UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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(The Nasdaq Global Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of September 10, 2021, the registrant had
Table of Contents
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Results and Operations |
16 |
Item 3. |
26 |
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Item 4. |
26 |
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PART II. |
28 |
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Item 1. |
28 |
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Item 1A. |
28 |
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Item 2. |
71 |
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Item 3. |
71 |
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Item 4. |
71 |
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Item 5. |
71 |
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Item 6. |
72 |
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73 |
PART I - FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudited)
Eliem Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(unaudited)
Assets |
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June 30, 2021 |
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December 31, 2020 |
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Current assets: |
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Cash |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Total current assets |
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$ |
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$ |
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Long-term assets |
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Total assets |
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$ |
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$ |
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Liabilities, Redeemable Convertible Preferred Stock, and |
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Current liabilities: |
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Accounts payable |
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Accounts payable, related party |
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Accrued expenses |
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Accrued expenses, related party |
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Redeemable convertible preferred stock tranche liability |
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Total current liabilities |
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$ |
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$ |
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Total liabilities |
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$ |
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$ |
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Redeemable convertible preferred stock, $ |
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Stockholders’ deficit: |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ deficit |
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$ |
( |
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$ |
( |
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Total liabilities, redeemable convertible preferred stock, |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Eliem Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(unaudited)
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Three months ended June 30, |
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Six months ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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Research and development, related party |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Change in fair value of redeemable convertible preferred stock tranche liability |
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( |
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Foreign currency gain (loss) |
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( |
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( |
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( |
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Total other income (expense) |
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( |
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( |
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( |
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Net loss and comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends |
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( |
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( |
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( |
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( |
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Net loss attributable to common stockholders |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Eliem Therapeutics, Inc.
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit
(In thousands, except share and per share amounts)
(unaudited)
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Redeemable Convertible Preferred Stock |
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Common Stock |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Deficit |
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Total Stockholders' (Deficit) |
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Balance as of December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Series A-1 Preferred Stock Issuance (net of |
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— |
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— |
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— |
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— |
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— |
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Reclassification of redeemable convertible |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options and release of |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance as of March 31, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Series B Preferred Stock Issuance (net of |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options and release of |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance as of June 30, 2021 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Balance as of December 31, 2019 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Accretion of Series A and A-1 Preferred |
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— |
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— |
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— |
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( |
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— |
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( |
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Release of restricted stock awards |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance as of March 31, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Accretion of Series A and A-1 Preferred |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Release of restricted stock awards |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance as of June 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Eliem Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
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Six Months Ended June 30, |
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2021 |
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2020 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Change in fair value of redeemable convertible preferred stock |
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— |
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Foreign currency gain from remeasurement |
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( |
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( |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
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( |
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( |
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Long-term assets |
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( |
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( |
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Accounts payable |
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( |
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Accrued liabilities |
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Accounts payable and accrued liabilities, related party |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash flows from financing activities |
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Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs |
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— |
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Proceeds from the exercise of stock options |
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— |
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Net cash provided by financing activities |
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— |
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Effect of exchange rate changes on cash |
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Net change in cash |
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( |
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Cash at beginning of period |
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Cash at end of period |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Redeemable convertible preferred stock accretion |
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$ |
— |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Eliem Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. Description of Organization and Summary of Significant Accounting Policies
Organization
Eliem Therapeutics, Inc. (the Company) is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, neuropsychiatry, epilepsy and other disorders of the peripheral and central nervous systems. Headquartered in Redmond, Washington, the Company was incorporated on
Basis of Presentation and Principles of Consolidation
The accompanying interim condensed consolidated financial statements of the Company and its wholly owned subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States (U.S. GAAP). All intercompany transactions and balances have been eliminated in consolidation.
The accompanying condensed consolidated balance sheet as of June 30, 2021, and condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of cash flows, and condensed consolidated statements of redeemable convertible preferred stock and stockholders’ deficit for the three months and six months ended June 30, 2021 and 2020, are unaudited. The consolidated balance sheet as of December 31, 2020 was derived from the audited financial statements as of and for the year ended December 31, 2020, but does not include all disclosures required by U.S. GAAP. The unaudited interim condensed financial statements have been prepared on a basis consistent with the audited annual financial statements as of and for the year ended December 31, 2020, and, in the opinion of management, reflect all adjustments, consisting solely of normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2021, the condensed results of its operations as of the three and six months ended June 30, 2021 and 2020, and its cash flows for the six months ended June 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and 2020 are also unaudited. The condensed results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the full year ending December 31, 2021 or any other period. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements included in the Company's final prospectus dated August 9, 2021 and filed with the Securities and Exchange Commission, or SEC, on August 11, 2021 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended.
