NASDAQ:BCAB BioAtla Q1 2025 Earnings Report $3.69 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$3.72 +0.04 (+0.95%) As of 05/22/2026 04:32 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast BioAtla EPS ResultsActual EPS-$14.50Consensus EPS -$14.00Beat/MissMissed by -$0.50One Year Ago EPSN/ABioAtla Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ABioAtla Announcement DetailsQuarterQ1 2025Date5/6/2025TimeAfter Market ClosesConference Call DateTuesday, May 6, 2025Conference Call Time4:30PM ETUpcoming EarningsBioAtla's Q2 2026 earnings is estimated for Thursday, August 6, 2026, based on past reporting schedules, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by BioAtla Q1 2025 Earnings Call TranscriptProvided by QuartrMay 6, 2025 ShareLink copied to clipboard.Key Takeaways In the Phase 1 dose escalation of BioAtlas’s EpCAM-CD3 bispecific T-cell engager, the maximum tolerated dose has not been reached, multiple patients have shown tumor reductions, the 100 µg cohort has cleared the toxicity window, and the first 300 µg patients are dosed with a mid-2025 data readout on track. The mavotamab vedotin (MACV) ADC demonstrated a 2-year landmark overall survival of 59% in KRAS-mutant NSCLC (versus <20% historical) and a 1-year survival of 73% in various soft tissue sarcomas, supporting a planned pivotal trial with Phase 2 data due in H1 2026. In heavily pretreated metastatic HPV-positive head and neck cancer, the vosoritamab vedotin (OSV) ADC achieved a 100% disease control rate and a 45% overall response rate, earning Fast Track designation and ongoing FDA discussions on a Phase 3 regimen. The abalastatug (CAB CTLA-4) antibody showed a 67% overall response rate and 92% disease control in metastatic cutaneous melanoma patients previously treated with PD-1 therapy, and partnering conversations are underway to position it as a best-in-class option. For Q1 2025, R&D expenses decreased to $12.4 M (from $18.9 M), net loss narrowed to $15.3 M (from $23.2 M), and cash stood at $32.4 M, with cost reductions and focused pipelines expected to fund operations into key H1 2026 clinical readouts. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallBioAtla Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good 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. I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Bruce Mackle with LifeSci Advisors. Please go ahead. Bruce MackleManaging Director at LifeSci Advisors00:00:30Thank you, Operator, and good afternoon, everyone. 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 first quarter ended March 31, 2025. A copy of the press release and corporate presentation are available on the company's website. Bruce MackleManaging Director at LifeSci Advisors00:01:13Before 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. Bruce MackleManaging Director at LifeSci Advisors00:02:19These 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 6, 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? Jay ShortCEO at BioAtla00:03:11Thank 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. Jay ShortCEO at BioAtla00:04:06Today, I will begin with our phase I 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 microgram 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. Jay ShortCEO at BioAtla00:05:01We continue to believe that our dual CAB 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 Ozuriftamab Vedotin continues to demonstrate exceptional overall survival at the 1.8 mg/kg Q2W dosing regimen with a two-year landmark survival of 59% in KRAS 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 two-year landmark survival of only less than 20%. We continue to observe a high correlation of AXL and KRAS expression, and the study follow-up is ongoing. Jay ShortCEO at BioAtla00:06:10A particular note, we recently observed a similar exceptional overall survival using McV across several subtypes of soft tissue sarcoma, including leiomyosarcoma, undifferentiated pleomorphic sarcoma, and liposarcoma, with a one-year landmark survival of 73%. Observing exceptional overall survival in two different heavily pretreated solid tumor types strengthens our conviction that McV 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 II data readout in the first half of 2026. Transitioning to the phase II 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. Jay ShortCEO at BioAtla00:07:18First, regarding our CAB-ROR2-ADC, OSV, 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 an ORR of only 0%-3.4% among HPV-positive head and neck cancer patients. As of the March 24th 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. Jay ShortCEO at BioAtla00:08:27We 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. 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 Ozuriftamab Vedotin 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. Jay ShortCEO at BioAtla00:09:32To 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 PD-1 adjuvant or neoadjuvant 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 for Cancer Research, and the ASCO Gastrointestinal Cancers Symposium. Additionally, we are invited to give a presentation at the upcoming PEX 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. Jay ShortCEO at BioAtla00:10:41Rick? Richard WaldronCFO at BioAtla00:10:42Thank 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 II trials for Ozuriftamab Vedotin, Ozuriftamab, and Evalstotug as we complete trials for certain indications. These decreases were partially offset by a $500,000 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 II 