BCAB

You all sites on hold. We appreciate your patience, and please continue to stand by. All sites on hold. We appreciate your patience, and please continue to stand by. Sites on hold. We appreciate your patience, and please continue to stand by. Good day, everyone, and welcome to today's BioAtla, Inc. Third Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. Later, you may have the opportunity to ask questions during the question and answer session. I will be standing by should you need any assistance. 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, Inc. are Dr. Jay M. Short, Chairman, CEO, and Co-founder; Dr. Eric L. Sievers, Chief Medical Officer; Sheri Lydick, Chief Commercial Officer; and Richard A. Waldron, Chief Financial Officer. Earlier this afternoon, BioAtla, Inc. released financial results and a business update for the quarter ended 09/30/2025. 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, Inc.'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, 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 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, 11/13/2025. And BioAtla, Inc. 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 M. Short. Jay?

Thank you, Julie. And thanks to everyone for joining us for our third quarter 2025 BioAtla, Inc. earnings call. First and foremost, it is important to update that we are 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 three OSV 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 three 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 OSV phase three study and remain on track to advance this program. We also recently presented compelling data with programs, including our dual CAB EpCAM TCE or BA 3182, and MACV. 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 BA 3182 recently presented at ESMO. Finally, our MEKV 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 Lydick to provide an overview of the substantial market opportunity for OSFI our CAB ROR2 ADC. Sheri?

Thank you, Jay, and good afternoon, everyone. OSFI 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 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. The unmet need is significant in current standards of care, 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 OSFI to be approximately $800 million in second-line and later, OPS 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 three 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 L. Sievers for additional clinical and program updates. Eric?

Thank you, Sheri. Phase three trial preparations for OSFI continue as we achieved alignment on the phase three registrational trial design with the potential for accelerated approval followed by full approval with its dual endpoint design. Importantly, OSV offers a differentiated profile in HPV-positive OPSCC. As overexpression of the ROR2, a target of the ADC, is driven by oncoproteins associated with HPV infection forming a cancer axis that is associated with poor prognosis and resistance to chemo and immunotherapies. 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 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. 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 one 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 six months. We also remain encouraged by the performance of mecobotamab vedotin, or MEKV. Data from our phase two trial of MEKV 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 two trial of MEKV and support its potential utility as a treatment for solid tumors. The safety profile of MEKV as a monotherapy and in combination with an anti-PD-1 antibody was manageable and is consistent with conditional binding of the axil target restricted to the tumor microenvironment. No new safety signals were identified. I shall now hand it over to Richard A. Waldron to review the third quarter 2025 financials. Rick?

Thank you, Eric. As of 09/30/2025, 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, Inc.'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 09/30/2025, 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 non-cash loss on warrant liability recorded in 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 09/30/2025, 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 announced in March 2025, and lower non-cash 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 09/30/2025 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, Inc. 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. 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 one 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 the key clinical trial readout in 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.

You may withdraw yourself from the queue at any time by pressing star 2. Star and 1. Once again, that is star and 1. We'll take our first question from Arthur Hayes with CU. Line is open.

Hey. Good afternoon, Jay and team. Thanks for taking my question. So maybe for Eric, for the ROR2 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 an accelerated approval readout there? And also, for the control arm, is there any stratification according to different treatments that the patient is going to 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 on our corporate deck where we discuss the phase two 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 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? And, again, stratification factors are to ensure that there's equal distribution of patients based on important prognostic factors across the two arms.

Thanks, Eric. And maybe for the 3182, could you tell us a little bit more, like, what kind of data we can expect here for next year? The readout-wise?

Sure. So as you know from the ESMO dataset, 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 and 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. Don't really have anything to add on that. But I think, you know, certainly, I think we'll be able to meet the timeline of being in the first half.

Okay. Awesome. Thanks. Thanks, Jay, and congrats on the progress.

Yeah. Thank you, Arthur. Once more for your questions, that is star and 1. We'll pause just a moment. And it does appear that there are no further questions at this time. I would now like to turn the call back to Jay M. Short for any additional or closing remarks.

I 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.

