Agenus flags going-concern doubt; cash use $87.2M
Agenus projects funding through the third quarter of 2027 without warrant exercises, while disclosing substantial doubt about its ability to continue as a going concern.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Agenus Inc. reported nine-month 2026 revenue of $99.7 million, versus $80.0 million in 2025, and net income of $41.4 million versus $7.5 million. Revenue included $82.7 million of non-cash royalty revenue and $17.0 million of pre-commercial product revenue; net income included a $40.4 million gain on the Zydus asset sale.
Agenus received $91.0 million of consideration under Zydus agreements, subject to adjustments. A July 15, 2026 private placement generated approximately $85.0 million in gross upfront proceeds before expenses; Series A and B warrant exercises could add up to $255.0 million in gross proceeds if exercised in full, at holders' discretion, with no assurance Agenus will receive proceeds. Cash and cash equivalents were $66.9 million at September 30, 2026, excluding $7.6 million held in escrow under the Zydus agreements; nine-month operating cash use was $87.2 million.
Based on its current projections, management expects existing cash and private-placement net proceeds to fund operations and capital expenditures through the third quarter of 2027, assuming no Series A or Series B warrant exercises. It disclosed substantial doubt about Agenus' ability to continue as a going concern for at least one year after the statements are issued, because the timing and completion of financing and strategic transactions are not entirely within its control.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNine-month revenue reached $99.7 million, versus $80.0 million in 2025.
Negative
- Major pointGoing-concern doubt is stated for at least one year after the statements are issued.
- Moderate pointNine-month operating cash use was $87.2 million, versus $60.6 million in 2025.
Filing Explained
Agenus issued 1,626,015 common shares in the closed
Key Figures
Key Terms
non-cash royalty revenue financial
pre-funded warrants financial
going concern financial
two-class method financial
early access programs medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was AGEN's revenue for the first nine months of 2026?
How much additional gross proceeds could AGEN receive from its warrants?
How long does AGEN expect its cash to fund operations?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
For the quarterly period ended
or
For the transition period from to
Commission File Number:
Agenus Inc.
(exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code:
(
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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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Non-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
Number of shares outstanding of the issuer’s Common Stock as of November 3, 2026:
Agenus Inc.
Nine Months Ended September 30, 2026
Table of Contents
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Page |
PART I |
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ITEM 1. |
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Financial Statements: |
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2 |
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Condensed Consolidated Balance Sheets as of September 30, 2026 (Unaudited) and December 31, 2025 |
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2 |
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Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2026 and 2025 (Unaudited) |
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3 |
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Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit for the three and nine months ended September 30, 2026 and 2025 (Unaudited) |
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Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 (Unaudited) |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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ITEM 2. |
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Management's Discussion and Analysis of Financial Condition and Results of Operations |
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ITEM 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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31 |
ITEM 4. |
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Controls and Procedures |
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31 |
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PART II |
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ITEM 1. |
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Legal Proceedings |
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32 |
ITEM 1A. |
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Risk Factors |
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ITEM 5. |
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Other Information |
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ITEM 6. |
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Exhibits |
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33 |
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Signatures |
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
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September 30, 2026 |
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December 31, 2025 |
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ASSETS |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Zydus agreements escrow receivable (Note R) |
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Zydus agreements contract assets (Note R) |
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Accounts receivable |
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Prepaid expenses |
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Related party note receivable from MiNK Therapeutics, Inc. |
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Assets held for sale |
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Other current assets |
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Total current assets |
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Property, plant and equipment, net of accumulated amortization and depreciation of |
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Operating lease right-of-use assets |
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Goodwill |
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Acquired intangible assets, net of accumulated amortization of $ |
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Equity method investment in MiNK Therapeutics, Inc. |
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Due from related party (MiNK Therapeutics, Inc.) |
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Other long-term assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Short-term debt |
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$ |
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$ |
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Current portion, liability related to sale of future royalties and milestones (Note H) |
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Current portion, operating lease liabilities |
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Accounts payable |
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Accrued liabilities |
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Liabilities held for sale |
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Other current liabilities |
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Total current liabilities |
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Long-term debt |
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Liability related to sale of future royalties and milestones, net of current portion (Note H) |
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Deferred revenue |
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Operating lease liabilities, net of current portion |
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Other long-term liabilities |
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Commitments and contingencies |
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STOCKHOLDERS’ DEFICIT |
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Preferred stock, par value $ |
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Series A-1 convertible preferred stock; |
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Common stock, par value $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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Total stockholders’ deficit attributable to Agenus Inc. |
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Non-controlling interest |
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Total stockholders’ deficit |
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Total liabilities and stockholders’ deficit |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
2
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(Unaudited)
(Amounts in thousands, except per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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Pre-commercial product revenue |
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Service revenue |
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Non-cash royalty revenue related to the sale of future royalties (Note H) |
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Total revenues |
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Operating expenses: |
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Cost of revenue |
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Research and development |
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General and administrative |
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( |
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( |
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( |
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Fair value adjustments |
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Total operating expenses |
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( |
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( |
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Operating income (loss) |
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Other income (expense): |
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Non-operating income (expense) |
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( |
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Gain from deconsolidation of MiNK Therapeutics, Inc. |
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MiNK Therapeutics, Inc. equity method investment fair value adjustment |
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Gain on Zydus asset sale |
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Interest expense, net |
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( |
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( |
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( |
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( |
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Net income |
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Dividends on Series A-1 convertible preferred stock |
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( |
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( |
) |
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( |
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( |
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Less: net loss attributable to non-controlling interest |
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( |
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( |
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( |
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( |
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Less: allocation of undistributed earnings to participating securities |
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( |
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( |
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Net income attributable to Agenus Inc. common stockholders |
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$ |
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$ |
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$ |
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$ |
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Per common share data: |
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Net income attributable to Agenus Inc. common stockholders: |
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Basic |
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$ |
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$ |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average number of Agenus Inc. common shares outstanding: |
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Basic |
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Diluted |
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Other comprehensive loss: |
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Foreign currency translation loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive loss |
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( |
) |
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( |
) |
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( |
) |
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( |
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Comprehensive income |
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$ |
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$ |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(Unaudited)
(Amounts in thousands)
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Series A-1 |
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Convertible |
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Preferred Stock |
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Common Stock |
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Treasury Stock |
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Number of |
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Par |
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Number of |
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Par |
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Additional |
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Number |
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Amount |
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Accumulated |
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Non-controlling |
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Accumulated |
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Total |
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Balance at December 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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( |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Share-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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— |
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Shares sold to Zynext Ventures USA LLC, net of issuance costs |
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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 sold at the market |
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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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Payment of CEO payroll in shares |
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— |
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— |
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— |
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— |
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— |
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— |
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Modification of warrants |
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— |
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— |
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— |
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— |
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Issuance of shares for services |
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— |
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— |
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Issuance of shares in connection with debt agreement |
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— |
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— |
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— |
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— |
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Vesting of nonvested shares |
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— |
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— |
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( |
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— |
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— |
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— |
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— |
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Employee share purchases |
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— |
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— |
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— |
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— |
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Issuance of shares for employee salaries |
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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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Retirement of treasury shares related to employee withholding |
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— |
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— |
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( |
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— |
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( |
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— |
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— |
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— |
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— |
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Balance at March 31, 2026 |
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$ |
— |
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$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Shares sold at the market |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Payment of CEO payroll in shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Modification of warrants |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of shares for services |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of shares in connection with debt agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of shares for employee salaries |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Retirement of treasury shares related to employee withholding |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at June 30, 2026 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of common stock, pre-funded warrants, Series A Warrants, and Series B Warrants in connection with Securities Purchase Agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Payment of CEO payroll in shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares for services |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares in connection with debt agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of nonvested shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Employee share purchases |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Exercise of warrants |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares for employee salaries |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Retirement of treasury shares |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at September 30, 2026 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||
See accompanying notes to unaudited condensed consolidated financial statements.