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. Richard WaldronCFO at BioAtla00:12:09The $0.3 million decrease was primarily due to lower stock-based compensation and lower D&O insurance premiums, offset by a $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. Richard WaldronCFO at BioAtla00:13:30We 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. Jay ShortCEO at BioAtla00:13:59Thank you, Rick. I'm encouraged with the progress across our CAB platform, particularly with our phase I dose escalation study evaluating our dual conditionally binding EpCAM and CD3 bispecific T cell engager. I'm also encouraged with the maturing phase II data sets, including the exceptional overall survival among patients treated with Ozuriftamab Vedotin, as well as the compelling anti-tumor activity demonstrated with ozuriftamab in 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. Operator00:14:50At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star two. Once more, for your questions, that is star and one. We'll pause a moment to allow questions to queue. Again, that is star and one. We'll take our first question from Jeet Mukherjee with BTIG. Your line is open. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:15:28Great. Thanks for taking the question. I was wondering, will the poster presentation for the ROR2 program at ASCO contain an updated data cut? For the EpCAM update in July, will we have data from the 300 microgram dose as well as the 900 microgram dose? Thanks. Jay ShortCEO at BioAtla00:15:46Eric, why don't you answer the first question? Eric SieversCMO at BioAtla00:15:51Are you inquiring about the OSV, the ROR2 ADC asset? Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:15:58That's correct. Yep. Eric SieversCMO at BioAtla00:16:00Yeah. We do have an updated data cut. We include additional safety data from the every other week dosing regimen of 1.8 mg/kg, and then we also will have some additional update on long-term outcomes. You had a second question about EpCAM, and I think there I would anticipate around a 25-30 patient update from our dose escalation data set, and that'll occur mid this year. Jay ShortCEO at BioAtla00:16:34I don't. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:16:35Got it. Jay ShortCEO at BioAtla00:16:35I don't think we have insight. We don't have insight at the 900 microgram level at this point as we get closer because it just depends on timing of patients. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:16:46Got it. Okay. 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. Jay ShortCEO at BioAtla00:17:01Eric, do you want to? Eric SieversCMO at BioAtla00:17:02Yeah, 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 the now eight 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. 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. Eric SieversCMO at BioAtla00:17:58I 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. That is kind of exciting, and we certainly have got some interesting discussions going on on the potential partnering front because of that potential acceleration. Eric SieversCMO at BioAtla00:18:22Yeah. And that's for the Ozuriftamab. Eric SieversCMO at BioAtla00:18:24That's Ozuriftamab, yeah, ROR2 ADC. Operator00:18:34We'll move next to Ren Benjamin with Citizens. Your line is open. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:18:41Hey, 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? I have a follow-up. Jay ShortCEO at BioAtla00:19:13This is great for Eric. Eric SieversCMO at BioAtla00:19:15Yeah. I'm going to answer this question with an attention that mid-year 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 eight 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 RECIST response. 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. 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. Eric SieversCMO at BioAtla00:20:31I think that the safety issues are really not concerning, and we continue to dose escalate. We have a lot of enthusiastic enrollers. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:20:43Great. Just regarding McV, 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 will 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? Jay ShortCEO at BioAtla00:21:23I think it's very exciting. The reason we're talking about landmark survivals is because we haven't hit the median survival yet. We're still above 50% and extending. I think the cross-trial comparison on slide 26 of the deck really emphasizes that, especially when you consider that our data have patients had three prior lines of therapy, whereas the other comparators are in second line, basically, and we're performing very well there. I think in addition, while we're focused more on lung, the sarcoma overall survival data was quite interesting. Here's another independent indication, different set of potential therapies downstream, and yet we're seeing a pretty and a really exceptional overall survival there across two different indications. Jay ShortCEO at BioAtla00:22:20I'll just remind everyone, this is where drugs fail, especially in non-small cell lung cancer, is in this overall survival quadrant. Wow, this is great. Eric SieversCMO at BioAtla00:22:31Yeah, Ren, 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. 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. Really, overall survival's the bottom line here. We have to do that. We have an antibody-drug conjugate approach for these mutated KRAS patients that express AXL at a very high rate. 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. