Q3 2025 BioAtla Inc Earnings Call
Speaker #1: At this time, all participants are in a listen-only mode. to ask questions Later, you may have the opportunity during the question and answer session.
Speaker #1: I will be standing by should you need any assistance. It is now my pleasure to turn the BioAtla Q3 2025 conference over to Julie Miller with LifeSci Advisors.
Speaker #1: Please go ahead.
Speaker #2: Thank you, Operator, and good afternoon, everyone. With me today on the phone from bioAtla are CEO, and co-founder; Dr. Jay Short, Chairman, Dr. Eric Sievers, Chief Medical Chief Commercial Officer; and Richard Waldron, Chief Financial Officer.
Speaker #2: Earlier this results and a business update for the afternoon, bioAtla released financial quarter ended September 30th, 2025. A copy of the press release is available on the we begin, I'd like to remind everyone that statements made during company's website.
Speaker #2: forward-looking statements including but not limited to statements regarding bioAtla's business plans Before and prospects, potential selective licensing, collaborations, this conference call will include partnerships.
Speaker #2: The potential for our clinical trials to be registrational results conduct progress and expectations with respect to enrollment and dosing in our clinical trials; the timing of our research and development anticipated clinical benefits, safety, efficacy, and market potential of our product candidates; plans and other strategic and expectations regarding future data updates, clinical trials, regulatory meetings, and regulatory approval path for our product regulatory submissions.
Speaker #2: candidates, expectations about the sufficiency of our cash and cash G&A expenses. These programs and clinical trials statements are based on current expectations and assumptions and are subject The potential to various risks and uncertainties.
Speaker #2: implied. These risks and to differ materially from uncertainties are described in our filings made with those expressed or most recent quarterly report on They can cause actual results Form 10Q and other the SEC.
Speaker #2: subsequent filings. You are cautioned not to place undue reliance on these forward-looking statements, equivalents, and expected R&D and November 13th, which speak only as of today, Including the 2025.
Speaker #2: And bioAtla disclaims any obligation to update or revise such statements to reflect new information, future except as required by events, or circumstances law. With that, I'd like to turn the call over to Jay Short.
Speaker #2: Jay?
Speaker #3: Julie. And thanks to everyone for joining us for Thank you, our third quarter 2025 bioAtla earnings foremost, it is important to update that we are currently in advanced stages call.
Speaker #3: Transaction with a potential partner by year-end. Further, in September, I'm pleased to report that we achieved FDA alignment on the Phase Three OSV registrational trial design, including first and dosing regimen, comparator arm, and approval endpoints for the treatment of second-line plus oropharyngeal squamous cell carcinoma or OPSCC.
Speaker #3: 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.
Speaker #3: design provides the opportunity for achieving accelerated And this dual endpoint approval, followed by full approval. We are currently preparing for initiation of the OSV phase three study and remain on track to advance this program.
Speaker #3: We also recently presented compelling data with multiple programs including our dual CAB EPCAM TCE or BA 3182 and MECV. Which further validates the potential of our CAB platform to deliver differentiated therapies for patients with difficult-to-treat cancers.
Speaker #3: In a few moments, Eric will provide an overview of these data. I'm also pleased to share that we achieved the development milestone under our license agreement with context therapeutics, related to the dual CAB Nectin 4 TCE program.
Speaker #3: 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 overall by our CAB T-cell engager results, including this milestone achievement as well as the platform.
Speaker #3: Promising interim data from BA 3182 was recently presented at ESMO. It distinguishes itself with the potential for increasing overall survival compared with approved treatments in soft tissue sarcoma. Our MECV program continues to encourage us at SITSI.
Speaker #3: These prolonged overall survival data for non-small cell lung cancer patients, with which we observe in mutant KRAS overall survival data, are analogous. I would now like to turn the call over to Sherry to provide an overview of the substantial market opportunity for OSV, our CAB Ward 2 ADC.
Speaker #3: Sherry?
Speaker #4: Thank you, Jay, and good afternoon, everyone. OSV has demonstrated compelling clinical activity in heavily pretreated patients with HPV positive OPSCC, a population with a poor prognosis.
Speaker #4: OPSCC is a steadily growing indication, primarily driven by prior HPV infection. Up to 80% of OPSCC cases in the US are caused by HPV, and by 2030, OPSCC is projected to become the most common subtype of head and neck cancer in the US.
Speaker #4: The unmet need is significant, and current standards of care including EGFR inhibitors provide minimal benefit in this setting. This epidemiology underscores the urgency of therapies.
Speaker #4: From a commercial perspective, the opportunity is significant. We estimate advancing new treatment options to be approximately 800 OPSCC cases alone. The total worldwide OPSCC market is projected to reach $3 billion by the broader HPV-positive solid tumor market, including $1 million in second line and later worldwide peak sales of OSV, including cervical cancer, in dollars globally.
