NASDAQ:BCAB BioAtla Q4 2024 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-$16.00Consensus EPS -$20.00Beat/MissBeat by +$4.00One Year Ago EPSN/ABioAtla Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ABioAtla Announcement DetailsQuarterQ4 2024Date3/27/2025TimeAfter Market ClosesConference Call DateThursday, March 27, 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)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by BioAtla Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 27, 2025 ShareLink copied to clipboard.Key Takeaways The EpCAM CAB-TCE dose escalation is progressing without reaching a maximally tolerated dose and has shown early tumor reductions, with a Phase I readout expected mid-2025 and an expansion cohort update in H1 2026. The CABAXEL ADC in KRAS-mutant NSCLC at 1.8 mg/kg Q2W delivered multiple confirmed responses—including a >2-year complete response—and achieved 66% and 58% overall survival at one and two years, with median OS not reached and a favorable safety profile. In refractory head and neck cancer, the OSV ADC at 1.8 mg/kg Q2W achieved 100% disease control and a 45% objective response rate among HPV-positive patients, including a complete response ongoing beyond 16 months, supporting its $1 billion+ peak sales potential. Avacitag, a CTLA-4 CAB antibody plus PD-1 blockade, yielded a 64% response rate and 100% disease control in metastatic melanoma, with only 18% grade 3 immune-mediated AEs versus ~40% reported for ipilimumab, suggesting a differentiated safety and efficacy profile. Following >30% workforce reduction, BioAtla ended Q4 2024 with $49 million cash, reduced R&D and G&A expenses ($11.6 M and $4.6 M) and a net loss of $14.9 M, extending its cash runway beyond key mid-2026 clinical milestones. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallBioAtla Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00It is now my pleasure to turn the conference over to Mr. Bruce Mackle of LifeSci Advisors. Please go ahead, sir. Bruce MackleManaging Director of Investor Relations at LifeSci Advisors00:00:07Thank 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 fourth quarter and full year ended December 31, 2024. A copy of the press release and corporate presentation are available on the company's website. Bruce MackleManaging Director of Investor Relations at LifeSci Advisors00:00:43Before 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 of Investor Relations at LifeSci Advisors00:01:38These 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, March 27, 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 ShortChairman, CEO, and Co-founder at BioAtla00:02:23Thank you, Bruce, and thanks to everyone for joining us for our Fourth Quarter and Full Year 2024 BioAtla Earnings Call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the posters which were recently presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium and the European Lung Cancer Congress on our phase II assets, ozurithamab vedotin, or Oz-V, and mecbotamab vedotin, or Mec-V, respectively, are also available on our website. I will begin with updates on our conditionally active biologic, or CAB, platform clinical programs that we are advancing internally at BioAtla. All of these CAB-based programs are designed to efficiently increase the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need. Jay ShortChairman, CEO, and Co-founder at BioAtla00:03:23Beginning with our first-in-class dual conditionally binding CAB, EpCAM, and CAB-CD3 bispecific T-cell engager antibody. EpCAM is an attractive therapeutic target because it is widely expressed in most solid tumors. However, it has been a difficult target to drug with traditional antibody technologies because it is also widely expressed in normal epithelial tissues. EpCAM's ubiquitous expression in both tumors and normal tissues makes it generally undruggable without a differentiating technology like CABs. Successfully enabling the selective targeting of solid tumors with CAB technology offers the potential for developing one of the first pan-cancer therapies outside of immune checkpoint inhibitors. To date, our dose escalation is progressing well. As hoped, the maximally tolerated dose has not yet been reached, and multiple patients are already experiencing tumor reduction, including one colorectal cancer patient with continued stable disease for more than one year. Jay ShortChairman, CEO, and Co-founder at BioAtla00:04:32At present, three patients have received the target dose of 100 micrograms weekly. Two of these three patients have already cleared the dose-limiting toxicity period, and the third patient is on track to clear the DLT period on April 8th. We are now also screening patients for the next cohorts who are anticipated to receive the target dose of 300 micrograms. Details about the dosing schematic can be found in our corporate deck. It's worth noting that animal modeling data indicate that significant tumor reduction is expected to occur at target doses of approximately 200 micrograms and above, so we believe that we are reaching exposures where we will start observing formal objective responses. We remain on track for a data readout of the dose escalation portion of the study in mid-2025. Jay ShortChairman, CEO, and Co-founder at BioAtla00:05:22We also anticipate a data readout for the cohort expansion portion of the study in the first half of 2026. CAB T-cell engager bispecifics represent a novel approach to harnessing the body's immune system to target and destroy cancer cells, offering the promise of more precise and effective treatment options for cancer patients. We believe our dual CAB, EpCAM, and CAB-CD3 T-cell engager has the potential to be at the forefront of this exciting and powerful approach and has the potential to treat a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas, and prostate, among others. Now moving on to CAB AXL ADC, Mec-V. Last quarter, we announced that we are observing ongoing anti-tumor activity with multiple confirmed responses among 21 evaluable patients with tumors expressing mKRAS across nine different KRAS mutations. Jay ShortChairman, CEO, and Co-founder at BioAtla00:06:27As part of today's update, we are excited to share promising results from the 1.8 mg/kg Q2W dosing cohort. From the 16 evaluable patients in this cohort, we have observed multiple confirmed responses across different mKRAS variants while also demonstrating an encouraging clinical benefit risk profile, as well as a patient who had a prior failure of sotorasib who experienced a partial response. In addition, a patient who achieved a complete response remains in complete response now for over two years. Importantly, our initial findings for overall survival continue to be compelling, as we are now seeing an exceptional overall survival with 66% and 58% of patients with mKRAS non-small cell lung cancer alive at a landmark of one year and two years, respectively, which we believe exceeds what has been observed with the standard of care. Jay ShortChairman, CEO, and Co-founder at BioAtla00:07:24The median overall survival has not been reached at 35 months from the first dose, with continued follow-up ongoing. Mec-V is associated with a generally well-tolerated safety profile, both with and without nivolumab, and no new safety signals have been identified. Notably, the drug-related treatment discontinuation rate was only 7%. We are presenting these