.

B-Cell Depletion Therapies

The body’s immune system detects foreign pathogens and utilizes various cells to mount a response. A key feature of the immune system is its ability to differentiate between self and non-self. When this differentiation is disrupted, the immune system may attack “self” antigens, which may result in autoimmune disease. These diseases include SLE, ITP and MN, among others. Dysfunctional cells in the adaptive immune system, especially B cells, are primary contributors to autoimmune disease.

B cells are primarily generated from hematopoietic stem cells as pro-B cells in the bone marrow and mature in various stages, eventually into plasmablasts and plasma cells. Plasmablasts and plasma cells in a healthy immune system are activated in the presence of an antigen and secrete a small or large amount of antibodies, respectively, to combat pathogens. A dysfunctional B cell may be activated by a “self” antigen, and may differentiate into cells that will secrete an antibody, referred to as antibody secreting cells, that will bind to such “self” antigen and contribute to autoimmune disease by negatively modulating important biological pathways. These antibodies are referred to as autoantibodies, and occur in the later stages of B cell maturation.

Therapies that deplete B cells, including monoclonal antibodies, have been utilized for decades, first in oncology and more recently in autoimmune diseases. These therapies target various receptors on B cells, including CD20, CD38, CD22, BAFF-R and CD319. Such therapies have modest clinical benefit but have not been able to address the full spectrum of B cells from pro-B to plasma cells because the targeted antigen is not expressed on all cell types.

The competitive landscape for anti-CD19 mAbs with enhanced cell-killing properties is limited to only two other programs of which Tenet is aware, Amgen’s inebilizumab and Incyte’s tafasitamab. Tenet believes CD19 is a promising target for mAb therapies for autoimmune diseases, including SLE, ITP and MN, due to CD19’s expression on many autoantibody secreting cells, including progenitor cells. Given such, Tenet believes TNT119 administration could result in a durable depletion of autoantibody secreting cells.

TNT119 Overview

TNT119 is an anti-CD19 mAb that is designed to achieve broad and deep depletion of pathogenic B-cells. Tenet is developing TNT119 to be administered both as an infusion and for subcutaneous administration. A key component of Tenet’s therapeutic hypothesis is that deeper depletion of autoantibody-secreting cells will correlate with improved clinical benefit in autoimmune diseases like SLE. While existing B-cell targeted approaches provide modest clinical benefit and support the role of B-cells in lupus disease pathogenesis, as an Fc-engineered anti-CD19 antibody, TNT119 is designed to achieve rapid and durable depletion of B cells to potentially improve clinical benefit.

TNT119 for Systemic Lupus Erythematosus

TNT119’s lead indication is in systemic lupus erythematosus, an autoimmune disease in which the immune system attacks its own tissue causing widespread inflammation and tissue damage in affected organs including joints, skin, brain, lungs kidneys and blood vessels. In SLE, the underlying pathology involves the production of autoantibodies by autoreactive B cells that contribute to inflammation and tissue damage. CD19 is a protein expressed on the surface of these B cells, and it plays a role in B cell activation. TNT119 is designed to target

 

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and deplete CD19-expressing B cells known to produce autoantibodies, thereby providing an approach to the potential treatment of SLE. Tenet expects to initiate a Phase 2 clinical trial of TNT119 for the treatment of SLE in the second half of 2024.

Clinical validation for targeting CD19 in lupus has recently been achieved via several sets of impressive data from third parties utilizing CD19-directed CAR-T, where patients achieved what effectively appears to be complete resolution of disease markers and symptoms. Tenet believes that the safety, tolerability and any potential durability challenges with CAR-T therapy could favor an antibody-based approach, such as TNT119, which has the potential to be better tolerated, more conveniently administered and easier to manufacture. Specifically, safety concerns like cytokine release syndrome and neurotoxicity have occurred in patients receiving CD19-directed CAR-T therapy. Tenet believes that an anti-CD19 antibody approach has the potential to access and deplete tissue-level B-cell niches that are the main drivers of disease, potentially providing similar levels of B-cell depletion as CAR-T therapy, but with the opportunity for improved durability and tolerability.

TNT119 for Immune Thrombocytopenia

Immune thrombocytopenia is an autoimmune disease in which the body’s immune system destroys platelets. Destruction of platelets, which are a key contributor to blood coagulation, can lead to severe internal bleeding and hemorrhaging. A major cause of ITP is breakdown of immune tolerance to platelets, followed by production of autoantibodies that target and destroy platelets.

Tenet believes targeting plasmablasts and plasma cells is likely to decrease the production of autoantibodies, increase platelet count and ameliorate disease. B-cell depletion with the anti-CD20 antibody rituximab has demonstrated efficacy in this disease, however many patients do not respond or respond inadequately. Tenet believes those patients who do not respond to anti-CD20 therapy may have a population of pathogenic CD20-/CD19+cells that could be depleted by an anti-CD19 approach, such as TNT119. Tenet expects to initiate a Phase 2 clinical trial of TNT119 for the treatment of ITP in the second half of 2024.

TNT119 for Membranous Nephropathy

Membranous nephropathy is a disease that largely affects the kidney’s ability to function due to autoantibody-mediated inflammation in the glomerular basement membrane. These patients often spill excess protein, known as proteinuria, which, if left untreated, can lead to kidney failure.

Prior to the acquisition of TNT119 by Acelyrin, ValenzaBio, Inc. (“ValenzaBio”) randomized the first patient in the Phase 1b clinical trial of TNT119 in MN in November 2021 and the trial was conducted by ValenzaBio and then Acelyrin at several sites across the United States. In the trial, two cohorts of MN patients were eligible to receive up to 4 total doses of either 100 mg or 200 mg of TNT119, dosed at Weeks 0, 2, 24 and 26. Changes in B-cell counts, as measured by circulating CD20+ cells, and changes in proteinuria, as measured by urine protein creatinine ratio (“UPCR”), were tracked in patients. The primary efficacy endpoint of the trial was the achievement of a complete remission (“CR”) of proteinuria, defined as UPCR ≤ 0.3 g/g. The data graphed below shows the mean B-cells (+/- standard error of measurement (“SEM”)) and mean UPCR (+/- SEM) from baseline to Week 72 in the 5 patients who received 4 doses of TNT119 and had follow up data out to at least 48 weeks.

 

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Note: Preliminary data as of 01/23/2024, subject to change upon review of final data set post-database lock.

Complete B-cell depletion (B-cells < 5.02 cells/µL) occurred in all patients (5/5, 100%) by week 12. In addition, a majority of patients (3/5, 60%) achieved CR by Week 48, and two of these patients with available follow-up out to Week 72 maintained CR. Importantly, all five patients who received four doses of TNT119 achieved substantial reductions in proteinuria from their baseline value. In the Phase 1b trial, TNT119 was generally well-tolerated, with no drug-related serious adverse events in the trial. Tenet believes the rapid onset and magnitude of benefit observed in these preliminary data is an encouraging signal of TNT119’s potential in MN. Tenet plans to present more detailed data related to the above five patients at a medical conference in the second half of 2024.

 

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Additional Indications

While Tenet has a focused set of initial lead indications, Tenet also believes that there is an opportunity to develop TNT119 for other autoimmune diseases in addition to SLE, ITP and MN. Across both orphan and larger indications, nearly 50 million patients in the United States are living with an autoantibody-mediated disease. There are several areas of high unmet need, such as rheumatoid arthritis and myasthenia gravis, and Tenet plans to evaluate the development of TNT119 for additional indications.

Collaboration and License and Agreements

Asset purchase agreement with Acelyrin, Inc.

On January 11, 2024, Tenet entered into an asset purchase agreement with Acelyrin (the “Asset Purchase Agreement”), for the acquisition of certain assets of Acelyrin related to TNT119 (the “Transferred Assets”), including certain assigned contracts. Under these assigned contracts, Tenet (i) received worldwide licenses (with the right to sublicense) to certain patents, know-how and other intellectual property rights to develop, manufacture, use and commercialize TNT119 (budoprutug) for any non-oncology indication, and (ii) assumed certain liabilities of Acelyrin arising from (1) governmental authority action or notification relating to TNT119, (2) contracts assigned to Tenet pursuant to the Asset Purchase Agreement and (3) Tenet’s ownership, lease or operation of the Transferred Assets. The Asset Purchase Agreement includes customary representations, warranties and covenants, as well as standard mutual indemnities, including those covering losses arising from any material breach of the Asset Purchase Agreement.

