BioAtla Inc Aktie

Good day, everyone, and welcome to today's BioAtla Third Quarter 2025 Earnings Call. [Operator Instructions] 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; Sheri Lydick, 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 30, 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 BioAtla's 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 10-Q 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 III Oz-V 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 III 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 Oz-V 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 Mec-V, 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 ASMO. Finally, our Mec-V program continues to distinguish itself with the potential for increasing overall survival compared with approved treatments in soft tissue sarcoma recently presented at SITC. These overall survival data are analogous to the prolonged overall survival data we observed in mutant KRAS non-small cell lung cancer patients.

With that, I would now like to turn the call over to Sheri to provide an overview of the substantial market opportunity for Oz-V, our CAB-ROR2-ADC. Sheri?

Thank you, Jay, and good afternoon, everyone. Oz-V has demonstrated compelling clinical activity in heavily pretreated patients with HPV-positive OPSCC, a population with a poor prognosis. OPSCC is a steadily growing indication, primarily driven by prior HPV infection.

Up to 80% of OPSCC cases in the U.S. are caused by HPV. And by 2030, OPSCC is projected to become the most common subtype of head and neck cancer in the U.S. 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 advancing new therapies. From a commercial perspective, the opportunity is significant. We estimate worldwide peak sales of Oz-V to be approximately $800 million in second line and later OPSCC alone.

The total worldwide OPSCC market is projected to reach $3 billion by 2032. And when you consider the broader HPV-positive solid tumor market, including cervical cancer, the value exceeds $7 billion globally. We continue preparations for enabling initiation of the Phase III study with the goal of advancing the study with a strategic partner early next year.

With that, I would now like to turn the call over to Eric for additional clinical and program updates. Eric?

Thank you, Sheri. Phase III trial preparations for Oz-V continue as we achieved alignment on the Phase III registrational trial design with the potential for accelerated approval followed by full approval with its dual endpoint design. Importantly, Oz-V offers a differentiated profile in HPV-positive OPSCC as overexpression of the ROR2, the target of the ADC is driven by oncoproteins associated with HPV infection forming a cancer access that is associated with poor prognosis and resistance to chemo and immunotherapies.

We have seen Oz-V's potential with our strong Phase II 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 with standard therapies. Beyond Oz-V, 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. 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.

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. We recently presented preliminary data from our Phase I trial with our Dual-CAB EpCAM T cell engager in advanced adenocarcinomas at the Annual 2025 European Society for Medical Oncology Congress.

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. This responding patient with intrahepatic cholangiocarcinoma, a particularly challenging cancer of the biliary tract, remains on treatment without progression now for more than 6 months.

We also remain encouraged by the performance of mecbotamab vedotin, or Mec-V. Data from our Phase II trial of Mec-V alone and in combination with nivolumab in patients with treatment refractory soft tissue sarcomas were recently presented at the Society for Immunotherapy of Cancer Annual Meeting.

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. Further, these overall survival observations are directionally consistent with prior experience in mutated KRAS non-small cell lung cancer from our other ongoing Phase II trial of Mec-V and support its potential utility as a treatment for solid tumors.

The safety profile of Mec-V as a monotherapy and in combination with an anti-PD-1 antibody was manageable and is consistent with conditional binding of the AXL target restricted to the tumor microenvironment. No new safety signals were identified.

I shall now hand it over to Rick to review the third quarter 2025 financials. Rick?

Thank you, Eric. As of September 30, 2025, we had $8.3 million in cash and cash equivalents. In October 2025, Context Therapeutics triggered a $2 million milestone payment to us under the license agreement for the Dual-CAB Nectin-4 TCE. The payment was received recently and reflects continued progress and 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. For the third quarter ended September 30, 2025, we reported a net loss of $15.8 million compared to a net loss of $10.6 million in the same quarter of 2024, which included $11 million 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 noncash loss on warrant liability recorded in the third quarter of 2025 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 $9.5 million for the quarter ended September 30, 2025, compared to $16.4 million for the same quarter in 2024. 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 noncash stock-based compensation.

