BioAtla Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: Early Phase I data for BA-3182, the dual‐conditionally binding EpCAM × CD3 T-cell engager, show acceptable tolerability and objective tumor reductions in seven heavily pretreated patients, with a Phase I data readout expected in H2 2025.
  • Positive Sentiment: OSV, the CABWAR2 ADC for metastatic HPV-positive head and neck cancer, achieved a 45% ORR and 11.6-month median OS versus 3.4% ORR and 4.4-month median OS for standard of care, and the FDA has signaled support for a pivotal randomized trial.
  • Positive Sentiment: Pipeline assets McVe (AXLE ADC) reported 67% and 59% one‐year and two‐year OS rates in KRAS-mutant NSCLC, while ivastatug showed potent antitumor activity with reduced immune‐mediated adverse events in refractory metastatic melanoma.
  • Negative Sentiment: Cash and cash equivalents declined to $18.2 million at June 30, 2025 from $49 million year‐end, with ongoing net losses and significant cash burn driving reliance on non‐dilutive funding and expense controls.
  • Positive Sentiment: BioAtla has reached a term sheet for a partnering deal on one Phase II asset and expects to close the transaction this year, bolstering funding for key clinical programs.
AI Generated. May Contain Errors.
Earnings Conference Call
BioAtla Q2 2025
00:00 / 00:00

There are 6 speakers on the call.

Operator

Day, everyone, and welcome to the Bio Atlas Second Quarter twenty twenty five 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.

Operator

We will be standing by if you should need any assistance. It's my pleasure to turn today's conference over to Christy Grabowski with Life Science Advisors. Please go ahead.

Speaker 1

With me today on the phone from BioAlla are Doctor. Jay Short, Chairman, CEO and Co Founder and Richard Waldron, Chief Financial Officer. Following today's call, Doctor. Eric Sievers, Chief Medical Officer and Sherry Leitich, Chief Commercial Officer, will join Jay and Rick in a short Q and A. Earlier this afternoon, BioAtla released financial results and a business update for the second quarter ended 06/30/2025.

Speaker 1

A copy of the press release and corporate presentation are available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward looking statements, including but not limited to statements regarding BioAtlas business plans and prospects and whether its clinical trials will support registration, 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 and 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 ks 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, 08/07/2025, and BioAtlas disclaims any obligation to update such statements to reflect future information, events or circumstances, except as required by law.

Speaker 1

With that, I'd like to turn the call over to Doctor. Jay Short. Jay?

Speaker 2

Thank you, Christy, and thanks to everyone for joining us for our second quarter twenty twenty five BIOLLADLA 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 BA-three 182. We are encouraged with the progress of our Phase one dose escalation study and recently presented interim data at the ESMO GI and ESMO Targeted Anticancer Therapies Congresses.

Speaker 2

Based on preliminary data, BA-three thousand one hundred eighty two continues to be acceptably tolerated using a priming dose of zero point one milligrams followed with higher treatment doses. A strategy successfully employed with marketed T cell engagers. EA-three thousand one eighty two 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 zero point six milligrams, all five evaluable patients have achieved stable disease and continue on treatment. We are currently dosing the one point two milligram cohort and remain on track for a Phase one data readout expected in the second half of this year with a further expansion data readout anticipated in the 2026.

Speaker 2

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 Zepcam is widely expressed, BA-three 182 has the potential to serve over one 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 CABWAR2 ADC OSV. 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.

Speaker 2

In our cross trial comparison, OSV demonstrated a resounding ORR of forty five percent compared to only three point four percent for the standard of care using methotrexate, docetaxel, or cetuximab. OSV also showed median overall survival of eleven point six months, which is still ongoing compared to the standard of care of only four point four 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 OSV 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 three study in treatment refractory metastatic HPV positive oropharyngeal squamous cell carcinoma.

