Agenus (AGEN) investor relations material

Strategic focus and market opportunity

• Prioritizing development of BOT + BAL, a next-generation Fc-enhanced anti-CTLA-4 and anti-PD-1 combination, for neoadjuvant treatment of high-risk Stage II/III MSS colon cancer, a market exceeding $7B in the US annually.

• Shift from late-line metastatic CRC to earlier-stage, curative-intent population to maximize patient benefit and economic value.

• No major advances in MSS colon cancer treatment in over 20 years; MSS accounts for ~85% of early-stage CRC cases.

• BOT + BAL offers a chemotherapy-free, organ-sparing option with a manageable safety profile.

Clinical efficacy and safety data

• NEST and UNICORN trials in neoadjuvant MSS colon cancer showed ~30% pathologic complete response, ~40% major pathologic response, and 100% event-free survival at 9–18 months median follow-up.

• No disease or ctDNA recurrences reported in 38 BOT + BAL-treated patients; deep pathologic responses and ctDNA clearance observed.

• Favorable safety profile with low incidence of grade ≥3 immune-related adverse events and minimal surgical delays.

• BOT + BAL demonstrated clinical activity across 9+ cold and ICI-refractory tumor types, converting cold tumors to hot.

Phase 3 ROBBIN trial and regulatory alignment

• ROBBIN Phase 3 trial (n=850) is FDA-aligned, randomized 1:1, with primary endpoint of event-free survival; first patient in anticipated Q1 2027.

• Interim pathologic response data expected 2H 2027; interim EFS analysis 2H 2029; final EFS analysis 2H 2030.

• Trial design and endpoints based on FDA feedback, targeting high-risk Stage II/III MSS colon cancer.

• Expected to demonstrate superior value over conventional therapies, with potential for 4–10x greater life years gained per 100 patients.