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 $4.2 million for the quarter ended September 30, 2025, compared to $5.9 million for the same quarter in 2024. The $1.7 million decrease was primarily attributable to reduced personnel costs related to the workforce reduction in March 2025 and lower stock-based compensation expense.

And now back to Jay.

Thank you, 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 III trial design for OPSCC, we are poised to begin enrolling our registrational Phase III trial early next year. 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 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.

We expect a 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. 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 questions.

[Operator Instructions] We take our first question from Arthur He with H.C.

So maybe for Eric, for the R2 program, the Phase III study design-wise, could you give us more color around what's the patient number side by the agency to getting accelerated approval rate out there? And also for the control arm, is there any stratification according to different treatment that the patient receive?

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 in our corporate deck, where we discuss the Phase II meeting key outcomes. 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.

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. And then your second question is about stratification factors for the 2 arms. And we haven't disclosed that, but there p16 would be one of them, and then it would have to do with local regional disease, yes or no. And again, stratification factors are to ensure that there's equal distribution of patients based on important prognostic factors across the 2 arms.

And maybe for the BA3182, could you tell us a little bit more like what kind of data we could expect for next year, the readout wise?

Sure. So 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 in their experience on Slide 23, which is the swimmers plot showing the confirmed partial response 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, and we would be reporting pretty comprehensively on the additional dose and schedule evaluations that we'll be doing over the course of the next few months to try to provide a really fulsome accounting of the experience altogether. Jay, did you want to add anything?

No, I think that captures it, Eric. I don't really have anything to add on that. But I think -- certainly, I think we'll be able to meet the time line of being in the first half.

[Operator Instructions] And it does appear that there are no further questions at this time. I would now like to turn the call back to Jay Short for any additional or closing remarks.

I'd just like to say I think it's a 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. Bye-bye.

This does conclude today's program. Thank you for your participation. You may disconnect at any time, and have a wonderful rest of your day.

Good day, everyone, and welcome to the BioAtla Second Quarter 2025 Earnings Call. [Operator Instructions] And it is my pleasure to turn today's conference over to Kristy Grabowski with Life Science Advisors. Please go ahead.

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 Sheri Lydick, Chief Commercial Officer, will join Jay and Rick in a short Q&A.

Earlier this afternoon, BioAtla released financial results and a business update for the second quarter ended June 30, 2025. 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 and whether its clinical trials will support registration, timing of and ability to form collaborations and other strategic partnerships for selected assets, 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 expected 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 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 7, 2025, 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, Kristy, and thanks to everyone for joining us for our second quarter 2025 BioAtla earnings call.

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. Also, the posters and oral presentations, which were recently presented at various conferences are available on our website.

I will begin today's update with our dual conditionally binding EpCAM CD3 T cell engager, BA3182. We are encouraged with the progress of our Phase I dose escalation study and recently presented interim data at the ESMO GI and ESMO Targeted Anticancer Therapies Congresses. Based on preliminary data, BA3182 continues to be acceptably tolerated using a priming dose of 0.1 milligrams followed with higher treatment doses, a strategy successfully employed with marketed T cell engagers. BA3182 has demonstrated evidence of objective tumor reductions in 7 heavily pretreated adenocarcinoma patients across multiple solid tumors, including advanced widely metastatic cancers of the colon, breast, bile ducts, lung and pancreas.

Notably, in the most recent cohort receiving weekly subcutaneous doses of 0.6 milligrams, all 5 evaluable patients have achieved stable disease and continue on treatment. We are currently dosing the 1.2 milligram cohort and remain on track for a Phase I data readout expected in the second half of this year with a further dose expansion data readout anticipated in the first half of 2026. We continue to believe that our dual CAB EpCAM CD3 bispecific T cell engager could be at the forefront of a novel approach to harnessing the body's immune system to target and destroy cancer cells. Because EpCAM is widely expressed, BA3182 has the potential to serve over 1 million patients spanning a wide range of metastatic solid tumors, including cancers of the colon, lung, breast, pancreas and prostate, among others.

