UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
OR
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 Identification No.) |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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.
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, a 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
As of August 9, 2024, the registrant had
VACCINEX, INC.
FORM 10-Q
TABLE OF CONTENTS
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Item 1. |
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3 |
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3 |
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Condensed Statements of Operations and Comprehensive Loss (Unaudited) |
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4 |
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Condensed Statements of Stockholders’ Equity (Deficit) (Unaudited) |
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5 |
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6 |
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7 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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24 |
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Item 3. |
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35 |
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Item 4. |
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35 |
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Item 1A. |
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36 |
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Item 6. |
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38 |
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39 |
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
VACCINEX, INC.
Condensed Balance Sheets (Unaudited)
(in thousands, except share and per share data)
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As of |
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As of |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable |
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Prepaid expenses and other current assets |
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Derivative asset |
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- |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset |
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TOTAL ASSETS |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Deferred revenue |
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Current portion of long-term debt |
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Operating lease liability |
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Warrant liability |
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Total current liabilities |
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Long-term debt |
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- |
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TOTAL LIABILITIES |
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Stockholders’ equity (deficit): |
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Convertible preferred stock (Series A), par value of $ |
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Common stock, par value of $ |
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Additional paid-in capital |
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Treasury stock, at cost; |
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( |
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Accumulated deficit |
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( |
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( |
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TOTAL STOCKHOLDERS’ EQUITY/(DEFICIT) |
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( |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
3
VACCINEX, INC.
Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue |
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$ |
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$ |
- |
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$ |
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$ |
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Costs and expenses: |
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Research and development |
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General and administrative |
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Total costs and expenses |
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Loss from operations |
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Interest expense |
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- |
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- |
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- |
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( |
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Financing costs - warrant liabilities |
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- |
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- |
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( |
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- |
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Change in fair value of warrant liabilities |
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- |
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- |
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Change in fair value of derivative asset |
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( |
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- |
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( |
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- |
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Other income (expense), net |
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Loss before provision for income taxes |
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( |
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Provision for income taxes |
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Net loss attributable to Vaccinex, Inc. common stockholders |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Comprehensive loss |
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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 Vaccinex, Inc. common |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted-average shares used in computing net loss per share |
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The accompanying notes are an integral part of these condensed financial statements.
4
VACCINEX, INC.
Condensed Statements of Stockholders’ Equity (Deficit) (Unaudited)
(in thousands, except share data)
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Preferred Stock |
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Common Stock |
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Treasury 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 |
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Common |
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Amount |
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Accumulated |
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Total |
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Balance as of January 1, 2023 |
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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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Issuance of common stock |
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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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- |
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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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( |
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( |
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Balance as of March 31, 2023 |
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( |
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( |
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Issuance of Common Shares |
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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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- |
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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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( |
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( |
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Balance as of June 30, 2023 |
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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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Preferred Stock |
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Common Stock |
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Treasury 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 |
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Common |
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Amount |
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Accumulated |
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Total |
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Balance as of January 1, 2024 |
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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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Issuance of common stock |
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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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- |
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Issuance of common stock and pre-funded warrants in private placement offerings |
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- |
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- |
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- |
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- |
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Issuance of warrants in private placement offerings |
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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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Issuance of warrants |
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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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Issuance of preferred stock |
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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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Reclassification of public warrants, as amended |
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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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Reclassification of private placement warrants, as amended |
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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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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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( |
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( |
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Balance as of March 31, 2024 |
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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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- |
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- |
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Amortization of preferred stock discount |
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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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- |
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Issuance of restricted stock |
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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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- |
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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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( |
) |
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( |
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Balance as of June 30, 2024 |
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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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The accompanying notes are an integral part of these condensed financial statements.
5
VACCINEX, INC.
Condensed Statements of Cash Flows (Unaudited)
(in thousands)
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Six Months Ended June 30, |
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2024 |
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2023 |
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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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Depreciation |
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Stock-based compensation |
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Change in fair value of warrant liability |
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( |
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- |
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Change in fair value of derivative asset |
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- |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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Prepaid expenses and other current assets |
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( |
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Accounts payable |
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Accrued expenses |
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Deferred revenue |
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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 INVESTING ACTIVITIES: |
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Purchase of property and equipment |
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( |
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( |
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Net cash used in investing 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 common stock, and |
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- |
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Proceeds from issuance of warrants in private placement offerings |
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- |
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Proceeds from private offering of common stock |
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- |
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Payments of long-term debt |
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( |
) |
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( |
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Proceeds from issuance of preferred stock and accompanying warrants |
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- |
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Proceeds from issuance of common stock, and |
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- |
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Proceeds from issuance of common stock |
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- |
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Net cash provided by financing activities |
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NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS |
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( |
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( |
) |
CASH AND CASH EQUIVALENTS–Beginning of period |
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CASH AND CASH EQUIVALENTS–End of period |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
6
VACCINEX, INC.