data at the European Lung Cancer Congress and encourage you to visit the poster on our website. Based on our evaluation of patients with mutant KRAS non-small cell lung cancer, we continue to observe a high correlation of AXL and mKRAS expression and believe the mechanistic link between AXL and mKRAS that drives tumor resistance, coupled with the exceptional overall survival that we are seeing in the Q2W dosing cohort, supports a potential anti-AXL pan mKRAS strategy. Jay ShortChairman, CEO, and Co-founder at BioAtla00:08:24Now I'd like to pivot to the phase II clinical programs that we are currently advancing toward corporate partnerships, beginning with our CAB ROR2 ADC, Oz-V, which is being evaluated as a monotherapy in treatment refractory head and neck cancer patients. Last quarter, we reported an emerging clinical profile in treatment refractory patients with a median of three prior lines of therapy, with the potential to become the standard of care in the second-line plus head and neck cancer population. Additionally, we shared that we received a fast-track designation and actionable guidance from the FDA on our proposed randomized pivotal trial design with Oz-V monotherapy versus investigators' choice among patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-based chemotherapy and PD-1 antibody therapy. Jay ShortChairman, CEO, and Co-founder at BioAtla00:09:22As part of today's update, the fully enrolled phase II study using Oz-V monotherapy continues to demonstrate new responses in treatment refractory second-line plus head and neck cancer at the 1.8 mg/kg Q2W dosing regimen. We also continue to capture efficacy data for several endpoints, including overall response rate, duration of response, progression-free survival, and overall survival. A particular interest is that we have observed a compelling signal in patients with metastatic HPV-positive head and neck cancer who represent a high unmet need as they are poorly served by agents that inhibit EGFR. These new data, as well as evolving data in the overall head and neck cancer cohort, were presented as a poster today at the Mayo Multidisciplinary Head and Neck Cancer Symposium. Jay ShortChairman, CEO, and Co-founder at BioAtla00:10:21To highlight, among the 11 patients with HPV-positive head and neck cancer treated with 1.8 mg/kg Q2W, there was a 100% disease control rate, a 45% overall response rate, and so far a 27% confirmed response rate with a duration of response greater than 5.3 months that is ongoing. Multiple patients remain on treatment and have the potential to have responses that deepen with time. It is noteworthy that an HPV-positive patient achieved a complete response that continues in complete remission, now at greater than 16 months and ongoing. We believe Oz-V, especially at the 1.8 mg/kg Q2W dose, has been remarkably well tolerated, and there are no new identified safety findings. Jay ShortChairman, CEO, and Co-founder at BioAtla00:11:16Further, these results in HPV-positive head and neck cancer are mechanistically supported by recent literature showing that HPV-associated oncogenes upregulate ROR2 expression, driving proliferation and invasiveness, thus now providing a compelling rationale for also targeting ROR2 in cancers associated with human papillomavirus infection. 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. We are encouraged by the differentiated findings in second-line plus head and neck cancer patients, particularly in both HPV-negative and HPV-positive patients. For partners, the second-line plus population represents a worldwide commercial opportunity of greater than $1 billion in peak sales, with upside opportunity in the first-line setting, as well as in other HPV-positive cancers. Moving now to our CAB-CD4 antibody evalstotug. Jay ShortChairman, CEO, and Co-founder at BioAtla00:12:32Evalstotug is similar to Ipi with respect to epitope, affinity, and half-life, but differs from Ipi with respect to its ability to avoid binding in the normal tissue environment. As part of today's update, we have dosed a total of 12 patients with unresectable and/or metastatic melanoma, eight of whom received 5 mg/kg, three were dose escalated to 10 mg/kg, and one dose escalated all the way to 14.3 mg/kg. While we continue to observe compelling anti-tumor activity with a differentiated safety profile, 10 of the 11 evaluable patients showed tumor reduction, and with the 11 showing no growth to date. Of these 11 evaluable patients with unresectable and/or metastatic melanoma treated with evalstotug in combination with the PD-1 antibody, so far we observe across multiple doses an overall response rate of 64% and disease control rate of 100%. Jay ShortChairman, CEO, and Co-founder at BioAtla00:13:36Notably, we observe a partial response in a patient with acral, subungual, or under-the-fingernail melanoma, which is a rare and difficult-to-treat form of melanoma that generally has a poorer prognosis than cutaneous melanoma. The safety profile of evalstotug continues to be differentiated with a relatively low incidence and severity of immune-mediated AEs, particularly among patients who received 5 mg/kg for less than or equal to 18 weeks in a total of 17 patients. Focusing on these 17 patients, we observed 18% grade 3 immune-mediated adverse events and no grade 4 events while maintaining strong efficacy. This safety profile compares favorably to ipilimumab with a reported rate of 40% grade 3 and 4 immune-mediated adverse events. We believe evalstotug has demonstrated a differentiated clinical profile relative to other CTLA-4 antibodies and has the potential to be best in class. Jay ShortChairman, CEO, and Co-founder at BioAtla00:14:46As such, we have recently initiated partnering discussions with the intent to align with a partner that can maximize the value of this asset. Onto our ongoing clinical communications. I am pleased to report our progress with the medical and scientific communities, as acknowledged with numerous publications and presentations at prestigious conferences, including the European Lung Cancer Congress, Mayo Multidisciplinary Head and Neck Symposium, and the American Society of Clinical Oncology. Finally, for our corporate updates, BioAtla is further extending our runway beyond key clinical readouts in the first half of 2026 by streamlining and realigning resources, which includes a workforce reduction of over 30%. We estimate that we will incur approximately $0.6 million of one-time cash payments related to the workforce reduction, which will mostly be paid in the second quarter. Jay ShortChairman, CEO, and Co-founder at BioAtla00:15:52We intend to retain all employees essential for advancing our two internal priority programs, as well as supporting partnering of other clinical assets, which are improving with the ongoing data readouts. I also wish to express my deep appreciation and respect to our employees, both past and present, who have contributed so much with their creativity and hard work to advance these important cures for patients. With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2024 financials. Rick. Richard WaldronCFO at BioAtla00:16:30Thank you, Jay. Research and development, that is R&D, expenses were $11.6 million for the quarter ended December 31, 2024, compared to $22.7 million for the same quarter in 2023. Richard WaldronCFO at BioAtla00:16:51The decrease of $11.1 million was due to lower clinical