Good day, everyone, and welcome to today's BioAtla First Quarter 2025 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. [Operator Instructions] It is now my pleasure to turn the conference over to Mr. Bruce Mackle of LifeSci Advisors. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, Chairman, CEO, and Cofounder; 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 first quarter ended March 31, 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, plans 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 and expectations about the sufficiency of its cash and cash equivalents to fund operations and expected R&D 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 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, May 06, 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, Bruce, and thanks to everyone for joining us for our first 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, which were recently presented at the 2025 AACR annual meeting are available on our website. Just a few short weeks ago, I provided updates on our conditionally active biologic or CAB platform clinical programs that we are advancing internally at BioAtla, as well as the clinical programs we are currently advancing toward corporate partnerships. All of these CAB-based programs are designed to increase both the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need. Today, I will begin with our Phase one dose escalation study evaluating the dual conditionally binding EpCAM and CD3 T cell engager. As a brief update to our call in March, the study is progressing well and the maximally tolerated dose has not yet been reached. We continue to observe multiple patients achieving tumor reduction and tolerating the therapy over many months without progression. Further, all three patients in the 100 micrograms treatment dose cohort have cleared the dose limiting toxicity period. We have also dosed the first three patients at the treatment dose of 300 micrograms and we remain on track for our dose escalation clinical data readout in mid-2025. We also anticipate a data readout for the cohort expansion portion of the study in the first half of 2026. We continue to believe that our dual EpCAM CAB CD3 bispecific T cell engager has the potential to be at the forefront of a novel approach to harnessing the body's immune system to target and destroy cancer cells and has the potential to treat a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas and prostate among others. Next on to our CAB-AXL-ADC Mec-V. Mec-V continues to demonstrate exceptional overall survival at the 1.8 mg/kg Q2W dosing regimen with a 2-year landmark survival of 59% in mKRAS non-small cell lung cancer patients. This is particularly compelling given the previous studies among patients treated with standard of care agents have reported a 2-year landmark survival of only less than 20%. We continue to observe a high correlation of AXL and mKRAS expression and the study follow-up is ongoing. Of particular note, we recently observed a similar exceptional overall survival using Mec-V across several subtypes of soft tissue sarcoma including leiomyosarcoma, undifferentiated pleomorphic sarcoma and liposarcoma with a 1-year landmark survival of 73%. Observing exceptional overall survival in two different heavily pretreated solid tumor types strengthens our conviction that Mec-V is fundamentally improving the natural history of the disease, enabling patients to live considerably longer regardless of the subsequent treatment they receive. We remain focused on positioning this asset for a future pivotal trial with Phase 2 data readout in the first half of 2026. Transitioning to the Phase 2 clinical programs that are planned for advancement through corporate partnerships, we remain committed to aligning with a partner that can maximize the value of these assets, and we are very encouraged by our active discussions with multiple potential collaborators. First, regarding our CAB-ROR2-ADC, Oz-V, we continue to observe a compelling signal in patients with metastatic HPV positive head and neck cancer. This group of patients represents a significant and growing segment of the head and neck cancer population with high unmet need. This large patient population is currently poorly served by agents that inhibit EGFR as well as other standard of care agents. More specifically, other studies using standard of care agents have reported ORR of only 0% to 3.4% among HPV positive head and neck cancer patients. As of the March 24 data cutoff, 11 treatment refractory HPV positive head and neck patients who had three prior lines of therapy treated with the 1.8 mg/kg Q2W dosing regimen showed a remarkable 100% disease control rate, a 45% overall response rate with 27% confirmed to date. We continue to collect data on duration of response, median progression free survival and median overall survival, all of which are ongoing and we plan to share these data at an upcoming medical meeting. So far, we have received timely responses from the FDA and are now utilizing our Fast Track Designation for additional discussions with the FDA regarding treatment refractory metastatic HPV positive squamous cell carcinoma of the head and neck. We believe our extended experience with Q2W dosing of Oz-V also has the potential to satisfy Project Optimus requirements, and we plan to share our results with the FDA to seek confirmation regarding our proposed recommended Phase III treatment regimen. Moving now to our CAB-CTLA-4 antibody, evalstotug. Partnering discussions are ongoing and we continue to believe that evalstotug has the potential to be best-in-class with a differentiated clinical profile relative to other CTLA-4 antibodies. To date, we have observed a 67% overall response rate and a 92% disease control rate in 12 evaluable patients with metastatic cutaneous melanoma. These results are notable given that 10 of 12 patients had received prior PD1 adjuvant or neo adjuvant treatment. We look forward to sharing additional data updates at a medical meeting later this year. With respect to our ongoing clinical communications, I am pleased to report our progress with the medical and scientific communities as acknowledged with ongoing abstract acceptances at prestigious conferences, including the American Society of Clinical Oncology, the American Association of Cancer Research and the Asthma Gastrointestinal Cancers Congress. Additionally, we are invited to give a presentation at the upcoming PEGS conference around our dual CAB EpCAM and CAB CD3 bispecific T cell engager. With that, I would now like to turn the call over to Rick to review the first quarter 2025 financials. Rick?

