BioAtla Q1 2025 Earnings Call Transcript

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May 6, 2025

There are 7 speakers on the call.

Operator

Good day, everyone, and welcome to today's BioAtlas First Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session.

Operator

I will be standing by should you need any assistance. And it is now my pleasure to turn the conference over to Bruce Mackle with LifeSci Advisors. Please go ahead.

Speaker 1

Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtlas are Doctor. Jay Short, Chairman, CEO, and Co Founder and Richard Waldron, Chief Financial Officer. Following today's call, Doctor. Eric Sievers, Chief Medical Officer and Sherry Leidich, Chief Commercial Officer will join Jay and Rick in a short Q and A.

Speaker 1

Earlier this afternoon, BioAtlas released financial results and a business update for the first quarter ended 03/31/2025. A copy of the press release and corporate presentation are available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward looking statements, including but not limited to statements regarding BioAtlas 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 and D expenses. These statements are subject to various risks, assumptions and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent annual report on Form 10 ks and subsequent quarterly reports on Form 10 Q. You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today, 05/06/2025, and Bio Atlas disclaims any obligation to update such statements to reflect future information, events, or circumstances, except as required by law.

Speaker 1

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

Speaker 2

Thank you, Bruce, and thanks to everyone for joining us for our first quarter twenty twenty five BIOLASA 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 twenty twenty five AACR Annual Meeting are available on our website. Just a few short weeks ago, I provided updates on our Conditionally Active Biologic or CAD platform clinical programs that we are advancing internally at BioAtlas, as well as the clinical programs we are currently advancing toward corporate partnerships. All of these CAD 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.

Speaker 2

Today, I will begin with our Phase one dose escalation study evaluating the dual conditionally binding F CAM 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 one hundred microgram treatment dose cohort have cleared the dose limiting toxicity period. We have also dosed the first three patients at the treatment dose of three hundred micrograms and we remain on track for our dose escalation clinical data readout in mid-twenty twenty five.

Speaker 2

We also anticipate a data readout for the cohort expansion portion of the study in the first half of twenty twenty six. We continue to believe that our dual CABEPCAM, CAB CD3 bispecific T cell engager has the potential to be at the forefront of a novel approach to harnessing the body's immune system to target and destroy cancer cells and has the potential to treat a wide range of metastatic tumors including cancers of the colon, lung, breast, pancreas, and prostate among others. Next on to our calve axle ADC MACV. MACV continues to demonstrate exceptional overall survival at the one point eight mgkg Q2W dosing regimen with a two year landmark survival of fifty nine percent in MKRAS non small cell lung cancer patients. This is particularly compelling given the previous studies among patients treated with standard of care agents have reported a two year landmark survival of only less than twenty percent.

Speaker 2

We continue to observe a high correlation of axonal MKRAS expression and the study follow-up is ongoing. A particular note, we recently observed a similar exceptional overall survival using MACV across several subtypes of soft tissue sarcoma, including leiomyosarcoma, undifferentiated pleomorphic sarcoma, and liposarcoma with a one year landmark survival of seventy three percent. Observing exceptional overall survival in two different heavily pretreated solid tumor types strengthens our conviction that MACV 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 two data readout in the first half of twenty twenty six. Transitioning to the Phase two 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.

Speaker 2

First, regarding our CAVRORA2 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 zero percent to three point four percent among HPV positive head and neck cancer patients. As of the March 24 data cutoff, eleven treatment refractory HPV positive head and neck patients who had three prior lines of therapy treated with the one point eight mgs per kg Q2W dosing regimen showed a remarkable one hundred percent disease control rate, a forty five percent overall response rate with twenty seven percent confirmed to date.

Speaker 2

We continue to collect data on duration of response, median progression free survival, and median overall survival, all of which are ongoing and we plan to share these data at an upcoming medical meeting. So far, we have received timely responses from the FDA and are now utilizing our Fast Track designation for additional discussions with the FDA regarding treatment refractory metastatic HBV positive squamous cell carcinoma of the head and neck. We believe our extended experience with Q2W dosing of OSV also has the potential to satisfy Project OPTIMA's requirements and we plan to share our results with the FDA to seek confirmation regarding our proposed recommended Phase three treatment regimen. Moving now to our CAB CTLA-four antibody avastatug, partnering discussions are ongoing and we continue to believe that avastatug has the potential to be best in class with a differentiated clinical profile relative to other CTLA-four antibodies. To date, we have observed a sixty seven percent overall response rate and a ninety two percent disease control rate in twelve evaluable patients with metastatic cutaneous melanoma.

Speaker 2

These results are notable given that ten of twelve patients had received prior PD-one 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 of Cancer Research, and the Asthma Gastrointestinal Cancers Congress. Additionally, are invited to give a presentation at the upcoming PEGs Conference around our Dual Cab, EpCAM and Cab CD3 bispecific T cell engager. With that, I would now like to turn the call over to Rick to review the first quarter twenty twenty five financials.

Speaker 2

Rick?