4
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(Unaudited)
(Amounts in thousands)
|
|
Series A-1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
Convertible |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
|
Preferred Stock |
|
|
Common Stock |
|
|
|
|
|
Treasury Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
Number of |
|
|
Par |
|
|
Number of |
|
|
Par |
|
|
Additional |
|
|
Number |
|
|
Amount |
|
|
Accumulated |
|
|
Non-controlling |
|
|
Accumulated |
|
|
Total |
|
|||||||||||
Balance at December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Shares sold at the market |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Payment of CEO payroll in shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of warrants |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of shares for services |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares in connection with debt agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of nonvested shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Exercise of stock options and employee share purchases |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||||
Issuance of shares for employee salaries |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Retirement of treasury shares related to employee withholding |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at March 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Shares sold at the market |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Payment of CEO payroll in shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares for services |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares in connection with debt agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Vesting of nonvested shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of shares for employee salaries |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Retirement of treasury shares |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Shares sold at the market |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Payment of CEO payroll in shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares for services |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Issuance of shares in connection with debt agreement |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Deconsolidation of a subsidiary |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
Vesting of nonvested shares |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Employee share purchases |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Issuance of shares for certain employee bonuses |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Retirement of treasury shares |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Balance at September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||||
See accompanying notes to unaudited condensed consolidated financial statements.
5
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Amounts in thousands)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net income |
|
$ |
|
|
$ |
|
||
Adjustments to reconcile net income to net cash used in operating activities: |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Share-based compensation |
|
|
|
|
|
|
||
Non-cash royalty revenue |
|
|
( |
) |
|
|
( |
) |
Non-cash interest expense |
|
|
|
|
|
|
||
Loss (gain) on sale or disposal of assets, net |
|
|
( |
) |
|
|
|
|
Gain from deconsolidation of MiNK Therapeutics, Inc. |
|
|
|
|
|
( |
) |
|
Unrealized (gain) loss on long-term investments |
|
|
( |
) |
|
|
|
|
Gain on Zydus asset sale |
|
|
( |
) |
|
|
|
|
Other, net |
|
|
|
|
|
( |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
( |
) |
Prepaid expenses |
|
|
( |
) |
|
|
|
|
Accounts payable |
|
|
( |
) |
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
||
Accrued liabilities and other current liabilities |
|
|
|
|
|
|
||
Other operating assets and liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of plant and equipment |
|
|
|
|
|
( |
) |
|
Proceeds from sale of plant and equipment |
|
|
|
|
|
|
||
Proceeds from Zydus asset sale, net |
|
|
|
|
|
|
||
Proceeds from repayment of MiNK related party note |
|
|
|
|
|
|
||
Purchases of short-term investments |
|
|
( |
) |
|
|
— |
|
Proceeds from sale of long-term investment |
|
|
|
|
|
|
||
Net cash provided by investing activities |
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Net proceeds from sale of equity |
|
|
|
|
|
|
||
Net proceeds from equity sold under Zynext SPA, net |
|
|
|
|
|
|
||
Proceeds from Private Placement, net of issuance costs |
|
|
|
|
|
|
||
Proceeds from employee stock purchases and option exercises |
|
|
|
|
|
|
||
Proceeds from warrant exercises |
|
|
|
|
|
|
||
Proceeds from the issuance of long-term debt, net |
|
|
|
|
|
|
||
Impact of cash resulting from deconsolidation of a subsidiary |
|
|
|
|
|
( |
) |
|
Purchase of treasury shares to satisfy tax withholdings |
|
|
( |
) |
|
|
( |
) |
Payment of long-term debt |
|
|
( |
) |
|
|
( |
) |
Payment of finance lease obligation |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Effect of exchange rate changes on cash |
|
|
( |
) |
|
|
|
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
|
|
|
( |
) |
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Supplemental disclosures - non-cash activities: |
|
|
|
|
|
|
||
Insurance financing agreement |
|
$ |
|
|
$ |
|
||
Issuance of stock options for payment of certain employee bonuses |
|
$ |
|
|
$ |
|
||
Issuance of common stock, $ |
|
$ |
|
|
$ |
|
||
Lease right-of-use assets obtained in exchange for new operating lease liabilities |
|
$ |
|
|
$ |
|
||
Lease right-of-use assets obtained in exchange for new finance lease liabilities |
|
$ |
|
|
$ |
|
||
See accompanying notes to unaudited condensed consolidated financial statements.
6
AGENUS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2026
Note A – Business, Liquidity and Basis of Presentation
Business:
Agenus Inc. (including its subsidiaries, collectively referred to as “Agenus,” the “Company,” “we,” “us,” and “our”) is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious disease. Our lead clinical program is botensilimab (“BOT” or “AGEN1181”), alone and in combination with balstilimab (“BAL”). Agenus also maintains an equity investment in MiNK Therapeutics, Inc. ("MiNK") and a majority ownership of a vaccine adjuvant business through our subsidiary SaponiQx, Inc. ("SaponiQx").
Our discovery platforms, antibody programs, STIMULON cpcQS-21 adjuvant platform and the allogeneic invariant natural killer T-Cell pipeline controlled by MiNK are described in Item 2 of this report and in our Annual Report on Form 10-K for the year ended December 31, 2025 (the "2025 Form 10-K"). Following our strategic realignment announced in December 2024, we prioritized the BOT and BAL programs and temporarily paused certain non-core preclinical and clinical activities while we evaluate partnering and targeted funding opportunities.
Liquidity and Going Concern:
We have incurred significant losses since our inception in 1994. As of September 30, 2026, we had an accumulated deficit of $
During the nine months ended September 30, 2026, we materially strengthened our liquidity position. MiNK repaid a $
On July 15, 2026, we closed a private placement (the "Private Placement") with certain institutional and other accredited investors (each, a "Purchaser" and collectively, the "Purchasers"). The Company agreed to issue and sell (i)
As of September 30, 2026, we had cash and cash equivalents of $
Based on our current operating plan and projections, our existing cash and cash equivalents, together with the net proceeds of the Private Placement, are expected to fund our operations and capital expenditure requirements through the third quarter of 2027, assuming no exercise of the Series A or Series B Warrants. These projections reflect anticipated revenues from our early access programs and scheduled debt payments in the look-forward period, the majority of which is secured by certain real estate properties. However, advancing our planned registration and commercialization strategy for BOT and BAL, and funding the company through achievement of profitability, will require additional capital.
We have historically financed our operations through corporate partnerships, advance royalty transactions, and debt and equity financings. We are actively pursuing additional financing and strategic alternatives, including corporate transactions, out-licensing arrangements, asset sales, project financing, additional debt or equity financings, and other strategic transactions, and we are in active discussions with potential strategic and financial partners regarding several of these alternatives. We have also implemented cost management measures to preserve liquidity.
7
Because the timing and completion of these transactions are not entirely within our control, in accordance with applicable accounting standards, substantial doubt exists about our ability to continue as a going concern for at least one year after the date these condensed consolidated financial statements are issued. The consolidated financial statements have been prepared assuming we will continue as a going concern and contemplate the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Basis of Presentation:
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual consolidated financial statements. In the opinion of our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the nine months ended September 30, 2026, are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. For further information, refer to our consolidated financial statements and footnotes thereto included in our 2025 Form 10-K filed with the Securities and Exchange Commission (“SEC”).
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
For our foreign subsidiaries, the local currency is the functional currency. Assets and liabilities of our foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while revenues and expenses are translated into U.S. dollars using average exchange rates during the period. The cumulative translation adjustment resulting from changes in exchange rates is included in the consolidated balance sheets as a component of accumulated other comprehensive loss in total stockholders’ deficit.
Note B – Summary of Significant Accounting Policies
There have been no material changes to our significant accounting policies during the nine months ended September 30, 2026, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Note C – Net Income Per Share
The Company follows the two-class method when computing net income per share as the Company has issued instruments which meet the definition of participating securities. The two-class method determines net income for each class of common shares according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires net income for the period to be allocated between common and participating securities based upon their respective rights to share in undistributed earnings as if all earnings for the period had been distributed.
The following table sets forth the computation of basic and diluted net income per share (in thousands, except for per share data):
8
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Amounts used for basic and diluted per share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income attributable to Agenus Inc. common stockholders |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of Agenus Inc. common shares outstanding - basic |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Effect of potentially dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share based compensation awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of Agenus Inc. common shares outstanding - diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income attributable to Agenus Inc. per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Diluted |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Basic net income per common share is calculated by dividing the net income attributable to common stockholders by the weighted average number of common shares outstanding which includes common shares issuable under our Amended and Restated Directors’ Deferred Compensation Plan, or “DDCP” and the weighted average pre-funded warrants, which were issued in July 2026, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-vested shares |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Series A-1 convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The Company's participating securities are comprised of the Series A and Series B Warrants issued in connection with the Private Placement, which contractually entitle the holders of such securities to participate in dividends but do not contractually require the holders of such securities to participate in losses of the Company. Accordingly, in periods in which the Company reports a net loss, such losses are not allocated to such participating securities.
