BioAtla, Inc.

Greetings and welcome to the BioATLA second quarter 2023 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, Mr. Bruce Mackle with LifeSci 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, and Richard Waldron, Chief Financial Officer. Following today's call, Dr. Eric Seavers, Chief Medical Officer, and Sherry Lydick, Chief Commercial Officer, will join Jay and Rick for a short Q&A. Earlier this afternoon, BioAtla released financial results and a business update for the second quarter ended June 30, 2023. A copy of the 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 BioAtla's business plans and prospects, potential selective licensing, collaborations and other strategic partnerships, whether its clinical trials will be potentially registrational, 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, and expected R&D and G&A expenses. 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 quarterly report on Form 10Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 1st, 2023, and Bio-Outlet 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?

Thank you, Bruce, and thanks to everyone for joining us for our second quarter 2023 BioATLA earnings call. BioATLA is the inventor and leader in the development of novel therapies using a proprietary conditionally-active biologics CAHBS platform with improved selectivity for attacking tumor cells while avoiding healthy cells, thereby addressing urgent unmet needs in oncology to improve patients' lives. We made significant progress last year across our multiple ongoing Phase II trials for our two latest stage first-in-class CAB ADC product candidates, BA3011 and BA3021, targeting solid tumor types with high unmet medical needs. As we are now a little over halfway through 2023, we continue our positive trajectory and remain on track to achieve our recently guided milestones outlined on the first quarter call in May. We remain focused on further advancing the development of our innovative clinical programs, leveraging the broad applicability of our CAB technology across several clinical stage antibody types, including CAB-AXL and CAB-LOR2 ADCs, CAB, CTLA-4, and immuno-oncology naked antibody, and our first dual CAB bispecific EPCAM CD3 T-cell engager. Additional details related to what I'm going to provide are available on our website as part of our updated company presentation that may be helpful to you. We remain excited about our lead asset, BA3011, for multiple indications. Previously, we shared the encouraging partial interim data on our BA3011 Phase II Part I sarcoma study and our BA3011 Phase II Part I non-small cell lung cancer study. We also shared additional insights on how we have applied the learnings from our differentiated safety data and exposure response analyses, as well as our UPS-related FDA interactions to study more frequent dose-intensive regimens more broadly across our AXL-ADC and ROR2-ADC programs. The goal of studying more frequent dose-intensive regimens across programs is to provide data to allow us to set study parameters that maximize the company's likelihood of success for our Phase II potentially registrational studies. A summary of our current dose regimens can be found in the updated corporate presentation on our website. Let's now move to our clinical, operational, and financial updates for the second quarter 2023. First, we are advancing BA3011 in our ongoing sarcoma phase two studies, including a potential registrational study in UPS. Without specific treatments approved for UPS, there is a significant commercial opportunity as a standalone indication. We have shown strong execution and promising results with continued anti-tumor activity, lack of disease progression, and a differentiated safety profile of BA3011 in UPS to date. Based on these results, together with the continued differentiated safety profile and encouraging feedback from the FDA around the study design, last year we initiated part two of the potentially registrational portion of the trial. The first 40 patients are being randomized one to one between the more frequent dose-intensive regimens. Following the first 40 patients, we plan to enroll an additional 40 patients at the selected dose to complete the study. The primary efficacy endpoint ORR will be based on approximately 60 patients treated at the selected dosing regimen. As an update, we achieved first patient in and are actively enrolling patients. In addition to UPS, we have completed enrollment of the Phase 2 Part 1 Lyomyosarcoma cohort using the 3Q4W dosing regimen and are on track with an anticipated data readout on 10 to 15 patients in the second half of this year. Further, the remaining bone sarcoma cohorts in Phase 2, Part 1 are on track to finish enrolling in the second half of 2023. With regards to safety profile across all sarcoma subtypes, there are no new safety signals to report. BA3011 continues to be generally well tolerated with a Phase 2 safety profile across all doses consistent with the profile we observed in Phase 1. Regarding our BA3011 phase two study in actual positive multi-refractory non-small cell lung cancer, we continue to be encouraged about the data from the Q2W dosing regimen, while we anticipate data from the more frequent dose intensive regimens. Currently, the scan treatment options in patients who progress on immune checkpoint inhibitors have suboptimal overall response rates of approximately 10 to 20% and four month PFS rates. Part one of a phase two study in non-small cell lung cancer is ongoing in axial positive