On the signing date of the Asset Purchase Agreement, the cash payment paid by Tenet was $7.3 million, in addition to inheriting the rights and obligations, including financial obligations, under the CRH Agreement and ProBioGen Agreement (in each case, as defined below). In consideration for the license and other rights Tenet received under the Asset Purchase Agreement, Tenet is obligated to (i) make total payments of up to $157.5 million to Acelyrin upon the achievement of various development, regulatory and commercial milestones, (ii) pay royalties in the single-digit percentages, subject to specified reductions, to Acelyrin on worldwide net sales in a given calendar year, and (iii) make non-refundable and non-creditable payments to Acelyrin on sublicense income with rates ranging from the low single digit to mid teen percent depending on the stage of development of the most advanced Products (as defined below) at the time of such sublicense. The royalty term continues for each licensed product incorporating or comprising TNT119 (a “Product”) on a country-by-country and Product-by-Product basis beginning on the first commercial sale of such Product and ending on the latest of (a) the date when such Product is no longer covered by a valid claim of a royalty-bearing patent in such country, (b) the expiration of any regulatory exclusivity period for such Product in such country, and (c) the twelfth anniversary of the first commercial sale of such Product in such country.

Tenet is obligated to use commercially reasonable efforts to commercialize at least one Product in the United States and to achieve specified development, regulatory and commercial milestones set forth in the Asset Purchase Agreement. If Acelyrin asserts that Tenet has failed to meet one or more of these diligence obligations within specified time periods, and such failure is finally determined through a dispute resolution process, Acelyrin shall have the right to repurchase the Transferred Assets at the then-fair market value of such Transferred Assets, as Acelyrin’s sole and exclusive remedy for such breach.

If, within a specified period, Tenet receives a bona fide offer or proposal from a third party to sell, transfer or otherwise divest all or substantially all of the rights to the Transferred Assets or Products, or grant an exclusive license or exclusive sublicense to such third party to develop and commercialize Products under specified terms, then prior to entering into any discussions or negotiations with any third party in relation to such a transaction, Tenet shall provide written notice to Acelyrin of such intent or receipt of proposal. Acelyrin shall have the right to negotiate with Tenet the terms for a definitive agreement with respect to such sale, transfer or grant of the rights to Products for a specified period of time. If Acelyrin does not exercise its right to negotiate or the parties are unable to agree on the terms of a definitive agreement, Tenet shall have the right to negotiate or enter into an agreement with a third party with respect to such transaction, subject to specified conditions.

 

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For a specified period after the Asset Purchase Agreement closing date, Tenet shall not solicit, induce, or attempt to induce any employees of Acelyrin to become employees or independent contractors of Tenet. If Tenet does hire or engage an employee of Acelyrin during such period, Tenet is obligated to make a certain payment to Acelyrin.

Tenet may not sell, assign or transfer all or substantially all of the rights to develop or commercialize a Product unless, as a condition to such sale, assignment or transfer, the purchaser, assignee or transferee (as applicable) assumes in writing all obligations of Tenet as set forth in the Asset Purchase Agreement with respect to the applicable Products.

Amended and Restated License Agreement with Cancer Research Technology Limited

In connection with the Asset Purchase Agreement, in January 2024 Tenet was assigned a license agreement with CRH and, in connection with such assignment, Tenet entered into an amended and restated license agreement with CRH (the “CRH Agreement”). The CRH Agreement granted Tenet a worldwide exclusive license (other than specified patent rights and materials, which are licensed to Tenet on a non-exclusive basis) under certain know-how, patents and materials, or the licensed rights, to research, develop, test, manufacture or sell certain licensed products related to TNT119, for all therapeutic uses except for oncology indications. Tenet is permitted to grant a sublicense under these licenses with CRH’s prior written consent. CRH retains, on behalf of itself and the charitable company Cancer Research U.K., a worldwide, fully paid-up, perpetual and irrevocable right in the licensed rights and in certain intellectual property owned or controlled by Tenet that is necessary to exploit the licensed products and used, conceived or generated in the course of exercising the license or exploiting any licensed product, or product-specific foreground intellectual property, for the purpose of non-commercial, non-clinical scientific research.

Tenet is obligated to use commercially reasonable efforts to perform all activities set forth in a mutually agreed-upon development plan within the timelines set forth therein. Tenet is also obligated to develop at least one licensed product in an autoimmune indication and to pursue worldwide regulatory authorization for licensed products. Tenet must use commercially reasonable efforts to commercialize each licensed product throughout each of the specified major markets as soon as practicable following receipt of regulatory authorization for such product in such market. Additionally, Tenet must make the licensed product available through the United Kingdom and negotiate with relevant regulatory authorities to make each licensed product available through the National Health Service in England and Wales within a specified time of the licensed product being made available elsewhere in the territory. If Tenet fails to meet one or more of these diligence obligations, and such failure is not remedied within the specified cure period, CRH shall have the right to terminate the CRH Agreement with respect to the relevant licensed product.

Tenet paid a signature fee to CRH of £0.4 million ($0.4 million) at the execution of the CRH Agreement, and Tenet is obligated to pay CRH a mid-five figure digit fee on each anniversary of the effective date. Tenet is obligated pay up to an aggregate of £106.8 million ($136.1 million) upon the achievement of specified development, regulatory, commercial and sales milestone events, including: (i) payments of up to mid-six figure digits in pounds sterling for certain development milestones, (ii) payments of up to low-eight figures in pounds sterling per indication (for up to three indications) for certain regulatory and commercial milestones and (iii) payments up to mid-eight figures in pounds sterling for certain sales milestones. Tenet is also obligated to pay tiered royalties ranging from a rate in the mid-single digit to high-single digit percentage on net sales. The royalty term continues for each licensed product on a country-by-country basis beginning on the first commercial sale of such licensed product and ending on the latest of (a) the date when such licensed product is no longer covered by a valid claim of a licensed patent in such country, (b) the expiration of the exclusivity period for such licensed product in such country, and (c) the tenth anniversary of the first commercial sale of such licensed product in such country. Tenet is also responsible for a sublicensing revenue payment ranging from a rate in the mid-single digit to mid-double digits for any sublicense revenue.

The agreement shall remain in effect in each country in the territory until the expiry of Tenet’s obligation to pay royalties in such country. Either party may terminate this agreement if the other party is in material breach that

 

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has not been remedied within the specified cure period or if the other party becomes insolvent. CRH also has the right to terminate the agreement if Tenet or one of Tenet’s sublicensees or affiliates challenges a licensed patent, or if Tenet is acquired by a tobacco company.

ProBioGen Development, Manufacturing Services and License Agreement

Under the Asset Purchase Agreement, Tenet was assigned a cell line development, manufacturing services and license agreement (the “ProBioGen Agreement”) originally entered into by ValenzaBio and ProBioGen AG (“ProBioGen”) in February 2021. Tenet did not make any separate payments for the assignment of the ProBioGen Agreement from Acelyrin.

The ProBioGen Agreement granted Tenet a non-exclusive license under certain know-how, patents and materials, to use cell lines in which ProBioGen’s proprietary technology is applied, to research, develop, manufacture, use, sell, offer to sell, import or export TNT119. This license includes a non-exclusive sublicense by ProBioGen of certain third party patent rights, limited to the use of TNT119.

Tenet is obligated to (i) make payments of up to €10.0 million ($10.9 million) upon the achievement of certain development, manufacturing and commercial milestones, including the start of a Phase 2 clinical trial for TNT119, and (ii) make milestone payments of up to €7.0 million ($7.7 million) upon the achievement of certain sales milestones. If Tenet elects to contract ProBioGen to perform certain manufacturing services for TNT119, the milestone payments would be reduced by €0.9 million ($1.1 million). For the period from the assignment of the ProBioGen Agreement to March 31, 2024, no milestone payments had been accrued as the underlying milestones were not achieved.

The ProBioGen Agreement will remain in effect until the services are completed for the service-related component and until the payment obligations expire in connection with the commercial license component. Both parties have the right to terminate the ProBioGen Agreement if the other party becomes insolvent, or materially breaches the ProBioGen Agreement and fails to remedy such default within the specified cure period.

Intellectual Property

Tenet strives to protect the proprietary technology, inventions and improvements that are commercially important to its business, including seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties. Tenet also relies on know-how relating to its proprietary technology, product candidates and continuing innovation to develop, strengthen and maintain its proprietary position. In addition, Tenet plans to rely on data exclusivity, market exclusivity and patent term extensions or adjustments when available. Tenet’s commercial success will depend in part on its ability to obtain and maintain patent and other proprietary protection for its technology, inventions and improvements; to defend and enforce its proprietary rights, including any patents that Tenet may own or in-license in the future; and to operate without infringing the valid and enforceable patents and other proprietary rights of third parties. Intellectual property rights may not address all potential threats to Tenet’s competitive advantage.

