Agenus (AGEN) Status update summary

Strategic collaborations and operational readiness

• Closed a major collaboration with Zydus Lifesciences, securing long-term US-based biologics manufacturing and providing essential capital for future growth.

• The Emeryville facility will serve as a flagship for both clinical supply and future commercialization, with the original expert team retained.

• Zydus gains US manufacturing for biosimilars, while the partnership enables development and commercialization of BOT/BAL in India and Sri Lanka.

• The transaction required extensive regulatory review, including CFIUS, but closure now enables execution of 2026 priorities.

• Operating cash burn reduced to $50 million annually, with a cash position over $60 million post-transaction.

Patient access and regulatory progress

• France’s AAC program expanded reimbursement for BOT/BAL to include colorectal, sarcoma, and ovarian cancers, reflecting urgent patient need.

• Growing physician and patient interest is driving expansion of medical affairs infrastructure to support responsible access.

• Named patient and paid access programs are expanding in Europe and Latin America, with France leading in government reimbursement.

• Real-world data from these programs is being collected to support regulatory filings and inform global access strategies.

• Plans to pursue accelerated approval in the US and conditional approval in Europe, leveraging both clinical and real-world evidence.

Clinical development and evidence generation

• BATON, a global phase 3 trial in MSS metastatic colorectal cancer, is launching soon, targeting a population unresponsive to current immunotherapies.

• Early efficacy data from nearly 500 patients in phase 1/2 trials is driving optimism for rapid enrollment and regulatory success.

• BOT/BAL has shown promising results in historically resistant cancers, including durable responses in sarcoma and other immune-cold tumors.

• Over 1,200 patients have received BOT/BAL across more than nine tumor types, with consistent efficacy and tolerability.

• Real-world and clinical trial data are being integrated to support global registration and access.