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:23:38Got 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? Number two, I think that you mentioned that during the workforce cutting and trying to save your cash, you're going to focus on two internal programs. I'm counting three: the EpCAM, McV, and OSV. Can you just help clarify for me which are the two that you'll be focusing on moving forward? Jay ShortCEO at BioAtla00:24:21The head count reduction was to align with the number of programs that we're taking forward internally. 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. We selected two initially, the ROR2 and CTLA-4 programs for partnering. That doesn't mean we're not listening to potential partnerships for McV or the Axle asset, and we do have those kind of discussions going on. I think we're pretty enthusiastic about there's not a program that we dislike, really, but we have to focus. We focus the workforce. We're focusing at our internal versus external. Then you'd say the next part of your question, what's the ideal kind of partnership? Jay ShortCEO at BioAtla00:25:22I 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. With another one, I would say I'd be more leaning into something that generates substantial cash value between upfront and near-term milestones. Those combinations give us the power to help drive a phase three through either independently or with a partner. 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. While it's as we learned late last year in August when we thought we might close two partnerships, we guided one. Jay ShortCEO at BioAtla00:26:14We closed the smaller of the two, but I think we're in a good position to at least advance the partnerships here, and we remain optimistic, and we are managing our cash runway to make sure that we get into next year with some key readouts on top. Of course, milestones along the way are potential there. We may be able to add those as well. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:26:43Perfect. Thanks for taking the questions. Operator00:26:48Once again, for your questions, that is star and one. We'll move next to Arthur Hee with HC Wainwright. Your line is open. Arthur HeEquity Research VP at H.C. Wainwright & Co00:27:01Hey, good afternoon, Jay and Tee. Congrats on the progress. Just a couple of quick questions on the EpCAM program. When we are looking at the mid-year readouts from the dose escalation part, I'm sure we probably get the data from the 300 microgram cohort. How about the D cohort with the 3,100 and 300 microgram? That's question one. 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? Jay ShortCEO at BioAtla00:27:53I would say 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 on the courage where we're headed, and we're going to stick to this mid-year readout no matter where we are in that dose escalation. We want to give some visibility to the data. I'll let Eric add to this and also maybe comment on the D cohort as well. Eric SieversCMO at BioAtla00:28:20Sure. 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 open 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. We'll try to provide as fulsome of an update as we can at the medical congress. 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. Eric SieversCMO at BioAtla00:29:05As 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 the every other dosing every other week regimen. That's another possibility as well. Lots of optionality built into our protocol. Arthur HeEquity Research VP at H.C. Wainwright & Co00:29:28Gotcha. That's very helpful. The second another question is regarding the CRS control regimen. Could you tell us what's the regimen you guys are using to control the CRS in the study? Eric SieversCMO at BioAtla00:29:49Sure. 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. 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. 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. Eric SieversCMO at BioAtla00:30:48We 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. Arthur HeEquity Research VP at H.C. Wainwright & Co00:31:01Awesome. Thank you very much for the additional color. Yeah. Eric SieversCMO at BioAtla00:31:07You're welcome. Operator00:31:10It 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. Jay ShortCEO at BioAtla00:31:21Thank you for your attendance, and we look forward to communicating here very shortly again. Take care. Operator00:31:29This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful afternoon. Operator00:31:38Good.Read moreParticipantsExecutivesJay ShortCEORichard WaldronCFOEric SieversCMOAnalystsBruce MackleManaging Director at LifeSci AdvisorsRen BenjaminManaging Director at Citizens Capital Markets and AdvisoryArthur HeEquity Research VP at H.C. Wainwright & CoJeet MukherjeeVP and Biotechnology Analyst at BTIGPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) BioAtla Earnings HeadlinesBioAtla Announces Share ConsolidationMarch 31, 2026 | globenewswire.comBioAtla Reports Fourth Quarter and Full Year 2025 Financial Results and Business HighlightsMarch 31, 2026 | globenewswire.comTicker Revealed: Pre-IPO Access to "Next Elon Musk" CompanyWe’ve found The Next Elon Musk… and what we believe to be the next Tesla. It’s already racked up $26 billion in government contracts. Peter Thiel just bet $1 Billion on it. | Banyan Hill Publishing (Ad)BioAtla, Inc. Initiates Strategic Review Process and Workforce Restructuring to Enhance Shareholder ValueMarch 2, 2026 | quiverquant.comQBioAtla Announces Formal Process to Evaluate Strategic Options to Monetize