Tenet intends, or understand that its licensors intend, to pursue patent protection covering, when possible, compositions, methods of use, dosing and formulations of TNT119 and other intellectual property rights. Tenet or its licensors also may pursue patent protection with respect to manufacturing and drug development processes and technologies. Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies. Tenet or its licensors may not be able to obtain patent protections for Tenet’s compositions, methods of use, dosing and formulations, manufacturing and drug development processes and technologies throughout the world. Issued patents can provide protection for varying periods of time, depending upon the date of filing of the patent application, the date of patent issuance and the legal term of patents in the countries in which they are obtained. In general, patents issued for applications filed in the United States can provide exclusionary rights for 20 years

 

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from the earliest non-provisional or Patent Cooperation Treaty (“PCT”) filing date. In addition, in certain instances, the term of an issued U.S. patent that is directed to or claims an FDA-approved product can be extended to recapture a portion of the term effectively lost as a result of the FDA regulatory review period, which is called “patent term extension.” The restoration period cannot be longer than five years and the total patent term, including the restoration period, must not exceed 14 years following FDA approval. The term of patents outside of the United States varies in accordance with the laws of the jurisdiction, but typically is also 20 years from the earliest non-provisional or PCT filing date plus any extensions of term that may be available under national law. However, the actual protection afforded by a patent varies on a product-by-product basis, from country-to-country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country, and the validity and enforceability of the patent. Patent term may be inadequate to protect Tenet’s competitive position on its products for an adequate amount of time.

The patent positions of companies like Tenet are generally uncertain and involve complex legal and factual questions. No consistent policy regarding the scope of claims allowable in patents in the field of biopharmaceuticals has emerged in the United States. The relevant patent laws and their interpretation outside of the United States are also uncertain. Changes in either the patent laws or their interpretation in the United States and other countries may diminish Tenet’s ability to protect its technology or product candidates and could affect the value of such intellectual property. In particular, Tenet’s ability to stop third parties from making, using, selling, offering to sell or importing products that infringe its intellectual property will depend in part on its success in obtaining and enforcing patent claims that cover its technology, inventions and improvements. Tenet cannot guarantee that patents will be granted with respect to any of its pending patent applications or with respect to any patent applications it or its licensors may file in the future, nor can Tenet be sure that any patents that may be granted to it or its licensors in the future will be commercially useful in protecting Tenet’s products, the methods of use or manufacture of those products. Moreover, even Tenet’s issued patents do not guarantee it the right to practice its technology in relation to the commercialization of its products. Patent and other intellectual property rights in the pharmaceutical and biotechnology space are evolving and involve many risks and uncertainties. For example, third parties may have blocking patents that could be used to prevent Tenet from commercializing its product candidates and practicing its proprietary technology, and Tenet’s issued patents may be challenged, invalidated, deemed unenforceable or circumvented, which could limit its ability to stop competitors from marketing related products or could limit the term of patent protection that otherwise may exist for its product candidates. In addition, the scope of the rights granted under any issued patents may not provide Tenet with protection or competitive advantages against competitors with similar technology. Furthermore, Tenet’s competitors may independently develop similar technologies that are outside the scope of the rights granted under any issued patents. For these reasons, Tenet may face competition with respect to TNT119. Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent directed to such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.

In-licensed Patents and Patent Applications

As of May 10, 2024, Tenet exclusively in-licenses from CRH four issued U.S. patents and 56 foreign patents and/or patent applications. Tenet also non-exclusively in-licenses additional patents and patent applications. Each of the exclusively in-licensed patents and applications relates to TNT119, including its composition-of-matter, uses, dosage forms, methods of making, or its derivatives and uses thereof. The issued patents, or patents that may be issued from the pending patent applications that Tenet exclusively in-licenses from CRH are expected to expire in 2026, excluding any patent term adjustment that might be available following the grant of the patent and any patent term extensions that might be available following the grant of marketing authorizations.

However, there can be no assurance that any of the pending patent applications will issue. Furthermore, there can be no assurance that Tenet will benefit from any patent term extension or favorable adjustments to the term of

 

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any of the issued patents or patents that may issue from any pending patent applications in the future. The applicable authorities, including the FDA in the United States and the USPTO, may not agree with Tenet’s assessment of whether such patent term extensions or adjustments should be granted, and, if granted, they may grant more limited extensions or adjustments than Tenet request.

Sales and Marketing

Tenet has not yet defined its sales, marketing or product distribution strategy for TNT119 because TNT119 is still in development. Tenet’s commercial strategy may include the use of strategic partners, distributors, a contract sales force or the establishment of Tenet’s own commercial sales force. Tenet plans to further evaluate these alternatives as it approaches approval for TNT119.

Competition

The development and commercialization of new drug products is highly competitive. Moreover, the immunology and inflammation field is characterized by rapidly changing technologies, significant competition, and a strong emphasis on intellectual property. Tenet will face competition with respect to TNT119 from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing and commercialization.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which Tenet is developing TNT119. Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to Tenet’s approach, and others are based on entirely different approaches.

Companies developing biologics and other modalities include Roche Holding AG (currently markets Rituxan (rituximab), which is used for a broad number of autoimmune diseases), Amgen (UPLINZA (inebilizumab) for the treatment of neuromyelitis optica spectrum disorder) and Ocrevus (ocrelizumab for the treatment of multiple sclerosis), each of which target CD20 on B cells, and others who have biologics aimed at other targets relevant to autoimmune diseases, including, for example, AbbVie, Johnson & Johnson, Bristol Myers Squibb and Novartis.

Many of Tenet’s current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise than it does in research and development, manufacturing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products. Mergers and acquisitions in the pharmaceutical, biotechnology, and gene therapy industries may result in even more resources being concentrated among a smaller number of Tenet’s competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Tenet in recruiting and retaining qualified scientific and management consultants and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Tenet’s programs. Tenet’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than TNT119 or that would render TNT119 obsolete or non-competitive. Tenet’s competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than Tenet may obtain approval for TNT119, which could result in its competitors establishing a strong market position before Tenet is able to enter the market. Additionally, technologies developed by Tenet’s competitors may render TNT119 uneconomical or obsolete, and Tenet may not be successful in marketing TNT119 against competitors.

In addition, as a result of the expiration or successful challenge of Tenet’s patent rights, Tenet could face more litigation with respect to the validity and/or scope of patents relating to its competitors’ products. The availability of Tenet’s competitors’ products could limit the demand, and the price Tenet is able to charge, for TNT119.

 

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If Tenet successfully obtains approval for TNT119, Tenet believes that the key competitive factors that will affect the success of these candidates will be efficacy, safety, tolerability, convenience, price and the availability of reimbursement from government and other third-party payors relative to such competing products. Tenet’s commercial opportunity could be reduced or eliminated if its competitors have products that are superior in one or more of these categories.

Government Regulation

FDA Regulation

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign jurisdictions, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of all pharmaceutical products such as the monoclonal antibody that Tenet is developing. Tenet, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which Tenet wishes to conduct studies or seek approval or licensure of TNT119.

Licensure and Regulation of Biologics in the United States

In the United States, the FDA regulates biologics under both the Federal Food, Drug and Cosmetic Act and the Public Health Services Act and their implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve a pending BLA, withdrawal of an approval, imposition of a clinical hold, issuance of untitled or warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution, injunctions, debarment, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

The process required by the FDA before biologic product candidates may be licensed for marketing in the United States generally involves the following:

 

   

Completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current GLPs;

 

   

submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made;

 

   

approval by an IRB or ethics committee for each clinical site before the trial may commence at that particular site;

 

   

performance of adequate and well-controlled human clinical trials in accordance with GCPs to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose;

 

   

preparation of and submission to the FDA of a BLA after completion of all pivotal clinical trials that includes substantial evidence of safety, purity and potency in the target patient population, and identity, strength, quality, purity and potency of the proposed biologic product candidate for its intended purpose from results of nonclinical testing and clinical trials;

 

   

a determination by the FDA within 60 days of its receipt of a BLA that the application is sufficiently complete to file for review;

 

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satisfactory completion of an FDA Advisory Committee review, if applicable;

 

   

satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMPs and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with GCPs; and

 

   

FDA review and approval of the BLA and licensure of the proposed product to permit commercial marketing of the product for particular indications for use in the United States.

