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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): June 03, 2025

 

 

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. ☐

 


Item 1.01 Entry into a Material Definitive Agreement.

Asset Purchase Agreement

On June 3, 2025, Agenus Inc. (the “Company”) and its wholly-owned subsidiary Agenus West, LLC (“Agenus West” and together with the Company, “Agenus”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Zydus Pharmaceuticals (USA) Inc. (“Zydus”), a wholly owned subsidiary of Zydus Lifesciences Limited, for the sale to Zydus of substantially all of the assets comprising Agenus’ manufacturing operations run primarily through Agenus West (the “Purchased Assets”), including without limitation real estate, equipment and certain assumed contracts.

In consideration for the sale of the Purchased Assets, Zydus will pay Agenus up to $125 million, comprised of $75 million to be paid at closing (minus any amounts used by Zydus to satisfy related indebtedness at closing) and contingent payments of up to an additional $50 million that may be earned based on usage by Agenus of Zydus’ manufacturing business during the 36-month period following the closing.

The Purchase Agreement contains customary representations, warranties and agreements by Agenus and Zydus, indemnification obligations of the parties and certain other obligations of the parties. Closing of the transaction is subject to customary conditions, including receipt of all required government approvals, as well as the entry into a contract manufacturing agreement (under which Agenus will use Zydus for agreed manufacturing needs), the SPA (as defined below) and a license agreement (under which Zydus would receive an exclusive license to develop, manufacture and commercialize botensilimab and balstilimab (“BOT/BAL”) in India and Sri Lanka (the “Territory”) in exchange for a royalty on net sales in the Territory) (the “License Agreement”).

Securities Purchase Agreement

On June 3, 2025 and in connection with the execution of the Purchase Agreement, the Company and Zynext Ventures USA LLC (“Zynext”), a wholly-owned subsidiary of ZyNext Ventures PTE.LTD Singapore, a wholly-owned subsidiary of Zydus Lifesciences Limited, entered into a Securities Purchase Agreement (the “SPA” and together with the License Agreement and Purchase Agreement the “Zydus Agreements”), pursuant to which Zynext agreed to purchase 2,133,333 shares of the Company’s common stock (the “Shares”) for an aggregate purchase price of approximately $16.0 million, or $7.50 per share. Under the SPA, Zynext has agreed not to dispose of any of the Shares for a period of 12 months and to refrain from acquiring additional shares of Common Stock for a period of 12 months, other than in specified circumstances. The Company has agreed to register the Shares for resale under the Securities Act of 1933, as amended (the “Securities Act”). The Company has also agreed to allow Zynext to designate a non-voting board observer or, in lieu of delegating a board observer, to nominate one director for election to the Company’s Board of Directors, subject to Zynext or its affiliates maintaining certain ownership in the Company. Subject to certain restrictions, customary information rights and preemptive rights will be granted to Zynext under the SPA for so long as Zynext maintains certain ownership of Company’s outstanding Common Stock. Closing under the SPA is subject to customary closing conditions, including receipt of all required government approvals and satisfaction or waiver of the conditions precedent to closing contained in the Asset Purchase Agreement. The SPA also includes customary representations and warranties, covenants and indemnification obligations.

License Agreement

Under the License Agreement, the Company grants Zydus Lifesciences Limited an exclusive license in the Territory under its patents and know-how to develop, manufacture, and commercialize products based on its proprietary BOT/BAL cancer immunotherapy drug product. As consideration for this license Zydus agrees to pay Agenus a royalty on net sales at a rate of 5%, as may be adjusted by the occurrence of certain contingencies, for a period ending at the later of the expiration of Agenus’ patent rights in a given country in the Territory or 10 years following first commercial sale in such country. The parties further agree in the License Agreement to use reasonable efforts to enter into supply agreements under which Agenus would supply BOT/BAL to Zydus for clinical trials and commercialization. Zydus agrees to be responsible for conducting clinical trials and seeking regulatory approval in the Territory as set forth in the License Agreement. The License Agreement contains customary representations and warranties by Agenus and Zydus, confidentiality and indemnification obligations of the parties, customary termination conditions, and certain other obligations of the parties customary for these types of license agreements. Effectiveness of the License Agreement is subject to conditions to effectiveness, including satisfaction or waiver of the conditions precedent to closing contained in the Purchase Agreement and the SPA.

The foregoing description of the Zydus Agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the Zydus Agreements, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.

 

Item 7.01 Regulation FD Disclosure.

On June 3, 2025, the Company issued a press release announcing its entry into the Zydus Agreements, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 furnished herewith, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release dated June 3, 2025

 


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:

June 4, 2025

By:

/s/ Garo H. Armen, Ph.D.

 

 

 

Garo H. Armen, Ph.D.
Chairman and CEO

 


EX-99.1 2 agen-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

img250783414_0.jpg

 

FOR IMMEDIATE RELEASE

 

Agenus and Zydus Lifesciences Enter $141M Strategic Collaboration to Advance BOT/BAL, Expand Zydus’ Biologics Manufacturing in the US

 

$75M upfront payment to Agenus for the transfer of manufacturing assets
$50M of contingent payments to Agenus
Exclusive license for BOT/BAL in India and Sri Lanka
$16M equity investment at $7.50 per share

LEXINGTON, Mass– June 3, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as “Zydus,” designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL).

 

The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally.

 

Agenus will become Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen’s BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization.

 

Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus’ established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries.

 

In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds.


Exhibit 99.1

Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL.

 

By uniting Agenus’ pioneering research and development capabilities with Zydus’ worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond.

 

“With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,” said Dr. Garo Armen, CEO of Agenus. “There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.”

 

“We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer,” said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd.

 

The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days.

 

Conference Call and Webcast

 

Date/Time: Tuesday, June 3rd; 4:30 p.m. ET

To access dial-in numbers, please register at: https://registrations.events/direct/Q4I127881000000000.

Conference ID: 12788

 

Advisors

 

As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations.

 

About Agenus


Exhibit 99.1

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 Zydus Lifesciences

Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com

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 1,200 patients have been treated with botensilimab and/or balstilimab 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.

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.


Exhibit 99.1

It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

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.

Agenus Investors
917-362-1370
investor@agenusbio.com

Agenus Media
781-674-4422

communications@agenusbio.com

Source: Agenus Inc.