Agenus (AGEN) Investor update summary

Strategic Focus and Financing

• Prioritizing neoadjuvant BOT/BAL (botensilimab + balstilimab) for high-risk Stage II/III MSS colon cancer, supported by robust clinical data and FDA-aligned Phase 3 trial design.

• Secured up to $340 million in private placement financing, with $85 million upfront and up to $255 million via warrant exercise, to fund the ROBBIN Phase 3 trial and operations through 2031.

• The ROBBIN trial is a global, randomized, registration-enabling Phase 3 study targeting 850 patients, with event-free survival as the primary endpoint.

• Interim pathologic response data expected in H2 2027, interim EFS in H2 2029, and final EFS in H2 2030.

• The shift from late-line to neoadjuvant focus is driven by greater patient impact, larger addressable market, and alignment with clinical and commercial value.

Clinical Rationale, Efficacy, and Safety Data

• MSS colon cancer represents 85% of cases and is largely unresponsive to conventional immunotherapy; BOT/BAL aims to address this unmet need.

• NEST and UNICORN Phase 2 studies showed up to 30% pathologic complete response, 40% major pathologic response, and 100% event-free survival at 9–18 months.

• BOT/BAL demonstrated deep, durable responses, with no disease recurrence or ctDNA recurrences reported in treated patients.

• Safety profile is favorable: low incidence of grade ≥3 immune-related adverse events, no unresolved high-grade irAEs, and minimal surgical delays.

• Comparative data show BOT/BAL outperforms prior immunotherapy combinations in pathologic response rates.

Market Opportunity and Commercial Outlook

• The addressable U.S. market for high-risk Stage II/III MSS colon cancer is about 38,000 patients annually, translating to a potential >$7 billion opportunity at an illustrative $200,000 treatment course.

• The neoadjuvant setting offers a larger patient population and greater impact on long-term survival compared to late-line metastatic programs.

• BOT/BAL is positioned as a potential new standard for neoadjuvant immunotherapy in MSS colon cancer, with robust clinical and economic rationale.

• Patent runway is sufficient to complete the study and reach market with exclusivity.

• BOT/BAL adopted in paid compassionate access programs in France for MSS CRC, sarcomas, and ovarian cancer, with growing pre-commercial revenues.