FDA Regulation of the Clinical Development Program

Prior to beginning a clinical trial in the United States, Tenet must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational product to humans within a specific defined clinical study or studies. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing the toxicology, PK, pharmacology, and PD characteristics of the product candidate; chemistry, manufacturing, and controls (“CMC”) information; and any available human data or literature to support the use of the investigational product. An IND must be cleared before human clinical trials may begin in the U.S. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial, including any CMC issues. In such a case, the IND may be placed on clinical hold until the IND sponsor and the FDA resolve the outstanding concerns or questions. The FDA also may impose a partial clinical hold that would limit a trial, for example, to certain doses or for a certain length of time or to a certain number of subjects. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. For new indications, a separate new IND may be required. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial, its informed consent form and other communications to study subjects before the clinical trial begins at that site. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB must monitor the study until completed, including any changes to the study plans while it is being conducted.

Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk, the clinical trial is not being conducted in accordance with the FDA’s or IRB’s requirements, if the investigational product has been associated with unexpected serious harm to subjects or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring committee, which provides advice to the sponsor on whether or not a study should move forward at designated check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. Information about some clinical trials, including a description of the trial and trial results, must be submitted within specific timeframes to the National Institutes of Health for public dissemination on their ClinicalTrials.gov website. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. These reports must include a development safety update report. In addition, IND safety reports must be submitted to the FDA for any of the

 

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following: serious and unexpected suspected adverse reactions; findings from other trials or animal or in vitro testing that suggest a significant risk in humans exposed to the product; and any clinically important increase in the occurrence of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined.

 

   

Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism, distribution and elimination of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

 

   

Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

 

   

Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and labeling.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These post-approval or post-marketing studies may be made a condition to approval of the BLA. Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate. In addition, the sponsor must develop and validate analytical methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

In addition, under the Pediatric Research Equity Act (“PREA”), a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the investigational product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers from the pediatric data requirements. A deferral may be granted for several reasons, including a finding that the investigational biologic is ready for approval for use in adults before pediatric trials are completed. The FDA is required to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments under PREA, have failed to seek or obtain a deferral or deferral extension or have failed to request approval for a required pediatric formulation. Unless otherwise required by regulation, PREA does not apply to any investigational product for an indication for which orphan designation has been granted, although the FDA has taken steps to limit what it considers abuse of this statutory exemption in PREA. The FDA also maintains a list of diseases that are exempt from PREA requirements due to low prevalence of disease in the pediatric population.

BLA Submission, Review and Approval

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from pertinent preclinical and clinical studies, including negative or ambiguous results as well as

 

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positive findings, together with detailed information relating to the product’s CMC and proposed labeling, among other things. The submission of a BLA requires payment of a substantial application user fee to FDA, unless a waiver or exemption applies.

Once the FDA receives an application, it has 60 days to review the BLA to determine if it is substantially complete to permit a substantive review, before it accepts the BLA for filing. If the FDA determines that a BLA does not satisfy this standard, the FDA will issue a Refuse to File determination to the sponsor. The FDA may request additional information and studies, and the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the BLA. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA has 10 months from acceptance of filing in which to complete its initial review of a standard BLA and respond to the applicant, and six months from acceptance of filing for a priority BLA. The FDA does not always meet its PDUFA goal dates. The review process and the PDUFA goal date may be extended by three months or longer if the FDA requests that the BLA sponsor provides additional information or clarification regarding information already provided in the submission before the PDUFA goal date.

After the BLA is accepted for filing, the FDA reviews a BLA to determine, among other things, whether a product is safe, potent and pure, and whether the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued quality standards. The FDA may convene an advisory committee to provide clinical insight on application review questions.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts any necessary inspections, the FDA may issue an approval letter or a Complete Response letter (“CRL”). An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL, which indicates that the review cycle is complete, will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre-and post-marketing requirements is not maintained or if

 

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problems occur after the product reaches the marketplace. The FDA may require one or more post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Expedited Development and Review Programs

The FDA is authorized to expedite the review of applications in several ways. While none of these expedited programs changes the standards for approval, each may help expedite the development or approval process governing product candidates. A product is eligible for priority review if the FDA determines that it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition compared to marketed products. For products containing new molecular entities, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (compared with ten months under standard review).

To be eligible for a fast track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need by providing a therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. Fast track designation provides additional opportunities for frequent interactions with the FDA review team to expedite development and review of the product. The FDA may also review sections of the BLA for a fast track product on a rolling basis before the complete application is submitted, if the sponsor and FDA agree on a schedule for the submission of the application sections, and the sponsor pays any required user fees upon submission of the first section of the BLA. The review clock does not begin until the final section of the BLA is submitted. The FDA may decide to rescind the fast track designation if it determines that the qualifying criteria no longer apply.

In addition, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Products designated as breakthrough therapies are eligible for intensive guidance from the FDA on an efficient development program, organizational commitment to the development and review of the product including involvement of senior managers, and, like fast track products, are also eligible for rolling review of the BLA. Both fast track and breakthrough therapy products may also be eligible for accelerated approval and/or priority review if relevant criteria are met.

Additionally, products studied for their safety, potency and purity in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), the FDA may require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a product or indication approved under accelerated approval if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products being considered for accelerated approval, the FDA generally requires, unless otherwise informed by the FDA, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the

 

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FDA for review during the pre-approval review period, which could adversely impact the timing of the commercial launch of the product.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review and approval will not be shortened. Furthermore, priority review, fast track designation, breakthrough therapy designation, and accelerated approval do not change the standards for approval but may expedite the development or approval process.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan designation must be requested before submitting a BLA. After the FDA grants orphan designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or automatically shorten the duration of, the regulatory review or approval process.

If a product that has orphan designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

A designated orphan product may not receive orphan exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. This may be particularly true in light of a decision from the Court of Appeals for the 11th Circuit in 2021 finding that, for the purpose of determining the scope of exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” On January 23, 2023, the FDA announced that, in matters beyond the scope of that court order, the FDA will continue to apply its existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug was approved.

Pediatric Exclusivity

Pediatric exclusivity is another type of non-patent exclusivity in the United States and for biologics, if granted, provides for the attachment of an additional six months of regulatory exclusivity to the term of any existing regulatory exclusivity, including orphan exclusivity. This six-month exclusivity may be granted if a BLA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity that cover the product are extended by six months.

 

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Biosimilars and Reference Product Exclusivity

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. To date, a number of biosimilars have been licensed under the BPCIA, and numerous biosimilars have been approved in Europe. The FDA has issued several guidance documents outlining its approach to the review and approval of biosimilars. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. Complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.

Patent Term Restoration and Extension

In the United States, a patent claiming a new biologic product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Drug Price Competition and Patent Term Restoration Act, which permits a patent extension of up to five years for patent term lost during product development and FDA regulatory review. Assuming grant of the patent for which the extension is sought, the restoration period for a patent covering a product is typically one-half the time between the effective date of the IND clearing clinical studies and the submission date of the BLA, plus the time between the submission date of the BLA and the ultimate approval date. Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years from the product’s approval date in the United States. Only one patent applicable to an approved product is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent for which extension is sought. A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews and approves the application for any patent term extension in consultation with the FDA.

U.S. Foreign Corrupt Practices Act

The U.S. Foreign Corrupt Practices Act, to which Tenet is subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity.

 

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It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.

Employees and Human Capital Resources

Tenet currently has no employees. Tenet’s research and development and professional services functions, including the services of Tenet’s executive officers, are currently performed pursuant to the Sera Services Agreement. See “Certain Relationships and Related Person Transactions–Certain Relationships of Tenet–Relationship with Sera Services, Inc.

Facilities

Tenet currently has no physical offices or facilities. Tenet is a fully-virtual company and believes that its current remote operations are adequate for Tenet’s near-term needs. Tenet also believes that it will be able to obtain office or research space, as needed, on commercially reasonable terms.

Legal Proceedings

From time to time, Tenet may be involved in various other claims and legal proceedings relating to claims arising out of Tenet’s operations. Tenet is not currently a party to any material legal proceedings.

 

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ELIEM’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

For Eliem’s management’s discussion and analysis of financial condition and results of operations, please refer to the section titled “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” set forth in Eliem’s 2023 Annual Report, as filed with the SEC on March 28, 2024, and the section titled “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Eliem’s subsequent Q1 Quarterly Report, as filed with the SEC on May 15, 2024.

