BioAtla, Inc.

Good day, everyone, and welcome to today's BioATLA third quarter 2024 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Bruce Mackel with LifeSci Advisors.

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 Sievers, Chief Medical Officer, and Sherry Lydick, Chief Commercial Officer, will join Jay and Rick in a short Q&A. Earlier this afternoon, BioAtlas released financial results and a business update for the third quarter ended September 30, 2024. 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 BioAtlas business plans and prospects, and whether its clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets, achievement 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, November 7, 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 Dr. Jay Short. Jay?

Thank you, Bruce, and thanks to everyone for joining us for our third quarter 2024 Biolab earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the slides from the oral presentation given at the Society for Melanoma Research in September is available on our website. And the upcoming poster, which will be presented tomorrow at the Society for Immunotherapy of Cancer, CITSE, will also be available on our website at the conclusion of the poster session. Now, on to our ongoing clinical program updates. Beginning with our CAB War II ADC, Zuriftamab-Vidodin, being evaluated as a monotherapy in treatment for refractory head and neck cancer patients who received a median of three prior lines of treatment. We shared last quarter that out of our 29 available patients, we have observed a total of 11 responses, six of which were confirmed responses, including an ongoing complete response, which underscores our assets activity in this difficult to treat patient population. We also shared that given the strength of the data and the profound unmet medical need, the drug candidate was granted fast-track designation by the FDA. In September, we presented an earlier data cut at ESMO that demonstrated meaningful anti-tumor activity with manageable tolerability. As part of today's update, we have additional data from these heavily pretreated patients showing that the median duration of response for all confirmed responders is now at 4.4 months, with the median overall survival now at approximately 9 months, which is ongoing. These are meaningful results in view of this being one of the first reported studies in head and neck cancer to evaluate a patient population with a median of three prior lines of therapy. Based on cross-trial comparisons of current standard of care monotherapy agents, methotrexate docetaxel, or cetuximab used to treat the second-line plus head and neck cancer patients. ORRs range from 6% to 13%, and the median overall survival range is 5.1 to 6.9 months. Notably, these results were in less heavily pretreated patients with only one to two median prior lines of therapy. We believe the clinical profile emerging for azuristamab-vidotin monotherapy in head and neck cancer is very competitive and has the potential to position our CABOR2 ADC as a standard of care in the second-line plus population. We recently received actionable feedback from the FDA regarding our proposed pivotal trial for azuristamab-vidotin monotherapy versus investigator's choice among patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-based chemotherapy and PD-1 antibody therapy. We are pleased to report that the FDA is supportive of our proposed prospective randomized trial design, investigator choice treatment options, and endpoints that have the potential to support a possible accelerated marketing authorization followed by confirmation of clinical benefit in the same trial with additional follow-up. At the current dose of 1.8 mgs per kg of aziristamab-vidotin, the FDA supported a limited randomized evaluation of the Q2W and 2Q3W dosing schedules, which is underway. As part of the overall pivotal trial design, we believe we now have a seamless path to confirming the dose schedule leading into the phase three trial in second-line plus head and neck cancer. Moving now to our CAB-CTLA-4 antibody, Avalcitug, which was generated from ipilimumab, or IPI, for the important conditionally active binding activity. We recently presented preclinical and clinical data at the Society for Melanoma Research in September, showing that Avalcitug is similar to IPI with respect to epitope, affinity, and half-life. However, Valsatug differs from IPI with respect to the absence of binding in the normal tissue environment, and we believe this feature will continue to demonstrate considerable safety benefits, enabling patients to receive higher and extended tumor-specific CTOA4 exposure. We will also be presenting a poster at CITSE's annual meeting tomorrow, highlighting our Phase II study in first-line unresectable or metastatic melanoma. The poster will be available on our website following the conclusion of that presentation. However, since the embargo has lifted for CITSE, I'd like to share the summary of our initial first line phase two melanoma patient data. All eight patients treated with Avastatug plus PD-1 achieved tumor reduction. To briefly review, IPI is typically dosed at either one milligram per kilogram or three milligrams per kilogram in routine clinical practice. With our approach, considerable CTLA-4 inhibition was safely achieved using relatively high avocetone dosing. Five patients received a 350 milligram dosing level that represents five milligrams per kilogram IPI equivalent. and three received at least 700 milligrams, representing 10 milligrams per kilogram IPI-equivalent dosing. We have now observed four responders, including three partial responses and one complete