Initial Public Offering
On August 12, 2021, the Company completed its initial public offering (IPO) of
Liquidity
Since inception, the Company has experienced recurring losses from operations and generated negative cash flows from operations. The Company has an accumulated deficit of $
5
These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
Use of Estimates
The preparation of the interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Key management estimates include those related to the valuation of assets acquired, accrual of research and development expenses, the valuation of stock-based awards, the valuation of common stock and redeemable convertible preferred stock, and the valuation of redeemable convertible preferred stock tranche liabilities. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash. The Company’s cash is held by one financial institution in the United States (U.S.) and one financial institution in the United Kingdom (U.K.). The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company’s deposits held in the U.S. and U.K. may exceed the Federal Depository Insurance Corporation and Financial Services Compensation Scheme, respectively, insured limits.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on single-source vendors and collaborators, availability of raw materials, patentability of the Company’s products and processes and clinical efficacy and safety of the Company’s products under development, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials, and regulatory approval, prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting.
There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
Moreover, the current COVID-19 pandemic, which is impacting worldwide economic activity, poses risk that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time which may delay the start-up and conduct of the Company’s clinical trials, and negatively impact manufacturing and testing activities performed by third parties. Any significant delays may impact the use and sufficiency of the Company’s existing cash reserves, and the Company may be required to raise additional capital earlier than it had previously planned. The Company may be unable to raise additional capital if and when needed, which may result in delays or suspension of its development plans. The extent to which the pandemic will impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (the CODM). The Company’s CODM is its chief executive officer who reviews financial information together with certain operating metrics principally to make decisions about how to allocate resources and to measure the Company’s performance. Management has determined that the Company operates as a single operating and reportable segment. The Company’s CODM evaluates financial information on a consolidated basis. As the Company operates as one operating segment, all required segment financial information is found in the interim condensed consolidated financial statements.
6
Fair Value Measurement
Assets and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The Company measures fair value based on a three-tier hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liabilities. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
In determining fair value, the Company utilizes quoted market prices, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
There were
The Company’s fair value measurements as of December 31, 2020 was as follows (in thousands):
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December 31, 2020 |
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|
Level 1 |
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|
Level 2 |
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|
Level 3 |
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Balance |
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Liabilities: |
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|
|
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|
|
|
|
|
|
|
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||||
Redeemable convertible preferred stock |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
The redeemable convertible preferred stock tranche liability was settled on March 9, 2021.
Summary of Significant Accounting Policies
Deferred Offering Costs
Costs that were directly related to the Company’s IPO were deferred for expense recognition and capitalized and recorded within prepaid and other current assets on the accompanying condensed consolidated balance sheet. These costs consist of legal fees, accounting fees, and other applicable professional services. These deferred offering costs will be reclassified to additional paid in capital upon the closing of the IPO in August 2021. As of June 30, 2021, $
There have been no other significant changes in the Company’s accounting policies during the three and six months ended June 30, 2021.
2. Certain Balance Sheet Accounts
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
||
Recoverable research and development tax credits |
|
$ |
|
|
$ |
|
||
Prepaid research and development expenses |
|
|
|
|
|
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||
Deferred offering costs |
|
|
|
|
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Other assets |
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|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
7
Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
||
Accrued research and development expenses |
|
$ |
|
|
$ |
|
||
Accrued payroll |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
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||
Total accrued expenses |
|
$ |
|
|
$ |
|
3. Redeemable Convertible Preferred Stock
As of June 30, 2021 and December 31, 2020, the Company’s redeemable convertible preferred stock consisted of the following balance (in thousands, except share and per share amounts):
|
|
As of June 30, 2021 |
|
|||||||||||||||||
|
|
Issue |
|
|
Shares |
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|
Shares Issued and Outstanding |
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|
Carrying |
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Aggregate |
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|||||
Series A |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Series A (Athenen Acquisition) |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Series A-1 |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Series B |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Ending balance |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|||||
|
|
As of December 31, 2020 |
|
|||||||||||||||||
|
|
Issue |
|
|
Shares |
|
|
Shares Issued and Outstanding |
|
|
Carrying |
|
|
Aggregate |
|
|||||
Series A |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Series A (Athenen Acquisition) |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Series A-1 |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|||||
Ending balance |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
In March 2021, Series A-1 preferred stockholders exercised their tranche rights in connection with milestone achievements related to Phase 1 clinical trial results of ETX-155. As a result, the Company issued an additional
In May 2021, the Company issued