 

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TENET’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Unless the context indicates or otherwise requires, references in this Tenet’s Management’s Discussion and Analysis of Financial Condition and Results of Operations section to “we,” “us,” “Tenet” or the “Company” refer to Tenet Medicines, Inc. References to our “management” or our “management team” refer to Tenet’s officers and directors. The following discussion and analysis of financial condition and results of operations should be read in conjunction with our unaudited condensed interim financial statements and our audited historical financial statements and the notes to those financial statements included elsewhere in this proxy statement. Certain information contained in the discussion and analysis set forth below includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks, uncertainties and assumptions that could cause actual results to differ materially from Tenet’s management’s expectations. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those set forth under “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and elsewhere in this proxy statement. All forward-looking statements included in this proxy statement are based on information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement.

All amounts presented are in accordance with GAAP. The information and analysis of our business and financial performance relates to the period prior to the proposed Acquisition of Tenet by Eliem Therapeutics, Inc.

Overview

Tenet is a clinical stage biotechnology company dedicated to developing our product candidate, TNT119, also known as budoprutug. TNT119 is an anti-CD19 mAb designed for a broad range of autoimmune disorders, including SLE, ITP and MN. Tenet was founded in November 2023 and entered into an asset purchase agreement with Acelyrin in January 2024, which granted us worldwide licenses to develop, manufacture, use and commercialize TNT119 for any non-oncology indication. Since our inception, we have devoted substantially all of our efforts to organizing the company, business planning, raising capital, acquiring intellectual property related to TNT119 and developing TNT119. We have a limited operating history, and we have incurred net losses since our inception. We expect to continue to incur net losses for the foreseeable future as we continue the development of TNT119. Our ability to achieve and sustain profitability will depend on our ability to successfully develop, obtain regulatory approval for, and commercialize TNT119. There can be no assurance that we will ever earn revenues or achieve profitability, or if achieved, that the revenues or profitability will be sustained on a continuing basis. To date, we have funded our operations with proceeds from the Tenet SAFEs. Through March 31, 2024, we have received aggregate gross proceeds of $10.0 million from the issuance of the Tenet SAFEs.

Our net loss for the three months ended March 31, 2024 was $9.0 million and our net loss for the period from inception to December 31, 2023 was $0.6 million. As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of $9.5 million and $0.6 million, respectively. Substantially all of our net losses have resulted from costs incurred in connection with our acquisition of license rights to TNT119, research and development expenses related to the development of TNT119, general and administrative costs associated with our operations and the remeasurement of the Tenet SAFEs. We expect that our expenses and operating losses will increase significantly as we commence our planned clinical trials, continue research and development activities, utilize third parties to manufacture drug products and related raw materials, hire additional personnel, and protect our intellectual property rights. Our net losses and operating losses are also likely to fluctuate significantly from quarter to quarter and year to year depending, primarily, on the timing of our clinical trials, our other research and development expenses, and the timing and amount of any milestone or royalty payments due under our existing or future license agreements.

Because of the numerous risks and uncertainties associated with therapeutic product development, we may never achieve or sustain profitability and, unless and until we are able to develop and commercialize TNT119, we will

 

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need to continue to raise additional capital. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through public or private equity or debt financings, or potentially other capital sources, such as collaboration or licensing arrangements with third parties or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans when needed, on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or TNT119 or grant licenses on terms that may not be favorable to us. If we are unable to raise capital as and when needed, or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of TNT119.

As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of $9.5 million and $0.6 million, respectively. As of March 31, 2024 and December 2023, we had cash of $1.7 million and $9.9 million, respectively. As further described below, on January 11, 2024, we entered into the Asset Purchase Agreement with Acelyrin, which granted us certain worldwide licenses to develop, manufacture, use and commercialize TNT119. The cash consideration paid by us to Acelyrin was $7.3 million. In connection with the Asset Purchase Agreement, we became the successor to the CRH Agreement between Acelyrin and CRH. We also became the successor to the ProBioGen Agreement. In connection with the CRH Agreement, we paid CRH an additional signature fee of approximately $0.4 million, and we did not make any separate payments for the assignment of the ProBioGen Agreement.

Our future viability is largely dependent on our ability to generate cash from operating activities and to raise additional capital to finance our operations. Failure to raise capital as needed would have a negative impact on our financial condition and our ability to continue to pursue our business strategies. Accordingly, if additional financing is not obtained or the Acquisition does not occur, there is substantial doubt about our ability to continue as a going concern as we do not believe that our cash will be sufficient to fund operations for at least twelve months from the date of issuance of our audited and unaudited financial statements included elsewhere in this proxy statement.

Recent Developments

The Acquisition

On April 10, 2024, we entered into the Acquisition Agreement with Eliem and Transitory Subsidiary. The Acquisition Agreement provides for the acquisition of Tenet by Eliem through the merger of Transitory Subsidiary into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem.

At the effective time of the Acquisition, and without any action on the part of the holders of common stock of Tenet, (i) all issued and outstanding shares of the common stock of Tenet and (ii) all securities convertible into shares of common stock of Tenet will be converted into the right to receive, in the aggregate, a number of shares of Eliem common stock (rounded to the nearest whole share) equal to fifteen and two-fifths percent (15.4%) of the outstanding shares of the Eliem common stock as of immediately following the closing of the Acquisition (and for the avoidance of doubt, before giving effect to the issuance of any securities pursuant to the Private Placement), calculated on a fully-diluted basis using the treasury stock method (including, for clarity, calculated by disregarding any out-of-the-money outstanding stock options of Eliem). The Acquisition is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.

 

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The Acquisition Agreement contains certain termination rights of both Tenet and Eliem, including if Eliem’s stockholders fail to adopt and approve the Share Issuance Proposal. Upon termination of the Acquisition Agreement under specified circumstances, Eliem may be required to pay Tenet a termination fee of $1.0 million and reimburse Tenet’s transaction-related expenses up to a maximum of $0.5 million.

In addition, pursuant to the Acquisition Agreement, the SAFE Holders will enter into the SAFE Cancellation Agreements prior to the closing of the Acquisition with the Company, and in accordance with the Acquisition Agreement, immediately prior to the closing of the Acquisition, each Tenet SAFE that is then outstanding shall, without any action on the part of Eliem, the Company, any SAFE Holder or any other person, terminate and be canceled, and be converted into the right to receive the applicable portion of the Aggregate Consideration as set forth in accordance with the Acquisition Agreement.

Bridge Loan

On May 14, 2024, Tenet entered into a Senior Secured Promissory Note (the “Note”) with Eliem pursuant to which Eliem will make short-term loans (the “Loan” or “Loans”) to Tenet in an aggregate principal amount of up to $15.0 million. On or about the date of execution of the Note, Eliem made an initial Loan to Tenet of $5.0 million to provide Tenet with sufficient cash to fund its operations prior to the consummation of the Acquisition. Tenet’s ability to borrow the remaining $10.0 million under the Note is subject to certain conditions and restrictions on use.

The Loans will bear simple interest at a fixed rate per annum of 6%. All outstanding Loans, together with accrued interest, will become due and payable upon the earlier of (i) 12 months from the date of issuance the Note, (ii) the occurrence of specified corporate transactions, or (iii) Tenet’s receipt of at least $15.0 million in gross proceeds from the closing of a bona fide equity and/or debt financing.

Under the Note, Tenet granted Eliem a continuing, first-priority perfected security interest in all of Tenet’s present and future assets, properties and rights, whether tangible or intangible, including, without limitation, the intellectual property of Tenet. The Note contains certain customary representations and warranties and certain customary events of default.

License Agreements

Below is a summary of the key terms of our license agreements.

Asset Purchase Agreement with Acelyrin

On January 11, 2024, we entered into the Asset Purchase Agreement with Acelyrin for the acquisition of TNT119. Pursuant to the Asset Purchase Agreement, we received the Transferred Assets from Acelyrin, including certain assigned contracts. Under these assigned contracts, we (i) received worldwide licenses (with the right to sublicense) to certain patents, know-how and other intellectual property rights to develop, manufacture, use and commercialize TNT119 (budoprutug) for any non-oncology indication, and (ii) assumed certain liabilities of Acelyrin arising from (a) governmental authority action or notification relating to TNT119, (b) contracts assigned to Tenet pursuant to the Asset Purchase Agreement and (c) Tenet’s ownership, lease or operation of the Transferred Assets. The Asset Purchase Agreement includes customary representations, warranties and covenants, as well as standard mutual indemnities, including those covering losses arising from any material breach of the Asset Purchase Agreement.