AssetsMarch 2, 2026 | globenewswire.comBioAtla Faces Nasdaq Trading Suspension and Potential DelistingFebruary 6, 2026 | tipranks.comSee More BioAtla Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like BioAtla? Sign up for Earnings360's daily newsletter to receive timely earnings updates on BioAtla and other key companies, straight to your email. Email Address About BioAtlaBioAtla (NASDAQ:BCAB) (NASDAQ: BCAB) is a clinical‐stage biotechnology company focused on the development of conditionally active biologics (CABs) for oncology and other serious diseases. Utilizing its proprietary CAB technology platform, BioAtla engineers monoclonal antibodies, bispecifics and antibody-drug conjugates that remain inactive in healthy tissues but become activated in the tumor microenvironment. This targeted approach aims to improve therapeutic index by enhancing anti‐tumor potency while minimizing off-target effects and systemic toxicity. Founded in 2012 and headquartered in San Diego, California, BioAtla has advanced multiple product candidates into clinical trials. Lead programs include BA3011, a conditionally active antibody targeting cMet for solid tumors, and BA3071, a conditionally active T-cell–engaging bispecific targeting prostate‐specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer. The company’s research pipeline also features several discovery‐stage CAB molecules directed against tumor-associated antigens and immune checkpoints, reflecting its strategy to address high‐unmet‐need indications. BioAtla serves a global patient population through internal research and development operations in the United States and China. The company’s R&D infrastructure integrates molecular engineering, translational biology and preclinical pharmacology, enabling rapid optimization of CAB candidates. In addition to its internal programs, BioAtla has entered into strategic collaborations and licensing agreements to accelerate development and broaden the therapeutic reach of its platform. Led by President and Chief Executive Officer Christian S. Neal, BioAtla’s management team brings extensive experience in antibody engineering, clinical development and regulatory affairs. The company’s mission is to transform the safety and efficacy profile of biologic therapies by harnessing the precision of conditionally active molecules. As BioAtla advances its clinical portfolio, it aims to deliver innovative treatment options that improve patient outcomes and set new standards in targeted oncology therapy.View BioAtla ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Was Decker’s Double Beat a Bullish Signal—Or Mere HOKA’s-Pocus?Workday Validates AI Flywheel: Stock Price Recovery BeginsOverextended, e.l.f. Beauty Is Primed to Rebound in Back HalfDeere Beats Q2 Estimates, But Ag Weakness Weighs on OutlookNVIDIA Price Pullback? 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PresentationSkip to Participants Operator00:00:00Good 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. I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Bruce Mackle with LifeSci Advisors. Please go ahead. Bruce MackleManaging Director at LifeSci Advisors00:00:30Thank you, Operator, and good afternoon, everyone. 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 first quarter ended March 31, 2025. A copy of the press release and corporate presentation are available on the company's website. Bruce MackleManaging Director at LifeSci Advisors00:01:13Before 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. Bruce MackleManaging Director at LifeSci Advisors00:02:19These 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 6, 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? Jay ShortCEO at BioAtla00:03:11Thank 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. Jay ShortCEO at BioAtla00:04:06Today, I will begin with our phase I 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 microgram 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. Jay ShortCEO at BioAtla00:05:01We continue to believe that our dual CAB 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 Ozuriftamab Vedotin continues to demonstrate exceptional overall survival at the 1.8 mg/kg Q2W dosing regimen with a two-year landmark survival of 59% in KRAS 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 two-year landmark survival of only less than 20%. We continue to observe a high correlation of AXL and KRAS expression, and the study follow-up is ongoing. Jay ShortCEO at BioAtla00:06:10A particular note, we recently observed a similar exceptional overall survival using McV across several subtypes of soft tissue sarcoma, including leiomyosarcoma, undifferentiated pleomorphic sarcoma, and liposarcoma, with a one-year landmark survival of 73%. Observing exceptional overall survival in two different heavily pretreated solid tumor types strengthens our conviction that McV 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 II data readout in the first half of 2026. Transitioning to the phase II 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. Jay ShortCEO at BioAtla00:07:18First, regarding our CAB-ROR2-ADC, OSV, 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 an ORR of only 0%-3.4% among HPV-positive head and neck cancer patients. As of the March 24th 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. Jay ShortCEO at BioAtla00:08:27We 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. 