SEC Form 10-Q filed by Alaunos Therapeutics Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 |
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, including zip code, and telephone number, including area code, of registrant's principal executive offices)
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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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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 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 ☐ No
As of August 14, 2025 the number of outstanding shares of the registrant's common stock, $0.001 par value, was
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are all statements contained in this Quarterly Report that are not historical fact, and in some cases can be identified by terms such as: “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “target,” "potential," “will” and other words and terms of similar meaning.
These statements are based on management’s current beliefs and assumptions and on information currently available to management. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance or achievements to be materially different from any future results, level of activity, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results, levels of activity or performance of achievements to differ materially from current expectations include, among other things, those described under Part I, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
Unless the context requires otherwise, references in this Annual Report to “Alaunos,” the “Company,” “we,” “us” or “our” refer to Alaunos Therapeutics, Inc.
We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the Alaunos® and hunTR® trademarks as well as the graphic trademark found on our website. Other trademarks, service marks and trade names appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to
i
in this Quarterly Report on Form 10-Q are listed without the ® and ™ symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names.
ii
SUMMARY OF SELECTED RISKS ASSOCIATED WITH OUR BUSINESS
Our business faces significant risks and uncertainties. If any of the following risks are realized, our business, financial condition, results of operations, cash flows and prospects could be materially and adversely affected. You should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors” in Part I, Item 1A of our Annual Report, filed with the SEC on March 31, 2025 and as amended by Amendment No. 1 filed with the SEC on April 30, 2025. Some of the more significant risks include the following:
iii
iv
Table of Contents
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PART I. |
FINANCIAL INFORMATION |
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Item 1. |
2 |
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Condensed Balance Sheets as of June 30, 2025 (unaudited) and December 31, 2024 |
2 |
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3 |
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4 |
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Condensed Statements of Cash Flows for the six months ended June 30, 2025 and 2024 (unaudited) |
7 |
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8 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
16 |
Item 3. |
21 |
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Item 4. |
21 |
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PART II. |
OTHER INFORMATION |
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Item 1. |
23 |
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Item 1A. |
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Item 2. |
24 |
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Item 3. |
24 |
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Item 4. |
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Item 5. |
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Item 6. |
25 |
1
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements (unaudited)
Alaunos Therapeutics, Inc.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
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June 30, |
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December 31, |
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2025 |
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2024 |
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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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Receivables |
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Prepaid expenses and other current assets, current |
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Total current assets |
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Prepaid expenses and other assets, non current |
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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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Total current liabilities |
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Total liabilities |
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$ |
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$ |
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Stockholders' equity |
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Series A-1 preferred stock $ |
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Series A-2 preferred stock $ |
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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' equity |
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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.
2
Alaunos Therapeutics, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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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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Operating expenses: |
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Research and development |
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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 warrant liability |
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( |
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( |
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Other income, net |
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Other income (expense), net |
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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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$ |
( |
) |
Basic and diluted earnings per share |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these condensed financial statements.
3
Alaunos Therapeutics, Inc.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share and per share data)
For the Three Months Ended June 30, 2025
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Common Stock |
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Series A-1 Preferred Stock |
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Series A-2 Preferred Stock |
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Additional Paid in Capital |
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Accumulated Deficit |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Balance at March 31, 2025 |
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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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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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Shares issued as consideration for board service fees |
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— |
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Sale of Series A-1 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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Issuance of common stock in registered direct offering, net of offering cost |
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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 prefunded warrants in registered direct offering |
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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 Warrant Liability to equity |
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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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Exercise of prefunded 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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— |
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Sale of Series A-2 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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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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( |
) |
Balance at June 30, 2025 |
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$ |
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$ |
- |
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$ |
- |
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$ |
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$ |
( |
) |
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$ |
|
4
Alaunos Therapeutics, Inc.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share and per share data)
For the Six Months Ended June 30, 2025
|
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Common Stock |
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Series A-1 Preferred Stock |
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Series A-2 Preferred Stock |
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Additional Paid in Capital |
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Accumulated Deficit |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Balance at January 1, 2025 |
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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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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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Shares issued as consideration for board service fees |
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— |
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Sale of Series A-1 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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Issuance of common stock in registered direct offering, net of offering cost |
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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 prefunded warrants in registered direct offering |
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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 Warrant Liability to equity |
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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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Exercise of prefunded 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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— |
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Sale of Series A-2 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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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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( |
) |
Balance at June 30, 2025 |
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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
Alaunos Therapeutics, Inc.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share and per share data)
For the Three Months Ended June 30, 2024
|
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Common Stock |
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Additional Paid in Capital |
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Accumulated Deficit |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Balance at March 31, 2024 |
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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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Net loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at June 30, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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For the Six Months Ended June 30, 2024
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Common Stock |
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Additional Paid in Capital |
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Accumulated Deficit |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Balance at January 1, 2024 |
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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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Net loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at June 30, 2024 |
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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.
6
Alaunos Therapeutics, Inc.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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For the Six Months Ended June 30, |
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2025 |
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2024 |
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Cash flows from operating activities: |
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Net loss |
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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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Change in fair value of warrant liability |
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Stock-based compensation |
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Changes in operating assets and liabilities: |
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Receivables |
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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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( |
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Accrued expenses |
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( |
) |
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Net cash flows from operating activities |
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( |
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( |
) |
Cash flows from financing activities: |
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Proceeds from the issuance of common stock and pre funded warrants, net of offering costs |
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Proceeds from sale of Series A-1 preferred stock |
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Proceeds from sale of Series A-2 preferred stock |
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||
Net cash flows from financing activities |
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||
Net increase (decrease) in cash, cash equivalents |
|
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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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||
Supplementary disclosure of cash flow information: |
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||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Noncash financing activities: |
|
|
|
|
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||
Recognition of warrant liability in connection with the equity line of credit agreement |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
7
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Overview
Alaunos Therapeutics, Inc., which is referred to herein as “Alaunos,” or the “Company,” is a pre-clinical obesity and metabolic disorder and clinical-stage oncology-focused cell therapy company with a current focus on developing small molecules that are expected to be efficacious against obesity and other metabolic disorders. The Company was historically involved in the development of adoptive TCR therapies, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. Additionally, the Company is currently working to develop novel small molecule-based obesity therapeutics.