development expenses in 2024 from the lower overall targeted enrollment across our clinical trials in 2024, resulting from our program prioritization in 2023. We expect our R&D expenses to continue to decrease overall in the first half 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 expenses were $4.6 million for the quarter ended December 31, 2024, compared to $5.9 million for the same quarter in 2023. The $1.3 million decrease was primarily due to lower stock-based compensation, personnel-related costs, and D&O insurance premiums. Net loss for the quarter ended December 31, 2024, was $14.9 million compared to a net loss of $26.9 million for the same quarter in 2023. Richard WaldronCFO at BioAtla00:18:24Net cash used in operating activities for the full year ended December 31, 2024, was $72 million compared to net cash used in operating activities of $104 million for the same period in 2023. Cash used for the quarter ended December 31, 2024, was $7.5 million. Cash and cash equivalents as of December 31, 2024, were $49 million compared to $111.5 million as of December 31, 2023. Excluding any potential future milestones, we believe that cost reductions to be subsequently realized from the realigning of resources and focus on our two internal priority programs further extends our runway beyond key clinical readouts in the first half of 2026. Jay ShortChairman, CEO, and Co-founder at BioAtla00:19:30Thank you, Rick. We are encouraged by the clinical outcomes observed from our evolving CAB program data sets, which continue to be differentiated in some of the most challenging solid tumor types. Jay ShortChairman, CEO, and Co-founder at BioAtla00:19:47As a result, we continue to advance multiple discussions with potential collaborators on our phase II assets, as well as initiate new ones. We believe the compelling results we are obtaining will serve as important catalysts, including our EpCAM T-cell engager program, and have the potential to be transformative for our patients and shareholders alike. Thank you for your attention and continued support. With that, we will turn it back to the operator to take your questions. Operator00:20:19Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We will pause for a moment to allow questions to queue. We will go first to Jeet Mukherjee at BTIG. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:20:55Great. Thanks for taking the question. Just in terms of the partnered programs, I noticed in the corporate deck you had mentioned the ROR2 program is in the process of partnering while CTLA-4 is initiating partnering. Could you perhaps just give a bit more color on where you are on these discussions and what's perhaps needed to get one or both across the finish line? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:21:16This is Jay. We have both advanced discussions and newer discussions. This HPV-positive data is pretty new to most of the people we're in discussions with, except for just a small number. We also expect additional interest prior to this report. We're pretty encouraged with the discussions that are underway. I think it covers a range, and I'm expecting some new participants to get involved as well. Because I think this has been a significant problem in the treatment of head and neck cancer is being able to add in effective treatments in these refractory HPV-positive patients. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:22:07Understood. Maybe if I could just ask a follow-up for the AXL program. I believe last time you were still analyzing some patient samples for both AXL and KRAS expression. In your hands, what percentage of patients are double positive for mutant KRAS and AXL? Have any patients on the study to date been treated with a pan-RAS inhibitor? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:22:32I'll share some of this question with Eric. I'll just start off by saying in our immunohistochemical analysis, we saw a bit over 70% that were positive across all types of mKRAS mutants. I think the G12C was, I think, 100%. Jay ShortChairman, CEO, and Co-founder at BioAtla00:22:57Also, we know that if you look at mRNA levels, that it's much, much higher than even that. It's a very strong correlation, keeping in mind that mRNA is likely to be more sensitive than immunohistochemical data. It's a very strong correlation. Further, there's a fundamental mechanistic alignment. You'll see if you refer to the corporate deck, you'll see that laid out there on slide 23 within that deck. Eric, you want to add anything to this? Eric SieversChief Medical Officer at BioAtla00:23:29Sure. Thank you, Jay. Thanks for the question, Jeet. On slide 24, we indicate that one of the patients had prior treatment with sotorasib, and they did experience a response. We did not treat anyone with a known prior exposure to a pan-KRAS inhibitor, which was your question. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:23:47Thank you. Operator00:23:48We will move next to Kelly Shi with Jefferies. Operator00:23:58Hi. This is Humphrey for Kelly. Thanks for taking my question. As you near-term data coming up with BA3182, just curious what kind of data we're expecting and have you reached a recommended phase II dose and what we're looking for in the next follow-up data and expansion portion of the study. Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:24:21Eric, you want to take that one? Eric SieversChief Medical Officer at BioAtla00:24:25Sure. Thank you, Kelly. I appreciate the question. On slide 19 of our recently released corporate deck, we have the BA3182 dose escalation schema. Just to remind everyone, this is the EpCAM targeted T-cell engager where it's conditionally binding both on the EpCAM arm and the CD3 T-cell binding arm to really drive the therapeutic window even further to benefit. This gives you a sense of the dose escalation. We've achieved cohorts A1, B1, and B2, and then we're moving up with a one-step priming dose and a two-step priming dose. Eric SieversChief Medical Officer at BioAtla00:25:07We're doing that concurrently. You can see there's a schema for cohorts C and D that are both enrolling concurrently. You asked about the recommended phase II dose. We think we're in a zone where we're seeing meaningful tumor control. As the animal model suggests that tumor reduction would occur right around 200 micrograms given weekly, it's really consistent with that. We are enthusiastic to be able to report more fully on this phase I data set in the coming months. I'll note that two of the three patients in cohort C4, as you see on the slide, have already cleared the DLT observation window, and the third patient will clear very shortly, as Jay just mentioned, in early April. Operator00:26:01We'll move next to Reni Benjamin with Citizens. Operator00:26:11Hi. This is Simon for Reni. Just a quick one on 3182 as well. Are there any partnership discussions ongoing for this asset? If so, are these contingent upon the mid-2025 data? Jay ShortChairman, CEO, and Co-founder at BioAtla00:26:26Sheri, you want to touch on that one? Sure. Sheri LydickChief Commercial Officer at BioAtla00:26:34Sure. Hi there. Thanks for the question. We currently have had interest in this program. Our goal is to get through phase I and also the expansion cohorts so that we have a data set that can really drive a lot of value for this program. While we've had interest, we're not at a point where we necessarily would engage in discussions until we have a look at what the dose escalation and expansion data look like. Sheri LydickChief Commercial Officer at BioAtla00:27:10Got it. Thank you for the color. Operator00:27:14Once again, if you would like to ask a question, please press star one on your telephone keypad. We will go next to Tony Butler with Rodman & Renshaw. Tony ButlerSenior Managing Director at Rodman & Renshaw00:27:25Thanks very much. Eric, one question on the HPV-positive patients for the head and neck cancer program. Were all of those patients that responded smokers? That's actually somewhat important. Jay, you had mentioned a partnering program, but in the deck again, it makes reference to moving toward discussions with mid-tier companies. I just wonder why that strategy, or is it in fact an argument such that the market opportunity may be somewhat smaller than a large pharma would engender and a mid-tier company would like very much? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:28:18Why don't I start with the last one, and then we'll go to the other one? We think that it's a billion-dollar opportunity, over a billion dollars in the second line. We did experience one larger company that indicated that they were wanting a multi-billion dollar opportunity. Jay ShortChairman, CEO, and Co-founder at BioAtla00:28:45We recognized from that discussion that maybe we'll add in more of the mid-tier companies. That is really where that is derived from. Let's face it, a $1 billion opportunity in a refractory patient population with a fairly efficient trial and a big differential from the standard of care is still pretty exciting. I would also note, even in the HPV-positive subpopulation, it is over $500 million risk-adjusted. I think either way you cut it, it is pretty good. You still have the opportunity to advance to first line, have the opportunity to advance to other indications as well. You are right in this regard, Tony, that we said we recognize that adding in some of these mid-tier players matters. Jay ShortChairman, CEO, and Co-founder at BioAtla00:29:38Actually, I would say it does matter because we're seeing some people that have capital but have really not been able to perform with their late-line drugs and are very interested in getting into some strong phase II compounds that can move to efficient phase III. Hopefully, that helps address some of it. It does. Tony ButlerSenior Managing Director at Rodman & Renshaw00:30:00Thank you, Jay. Eric SieversChief Medical Officer at BioAtla00:30:00Hey, Tony. You have a really interesting question about smokers amongst the patients that have the p16 positive protein on the HPV analysis. We have a total of 26 patients in this that had the HPV of 40 total. As you know, the HPV-negative patients were really more associated with smoking and alcohol exposure, the environmental exposure form. HPV is much more the oncogene-driven side with a particular unmet need amongst patients when they reached second and third line setting because of the lack of EGFR benefit. Eric SieversChief Medical Officer at BioAtla00:30:47I do not have the smoking correlation set up, but that is something I can try to obtain for you after the call. Thank you. I appreciate that. The key is whether it is smokers and non-smokers. That is really where I want to go with that HPV-positive cohort. Thank you. Yes, we have the smoking data. It is just we have not made a correlation with the HPV. It is a great question, and we will get right on it. Tony ButlerSenior Managing Director at Rodman & Renshaw00:31:16Thank you. Eric SieversChief Medical Officer at BioAtla00:31:18Thank you. Operator00:31:20We will move next to Arthur He with HC Wainwright. Arthur HeVP of Equity Research at H.C. Wainwright00:31:24Hey, good afternoon, Jay and team. Thanks for taking my question. I have three quick questions. First, for the EpCAM program, regarding the data coming this year, which kind of dose level of the data can we see? Can we go up to the 3,300 micrograms, sorry, microgram cohort data, or it's probably more at the lower dose levels? Jay ShortChairman, CEO, and Co-founder at BioAtla00:32:00Certainly the 300 we should have, assuming all the dosing goes well. Is there a chance to see 900 possibly if we do it in July? We'll just make sure. It also depends a little bit on patient recruitment, but I'm very comfortable that the 300 will be there and potentially higher. Arthur HeVP of Equity Research at H.C. Wainwright00:32:22Gotcha. Jay, when you're talking about 300, you mean 300 from both C and D arms, or just the C arms? Jay ShortChairman, CEO, and Co-founder at BioAtla00:32:31No, I'm talking about C. I think the D formally is just behind the other, but tends to reinforce. Yeah, I'm focused on C right at the moment. Arthur HeVP of Equity Research at H.C. Wainwright00:32:43Gotcha. Thanks for that. My second question is regarding the AXL program. Maybe correct me if I was wrong. Are you guys going to treat more patients in terms of the AXL program, or I mean, is there any more additional patient data we can see in the future? Jay ShortChairman, CEO, and Co-founder at BioAtla00:33:10I think our hope is, I mean, EpCAM is a priority right now because of many reasons and because of the safety that we're seeing, which we're liking, and the broad applicability. I mean, it's a pan-cancer drug, and it's hard to ignore how big this could be. With AXL, though, we see some advantage of being able to do a few more patients on that. Our hope is to add in a few more patients. They haven't been added yet. We're in the process of amending our trial to allow more patients. We're going to have a pretty good picture of what happens on EpCAM. Jay ShortChairman, CEO, and Co-founder at BioAtla00:33:47Our intent is to drive some additional patients there, but I will allow that EpCAM could turn into something so exciting that we may decide to double down there. For now, yes, that's our plan. Arthur HeVP of Equity Research at H.C. Wainwright00:33:59Gotcha. Thanks for that. My last question is regarding the BD or strategic-wise. Besides you think about to part out the ROR2 and CTLA-4 program, are you open to any other strategy to maximize the shareholder value? Jay ShortChairman, CEO, and Co-founder at BioAtla00:34:26Oh, yeah. I mean, we certainly would be open if a partner decided that they want to drive AXL instead of Oz-V, and both are pretty exciting. We're also always looking at backup strategies where partnering timing sometimes, as we've learned, can be hard to exactly forecast, but we're definitely doing both of those things. Arthur HeVP of Equity Research at H.C. Wainwright00:34:50Gotcha. Thanks for taking my question, and congrats on the progress. Jay ShortChairman, CEO, and Co-founder at BioAtla00:34:56I think they're coming in very nicely. I think it's kind of rare in this world where everything is working. Thank you. Arthur HeVP of Equity Research at H.C. Wainwright00:35:10Thank you. Operator00:35:11Thank you. It appears that we have no further questions at this time. I will now turn the program back over to Jay Short for any additional or closing remarks. Jay ShortChairman, CEO, and Co-founder at BioAtla00:35:20I just want to thank you all for your time. I think hopefully you've heard some of this data. We're pretty excited about the differentiation we're seeing in the ROR2 programs. EpCAM, we think we're pioneering there. We also