AGENUS INC Q4 FY2023 earnings call

• BOT/BAL therapy underwent rigorous testing in over 900 patients, showing promising activity in cancers like colon cancer, with response rates, durability, and efficacy observed. Data was presented at scientific forums and published in journals. The FDA granted fast track designation for refractory MSS-CRC.
• Neoadjuvant CRC study: 12 patients treated with BOT and BAL showed significant pathologic responses in MSI high and MSI stable patients. The study is expanding to a 6-8 week treatment period to evaluate deeper responses and surgical outcomes.
• Pancreatic cancer: Data on six patients in second-line pancreatic cancer showed activity with botensilimab in combination with chemotherapy. A randomized Phase 2 study is enrolling, with preliminary data expected in the second half of 2024.
• Strategic partnerships: Received a $25 million milestone from BMS triggered by a Phase 2 study with BMS-986442. Actively exploring royalty financing and project funding opportunities, and engaging with five biopharmaceutical parties for partnerships.

In 2023, Agenus recognized revenue of $156 million and incurred a net loss of $257 million ($0.69 per share). For the fourth quarter ended December 31, 2023, revenue was $84 million and the net loss was $49 million ($0.13 per share). Revenue primarily stems from collaboration agreements, including milestones. The BOT/BAL program was a key operational focus, with clinical trials demonstrating promising activity in multiple cancer types, contributing significantly to the company's operational and financial landscape.

• In 2024, primary objective is to pursue a global regulatory strategy for BOT/BAL in the fast track indication. Plan to submit a Biologics License Application (BLA) to the FDA for potential accelerated approval after aligning with FDA standards. Intend to initiate a Phase 3 study in the proposed indication by the end of 2024. Plan to submit to the European Medicines Agency (EMA) in 2025 following scientific and regulatory advice in Europe.

• Regulatory risks: Uncertainty in FDA and EMA review timelines and requirements for BLA submission.
• Trial risks: Uncertainty in trial outcomes and ability to meet endpoints, affecting regulatory approval and commercialization.
• Partnership risks: Challenges in partnership negotiations, potential delays, and maintaining confidentiality during discussions.

Q: On the neoadjuvant CRC study, how does the longer treatment period impact efficacy and surgical outcomes?

A: The longer treatment period from 4 to 6-8 weeks is expected to deepen responses, and the study is evaluating surgical outcomes and post-surgery relapses.

Q: Timing of BLA submission for MSS CRC?

A: Plan to meet with the FDA mid-year to get guidance on BLA submission, with data maturation expected before that meeting.

Q: On biopharma strategic discussions, what areas align for partnerships?

A: Discussions involve confidentiality, but clinical trial enrollment growth and data maturity have increased interest from prospective partners.

Q: Pancreatic and lung data update timing?

A: Pancreatic trial has 60 patients, 30 on each arm, actively accruing. Lung data from expanded cohort of ~50 patients, maturing with more data in second half of 2024.