Next, regarding our CAB-ROR2-ADC Oz-V, last quarter, we reported compelling antitumor activity in patients with metastatic HPV-positive head and neck cancer. This is a large and growing patient population that is poorly served by the current standard of care and largely resistant to existing and emerging EGFR-related therapies. In our cross-trial comparison, Oz-V demonstrated a resounding ORR of 45% compared to only 3.4% for the standard of care using methotrexate, docetaxel or cetuximab. Oz-V also showed median overall survival of 11.6 months, which is still ongoing compared to the standard of care of only 4.4 months.

We previously received actionable FDA guidance on a pivotal trial in the second-line plus setting in head and neck cancer, whereby the agency conveyed support of a proposed pivotal randomized controlled trial of Oz-V monotherapy versus investigator's choice. This study would use the dual primary endpoints of ORR and OS. We now have a scheduled meeting with the FDA in the third quarter of this year for guidance on a proposed Phase III study in treatment refractory metastatic HPV-positive oropharyngeal squamous cell carcinoma. We believe with our compelling ORR and OS data, we have an opportunity for accelerated approval followed by full approval.

Regarding our pipeline assets, Mec-V and evalstotug, we have compelling and differentiated emerging clinical profiles. Mec-V, our CAB-AXL-ADC has demonstrated exceptional overall survival among heavily pretreated patients with mKRAS non-small cell lung cancer across multiple mKRAS variants with 1-year and 2-year landmark survival of 67% and 59%, respectively, to date. AXL expression is a fundamental driver of tumor resistance leading to poor patient outcomes and survival. Mec-V offers the potential opportunity to address the tumor resistance associated with IO or mKRAS inhibitor therapies and has an efficacy and safety profile that may allow it to work as either a monotherapy or as a combination therapy in refractory patients.

In addition, evalstotug, our CAB-CTLA-4 antibody, has demonstrated potent antitumor activity with reduced immune-mediated adverse events in a metastatic melanoma population who have experienced progression after adjuvant and neoadjuvant therapy regimens that include PD-1 LAG-3 and/or CTLA-4.

Now with respect to our corporate updates, BioAtla intends to present its plan to NASDAQ to regain and sustain compliance with listing requirements. As for our clinical communications, I am pleased to report our progress with the medical and scientific communities as acknowledged by our ongoing abstract acceptances at medical conferences. Additionally, we have an abstract accepted for poster presentation at the upcoming ESMO Annual Meeting in October, where we will present updated Phase I data on BA3182. We are progressing partnering discussions across our CAB portfolio given the strength and translatability of our technology and the advanced Phase II and Phase III-ready clinical stage of our assets. Notably, diligence has been successfully completed for one of these assets, and we are now at the term sheet stage. As a result, we believe that we are on track to close the transaction this year.

With that, I would now like to turn the call over to Rick to review the second quarter 2025 financials. Rick?

Thank you, Jay. Research and development or R&D expenses were $13.7 million for the quarter ended June 30, 2025, compared to $16.2 million for the same quarter in 2024. The decrease of $2.5 million was primarily due to a $1.2 million decrease in headcount-related expenses, including the impact of our workforce reduction announced in March 2025, a $0.6 million decrease in program development expenses in 2025 due to program prioritization efforts implemented previously and our ongoing work on completing Phase II trials in several indications and a $0.6 million decrease in noncash stock-based compensation expense. We expect our R&D expenses to continue to decrease for the remainder of 2025 as we complete the Phase II trials for several indications and focus our ongoing development on our prioritized programs.

General and administrative or G&A expenses were $5 million for the quarter ended June 30, 2025, compared to $5.8 million for the same quarter in 2024. The $0.8 million decrease was primarily due to lower stock-based compensation and lower headcount-related expenses related to our workforce reduction.

