Agenus (AGEN) investor relations material

Strategic focus

• In July, registration-enabling focus shifted from late-line BATTMAN to the 850-patient Phase III ROBBIN trial in high-risk stage II/III MSS colon cancer.

• The decision reflected trial bandwidth and capital constraints; management identified the neoadjuvant setting as the area with greatest potential patient impact.

• Dana-Farber’s Benjamin Schlechter viewed BOT/BAL’s strongest biological fit as neoadjuvant treatment, while emphasizing continued unmet need in refractory disease.

ROBBIN rationale and evidence

• NEST and UNICORN results showed major responses after a short treatment course; Schlechter cautioned that response does not establish cure.

• Updated NEST data showed no recurrences beyond two to three years; across roughly 40 NEST/UNICORN patients, this was contrasted with a cited ~25% recurrence rate after standard surgery and chemotherapy.

• BOT/BAL treatment is planned over four to six weeks, with no reported surgery delays and less than 5% Grade 3 adverse events, described as manageable.

• Management cited an HR of 0.65 as the trial objective, corresponding to at least 35% lower recurrence if achieved; chemotherapy de-escalation and maintained ctDNA negativity are secondary or exploratory aims.

Trial milestones

• First ROBBIN patient enrollment is expected in Q1 2027; the 60th enrollment is anticipated in Q2 2027 and would trigger a financing warrant tranche yielding $85 million if all warrants are exercised.

• A Q4 2027 interim will assess pathologic response in the first 100 patients, split evenly between BOT/BAL and control; it is not a primary endpoint or trial go/no-go gate.

• The pathologic response assessment includes partial response, major pathologic response (90%-99% tumor shrinkage), and complete response rates; management described it as a near-term read-through.

• Interim event-free survival analysis at 75% information fraction is anticipated in H2 2029, with final analysis in H2 2030.

• Schlechter predicted enrollment could start slowly, then accelerate if interim data show a 40%-50% pathologic complete response rate.