think AXL is also, as well as CTLA-4, are showing the differentiation that we expected from CAB. I think that's going to translate into partnerships sooner than later. Thank you for your time. Operator00:35:51Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time.Read moreParticipantsExecutivesSheri LydickChief Commercial OfficerJay ShortChairman, CEO, and Co-founderRichard WaldronCFOEric SieversChief Medical OfficerAnalystsAnalyst at CitizensAnalyst at JefferiesBruce MackleManaging Director of Investor Relations at LifeSci AdvisorsArthur HeVP of Equity Research at H.C. WainwrightJeet MukherjeeVP and Biotechnology Analyst at BTIGTony ButlerSenior Managing Director at Rodman & RenshawPowered by Earnings DocumentsPress Release(8-K)Annual report(10-K) 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.comYour book is insideThe "Sucker's Bet" Most New Options Traders Fall For Most people who try options lose money the same way. They don't know the rules. They don't know what to avoid. And they hand their account to Wall Street on a silver platter. Normally $29.97. Free today. | Profits Run (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 Operator00:00:00It is now my pleasure to turn the conference over to Mr. Bruce Mackle of LifeSci Advisors. Please go ahead, sir. Bruce MackleManaging Director of Investor Relations at LifeSci Advisors00:00:07Thank 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 fourth quarter and full year ended December 31, 2024. A copy of the press release and corporate presentation are available on the company's website. Bruce MackleManaging Director of Investor Relations at LifeSci Advisors00:00:43Before 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 of Investor Relations at LifeSci Advisors00:01:38These 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, March 27, 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 ShortChairman, CEO, and Co-founder at BioAtla00:02:23Thank you, Bruce, and thanks to everyone for joining us for our Fourth Quarter and Full Year 2024 BioAtla Earnings Call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the posters which were recently presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium and the European Lung Cancer Congress on our phase II assets, ozurithamab vedotin, or Oz-V, and mecbotamab vedotin, or Mec-V, respectively, are also available on our website. I will begin with updates on our conditionally active biologic, or CAB, platform clinical programs that we are advancing internally at BioAtla. All of these CAB-based programs are designed to efficiently increase the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need. Jay ShortChairman, CEO, and Co-founder at BioAtla00:03:23Beginning with our first-in-class dual conditionally binding CAB, EpCAM, and CAB-CD3 bispecific T-cell engager antibody. EpCAM is an attractive therapeutic target because it is widely expressed in most solid tumors. However, it has been a difficult target to drug with traditional antibody technologies because it is also widely expressed in normal epithelial tissues. EpCAM's ubiquitous expression in both tumors and normal tissues makes it generally undruggable without a differentiating technology like CABs. Successfully enabling the selective targeting of solid tumors with CAB technology offers the potential for developing one of the first pan-cancer therapies outside of immune checkpoint inhibitors. To date, our dose escalation is progressing well. As hoped, the maximally tolerated dose has not yet been reached, and multiple patients are already experiencing tumor reduction, including one colorectal cancer patient with continued stable disease for more than one year. Jay ShortChairman, CEO, and Co-founder at BioAtla00:04:32At present, three patients have received the target dose of 100 micrograms weekly. Two of these three patients have already cleared the dose-limiting toxicity period, and the third patient is on track to clear the DLT period on April 8th. We are now also screening patients for the next cohorts who are anticipated to receive the target dose of 300 micrograms. Details about the dosing schematic can be found in our corporate deck. It's worth noting that animal modeling data indicate that significant tumor reduction is expected to occur at target doses of approximately 200 micrograms and above, so we believe that we are reaching exposures where we will start observing formal objective responses. We remain on track for a data readout of the dose escalation portion of the study in mid-2025. Jay ShortChairman, CEO, and Co-founder at BioAtla00:05:22We also anticipate a data readout for the cohort expansion portion of the study in the first half of 2026. CAB T-cell engager bispecifics represent a novel approach to harnessing the body's immune system to target and destroy cancer cells, offering the promise of more precise and effective treatment options for cancer patients. We believe our dual CAB, EpCAM, and CAB-CD3 T-cell engager has the potential to be at the forefront of this exciting and powerful approach and has the potential to treat a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas, and prostate, among others. Now moving on to CAB AXL ADC, Mec-V. Last quarter, we announced that we are observing ongoing anti-tumor activity with multiple confirmed responses among 21 evaluable patients with tumors expressing mKRAS across nine different KRAS mutations. Jay ShortChairman, CEO, and Co-founder at BioAtla00:06:27As part of today's update, we are excited to share promising results from the 1.8 mg/kg Q2W dosing cohort. From the 16 evaluable patients in this cohort, we have observed multiple confirmed responses across different mKRAS variants while also demonstrating an encouraging clinical benefit risk profile, as well as a patient who had a prior failure of sotorasib who experienced a partial response. In addition, a patient who achieved a complete response remains in complete response now for over two years. Importantly, our initial findings for overall survival continue to be compelling, as we are now seeing an exceptional overall survival with 66% and 58% of patients with mKRAS non-small cell lung cancer alive at a landmark of one year and two years, respectively, which we believe exceeds what has been observed with the standard of care. Jay ShortChairman, CEO, and Co-founder at BioAtla00:07:24The median overall survival has not been reached at 35 months from the first dose, with continued follow-up ongoing. Mec-V is associated with a generally well-tolerated safety profile, both with and without nivolumab, and no new safety signals have been identified. Notably, the drug-related treatment discontinuation rate was only 7%. We are presenting these data at the European Lung Cancer Congress and encourage you to visit the poster on our website. Based on our evaluation of patients with mutant KRAS non-small cell lung cancer, we continue to observe a high correlation of AXL and mKRAS expression and believe the mechanistic link between AXL and mKRAS that drives tumor resistance, coupled with the exceptional overall survival that we are seeing in the Q2W dosing cohort, supports a potential anti-AXL pan mKRAS strategy. Jay ShortChairman, CEO, and Co-founder at BioAtla00:08:24Now I'd like to pivot to the phase II clinical programs that we are currently advancing toward corporate partnerships, beginning with our CAB ROR2 ADC, Oz-V, which is being evaluated