Note D – Cash Equivalents
Cash equivalents consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||||||||||
|
|
Cost |
|
|
Estimated |
|
|
Cost |
|
|
Estimated |
|
||||
Institutional money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
As a result of the short-term nature of these investments, there were immaterial unrealized holding gains or losses for the three and nine months ended September 30, 2026 and 2025.
As of both September 30, 2026 and December 31, 2025, all of the investments listed above were classified as cash equivalents on our condensed consolidated balance sheets.
9
Note E – Acquired Intangible Assets
Acquired intangible assets consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
|
|
As of September 30, 2026 |
|
|||||||||||
|
|
Amortization |
|
Gross carrying |
|
|
Accumulated |
|
|
Net carrying |
|
|||
Intellectual property |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Trademarks |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Other |
|
|
|
|
|
|
( |
) |
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
As of December 31, 2025 |
|
|||||||||||
|
|
Amortization |
|
Gross carrying |
|
|
Accumulated |
|
|
Net carrying |
|
|||
Intellectual property |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Trademarks |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Other |
|
|
|
|
|
|
( |
) |
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
The weighted average amortization period of our finite-lived intangible assets is
Note F – Investment in MiNK Therapeutics, Inc.
In July 2025, our ownership percentage of MiNK dropped below
All subsequent changes in fair value are reported as part of Non-operating income (expense) in our condensed consolidated statements of operations and comprehensive income. We continue to have involvement with MiNK, including providing services under an Amended and Restated Intercompany Services Agreement, and MiNK has been deemed a related party. Refer to Note P for further detail.
The fair value of our equity investment in MiNK at September 30, 2026 was $
Our investment in MiNK is considered a significant investee as the carrying value of our total investment is greater than
|
|
September 30, 2026 |
|
|
Current assets |
|
$ |
|
|
Non-current assets |
|
|
|
|
Current liabilities |
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||
|
|
2026 |
|
|
2026 |
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to Agenus |
|
|
( |
) |
|
|
( |
) |
10
The summarized amounts presented above are provided solely to satisfy the disclosure requirements applicable to a significant investee. They are not recognized in our results of operations, which reflect the fair value option election described above.
Note G – Debt
Debt obligations consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
Debt instrument |
|
Principal at |
|
|
Unamortized |
|
|
Balance at |
|
|||
Current Portion: |
|
|
|
|
|
|
|
|
|
|||
2015 Subordinated Notes |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Debentures |
|
|
|
|
|
— |
|
|
|
|
||
Other |
|
|
|
|
|
— |
|
|
|
|
||
Long-term Portion: |
|
|
|
|
|
|
|
|
|
|||
Promissory Note |
|
|
|
|
|
( |
) |
|
|
|
||
Total |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Debt instrument |
|
Principal at |
|
|
Unamortized |
|
|
Balance at |
|
|||
Current Portion: |
|
|
|
|
|
|
|
|
|
|||
2015 Subordinated Notes |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
Zydus Promissory Note |
|
|
|
|
|
— |
|
|
|
|
||
Debentures |
|
|
|
|
|
— |
|
|
|
|
||
Promissory Note |
|
|
|
|
|
( |
) |
|
|
|
||
Other |
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
As of September 30, 2026 and December 31, 2025, the principal amount of our outstanding debt balance was $
Zydus Promissory Note
On January 15, 2026, in connection with the closing of the Zydus Asset Purchase Agreement, $
Subordinated Notes
On January 15, 2026, in connection with the closing of the Zydus Asset Purchase Agreement, approximately $
On June 29, 2026, we entered into an Amendment to Notes, Extension of Warrants and Sale of New Warrants with existing noteholders, pursuant to which we:
11
This Amendment was accounted for as a debt modification. As part of the Amendment, we recorded debt discount of approximately $
Promissory Note
On August 12, 2026, the Company, through a subsidiary, amended its promissory note with Ocean 1181 LLC (the "Lender") to extend the maturity date of the outstanding principal balance of $
Note H – Liability Related to the Sale of Future Royalties and Milestones
The following table shows the activity within the liability account in the nine months ended September 30, 2026 (in thousands):
|
|
Period from |
|
|
Liability related to sale of future royalties and milestones - beginning balance |
|
$ |
|
|
Non-cash royalty revenue |
|
|
( |
) |
Non-cash interest expense recognized |
|
|
|
|
Liability related to sale of future royalties and milestones - ending balance |
|
|
|
|
Less: unamortized transaction costs |
|
|
( |
) |
Liability related to sale of future royalties and milestones, net |
|
$ |
|
|
Healthcare Royalty Partners
In January 2018, we, through our wholly-owned subsidiary Antigenics, LLC (“Antigenics”), entered into a Royalty Purchase Agreement (the “HCR Royalty Purchase Agreement”) with Healthcare Royalty Partners III, L.P. and certain of its affiliates (collectively, “HCR”). Pursuant to the terms of the HCR Royalty Purchase Agreement, we sold to HCR
During the nine months ended September 30, 2026, we recognized $
As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future royalty payments to be received by HCR. The sum of these amounts less the $
12
Ligand Pharmaceuticals
In May 2024, we and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the "Ligand Purchase Agreement") with Ligand Pharmaceuticals Incorporated ("Ligand"). Pursuant to the terms of the Ligand Purchase Agreement, Ligand will receive (i)
The total amounts payable to Ligand are subject to a
In consideration for the sale of the Purchased Assets, we received gross proceeds of $
In connection with the sale of the Purchased Assets, we issued to Ligand a warrant (the "Ligand Warrant") to purchase
The $
Liability related to sale of future royalties and milestones |
|
$ |
|
|
Ligand Warrant |
|
|
|
|
Purchaser Upsize Option |
|
|
|
|
Total Ligand Purchase Agreement gross proceeds |
|
$ |
|
As a result of our significant continuing involvement in the generation of the cash flows of the Purchased Assets, we are required to account for $
The Purchaser Upsize Option expired unexercised in 2025.
The Ligand Warrant is considered a freestanding financial instrument that as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement, which was determined to be equity-classified under ASC 815.
To allocate the proceeds, the Purchaser Upsize Option liability and equity-classified Ligand Warrants were recognized based on their fair values and the residual was allocated to a liability related to the sale of future royalties and milestones on our condensed consolidated balance sheets.
During the nine months ended September 30, 2026, we recorded $
As royalties are remitted to us and milestone and sales are earned from the Purchased Assets, the balance of the recorded liability will be effectively repaid over the life of the Ligand Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments that Ligand is entitled to under the Ligand Purchase Agreement. The sum of these amounts less the $
In January 2026, we entered into an amendment and release agreement (the “Amendment Agreement”) with Ligand related to the Ligand Purchase Agreement and Ligand Warrant. The Amendment Agreement provided for a release by Ligand of liens it had on certain of the Company’s assets in exchange for a modification of the exercise price under the Ligand Warrant from $
13
Note I – Accrued Liabilities
Accrued liabilities consisted of the following as of September 30, 2026 and December 31, 2025 (in thousands):
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Payroll |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Contract manufacturing costs |
|
|
|
|
|
|
||
Research services |
|
|
|
|
|
|
||
Accrued rebates |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Note J – Fair Value Measurements
Assets and liabilities measured at fair value are summarized below (in thousands):
Description |
|
September 30, 2026 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Institutional money market funds (Note D) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Certificates of deposit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investment in MiNK Therapeutics, Inc. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Description |
|
December 31, 2025 |
|
|
Quoted Prices in |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents (Note D) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Related party note receivable |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investment in MiNK Therapeutics, Inc. |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
We measured the Related party note receivable at fair value. The fair value of the Note Receivable was determined using a scenario based present value methodology that was derived by evaluating the nature and terms of the Note Receivable and considering the prevailing economic and market conditions at the balance sheet date, some of which are considered Level 2 inputs under the fair value measurements standard. In January 2026, in accordance with the terms of the note agreement, MiNK repaid the full principal and accrued interest balance.
Our long-term equity investment in MiNK is measured at fair value and is calculated using readily determinable pricing available on a securities exchange and is classified as a Level 1 asset.
