Agenus (AGEN) Investor update summary

Strategic progress and clinical development

• The ROBBIN phase III neoadjuvant program is underway, targeting 850 patients globally, with operational execution and site activation across North America, Europe, South America, and Asia.

• The trial aims to enroll its first patient in Q1 2027, with early pathologic response data expected in 2H 2027 and interim EFS analysis in 2H 2029.

• The primary goal is to reduce recurrences and improve survival while potentially decreasing chemotherapy use in high-risk stage II and III colon cancer.

• The study leverages a multidisciplinary approach, requiring coordination among oncologists, surgeons, radiologists, pathologists, and research teams.

• The program is fully funded through 2031 with up to $340M secured in July 2026 financing.

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.

• Safety profile is favorable: low incidence of grade ≥3 adverse events, no unresolved high-grade immune-related AEs, and only one short surgical delay among 52 patients.

• Recent peer-reviewed publications highlight durable responses and long-term benefits of BOT+BAL, fueling increased investigator and physician interest.

• BOT + BAL offers a chemotherapy-free, organ-sparing option with demonstrated efficacy in over 1,300 patients across metastatic and locally advanced settings.

Access programs and physician engagement

• Two main access programs are active: the French AAC program with government reimbursement and a paid Named Patient Program in multiple countries, both seeing growing demand.

• Early access programs in France and other markets show strong physician and patient demand, with pre-commercial revenues recognized.

• Physician enthusiasm is driven by credible published data and clinical experience, leading to repeat requests for BOT+BAL.

• Despite expected seasonal slowdowns, physician and patient demand for BOT+BAL has increased, indicating strong momentum.

• Infrastructure and logistics have been strengthened through partnerships, ensuring rapid product delivery and robust safety monitoring.