The Company’s operations to date have consisted primarily of conducting research and development and raising capital to fund those efforts.
As of June 30, 2025, there were
The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business.
Liquidity and Going Concern
The Company has operated at a loss since its inception in 2003 and has no recurring revenue from operations. The Company anticipates that losses will continue for the foreseeable future. As of June 30, 2025, the Company had approximately $
Based on the current cash forecast and the Company's dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, management has determined that the Company's present capital resources will not be sufficient to fund its planned operations for at least one year from the issuance date of the condensed financial statements, and substantial doubt as to the Company's ability to continue as a going concern exists. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors.
Basis of Presentation
The accompanying unaudited interim condensed financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. The unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on March 31, 2025 and as amended by Amendment No. 1 filed with the SEC on April 30, 2025. (collectively, the “2024 Annual Report”)
The results disclosed in the statements of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the full fiscal year 2025.
Use of Estimates
The preparation of condensed financial statements in conformity with 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 at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company
8
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
regularly assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known.
Increase in Authorized Shares
On July 3, 2025, the Company stockholders approved an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock from
Equity Incentive Plan Amendment
On July 3, 2025, the Company's stockholders approved an amendment to the Company’s 2020 Equity Incentive Plan to increase the number of shares of common stock authorized for issuance under the plan from
Nasdaq Stockholders' Equity Deficiency Notice
On April 7, 2025, the Company received a notice (the “Notice”) from the Listing Qualifications staff of Nasdaq notifying the Company that the Company’s stockholders equity, as reported in its 2024 Annual Report, did not satisfy the continued listing requirements under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market, which requires that a listed company’s stockholder equity be at least $
The Notice has no immediate effect on the Company’s listing on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the notification to submit a plan to regain compliance with Nasdaq Listing Rule 5550(b)(1). On May 22, 2025, The Company submitted a compliance plan within 45 days of the date of the notification to Nasdaq and is effectuating the provided plan in order to resolve the deficiency and regain compliance. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from April 7, 2025, to evidence compliance.
2022 Equity Distribution Agreement
On August 12, 2022, the Company entered into an Equity Distribution Agreement with Piper Sandler & Co. pursuant to which the Company can offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $
See Note 6. Equity for details related to the Company's equity financings.
Certain of our accounting estimates are important to the portrayal of our financial condition, since they require management to make difficult, complex or subjective judgments, some of which may relate to matters that are inherently certain. Estimates are susceptible to material changes as a result of changes in facts and circumstances. Management believes that clinical trial expenses and other research and development expenses, collaboration agreements, fair value measurements of share based arrangements, and income taxes are its most critical accounting estimates. Our accounting policies are discussed in detail in Note 3 – Summary of Significant Accounting Policies in the audited financial statements included in the Company’s 2024 Annual Report There have been no material changes in those policies since the filing of the 2024 Annual Report, except as described below under the heading Derivative Liabilities.
Derivative Liabilities
In accordance with applicable accounting standards, upon issuance of financial instruments, whether stand alone or embedded, the Company performs an analysis to determine the appropriate classification of the financial instrument as either a derivative liability, or
9
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
if certain conditions are met, as equity. Derivative liabilities are initially recorded at fair value and subsequently remeasures the derivative liability at each reporting period with changes in fair value recognized in earnings. The Company continually evaluates the classification and if the terms of the agreement are modified, the Company performs an assessment of the impact. Upon modification, if the instrument qualifies for equity classification, at that time it is remeasured at fair value, with changes in fair value since last measurement recognized in earnings and thereafter the balance is reclassified at its then fair value to equity. During the six months ended June 30, 2025, the Company determined that certain warrants initially qualified as derivative liabilities. Such warrants were subsequently modified at which point the warrants qualified for equity classification. See further discussion in Note 8 - Warrants.
Basic earnings per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per share is computed using the weighted-average number of shares of common stock outstanding during the period, plus the dilutive effect of outstanding options and warrants, using the treasury stock , unless the effect on net earnings per share is antidilutive.
|
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June 30, |
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2025 |
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2024 |
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Common stock options |
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Warrants |
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License Agreements
Exclusive License Agreement with Precigen
On April 3, 2023, the Company entered into the Amended and Restated Exclusive License Agreement with Precigen, or the A&R License Agreement, which restated and amended the parties' previous license agreement in full. Under the A&R License Agreement, the Company still had exclusive, worldwide rights to research, develop and commercialize TCR products designed for neoantigens or driver mutations for the treatment of cancer and non-exclusive rights to use non-driver mutation TCRs. On October 4, 2024, pursuant to Section 10.2 of the License Agreement, the Company duly notified Precigen of its full termination of all rights under the License Agreement.
The decision to terminate the A&R License Agreement was made after a thorough review of our strategic priorities and business objectives, including recognizing that the non-viral Sleeping Beauty gene transfer platform patent will expire in 2026. The Company continues to prosecute certain of the intellectual property underlying the TCRs targeting driver mutations such as KRAS, TP53 and EGFR, and the hunTR TCR discovery platform used in the discovery of our proprietary TCR library. The Company continues to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.
License Agreement and Research and Development Agreement —The University of Texas MD Anderson Cancer Center
In 2015, the Company, together with Precigen, entered into a license agreement, or the MD Anderson License with MD Anderson (which Precigen subsequently assigned to PGEN). Pursuant to the MD Anderson License, the Company, together with Precigen, holds an exclusive, worldwide license to certain technologies owned and licensed by MD Anderson including technologies relating to novel CAR T-cell therapies, non-viral gene transfer systems, genetic modification and/or propagation of immune cells and other cellular therapy approaches, Natural Killer, or NK Cells, and TCRs.