Thank you, Jay. Research and development or R&D expenses were $12.4 million for the quarter ended March 31, 2025, compared to $18.9 million for the same quarter in 2024. The decrease of $6.5 million was primarily due to lower clinical development expenses in 2025 for our Phase 2 trials for mecbotamab vedotin, ozuriftamab vedotin and evalstotug as we complete trials for certain indications. These decreases were partially offset by a $0.5 million charge related to our workforce reduction announced in March 2025. We expect our R&D expenses to continue to decrease for the remainder of 2025 due to our recent restructuring and as we complete Phase 2 trials for several indications and focus our ongoing development on our prioritized programs. General and administrative or G&A expenses were $5.3 million for the quarter ended March 31, 2025, compared to $5.6 million for the same quarter in 2024. The $0.3 million decrease was primarily due to lower stock-based compensation and lower D&O insurance premiums offset by $100,000 charge related to our workforce reduction announced in March 2025. Net loss for the quarter ended March 31, 2025, was $15.3 million compared to a net loss of $23.2 million for the same quarter in 2024. Net cash used in operating activities for the quarter ended March 31, 2025, was $16.3 million compared to net cash used in operating activities of $30.8 million for the same period in 2024. Cash used for the quarter ended March 31, 2025 was $16.7 million. Cash and cash equivalents as of March 31, 2025, were $32.4 million compared to $49 million as of December 31, 2024. We expect that the significant cost reductions to be subsequently realized from our realignment of resources and focus on our two internal priority programs will provide the company with sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026, excluding any funds from potential new partnerships. Now back to Jay.

Thank you, Rick. I'm encouraged with the progress across our CAB platform, particularly with our Phase 1 dose escalation study evaluating our dual conditionally binding EpCAM and CD3 bispecific T cell engager. I'm also encouraged with the maturing Phase 2 data sets, including the exceptional overall survival among patients treated with Mec-V as well as the compelling antitumor activity demonstrated with Oz-V and HPV positive head and neck cancer. These assets continue to be differentiated in some of the most challenging solid tumor types and have the potential to make a meaningful impact for patients suffering from these debilitating cancers. With that, we will turn it back to the operator to take your questions.

Thank you. [Operator Instructions] We'll take our first question from Jeet Mukherjee with BTIG. Your line is open.

Great. Thanks for taking the question. I was wondering, will the poster presentation for the ROR2 program at ASCO contain an updated data cut? And for the EpCAM update in July, will we have data from the 300 microgram dose as well as the 900 microgram dose? Thanks.

Eric, why don't you answer the first question?

So the first question, are you inquiring about the Oz-V the ROR2-ADC asset?

That's correct. Yes.

Yes. So we do have an updated data cut. We include any additional safety data from every other week dosing regimen of 1.8 mg/kg. And then we also will have some additional update on long term outcomes. And then you had a second question about EpCAM. And I think there, I would anticipate around the 25 to 30 patient update from our dose escalation data set, and that will occur mid this year.

And I don't think we have insight at the 900 microgram level at this point as we get closer. So it just depends on timing of patients.

Got it. Okay. And if I could just ask a follow-up, just any thoughts on a pivotal design for the AXL program and options for accelerated approval that might be there? Thanks.