We paid $7.3 million in cash consideration to Acelyrin on the signing date of the Asset Purchase Agreement, in addition to inheriting the rights and obligations, including financial obligations, under the CRH Agreement and ProBioGen Agreement. We determined that the Asset Purchase Agreement should be accounted for as an asset acquisition after considering whether substantially all of the fair value of the gross assets acquired was concentrated in a single asset or group of assets by performing an initial screen test in accordance with FASB ASC Topic 805 Business Combinations.

 

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In consideration for the license and other rights we received under the Asset Purchase Agreement, we are obligated to (i) make total payments of up to $157.5 million to Acelyrin upon the achievement of various development, regulatory and commercial milestones, (ii) pay royalties in the single-digit percentages, subject to specified reductions, to Acelyrin on worldwide net sales in a given calendar year, and (iii) make non-refundable and non-creditable payments to Acelyrin on sublicense income with rates ranging from the low single digit to mid teen percent depending on the stage of development of the most advanced Products at the time of such sublicense. The royalty term continues for each Product on a country-by-country and Product-by-Product basis beginning on the first commercial sale of such Product and ending on the latest of (a) the date when such Product is no longer covered by a valid claim of a royalty-bearing patent in such country, (b) the expiration of any regulatory exclusivity period for such Product in such country, and (c) the twelfth anniversary of the first commercial sale of such Product in such country. For the period from January 11, 2024 to March 31, 2024, no milestone payments had been accrued as the underlying milestones were not achieved.

We are obligated to use commercially reasonable efforts to commercialize at least one Product in the United States and to achieve specified development, regulatory and commercial milestone set forth in the Asset Purchase Agreement. If Acelyrin asserts that Tenet has failed to meet one or more of these diligence obligations within specified time periods, and such failure is finally determined through a dispute resolution process, Acelyrin shall have the right to repurchase the Transferred Assets at the then-fair market value of such Transferred Assets, as Acelyrin’s sole and exclusive remedy for such breach.

If, within a specified period, we receive a bona fide offer or proposal from a third party to sell, transfer or otherwise divest all or substantially all of the rights to the Transferred Assets or Products, or grant an exclusive license or exclusive sublicense to such third party to develop and commercialize Products under specified terms, then prior to entering into any discussions or negotiations with any third party in relation to such a transaction, we shall provide written notice to Acelyrin of such intent or receipt of proposal. Acelyrin shall have the right to negotiate with us the terms for a definitive agreement with respect to such sale, transfer or license of the rights to Products for a specified period of time. If Acelyrin does not exercise its right to negotiate or the parties are unable to agree on the terms of a definitive agreement, we shall have the right to negotiate or enter into an agreement with a third party with respect to such transaction, subject to specified conditions.

For a specified period after the closing date of the Asset Purchase Agreement, we shall not solicit, induce, or attempt to induce any employees of Acelyrin to become employees or independent contractors of Tenet. If we do hire or engage an employee of Acelyrin during such period, we are obligated to make a certain payment to Acelyrin.

We may not sell, assign or transfer all or substantially all of the rights to develop or commercialize a Product unless, as a condition to such sale, assignment or transfer, the purchaser, assignee or transferee (as applicable) assumes in writing all obligations of Tenet as set forth in the Asset Purchase Agreement with respect to the applicable Products.

The acquired asset, including the prepaid expenses, was measured and recognized as an allocation of the transaction price based on the relative fair value as of the transaction date with any value associated with in-process research and development (“IPR&D”) being expensed. The fair value of the total consideration was $7.3 million, which consisted solely of cash. The allocation of the purchase price was as follows (amounts in thousands):

 

Acquired in-process research and development

   $ 7,003  

Prepaid expenses

     297  
  

 

 

 

Net assets acquired

   $ 7,300  
  

 

 

 

The IPR&D asset acquired related to TNT119. As a result, the entire cash consideration, other than prepaid expenses, was allocated to TNT119. We concluded that the acquired asset did not have an alternative future use

 

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and recognized the full amount of $7.0 million as IPR&D expense in the condensed statement of operations and comprehensive loss for the three-month period ending March 31, 2024.

Amended and Restated License Agreement with CRH

In connection with the Asset Purchase Agreement, in January 2024 we were assigned a license agreement with CRH and, in connection with such assignment, we entered into the CRH Agreement with CRH, which granted us a worldwide exclusive license (other than specified patent rights and materials, which are licensed to us on a non-exclusive basis) under certain know-how, patents and materials, or the licensed rights, to research, develop, test, manufacture or sell certain licensed products related to TNT119, for all therapeutic uses except for oncology indications. We are permitted to grant a sublicense under these licenses with CRH’s prior written consent. CRH retains, on behalf of itself and the charitable company Cancer Research U.K., a worldwide, fully paid-up, perpetual and irrevocable right in the licensed rights and in certain intellectual property owned or controlled by us that is necessary to exploit the licensed products and used, conceived or generated in the course of exercising the license or exploiting any licensed product, or product-specific foreground intellectual property, for the purpose of non-commercial, non-clinical scientific research.

We are obligated to use commercially reasonable efforts to perform all activities set forth in a mutually agreed-upon development plan within the timelines set forth therein. We are also obligated to develop at least one licensed product in an autoimmune indication and to pursue regulatory authorization throughout the territory for licensed products. We must use commercially reasonable efforts to commercialize each licensed product throughout each major market as soon as practicable following receipt of regulatory authorization for such product in such market. Additionally, we must make the licensed product available in the United Kingdom and negotiate with relevant regulatory authorities to make each licensed product available through the National Health Service in England and Wales within a specified time of the licensed product being made available elsewhere in the territory. If we fail to meet one or more of these diligence obligations, and such failure is not remedied within the specified cured period, CRH shall have the right to terminate the CRH Agreement with respect to the relevant licensed product.

We paid a signature fee to CRH of £0.4 million ($0.4 million) at the execution of the agreement, and we are obligated to pay CRH a mid-five figure digit fee on each anniversary of the effective date. We are obligated pay up to an aggregate of £106.8 million ($136.1 million) upon the achievement of specified development, regulatory, commercial and sales milestone events, including: (i) payments of up to mid-six figure digits in pounds sterling for certain development milestones, (ii) payments of up to low-eight figures in pounds sterling per indication (for up to three indications) for certain regulatory and commercial milestones and (iii) payments up to mid-eight figures in pounds sterling for certain sales milestones. We are also obligated to pay tiered royalties ranging from a rate in the mid-single digit to high-single digit percentage on net sales. The royalty term continues for each licensed product on a country-by-country basis beginning on the first commercial sale of such licensed product and ending on the latest of (a) the date when such licensed product is no longer covered by a valid claim of a licensed patent in such country, (b) the expiration of the exclusivity period for such licensed product in such country, and (c) the tenth anniversary of the first commercial sale of such licensed product in such country. We are also responsible for a sublicensing revenue payment ranging from a rate in the mid-single digit to mid-double digits for any sublicense revenue.

We concluded that the signature fee of £0.4 million ($0.4 million) paid to CRH should be accounted for separately and was recorded as a contract expense as research and development expense on the statement of operations and comprehensive loss. We will account for future payments under the CRH Agreement when the applicable milestones have been achieved. We will expense the annual fee to be paid to CRH on the anniversary date of the CRH Agreement, as research and development expense. For the period from the execution of the CRH Agreement to March 31, 2024, no milestone payments had been accrued as no milestones under the CRH Agreement had been achieved.

 

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The CRH Agreement shall remain in effect in each country in the territory until the expiry of our obligation to pay royalties in such country. Either party may terminate the CRH Agreement if the other party is in material breach of the CRH Agreement that has not been remedied within the specified cure period or if the other party becomes insolvent. CRH also has the right to terminate the CRH Agreement if we or one of our sublicensees or affiliates challenges a licensed patent, or if we are acquired by a tobacco company.

ProBioGen Development, Manufacturing Services and License Agreement

In connection with the Asset Purchase Agreement, we were also assigned the ProBioGen Agreement entered into between ValenzaBio and ProBioGen. ValenzaBio originally entered into the ProBioGen Agreement in connection with the research, development and commercialization of innovative therapies using ProBioGen’s proprietary technology, and ValenzaBio used this technology in the development of TNT119. At the time we entered into the Asset Purchase Agreement, the development and manufacturing services provided under the ProBioGen Agreement were complete, and we did not make any separate payments for the assignment of the ProBioGen Agreement.

