Agenus Faces Uphill Battle After FDA Rejects Accelerated Approval for Cancer Drug Combo

1. FDA Rejection: The FDA advised against pursuing accelerated approval for Agenus' BOT/BAL colorectal cancer combination therapy, leading to a significant stock selloff.
2. Stock Impact: Agenus shares plummeted over 54% following the FDA's decision.
3. Phase 2 Study Results: The Phase 2 study showed a 19.4% overall response rate (ORR) and a 90% 6-month survival rate for the 75mg dosage of BOT/BAL.
4. Concerns Over Survival Benefits: The FDA's concerns about the therapy's survival benefits led to the rejection of accelerated approval.
5. Company's Response: Agenus remains committed to exploring alternative pathways to bring the treatment to market, including plans to incorporate a BOT monotherapy arm in its upcoming Phase 3 trial.
6. Financial Resilience: Despite the setback, Agenus has a strong financial position, ending the first quarter with $52.9 million in cash.
7. European Regulatory Engagements: The company plans to engage with European regulators in the third quarter of 2024 to discuss regulatory pathways for BOT/BAL.