Other long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.
14
Note K – Revenue from Contracts with Customers
Pre-commercial Product Revenue
During the year ended December 31, 2025, we began recognizing pre-commercial product revenue for BOT plus BAL ("BOT/BAL") provided to patients through regulatory-authorized early access pathways, including France's Autorisation d'Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs") in jurisdictions where permitted.
For the three and nine months ended September 30, 2026, we recognized approximately $
Revenue is recognized as the gross amount invoiced to the customer, less reserves for estimated variable consideration, consisting primarily of government rebates, when the customer (hospital or physician) obtains control of the product at delivery. The estimated variable consideration is fully constrained until the calculations are finalized with the government authority and remitted annually. For the three and nine months ended September 30, 2026, our estimate of rebates reduced reported revenue by approximately $
Zydus License Agreement
In January 2026, we entered into a license agreement (see Note R) with Zydus under which Zydus received an exclusive license to develop, manufacture and commercialize BOT and BAL in India and Sri Lanka in exchange for a royalty on net sales at a rate of
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three and nine months ended September 30, 2026 and 2025, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.
|
|
Three Months Ended September 30, 2026 |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Pre-commercial product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|||
|
|
Three Months Ended September 30, 2025 |
|
|||||||||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
Nine Months Ended September 30, 2026 |
|
|||||||||
|
|
United States |
|
|
Rest of World |
|
|
Total |
|
|||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Pre-commercial product revenue |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|||
|
|
Nine Months Ended September 30, 2025 |
|
|||||||||
Revenue Type |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Other services |
|
|
— |
|
|
|
|
|
|
|
||
Non-cash royalties |
|
|
|
|
|
— |
|
|
|
|
||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
15
Contract Balances
Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. Currently, we do not have any contract assets which have not transferred to a receivable, other than those related to Zydus as described in Note R. We had
The following table provides information about contract liabilities from contracts with customers and accrued rebates (in thousands):
Nine Months Ended September 30, 2026 |
|
Balance at beginning of period |
|
|
Additions |
|
|
Deductions |
|
|
Balance at end of period |
|
||||
Contract liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Pre-commercial product rebates: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Accrued rebates |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
During the nine months ended September 30, 2026, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods.
Note L – Share-based Compensation Plans
In June 2026, our stockholders approved an amendment to our Amended and Restated 2019 Equity Incentive Plan (the "2019 EIP") that increased the maximum number of shares of our common stock available for issuance under our 2019 EIP by
We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors. However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. All stock options have
A summary of option activity for the nine months ended September 30, 2026 is presented below:
|
|
Options |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested or expected to vest at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The weighted average grant-date fair values of stock options granted during the nine months ended September 30, 2026 and 2025 were $
16
On June 16, 2026, our stockholders approved a one-time exchange of options to purchase shares of our common stock issued under our 2019 EIP, the Amended and Restated 2009 Equity Incentive Plan (the “2009 EIP”), and the Company’s 2015 Inducement Equity Plan (the “2015 Plan” and, together with the 2019 EIP and 2009 EIP, the “Equity Plans”) that were held by our executive officers, other employees, consultants, and non-employee directors, for new options to purchase shares of our common stock (the “Option Exchange”). Pursuant to the Option Exchange, eligible options were cancelled in exchange for an equal number of new options to purchase shares of common stock with an exercise price greater than or equal to the fair market value of the Company’s common stock at the time of the Option Exchange and a term of the option that extends ten years from the date of grant. An eligible stock option generally included any outstanding stock option that had an exercise price equal to or greater than $
In August 2026, the Compensation Committee of the Board of the Company approved a special share-based compensation package for our CEO containing stock options to purchase a total of
During the nine months ended September 30, 2026, all options, other than those granted to our CEO described above, were granted with exercise prices equal to the market value of the underlying shares of common stock on the grant date.
As of September 30, 2026, there was approximately $
Certain employees and consultants have been granted non-vested stock. The fair value of non-vested market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.
A summary of non-vested stock activity for the nine months ended September 30, 2026 is presented below:
|
|
Non-vested |
|
|
Weighted |
|
||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Outstanding at September 30, 2026 |
|
|
|
|
$ |
|
||
As of September 30, 2026, there was approximately $
During the nine months ended September 30, 2026,
17
The impact on our results of operations from share-based compensation for the three and nine months ended September 30, 2026 and 2025, was as follows (in thousands):
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note M – Restricted Cash
As of September 30, 2026, and December 31, 2025, we maintained non-current restricted cash of $
The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
|
|
Nine Months Ended September 30, 2026 |
|
|
Nine Months Ended September 30, 2025 |
|
||||||||||
|
|
Beginning of Period |
|
|
End of Period |
|
|
Beginning of Period |
|
|
End of Period |
|
||||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note N – Equity
On March 14, 2024, we filed a Post-Effective Amendment to an Automatic Shelf Registration Statement on Form POSASR (file no. 333-272911) and a Post-Effective Amendments for Registration Statement on Form POS AM (file no. 333-272911) (together, the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time of up to $
During the nine months ended September 30, 2026, we received net proceeds of approximately $
In January 2026, we entered into an amendment and release agreement (the “Amendment Agreement”) with Ligand related to the Ligand Purchase Agreement and Ligand Warrant. The Amendment Agreement provided for a release by Ligand of liens it had on certain of the Company’s assets in exchange for a modification of the exercise price under the Ligand Warrant from $
In connection with the Zydus Asset Purchase Agreement and Securities Purchase Agreement described in Note R, on January 15, 2026, we issued to Zynext Ventures USA LLC
On January 10, 2025, we entered into a payment agreement with Medpace, Inc. ("Medpace"), pursuant to which we agreed with Medpace to certain matters related to payments due to Medpace by us under a master services agreement with Medpace dated June 8, 2022. In connection with the agreements set forth in the payment agreement, we issued to Medpace in a private issuance
18
In connection with a modification of the payment terms as provided for in the payment agreement, on December 29, 2025, we entered into a forbearance agreement with Medpace pursuant to which we agreed, among other things, to register for resale the Medpace Shares. In addition, Medpace agreed to, under certain circumstances if applicable (including the payment in cash by us of amounts due under the payment agreement), return some or all of the Medpace Shares to us. As of and for the year ended December 31, 2025, these shares were deemed to be contingently returnable and as such, the Medpace Shares were not deemed outstanding as of December 31, 2025. In connection with the closing of the Zydus Asset Purchase Agreement in January 2026, we fully settled our obligation to Medpace in cash. As such, Medpace returned all of the
On July 13, 2026, the Company entered into a Securities Purchase Agreement for a private placement with certain institutional and other accredited investors. The closing of the Private Placement occurred on July 15, 2026, subject to the satisfaction of customary closing conditions.
Under the terms of the Purchase Agreement, the Company has sold (i)
The pre-funded warrants have an exercise price of $
The Series A Warrants are exercisable immediately and expire upon the earlier of (i) the fifth anniversary of the closing date of the Private Placement and (ii) the date that is 30 days following the day on which the Company publicly discloses, by press release or Current Report on Form 8-K, that at least
The Series B Warrants are exercisable immediately and expire upon the earliest of (i) the fifth anniversary of the closing date of the Private Placement, (ii) the date that is 30 days following the day on which the Company publicly discloses, by press release or Current Report on Form 8-K, pathologic response data for at least
Exercise of the Series A Warrants and Series B Warrants is at the discretion of the holders. No assurance can be given that any such warrants will be exercised or that the Company will receive any additional proceeds from them. The Series A Warrants and Series B Warrants are equity-classified. No pre-funded warrants, Series A Warrants, or Series B Warrants have been exercised as of September 30, 2026.
Note O – Non-controlling Interest
Non-controlling interest recorded in our condensed consolidated financial statements as of September 30, 2026 and December 31, 2025, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
SaponiQx, Inc. |
|
|
% |
|
|
% |
||
Changes in non-controlling interest for the periods ended September 30, 2026 and December 31, 2025, were as follows (in thousands):
19
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Beginning balance |
|
$ |
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
||
Net loss attributable to non-controlling interest |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Other items: |
|
|
|
|
|
|
||
Deconsolidation of a subsidiary |
|
|
— |
|
|
|
( |
) |
Issuance of subsidiary shares for services |
|
|
— |
|
|
|
|
|
Issuance of subsidiary shares for employee stock purchase plan and exercise of options |
|
|
— |
|
|
|
|
|
Subsidiary share-based compensation |
|
|
|
|
|
|
||
Total other items |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
||
Ending balance |
|
$ |
( |
) |
|
$ |
( |
) |
Deconsolidation of a subsidiary
In 2025, we deconsolidated MiNK and derecognized the associated non-controlling interest balance.