Net loss for the quarter ended June 30, 2025, was $18.7 million compared to a net loss of $21.1 million for the same quarter in 2024.

Net cash used in operating activities for the 6 months ended June 30, 2025, was $30.4 million compared to net cash used in operating activities of $50 million for the same period in 2024.

Cash used for the quarter ended June 30, 2025, was $14.1 million, including $0.6 million in costs related to our workforce reduction. We expect our quarterly cash burn to decrease as we continue to close out Phase II clinical trials for several indications.

Cash and cash equivalents as of June 30, 2025, were $18.2 million compared to $49 million as of December 31, 2024. The company is primarily pursuing nondilutive funding through partnering in the development and commercialization of certain CAB programs.

The company continues to take additional cash preservation measures by controlling expenses and monitoring encouraging progress for near-term milestone payments while progressing partnership discussions that support key clinical activities and readouts. These activities, along with upcoming data readouts from our EpCAM Phase I trial have the potential to lead to transformational value creation for the company and its stockholders. Now back to Jay.

Thank you, Rick. BioAtla continues to progress our clinical trials as well as partnering discussions across our CAB platform. We are positioning our ROR2 asset, Oz-V for a planned Phase III study, and we'll garner additional guidance during our scheduled meeting with the FDA later this quarter.

We are also encouraged with our Phase I dose escalation study evaluating our dual conditionally binding EpCAM and CD3 bispecific T cell engager and look forward to our Phase I data readout expected later this year. Finally, we continue to carefully manage our cash resources and remain confident that we will close one or more partnering transactions this year.

Thank you for your time today. With that, we will turn it back to the operator to take your questions.

[Operator Instructions] We'll take our first question from Arthur He with H.C.

So just a couple of questions on the EpCAM program. So regarding the expansion cohort study, have you guys decided which indication to go after? Or in other way, what kind of criteria or we are thinking about how to choose the indication wise?

Eric, you should grab that one.

Arthur, thank you for your question. We're looking at a variety of indications, but colorectal cancer is particularly attractive given the very high EpCAM expression across those tumors, and it's also a very high expression HER tumor with 3-plus staining. And there's a marked unmet need for patients with advanced metastatic colorectal cancer. And so while we've not formally made a decision, we are leaning in that direction. And I do want to also point out that cholangiocarcinoma is an attractive indication with very few available therapies, no approved therapies in the second-line setting, and we provided scans and showing a patient with 13% reduction and now 21 weeks without progression on study. So that's another attractive indication.

Got you. And second question, speak of the colorectal cancer. I noticed so you have 2 patients has tumor reduction level. Just curious, have you guys disclosed which dose cohort those 2 patients are in?

I'm happy to also take that, Arthur. On Slide 24 of our corporate deck, we've updated that to now have 3 patients with colorectal cancer with disease reduction of minus 6%, minus 8% and minus 10%. Some of those occurred with the IV dosing before we shifted to subcutaneous dosing. And we've also added another patient with pancreas cancer, minus 5% to make a total of 7 individuals that have had objective tumor size reductions.

I see. How about the corresponding dosing cohort for the...

We will be updating that possibly -- we'll be updating it later this year. We also are presenting at ESMO in October, but I don't know whether we'll do it there or a little bit later in the year, but it will be sometime in the second half here.

[Operator Instructions] And there are no further questions on the line at this time. I'll turn the program back to our presenters for any additional or closing remarks.

I'd like to say that I'm looking forward to the feedback from the FDA on the Oz-V asset. Also looking forward to [ EpCAM ] readouts. And I'm very pleased that we've been able to agree with a partner on the major terms for -- term sheet for partnership with one of our Phase II assets. And so we appreciate you taking the time today, and we look forward to continuing to our next call.

This does conclude the BioAtla Second Quarter 2025 Earnings Call. Thank you for your participation, and you may now disconnect.