Agenus (AGEN) Wells Fargo 2024 Healthcare Conference summary

Company overview and strategy

• Thirty-year history focused on leveraging the immune system for curative cancer outcomes.

• Vertically integrated operations, including R&D, CMC, and clinical teams in the US and UK.

• Recent formation of a commercial team in preparation for a major product launch.

Lead program: BOT/BAL in colorectal cancer

• BOT (botensilimab) is a next-generation, Fc-enhanced CTLA-4 antibody; BAL (balstilimab) is a PD-1 inhibitor.

• BOT/BAL combination achieved a 23% response rate and 21-month overall survival in relapsed/refractory MSS colorectal cancer, outperforming standard care.

• Five of nine patients in a neoadjuvant study achieved complete pathologic response, compared to 4-8% with standard chemo.

• Phase III design, dose, and CMC components are agreed upon with FDA; EMA discussions for conditional approval planned for fall.

Clinical data and regulatory progress

• Over 1,100 patients treated in phase I/II studies, showing safety and efficacy in cold tumors.

• Consistent results between phase I and II support regulatory submissions for accelerated or conditional approval.

• Data maturity and longer follow-up are expected to further strengthen the case for approval.

• Regulatory alignment with FDA achieved for pivotal study; EMA discussions upcoming.