Note P – Related Party Transactions
In September 2021, we entered into an Intellectual Property Assignment and License Agreement with MiNK (the “Assignment and License Agreement”). Pursuant to the Assignment and License Agreement, we assigned to MiNK certain patent rights and know-how related to its iNKT cell platform, product candidates and other patents and know-how related to its business. In addition to the patent rights assigned to MiNK by us, MiNK also received an exclusive, royalty-free, sublicensable license to research, develop, manufacture and commercialize certain licensed technology in the field. The Assignment and License Agreement further provides for MiNK to grant us a field-limited, non-exclusive, royalty-free license under the assigned patent rights, subject to MiNK’s discretion and provided such access would not reasonably result in a disruption of planned MiNK activities. We have also agreed to provide MiNK with our biological material upon written request in order for MiNK to use such material in its development activities of a combination therapy. We may withhold the transfer of biological material, including, but not limited to, checkpoint modulating antibodies, for various reasons, including if such transfer would reasonably result in a disruption of our planned activities. For any materials we do share with MiNK, the parties have agreed to enter into a separate agreement governing the transfer and providing for joint ownership of the data. We have agreed that during the full term of the Assignment and License Agreement, and for
Effective April 1, 2022, we entered into an Amended and Restated Intercompany Services Agreement (the “New Intercompany Agreement”) with MiNK, which amended and restated the Intercompany General & Administrative Agreement between us and MiNK dated September 10, 2021 (the “Prior Intercompany Agreement”). Under the New Intercompany Agreement, we provide MiNK with certain general and administrative support, including, without limitation, financial, facilities management, human resources and information technology administrative support (the “Agenus Services”), and we and MiNK provide each other with certain research and development services (the “R&D Services”) and other support services, including legal and regulatory support (the “Shared Services”). MiNK is required to pay
Allocated Agenus services primarily include payroll related expenses, facility costs, insurance and stock-based compensation, and are included in the accompanying financial statements based on certain estimates and allocations described above.
Allocation of Agenus services, net, of approximately $
20
and comprehensive income and “Due from related party,” of $
On February 12, 2024, we entered into a Convertible Promissory Note Purchase Agreement (the "Purchase Agreement") with MiNK pursuant to which MiNK issued us a convertible promissory note in the principal amount of up to $
The Note carried an annual interest rate of
In June 2024, Dr. Jennifer Buell, CEO of MiNK, was appointed to our Board of Directors. Dr. Buell's spouse is a partner in the law firm of Wolf, Greenfield & Sachs, P.C. (“Wolf Greenfield”), which provides us legal services. For the three and nine months ended September 30, 2026, we expensed Wolf Greenfield fees totaling approximately $
Note Q – Segment Information
We are managed and currently operate as
Our Chief Executive Officer serves as our Chief Operating Decision Maker (“CODM”) and is responsible for reviewing company performance and making decisions regarding resource allocation.
The following table presents selected financial information related to our single reportable segment for the three and nine months ended September 30, 2026 and 2025 (in thousands):
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|
Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenues |
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$ |
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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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|
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|
||||
External expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Payroll related expenses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other operating expenses |
|
|
( |
) |
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|
( |
) |
|
|
( |
) |
|
|
( |
) |
Operating income (loss) |
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( |
) |
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( |
) |
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Other income (expense): |
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||||
Interest expense |
|
|
( |
) |
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|
( |
) |
|
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( |
) |
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|
( |
) |
Interest income |
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Other income (expense) |
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Net income |
|
$ |
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|
$ |
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|
$ |
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$ |
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||||
In the table above, “Other operating expenses” includes items such as depreciation and amortization expense, stock-based compensation expense, certain fair value adjustments and expenses related to certain foreign subsidiaries.
21
Note R – Sale of Manufacturing Facilities to Zydus
On January 15, 2026, we completed the previously announced sale of substantially all of the assets comprising our manufacturing operations (the “Purchased Assets”) to Zydus pursuant to the Asset Purchase Agreement (“Purchase Agreement”) entered into on June 3, 2025.
In connection with the Purchase Agreement, on January 15, 2026, we also entered into the previously announced license agreement with Zydus (the “License Agreement”) under which Zydus received an exclusive license to develop, manufacture and commercialize BOT and BAL in India and Sri Lanka (the “Territory”) in exchange for a royalty on net sales at a rate of
Also in connection with the Purchase Agreement, on January 15, 2026, we completed the previously announced sale of
Because the Purchase Agreement represents the sale of nonfinancial assets to a counterparty that is not a customer, we accounted for the transaction under ASC 610‑20, Other Income—Gains and Losses from the Derecognition of Nonfinancial Assets.
We recognized a $
At closing of the Zydus Agreements, we received total cash consideration of $
Under the Purchase Agreement, we may receive up to $
We recorded a $
During the nine months ended September 30, 2026, we met the conditions for the first payment into escrow of $
We will reassess the estimate of non-cash consideration each reporting period and recognize changes as a change in the gain on sale of non-financial assets during the period in which the change in estimate occurs.
22
Note S – Contingencies
On May 4, 2026, the U.S. Securities and Exchange Commission (the "SEC") informed the Company that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action against the Company. The investigation originated in September 2024, when the Company received a subpoena from the Boston Regional Office of the SEC seeking records relating to certain of its product candidates, correspondence with the FDA, public disclosure, and other matters. The Company produced records pursuant to the subpoena and cooperated with the SEC throughout the investigation.
On March 24, 2026, the U.S. District Court for the District of Massachusetts (the "Court") granted the Company's motion to dismiss the putative securities class action captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, in its entirety, ruling in favor of the Company and the individual defendants, and denied the lead plaintiff's request for leave to amend his complaint. The action was originally filed in September 2024 against the Company and certain of its executives and directors. The amended complaint, filed February 7, 2025 by the court-appointed lead plaintiff, alleged that Agenus, three of its current officers, and one member of its advisory board violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of BOT and BAL. The lead plaintiff sought to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023 and July 17, 2024, and sought damages, interest, and an award of costs, including attorneys' fees.
The lead plaintiff has appealed the Court's order to the U.S. Court of Appeals for the First Circuit in the matter captioned Olsen v. Agenus, Inc., et al., No. 26-01421. In his appeal the lead plaintiff contended that the Court erred as a matter of law in dismissing the claims against the Company and Garo Armen, the Company’s Chairman and Chief Executive Officer. The Company argued that the complaint failed to adequately plead the required elements of the claims and that the dismissal order should be affirmed. Briefing on the appeal concluded in September 2026. Oral argument on the appeal has not yet been scheduled, and a decision remains pending. The Company is unable to estimate a range of loss, if any, that could result from an adverse outcome on appeal.
The Company has also been served with
The Company is not currently a party to any other material legal proceedings. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of business. Regardless of outcome, litigation can have a material adverse effect on the Company because of defense and settlement costs, diversion of management resources, and other factors.
Note T – Recent Accounting Pronouncements
Recently Issued, Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (DISE). This new guidance requires all public entities to incorporate disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. Public entities must adopt ASU 2024-03 prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. We are currently evaluating the impact that ASU 2024-03 will have on our consolidated financial statements.
No other new accounting pronouncement issued or effective during the nine months ended September 30, 2026 had or is expected to have a material impact on our consolidated financial statements or disclosures.
23
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward Looking Statements
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.
Overview
Agenus is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious disease.
Our primary business is immuno-oncology ("I-O"), where we are advancing antibody-based programs to activate innate and adaptive immunity, overcome tumor immune evasion and expand the population of patients who may benefit from immunotherapy. Our lead clinical program is botensilimab ("BOT"), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, alone and in combination with balstilimab ("BAL"), a fully human monoclonal IgG4 anti-PD-1 antibody. BOT is designed to prime and activate T cells, downregulate intratumoral regulatory T cells, activate myeloid cells and induce long-term memory responses, with the goal of extending immunotherapy benefit to “cold” tumors that generally respond poorly to standard of care and to conventional PD-1 and CTLA-4 therapies. BAL is designed to block PD-1 from interacting with PD-L1 and PD-L2. BOT/BAL is investigational and has not been approved by the U.S. Food and Drug Administration (the “FDA”) or authorized for commercial sale in the European Union or any other jurisdiction.