Yes, we can talk a little bit about the AXL program. I think the key finding there is a remarkable overall survival. And I think that's nicely illustrated on Slide 26, of our corporate deck, where, with all the caveats, we're looking cross trial comparison. You can see that the now 8 patients with an extended overall survival of 18 months or more. And it's really a striking difference compared to the standard of care, which is docetaxel. So I think that the pivotal trial would likely be in second- and third-line patients with mutated KRAS non-small cell lung cancer randomized one to one against docetaxel. We've seen that approach employed by many sponsors, and we've received FDA guidance to that effect. They're supportive of that randomization.

I think from an accelerated approval standpoint, we think the ROR2 asset in head and neck cancer and second line plus probably does have that opportunity in HPV positive patients. So that's kind of exciting, and we certainly got some interesting discussions going on the potential partnering front because of that potential acceleration.

Yeah. And that's for the ozuriftamab.

We'll move next to Reni Benjamin with Citizens JMP. Your line is open.

Hey, guys. Thanks for taking the questions. I guess also starting off with maybe the EpCAM program, can you provide some color regarding the types of tumor regressions that you're seeing? Jay, I think in your prepared remarks, you mentioned you're seeing tumor regressions as well as patients being on therapy for months. Can you give us a range maybe of how long these patients have been on therapy and any toxicities of note that have been seen to date? Then I have a follow-up.

This is great for Eric.

Yes. So I'm going to answer this question with an attention that midyear will be provided a more fulsome update in the medical congress. There have been two individuals, both with colorectal adenocarcinoma, that have had a remarkably extended progression free interval, one for more than a year and another for about 8 months and ongoing. We have three patients that have double-digit tumor reductions. But I want to be clear that we haven't yet observed a formal resist response. And the maximally tolerated dose has not been reached. We continue dose escalation. We anticipate that the biologically optimal dose might be 200 micrograms or more. And then you also asked about safety. And I've been pleased by what we're seeing to date. I think our stepwise dosing approach that's consistent with how other marketed T cell engagers are given is working. So I think that the safety issues are really non-concerning, and we continue to dose escalate. We have a lot of enthusiastic enrollers.

Great. And then just regarding Mec-V, I guess I'm kind of curious as to how we should be thinking about these landmark survival curves that you have and the readouts that you're reading, especially as it compares to not just maybe the standard of care, but also as you guys probably look at other drugs in development, the competitive landscape as it's kind of evolving. Could you maybe give us a sense as to how you're viewing this data in regards to that?

Well, I think it's very exciting. We're seeing the reason we're talking about landmark survival is because we haven't hit the median survival yet. We're still above the yeah. We're still above 50% and extending. So, I think, the cross-traffic impairment on slide 26 that really emphasized especially when you consider that our data have patients have three prior lines of therapy whereas the other comparators have they're in second line basically and were performing very well there. And I think in addition, I really while we're not while we're focused more on lung, I think the Sarcoma overall survival data was quite interesting. Here's another independent indication, different set of, potential therapies downstream, and yet we're seeing pretty, and a really exceptional overall survival there, positive indications. And really this I'm just reminded everyone. This is where the drugs fail, especially in non-small cell lung cancer is in this overall surviving quadrant. And, this is great.

Yeah. Reni, maybe I'll just add a few points to that. Really looking at slide 26 and, the mutated KRAS non-small cell space is certainly changing with Revolution Medicine and others. But we also know that Sotorasib and their efforts to confirm clinical benefit were not successful. They had a non-evaluable trial for confirmation of clinical benefit. And really, overall survival is the bottom line here. We have to do that. So we have an antibody drug conjugate approach for these mutated KRAS patients that express AXL at a very high rate. And so I think it's interesting. Our approach is orthogonal to the new KRAS inhibitors that we're hearing about. I'm thrilled for patients that they have these options. But I think in the second line setting, our data are really standing quite strongly. And obviously they need to be confirmed in a prospective randomized trial.