Speaker #4: And when you consider ADC, is driven by oncoproteins
Speaker #4: We continue preparations for phase three study, with the goal value exceeding $7 billion of advancing the study with a strategic partner. Early next, I would now like to turn the call over to Eric for additional updates.
Speaker #4: We continue preparations for phase three study, with the goal value exceeds 7 billion of advancing the study with a strategic partner, early next I would now like to turn the call over 2032.
Speaker #5: Phase three trial preparations for OSV continue as we achieved alignment on the phase three with the potential for accelerated approval, followed by full approval, with its dual endpoint registrational trial design, design.
Speaker #5: differentiated profile in HPV positive OPSCC, as overexpression of the Ward
Speaker #5: infection forming a cancer associated with HPV axis that is associated with poor 2, the target of the prognosis and resistance to chemo and immunotherapies.
Speaker #5: We have seen OSV's potential with our strong phase two data, in late line patients demonstrating an overall response rate of 45% and a median overall survival of 11.6 months compared to the historical response rates of only 0% to 3.4% and median overall survival of only 4.4 months.
Speaker #5: With standard therapies. Beyond OSV, we continue to make exciting progress with our dual CAB EPCAM T-cell engager, EPCAM is broadly expressed across adenocarcinomas of the colon, stomach, pancreas, biliary tract, lung, breast, prostate, and thyroid, making it a compelling bispecific T-cell engager target.
Speaker #5: However, EPCAM is also broadly expressed on healthy epithelial tissues, and this broad expression is associated with on-target, off-tumor toxicities when targeted by traditional antibodies.
Speaker #5: We believe we have a notable advantage with our dual CAB EPCAM T-cell engager, as it is designed to selectively bind within the acidic tumor microenvironment and eliminate on-target off-tumor toxicity.
Speaker #5: We recently presented preliminary data from our phase one trial with our dual CAB EPCAM T-cell engager, and advanced adenocarcinomas at the annual 2025 European Society for Medical Oncology Congress.
Speaker #5: Overall, data indicate that the safety profile is manageable. In addition, we are continuing to see encouraging preliminary signs of tumor reductions across a broad range of indications, and notable prolonged tumor control, with a confirmed partial response at the 0.6 milligram dose.
Speaker #5: This responding patient with intrahepatic cholangiocarcinoma, a particularly challenging cancer of the biliary tract, remains on treatment without progression now for more than six months.
Speaker #5: We also remain encouraged by the performance of McBodemab-Vadoten, or MECV, data from our phase two trial of MECV alone and in combination with nivolumab in patients with treatment refractory soft tissue sarcomas where recently presented at the Society for Immunotherapy of Cancer annual meeting.
Speaker #5: Data from 44 evaluable patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma showed median overall survival of 21.5 months compared to median overall survivals of only 11.5 to 13.6 months reported for approved agents in similar advanced soft tissue sarcoma populations.
Speaker #5: Further, these overall survival observations are directionally consistent with prior experience in mutated KRAS non-small cell lung cancer from our other ongoing phase two trial of MECV and support its potentially utility as a treatment for solid tumors.
Speaker #5: The safety profile of MECV as a monotherapy and in combination with an anti-PD-1 antibody was manageable and is consistent with conditional binding of the axial target restricted to the tumor microenvironment.
Speaker #5: No new safety signals were identified. I shall now hand it over to Rick to review the third quarter 2025 financials. Rick?
Speaker #6: Thank you, Eric. As of September 30, 2025, we had 8.3 million dollars in cash and cash equivalents. In October 2025, context therapeutics triggered a 2 million dollar milestone payment to us under the license agreement for the dual CAB Nectin 4 TCE.
Speaker #6: The payment was received recently and reflects continued progress in validation of bioAtla's differentiated T-cell engager platform. Of note, our third quarter cash and cash equivalents do not include this payment or any R&D funding from the collaboration.
Speaker #6: For the third quarter ended September 30, 2025, we reported a net loss of 15.8 million dollars compared to a net loss of 10.6 million dollars in the same quarter of 2024.
Speaker #6: Which included 11 million dollars in collaboration revenue from our license with context therapeutics. The increase in net loss was primarily due to the collaboration revenue recorded in 2024 and a 2.1 million dollar non-cash loss on warrant liability recorded in the third quarter of 2025.
Speaker #6: Related to warrants issued in the December 2024 financing, offset by decreases in R&D and G&A expense. Research and development, or R&D expenses, were a 9.5 million dollars for the quarter ended September 30, 2025, compared to 16.4 million dollars for the same quarter in 2024.