Speaker 3

Thank you, Jay. Research and development or R and D expenses were $12,400,000 for the quarter ended 03/31/2025, compared to $18,900,000 for the same quarter in 2024. The decrease of $6,500,000 was primarily due to lower clinical development expenses in 2025 for our Phase two trials for magvotamab vedotin, vosoritamab vedotin, and abalastatog as we complete trials for certain indications. These decreases were partially offset by a half million dollar charge related to our workforce reduction announced in March 2025. We expect our R and D expenses to continue to decrease for the remainder of 2025 due to our recent restructuring and as we complete phase two trials for several indications and focus our ongoing development on our prioritized programs.

Speaker 3

General and administrative or G and A expenses were 5,300,000 for the quarter ended 03/31/2025, compared to $5,600,000 for the same quarter in 2024. The $300,000 decrease was primarily due to lower stock based compensation and lower D and O insurance premiums offset by a $100,000 charge related to our workforce reduction announced in March 2025. Net loss for the quarter ended 03/31/2025 was $15,300,000 compared to a net loss of $23,200,000 for the same quarter in 2024. Net cash used in operating activities for the quarter ended 03/31/2025 was $16,300,000 compared to net cash used in operating activities of $30,800,000 for the same period in 2024. Cash used for the quarter ended 03/31/2025 was $16,700,000 Cash and cash equivalents as of 03/31/2025 were $32,400,000 compared to $49,000,000 as of 12/31/2024.

Speaker 3

We expect that the significant cost reductions to be subsequently realized from our realignment of resources and focus on our two internal priority programs will provide the company with sufficient runway to fund operations and achieve key clinical readouts in the first half of twenty twenty six, excluding any funds from potential new partnerships. Now back to Jay.

Speaker 2

Thank you, Rick. I'm encouraged with the progress across our CAD platform, particularly with our Phase one dose escalation study evaluating our dual conditionally binding EpCAM and CD3 bispecific T cell engager. I'm also encouraged with the maturing Phase two data sets, including the exceptional overall survival among patients treated with MACV, as well as the compelling anti tumor activity demonstrated with OSV and HBV 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.

Operator

We'll take our first question from Jeet Mukherjee with BTIG. Your line is open.

Speaker 4

Great. Thanks for taking the question. I was wondering, will the poster presentation for the ROAR-two program at ASCO contain an updated data cut? And for the FCAM update in July, will we have data from the three hundred microgram dose as well as the nine hundred microgram dose? Thanks.

Speaker 2

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

Speaker 4

are you inquiring about the AUSD, the ROAR-two ADC asset? That's correct. Yep. Yeah, so we do have an updated data cut. We include additional safety data from the every other week dosing regimen of one point eight mgs per kg.

Speaker 4

And then we also will have some additional update on long term outcomes. And then you had a second question about and I think there I would anticipate around the twenty five to thirty patient update from our dose escalation data set and that will occur mid this year.

Speaker 2

I don't

Speaker 4

got it.

Speaker 2

I don't think we have been. We don't have insight at the nine hundred microgram level at this point as we get closer because it just depends on timing of patients.

Speaker 4

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

Speaker 2

Yeah,

Speaker 4

we can talk a little bit about the actual program. I think the key finding there is a remarkable overall survival. And I think that's nicely illustrated on slide 26 of our corporate deck where with all the caveats, we're looking cross trial comparison. You can see that now eight patients with an extended overall survival of eighteen months or more. And it's really a striking difference compared to the standard of care, which is docetaxel.

Speaker 4

And so I think that the pivotal trial would likely be in second and third line patients with mutated KRAS non small cell lung cancer randomized one to one against docetaxel. We've seen that approach employed by many sponsors and we've received FDA guidance to that effect. They're supportive of that.

Speaker 2

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

Speaker 4

Yeah, and that's for the Oozarift in that. That's Oozarift in that. Yeah.

Speaker 2

War II.

Operator

Move next to Ren Benjamin with Citizens. Your line is open.

Speaker 5

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

Speaker 5

I have a follow-up.

Speaker 4

This is great for Eric. Yeah, so 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 great 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 Resist response and the maximally tolerated dose has not been reached. We continue dose escalation.

Speaker 4

We anticipate that the biologically optimal dose might be two hundred micrograms or more. Then you also asked about safety, and I've been pleased by what we're seeing to date. I think our stepwise dosing approach that's consistent with how other marketed T cell engagers are given is working. So I think that the safety issues are really nonconcerning, and we continue to dose escalate. We have a lot of enthusiastic enrollers.

Speaker 5

Great. And then just regarding MEKV, 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 would 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?

Speaker 2

Well, I think it's very exciting. We're seeing 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. So I think the cross traffic comparison on slide 26 that really emphasize, especially when you consider that our data have patients had three prior lines of therapy, whereas the other competitors have. They're in second line basically, and we're performing very well there.

