Agenus Inc. Reports Q1 2024 Financial Results and Highlights Advancements in Immuno-Oncology Programs with Botensilimab and Balstilimab

Agenus Inc., a prominent player in the field of immuno-oncology, has announced its financial results for the first quarter of 2024, alongside significant advancements in its clinical programs. The company reported a notable $100 million royalty financing agreement with Ligand Pharmaceuticals, a move designed to bolster the development and market launch readiness of its key therapeutic program, botensilimab (BOT) and balstilimab (BAL), particularly in the treatment of non-metastatic relapsed/refractory colorectal cancer (r/r MSS CRC NLM).

The financial agreement with Ligand is seen as a strategic capital infusion that avoids equity dilution, allowing Agenus to advance its lead BOT/BAL program efficiently. CEO Garo Armen expressed enthusiasm about the deal, emphasizing its importance for progressing BOT/BAL, which has shown promising results in Phase 1 and Phase 2 studies for relapsed/refractory MSS CRC. The company plans to engage with the FDA in the latter half of 2024, aiming to submit a Biologics License Application for BOT/BAL under the accelerated approval provision.

In addition to the financial and clinical progress, Agenus has also achieved market compliance with Nasdaq listing requirements, following a 20:1 reverse stock split executed in the first quarter of 2024. This strategic move not only ensured eligibility for inclusion in the Russell Indices but also attracted investment from institutional investors by maintaining a stock price above $5 per share.

The company’s quarterly highlights include impressive clinical data from its BOT/BAL program. In a Phase 1b trial involving 77 patients with relapsed-refractory MSS CRC NLM, the combination therapy demonstrated a minimum overall response rate of 23%, with a median overall survival of 21.2 months. These results are notably superior to the standard of care therapies, which typically show response rates between 1% and 6.1%, and a median overall survival of 12.9 months. Furthermore, the most common side effects observed were manageable, with Grade 3+ treatment-related diarrhea/colitis occurring in about 16% of patients.

Agenus also presented data at the ASCO-GI conference in January 2024, showcasing significant tumor shrinkage in patients with resectable localized colon or rectal cancer treated with BOT/BAL in a neoadjuvant setting. In the study, 100% of patients with microsatellite instability-high (MSI-H) CRC experienced major pathological responses, and 67% of patients with MSS CRC showed tumor shrinkage of 50% or more. These promising early results are driving Agenus to prioritize further clinical development in the neoadjuvant MSS CRC treatment setting.

Outside of colorectal cancer, Agenus is progressing with Phase 1 and 2 clinical trials of BOT/BAL in other cancer types, including melanoma, lung cancer, sarcoma, and pancreatic cancer, with updates expected later this year.

Financially, Agenus ended Q1 2024 with $52.9 million in cash and cash equivalents, down from $76.1 million at the end of December 2023. The company’s net loss for the quarter was $63.5 million, compared to $70.9 million for the same period in the previous year. Revenues for Q1 2024 were reported at $28 million, driven primarily by non-cash royalty revenues.

In preparation for the commercial launch of BOT/BAL, Agenus is ensuring the availability of its treatments through third-party manufacturing partners and its own cGMP-grade facility. The company has also strengthened its commercial leadership team to support the anticipated market introduction of BOT/BAL, reflecting its commitment to delivering innovative cancer therapies to patients in need.

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