as a monotherapy in treatment refractory head and neck cancer patients. Last quarter, we reported an emerging clinical profile in treatment refractory patients with a median of three prior lines of therapy, with the potential to become the standard of care in the second-line plus head and neck cancer population. Additionally, we shared that we received a fast-track designation and actionable guidance from the FDA on our proposed randomized pivotal trial design with Oz-V monotherapy versus investigators' choice among patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-based chemotherapy and PD-1 antibody therapy. Jay ShortChairman, CEO, and Co-founder at BioAtla00:09:22As part of today's update, the fully enrolled phase II study using Oz-V monotherapy continues to demonstrate new responses in treatment refractory second-line plus head and neck cancer at the 1.8 mg/kg Q2W dosing regimen. We also continue to capture efficacy data for several endpoints, including overall response rate, duration of response, progression-free survival, and overall survival. A particular interest is that we have observed a compelling signal in patients with metastatic HPV-positive head and neck cancer who represent a high unmet need as they are poorly served by agents that inhibit EGFR. These new data, as well as evolving data in the overall head and neck cancer cohort, were presented as a poster today at the Mayo Multidisciplinary Head and Neck Cancer Symposium. Jay ShortChairman, CEO, and Co-founder at BioAtla00:10:21To highlight, among the 11 patients with HPV-positive head and neck cancer treated with 1.8 mg/kg Q2W, there was a 100% disease control rate, a 45% overall response rate, and so far a 27% confirmed response rate with a duration of response greater than 5.3 months that is ongoing. Multiple patients remain on treatment and have the potential to have responses that deepen with time. It is noteworthy that an HPV-positive patient achieved a complete response that continues in complete remission, now at greater than 16 months and ongoing. We believe Oz-V, especially at the 1.8 mg/kg Q2W dose, has been remarkably well tolerated, and there are no new identified safety findings. Jay ShortChairman, CEO, and Co-founder at BioAtla00:11:16Further, these results in HPV-positive head and neck cancer are mechanistically supported by recent literature showing that HPV-associated oncogenes upregulate ROR2 expression, driving proliferation and invasiveness, thus now providing a compelling rationale for also targeting ROR2 in cancers associated with human papillomavirus infection. 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. We are encouraged by the differentiated findings in second-line plus head and neck cancer patients, particularly in both HPV-negative and HPV-positive patients. For partners, the second-line plus population represents a worldwide commercial opportunity of greater than $1 billion in peak sales, with upside opportunity in the first-line setting, as well as in other HPV-positive cancers. Moving now to our CAB-CD4 antibody evalstotug. Jay ShortChairman, CEO, and Co-founder at BioAtla00:12:32Evalstotug is similar to Ipi with respect to epitope, affinity, and half-life, but differs from Ipi with respect to its ability to avoid binding in the normal tissue environment. As part of today's update, we have dosed a total of 12 patients with unresectable and/or metastatic melanoma, eight of whom received 5 mg/kg, three were dose escalated to 10 mg/kg, and one dose escalated all the way to 14.3 mg/kg. While we continue to observe compelling anti-tumor activity with a differentiated safety profile, 10 of the 11 evaluable patients showed tumor reduction, and with the 11 showing no growth to date. Of these 11 evaluable patients with unresectable and/or metastatic melanoma treated with evalstotug in combination with the PD-1 antibody, so far we observe across multiple doses an overall response rate of 64% and disease control rate of 100%. Jay ShortChairman, CEO, and Co-founder at BioAtla00:13:36Notably, we observe a partial response in a patient with acral, subungual, or under-the-fingernail melanoma, which is a rare and difficult-to-treat form of melanoma that generally has a poorer prognosis than cutaneous melanoma. The safety profile of evalstotug continues to be differentiated with a relatively low incidence and severity of immune-mediated AEs, particularly among patients who received 5 mg/kg for less than or equal to 18 weeks in a total of 17 patients. Focusing on these 17 patients, we observed 18% grade 3 immune-mediated adverse events and no grade 4 events while maintaining strong efficacy. This safety profile compares favorably to ipilimumab with a reported rate of 40% grade 3 and 4 immune-mediated adverse events. We believe evalstotug has demonstrated a differentiated clinical profile relative to other CTLA-4 antibodies and has the potential to be best in class. Jay ShortChairman, CEO, and Co-founder at BioAtla00:14:46As such, we have recently initiated partnering discussions with the intent to align with a partner that can maximize the value of this asset. Onto our ongoing clinical communications. I am pleased to report our progress with the medical and scientific communities, as acknowledged with numerous publications and presentations at prestigious conferences, including the European Lung Cancer Congress, Mayo Multidisciplinary Head and Neck Symposium, and the American Society of Clinical Oncology. Finally, for our corporate updates, BioAtla is further extending our runway beyond key clinical readouts in the first half of 2026 by streamlining and realigning resources, which includes a workforce reduction of over 30%. We estimate that we will incur approximately $0.6 million of one-time cash payments related to the workforce reduction, which will mostly be paid in the second quarter. Jay ShortChairman, CEO, and Co-founder at BioAtla00:15:52We intend to retain all employees essential for advancing our two internal priority programs, as well as supporting partnering of other clinical assets, which are improving with the ongoing data readouts. I also wish to express my deep appreciation and respect to our employees, both past and present, who have contributed so much with their creativity and hard work to advance these important cures for patients. With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2024 financials. Rick. Richard WaldronCFO at BioAtla00:16:30Thank you, Jay. Research and development, that is R&D, expenses were $11.6 million for the quarter ended December 31, 2024, compared to $22.7 million for the same quarter in 2023. Richard WaldronCFO at BioAtla00:16:51The decrease of $11.1 million was due to lower clinical development expenses in 2024 from the lower overall targeted enrollment across our clinical trials in 2024, resulting from our program prioritization in 2023. We expect our R&D expenses to continue to decrease overall in the first half 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 expenses were $4.6 million for the quarter ended December 31, 2024, compared to $5.9 million for the same quarter in 2023. The $1.3 million decrease was primarily due to lower stock-based compensation, personnel-related costs, and D&O insurance premiums. Net loss for the quarter ended December 31, 2024, was $14.9 million compared to a net loss of $26.9 million for the same quarter in 2023. Richard WaldronCFO at