Notes to Condensed Financial Statements (Unaudited)
Note 1. COMPANY AND NATURE OF BUSINESS
Vaccinex, Inc. (the “Company”) was incorporated in Delaware in April 2001 and is headquartered in Rochester, New York. The Company is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including neurodegenerative diseases, cancer, and autoimmune disorders. Since its inception, the Company has devoted substantially all of its efforts toward product research, manufacturing and clinical development, and raising capital.
The Company is subject to a number of risks and uncertainties common to other early-stage biotechnology companies including, but not limited to, dependency on the successful development and commercialization of its product candidates, rapid technological change and competition, dependence on key personnel and collaborative partners, uncertainty of protection of proprietary technology and patents, clinical trial uncertainty, fluctuation in operating results and financial performance, the need to obtain additional funding, compliance with governmental regulations, technological and medical risks, management of growth and effectiveness of marketing by the Company. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability.
Going Concern
These condensed financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such a time it can generate significant revenue from the commercialization of its product candidates. The Company reported cash used in operations of $
In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity, debt financing or funds from other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
7
Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Consolidation
The accompanying unaudited condensed financial statements reflect the accounts and operations of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented.
These condensed financial statements should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023, filed with the SEC on April 25, 2024.
Common Stock Reverse Splits
On September 25, 2023, the
Use of Estimates
These condensed financial statements have been prepared in conformity with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements and the reported amount of expenses during the reporting period. Such management estimates include those relating to assumptions used in the valuation of stock option awards, valuation of the warrant liabilities, valuation of the derivative asset, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.
Convertible Preferred Stock
In March 2024, the Company issued shares of a newly designated series of convertible preferred stock (see Note 9). The convertible preferred stock contained embedded redemption features requiring bifurcation and separate accounting apart from the convertible preferred stock host instrument. The Company recorded the fair value of the embedded redemption features as a derivative asset on the Company’s balance sheets in accordance with ASC Topic 815, Derivatives and Hedging. See Note 4 for the key inputs used in the fair value measurements of the derivative asset.
Fair Value of Financial Instruments
Financial instruments consist of cash, accounts receivable, derivative asset, accounts payable, accrued liabilities, long-term debt, warrant liabilities, and convertible preferred stock. Cash, accounts receivable, accounts payable, accrued liabilities, debt, and convertible preferred stock are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts. Warrant liabilities and the derivative asset are measured at fair value on a recurring basis with the assumptions discussed in Note 4.
8
Concentration of Credit Risk, Other Risks and Uncertainties
The Company is subject to a number of risks, including, but not limited to, the lack of available capital; the possible delisting of our common stock from Nasdaq; possible failure of preclinical testing or clinical trials; inability to obtain regulatory approval of product candidates; competitors developing new technological innovations; potential interruptions in the manufacturing and commercial supply operations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products; and protection of proprietary technology.
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Cash equivalents are deposited in interest-bearing money market accounts. Although the Company deposits its cash with multiple financial institutions, cash balances may occasionally be in excess of the amounts insured by the Federal Deposit Insurance Corporation. Management believes the financial risk associated with these balances is minimal and has not experienced any losses to date.
The Company has historically raised capital in transactions with investors that include members of its board of directors and entities controlled by certain board members. As such, the Company's directors, directly and indirectly, control a significant ownership percentage of the Company. The Company can provide no assurances that future financing will be available in sufficient amounts or on terms acceptable to it or that its directors or entities controlled by certain board members will be willing or able to participate in future capital raises by the Company.