We also maintain select clinical-stage immuno-oncology assets that may be used as standalone agents or as complements to BOT/BAL. Agenus also maintains an equity investment in MiNK Therapeutics, Inc. ("MiNK"), with an approximate fair value of $27.3 million as of September 30, 2026, and a majority ownership of a vaccine adjuvant business through our subsidiary SaponiQx, Inc. ("SaponiQx"). Our common stock is listed on The Nasdaq Capital Market under the symbol "AGEN."
The nine months ended September 30, 2026 included several developments that materially advanced our strategic priorities: the closing of the strategic collaboration with Zydus Lifesciences Ltd. and the Company meeting the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026; the conclusion of the SEC’s investigation as to the Company; the dismissal of the related putative securities class action; continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partner; the announcement of ROBBIN, our planned registrational Phase 3 trial of neoadjuvant BOT/BAL in high-risk Stage II and Stage III MSS colon cancer, together with the discontinuation of our financial support for the CCTG-sponsored BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer and the closing of a private placement providing approximately $85.0 million in upfront gross proceeds, before the deduction of placement expenses, and up to an additional $255.0 million upon the full exercise of the accompanying purchase warrants.
Strategic Prioritization of Neoadjuvant BOT/BAL in Colon Cancer
On July 13, 2026, in connection with the Private Placement, the Company announced that it will conduct, and that the net proceeds of the Private Placement are expected to support, a strategic prioritization of BOT/BAL for the neoadjuvant treatment of
24
microsatellite-stable (“MSS”) colon cancer, including the advancement of ROBBIN. High-risk Stage II and Stage III MSS colon cancer affects an estimated 38,000 patients annually in the United States and more than 200,000 patients worldwide, representing an estimated U.S. addressable annual sales opportunity of more than $7 billion, with no new curative-intent therapies approved in more than 20 years. The addressable opportunity is a Company estimate based on third-party epidemiology data and internal assumptions regarding pricing and market penetration, and actual results may differ materially.
ROBBIN is a planned global randomized Phase 3 trial evaluating neoadjuvant BOT/BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial is expected to enroll approximately 850 patients, randomized 1:1, with event free survival (“EFS”) as its primary endpoint. Following interactions with the FDA, key elements of the proposed ROBBIN Phase 3 trial design, including patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan, have been informed by FDA feedback.
Anticipated ROBBIN milestones are as follows:
The clinical rationale for ROBBIN is derived from NEST and UNICORN, two independent investigator-sponsored Phase 2 studies evaluating neoadjuvant BOT/BAL in MSS colorectal cancer. Across those studies, BOT/BAL produced pathologic response in approximately 60% to 70% of patients, major pathologic response in approximately 35% to 40% of patients, and pathologic complete response in approximately 30% of patients. Deep pathologic responses in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer. At median follow-up of approximately 23.5 months for NEST 1, 32.2 months for NEST 2 and 19.2 months for UNICORN MSS cohort, all treated patients remained disease free, and circulating tumor DNA clearance was observed during treatment. NEST and UNICORN were small studies. Neither included a comparison arm, and neither was designed to determine whether BOT/BAL reduces the risk of recurrence. The Phase 3 ROBBIN study is designed to evaluate whether neoadjuvant BOT/BAL improves event free survival compared with standard of care alone. Results from NEST and UNICORN were published in Clinical Cancer Research and Nature Medicine, respectively.
The Company’s neoadjuvant development strategy is also informed by investigator-sponsored studies evaluating BOT/BAL in additional colon cancer populations. NEOASIS contributes to the broader clinical rationale for evaluating short-course BOT/BAL before surgery, although its dMMR colon cancer cohort is biologically distinct from the MSS population planned for ROBBIN.
On October 25, 2026, the Company announced results presented at the European Society for Medical Oncology (“ESMO”) Congress 2026 from the mismatch repair-deficient (“dMMR”) colon cancer cohort of NEOASIS, an investigator-initiated, single-center Phase 2 study sponsored by the Netherlands Cancer Institute. Among 18 patients with locally advanced, non-metastatic, resectable disease, six weeks of neoadjuvant BOT/BAL resulted in an 83% major pathologic response rate, meeting the cohort’s primary endpoint, and a 72% pathologic complete response rate. All patients underwent surgery. Immune-related adverse events were predominantly Grade 1 or 2, with one Grade 3 colitis event that resolved with treatment. One patient underwent surgery earlier than planned because of ileus. At a median follow-up of 15 months, all patients were alive and 16 of 18 remained free of recurrence. These findings are preliminary and relate to a biologically distinct population from the MSS population planned for ROBBIN.
In connection with this prioritization, Agenus discontinued financial support for the BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer, after which CCTG formally terminated the study.
Clinical Data
At the European Society for Medical Oncology Gastrointestinal Cancers Congress in July 2026, follow-up from the fully enrolled 123-patient Phase 1b cohort in refractory MSS metastatic colorectal cancer without active liver metastases showed median overall survival of 21.2 months and three-year overall survival of 33%. Median duration of response was not reached, and 17% of patients were alive and off all systemic cancer therapy at last follow-up. Extended follow-up identified no new safety signals and no treatment-related deaths. Treatment-related immune-mediated diarrhea or colitis, the most common immune-mediated adverse event, resolved in 98% of affected patients. Data reported during the quarter also showed activity in checkpoint-refractory melanoma and in hepatocellular carcinoma following prior immunotherapy.
In our randomized Phase 2 trial reported at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2025, the BOT 75 mg plus BAL regimen achieved a 19% objective response rate and a 55% disease control rate in heavily pretreated patients with refractory MSS metastatic colorectal cancer without active liver metastases, with no objective responses observed in the control arm. Pan-tumor data from more than 400 heavily pretreated patients in the Phase 1b C-800-01 study, presented
25
in October 2025, showed approximately 39% two-year overall survival and median overall survival of 17.2 months across multiple tumor types.
Sarcoma data published in the Journal of Clinical Oncology in January 2025 showed a 19.2% objective response rate among 52 efficacy-evaluable patients, including 27.8% among 18 patients with angiosarcoma, and median duration of response of 21.7 months in the overall efficacy-evaluable population.
Updated results from the ovarian cancer cohort of the Phase 1b C-800-01 study, presented at the International Gynecologic Cancer Society Annual Global Meeting in October 2026, showed estimated three-year overall survival of 48% among 35 efficacy-evaluable patients, unchanged from the two-year estimate. The objective response rate was 23%, and median overall survival was 14.8 months. Patients had received a median of four prior lines of therapy, and approximately three-quarters had platinum-resistant or refractory disease. At last follow-up, 11 of all 44 treated patients (25%) were alive and off all therapy. No new safety signals or treatment-related deaths were reported.
BOT, in combination with BAL, has been evaluated in approximately 1,500 patients across more than 60 centers worldwide and across nine tumor types, including colorectal cancer, sarcoma, non-small cell lung cancer, hepatocellular cancer, pancreatic cancer, melanoma, ovarian cancer and triple-negative breast cancer.
Patient Access Programs
In France, BOT/BAL is available under the national Autorisation d'Accès Compassionnel ("AAC") framework for eligible patients in MSS metastatic colorectal cancer without active liver metastases (added September 2025), platinum-resistant or platinum-refractory ovarian cancer (added January 2026), and certain advanced soft-tissue sarcomas (added January 2026). Treatment under the AAC framework is reimbursed through the French national health system. Outside France, BOT/BAL may be available in select countries through paid named-patient programs initiated by treating physicians and governed by local regulations and national reimbursement or coverage frameworks. In April 2026, we named BAP Pharma as our global distribution partner to support BOT/BAL access programs end-to-end, including request coordination, regulatory navigation, distribution logistics and payment processing. These programs are physician-driven and are not promotional. They do not constitute marketing approval, may be modified or discontinued by applicable authorities, and do not assure future regulatory approvals.
