Bioatla - Earnings Call - Q2 2025

Transcript

Speaker 0

Good day, everyone, and welcome to the BioAtla second quarter 2025 earnings call. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. We will be standing by if you should need any assistance, 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.

Speaker 2

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 x CD3 T-cell engager BA3182. We are encouraged with the progress of our phase 1 dose escalation study and recently presented interim data at the ESMO GI and the ESMO Targeted Anti-Cancer Therapies Congress. 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 seven 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 five 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 1 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 x 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, ozuriftamab vedotin (OZV), last quarter we reported compelling anti-tumor 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, OZV demonstrated a resounding ORR of 45% compared to only 3.4% for the standard of care using methotrexate, docetaxel, or cetuximab. OZV 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 OZV 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 3 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, MCV and evalstotug, we have compelling and differentiated emerging clinical profiles.

MCV, our CAB-AXL ADC, has demonstrated exceptional overall survival among heavily pretreated patients with KRAS non-small cell lung cancer across multiple KRAS variants, with one-year and two-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. MCV offers the potential opportunity to address the tumor resistance associated with IO or KRAS 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 anti-tumor 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, LAG3, 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 1 data on BA3182. We are progressing partnering discussions across our CAB portfolio, given the strength and translatability of our technology and the advanced phase 2 and phase 3 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 a transaction this year.

With that, I would now like to turn the call over to Rick to review the second quarter of 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 2 trials in several indications, and a $0.6 million decrease in non-cash stock-based compensation expense. We expect our R&D expenses to continue to decrease for the remainder of 2025 as we complete the phase 2 trials with 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 six 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 2 clinical trials with 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 non-dilutive 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 1 trial, have the potential to lead to transformational value creation for the company and its stockholders. Now, back to Jay.

Speaker 0

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, ozuriftamab vedotin, for a planned phase 3 study and will garner additional guidance during our scheduled meeting with the FDA later this quarter. We are also encouraged with our phase 1 dose escalation study, evaluating our dual-conditionally binding EpCAM and CD3 bispecific T-cell engager, and look forward to our phase 1 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.

Speaker 3

Absolutely. At this time, if you would like to ask a question, please press the star and one keys on your telephone keypad. Keep in mind you may remove yourself from the question queue at any time by pressing star and two. Again, it is star and one if you'd like to ask a question today. We will pause for a moment to allow any questions to queue. We'll take our first question from Arthur He with H.C. Wainwright & Co. Please go ahead. Your line is open.

Speaker 4

Hey, good afternoon, Jay and team. Thanks for taking my question. Just a couple of questions on the EpCAM program. Regarding the expansion cohort study, have you guys decided which indication you go after, or in another way, what kind of criteria are you thinking about for how to choose the indication-wise?

Speaker 0

Eric, you should grab that one. Hi, Arthur.

Speaker 1

Hi, 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 per tumor with 3+ staining. There's a marked unmet need for patients with advanced metastatic colorectal cancer. While we've not formally made a decision, we are leaning in that direction. 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. We provided scans showing a patient with 13% reduction and now 21 weeks without progression on study. That's another attractive indication.

Speaker 4

Gotcha. Thanks, Eric. Second question, speaking of the colorectal cancer, I noticed you have two patients that have tumor reduction level. Just curious, have you guys disclosed which dose cohort those two patients are in?

Speaker 1

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

Speaker 4

I see. How about the corresponding dosing cohort? Was that correct?

Speaker 2

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

Speaker 4

Okay, gotcha. Thanks, Jay. I think that's it. Thanks for taking my question. Talk soon.

Speaker 3

If you'd like to ask a question today, please press the star and one keys on your telephone keypad. We can pause for a moment to allow any further questions to queue. 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.

Speaker 2

I'd like to say that I'm looking forward to the feedback from the FDA on the OZV asset. Also, looking forward to CRAM readouts, and I'm very pleased that we've been able to agree with a partner on the major terms for a term sheet for partnership with one of our phase 2 assets. We appreciate you taking the time today, and we look forward to continuing to our next call. Thank you.

Speaker 3

This does conclude the BioAtla second quarter 2025 earnings call. Thank you for your participation, and you may now disconnect.