On May 7, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, reported results for the first quarter 2024 (Press release, Agenus, MAY 7, 2024, View Source [SID1234642754]). In a concurrent press release accompanying Agenus’ earnings announcement, a $100M royalty financing agreement between Ligand and Agenus was reported. This pivotal, minimally dilutive capital infusion will support the key development and launch readiness initiatives needed to advance the company’s lead program, BOT/BAL, in relapsed/refractory non-MSI high colorectal cancer without liver metastases (r/r MSS CRC NLM).
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"We are thrilled to announce a significant $100 million royalty financing agreement with Ligand, a milestone that investors have eagerly anticipated. This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment," said Garo Armen, CEO of Agenus. He continued, "The BOT/BAL combination has consistently demonstrated deep and durable responses in ‘cold’ solid tumors, especially in our advanced studies of relapsed/refractory MSS CRC. With the promising results we have seen, and additional data from our ongoing Phase 2 study, we plan to engage with the FDA in the second half of 2024. Pending the outcomes of these discussions, we aim to commence the submission of a Biologics License Application under the accelerated approval provision for BOT/BAL in refractory MSS CRC NLM."
In parallel, Agenus has successfully reduced its cash burn rate. The company successfully executed a 20:1 reverse stock split during Q1 2024. This reverse stock split was implemented to achieve multiple key objectives, including satisfying the eligibility criteria for inclusion in the Russell Indices, regaining compliance with Nasdaq listing requirements, and maintaining a stock price above $5 per share, enabling investment by certain institutional investors. Regaining of compliance with NASDAQ listing requirements was confirmed in a press release on April 30th, 2024. This reverse stock split comes as part of a series of strategic initiatives meant to lower Agenus’ cost of capital and to broaden its investor base, benefitting both shareholders and patients.
Q1 2024 Highlights on Botensilimab:
Colorectal cancer:
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Data presented from the company’s lead BOT/BAL program included an update of the Phase 1b trial in patients with relapsed-refractory MSS CRC NLM.
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This updated dataset (n=77) demonstrated a minimum of 23% RECIST-confirmed overall response rate (ORR) with a median overall survival (mOS) of 21.2 months, a 12-month overall survival (OS) estimate of 71%, and an 18-month OS estimate of 62% in 77 patients after a median follow up of 13.6 months. As of the data cutoff of March 1, 2024, the median duration of response was not yet reached.
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These data, which continue to mature, stand in stark contrast to standard of care therapies in this treatment setting with standard of care therapies ranging from 1% to 6.1% with a median OS of 12.9 months1, 2.
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The most common safety observations are immune-related diarrhea and colitis, which are managed in accordance with standard therapies. Grade 3+ treatment related diarrhea/colitis occurred in approximately 16% of patients.
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A poster presentation at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in June on this same r/r MSS CRC cohort from the Phase 1b includes results from a sub-analysis conducted to determine whether treatment outcomes are correlated with specific sites of metastatic disease in patients with non-active liver metastases.
Neoadjuvant CRC:
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Clinical data from an ongoing Investigator Sponsored Study (IST) at Weill-Cornell testing BOT/BAL in the neoadjuvant CRC population were presented at ASCO (Free ASCO Whitepaper)-GI in January 2024.
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In this IST (NEST-1) led by Dr. Pashtoon Kasi, patients diagnosed with resectable localized colon or rectal cancer were treated with one dose of BOT and two doses of BAL approximately 4 weeks prior to planned surgery.
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After surgery, pathologic analysis reported significant tumor shrinkage: 3/3 patients (100%) with microsatellite instability-high (MSI-H) CRC experienced major pathological responses (>90% tumor shrinkage) in less than 4 weeks, while 6/9 (67%) MSS CRC patients had tumor shrinkage of 50% or more.
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Longer follow-up on these initial 12 patients (NEST-1) will be presented at an upcoming medical meeting.
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Part 2 of this IST is rapidly enrolling and allows a total of four BAL doses with one dose of BOT followed by surgery at 8 weeks (compared to surgery at 4 weeks in Part 1)
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Based upon these early encouraging data, Agenus plans to prioritize clinical development activities in the neoadjuvant MSS CRC treatment setting and is evaluating study designs for subsequent pivotal trials.
Outside of CRC, Agenus expects to release updated Phase 1 and 2 data in melanoma, lung cancer, sarcoma and pancreatic cancer later this year.
In parallel with these ongoing BOT/BAL development and regulatory activities around the company’s planned BLA submission, Agenus has prioritized resources and efforts towards advancing critical commercial launch readiness activities. This includes ensuring quality and availability of BOT/BAL supply,
through both third-party CMO partners and Agenus’ wholly owned cGMP-grade facility in Emeryville, and the hiring of an established and seasoned commercial leadership team with extensive experience in launching oncology therapeutics. "We are partnering closely with our Global Medical Affairs and Clinical Team to gather insights from the world’s experts in GI oncology and have conducted market research with over 150 US-based GI oncologists, both in the academic and community hospital settings. It is clear to us that there is significant anticipation for BOT/BAL, which underscores the urgency we feel to deliver this important treatment option to patients," said Robin Taylor, Chief Commercial Officer of Agenus.
First Quarter 2024 Financial Overview:
We ended our first quarter 2024 with a cash and cash equivalent balance of $52.9 million, compared to $76.1 million on December 31, 2023. This morning, we announced a $100 million agreement with Ligand Pharmaceuticals, consisting of an initial investment of $75 million with an option to invest an additional $25 million. Our cash used in operations for this first quarter was $38.2 million, compared to $40.6 million during the fourth quarter ended December 31, 2023.
For the first quarter ended March 31, 2024, we recognized revenue of $28 million and incurred a net loss of $63.5 million (including non-cash expenses of $38.3 million) or $3.04 per share. This compares to a net loss of $70.9 million (including non-cash expenses of $24.9 million) or $4.31 per share for the same period in 2023.