8-K
AGENUS INC (AGEN)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported): May 12, 2025 |
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AGENUS INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 000-29089 | 06-1562417 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 3 Forbes Road | ||
| Lexington, Massachusetts | 02421 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: 781 674-4400 | ||
| --- |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.01 par value per share | AGEN | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 12, 2025, Agenus Inc. announced its financial results for the quarter ended March 31, 2025. In connection with the announcement, the Company issued a press release, which is being furnished as Exhibit 99.1 to this current report on Form 8-K.
The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit
The following exhibit is furnished herewith:
99.1 [Press Release dated May 12, 2025](agen-ex99_1.htm)
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 hereunto duly authorized.
| Date: | May 12, 2025 | By: | /s/ Christine M. Klaskin |
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| Christine M. Klaskin, VP Finance |
EX-99.1
Exhibit 99.1
Agenus Reports Q1 2025 Financial Results and Key Business Updates
- BOT/BAL Achieves Breakthrough Response Rates in MSS Cancers — Oral AACR Data Spotlight Pan-Tumor Neoadjuvant Success
- Seasoned Leader Onboard to Accelerate BOT/BAL Toward Registration Milestones
- Near-Term Capital Transaction Poised to Bolster Liquidity
May 12, 2025
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (“Agenus” or the “Company”) (NASDAQ: AGEN), a leader in immuno-oncology, today reported financial and operational results for the first quarter of 2025, and shared key clinical and strategic milestones supporting the advancement of its botensilimab (BOT) and balstilimab (BAL) program.
“The growing strength of our BOT/BAL data across multiple hard-to-treat cancers reinforces our conviction in its transformative potential and fuels our unwavering commitment to delivering this combination to patients.” said, Garo Armen, Ph.D., Chairman and CEO of Agenus. “With expanded datasets, key leadership appointments, and the FDA’s renewed focus on accelerating cures and meaningful treatments, Agenus is entering a pivotal phase—advancing toward regulatory engagement with financial discipline and a sharp focus on bringing innovative immunotherapies to individuals living with cancer.”
Key Highlights from Q1 2025
New Data:
- BOT/BAL continues to demonstrate robust and durable responses across microsatellite stable (MSS) “cold tumors” where current immuno-oncology treatments have historically failed. At American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, new data highlighted the activity and safety profile in both multiple mismatch repair–proficient (pMMR/MSS) and mismatch repair–deficient (dMMR/MSI-H) solid tumors in neoadjuvant and later line treatment settings.
- Notably, new data from the investigator-sponsored pan-cancer NEOASIS study--a now the third clinical study evaluating BOT/BAL in the neoadjuvant setting--were presented. These initial results from the safety run-in portion indicate that BOT/BAL can induce pathological responses in patients with solid tumors beyond CRC, including TNBC and sarcomas. No dose-limiting toxicities were observed, and all patients proceeded to their scheduled surgery.
Exhibit 99.1
- 100 percent of dMMR CRC patients given a higher dose of BOT/BAL achieved pCR.
- New data from the HCC cohort of the ongoing Phase 1 study were also presented. The HCC cohort comprised of patients with difficult-to-treat disease who had progressed following standard treatments, including approved immunotherapies. The durable responses and disease control in heavily pretreated HCC patients highlight the strength and differentiation of the BOT/BAL combination.
- data on late stage pan tumor activity to be presented at an upcoming kay cancer conference.
New Leadership:
- Dr. Richard Goldberg, an internationally recognized leader in GI cancer treatment and research, stepped out of early retirement to join Agenus as Chief Development Officer to support the advancement of BOT/BAL for patients. Dr. Goldberg will lead the company’s efforts as it prepares to re-engage global regulatory authorities with expanded data and longer-term follow-up in metastatic CRC.
New Efficiencies:
- Agenus is on track to reduce its annualized operating cash burn below $50 million starting in the second half of 2025, supported by recent cost optimization measures enabling the company to direct resources toward ensuring the potential of BOT/BAL is realized. The company is in final stages of an important collaboration which will result in substantial cash infusion.
Q1 2025 Financial Highlights
Agenus ended the first quarter 2025 with a consolidated cash balance of $18.5 million compared to $40.4 million on December 31, 2024. Cash used in operations for the first quarter ended March 31, 2025 was $25.6 million, reduced from $38.2 million for same period in 2024.
For the first quarter ended March 31, 2025, Agenus recognized revenue of $24.1 million and incurred a net loss of $26.4 million, or $1.03 per share. For the first quarter ended March 31, 2024, Agenus recognized revenue of $28.0 million and incurred a net loss of $63.5 million or $3.04 per share. Revenue primarily includes non-cash royalty revenue.
| Financial Highlights | ||
|---|---|---|
| (in thousands, except per share data) | ||
| (unaudited) | ||
| Cash and cash equivalents | ||
| March 31, 2025 | 18,488 | |
| December 31, 2024 | 40,437 | |
| Key Financial Metrics | Q1 2024 | |
| Cash used in operations | $ 38,191 | |
| Revenue, including non-cash royalties | 28,005 | |
| Net loss | 63,454 | |
| Non-cash expenses included in net loss | 38,255 |
All values are in US Dollars.
Exhibit 99.1
| Net loss per share attributable to Agenus Inc. common stockholders | 1.03 | 3.04 |
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Conference Call
Date: Monday, May 12th, at 8:30 a.m. ET To access dial-in numbers, please register here. Conference ID: 73242
Webcast
A live webcast and replay of the conference call will be accessible on the company’s website at https://investor.agenusbio.com/events-and-presentations.
About Botensilimab (BOT)
Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio.
Exhibit 99.1
Information that may be important to investors will be routinely posted on our website and social media channels.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Investors 917-362-1370 investor@agenusbio.com
Media 781-674-4422
communications@agenusbio.com
Source: Agenus Inc.