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 Ozuriftamab Vedotin 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. Jay ShortCEO at BioAtla00:09:32To 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 PD-1 adjuvant or neoadjuvant 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 for Cancer Research, and the ASCO Gastrointestinal Cancers Symposium. Additionally, we are invited to give a presentation at the upcoming PEX 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. Jay ShortCEO at BioAtla00:10:41Rick? Richard WaldronCFO at BioAtla00:10:42Thank 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 II trials for Ozuriftamab Vedotin, Ozuriftamab, and Evalstotug as we complete trials for certain indications. These decreases were partially offset by a $500,000 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 II 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. Richard WaldronCFO at BioAtla00:12:09The $0.3 million decrease was primarily due to lower stock-based compensation and lower D&O insurance premiums, offset by a $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. Richard WaldronCFO at BioAtla00:13:30We 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. Jay ShortCEO at BioAtla00:13:59Thank you, Rick. I'm encouraged with the progress across our CAB platform, particularly with our phase I dose escalation study evaluating our dual conditionally binding EpCAM and CD3 bispecific T cell engager. I'm also encouraged with the maturing phase II data sets, including the exceptional overall survival among patients treated with Ozuriftamab Vedotin, as well as the compelling anti-tumor activity demonstrated with ozuriftamab in 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. Operator00:14:50At this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star two. Once more, for your questions, that is star and one. We'll pause a moment to allow questions to queue. Again, that is star and one. We'll take our first question from Jeet Mukherjee with BTIG. Your line is open. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:15:28Great. Thanks for taking the question. I was wondering, will the poster presentation for the ROR2 program at ASCO contain an updated data cut? For the EpCAM update in July, will we have data from the 300 microgram dose as well as the 900 microgram dose? Thanks. Jay ShortCEO at BioAtla00:15:46Eric, why don't you answer the first question? Eric SieversCMO at BioAtla00:15:51Are you inquiring about the OSV, the ROR2 ADC asset? Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:15:58That's correct. Yep. Eric SieversCMO at BioAtla00:16:00Yeah. We do have an updated data cut. We include additional safety data from the every other week dosing regimen of 1.8 mg/kg, and then we also will have some additional update on long-term outcomes. You had a second question about EpCAM, and I think there I would anticipate around a 25-30 patient update from our dose escalation data set, and that'll occur mid this year. Jay ShortCEO at BioAtla00:16:34I don't. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:16:35Got it. Jay ShortCEO at BioAtla00:16:35I don't think we have insight. We don't have insight at the 900 microgram level at this point as we get closer because it just depends on timing of patients. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:16:46Got it. Okay. 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. Jay ShortCEO at BioAtla00:17:01Eric, do you want to? Eric SieversCMO at BioAtla00:17:02Yeah, 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 the now eight 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. 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. Eric SieversCMO at BioAtla00:17:58I 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. That is kind of exciting, and we certainly have got some interesting discussions going on on the potential partnering front because of that potential acceleration. Eric SieversCMO at BioAtla00:18:22Yeah. And that's for the Ozuriftamab. Eric SieversCMO at BioAtla00:18:24That's Ozuriftamab, yeah, ROR2 ADC. Operator00:18:34We'll move next to Ren Benjamin with Citizens. Your line is open. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:18:41Hey, 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? I have a follow-up. Jay ShortCEO at BioAtla00:19:13This is great for Eric. Eric SieversCMO at BioAtla00:19:15Yeah. I'm going to answer this question with an attention that mid-year 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 eight 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 RECIST response. 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. 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. Eric SieversCMO at BioAtla00:20:31I think that the safety issues are really not concerning, and we continue to dose escalate. We have a lot of enthusiastic enrollers. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:20:43Great. Just regarding McV, 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 will 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? Jay ShortCEO at BioAtla00:21:23I think it's very exciting. The reason we're talking about landmark survivals is because we haven't hit the median survival yet. We're still above 50% and extending. I think the cross-trial comparison on slide 26 of the deck really emphasizes that, especially when you consider that our data have patients had three prior lines of therapy, whereas the other comparators are in second line, basically, and we're performing very well there. I think in addition, while we're focused more on lung, the sarcoma overall survival data was quite interesting. Here's another independent indication, different set of potential therapies downstream, and yet we're seeing a pretty and a really exceptional overall survival there across two different indications. Jay ShortCEO at BioAtla00:22:20I'll just remind everyone, this is where drugs fail, especially in non-small cell lung cancer, is in this overall survival quadrant. Wow, this is great. Eric SieversCMO at BioAtla00:22:31Yeah, Ren, 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. 