Agenus Inc. Q1 FY2025 earnings call

Key Points

• BOT/BAL Data: New and more mature data showing durable responses in historically untreatable cold tumors, including results from AACR 2025 with pathological complete responses across multiple cancers in neoadjuvant setting and Phase 1 data in HCC showing deep and durable disease control in heavily pre-treated patients.
• Strategic Hire: Richard Goldberg joined as Chief Development Officer to steer regulatory path, with his expertise in GI-Oncology.
• Operational Efficiencies: On track to cut operational cash burn to below $50 million annualized in H2 2025.
• Near-Term Transactions: Received 4 formal proposals including Emeryville facility sale, significant equity investment, and 2 BOT/BAL licensing deals to strengthen balance sheet.
• Regulatory Environment: Favorable changes in FDA policies with potential for rapid approval of transformative therapies, and Agenus requested a Type B meeting with FDA for BOT/BAL.

In the first quarter ended March 31, 2025, Agenus recognized revenue of $24.1 million, primarily consisting of non-cash royalty revenue. The consolidated cash balance at the end of Q1 2025 was $18.5 million, down from $40.4 million at year end 2024. Cash used in operations for Q1 2025 was $25.6 million, reduced from $38.2 million in the same period of 2024.

Forward-Looking Statements

• Anticipates announcing at least one near-term transaction in coming days/weeks to materially strengthen balance sheet.
• On track to cut operational cash burn to below $50 million annualized in the second half of 2025.
• Believes new regulatory environment and data support potential accelerated approval of BOT/BAL.

Q: How much longer term follow up do you have from the Phase 2 study and have you hit on the overall survival endpoint yet? Assuming need for Phase 3 study, can you comment on ability to run it?

A: Dr. Steven O'Day noted median follow up for Phase 1 is 18 months, Phase 2 is over 12 months. Jennifer Buell mentioned expecting to present data at upcoming conference and will discuss randomized design and next steps with FDA regarding Phase 3.

Q: When do you expect the Type B meeting to occur and any update on European counterparts?

A: Jennifer Buell stated interactions with FDA regarding Type B meeting path are clear, and interactions with CHMP/European authorities were productive with agreement on selected dose, contribution of components, and conditional approval pathway consideration, with initial interactions with FDA first.

Q: Can you comment on the focus of the Type B meeting and European counterparts?

A: Richard Goldberg mentioned focus on colorectal cancer in late-line and neoadjuvant indications. Jennifer Buell discussed European interactions and conditional approval pathway progress.