Form 8-K - Current report

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, 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): December 05, 2024

 

 

AGENUS INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			000-29089	06-1562417
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer 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 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. ☐

 

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Item 2.05 Costs Associated with Exit or Disposal Activities.

On December 5, 2024, Agenus Inc. ("Agenus" or the "Company") announced further detail of its strategic realignment to streamline its operations, strengthen its financial position, and focus on advancing its most advanced programs, botensilimab and balstilimab, in preparation of 2025. As part of this effort, Agenus (excluding its independently operating subsidiaries) will be reducing its annual expenditures by 60% targeting a cash burn of $100 million for 2025 through decreased reliance on consultants and vendors while also reducing its workforce. Costs associated with the workforce reduction are primarily severance payments and are estimated at approximately $1.1 million. The Company expects to recognize substantially all charges related to the workforce reduction in the quarter ending March 31, 2025. These estimates are subject to assumptions and actual results may differ.

 

In connection with the announcement, the Company issued a press release, which is being included as Exhibit 99.1 to this current report on Form 8- K.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibit

 

The following exhibit is furnished herewith:

 

99.1 Press Release dated December 5, 2024

 

 

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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:	December 5, 2024	By:	/s/ Christine M. Klaskin
			Christine M. Klaskin, VP Finance

 

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Exhibit 99.1

 

 

Agenus Announces Strategic Realignment to Focus on Core Programs and Significantly Reduce Costs

LEXINGTON, Mass. – December 5, 2024 – Agenus Inc., a leader in immuno-oncology, today announced further details of its strategic realignment aimed at streamlining operations, strengthening its financial position, and prioritizing the advancement of its most impactful programs as it prepares for 2025. Reductions are designed to reduce cash burn to $100 million in FY 2025. This initiative follows the successful closing of a $22 million mortgage secured by key real estate assets, providing the company with enhanced operational flexibility during this pivotal period.

Key Measures Include:

•

Focusing on BOT/BAL: Agenus will concentrate its resources on its lead botensilimab/balstilimab (BOT/BAL) program, which has demonstrated robust clinical activity in microsatellite stable colorectal cancer (MSS CRC), non-small cell lung cancer (NSCLC), pancreatic cancer, sarcoma, and other difficult-to-treat cancers.

•

Reducing Costs: The company will implement significant cost-cutting measures, including staff reductions and operational adjustments, targeting a 60% reduction in annual expenditures and a cash burn of $100 million for FY 2025.

•

Optimizing Expert Manufacturing Capabilities: Agenus plans to transition its biologics CMC capabilities to a fee-for-service model, unlocking new revenue opportunities. This initiative is intended to be supported by external funding.

“These adjustments are necessary to position Agenus for success in a challenging biotech environment,” said Dr. Garo Armen, Chairman and CEO of Agenus. “We remain committed to advancing BOT/BAL for patients with cancers that have limited or no treatment options.”

BOT/BAL continues to demonstrate potential across multiple cancer types, particularly MSS CRC, a cancer historically unresponsive to existing treatments. Agenus is advancing BOT/BAL through clinical development and preparing for global regulatory submissions.

Supporting Employees

Agenus is grateful to the contributions of all our team members and will be providing support and assistance to affected employees to help with their transitions, reflecting the company’s appreciation for their contributions.

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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. Information that may be important to investors will be routinely posted on our website and social media channels.

About Botensilimab (BOT)

Botensilimab (BOT) 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.

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 2023, 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,

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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
[e-mail]

Media
612-839-6748
[e-mail]

 

 

 

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Document And Entity Information	Dec. 05, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 05, 2024
Entity Registrant Name	AGENUS INC.
Entity Central Index Key	0001098972
Entity Emerging Growth Company	false
Entity File Number	000-29089
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	06-1562417
Entity Address, Address Line One	3 Forbes Road
Entity Address, City or Town	Lexington
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02421
City Area Code	781
Local Phone Number	674-4400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value per share
Trading Symbol	AGEN
Security Exchange Name	NASDAQ

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