In 2015, the Company, Precigen and MD Anderson entered into the 2015 R&D Agreement to formalize the scope and process for the transfer by MD Anderson, pursuant to the terms of the MD Anderson License, of certain existing research programs and related technology rights, as well as the terms and conditions for future collaborative research and development of new and ongoing research programs.
As provided under the MD Anderson License, the Company provided funding for research and development activities in support of the research programs under the 2015 R&D Agreement. At various times, the Company amended the 2015 R&D Agreement to extend
10
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
the term until December 31, 2026 and in 2019 entered into the 2019 R&D Agreement, pursuant to which the Company agreed to collaborate with respect to the TCR program. The Company did
The 2019 R&D Agreement will terminate on December 31, 2026 and either party may terminate the 2019 R&D Agreement following written notice of a material breach. The 2019 R&D Agreement also contains customary provisions related to indemnification obligations, confidentiality and other matters.
In connection with the execution of the 2019 R&D Agreement, on October 22, 2019, the Company issued MD Anderson a warrant to purchase
Patent and Technology License Agreement—The University of Texas MD Anderson Cancer Center and the Texas A&M University System
In August 2004, the Company entered into a patent and technology license agreement with MD Anderson and the Texas A&M University System, which the Company refers to, collectively, as the Licensors. Under this agreement, the Company was granted an exclusive, worldwide license to rights (including rights to U.S. and foreign patent and patent applications and related improvements and know-how) for the manufacture and commercialization of two classes of organic arsenicals (water- and lipid-based) for human and animal use. The class of water-based organic arsenicals includes darinaparsin.
Under the terms of the agreement, the Company may be required to make payments to the Licensors upon achievement of certain milestones in varying amounts which, on a cumulative basis could total up to an additional $
Collaboration Agreement with Solasia Pharma K.K.
In 2011, the Company entered into a License and Collaboration Agreement with Solasia Pharma K. K., or Solasia, which was amended in 2014 to include an exclusive worldwide license and further amended in 2021 to revise certain payment schedule details, or, as so amended, the Solasia License and Collaboration Agreement. Pursuant to the Solasia License and Collaboration Agreement, the Company granted Solasia an exclusive license to develop and commercialize darinaparsin in both intravenous and oral forms and related organic arsenic molecules, in all indications for human use.
As consideration for the license, the Company is eligible to receive from Solasia development- and sales-based milestones, a royalty on net sales of darinaparsin, once commercialized, and a percentage of any sublicense revenue generated by Solasia.
During the six months ended June 30, 2025, the Company earned royalty revenue totaling $
Insurance Contract
During the six months ended June 30, 2025 , the Company entered into an insurance arrangement whereby an insurance contract for certain risks which was previously paid in full began to be in force for a period of six years. Accordingly, the Company began amortizing the prepaid expense related to the contract. The Company has classified the prepaid contract between its current portion and long term-portion. As of June 30, 2025, $
Director Resignation
11
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Series A-1 Preferred Stock
In April 2025, the Company entered into a Subscription Agreement (the “A-1 Agreement”), with an accredited investor, pursuant to which the Company sold
In connection therewith, the Company filed with the Secretary of State of the State of Delaware the Certificate of Designation of Series A-1 Convertible Preferred Stock of the Company, designating
Series A-1 Preferred Stock together with the aggregate accrued or accumulated and unpaid dividends thereon, is convertible, at any time at option of the holder, into shares of Common Stock at initial fixed “Conversion Price” of $
Director Compensation
On April 13, 2025, the Board of Directors of the Company elected to receive compensation in the form of shares of common stock and stock options in lieu of cash for the then outstanding cumulative deferred board service fees for the first quarter of 2025, totaling $
Securities Purchase Agreement for Registered Direct Offering
In June 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company agreed to sell (i)
Series A-2 Preferred Stock
In June 2025, the Company entered into a subscription agreement with certain accredited investors, pursuant to which the Company sold, in a private placement,
In connection therewith, the Company filed with the Secretary of State of the State of Delaware the Certificate of Designation of Series A-2 Convertible Preferred Stock of the Company, designating
Series A-2 Preferred Stock, together with the aggregate accrued or accumulated and unpaid dividends thereon, is convertible, at any time at the option of the holder, into shares of Common Stock at an initial fixed “Conversion Price” of $
12
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
single class, on any and all matters presented to the stockholders of the Company for their action on an as-converted basis, a number of votes equal to the number of shares of Common Stock into which the shares of Series A-2 Preferred Stock are convertible under the terms of the Certificate of Designation.
