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 continue to supply clinical and access programs, with the original expert team retained under Zydus leadership.

• The deal enables both operational resilience and financial stability, reducing cash burn to $50 million annually and boosting cash reserves to over $60 million.

• Zydus will be the exclusive manufacturer for BOT/BAL in clinical trials and access programs, including France’s AAC program and paid named patient programs.

• The collaboration also expands BOT/BAL development and commercialization into India and Sri Lanka.

Patient access and regulatory progress

• France’s AAC program now reimburses BOT/BAL for colorectal, sarcoma, and ovarian cancers, reflecting urgent patient need and regulatory flexibility.

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

• Other countries, including the UK, Switzerland, Brazil, and Argentina, allow access via out-of-pocket or special insurance, with efforts underway to expand government reimbursement.

• The company is preparing for global regulatory filings, aiming for accelerated approval in the US and conditional approval in Europe.

• Real-world data from access programs will supplement clinical trial evidence for regulatory submissions.

Clinical development and evidence generation

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

• Early efficacy data from nearly 500 patients in phase 1 and 2 trials support rapid enrollment and optimism for BATON.

• BOT/BAL has shown promising results in over nine tumor types, including durable responses in immune-cold tumors like sarcoma and MSS colorectal cancer.

• Over 1,200 patients have received BOT/BAL, with consistent efficacy and tolerability across multiple tumor types and disease stages.

• Real-world and clinical trial data are being leveraged to inform regulatory pathways and expand access.