The Company depends on third-party manufacturers for the manufacture of drug substances and drug product for clinical trials. The Company also relies on certain third parties for its supply chain. Disputes with these third- party manufacturers or shortages in goods or services from third-party suppliers could delay the manufacturing of the Company’s product candidates and adversely impact its results of operations.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires disclosure of additional categories of information about federal, state, and foreign income taxes in the rate reconciliation table and more details about the reconciling items in some categories if items meet a quantitative threshold. The ASU requires entities to disclose income taxes paid, net of refunds, disaggregated by federal (national), state and foreign taxes for annual periods and to disaggregate the information by jurisdiction based on a quantitative threshold. The guidance makes several other changes to the disclosure requirements. The ASU is required to be applied prospectively, with the option to apply it retrospectively. The ASU is effective for fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the ASU enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. The ASU does not change how an entity identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments. The ASU is required to be applied retrospectively to all periods presented in the financial statements. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently assessing the impact of the adoption of this guidance on its financial statements and disclosures.
9
Note 3. BALANCE SHEET COMPONENTS
Property and Equipment
Property and equipment consist of the following (in thousands):
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As of |
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As of |
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Leasehold improvements |
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$ |
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$ |
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Research equipment |
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Furniture and fixtures |
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Computer equipment |
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Property and equipment, gross |
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Less: accumulated depreciation and amortization |
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( |
) |
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( |
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Property and equipment, net |
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$ |
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$ |
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Depreciation expense related to property and equipment was $
Accrued Expenses
Accrued expenses consist of the following (in thousands):
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As of |
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As of |
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Accrued clinical trial cost |
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$ |
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$ |
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Accrued payroll and related benefits |
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Accrued consulting and legal |
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Accrued other |
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Accrued expenses |
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$ |
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$ |
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Note 4. FAIR VALUE MEASUREMENTS OF FINANCIAL MEASUREMENTS
Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis
Assets and liabilities recorded at fair value on a nonrecurring basis in the condensed balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Financial instruments consist of cash, accounts receivable, accounts payable, accrued liabilities, long-term debt, and convertible preferred stock. Cash, accounts receivable, accounts payable, accrued liabilities, debt, and convertible preferred stock are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
Fair value measurement standards also apply to certain financial assets and liabilities that are measured at fair value on a recurring basis (each reporting period). For the Company, these financial assets and liabilities include its cash equivalents deposited in money market funds, warrant liabilities, and the derivative asset. The Company does not have any nonfinancial assets or liabilities that are measured at fair value on a recurring basis.
The assets’ or liabilities’ fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
10
The following tables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):
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As of June 30, 2024 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Financial Assets: |
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Money market fund |
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$ |
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$ |
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$ |
- |
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$ |
- |
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Derivative asset |
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- |
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- |
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Total Financial Assets |
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$ |
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$ |
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$ |
- |
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$ |
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As of December 31, 2023 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Financial Assets: |
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Money market fund |
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$ |
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$ |
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$ |
- |
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$ |
- |
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||
Total Financial Assets |
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$ |
|
|
$ |
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$ |
- |
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$ |
- |
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As of June 30, 2024 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Financial Liabilities: |
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Warrant liabilities - public warrants |
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$ |
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$ |
- |
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$ |
- |
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$ |
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Warrant liabilities - private placement warrants |
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- |
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- |
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Total Financial Liabilities |
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$ |
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$ |
- |
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$ |
- |
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|
$ |
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As of December 31, 2023 |
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Fair Value |
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Level 1 |
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Level 2 |
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Level 3 |
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Financial Liabilities: |
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Warrant liabilities - public warrants |
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$ |
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$ |
- |
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$ |
- |
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$ |
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Warrant liabilities - private placement warrants |
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- |
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- |
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Total Financial Liabilities |
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$ |
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|
$ |
- |
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|
$ |
- |
|
|
$ |
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The Company did
Fair Value Measurement of Warrant Liabilities
The Company uses the Black-Scholes pricing model to determine the fair value of its warrant liabilities using Level 3 inputs. Inputs used to determine the estimated fair value of the warrant liabilities include the fair value of the underlying stock at the valuation date, the term of the warrants, and the expected volatility of the underlying stock. The significant unobservable input used in the fair value measurement of the warrant liabilities is the estimated term of the warrants.
The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at June 30, 2024, were as follows:
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Public Warrants |
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Private Placement Warrants |
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Low |
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High |
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Low |
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High |
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Risk-free interest rate |
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% |
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% |
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% |
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% |
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Volatility |
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% |
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% |
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% |
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% |
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Dividend yield |
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% |
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% |
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% |
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% |
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Expected term (years) |
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Share price |
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$ |
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$ |
|
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$ |
|
|
$ |
|
The key inputs into the respective valuation models used to estimate the fair value of the warrant liabilities at December 31, 2023, were as follows:
11
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Public Warrants |
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