AGENUS INC Q3 FY2023 earnings call

Key Remarks

• Garo Armen emphasized sustained benefits of botensilimab in treating challenging cancers, aimed to submit first biologics license application for colorectal cancer in mid-2024, prioritized other clinical programs, and reallocated resources.
• Steven O'Day provided data updates on botensilimab in various trials, including 24% ORR in colorectal cancer Phase Ib cohort, pathologic responses in neoadjuvant CRC, tumor marker reductions in pancreatic cancer, and durable responses in melanoma, lung cancer, and sarcomas.
• Todd Yancey discussed regulatory strategy for MSS CRC, planning to submit BLA in mid-2024, engaging with regulatory authorities, and exploring dosing schedules and combination studies.
• Christine Klaskin reported financials: cash balance at Q3 end was $100.63M, net loss of $64.5M for Q3 2023, and $208.9M net loss for 9 months 2023.

There is no traditional product segment breakdown. The focus is on the clinical performance of the BOT therapy across various cancer types, including colorectal cancer (Phase Ib cohort of 70 evaluable patients with 24% RECIST-confirmed overall response rate, 74% 12-month overall survival rate), pancreatic cancer (4 out of 6 patients with marked and sustained tumor marker reductions), melanoma (30% objective response rate in Phase Ib expansion cohort), lung cancer (56% ORR in combination of BOT and BAL), and sarcomas (20% overall response rate, 19.4 months median duration of response in 41 evaluable heavily pretreated sarcoma patients).

Financial and Development

• Cash balance at Q3 end was $100.63M. Expected milestone payment by end of 2023, sale of 2 nonstrategic assets and partial sale of milestones/royalties by end of H1 2024, totaling ~$200M, ensuring funding through end of 2024.
• Expect to meet and exceed goals with prospects of bringing hope to cancer patients through continued clinical progress and strategic financial moves.

Uncertainties

• Regulatory uncertainties in securing BLA approval and navigating confirmatory study designs.
• Market competition and challenges in clinical trial enrollment and data maturation.
• Dependence on successful execution of asset sales and partnerships for funding.

Q: Comment on initial Phase II data for MSS CRC study and neoadjuvant CRC strategy.

A: Garo Armen discussed data cleanup and plans to publish at BLA submission, with neoadjuvant plans to determine patient population and trial design.

Q: Regulatory bar for randomized CRC study.

A: Todd Yancey explained comparison to standard of care (3% ORR vs. 24% for Agenus, 12.9m OS vs. over 21m OS), and incremental contribution of balstilimab in combination.

Q: Phase III confirmatory study design and timing.

A: Garo Armen and Todd Yancey discussed considering second/third line vs. first line, awaiting ISD study data in Q1 2024 to inform decision.

Q: Pancreatic cancer trial enrollment and BOT combination strategy.

A: Steven O'Day mentioned expanding pancreatic trial with 60 more patients, and Garo Armen discussed structured financing and partnerships based on collaborator conviction and rapid development.

Q: CRC patients with liver mets in Phase III study.

A: Garo Armen and Steven O'Day discussed exploring reasons for liver mets response and aligning Phase III trial design for all-comer patients.