The ProBioGen Agreement granted us a commercial non-exclusive license under the license patent rights and licensed know-how in the territory in which ProBioGen’s proprietary technology is applied for the research, development, manufacture, use, sale, and offer for sale, import or export of TNT119. The commercial product license includes a non-exclusive sublicense of the licensed patent rights, limited to the use of TNT119.

In connection with the terms of the ProBioGen Agreement, we are obligated to (i) make payments of up to €10.0 million ($10.9 million) upon the achievement of certain development and manufacturing milestones such as the start of a Phase 2 clinical trial, and (ii) make milestone payments of up to €7.0 million ($7.7 million) upon the achievement of annual net sales-based milestones. If we elect to contract ProBioGen to perform certain manufacturing services, the milestone payments will be reduced by €0.9 million ($1.1 million). For the period from the assignment of the ProBioGen Agreement to March 31, 2024, no milestone payments had been accrued as the underlying milestones were not achieved.

The ProBioGen Agreement will remain in effect until the services are completed for the service-related component and until the payment obligations expire in connection with the ProBioGen license component. Both parties have the right to terminate the ProBioGen Agreement if the other party becomes insolvent, or materially breaches the ProBioGen Agreement and fails to remedy any such default within the specified cure periods.

Components of Results of Operations

Operating Expenses

Our operating expenses consist of (i) research and development expenses, (ii) IPR&D expenses, and (iii) general and administrative expenses.

Research and Development

Research and development expenses consist of external costs incurred in connection with our research and development activities, including our discovery and research efforts. Our research and development expenses primarily include external expenses, including expenses incurred under arrangements with related parties and third parties, such as CROs, contract manufacturing organizations, consultants and our scientific advisors. Currently, we do not have employees or facilities and therefore do not have internal costs that would be allocated to research and development expenses.

We expense research and development costs as incurred. Costs of certain activities are recognized based on an evaluation of the progress to completion of specific tasks. However, payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses on our balance sheets. The capitalized amounts are recognized as expense as the goods are delivered or as related services are performed.

 

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We expect our research and development expenses to increase substantially for the foreseeable future as we continue to conduct our ongoing research and development activities. The process of conducting preclinical studies, acquiring drug product supply, and conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for TNT119.

The timelines and costs associated with research and development activities are uncertain and can vary significantly for each product candidate and development program due to the inherently unpredictable nature of preclinical and clinical development. We anticipate that we will make determinations as to which indications to pursue for TNT119 and how much funding to direct to each such indication on an ongoing basis in response to preclinical and clinical results, regulatory developments, and ongoing assessments as to each indication’s commercial potential. We will need to raise substantial additional capital in the future.

Our future research and development costs may vary significantly based on factors such as:

 

   

the timing and progress of our research and development activities;

 

   

the number and scope of preclinical and clinical programs we decide to pursue;

 

   

the amount and timing of any milestone payment due under an existing, or any future, license or collaboration agreement;

 

   

the number of patients that participate in our clinical trials, and per participant clinical trial costs;

 

   

the number and duration of clinical trials required for approval of TNT119;

 

   

the number of sites included in our clinical trials, and the locations of those sites;

 

   

delays or difficulties in adding trial sites and enrolling participants in our clinical trials;

 

   

the countries in which the trials are conducted;

 

   

the cost and timing of manufacturing TNT119;

 

   

the efficacy and safety profile of TNT119; and

 

   

maintaining a continued acceptable safety profile of our products if any receive regulatory approval.

A change in the outcome of any of these variables with respect to the development of any of TNT119 could significantly change the costs and timing associated with the development of TNT119.

In-process Research and Development

Our IPR&D expenses consist of costs incurred in connection with the Asset Purchase Agreement. As the asset acquired under the Asset Purchase Agreement was in the research and development phase and was determined to not have any alternative future use, it was expensed as IPR&D expense.

We account for future payments upon the achievement of certain regulatory, development or sales milestones in such asset acquisitions when the underlying milestone is achieved.

General and Administrative

Our general and administrative expenses consist primarily of legal and consulting services, including those relating to intellectual property and corporate matters, professional fees for accounting, tax, and business consulting services.

We expect that our general and administrative expenses will increase substantially in the future as we continue to increase our general and administrative headcount to support our operations and, if TNT119 receives marketing approval, commercialization activities.

 

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Other Income (Expense), net

In November 2023, we entered into the Tenet SAFEs with the SAFE Holders for an aggregate of $10.0 million. The Tenet SAFEs granted the SAFE Holders with rights to participate in future equity financings. The Tenet SAFEs stipulate that if there is an equity financing before the expiration or termination of the Tenet SAFEs, we will be required to issue to the SAFE Holders a number of shares of standard preferred stock equal to the purchase amount divided by the price per share of the standard preferred stock and multiplied by the discount factor of 90%. In addition, the Tenet SAFEs stipulate that if there is a liquidity event before the expiration or termination of the Tenet SAFEs, we will be required to pay a cash payment equal to the greater of (i) the purchase amount or (ii) the amount payable on the number of shares of common stock equal to the purchase amount divided by the price per share of the common stock and multiplied by the discount factor of 90%. If there is an option provided to our stockholders with respect to the form and amount of proceeds to be received in a liquidity event, then the SAFE Holders will be given the same option. The Tenet SAFEs also stipulate that if there is a dissolution event before the expiration or termination of a Tenet SAFE, we will pay a cash payment to each SAFE Holder equal to the purchase amount of such SAFE Holder’s Tenet SAFE. The Tenet SAFEs will automatically terminate immediately following the earliest of either (i) the issuance of stock following the conversion of the Tenet SAFEs as outlined above in the event of an equity financing or (ii) the payment of amounts due to the SAFE Holders in the event of a liquidity event or dissolution.

On April 10, 2024, prior to the execution of the Acquisition Agreement, we and the SAFE Holders amended the Tenet SAFEs to change the discount factor from 90% to 100%. All other terms of the Tenet SAFEs remained unchanged. We elected to use the fair value option of accounting for the Tenet SAFE commitments. The Tenet SAFEs are measured at fair value at each reporting period with changes in the fair value recorded in other income (expense) in our statements of operations and comprehensive loss.

Results of Operations

For the three months ended March 31, 2024

The following table summarizes our results of operations for the three months ended March 31, 2024 (in thousands):

 

     Three Months
Ended
March 31, 2024
 

Operating expenses:

  

Research and development

   $ 917  

Research and development, related party

     261  

In-process research and development

     7,003  

General and administrative

     793  

General and administrative, related party

     146  
  

 

 

 

Total operating expenses

     9,120  
  

 

 

 

Loss from operations

   $ (9,120

Other income (expense), net

  

Change in fair value of simple agreements for future equity liability

     166  

Other expense

     (10
  

 

 

 

Total other income (expense), net

     156  
  

 

 

 

Net loss and comprehensive loss

   $ (8,964
  

 

 

 

Research and Development and Research and Development, Related Party

Our research and development expenses consisted primarily of the signature fee of $0.4 million we paid to CRH in relation to the CRH Agreement, and the remaining expenses relate to consulting costs incurred in connection

 

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with our discovery and research efforts and clinical trial planning activities. Research and development, related party expenses consisted of consulting costs with Sera Services and Blackbird Clinical Inc. (“Blackbird”). Refer to our interim condensed financial statements as of and for the period ending March 31, 2024 appearing elsewhere in this proxy statement for a description of our related party arrangement with Sera Services and Blackbird.

In-process Research and Development

Our IPR&D expense consisted of the costs incurred in connection with the Asset Purchase Agreement for $7.0 million. Refer to our interim condensed financial statements as of and for the period ending March 31, 2024 appearing elsewhere in this proxy statement for a description of the Asset Purchase Agreement.

General and Administrative and General and Administrative, Related Party

Our general and administrative expenses consisted primarily of legal costs relating to corporate matters, the Asset Purchase Agreement, the Acquisition, professional fees for accounting, tax and business consulting services, and recruiting costs. General and administrative, related party expenses consisted of business consulting costs provided by Sera Services.

Other Income (Expense), Net

Other income (expense), net was primarily attributable to a decrease in the fair value of the Tenet SAFEs, partially offset by foreign exchange losses.