Speaker 2

And I think, in addition, I really. While we're not, while we're focused more on lung, think the sarcoma overall survival there was quite interesting. Here's another independent indication. Different set of potential therapies downstream and yet we're seeing pretty And they're really exceptional overall survival there across two different indications and really this I'm just remind everyone. This is where the drugs fail, especially in non small cell lung cancer is in this overall surviving quadrant.

Speaker 2

Wow, this is great.

Speaker 4

Randy, maybe I'll just add a few points to that. Really looking at slide 26 and, the mutated KRAS non small cell space is certainly changing with revolution medicine and others. But we also know that sotorasib and their efforts to confirm clinical benefit were not successful. They had a non evaluable trial for confirmation of clinical benefit and really overall survival is the bottom line here. We have to do that.

Speaker 4

So we have an antibody drug conjugate approach for these mutated KRAS patients that express Axle at a very high rate. And so I think it's interesting. Our approach is orthogonal to the new KRAS inhibitors that we're hearing about. I'm thrilled for patients that they have these options, but I think in the second line setting, our data are really standing quite strongly, and obviously they need to be confirmed in a prospective randomized trial.

Speaker 5

Got it. Two other, maybe just quick ones for me. One, you're talking about partnerships and discussions are ongoing. What is the ideal deal kind of look like for you guys? And number two, I think that you had mentioned that during the workforce cutting and trying to save your cash, you're gonna focus on two internal programs.

Speaker 5

So, know, and I'm counting three, the Abcam, MechV, and OSV. Can you just help clarify for me which are the two that you'll be focusing on moving forward?

Speaker 2

Well, the headcount reduction was to align with the number of programs that we're taking forward internally. So we're obviously very excited about OR2, but we also obviously can't take four programs, even if they're all showing strong data through ourselves. So we selected two initially, the OR2 CTLA-four programs for partnering. That doesn't mean we're not listening to potential partnerships for MIPE or the actual 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.

Speaker 2

And so we focus the workforce, we're focusing on internal versus external. And so they say the next part of your question, what's the ideal kind of partnership? I think of it in terms of more than one partnership. And I think at least one of those partnerships I'd like to see us be able to maintain substantial value in North America, at least. And with another one, would say I'd be more leaning into something that generates substantial cash value between upfront and near term milestones.

Speaker 2

And so those combinations gives us the power to help drive a Phase III through either independently or with a partner. And so that combination is really what I'm looking for. And we have those kinds of discussions underway that could deliver both of those types of things. While it's as we learned last late last year in August, where we thought we might close two partnerships, we got in one. We closed the smaller of the two, but I think we're in a good position to at least advance some partnerships here.

Speaker 2

And we remain optimistic. Are managing our cash runway to make sure that we get into next year and with some key readouts on top. And of course, milestones along the way are potential there. We may be able to add those as well.

Speaker 5

Perfect. Thanks for taking the questions.

Operator

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

Speaker 6

Hey, good afternoon, JNT. Congrats on the progress. Just a couple of quick questions on the FKM program. So when we are looking at the midyear readouts from the dose escalation part. I'm sure we probably get the data from the three hundred microgram cohort.

Speaker 6

So how about the D cohort with the three thousand one hundred and three hundred microgram? That's question one. And the question two is when we are at the readout for the dose escalation part, Are you guys going to declare the expansion cohort dose level?

Speaker 2

I would say, I don't think we'll be declaring it at that point, we'll allow our data to teach us that. Because I think so far I'm encouraged where we're headed. And we're going to stick to this midyear readout no matter where we are in that dose escalation, we want to get some visibility to the data. But I'll let Eric add to this and also maybe comment on the B cohort as well.

Speaker 4

Sure. And so, Martha, 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'll, you know. Reopen that because we have such interest in the program from investigators and patients, and we wanted to also explore that two step dosing regimen as well as the one step. So we'll try to provide as fulsome of an update as we can at the Medical Congress.

Speaker 4

And you asked the question about would we declare the dose for the expansion cohort? I would imagine that we would, but at this time we haven't defined that dose yet. And so as Jay said, I'll just echo, you know, 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. So lots of optionality built into our protocol.

Speaker 6

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

Speaker 4

Sure. The approach that we're using a pretty standard approach, and I want to emphasize the importance of step dosing to give a relatively low dose and then subsequently a higher dose. We see that with marketed products, in particular the marketed product for small cell lung cancer. The second is to really use industry standard approaches for CRS prevention. So patients are hospitalized.

Speaker 4

We follow them very closely. We do employ atosolizumab prophylaxis strategy, and we really try to keep steroid use as modest as possible because steroids can affect T cell function, as you know. And as you see on slide 19, we've marched through the A, the B1, B2, all the way up through C1 up to C5 where we're dosing, and then the D cohort as well. So we continue to dose escalate, and I've been really pleased by what we're seeing and look forward to speaking to more data at an upcoming medical meeting.

Speaker 6

Awesome. Thank you very much for the additional color.

Speaker 2

You're welcome.

Operator

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

Speaker 2

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

Operator

This does conclude today's program. Thank you for your participation. You may disconnect at any time, and have a wonderful afternoon.

Speaker 2

Goodbye.

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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.
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