patients who have previously experienced failure of either PD-1, PD-L1, EGFR, or ALK inhibitors and continues to enroll patients. Anticipated data for all dosing regimens assisting with the study design for the potentially registrational portion of the trial remains on track for the second half of this year. We have submitted a meeting request to the FDA for potentially registrational BA3011 Phase 2 Part 2 non-small cell lung cancer study design and anticipate feedback in the second half of this year. And as a result, remain on track to initiate the Phase 2 Part 2 study in non-small cell lung cancer also in the second half of this year, maintaining our overall timeline for development of the non-small cell lung cancer indication. We continue to believe BA3011 has the potential to become a significant commercial asset for BioATMA, and of even greater importance, a first-in-class treatment for a significant number of patients who fail at least one prior line of therapy, thus addressing a significant unmet medical need. Regarding the ongoing multicenter investigator-initiated IIT Phase II clinical trial in patients with platinum-resistant ovarian cancer, the trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year. Now turning to our second CAB ADC asset, BA3021, a CAB War II ADC, Currently, BA3021 is the subject of phase two trials and the treatment of four different indications. We conducted a similar exposure response analysis of war two positive tumors to inform the more frequent dose intensity regimen of 3q4w in our phase two war two positive non-small cell lung cancer study. Based on this analysis, which is a similar strategy to our UPS phase two part two BA3011 study, I mentioned earlier, we are screening and enrolling patients. Based on the activity to date, we believe that we remain on track to obtain data this year to permit clinical trial prioritization across our portfolio. Regarding the melanoma phase two trial in patients who have previously experienced failure of PD-1 therapy, we are continuing to screen patients with a validated IHC liquid biopsy assay. As we stated last quarter, we have successfully identified war two positive tumors using the liquid biopsy assay, which is allowing us to enroll war two positive patients. And we are on track to dose patients in the second half of this year. In addition, our phase two head and neck study is ongoing in patients who have previously experienced failure of PD-1 therapy alone or in combination with platinum therapy. Earlier this year, we announced achievement of first patient in for the study. Since that time, multiple patients have been dosed, and we continue to enroll patients. Regarding the ongoing multicenter investigator-initiated Phase II clinical trial in patients with platinum-resistant ovarian cancer, the trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year. Now turning to our Phase I-II trial for our CAB CTLA-4 antibody, BA3071. As a reminder, the Phase 1-2 trial is being conducted in tumors known to be responsive to CTLA-4 treatment, and we are continuing to evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab. The trial is progressing as planned. Last quarter, we shared that we started treating patients in the fifth cohort at 350 milligrams, or 5 mg per kg, as monotherapy. and in combination with 3 mg per kg nivolumab. As part of today's update, I'm happy to report that the DLT observation period was cleared for the fifth cohort and no DLTs were reported. We are currently enrolling patients in the sixth cohort at 700 milligrams or 10 mg per kg as the monotherapy or in combination with 3 mg per kg of nivolumab and remain on track for a phase one data readout anticipated the second half of this year. We also remain on track to initiate DA371 phase two study also in the second half of this year. We believe there are significant unmet medical needs with sizable commercial opportunities across multiple tumor types where CTLA-4 can deliver efficacy with a manageable safety and tolerability profile that allows patients to stay on therapy for longer and thus achieve the full benefit of this important therapy. Next onto our potentially first in class dual CAB bispecific T-cell engager antibody, CAB-FCAM and CAB-CD3 or BA3182. As mentioned during last quarter's call, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We are now actively enrolling patients in this phase one study with the full data readout remaining on track for next year. similar to our other three clinical stage CAB assets. This antibody has shown significant promise in in vivo preclinical studies demonstrating an over 100-fold improvement in the therapeutic index relative to the non-CAB variants due to the combined selectivity of the dual CAB design. We believe that our dual CAB design has the potential to address the tremendous unmet need across several of the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas, and prostate. Finally, we continue to pursue opportunities to share our progress with the medical and scientific communities with an additional two trial and progress abstracts, one for BA3011 and another for BA3021, which were accepted for poster presentations at the upcoming World Conference on Lung Cancer this September. This brings the total confirmed medical meeting presentation talent to 11, since the beginning of the year. Additional abstracts have been submitted for several upcoming meetings as well. With that, I would now like to turn the call over to Rick to review the second quarter 2023 financials. Rick?