Agenus (AGEN) investor relations material

Strategic collaborations and operational readiness

• Closed a major collaboration with Zydus Lifesciences, securing long-term US-based biologics manufacturing and providing essential capital for resilience and execution in 2026.

• The Emeryville facility will serve as a flagship manufacturing site, ensuring supply for clinical trials and commercial needs, with the original expert team retained.

• Zydus will be the exclusive manufacturer for BOT/BAL, supporting clinical, French AAC, and paid named patient programs.

• The collaboration also enables Zydus to develop and commercialize BOT/BAL in India and Sri Lanka, leveraging their hospital and clinical trial infrastructure.

• The deal closure followed extensive regulatory review, including CFIUS, and now enables focused execution of 2026 priorities.

Patient access and regulatory progress

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

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

• The company is preparing for global regulatory filings, aiming for accelerated approval in the US and conditional approval in Europe, supported by both clinical trial and real-world evidence.

• Named patient programs are expanding beyond France to other European and Latin American countries, with increasing inquiries and treatments.

• Transitioned from unpaid compassionate use to paid named patient and reimbursed programs to ensure financial sustainability.

Clinical development and data highlights

• The BATON phase 3 trial in MSS metastatic colorectal cancer is launching soon, targeting a population historically unresponsive to immunotherapy.

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

• BOT/BAL has shown promising results in immune-cold tumors like sarcoma, with durable responses and favorable tolerability, as highlighted by independent experts.

• Over 1,200 patients have been treated with BOT/BAL across more than nine tumor types, with consistent activity observed in multiple cancers.

• Real-world data from expanded access programs is being collected to supplement regulatory filings and inform broader access.