BioAtla00:18:24Net cash used in operating activities for the full year ended December 31, 2024, was $72 million compared to net cash used in operating activities of $104 million for the same period in 2023. Cash used for the quarter ended December 31, 2024, was $7.5 million. Cash and cash equivalents as of December 31, 2024, were $49 million compared to $111.5 million as of December 31, 2023. Excluding any potential future milestones, we believe that cost reductions to be subsequently realized from the realigning of resources and focus on our two internal priority programs further extends our runway beyond key clinical readouts in the first half of 2026. Jay ShortChairman, CEO, and Co-founder at BioAtla00:19:30Thank you, Rick. We are encouraged by the clinical outcomes observed from our evolving CAB program data sets, which continue to be differentiated in some of the most challenging solid tumor types. Jay ShortChairman, CEO, and Co-founder at BioAtla00:19:47As a result, we continue to advance multiple discussions with potential collaborators on our phase II assets, as well as initiate new ones. We believe the compelling results we are obtaining will serve as important catalysts, including our EpCAM T-cell engager program, and have the potential to be transformative for our patients and shareholders alike. Thank you for your attention and continued support. With that, we will turn it back to the operator to take your questions. Operator00:20:19Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We will pause for a moment to allow questions to queue. We will go first to Jeet Mukherjee at BTIG. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:20:55Great. Thanks for taking the question. Just in terms of the partnered programs, I noticed in the corporate deck you had mentioned the ROR2 program is in the process of partnering while CTLA-4 is initiating partnering. Could you perhaps just give a bit more color on where you are on these discussions and what's perhaps needed to get one or both across the finish line? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:21:16This is Jay. We have both advanced discussions and newer discussions. This HPV-positive data is pretty new to most of the people we're in discussions with, except for just a small number. We also expect additional interest prior to this report. We're pretty encouraged with the discussions that are underway. I think it covers a range, and I'm expecting some new participants to get involved as well. Because I think this has been a significant problem in the treatment of head and neck cancer is being able to add in effective treatments in these refractory HPV-positive patients. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:22:07Understood. Maybe if I could just ask a follow-up for the AXL program. I believe last time you were still analyzing some patient samples for both AXL and KRAS expression. In your hands, what percentage of patients are double positive for mutant KRAS and AXL? Have any patients on the study to date been treated with a pan-RAS inhibitor? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:22:32I'll share some of this question with Eric. I'll just start off by saying in our immunohistochemical analysis, we saw a bit over 70% that were positive across all types of mKRAS mutants. I think the G12C was, I think, 100%. Jay ShortChairman, CEO, and Co-founder at BioAtla00:22:57Also, we know that if you look at mRNA levels, that it's much, much higher than even that. It's a very strong correlation, keeping in mind that mRNA is likely to be more sensitive than immunohistochemical data. It's a very strong correlation. Further, there's a fundamental mechanistic alignment. You'll see if you refer to the corporate deck, you'll see that laid out there on slide 23 within that deck. Eric, you want to add anything to this? Eric SieversChief Medical Officer at BioAtla00:23:29Sure. Thank you, Jay. Thanks for the question, Jeet. On slide 24, we indicate that one of the patients had prior treatment with sotorasib, and they did experience a response. We did not treat anyone with a known prior exposure to a pan-KRAS inhibitor, which was your question. Jeet MukherjeeVP and Biotechnology Analyst at BTIG00:23:47Thank you. Operator00:23:48We will move next to Kelly Shi with Jefferies. Operator00:23:58Hi. This is Humphrey for Kelly. Thanks for taking my question. As you near-term data coming up with BA3182, just curious what kind of data we're expecting and have you reached a recommended phase II dose and what we're looking for in the next follow-up data and expansion portion of the study. Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:24:21Eric, you want to take that one? Eric SieversChief Medical Officer at BioAtla00:24:25Sure. Thank you, Kelly. I appreciate the question. On slide 19 of our recently released corporate deck, we have the BA3182 dose escalation schema. Just to remind everyone, this is the EpCAM targeted T-cell engager where it's conditionally binding both on the EpCAM arm and the CD3 T-cell binding arm to really drive the therapeutic window even further to benefit. This gives you a sense of the dose escalation. We've achieved cohorts A1, B1, and B2, and then we're moving up with a one-step priming dose and a two-step priming dose. Eric SieversChief Medical Officer at BioAtla00:25:07We're doing that concurrently. You can see there's a schema for cohorts C and D that are both enrolling concurrently. You asked about the recommended phase II dose. We think we're in a zone where we're seeing meaningful tumor control. As the animal model suggests that tumor reduction would occur right around 200 micrograms given weekly, it's really consistent with that. We are enthusiastic to be able to report more fully on this phase I data set in the coming months. I'll note that two of the three patients in cohort C4, as you see on the slide, have already cleared the DLT observation window, and the third patient will clear very shortly, as Jay just mentioned, in early April. Operator00:26:01We'll move next to Reni Benjamin with Citizens. Operator00:26:11Hi. This is Simon for Reni. Just a quick one on 3182 as well. Are there any partnership discussions ongoing for this asset? If so, are these contingent upon the mid-2025 data? Jay ShortChairman, CEO, and Co-founder at BioAtla00:26:26Sheri, you want to touch on that one? Sure. Sheri LydickChief Commercial Officer at BioAtla00:26:34Sure. Hi there. Thanks for the question. We currently have had interest in this program. Our goal is to get through phase I and also the expansion cohorts so that we have a data set that can really drive a lot of value for this program. While we've had interest, we're not at a point where we necessarily would engage in discussions until we have a look at what the dose escalation and expansion data look like. Sheri LydickChief Commercial Officer at BioAtla00:27:10Got it. Thank you for the color. Operator00:27:14Once again, if you would like to ask a question, please press star one on your telephone keypad. We will go next to Tony Butler with Rodman & Renshaw. Tony ButlerSenior Managing Director at Rodman & Renshaw00:27:25Thanks very much. Eric, one question on the HPV-positive patients for the head and neck cancer program. Were all of those patients that responded smokers? That's actually somewhat important. Jay, you had mentioned a partnering program, but in the deck again, it makes reference to