Agenus Triggers First $20M Contingent Payment Under Zydus Life Sciences Collaboration to Support BOT+BAL Manufacturing Needs

Key Terms

chemistry, manufacturing and controls technical

Chemistry, manufacturing and controls (CMC) is the package of technical information that explains how a drug or biologic is made, tested and kept consistent, submitted to regulators to demonstrate the product’s safety, purity and reliable production. Investors care because robust CMC lowers the risk of manufacturing delays, regulatory rejection or costly recalls — think of it as the product’s recipe and kitchen controls that determine whether a medicine can be scaled, sold and generate revenue.

cmc technical

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

maa regulatory

MAA stands for Marketing Authorization Application, the formal request a drug developer files with regulators (commonly in the European Union) asking for permission to sell a medicine. Think of it like applying for a driver’s license for a product: approval means the company can market and earn revenue from the drug, while rejection or delays affect expected sales, timelines and the company’s valuation—so investors track MAAs as key risk/reward milestones.

cGMP technical

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

phase 3 trial medical

A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.

compassionate access regulatory

Compassionate access lets seriously ill patients use an experimental drug or therapy outside formal clinical trials when no approved treatments are available. For investors it matters because such programs act like letting people borrow a prototype before full launch: they can produce early real‑world safety and demand signals, shape public perception and regulatory scrutiny, and introduce legal or reputational risk, even though they rarely create significant near‑term revenue.

named patient programs regulatory

Named patient programs are arrangements that allow patients to access experimental or unapproved medicines outside of regular clinical trials, often through special approvals. They matter to investors because they can signal a company's efforts to bring new treatments to market and may impact perceptions of future sales potential or regulatory progress. These programs can also influence a company's reputation and relationships within the healthcare industry.

Work orders for key CMC and production activities activate first contingent payment as global demand expands across clinical and paid compassionate access programs

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has triggered the first $20 million contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences Ltd.

The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls (CMC) and production activities related to botensilimab (BOT) and balstilimab (BAL). These activities will allow Zydus to perform the initiation of its commercial supply of Agenus’ lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization.

This milestone marks the first operational activities between Agenus and Zylidac Bio LLC, the U.S.-based biologics manufacturing subsidiary of Zydus Life Sciences.

“This milestone reflects our commitment to progressing BOT and BAL to regulatory approval readiness, and to support our ongoing clinical development and paid compassionate access program needs,” said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “As reimbursed access continues in France under the AAC framework and named patient programs expand in permitted countries and enrollment advances in the global BATTMAN Phase 3 trial, it is essential that we proactively align manufacturing capacity with anticipated demand. Our partnership with Zydus enables us to scale thoughtfully while maintaining capital discipline.”

Agenus currently maintains sufficient cGMP clinical-grade BOT and BAL drug product inventory to support the ongoing BATTMAN Phase 3 trial, the ANSM-authorized French access program (AAC) program, paid named patient programs in select countries where permitted, and ongoing investigator-sponsored trials. The newly initiated manufacturing activities are designed to supplement existing supply and position the company to meet expanding demand across paid compassionate access, development and potential future commercial settings.

Under the collaboration agreement, up to $50 million in contingent payments may be triggered by BOT and BAL production orders. The $20 million payment announced today is contractually allocated specifically for production and CMC-related activities. This structure enables Agenus to execute critical manufacturing work in support of its development and access programs without additional capital expenditures impacting its cash position.

The strategic collaboration between Agenus and Zydus, originally announced in June 2025 and closed in January 2026, provides Agenus with long-term U.S.-based biologics manufacturing capacity to support BOT+BAL’s global development and potential commercialization.

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. 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 Global Access Pathways
Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework.

For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system (Assurance Maladie). Reimbursement is structured as a single, upfront, course-based reimbursement per patient that covers the patient’s full course of therapy according to the national AAC protocol, rather than on a per-dose basis. Once a patient is authorized and treatment is initiated under the protocol, full course of treatment and all subsequent administrations are supplied without additional product charges. In line with AAC requirements, the maximum indemnity applicable to BOT+BAL is declared to the relevant French authorities.

Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.

About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc-enhanced multifunctional anti-CTLA-4 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. In France, botensilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above.

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 more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. In France, balstilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above.

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 botensilimab and balstilimab, early access pathways, clinical development plans (including BATTMAN), and expected regulatory and clinical timelines, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” and similar expressions 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.

Source: Agenus Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260310252290/en/

Investors

917-362-1370 | investor@agenusbio.com



Media

781-674-4422 | communications@agenusbio.com

Source: Agenus Inc.