The following table presents share-based compensation expense on all employee and non-employee awards included in the accompanying condensed statements of operations as follows:
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
||||||||||
(in thousands) |
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
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General and administrative |
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Stock-based compensation expense |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
During the three and six months ended June 30, 2025, the Company granted an aggregate of
The grant date fair value of stock options was estimated on the date of grant using a Black-Scholes option valuation model with the following assumptions:
|
|
For the Three Months Ended June 30, |
|
For the Six Months Ended June 30, |
||||
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2025 |
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2024 |
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2025 |
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2024 |
Risk-free interest rate |
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Expected life in years |
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Expected volatility |
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Expected dividend yield |
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Stock option activity under the Company’s stock option plans for the six months ended June 30, 2025 was as follows:
(in thousands, except share and per share data) |
|
Number of Shares |
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Weighted- Average Exercise Price |
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Weighted- Average Contractual Term (Years) |
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Aggregate Intrinsic Value |
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Outstanding, December 31, 2024 |
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$ |
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$ |
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Granted |
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Exercised |
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Cancelled |
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( |
) |
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Outstanding, June 30, 2025 |
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$ |
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$ |
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Options exercisable, June 30, 2025 |
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$ |
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$ |
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Options available for future grant, June 30, 2025 |
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At June 30, 2025, total unrecognized compensation costs related to unvested stock options outstanding amounted to $
The following is a summary of the Company's warrant activity for the six months ended June 30, 2025:
13
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
(in thousands, except share and per share data) |
|
Number of Shares |
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Weighted- Average Exercise Price |
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Weighted- Average Contractual Term (Years) |
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Outstanding, December 31, 2024 |
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$ |
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Granted |
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Exercised |
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( |
) |
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Outstanding, June 30, 2025 |
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$ |
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Equity Purchase Agreement and Warrant
Due to anti-dilution and variable pricing features, the warrant was initially classified as a derivative liability measured at fair value using the Black-Scholes model, which was determined to be approximately equivalent to a lattice or monte carlo model. On the issuance date, the fair value of the derivative liability totaled $
The fair value of the warrant issued to the investor was initially measured using the Black-Scholes option pricing model as of May 19, 2025, based on the following assumptions: expected volatility of
The Chief Operating Decision Maker (“CODM”) for the Company is the (the "CEO"). The Company’s CEO reviews operating results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance and allocating resources. This decision-making process reflects the way in which financial information is regularly reviewed and used by the CODM to evaluate performance, set operational targets, forecast future financial results, and allocate resources. Accordingly, the Company has determined that it has a single reportable and operating segment related to biopharmaceutical research and development.
14
Alaunos Therapeutics, Inc.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Changes in Corporate Governance
On July 1, 2025, Dale Curtis Hogue, Jr. resigned from his positions as Chief Executive Officer and a member of the Board of Directors of the Company, effective immediately. His resignation was not due to any disagreement with the Company. In connection with his departure, the Company entered into a Consulting Agreement with Mr. Hogue, effective July 1, 2025, under which he will provide strategic and advisory services to the Company at a rate of $
On July 2, 2025, the Board appointed Holger Weis as Chief Executive Officer, effective immediately. Mr. Weis will continue to serve as Chair of the Board of Directors, but has relinquished his roles on the Audit and Compensation Committees, pursuant to applicable Nasdaq Listing Rules. In connection with his appointment, the Company entered into an Employment Agreement with Mr. Weis, providing for an annual base salary of $
On July 3, 2025, certain members of the Board of Directors of the Company elected to receive compensation in equity rather than in cash for their second quarter board service fees. The total deferred board service fees amounted to $
On July 15, 2025, the Board of Directors of the Company appointed Mr. Michael A. Jerman as an independent director of the Company, effective immediately, to fill the vacancy on the Board of Directors created by the resignation of Mr. Hogue and the vacancies on the audit and compensation committees from Mr. Weis’s appointment as CEO. In connection with his appointment, Mr. Jerman was also named to the Audit Committee and the Compensation Committee of the Board, and will serve as the Chair of the Audit Committee. Upon his appointment, Mr. Jerman was awarded options to purchase Common Stock pursuant to the Company's Non-employee Director Compensation Policy.
On July 16, 2025, Melinda Lackey notified the Company of her decision to terminate the Consulting Agreement dated November 14, 2023 (the “Agreement”) pursuant to terms of the agreement, with such termination to be effective 30 days from the date of notice, or August 15, 2025. In connection with the termination of the Agreement, Ms. Lackey will also resign from her roles as Legal and Administrative Officer and Corporate Secretary of the Company as of the effective Date. Ms. Lackey’s departure is not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.
On August 14, 2025, the Board of Directors of the Company appointed Mr. Groenewald as Corporate Secretary effective upon the resignation of Ms. Lackey.
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial information and related notes included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission, or the SEC, on March 31, 2025, or the Annual Report.
Except for the historical financial information contained herein, the matters discussed in this Quarterly Report on Form 10-Q may be deemed to contain forward-looking statements that reflect our plans, estimates and beliefs. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In this Quarterly Report on Form 10-Q, words such as “may,” “expect,” “anticipate,” “estimate,” “intend,” “plan” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
Our actual results could differ materially from those contained in or implied by any forward-looking statements. Factors that could cause or contribute to these differences include those risks identified under Part II, Item 1A. Risk Factors of our 2024 Annual Report.
Overview
On October 10, 2024, we announced our continued progress and evaluation of our internally developed small molecule oral obesity program. The aim of this program is to develop a drug for obesity with a differentiated profile relative to currently marketed and in development oral and injectable products.
We have also operated as a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial.
In connection with the reprioritization, we reduced our workforce during the third and fourth quarters of 2023, and we continue working to reduce costs in order to extend our cash runway. We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.
We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the six months ended June 30, 2025, we had a net loss of $2.1 million, and as of June 30, 2025, we have incurred approximately $922.6 million of accumulated deficit since our inception in 2003. We expect to continue to incur significant operating expenditures and net losses for the foreseeable future.
Small Molecule Oral Obesity Program
We are advancing our internally developed, preclinical small molecule program for the treatment of obesity and related metabolic disorders. This program focuses on discovering and developing novel, orally administered therapeutics with the potential for a differentiated and complementary profile compared to currently available therapies. While other pipeline therapies for obesity explore alternative hormonal pathways such as amylin or dual GIP/GLP-1 receptor agonism, our approach is focused on a non-hormonal mechanism of action. The program seeks to develop an oral therapeutic with the potential to address certain limitations of existing hormonal therapies, including the potential for preservation of lean muscle mass during weight loss and an improved tolerability profile.
