Agenus (AGEN) Chardan's 10th Annual Healthcare Conference summary

Strategic focus and clinical rationale

• July pivot made ROBBIN, an 850-patient phase III trial in high-risk stage II/III MSS colon cancer before surgery, the sole registration-enabling focus; resources and capital were prioritized over running two global phase III trials.

• The neoadjuvant setting may enable chemotherapy de-escalation and, in rectal cancer, less radiation and organ-preserving surgery; NEST participants remained treatment-free for multiple years after a short BOT/BAL course.

• Dana-Farber’s Benjamin Schlechter called the neoadjuvant setting BOT’s strongest biological fit, while emphasizing that late-line refractory disease remains an important unmet need.

• In NEST, nearly half of patients had no cancer detected after six weeks of therapy; Schlechter called the response impressive but cautioned that it does not establish cure.

ROBBIN endpoints and milestones

• First 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 analysis of the first 100 patients, 50 per arm, will assess pathologic response, major pathologic response and complete response; it is a read-through, not a trial go/no-go or primary endpoint.

• EFS interim analysis at 75% information fraction is anticipated in H2 2029, with final analysis in H2 2030.

• The primary endpoint target corresponds to HR 0.65, or at least 35% improvement in recurrence rate; management expects potential chemotherapy de-escalation and maintained ctDNA negativity as secondary or exploratory outcomes.

• Management expects the four-to-six-week regimen to have no surgery delays and cited a Grade 3 AE rate below 5%, with events described as manageable.

Data and enrollment outlook

• NEST updated data showed no disease recurrences beyond two and three years; management said standard surgery and chemotherapy are followed by recurrence in ~25% of patients in this setting.

• Management expects upcoming UNICORN updates to test consistency with NEST; Schlechter said comparable pathologic complete response results from the Italy and New York studies could encourage ROBBIN enrollment.

• Schlechter expects initial enrollment may be slow, then accelerate if the interim data show a 40%-50% pathologic complete response rate.

• ESMO posters, including NEOASIS, were expected the following week; agenT-797 combination work was expected at SITC in early November, with NEST and UNICORN manuscripts planned for H2.