Speaker 2

We believe with our compelling ORR and OS data, we have an opportunity for accelerated approval followed by full approval. Regarding our pipeline assets, McVe and avastatung, we have compelling and differentiated emerging clinical profiles. McVe, our cab axle ADC has demonstrated exceptional overall survival among heavily pretreated patients with MKRAS non small cell lung cancer across multiple MKRAS variants with one year and two year landmark survival of sixty seven percent and fifty nine percent respectively to date. Axial expression is a fundamental driver of tumor resistance leading to poor patient outcomes and survival. MEKV 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.

Speaker 2

In addition, ivastatug, our CAB CTLA-four antibody has demonstrated potent antitumor activity with reduced immune mediated adverse events in the metastatic melanoma population who have experienced progression after adjuvant and neoadjuvant therapy regimens that include PD-one LAG-three and or CTLA-four. Now with respect to our corporate updates, BioAtlant intends to present its plan to NASDAQ to regain a sustained 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 one data on BA-three thousand one hundred eighty two. 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.

Speaker 2

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 twenty twenty five financials. Rick?

Speaker 3

Thank you, Jay. Research and development or R and D expenses were $13,700,000 for the quarter ended 06/30/2025 compared to 16,200,000.0 for the same quarter in 2024. The decrease of $2,500,000 was primarily due to a 1,200,000.0 decrease in headcount related expenses, including the impact of our workforce reduction announced in March 2025, a $600,000 decrease in program development expenses in 2025 due to program prioritization efforts implemented previously and our ongoing work on completing phase two trials in several indications, and a $600,000 decrease in non cash stock based compensation expense. We expect our R and D expenses to continue to decrease for the remainder of 2025 as we complete the phase two trials for several indications and focus our ongoing development on our prioritized programs. General and administrative, or G and A, expenses were $5,000,000 for the quarter ended 06/30/2025, compared to 5,800,000.0 for the same quarter in 2024.

Speaker 3

The $800,000 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 06/30/2025, was $18,700,000 compared to a net loss of $21,100,000 for the same quarter in 2024. Net cash used in operating activities for the six months ended 06/30/2025, was $30,400,000 compared to net cash used in operating activities of $50,000,000 for the same period in 2024. Cash used for the quarter ended 06/30/2025, was $14,100,000 including $600,000 in costs related to our workforce reduction. We expect our quarterly cash burn to decrease as we continue to close out phase two clinical trials for several indications.

Speaker 3

Cash and cash equivalents as of 06/30/2025 were $18,200,000 compared to $49,000,000 as of 12/31/2024. The company is primarily pursuing non dilutive funding through partnering with 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.

Speaker 2

Thank you, Rick. BioLatlet continues to progress our clinical trials as well as partnering discussions across our CAB platform. We are positioning our ROAR-two asset, OSV, for a planned Phase III study and will garner additional guidance during our scheduled meeting with the FDA later this quarter. We are also encouraged with our Phase one 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.

Speaker 2

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

Operator

We'll take our first question from Arthur He with HC. Please go ahead. Your line is open.

Speaker 4

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

Speaker 2

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

Speaker 5

Hi, Thank you for your question. We're looking at a variety of indications but colorectal cancer is particularly attractive given the very high FCAM expression across those tumors and it's also a very high expression per tumor with three 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.

Speaker 5

And we provided scans and showing a patient with thirteen percent reduction and now twenty one weeks without progression on study. So, that's another attractive indication.

Speaker 4

Gotcha. Thanks, Eric. And second question, speak of the colorectal cancer, I noticed so you have two patient has tumor reduction level. Just curious, have you guys disclosed which dose cohort, dose two patients are in?

Speaker 5

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 minus six percent, minus eight percent and minus ten percent. 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 five percent, to make a total of seven individuals that have had objective tumor size reductions.

Speaker 4

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

Speaker 2

We will be updating that possibly up 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'll be sometime in the second half here.

Speaker 4

Okay. Gotcha. Thanks. Thanks, Jay. I think that's it.

Speaker 4

Thanks for taking my question. Talk soon.

Operator

Keypad. We can pause for a moment to allow any further questions to queue. 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.

Speaker 2

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

Operator

This does conclude the Bio Atlas second quarter twenty twenty five earnings call. Thank you for your participation and you may now disconnect.

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