During the fourth quarter of 2024, we engaged a contract development and manufacturing organization (CDMO) to synthesize active pharmaceutical ingredients (APIs) for our product candidates. We have since initiated a portfolio of preclinical studies to evaluate these product candidates. Initial in vitro characterization studies conducted by a contract research organization (CRO) encountered methodological issues related to the assay, which prevented the generation of conclusive data. This CRO has since completed the necessary method development to resolve these issues, and these studies are being repeated. In parallel, we have conducted an in vivo pharmacokinetic (PK) study of our product candidate ALN1003 and have initiated a pilot in vivo proof-of-concept (PoC) study of ALN1003 in a diet-induced obesity (DIO) mouse model.
Collectively, these ongoing studies are designed to assess our candidates’ effects on key biological pathways implicated in metabolic disease, including receptor binding, lipid accumulation, food consumption, weight loss, and the expression of genes related to thermogenesis and energy expenditure. We anticipate initial data from these ongoing in vitro and in vivo studies will be available no later than the fourth quarter of 2025. These data are intended to inform the future development strategy for our product candidates and guide indication selection.
The advancement of this program is subject to numerous risks and uncertainties inherent in early-stage drug development. Subject to favorable data from these preclinical studies and our ability to secure additional capital, we plan to advance a selected development
16
candidate into formal investigational new drug (IND)-enabling studies. We intend to actively explore strategic financing and collaboration opportunities to fund the continued development of this program.
Historical Development and Achievements in Cancer Therapeutics
We previously focused on developing TCR-T cell therapies for solid tumors using our non-viral Sleeping Beauty platform and hunTR® TCR discovery platform. Key milestones included:
In August 2023, however, due to substantial development costs and a challenging financing environment, we announced a strategic reprioritization, including the wind-down of our TCR-T Library Phase 1/2 Trial and cessation of further clinical development of TCR-T programs. This involved:
As a result, research and development expenses related to cancer programs have significantly declined, from $11.7 million for the six months ended June 30, 2023, to $0.3 million for the same period in 2025, reflecting the shift away from active oncology development.
We are actively exploring strategic alternatives to maximize stockholder value, including but not limited to acquisitions, mergers, reverse mergers, asset sales, strategic partnerships, or capital raises. These may involve monetizing cancer-related assets, such as out-licensing the TCR library or hunTR platform. We have engaged Cantor Fitzgerald & Co. as a strategic advisor for this process. However, there are no assurances that any transaction will be consummated, and failure to do so could lead to further operational curtailment or dissolution. Our primary focus has shifted to our preclinical small-molecule obesity and metabolic disorder program, with ongoing preclinical in vitro and in vivo studies.
Nasdaq Shareholders Equity Deficiency Notice
On April 7, 2025, the Company received a notice (the “Notice”) from the Listing Qualifications staff of Nasdaq notifying the Company that the Company’s stockholders equity as reported in its Annual Report on Form 10-K for the period ended December 31, 2024 (the “2024 10-K”), did not satisfy the continued listing requirements under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market, which requires that a listed company’s stockholder equity be at least $2.5 million. In its 2024 10-K, the Company reported stockholders’ equity of $2.1 million, and, as a result, does not currently satisfy Nasdaq Listing Rule 5550(b)(1).
The Notice has no immediate effect on the Company’s listing on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the notification to submit a plan to regain compliance with Nasdaq Listing Rule 5550(b)(1) to Nasdaq. The Company submitted a compliance plan within 45 days of the date of the notification, as required, and is evaluating available options to resolve the deficiency and regain compliance.
On May 22, 2025, the Company submitted its compliance plan to Nasdaq and is currently awaiting a response. If the compliance plan is accepted, Nasdaq may grant the Company an extension of up to 180 calendar days from the date of the notice, or until October 4, 2025, to evidence compliance with the rule. The Company is evaluating and pursuing available options to address the deficiency and regain compliance.
17
Results of Operations
Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024
Royalty Revenue
Royalty revenue during the three months ended June 30, 2025 and 2024 were as follows:
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Three Months Ended June 30, |
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2025 |
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2024 |
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Revenue |
$ |
— |
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$ |
4 |
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$ |
(4 |
) |
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(100 |
)% |
|
Research and Development Expenses
Research and development expenses during the three months ended June 30, 2025 and 2024 were as follows:
|
Three Months Ended June 30, |
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2025 |
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2024 |
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Change |
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($ in thousands) |
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Research and development expenses |
$ |
185 |
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$ |
180 |
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|
$ |
5 |
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3 |
% |
|
Research and development expenses for the three months ended June 30, 2025 increased by $5,000 when compared to the three months ended June 30, 2024, primarily due to an increase in consulting fees incurred in pursuit of our obesity program.
General and Administrative Expenses
General and administrative expenses during the three months ended June 30, 2025 and 2024 were as follows:
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Three Months Ended June 30, |
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|
2025 |
|
|
2024 |
|
|
Change |
|
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses |
$ |
854 |
|
|
$ |
990 |
|
|
$ |
(136 |
) |
|
|
(14 |
)% |
|
General and administrative expenses for the three months ended June 30, 2025 decreased by $136,000 as compared to the three months ended June 30, 2024, primarily due to a decrease in insurance costs, filing fees, bank fees and travel costs due to our downsized operations.
Other Income
Other income during the three months ended June 30, 2025 and 2024 were as follows:
|
Three Months Ended June 30, |
|
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
$ |
19 |
|
|
$ |
37 |
|
|
|
(18 |
) |
|
|
(49 |
)% |
|
Other income, net, for the three months ended June 30, 2025 decreased by $18,000 as compared to the three months ended June 30, 2024, primarily due to reduced interest cash reserves, corresponding to the reduced cash balances quarter over quarter.
Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
Royalty Revenue
Royalty revenue during the six months ended June 30, 2025 and 2024 were as follows:
|
For the six months ended June 30, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
||||
Revenue |
$ |
2 |
|
|
$ |
6 |
|
|
$ |
(4 |
) |
|
|
(67 |
)% |
18
Research and Development Expenses
Research and development expenses during the six months ended June 30, 2025 and 2024 were as follows:
|
For the six months ended June 30, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development expenses |
$ |
531 |
|
|
$ |
306 |
|
|
$ |
225 |
|
|
|
74 |
% |
Research and development expenses for the six months ended June 30, 2025 increased by $255,000 when compared to the six months ended June 30, 2024, primarily due to an increase of $200,0000 related to regulatory submissions as part of our wind-down clinical activities and consulting fees incurred in pursuit of our obesity program.
General and Administrative Expenses
General and administrative expenses during the six months ended June 30, 2025 and 2024 were as follows:
|
For the six months ended June 30, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses |
$ |
1,603 |
|
|
$ |
2,607 |
|
|
$ |
(1,004 |
) |
|
|
(39 |
)% |
General and administrative expenses for the six months ended June 30, 2025 decreased by $1,004,000 as compared to six months ended June 30, 2024, primarily due to a $200,000 decrease in employee-related expenses as a result of lower salaries and employee related costs, a $400,000 decrease in consulting expenses and a $400,000 decrease in insurance cost, filing fees, bank fees and travel costs and bank fees due to our downsized operations.
Other Income
Other income during the six months ended June 30, 2025 and 2024 were as follows:
|
For the six months ended June 30, |
|
|
|
|
|
|
|
|||||||
|
2025 |
|
|
2024 |
|
|
Change |
|
|||||||
($ in thousands) |
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
|
39 |
|
|
|
97 |
|
|
|
(58 |
) |
|
|
(60 |
)% |
Other income, net, for the six months ended June 30, 2025 decreased be $58,000 as compared to the six months ended June 30, 2024, primarily due to reduced interest income from our cash reserves, as our reduced cash reserves quarter over quarter.
Liquidity and Capital Resources
Liquidity
Sources of Liquidity
We have not generated any revenue from product sales and have only generated nominal royalty revenue. Since inception, we have incurred net losses and negative cash flows from our operations.
To date, we have financed our operations primarily through public offerings of our common stock, private placements of our convertible and preferred equity securities, term debt and collaborations.
Given our current development plans and cash management efforts, we anticipate that our cash resources will be sufficient to fund operations into the first quarter of 2026. Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in our focus and direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, management may need to curtail its development efforts and planned operations to conserve cash.
19
We operated at a loss since inception in 2003 and have no significant recurring revenue from operations. We anticipate that losses will continue for the foreseeable future. As of June 30, 2025, our accumulated deficit was approximately $922.6 million. Our working capital as of June 30, 2025 was $2.6 million, consisting of $3.7 million in current assets and $1.1 million in current liabilities. Our actual cash requirements may vary materially from those planned because of a number of factors, including changes in the focus, direction and pace of our development programs.
As of June 30, 2025, we had approximately $2.9 million of cash and cash equivalents. In light of our 2023 announced strategic reprioritization and the ensuing streamlining and cost efficiency efforts, we anticipate our cash resources will be sufficient to fund our operations into the first quarter of 2026. In order to continue our operations beyond our forecasted runway, including, if necessary, to continue to explore strategic alternatives, we will need to raise additional capital. Aside from the equity line of credit, we have no committed sources of additional capital at this time. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, we may be unable to persist as a going concern for sufficient time to identify or execute on any strategic alternatives.
Based on the current cash forecast, management has determined that our present capital resources will not be sufficient to fund our planned operations for at least one year from the issuance date of the condensed financial statements, which raises substantial doubt as to our ability to continue as a going concern. This forecast of cash resources and planned operations is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors.
Series A-1 Preferred Stock
In April 2025, we entered into a Subscription Agreement, with an accredited investor, pursuant to which we sold 500 shares of Series A-1 Convertible Preferred Stock, par value of $0.001 per share (the “Series A-1 Preferred Stock”), at a price per share of $1,000 (the “Preferred Offering”) for an aggregate purchase price of $500,000. The Preferred Offering also relates to the offering of the shares of our common stock (the "Common Stock") issuable upon the conversion of or otherwise pursuant to the terms of the Series A-1 Preferred Stock).
In connection therewith, we filed with the Secretary of State of the State of Delaware the Certificate of Designation of Series A-1 Convertible Preferred Stock, designating 1,000 shares of preferred stock as our Series A-1 Preferred Stock.
Series A-1 Preferred Stock together with the aggregate accrued or accumulated and unpaid dividends thereon, is convertible, at any time at option of the holder, into shares of Common Stock at initial fixed “Conversion Price” of $2.76 per share, subject to customary anti-dilution provisions. Prior thereto, the holders of Series A-1 Preferred Stock are entitled to receive dividends at a rate of 10% per annum, payable in shares of Series A-1 Preferred Stock, if and when declared by the Board of Directors. In addition, to the extent any other dividends or distributions are declared for holders of the common stock, the holders of Series A-1 Preferred Stock have participation rights on an as-converted basis. The holders of Series A-1 Preferred Stock are entitled to vote, together as a single class, on any and all matters presented to our stockholders for their action on an as-converted basis, a number of votes equal to the number of shares of common stock into which the shares of Series A-1 Preferred Stock are convertible under the terms of the Certificate of Designation.
Securities Purchase Agreement for Registered Direct Offering
In June 2025, we entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which we agreed to sell (i) 338,725 shares of common stock at a purchase price of $3.36 per share and (ii) 271,674 pre-funded warrants to purchase common stock at a purchase price of $3.359 per warrant share, in a registered direct offering. In connection therewith, we received net proceeds totaling $1,911,000 after deduction of transaction related expenses. Subsequent thereto and through June 30, 2025, a total of 96,500 the prefunded warrants were exercised at $0.001 per share, resulting in the issuance of 96,500 shares of common stock. Subsequent to June 30, 2025, an aggregate of 112,875 prefunded warrants were exercised resulting in the issuance of an additional 112,875 shares of common stock.