Got it. Two other maybe just quick ones for me. One, you're talking about partnerships and discussions are ongoing. What does the ideal deal kind of look like for you guys? And number two, I think that you had mentioned that during the workforce cutting and trying to save your cash, you're going to focus on two internal programs. And I'm counting three, the EpCAM, and Oz-V. Can you just help clarify for me which are the two that you'll be focusing on moving forward?

Well, the headcount reduction was to align with the number of programs that we're taking forward internally. So we're obviously very excited about ROR2, but we also obviously can't take four programs even if they're all showing strong data through ourselves. So we selected two initially, the ROR2 and CTLA4 programs for partnering. That doesn't mean we're not listening to potential partnerships for Mec-V or the actual asset, and we do have those kind of discussions going on. So, I think that the so I think we're pretty enthusiastic about -- there's not a program that we dislike really, but we have to focus. And so we focus the workforce. We're focusing, on their internal versus external. And so the next part of your question, what's the ideal kind of partnership? You know, I think of it in terms of more than one partnership. And I think at least one of those partnerships, I'd like to see us be able to maintain substantial value in North America at least. And with another one, I would say I'd be more leaning into something that generates substantial cash value between upfront and near-term milestones. And so those combinations gives us the power to help drive a Phase 3 through either independently or with a partner. And so that combination is really what I'm looking for. And, we have those kinds of discussions underway that could deliver both of those types of things. So, you know, while it's as we learned last late last year in August where we thought we might close, two partnerships, we guided one. We closed the smaller of the two, but I think we're in a good position to at least advance some partnerships here. And we remain optimistic, and we are managing our cash runway to make sure that we get into next year and with some key readouts on top. And of course, milestones along the way and potential there, we may be able to add those as well.

Perfect. Thanks for taking the questions.

We'll move next to Arthur He with H.C. Wainwright. Your line is open.

Hey, good afternoon, Jay and T. Congrats on the progress. Just a couple of quick question on the EpCAM program. So we are looking at the middle year readouts from the dose escalation part. I'm sure we probably get the data from the 300 microgram cohort. So how about the D cohort with the 300 microgram? That's question one. And the question two is, when we had the readout for the dose escalation part, are you guys going to declare the expansion cohort dose level?

I would say we're I don't think we'll be declaring it at that point, but, we'll allow our data to teach us that, because I think so far I've encouraged where we're headed. And we're going to stick to this midyear, readout, no matter where we are in that dose escalation, we're willing to get some visibility to the data. But will there be added to this and also maybe comment on the d cohort as well? Sure.

And so Arthur, you had two questions, and we'll do everything we can to include data from the d cohort that you see listed on slide 19. We reopen that because we have such interest in the program from investigators and patients. And we wanted to also explore that two-step dosing regimen, as well as the one step. So we'll try to provide us fulsome of an update as we can at the Medical Congress. And you asked the question about would we declare the dose for the expansion cohort. I would imagine that we would. But at this time, we haven't defined that dose yet. And so as Jay said, I'll just echo, we're letting the data really teach us about this drug, where we want to take it next, how we want to deliver it and whether we want to stick to this weekly dosing regimen or move to every other dosing -- every other week regimen, that's another possibility as well. So lots of optionality built into our protocol.

Got you. That's very helpful. And the another question is regarding the CRS control regimen. So could you tell us what's the regimen you guys are using to control the CRS in the study?

Sure. The approach that we're using is a pretty standard approach, and I want to emphasize the importance of step dosing, to give a relatively low dose and then subsequently a higher dose. We see that with marketed products, in particular, the marketed product for small cell lung cancer. The second is to really use industry standard approaches for CRS prevention. So patients are hospitalized. We follow them very closely. We do employ a tocilizumab prophylaxis strategy. And we really try to keep steroid use as modest as possible because steroids can affect T cell function as you know. And as you see on Slide 19, we've marched through the A, the B1, B2 all the way up through C1 up to C5 where we're dosing and then the D cohort as well. So, we continue to dose escalate. And I've been really pleased by what we're seeing and look forward to speaking to more data at an upcoming medical meeting.

Awesome. Thank you very much for the attention and color.

You're welcome.

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

Thank you for your attendance, and we look forward to communicating again very shortly again. So, take care.

[Operator Closing Remarks].