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BioAtla, Inc.
11/13/2025
Good day, everyone, and welcome to today's BioATLA third quarter 2025 earnings call. This time, all participants are in a listen-only mode. Later, you may have the opportunity to ask questions during the question and answer session. I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Julie Miller with LifeSci Advisors. Please go ahead.
Thank you, Operator, and good afternoon, everyone. With me today on the phone from BioATLA are Dr. Jay Short, Chairman, CEO, and Co-Founder, Dr. Eric Sievers, Chief Medical Officer, Sherry Lydic, Chief Commercial Officer, and Richard Waldron, Chief Financial Officer. Earlier this afternoon, BioATLA released financial results and a business update for the quarter ended September 30th, 2025. A copy of the press release is available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements, including but not limited to statements regarding BioAtlas business plans and prospects, potential selective licensing, collaborations, and other strategic partnerships. The potential for our clinical trials to be registrational, results, conduct, progress, and timing of our research and development programs and clinical trials, expectations with respect to enrollment and dosing in our clinical trials, the anticipated clinical benefits, safety, efficacy, and market potential of our product candidates, plans and expectations regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions. the potential regulatory approval path for our product candidates, expectations about the sufficiency of our cash and cash equivalents, and expected R&D and G&A expenses. These statements are based on current expectations and assumptions and are subject to various risks and uncertainties that can cause actual results to differ materially from those expressed or implied. These risks and uncertainties are described in our filings made with the SEC, including the most recent quarterly report on Form 10Q and other subsequent filings. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, November 13, 2025, and BioATLA disclaims any obligation to update or revise such statements to reflect new information, future events, or circumstances, except as required by law. With that, I'd like to turn the call over to Jay Short. Jay?
Thank you, Julie. And thanks to everyone for joining us for our third quarter 2025 BioATLA earnings call. First and foremost, it is important to update that we are currently in advanced stages to finalize a strategic transaction with a potential partner by year end. Further, in September, I'm pleased to report that we achieved FDA alignment on the Phase 3 OSVI registrational trial design, including dosing regimen, comparator arm, and approval endpoints for the treatment of second-line plus oropharyngeal squamous cell carcinoma, or OPSCC. OPSCC represents a sizable and steadily growing patient population poorly served by EGFR inhibitors and other standard of care regimens. Importantly, this randomized phase three trial will evaluate dual primary endpoints of overall response rate and overall survival. And this dual endpoint design provides the opportunity for achieving accelerated approval followed by full approval. We are currently preparing for initiation of the OSV Phase III study and remain on track to advance this program. We also recently presented compelling data with multiple programs, including our dual-CAB EPCAM TCE, or BA3182, and MEKV, which further validates the potential of our CAB platform to deliver differentiated therapies for patients with difficult-to-treat cancers. In a few moments, Eric will provide an overview of these data. I'm also pleased to share that we achieved a development milestone under our license agreement with Context Therapeutics related to the dual CAB Nectin-4 TCE program. This milestone not only provides non-dilutive capital, but also further validates the underlying biology and its impact on improving the therapeutic index of our CAB T-cell engager platform. We continue to be encouraged overall by our CAB T-cell engager results, including this milestone achievement as well as the promising interim data from BA3182 recently presented at ESMO. Finally, our MECHV program continues to distinguish itself with the potential for increasing overall survival compared with approved treatments in soft tissue sarcoma recently presented at CITSE. These overall survival data are analogous to the prolonged overall survival data we observe in mutant KRAS non-small cell lung cancer patients. With that, I would now like to turn the call over to Sherry to provide an overview of the substantial market opportunity for OSVI, our CAB Roar 280C. Sherry?
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