Series A-2 Preferred Stock
In June 2025, we entered into a subscription agreement with certain accredited investors, pursuant to which we sold, in a private placement, 850 shares of Series A-2 Convertible Preferred Stock, par value $0.001 per share, at a price of $1,000 per share, for aggregate gross proceeds of $850,000.
In connection therewith, we filed with the Secretary of State of the State of Delaware the Certificate of Designation of Series A-2
20
Convertible Preferred Stock, designating 1,000 shares of preferred stock as our Series A-2 Preferred Stock.
Series A-2 Preferred Stock, together with the aggregate accrued or accumulated and unpaid dividends thereon, is convertible, at any time at the option of the holder, into shares of Common Stock at an initial fixed “Conversion Price” of $4.49 per share, subject to customary anti-dilution provisions. Prior thereto, the holders of Series A-2 Preferred Stock are entitled to receive dividends at a rate of 10% per annum, payable in shares of Series A-2 Preferred Stock, if and when declared by the Board of Directors. In addition, to the extent any other dividends or distributions are declared for holders of the Common Stock, the holders of Series A-2 Preferred Stock have participation rights on an as-converted basis. The holders of Series A-2 Preferred Stock are entitled to vote, together as a single class, on any and all matters presented to our stockholders for their action on an as-converted basis, a number of votes equal to the number of shares of Common Stock into which the shares of Series A-2 Preferred Stock are convertible under the terms of the Certificate of Designation.
Cash Flows
The following table summarizes our net decrease in cash and cash equivalents for the six months ended June 30, 2025 and 2024:
|
|
For the six months ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
($ in thousands) |
|
|
|
|
|
|
||
Net cash flows from: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(1,473 |
) |
|
$ |
(3,598 |
) |
Financing activities |
|
|
3,261 |
|
|
|
— |
|
Net decrease in cash and cash equivalents |
|
$ |
1,788 |
|
|
$ |
(3,598 |
) |
Net cash flows used in operating activities for the six months ended June 30, 2025 was $1,473, as compared to net cash used in operating activities of $3,598 for the six months ended June 30, 2024. The decrease in net cash used in operating activities was primarily related to reductions in our net loss, offset by an increase in timing of accounts payable and accrued expenses.
The net cash flows from financing activities for the six months ended June 30, 2025 was $3,261 as compared to $0 for the six months ended June 30,2024. The financing activity was directly attributable to proceeds from the issuance of common stock and prefunded warrants, the sale of Series A-1 Preferred Stock, and the sale of Series A-2 Preferred Stock.
Capital Resources
Operating Leases
As of June 30, 2025, we have no lease commitments, other than a short-term lease.
Royalty and License Fees
In June 2022, Solasia Pharma K. K., or Solasia, announced that darinaparsin had been approved for relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the six months ended June 30, 2025 and 2024, the Company earned $2 and $6, respectively, in royalty revenues on net sales under the Solasia License and Collaboration Agreement. During the three months ended June 30, 2024, the Company earned $4, in royalty revenues on net sales under the Solasia License and Collaboration Agreement. No such royalty revenues were earned in the three months ended June 30, 2025.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
As a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act, we are not required to provide the information under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
Our management, with the participation of our principal executive officer and principal accounting officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of June 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods
21
specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our principal executive officer and principal financial officer has concluded that as of June 30, 2025, our disclosure controls and procedures were not effective.
Changes in Internal Controls over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) of the Exchange Act) that occurred during the six months ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
22
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities from time to time. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially affect our business, financial condition, results of operations, cash flows and prospects. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management attention and resources and other factors.
We do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, be reasonably likely to have a material adverse effect on our business, financial condition, results of operations, cash flows or prospects.
Item 1A. Risk Factors
The following important factors could cause our actual business and financial results to differ materially from those contained in forward-looking statements made in this Quarterly Report on Form 10-Q or elsewhere by management from time to time. The risk factors in this Quarterly Report have been revised to incorporate changes to our risk factors from those included in our Annual Report. The risk factors set forth below with an asterisk (*) before the title are new risk factors or ones containing substantive changes from the risk factors previously disclosed in Item 1A of our 2024 Annual Report. The market price of our common stock could decline if one or more of these risks or uncertainties actually occur, causing you to lose all or part of your investment. This situation is changing rapidly and additional impacts may arise. Additional risks that we currently do not know about, or that we currently believe to be immaterial, may also impair our business. Certain statements below are forward-looking statements. See “Special Note Regarding Forward-Looking Statements” in this Quarterly Report.
RISKS RELATED TO OUR BUSINESS
*Changes to United States tariff and import/export regulations may have an adverse effect on our business, financial condition and results of operations.
The United States has enacted and continues to enact significant new tariffs, and President Trump has directed various federal agencies to further evaluate key aspects of U.S. trade policy. There has been and are ongoing discussions and commentaries regarding potential significant changes to U.S. trade policies, treaties and tariffs. There exists significant uncertainty about the future relationship between the U.S. and other countries with respect to such trade policies, treaties and tariffs. These developments, or the perception that any of them could occur, may have a material adverse effect on global and domestic economic conditions, whether or not there will be a recession, and the stability of global and domestic financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the U.S. These actions and policies may adversely affect the ability of the Company to fund our operations, affect our ability to develop products and work with partner companies and generally carry on our respective businesses. Although it is not yet possible to assess their impact, any of these factors could depress economic activity and restrict access to suppliers or customers, hinder our ability to obtain funding from the government through grants and from investors, and have a material adverse effect on our overall business, financial condition and results of operations.
* If Nasdaq does not approve our plan for compliance with Nasdaq List Rule 5550(b)(1) following the April 7, 2025 notice that our stockholders' equity had fallen below the required $2,500,000, we may be delisted from the Nasdaq Capital Market exchange.