moving toward discussions with mid-tier companies. I just wonder why that strategy, or is it in fact an argument such that the market opportunity may be somewhat smaller than a large pharma would engender and a mid-tier company would like very much? Thank you. Jay ShortChairman, CEO, and Co-founder at BioAtla00:28:18Why don't I start with the last one, and then we'll go to the other one? We think that it's a billion-dollar opportunity, over a billion dollars in the second line. We did experience one larger company that indicated that they were wanting a multi-billion dollar opportunity. Jay ShortChairman, CEO, and Co-founder at BioAtla00:28:45We recognized from that discussion that maybe we'll add in more of the mid-tier companies. That is really where that is derived from. Let's face it, a $1 billion opportunity in a refractory patient population with a fairly efficient trial and a big differential from the standard of care is still pretty exciting. I would also note, even in the HPV-positive subpopulation, it is over $500 million risk-adjusted. I think either way you cut it, it is pretty good. You still have the opportunity to advance to first line, have the opportunity to advance to other indications as well. You are right in this regard, Tony, that we said we recognize that adding in some of these mid-tier players matters. Jay ShortChairman, CEO, and Co-founder at BioAtla00:29:38Actually, I would say it does matter because we're seeing some people that have capital but have really not been able to perform with their late-line drugs and are very interested in getting into some strong phase II compounds that can move to efficient phase III. Hopefully, that helps address some of it. It does. Tony ButlerSenior Managing Director at Rodman & Renshaw00:30:00Thank you, Jay. Eric SieversChief Medical Officer at BioAtla00:30:00Hey, Tony. You have a really interesting question about smokers amongst the patients that have the p16 positive protein on the HPV analysis. We have a total of 26 patients in this that had the HPV of 40 total. As you know, the HPV-negative patients were really more associated with smoking and alcohol exposure, the environmental exposure form. HPV is much more the oncogene-driven side with a particular unmet need amongst patients when they reached second and third line setting because of the lack of EGFR benefit. Eric SieversChief Medical Officer at BioAtla00:30:47I do not have the smoking correlation set up, but that is something I can try to obtain for you after the call. Thank you. I appreciate that. The key is whether it is smokers and non-smokers. That is really where I want to go with that HPV-positive cohort. Thank you. Yes, we have the smoking data. It is just we have not made a correlation with the HPV. It is a great question, and we will get right on it. Tony ButlerSenior Managing Director at Rodman & Renshaw00:31:16Thank you. Eric SieversChief Medical Officer at BioAtla00:31:18Thank you. Operator00:31:20We will move next to Arthur He with HC Wainwright. Arthur HeVP of Equity Research at H.C. Wainwright00:31:24Hey, good afternoon, Jay and team. Thanks for taking my question. I have three quick questions. First, for the EpCAM program, regarding the data coming this year, which kind of dose level of the data can we see? Can we go up to the 3,300 micrograms, sorry, microgram cohort data, or it's probably more at the lower dose levels? Jay ShortChairman, CEO, and Co-founder at BioAtla00:32:00Certainly the 300 we should have, assuming all the dosing goes well. Is there a chance to see 900 possibly if we do it in July? We'll just make sure. It also depends a little bit on patient recruitment, but I'm very comfortable that the 300 will be there and potentially higher. Arthur HeVP of Equity Research at H.C. Wainwright00:32:22Gotcha. Jay, when you're talking about 300, you mean 300 from both C and D arms, or just the C arms? Jay ShortChairman, CEO, and Co-founder at BioAtla00:32:31No, I'm talking about C. I think the D formally is just behind the other, but tends to reinforce. Yeah, I'm focused on C right at the moment. Arthur HeVP of Equity Research at H.C. Wainwright00:32:43Gotcha. Thanks for that. My second question is regarding the AXL program. Maybe correct me if I was wrong. Are you guys going to treat more patients in terms of the AXL program, or I mean, is there any more additional patient data we can see in the future? Jay ShortChairman, CEO, and Co-founder at BioAtla00:33:10I think our hope is, I mean, EpCAM is a priority right now because of many reasons and because of the safety that we're seeing, which we're liking, and the broad applicability. I mean, it's a pan-cancer drug, and it's hard to ignore how big this could be. With AXL, though, we see some advantage of being able to do a few more patients on that. Our hope is to add in a few more patients. They haven't been added yet. We're in the process of amending our trial to allow more patients. We're going to have a pretty good picture of what happens on EpCAM. Jay ShortChairman, CEO, and Co-founder at BioAtla00:33:47Our intent is to drive some additional patients there, but I will allow that EpCAM could turn into something so exciting that we may decide to double down there. For now, yes, that's our plan. Arthur HeVP of Equity Research at H.C. Wainwright00:33:59Gotcha. Thanks for that. My last question is regarding the BD or strategic-wise. Besides you think about to part out the ROR2 and CTLA-4 program, are you open to any other strategy to maximize the shareholder value? Jay ShortChairman, CEO, and Co-founder at BioAtla00:34:26Oh, yeah. I mean, we certainly would be open if a partner decided that they want to drive AXL instead of Oz-V, and both are pretty exciting. We're also always looking at backup strategies where partnering timing sometimes, as we've learned, can be hard to exactly forecast, but we're definitely doing both of those things. Arthur HeVP of Equity Research at H.C. Wainwright00:34:50Gotcha. Thanks for taking my question, and congrats on the progress. Jay ShortChairman, CEO, and Co-founder at BioAtla00:34:56I think they're coming in very nicely. I think it's kind of rare in this world where everything is working. Thank you. Arthur HeVP of Equity Research at H.C. Wainwright00:35:10Thank you. Operator00:35:11Thank you. It appears that we have no further questions at this time. I will now turn the program back over to Jay Short for any additional or closing remarks. Jay ShortChairman, CEO, and Co-founder at BioAtla00:35:20I just want to thank you all for your time. I think hopefully you've heard some of this data. We're pretty excited about the differentiation we're seeing in the ROR2 programs. EpCAM, we think we're pioneering there. We also think AXL is also, as well as CTLA-4, are showing the differentiation that we expected from CAB. I think that's going to translate into partnerships sooner than later. Thank you for your time. Operator00:35:51Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time.Read moreParticipantsExecutivesSheri LydickChief Commercial OfficerJay ShortChairman, CEO, and Co-founderRichard WaldronCFOEric SieversChief Medical OfficerAnalystsAnalyst at CitizensAnalyst at JefferiesBruce MackleManaging Director of Investor Relations at LifeSci AdvisorsArthur HeVP of Equity Research at H.C. WainwrightJeet MukherjeeVP and Biotechnology Analyst at BTIGTony ButlerSenior Managing Director at Rodman & RenshawPowered by