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. Really, overall survival's the bottom line here. We have to do that. We have an antibody-drug conjugate approach for these mutated KRAS patients that express AXL at a very high rate. 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. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:23:38Got 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? Number two, I think that you mentioned that during the workforce cutting and trying to save your cash, you're going to focus on two internal programs. I'm counting three: the EpCAM, McV, and OSV. Can you just help clarify for me which are the two that you'll be focusing on moving forward? Jay ShortCEO at BioAtla00:24:21The head count reduction was to align with the number of programs that we're taking forward internally. 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. We selected two initially, the ROR2 and CTLA-4 programs for partnering. That doesn't mean we're not listening to potential partnerships for McV or the Axle asset, and we do have those kind of discussions going on. I think we're pretty enthusiastic about there's not a program that we dislike, really, but we have to focus. We focus the workforce. We're focusing at our internal versus external. Then you'd say the next part of your question, what's the ideal kind of partnership? Jay ShortCEO at BioAtla00:25:22I 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. With another one, I would say I'd be more leaning into something that generates substantial cash value between upfront and near-term milestones. Those combinations give us the power to help drive a phase three through either independently or with a partner. 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. While it's as we learned late last year in August when we thought we might close two partnerships, we guided one. Jay ShortCEO at BioAtla00:26:14We closed the smaller of the two, but I think we're in a good position to at least advance the partnerships here, and we remain optimistic, and we are managing our cash runway to make sure that we get into next year with some key readouts on top. Of course, milestones along the way are potential there. We may be able to add those as well. Ren BenjaminManaging Director at Citizens Capital Markets and Advisory00:26:43Perfect. Thanks for taking the questions. Operator00:26:48Once again, for your questions, that is star and one. We'll move next to Arthur Hee with HC Wainwright. Your line is open. Arthur HeEquity Research VP at H.C. Wainwright & Co00:27:01Hey, good afternoon, Jay and Tee. Congrats on the progress. Just a couple of quick questions on the EpCAM program. When we are looking at the mid-year readouts from the dose escalation part, I'm sure we probably get the data from the 300 microgram cohort. How about the D cohort with the 3,100 and 300 microgram? That's question one. 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? Jay ShortCEO at BioAtla00:27:53I would say 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 on the courage where we're headed, and we're going to stick to this mid-year readout no matter where we are in that dose escalation. We want to give some visibility to the data. I'll let Eric add to this and also maybe comment on the D cohort as well. Eric SieversCMO at BioAtla00:28:20Sure. 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 open 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. We'll try to provide as fulsome of an update as we can at the medical congress. 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. Eric SieversCMO at BioAtla00:29:05As 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 the every other dosing every other week regimen. That's another possibility as well. Lots of optionality built into our protocol. Arthur HeEquity Research VP at H.C. Wainwright & Co00:29:28Gotcha. That's very helpful. The second another question is regarding the CRS control regimen. Could you tell us what's the regimen you guys are using to control the CRS in the study? Eric SieversCMO at BioAtla00:29:49Sure. 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. 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. 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. Eric SieversCMO at BioAtla00:30:48We 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. Arthur HeEquity Research VP at H.C. Wainwright & Co00:31:01Awesome. Thank you very much for the additional color. Yeah. Eric SieversCMO at BioAtla00:31:07You're welcome. Operator00:31:10It 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. Jay ShortCEO at BioAtla00:31:21Thank you for your attendance, and we look forward to communicating here very shortly again. Take care. Operator00:31:29This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful afternoon. Operator00:31:38Good.Read moreParticipantsExecutivesJay ShortCEORichard WaldronCFOEric SieversCMOAnalystsBruce MackleManaging Director at LifeSci AdvisorsRen BenjaminManaging Director at Citizens Capital Markets and AdvisoryArthur HeEquity Research VP at H.C. Wainwright & CoJeet MukherjeeVP and Biotechnology Analyst at BTIGPowered by