Agenus (AGEN) investor relations material

Clinical and regulatory milestones

• BOT/BAL immunotherapy shows consistent efficacy across multiple tumor types, including traditionally resistant (cold) tumors, with improved responses in earlier disease stages and neoadjuvant settings.

• Updated phase one data presented at ESMO included nearly 1,000 patients, making it one of the largest phase 1 studies, with robust and durable responses, even in patients who failed prior IO therapies.

• The French National Agency of Medicines granted full reimbursement and compassionate access (AAC) for BOT/BAL in refractory metastatic MSS colorectal cancer, marking the first such validation globally.

• France’s AAC program is expected to generate real-world evidence to support future full approvals and is seen as a model that may pressure other countries to follow.

• The Batman phase 3 study in collaboration with the Canadian Cancer Trials Group has regulatory and IRB approvals, with first patient enrollment expected by December.

Market access and commercialization

• BOT/BAL is now fully reimbursed for eligible French patients, with no cost to patients or hospitals, and the program is open to all under the French healthcare system.

• Pricing in France is set to support future market access across Europe, though explicit pricing details remain undisclosed.

• The French endorsement is anticipated to influence other European countries and accelerate broader access and potential approvals.

• Orders for BOT/BAL have already been received under the AAC program, reflecting strong physician and patient interest.

Pipeline and development updates

• Phase two overall survival data is expected in the coming months, with results to be communicated to stakeholders.

• The frontline colorectal cancer study (BB-APCO) is accruing and results are expected in 2026, depending on data maturity.

• Ongoing studies in pancreatic and renal cell carcinoma are underway, with phase two data pending; early results show deep and durable responses in multiple tumor types.

• Neoadjuvant studies in rectal and colon cancer are expanding, with dramatic responses observed and new trials in planning, aiming to avoid chemotherapy and extensive surgery.