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BioAtla, Inc.
5/14/2024
Greetings and welcome to the BioATLA first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Bruce Mackel, with Lifestyle Advisors. Thank you, Bruce. You may begin.
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. Following today's call, the team will participate in a short Q&A. Earlier this afternoon, BioAtla released financial results and a business update for the first quarter ended March 31st, 2024. A copy of that press release and corporate presentation are 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 and whether its clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets, achievements of milestones, results, conduct, progress, and timing of its research and development programs and clinical trials, expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions, the potential regulatory approval path for its product candidates, expectations about the sufficiency of its cash and cash equivalents to fund operations, and expectations regarding R&D expenses and cash burn. These statements are subject to various risks, assumptions, and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent quarterly report on Form 10Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, May 14th, 2024, and BioAtla disclaims any obligation to update such statements to reflect future information, events, or circumstances, except as required by law. With that, I'd like to turn the call over to Jay Short.
Jay? Jay? Thank you, Bruce, and thanks to everyone for joining us for our first quarter 2024 BioAtla earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, both of which are available on our website. We continue to make considerable progress across all of our ongoing clinical programs. We are pleased to share our recent encouraging data readouts for our CAVOR2 ADC and highly treatment refractory head and neck cancer patients who had a median of three prior lines of treatment. As illustrated in the best overall response slide of our corporate presentation, many patients achieved rapid and deep tumor control with 38% of patients responding. Having observed an 86% disease control rate, We believe these findings support use in earlier line settings. In addition, in view of the manageable safety profile, this holds considerable promise for future combination therapies. Given the strength of the data we observed with TAV or 280C, especially at the more intensive 2Q3W dosing regimen, we plan to meet with the FDA in the second half of this year for guidance on a potentially registrational trial. We obtained multiple responses and encouraging clinical benefit using the less intense Q2W dose of our CABWAR2 ADC in melanoma. However, we did not meet our internal bar. We do believe, though, that our CABWAR2 ADC at the more intensive regimen has potential in melanoma and other indications, including triple negative breast cancer, where we observed tumor reduction in our earlier phase one study. However, due to our ongoing prioritization, We do not plan to explore the more intensive regimen at this time. Next, I will cover our ongoing Phase 1-2 trial with our CAB CTLA-4 IO antibody. Our Phase 1 study, which was expanded to a higher dose due to the encouraging safety results, is progressing well. We've more than doubled the number of treated patients since our first data disclosure late last year, and we have observed multiple responses at the 350 milligram dose in combination with PD-1. We are pleased to report that our ongoing phase two study echoes our earlier report as very few immune-related adverse events have been observed to date, which is consistent with the anticipated benefits of our conditional binding technology. In addition, the observed safety profile also continues to hold now that we are treating patients at the 700 milligram flat dose or approximately 10 milligram per kilogram. We also remain on track to clear the DLT observation period with the unprecedented one gram dose later this quarter. The manageable safety at this high dose allows us to approach the maximum activity for a CTLA-4 inhibitor in the tumor, which has not previously been achieved in the clinic. As for our CAB axial ADC, we completed dosing patients in the first portion of our potentially registrational trial in undifferentiated pleomorphic sarcoma in April. We also remain on track to evaluate clinical benefit of the axial ADC in target agnostic cancer patients later this quarter. Finally, the phase one dose escalation trial with our first dual CAB bispecific EPCAM CD3 T-cell engager remains on track for readout in the second half. As we are now into the second quarter of 2024, we are focused on finalizing data readouts and reports for our Ward 2 and C24 assets for meetings with the FDA to obtain guidance on one or more potentially registrational trials in the second half of this year. In addition, we are advancing our discussions with potential pharmaceutical partners on selected preclinical and clinical assets to both accelerate their development and maximize their market potential. I will now turn the call over to Eric, who will provide additional insights and details on our ROR2 and CTLA-4 assets. Eric?
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