Zydus Collaboration
In January 2026, we closed the strategic collaboration with Zydus Lifesciences Ltd. ("Zydus"), under which we sold our Emeryville and Berkeley biologics manufacturing facilities and received $91.0 million in cash consideration at closing, subject to certain adjustments, comprising $75.0 million for the facilities and a $16.0 million equity investment in Agenus common stock. The collaboration also includes an exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories, and provides for up to $50.0 million in additional contingent payments tied to BOT and BAL production orders restricted to services provided to us by Zydus. In March 2026, the conditions for the first payment into escrow of $20.0 million (only for use in making payments to Zydus), reflecting the total value of the first tranche of clinical supply expected to be delivered by Zydus in 2026, were met based on contracted work orders for BOT/BAL chemistry, manufacturing and controls and production activities. The Zydus collaboration secures dedicated, long-term U.S. biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply. See Note R to our Condensed Consolidated Financial Statements for additional information.
Legal Proceedings
On May 4, 2026, the U.S. Securities and Exchange Commission informed the Company that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action against the Company. On March 24, 2026, the U.S. District Court for the District of Massachusetts granted the Company's motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has appealed to the U.S. Court of Appeals for the First Circuit, and briefing in the appeal commenced in June 2026 and concluded in September 2026. See Note S to our Condensed Consolidated Financial Statements and Part II, Item 1 (Legal Proceedings) for additional information.
Our strategy is to focus capital on execution of programs that we believe have the clearest path to meaningful clinical and commercial value, led by BOT/BAL in colorectal and colon cancer and selected other tumor types. We maintain manufacturing flexibility through strategic collaborations, with an emphasis on our Zydus collaboration. Our internal discovery and translational platforms support target identification, antibody generation, biomarker analysis and candidate selection, and have supported development of agents directed to CTLA-4, PD-1, CD137, CD73/TGF-beta, ILT2, LAG-3, TIM-3 and TIGIT, all of which remain proprietary assets of Agenus.
26
Historical Results of Operations
Three months ended September 30, 2026 compared to the three months ended September 30, 2025
Pre-commercial product revenue
We recognized pre-commercial product revenue of approximately $6.1 million during the three months ended September 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s Authorisation d’Accès Compassionnel ("AAC") framework and paid named patient programs ("NPPs"), where permitted.
Non-cash royalty revenue related to the sale of future royalties
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK decreased $3.7 million, to approximately $25.4 million for the three months ended September 30, 2026, from $29.1 million for the three months ended September 30, 2025, due to decreased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 51% to $11.6 million for the three months ended September 30, 2026 from $23.6 million for the three months ended September 30, 2025. The decreased expenses in the three months ended September 30, 2026 primarily relate to a $4.7 million decrease in professional service fees, mainly due to a decrease in external legal expenses, a $3.6 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $3.3 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $0.2 million decrease in expenses attributable to the activities of our subsidiaries.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 22% to $8.4 million for the three months ended September 30, 2026 from $10.9 million for the three months ended September 30, 2025. The decreased expenses in the three months ended September 30, 2026 primarily relate to a $0.7 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026 partially offset by an increase in share-based compensation expense, a $1.9 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026,partially offset by a $0.2 million increase in professional fees, mainly due to an increase in external legal expenses.
MiNK Therapeutics, Inc. equity method investment fair value adjustment
The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $1.9 million for the three months ended September 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.
Interest expense, net
Interest expense, net increased to approximately $14.5 million for the three months ended September 30, 2026 from $13.2 million for the three months ended September 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.
Nine months ended September 30, 2026 compared to the nine months ended September 30, 2025
Pre-commercial product revenue
27
We recognized pre-commercial product revenue of approximately $17.0 million during the nine months ended September 30, 2026, representing sales of BOT/BAL provided to patients through regulatory-authorized early access pathways under both France’s AAC framework and NPPs, where permitted.
Non-cash royalty revenue related to the sale of future royalties
In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note H to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $5.2 million, to approximately $82.7 million for the nine months ended September 30, 2026, from $77.5 million for the nine months ended September 30, 2025, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 47% to $38.2 million for the nine months ended September 30, 2026 from $71.8 million for the nine months ended September 30, 2025. The decreased expenses in the nine months ended September 30, 2026 primarily relate to a $6.6 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs and clinical trials, a $11.5 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026, a $8.9 million decrease in other research and development expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $6.6 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 44% to $23.8 million for the nine months ended September 30, 2026 from $42.1 million for the nine months ended September 30, 2025. The decreased expenses in the nine months ended September 30, 2026 primarily relate to a $5.0 million decrease in personnel related expenses, substantially due to a decrease in headcount due to the sale of our manufacturing operations to Zydus in January 2026 and a decrease in share-based compensation expense, a $3.1 million decrease in professional fees, mainly due to a decrease in external legal expenses, a $5.4 million decrease other general and administrative expenses, primarily attributable to a decrease in facility and depreciation expense due to the sale of our manufacturing operations to Zydus in January 2026, and a $4.8 million decrease in expenses attributable to the activities of our subsidiaries, which decrease is partially attributable to the deconsolidation of MiNK.
MiNK Therapeutics, Inc. equity method investment fair value adjustment
The MiNK Therapeutics, Inc. equity method investment fair value adjustment of $3.0 million for the nine months ended September 30, 2026, represents the fair value adjustment for our remaining investment in MiNK, for which we have elected the fair value option. The fair value of our equity investment is based on readily determinable pricing available on a securities exchange.
Gain on Zydus asset sale
The $40.4 million gain recognized at the closing of the Zydus transactions in January 2026 represents the total gain recognized from the Zydus Asset Purchase Agreement and Securities Purchase Agreement. This gain is not expected to recur. Refer to Note R to our Condensed Consolidated Financial Statements for additional detail.
Interest expense, net
Interest expense, net increased to approximately $44.4 million for the nine months ended September 30, 2026 from $39.3 million for the nine months ended September 30, 2025, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR, primarily attributable to increased sales forecasts of GSK’s vaccines containing our STIMULON QS-21 adjuvant and an increase of the non-cash interest expense recorded in connection with our Ligand Purchase Agreement.
28
Research and Development Programs
For the nine months ended September 30, 2026, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
|
|
|
|
Nine Months Ended September 30, |
|
|
Year Ended December 31, |
|
||||||||||
Research and |
Product |
2026 |
|
|
2025 |
|
|
2024 |
|
|
2023 |
|
||||||
Antibody programs |
|
Various |
|
$ |
21,862 |
|
|
$ |
55,493 |
|
|
$ |
113,135 |
|
|
$ |
178,445 |
|
Vaccine adjuvant |
|
STIMULON cpcQS-21 |
|
|
213 |
|
|
|
1,638 |
|
|
|
1,844 |
|
|
|
10,296 |
|
Cell therapies |
|
Various |
|
|
— |
|
|
|
3,282 |
|
|
|
7,558 |
|
|
|
16,283 |
|
Other research and development programs |
|
Various |
|
|
16,152 |
|
|
|
18,925 |
|
|
|
32,991 |
|
|
|
29,545 |
|
Total research and development expenses |
|
|
|
$ |
38,227 |
|
|
$ |
79,338 |
|
|
$ |
155,528 |
|
|
$ |
234,569 |
|
Research and development program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions and our review of the status of each program. Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations, and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients, and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.
Liquidity and Capital Resources
We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of September 30, 2026. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through September 30, 2026, we have raised aggregate net proceeds of approximately $2.2 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.
Cash Position and Outstanding Debt
We had cash and cash equivalents of $66.9 million as of September 30, 2026, compared with $3.0 million as of December 31, 2025. That balance excludes the $7.6 million held in escrow under the Zydus agreements, including $0.1 million of accrued interest, and does not include outstanding receivables under our early access programs, of which we have received $5.9 million during the third quarter of 2026 and we expect to receive the remaining balance, net of accrued rebates, of $11.8 million in future periods. As of September 30, 2026, we had debt outstanding of $30.2 million in principal, of which $24.8 million is due November 2029 and $5.1 million is due January 2027. See Note G.
Sources of Capital
During the nine months ended September 30, 2026, MiNK repaid a $5.2 million related-party note receivable, and we closed agreements with Zydus under which we received $91.0 million of consideration, subject to adjustments for reimbursable expenses, other required closing payments, including approximately $5.8 million of transaction expenses, and $7.5 million placed into a twelve-month escrow. See Note R.
We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 20.6 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. as our sales agent. We sold approximately 3.9
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million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2026 and received aggregate net proceeds totaling $15.1 million.
