Agenus Inc. Q3 FY2024 earnings call

Science and BOT/BAL

• BOT/BAL is showing unprecedented results in cancers resistant to previous therapies and in earlier-stage diseases. It represents a paradigm shift in cancer treatment, particularly in the neoadjuvant setting for MSS colorectal cancer, which historically resists immunotherapy.
• Initial data from the Cornell study presented at ESMO GI 2024 highlights this potential, with ongoing trials in Italy and the Netherlands expected to provide early data next year.

Financial Measures

• Implemented measures to reduce cash outflows, internalizing CRO and CDMO services.
• Monetizing real estate assets: vapable property appraised at over $45 million and Berkeley facility appraised at $25 million.
• Advanced discussions on strategic transactions to secure resources for BOT/BAL development.

Agenus ended the third quarter of 2024 with a consolidated cash balance of $44.8 million. Since then, they raised an additional $7.1 million. For the three months ended September 30, 2024, revenue included non-cash revenue of $25 million, and the net loss was $67 million. For the nine months ended September 30, 2024, revenue included non-cash revenue of $77 million, and the net loss was $186 million. Cash used in operations for the nine months ended September 2024 was $129.7 million, a reduction from $183.8 million in the same period of 2023.

Phase 3 Design

• Have feedback from FDA and EMA on Phase 3 design, need strategic partnership for financing to initiate the study.

Neoadjuvant Studies

• Two trials in the neoadjuvant setting to be presented in early 2025: one in colorectal cancer, one in a broader range of solid tumors that generally respond poorly to other treatments.

Phase 2 Relapsed Refractory

• Data from the Phase 2 colorectal refractory study, where the last patient was enrolled in November a year ago, to be presented in early 2025.
• Phase 2 trials in pancreas and melanoma refractory completed accrual, with randomized data expected in the first half of 2025.

• Financial constraints: Developing therapies with significant promise requires substantial resources, and the company operates under financial constraints with limited cash on hand.

Q: Now that you have guidance from the FDA and the EMA around the Phase 3 design, can you maybe just summarize how you're thinking about the Phase 3 design, and next steps and timelines for getting that study initiated? And then on the three investigator trials that you mentioned in the neoadjuvant setting, can you maybe just go through each of those and kind of how the designs, for those studies differ and maybe set some expectations, to what we can see in the early 2025 data readout?

A: Robin Taylor addressed the Phase 3 design noting feedback from EMA and FDA allows proceeding, but need strategic partnership for financing. Steven O'Day discussed the two neoadjuvant trials, one in colorectal cancer and one in a broader solid tumor population, both expected to have data in early 2025.

Q: On the Phase 2 relapsed refractory setting, do you see I believe previously you were saying you would have additional data, I believe, in first half of 2025. Is that still on track? And on some of the cohorts, and other tumor types like melanoma and pancreatic cancer in the near-term, or could you provide any updated timing for those cohorts?

A: Steven O'Day confirmed the Phase 2 colorectal refractory data is still on track for early 2025 presentation. Also, Phase 2 trials in pancreas and melanoma refractory completed accrual, with randomized data expected in the first half of 2025.