Agenus Inc. Q2 FY2024 earnings call

• Garo Armen highlighted progress in botansilamab (BOT) and bostilamab (BAL) development for colorectal cancer, with Phase II trial data showing ~20% confirmed overall response rate for the 75 mg BOT + 240 mg BAL combination, allowing further development including a confirmatory Phase III trial.
• Active engagement with regulatory bodies, including positive initial feedback from non-US agencies and plans to explore rapid approval pathways in Europe.
• Exciting data from a multi-cancer neoadjuvant study to be presented at a major conference.
• Regained full rights to AGEN1777 and AGEN2373 from BMS and Gilead, and are evaluating new partnerships.
• Strengthened cash position with first transfer of $75 million royalty financing, in talks for second closing.
• Tom Harrison joined the board, bringing healthcare communications and branding expertise.
• Steven O'Day provided clinical updates on BOT/BAL showing remarkable activity in various cancer types, including neoadjuvant settings with promising pathologic regression results.

Christine Klaskin reported that for the three and six-months ended June 30, 2024, revenues were $23.5 million and $51.5 million respectively, compared to $25.3 million and $48.2 million in the same periods of 2023. The consolidated cash balance ended the second quarter 2024 at $93.7 million, up from $76.1 million on December 31, 2023. The net loss for the three and six-month ended June 30, 2024, was $54.8 million and $118.3 million, including non-cash operating expenses of $33.5 million and $71.8 million respectively.

• Garo Armen stated a Phase III trial could commence as early as the next four months and enroll within a year, exploring options with subsidies for Phase III trial potentially as low as $10 million.
• Expecting maturing data in pancreatic and melanoma cancers in the coming months.

• Uncertainty regarding FDA's stance on BOT/BAL despite positive feedback from other regulatory agencies.
• Dependence on successful enrollment and data maturation for Phase III trial and regulatory approvals.

Q: Can you again discuss the FDA's guidance for the Phase III design in terms of the number of patients that you might need per arm, including the center of care arm and specific end points that you plan to look at? And then maybe if you can give any guidance to how soon you believe you could initiate a Phase III study and whether you believe the resources you have financially could support you running one along?

A: Among the options considered, a Phase III trial could commence as early as the next four months and enroll inside of a year, exploring options with subsidies as low as $10 million.

Q: You mentioned that you're expecting to have data in pancreatic and melanoma cancers in the coming months. Could you just confirm it as expected for the year and, if so, how much data should really be expecting?

A: Expecting maturing data in pancreatic and melanoma cancers in coming months; specific details ongoing but trends consistent with prior trials.

Q: For future discussions planned with the FDA, how much additional follow-up from the Phase II trial will you need in that more mature dataset?

A: Approximately six more months of follow-up versus what was presented in the submitted document.