On April 7, 2025, the Company received the Notice from the Listing Qualifications staff of Nasdaq notifying us that our stockholders equity as reported in our 2024 10-K, did not satisfy the continued listing requirements under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market (the "Nasdaq SE Rule"), which requires that a listed company’s stockholder equity be at least $2,500,000. In our 2024 10-K, we reported stockholders’ equity of $2,063,000, and, as a result, did not currently satisfy Nasdaq Listing Rule 5550(b)(1). While the Notice has no immediate effect on our Nasdaq listing, in order to regain compliance, we were required to present a our plan within 45 calendar days or by May 22, 2025 to Nasdaq staff and we did so. If our compliance plan is accepted, we may be granted up to 180 calendar days from April 7, 2025, to evidence compliance.
We timely presented a plan for compliance within the requisite 45 days. Even though we did present a compliance plan within the prescribed deadline, Nasdaq staff may find it insufficient to evidence compliance with the Nasdaq SE Rule. If they do not find it sufficient, we may be delisted. If the Nasdaq staff do find our plan to sufficiently demonstrate compliance with the Nasdaq SE Rule, we may be granted up to 180 calendar days to implement the plan and regain compliance. Nasdaq may provide us insufficient time to implement our compliance plan or at the end of the compliance period, we may not be able to demonstrate compliance for any number of reasons. If any of these events occur, we could be delisted.
23
OTHER RISKS RELATED TO OUR COMPANY
*Artificial intelligence used by us and our partners and vendors may have negative effects on our company.
Artificial intelligence ("AI") use in many industries has rapidly expanded. While we do not utilize any specific AI technologies internal to Alaunos, we may work with vendors or service providers that do utilize AI technologies with or without our knowledge. Areas in which our business that could be negatively impacted include novel cybersecurity threats such as malicious code or phishing attempts. AI could also perpetrate fraud or misappropriation of company funds. From a regulatory standpoint, we could be liable for noncompliance related to data compromise or perceived or actual noncompliance with data privacy or protection or AI requirements to various agencies or jurisdictions. There are also potential risks around ethical, social, and reputational risks should AI cause us to infringe on privacy rights or violate intellectual property rights. AI is also known for “deep fakes” or false information being spread electronically and attributed to innocent companies and their management or directors. Such accusations could negatively impact human rights, privacy, employment, or other social concerns, which may result in claims, lawsuits, brand or reputational harm, and increased regulatory scrutiny, any of which could harm our business, financial condition, and operating results. Operational risks potentially caused by AI technologies include unanticipated disruptions to systems, potential loss or corruption of data, implementation delays, and cost overruns that could stem from underlying defects in the AI tools used. Finally, competition risk may result from rapid adoption of AI that could provide unforeseen advantages to our competitors and lead to the erosion of our market share by potentially leading to the emergence of new products and categories, the rapid maturation of categories, cannibalization of categories, changing price points and product replacement and upgrade cycles.
Item 2. Unregistered Sale of Equity Securities and Use of Proceeds
The information set forth below relates to our issuances of securities without registration under the Securities Act of 1933 in reliance on Section 4(a)(2) of the Securities Act, and/or Regulation D promulgated thereunder.
In April 2025, the Company entered into a Subscription Agreement (the “A-1 Agreement”), with an accredited investor, pursuant to which the Company sold 500 shares of Series A-1 Convertible Preferred Stock, par value of $0.001 per share (the “Series A-1 Preferred Stock”), at a price per share of $1,000 (the “Preferred Offering”) for an aggregate purchase price of $500,000. The Preferred Offering also relates to the offering of the shares of the Company's common stock (the "Common Stock") issuable upon the conversion of or otherwise pursuant to the terms of the Series A-1 Preferred Stock.
On April 13, 2025, the Board of Directors of the Company elected to receive compensation in the form of shares of common stock and stock options in lieu of cash for the then outstanding cumulative deferred board service fees for the first quarter of 2025, totaling $139,000. Accordingly, the Company issued 38,269 shares of common stock with an aggregate fair value of $111,750 and granted 10,904 fully vested stock options, with an exercise price of $2.92 per share and an aggregate grant date fair value of $27,250.
In May 2025, the Company entered into an equity purchase agreement with an investor under which the Company has the option to sell up to $25.0 million of common stock over a period of 24 months at 97% of the prior trading day’s VWAP, subject to volume and ownership limitations. In connection with the agreement, the Company issued a warrant to purchase 79,900 shares of common stock at $4.00 per share, with a five-year term.
In June 2025, the Company entered into a subscription agreement with certain accredited investors, pursuant to which the Company sold, in a private placement, 850 shares of Series A-2 Convertible Preferred Stock, par value $0.001 per share, at a price of $1,000 per share, for aggregate gross proceeds of $850,000.
Item 3. Defaults upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
24
Item 6. Exhibits
Exhibit Number
|
Description
|
|
|
3.1 |
|
|
|
3.2 |
|
|
|
3.3 |
|
|
|
3.4 |
|
|
|
31.1+ |
|
|
|
32.1++ |
|
|
|
101.INS+ |
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). |
|
|
101.SCH+ |
Inline XBRL Taxonomy Extension Schema Document |
|
|
104+ |
Cover Page Interactive Data File—the cover page interactive data is embedded within the Inline XBRL document or included within the Exhibit 101 attachments |
|
|
+ |
Filed herewith. |
++ |
This certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
|
|
25
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ALAUNOS THERAPEUTICS, INC.
|
By: |
|
/s/ Holger Weis |
Holger Weis |
Chief Executive Officer |
(On Behalf of the Registrant and as Principal Executive Officer and Principal Financial Officer) Dated: August 14, 2025 |
|
By: |
|
/s/ Ferdinand Groenewald |
Ferdinand Groenewald |
Vice President, Finance |
(Principal Accounting Officer) Dated: August 14, 2025 |
26