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AGEN

AGENUS INC

AGENUS INC Q1 FY2024 earnings call

May 7, 2024 · fiscal period ended 2024-03

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Summary

Generated 2024-05-07

Management highlights

Garo Armen announced Agenus entered a $100 million loyalty financing agreement with Ligand Pharmaceuticals, allowing retention of BOT/BAL program and opening partnership options. Cash balance at end of first quarter was $52 million. Reverse stock split in Q1 to meet NASDAQ and Russell Index requirements. Steven O’Day provided update on BOT/BAL program: Phase 1b data in relapsed refractory MSS-CRC showed 23% confirmed overall response rate, median OS 21.2 months. Ongoing confirmatory Phase 3 study and commercialization readiness. Clinical trials include NEST in neoadjuvant colorectal cancer, FOLFOX 3B in first-line metastatic colorectal cancer, and Phase 2 trials in melanoma and pancreatic cancer. Robin Taylor discussed commercial preparations: hiring commercial leadership team, preparing for BOT/BAL launch, CMC team readiness, and market research with GI oncologists.

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Guidance

Anticipate securing up to $200 million by mid-year to support clinical R&D, registration, and commercialization. Meeting with FDA in July 2024 to align on BLA filing and confirmatory Phase 3 trial design. Expect Phase 2 data in melanoma, pancreatic cancer, etc., in second half of 2024.

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Risks

Risks associated with forward-looking statements including clinical development, regulatory, and commercialization timelines. Uncertainties in securing all investigator-sponsored trials and managing data generation for regulatory purposes.

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Q&A highlights

Q: Congrats on the progress. Could you confirm how many patients you've treated with BOT/BAL at the recommended Phase 2 dose across the Phase 1b and Phase 2 studies specifically for MS CRC patients without? And your confidence...

A: Garo Armen and Steven O’Day respond.

Q: In prior press release team, you've mentioned that your emerging data in Phase 2 is encouraging. Are you able to give a little bit more detail...

A: Garo Armen responds.

Q: About the catalyst in the second half. You said there will be a number of data in melanoma, lung, pancreatic in the second half. Can you provide like expectation...

A: Garo Armen responds.

Q: Congrats on the Ligand financing. Just wondering, the additional $25 million that can come from Ligand. Is that purely based on Ligand's decision?

A: Garo Armen responds.

Q: Congratulations on the Ligand financing. Could you just say when is the anticipated closing date? And then, in terms of share count...

A: Garo Armen and Christine Klaskin respond.

View in transcript ↓

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Transcript

May 7, 2024

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