On November 12, 2024 Agenus Inc. ("Agenus" or the "Company") (Nasdaq: AGEN), an immuno-oncology company focused on innovation, reported a corporate update and reported financial results for the third quarter of 2024 (Filing, 3 mnth, SEP 30, Agenus, 2024, NOV 12, 2024, View Source [SID1234648154]).
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"BOT/BAL represents one of the most significant advancements in cancer immunotherapy, showing remarkable results in MSS colorectal cancer where previous treatments have fallen short," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "Its potential extends beyond this challenging cancer type, with promising efficacy seen in the neoadjuvant setting and other hard-to-treat cancers. While we are excited by these achievements, we remain mindful of the financial challenges that come with advancing such breakthrough therapies. We are focused on strategic initiatives, including asset monetization and operational efficiencies, to strengthen our financial position and continue driving forward. We are confident in our path and unwavering in our commitment to deliver innovative treatments that redefine patient care and create long-term value for our patients and shareholders."
Key Highlights from Q3 2024
Breakthrough Clinical Progress – Botensilimab (BOT) and balstilimab (BAL) continues to deliver unprecedented outcomes across multiple cancer settings.
•Neoadjuvant MSS Colorectal Cancer (CRC): BOT/BAL is advancing in 3 ISTs with consistent clinical activity in MSS CRC, a tumor historically resistant to immunotherapy. Initial results from Cornell study (ESMO GI 2024) show groundbreaking potential; results from additional trials in Italy and the Netherlands expected to be presented at prestigious oncology conferences in early 2025.
•Broad and Durable Responses in Sarcoma and other cancers: Presentations at ESMO (Free ESMO Whitepaper)2024 highlighted BOT/BAL’s clinical activity advanced sarcomas and other difficult-to-treat cancers, reinforcing its potential to redefine cancer treatment. Additional data updates are expected to be shared at key oncology conferences in the coming months.
Expanding Patient Access Globally – Agenus is committed to expanding patient access to BOT/BAL through Compassionate Use and Named Patient Programs, providing innovative treatment options for patients with limited alternatives. These programs empower
physicians to deliver advanced care as regulatory frameworks evolve to support broader patient access.
Strategic Financial Initiatives – Agenus is actively pursuing a disciplined approach to strengthen its financial foundation:
•Operational Efficiencies: Cash outflows have been significantly reduced through focused measures.
•Asset Monetization: Discussions to monetize real estate assets are progressing, reflecting increased interest and opportunities following the recent U.S. elections, which have positively impacted financial markets. These monetization efforts are expected to provide near-term cash infusions to support operations.
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Near-Term Transaction: Agenus is also advancing discussions on a strategic transaction designed to deliver substantial resources. The company views its current financial initiatives as a bridge to this transformative step, which is expected to position Agenus for long-term growth while maximizing value for shareholders.
Regulatory Alignment – Ongoing discussions with the European Medicines Agency (EMA) have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. These achievements reflect a collaborative effort to enable access to this transformative combination to patients worldwide.