Speaker #6: The $6.9 million decrease was primarily driven by reduced program development costs due to prioritization of clinical programs; lower headcount-related expenses following the workforce reduction announced in March 2025; and lower non-cash stock-based compensation.
Speaker #6: We continue to expect R&D expenses to decline through the remainder of 2025 as we continue to concentrate resources on our prioritized programs. General and administrative, or G&A expenses, were a 4.2 million dollars for the quarter ended September 30, 2025, compared to 5.9 million dollars for the same quarter in 2024.
Speaker #6: The 1.7 million dollar decrease was primarily attributable to reduced personnel costs related to the workforce reduction in March 2025 and lower stock-based compensation expense.
Speaker #6: And now, back to
Speaker #6: Jay. Thank you,
Speaker #7: Rick, and thank you all for joining us today. As we look ahead, bioAtla is entering an exciting phase. Now, with FDA alignment on our phase three trial design for OPSCC, we are poised to begin enrolling our registrational phase three trial early next year.
Speaker #7: This program not only addresses a critical unmet need in oncology, but also represents a substantial commercial opportunity. In addition, we believe our dual CAB Epcam TCE program represents one of the broadest pan-cancer opportunities since PD-1.
Speaker #7: With the potential to treat over 1 million adenocarcinoma cancer patients per year in high unmet need areas. Not surprisingly, the potential of this program is attracting numerous early discussions with both investors and potential future partners.
Speaker #7: We expect the key clinical trial readout in the first half of next year with several important events related to this program throughout 2026. Finally, we remain focused on our prioritized programs for delivering meaningful therapies to patients and value to shareholders.
Speaker #7: We appreciate your support and look forward to sharing further updates in the exciting months ahead. With that, we will turn it back to the operator to take your
Speaker #7: questions. At this time, if you would like to
Speaker #8: ask a question, please press the star and one on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star two.
Speaker #8: Again, for your questions, that is star and one. We'll pause a moment to allow any questions to queue. Once again, that is star and one.
Speaker #8: We'll take our first question from Arthur Hay with CU. The line is
Speaker #8: open. Hey, good afternoon, Jay and
Speaker #9: team. Thanks for taking my question. So maybe for Eric, for the RR2 program, the phase three study design-wise, could you give us more color around what's the patient number side by the agency to getting accelerated approval readout there?
Speaker #9: And also, for the control arm, is there any stratification according to different treatments, the patient could receive?
Speaker #4: Thank you, Arthur. So your first question is about what would be the number of patients for an accelerated approval. And I want to refer everyone to slide 42 on our corporate deck, where we discuss the phase two meeting key outcomes.
Speaker #4: And here we talk about the pivotal trial design, where for full approval, we're looking at approximately 300 patients that are prospectively randomized and stratified.
Speaker #4: And for accelerated approval, it would be an interim analysis roughly about the time of the full enrollment of patients, but obviously that look would be much earlier.
Speaker #4: question is about stratification And then your second factors for the two arms. And we haven't disclosed that, but there we P16 would be one of them, and then it would have to do with local regional disease, yes or no.
Speaker #4: And again, stratification factors are to ensure that there's equal distribution of patients based on important prognostic factors across the two arms.
Speaker #3: Thanks, Eric. And maybe for the third one, 82, could you tell us a little bit more like what kind of data we can expect from next year?
Speaker #3: The readout-wise?
Speaker #4: Sure. As you know from the ESMO data set, we presented 35 patients, all receiving subcutaneous dosing, and then a pretty fulsome accounting of the patients and their experience on slide 23, which is the swimmer's plot showing the confirmed partial response.
Speaker #4: And the where we are in the dose escalation. For the next data output, we would anticipate it would be in the first half of next year.
Speaker #4: And we would be reporting a pretty comprehensively on the additional dose and schedule evaluations that we'll be doing over the course of the next few months.
Speaker #4: To try to provide a really fulsome accounting of the experience altogether. Jay, did you want to add?
Speaker #4: anything? No, I think
Speaker #2: Eric I don't really that captures what have anything to add on that. But I think certainly, I think we'll be able to meet the timeline of being in the first
Speaker #2: half. Okay.
Speaker #3: Awesome. Thanks. Thanks. Thanks, Jay. And congrats on the...
Speaker #3: progress. Yeah.
Speaker #2: Thank you, Arthur.
Speaker #8: Once more for your questions, that is star and one. We'll pause just a moment. And it does appear that there are no further questions at this time.
Speaker #8: I would now like to turn the call back to Jay Short for any additional or closing
Speaker #8: remarks. I'd just like to say, I think it's a
Speaker #2: very exciting time for the company. And we're very much looking forward to the key readouts that are just around the corner. So thank you for your continued support and for listening today.
Speaker #2: Bye-bye.