For the Period from November 08, 2023 (Inception) through December 31, 2023

The following table summarizes our results of operations for the period ended December 31, 2023 (in thousands):

 

     Period from
November 08, 2023
(Inception) through
December 31,

2023
 

Operating expenses:

  

Research and development

   $ 35  

Research and development, related party

     46  

General and administrative

     215  

General and administrative, related party

     28  
  

 

 

 

Total operating expenses

     324  
  

 

 

 

Loss from operations

   $ (324

Other expense

  

Change in fair value of simple agreements for future equity liability

     (232
  

 

 

 

Total other expense

     (232
  

 

 

 

Net loss and comprehensive loss

   $ (556
  

 

 

 

Research and Development Expenses

Our research and development expenses consisted primarily of consulting costs incurred in connection with our discovery and research efforts and clinical trial planning activities. Research and development, related party expenses consisted of consulting costs provided by Sera Services. Refer to our audited financial statements appearing elsewhere in this proxy statement for a description of our related party arrangement with Sera Services.

 

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General and Administrative Expenses

Our general and administrative expenses consisted primarily of legal costs relating to corporate matters associated with our formation as a company and professional fees for accounting, tax and business consulting services. General and administrative, related party expenses consisted of business consulting costs provided by Sera Services.

Other Expense

Other expense, net was attributable to the increase in the fair value of the Tenet SAFE commitments.

Liquidity, Capital Resources and Capital Requirements

Sources of Liquidity

Since our inception, we have not generated any revenue from product sales and have incurred operating losses and negative cash flows from our operations. Since inception, we have funded our operations through the issuance of the Tenet SAFEs.

As of March 31, 2024 and December 31, 2023, we had $1.7 million and $9.9 million in cash, respectively. On May 14, 2024, we entered into the Note with Eliem for $15.0 million that would enable us to fund operating expenses and capital requirements. Based on our current operating plan, we have concluded that there is substantial doubt about our ability to continue as a going concern.

Future Funding Requirements

Our primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs and general and administrative expenditures. We anticipate that we will continue to incur significant and increasing expenses for the foreseeable future as we continue to advance TNT119, including expand our corporate infrastructure, further our research and development initiatives for TNT119, and incur costs associated with potential commercialization. We are subject to all of the risks typically related to the development of biopharmaceutical candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.

Our future funding requirements will depend on many factors, including the following:

 

   

the type, number, scope, progress, expansions, results, costs, and timing of, discovery and research, potential clinical trials of TNT119, which we are pursuing or may choose to pursue in the future;

 

   

the costs and timing of manufacturing for TNT119 and commercial manufacturing if TNT119 is approved;

 

   

the costs, timing, and outcome of regulatory review of TNT119;

 

   

the terms and timing of establishing and maintaining licenses and other similar arrangements;

 

   

the legal costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights;

 

   

our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company;

 

   

the costs associated with hiring additional personnel and consultants as our discovery and research preclinical and clinical activities increase;

 

   

the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;

 

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our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payers and adequate market share and revenue for any approved products; and

 

   

costs associated with any products or technologies that we may in-license or acquire.

Furthermore, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, potentially including collaborations, licenses, and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or TNT119, or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts, or grant rights to develop and market TNT119 even if we would otherwise prefer to develop and market TNT119 ourselves.

Cash Flows

The following summarizes our cash flows for the three months ended March 31, 2024 and for the period ended December 31, 2023 (in thousands):

 

     Three Months
Ended
March 31, 2024
     Period from
November 08, 2023
(Inception) through
December 31, 2023
 

Net cash used in operating activities

   $ (938    $ (73

Net cash used in investing activities

     (7,265      —   

Net cash provided by financing activities

     —         10,002  
  

 

 

    

 

 

 

Net change in cash

   $ (8,203    $ 9,929  
  

 

 

    

 

 

 

Operating Activities

Net cash used in operating activities was approximately $0.9 million for the three months ended March 31, 2024. Cash used in operating activities in the three months ended March 31, 2024, included our net loss for the three months of $9.0 million. The net loss was adjusted by $7.0 million for IPR&D, $0.2 million in non-cash gain attributed to the decrease in the fair value of the Tenet SAFE liability and changes in working capital of $1.2 million.

Net cash used in operating activities was approximately $0.1 million for the period ended December 31, 2023. Cash used in operating activities in the period ended December 31, 2023, included our net loss for the period of $0.6 million. The net loss was adjusted by a $0.2 million non-cash expense attributed to the increase in the fair value of the Tenet SAFE liability and changes in working capital of $0.3 million.

 

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Investing Activities

Cash used in investing activities for the three months ended March 31, 2024, was related to the upfront cash payment for the Asset Purchase Agreement.

Financing Activities

Cash provided by financing activities for the period ended December 31, 2023, was primarily related to the proceeds from the issuance of the Tenet SAFEs of $10.0 million.

Contractual Obligations and Commitments

As of March 31, 2024, we did not have any long-term debt obligations, lease obligations, purchase obligations or long-term liabilities. We enter into contracts in the normal course of business for contract research services, professional services, and other services. These contracts generally provide for termination after a notice period and, therefore, are considered cancelable contracts. Refer to our unaudited condensed financial statements appearing elsewhere in this proxy statement for a description of our license agreements and the obligations under those agreements.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including but not limited to those related to the determination of the fair value of the Temet SAFE commitments. These estimates and assumptions are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates and assumptions could occur in the future. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies” to our audited financial statements appearing elsewhere in this proxy statement, we believe that the following accounting estimates is the most critical for fully understanding and evaluating our financial condition and results of operations.

Valuation of the Tenet SAFE Commitments

In November 2023, we issued and entered into the Tenet SAFEs with the SAFE Holders, which granted the SAFE Holders with rights to future equity upon the occurrence of an equity financing event. As permitted under ASC Topic 825, Financial Instruments, we have elected to use the fair value option to account for the Tenet SAFEs issued. We concluded that the terms of the Tenet SAFEs were at arms-length, and the cash received at issuance of the Tenet SAFEs represented fair value. The Tenet SAFEs are recorded as a liability on the balance sheet as they give investors the option to redeem the instrument for cash upon a change in control. We record changes in fair value of the Tenet SAFEs between issuance and settlement as a line item within other income (expense) in the statement of operations and comprehensive loss. Issuance costs related to the Tenet SAFEs are expensed in the period incurred.

The Tenet SAFEs are measured at fair value with the assistance of a third-party valuation firm and are subject to re-measurement at each balance sheet date. The valuation approach takes into consideration the probability of

 

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various events at different time periods, including liquidity events and equity financing events. The estimated fair values of the Tenet SAFEs at March 31, 2024, and December 31, 2023, were determined using a valuation model that considered the probability of the occurrence of certain future financing events, an assumed discount rate, and the estimated time period the Tenet SAFEs would be outstanding. The assumptions used to determine the fair value of the Tenet SAFEs as of March 31, 2024, and December 31, 2023, also included an estimated probability of a financing and a contractual conversion of 100% and 95%, respectively, an assumed discount rate of 21.0% and 19.0%, respectively, and an estimated time period the Tenet SAFEs would be outstanding of 0.25 years and 0.25 to 1.25 years, respectively. As these assumptions change, the fair value of the Tenet SAFEs will increase or decrease at each reporting period until settlement.

 

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MANAGEMENT FOLLOWING THE ACQUISITION

Assuming that both of the director nominees referenced in the section titled, “Matters Being Submitted to a Vote of Eliem Stockholders—Proposal No. 3: Election of Directors” beginning on page 103 of this proxy statement are approved by Eliem stockholders at the Meeting, the Eliem Board will be composed of the following directors: Andrew Levin, M.D., Ph.D., Judith Dunn, Ph.D., Liam Ratcliffe, M.D., Ph.D., Adam Rosenberg and Simon Tate. In the event that the two director nominees are elected at the Meeting but the Acquisition is not completed, both directors will continue in office until the Eliem 2027 annual meeting of stockholders.

In the event the Acquisition is completed, the Post-Closing Eliem Board will be composed of seven board members consisting of the following:

 

   

the five existing members of the Eliem Board;

 

   

Stephen Thomas, Ph.D., the expected interim Chief Executive Officer of Post-Closing Eliem; and

 

   

one director to be designated by Tenet prior to the Closing of the Acquisition.

The staggered structure of the Eliem Board will remain in place for the Post-Closing Eliem Board following closing of the Acquisition.

Directors

The following table sets forth the name, age and position of each of the individuals who are expected to serve as directors of Post-Closing Eliem as of May 10, 2024, assuming that both of the director nominees are approved at the Meeting.

 

Name

   Age