The Private Placement closed on July 15, 2026 and provided approximately $85.0 million in upfront gross proceeds, before deducting Private Placement expenses. The accompanying Series A Warrants and Series B Warrants, if exercised in full, would provide up to an additional $255.0 million in gross proceeds. The Series A Warrants expire upon the earlier of the fifth anniversary of the closing date and 30 days following the Company’s public disclosure that at least 60 patients have been dosed in ROBBIN. The Series B Warrants expire upon the earliest of the fifth anniversary of the closing date, 30 days following the Company’s public disclosure of pathologic response data for at least 50 patients dosed in ROBBIN, and, unless the holder has by that time exercised its Series A Warrant in full, immediately following the expiration date of the Series A Warrants. Exercise of the warrants is at the discretion of the holders, and no assurance can be given that the Company will receive any additional warrant proceeds. See Note N.
Funding Outlook and Going Concern
Based on our current operating plan and projections, including scheduled debt payments in the look-forward period (the majority of which is secured by certain real estate properties), we believe our existing cash and cash equivalents, which include the net proceeds from the Private Placement, are expected to fund operations and capital expenditure requirements through the third quarter of 2027, assuming no exercise of the Series A or Series B Warrants. These projections reflect anticipated revenues from our early access programs and scheduled debt payments in the look-forward period. If all such warrants are exercised for cash, the Company expects these resources to fund operations through year-end 2031. Advancing our planned registration and commercialization strategy for BOT/BAL, and funding the Company through achievement of profitability, will require additional capital.
We are actively pursuing additional financing and strategic alternatives, including corporate transactions, out-licensing arrangements, asset sales, project financing, additional debt or equity financings, and other strategic transactions, and we are in active discussions with potential strategic and financial partners regarding several of these alternatives. We have also implemented cost management measures to preserve liquidity.
Because the timing and completion of these transactions are not entirely within our control, in accordance with applicable accounting standards, substantial doubt exists about our ability to continue as a going concern for at least one year after the filing date of this Quarterly Report on Form 10-Q. The consolidated financial statements have been prepared assuming we will continue as a going concern and contemplate the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. We have also implemented cost management measures to preserve liquidity.
Contractual Commitments
Our operating expenses for the nine months ended September 30, 2026, include cash and non-cash expenses. Non-cash expenses for the period include share-based compensation expense, depreciation and amortization expense and certain other non-cash items. Operating expenses in the nine months ended September 30, 2026 also included expenses associated with our manufacturing facilities in the period before the facilities were sold to Zydus and costs incurred for services provided by Zydus that will be settled through the first contingent payment under the Zydus Purchase Agreement.
Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $690.7 million over the term of the related activities. Through September 30, 2026, we have expensed $635.8 million as research and development expenses and $609.7 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs, including ROBBIN.
Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.
Cash Flows
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Net cash used in operating activities for the nine months ended September 30, 2026 and 2025 was $87.2 million and $60.6 million, respectively. Net cash used in operating activities increased principally because of working-capital changes, including a $36.3 million reduction in accounts payable and a $15.2 million increase in accounts receivable, including receivables associated with our early access programs. These outflows more than offset the benefit of the reduced operating-expense base during the period.
Net cash provided by investing activities for the nine months ended September 30, 2026 was $49.3 million, driven principally by $63.9 million of net proceeds from the Zydus asset sale and $5.0 million from the repayment of the MiNK related party note, partially offset by $20.0 million in purchases of short-term investments.
Net cash provided by financing activities for the nine months ended September 30, 2026 was $101.3 million, consisting principally of $84.8 million of net proceeds from the Private Placement, $15.1 million of net proceeds from at-the-market sales of common stock, $6.4 million of net proceeds from the sale of common stock under the Zynext SPA, and $3.4 million of proceeds from employee stock purchases and option exercises, partially offset by $8.4 million of debt repayment.
Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2025 Form 10-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required for smaller reporting companies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act. Based on this evaluation, our Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective at a level that provides reasonable assurance. Our disclosure controls and procedures are designed to ensure that information we are required to disclose in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Any system of controls is designed to provide reasonable, but not absolute, assurance that the system will achieve its stated goals under all reasonably foreseeable circumstances.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
On March 24, 2026, the U.S. District Court for the District of Massachusetts (the "Court") granted the Company's motion to dismiss the putative securities class action captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, in its entirety, ruling in favor of the Company and the individual defendants, and denied the lead plaintiff's request for leave to amend his complaint. The action was originally filed in September 2024 against the Company and certain of its executives and directors. The amended complaint, filed February 7, 2025 by the court-appointed lead plaintiff, alleged that Agenus, three of its current officers, and one member of its advisory board violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to the efficacy and commercial prospects of BOT and BAL. The lead plaintiff sought to represent all persons who purchased or otherwise acquired Agenus securities between January 23, 2023 and July 17, 2024, and sought damages, interest, and an award of costs, including attorneys' fees.
The lead plaintiff has appealed the Court's order to the U.S. Court of Appeals for the First Circuit in the matter captioned Olsen v. Agenus, Inc., et al., No. 26-01421. In his appeal, the lead plaintiff contended that the Court erred as a matter of law in dismissing the claims against the Company and Garo Armen. The Company argued that the complaint failed to adequately plead the required elements of the claims and that the dismissal order should be affirmed. Briefing on the appeal concluded in September 2026. Oral argument on the appeal has not yet been scheduled, and a decision remains pending.
The Company has also been served with four derivative actions filed in the Court between November 2024 and January 2025 by purported stockholders. These actions name certain of the Company's executives and directors and allege that defendants made false or misleading statements and omissions of material fact related to the efficacy and commercial prospects of BOT and BAL. Plaintiffs seek an award of damages and an order directing the Company to reform and improve its corporate governance and internal procedures. On May 2, 2025, the Court consolidated the four actions in Case No. 1:24-cv-12823 and stayed all deadlines pending future developments in the securities class action. The Company is unable to estimate a range of loss, if any, that could result from an adverse outcome in these consolidated actions.
The Company is not currently a party to any other material legal proceedings. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of business. Regardless of outcome, litigation can have a material adverse effect on the Company because of defense and settlement costs, diversion of management resources, and other factors.
Item 1A. Risk Factors
Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes to the risk factors described in Part I, Item 1A "Risk Factors" of our 2025 Form 10-K.
Item 5. Other Information
Trading Plans of Our Directors and Officers
During the quarter ended September 30, 2026, none of our directors or "officers" (as defined in Rule 16a-1(f) under the Exchange Act)
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Item 6. Exhibits
Exhibit No. |
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Description |
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4.1 |
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Form of 2026 D Warrant, Filed as Exhibit 4.1 to our Current Report on Form 8-K (File No. 000-29089) filed on July 6, 2026 and incorporated herein by reference |
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4.1(1) |
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Amendment to Notes, Extension of Warrants and Sale of New Warrants, dated June 29, 2026, by and among Agenus Inc., Alice Saraydarian, Khalil Barrage and Nicky V LLC, including the Irrevocable Escrow Direction Letter dated June 29, 2026 and the Form of 2026 D Warrant attached as Exhibit I thereto |
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4.2 |
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Form of Pre-Funded Warrant, Filed as Exhibit 4.1 to our Current Report on form 8-K (File No. 000-29089) filed on July 13, 2026 and incorporated herein by reference. |
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4.3 |
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Form of Series A Warrant, Filed as Exhibit 4.2 to our Current Report on form 8-K (File No. 000-29089) filed on July 13, 2026 and incorporated herein by reference. |
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4.4 |
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Form of Series B Warrant, Filed as Exhibit 4.3 to our Current Report on form 8-K (File No. 000-29089) filed on July 13, 2026 and incorporated herein by reference. |
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10.1 |
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Form of Securities Purchase Agreement, Filed as Exhibit 10.1 to our Current Report on form 8-K (File No. 000-29089) filed on July 13, 2026 and incorporated herein by reference. |
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10.2 |
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Form of Registration Rights Agreement, Filed as Exhibit 10.2 to our Current Report on form 8-K (File No. 000-29089) filed on July 13, 2026 and incorporated herein by reference. |
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31.1 |
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Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith. |
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32.1* |
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Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Submitted herewith. |
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101.INS |
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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) |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101) |
* Furnished herewith.
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AGENUS INC.
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.
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November 5, 2026 |
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AGENUS INC. |
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/s/ GARO H. ARMEN, PH.D. |
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Garo H. Armen, Ph.D. Chairman and Chief Executive Officer (Principal Executive and Financial Officer) |
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