response, with acceptable tolerability and no disease progression observed to date. The safety profile in our Phase II study continues to suggest a relatively low incidence and severity of immune-related AEs. Two patients treated with prior adjuvant immunotherapy experienced grade three immune-related AEs that readily responded to standard treatments and continued to show tumor reduction without progression. Notably, several patients with decreasing tumor volume stable disease are early in their treatment courses and have the potential to also respond with additional follow-up. In addition, intrapatient dose escalation to higher doses that have been shown to be acceptably tolerated is permissible based on an investigator's decision. We now report several instances where increasing evals to tug exposure has directly led to reattainment of disease control with acceptable tolerability. Specifically, a cutaneous melanoma patient who was dose escalated from 70 milligrams to 210 milligrams and eventually to 350 milligrams achieved a confirmed PR at the higher dose And another cutaneous melanoma patient was dose escalated from 700 milligrams to 1,000 milligrams, experiencing decreasing tumor volume stable disease. Additionally, one recurrent metastatic melanoma patient whose dose was escalated from 210 to 350 milligrams also re-obtained disease control with stable disease. Consistent with prior observations with IPI in randomized trials, we are observing a relationship between exposure and anti-tumor activity, which is made possible due to the tolerability at higher evalsatug doses relative to that of IPI. We recently received FDA guidance on ongoing dose optimization and control arm to enable a Phase III registrational trial in first-line patients with metastatic or unresectable melanoma with anticipated initiation next year. Based on our evolving data, we continue to believe Avalsatug has the potential to be the best-in-class CTLA-4 that holds the promise to be used as often as a PD-1 antibody and potentially expand the indications where combined immune checkpoint inhibition can be effective. Now onto our Cab-Axyl-ADC asset, McBodumab-vidotin, Last quarter, we announced encouraging findings in non-small cell lung cancer patients expressing mutant KRAS or mKRAS. Among the 18 available patients with known KRAS mutations, we observed five responders, including one responder whose tumor expressed the mKRAS G12C variant and had experienced prior failure of sotoracib. In addition, we have a patient with a complete response that has been maintained now for over two years. demonstrating encouraging anti-tumor activity in patients with MK-RAS variants. Importantly, our initial findings support a trend for improved overall survival among treated patients with tumors expressing MK-RAS variants compared to the KRAS wild-type genotype. With today's update, we continue to observe anti-tumor activity with multiple confirmed responses among 21 available patients with tumors expressing MK-RAS now across nine different MK-RAS variants. Additionally, we continue to see an overall survival benefit among treated patients with mutant KRAS variants compared to KRAS wild type, with a median overall survival of 12.6 months compared to 8.7 months, respectively, and which is still ongoing. Furthermore, A manageable safety profile continues with no new safety signals identified in this patient population. As an update on our evaluation of patients with mutant KRAS non-small cell lung cancer, we continue to observe a high correlation of AXL and MKRAS expression. We believe this, coupled with the improved overall survival that we are seeing across nine different mutant KRAS variants, supports a potential pan-MK-LAS strategy in non-small cell lung cancer. Currently, we are determining the most efficient path for a future pivotal trial. Details will be forthcoming as they are available. Our Phase I-II dose escalation study for the CAB-EPChem CAB-CD3T cell engager is progressing well. The maximally tolerated dose has not yet been reached, and we are actively dose escalating. We have implemented a priming dose to modulate cytokine release syndrome that is commonly observed with T-cell engagers and can also occur in patients with heavy tumor volume. To date, we have observed multiple patients with anti-tumor activity with tumor volume reduction, including a colorectal patient with ongoing stable disease for one year. Given our continued dose escalation, We now anticipate data readout of the Phase I study around the middle of next year. We continue to be pleased with the progress of this program and the potential of our CAB-APTEM TCE to treat patients with a wide range of metastatic tumors, including cancers of colon, lung, breast, pancreas, and prostate, among others. Finally, we recently announced a worldwide license agreement for the preclinical CAB Nectin-4 bispecific T-cell engager. With a successful outlicensing of this preclinical asset to context therapeutics, we continue to focus on execution of our lead clinical CAB programs while ensuring the potential advancement of the Nectin-4 bispecific TCE, now referred to as CTO202. In addition, we are engaged in multiple active discussions regarding collaboration with one or more of our Phase II assets. Given the continued progress in these discussions, we are maintaining our guidance for a potential near-term collaboration for at least one of our Phase II assets. We continue to prioritize increasing shareholder value through non-diluted means while advancing our assets through key value-creating inflection points. With that, I would now like to turn the call over to Rick to review the third quarter 2024 financials.