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Jun 30, 2024
Agenus Q2 2024 Earnings Report
Agenus reported financial results for the second quarter of 2024 and provided a corporate update.
Key Takeaways
Agenus reported revenue of $23.5 million for the second quarter of 2024 and a net loss of $54.8 million. The company's cash balance was $93.7 million at the end of the quarter. Agenus is focused on advancing its BOT/BAL program and is in discussions with potential partners.
Agenus released interim data from its global randomized Phase 2 trial of BOT/BAL in relapsed/refractory MSS colorectal cancer.
Data from the BOT/BAL clinical program demonstrated activity across 10 different cancers and across early and late-stage disease.
Agenus initiated engagement with the European Medicines Agency (EMA) and will explore registration paths for BOT/BAL in other geographies.
Agenus closed the first tranche of its $75 million royalty financing led by Ligand Pharmaceuticals and is pursuing potential out-licensing transactions.
Agenus
Agenus
Forward Guidance
Agenus is focused on securing a global partnership for BOT/BAL and initiating a Phase 3 study in r/r MSS CRC.
Positive Outlook
- Agenus has gained alignment with the FDA on the proposed design and dosing regimen for its upcoming Phase 3 study in the r/r MSS CRC treatment setting.
- The company is in discussions with several major biopharma companies regarding a potential partnership for BOT/BAL.
- Agenus anticipates releasing further data later this year across the BOT/BAL program beyond MSS CRC.
- Agenus has received recent interest in partnerships for its wholly owned Chemistry, Manufacturing, and Controls (CMC) infrastructure.
- Agenus is launching a Named Patient Program for BOT/BAL to provide early access to eligible patients.
Challenges Ahead
- The FDA discouraged the submission of interim results for Accelerated Approval based on the dataset shared during the July End-of-Phase 2 meeting.
- Agenus plans to further engage the FDA with more mature data to support its AA strategy.
- The company's net loss for the three months ended June 30, 2024, was $54.8 million.
- Agenus is pursuing potential out-licensing transactions for several of its pipeline assets, indicating a need for external funding or strategic realignment.
- Agenus is continuing its efforts for a second closing of its $75 million royalty financing, suggesting potential challenges in securing the full amount.