BioAtla Inc. Q1 2023 Earnings Call
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Speaker 2: Greetings and welcome to the BioATLA First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. And as a reminder, this conference is being recorded.
Speaker 3: Thank 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.
Speaker 3: Following today's call, Philippe Martin, Chief of Clinical Development and Operations, Dr. Eric Sievers, Chief Medical Officer, and Sherry Leitek, Senior Vice President, Commercial Strategy, will join Jay and Rick for a short Q&A.
Speaker 3: Earlier this afternoon, BioAtla released financial results and a business update for the first quarter ended March 31, 2023. A copy of the press release is available on the company's website.
Speaker 3: 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 bio Atlas business plans and prospects. Potential selective licensing collaborations.
Speaker 3: and other strategic partnerships. Whether our clinical trials will be potentially registrational, results, conduct, progress, and timing of our research and development programs and clinical trials.
Speaker 3: Expectations with respect to enrollment and dosing in our clinical trials.
Speaker 3: plans regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions, the potential regulatory approval path for our product candidates, expectations about the sufficiency of our cash and cash equivalents.
Speaker 3: and expected R&D and GNA expenses.
Speaker 3: The 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 quarterly report on Form 10Q.
Speaker 3: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, May 11, 2023, and Bio-Atlant Disclams 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 Jay Short.
Speaker 4: Thank you, Bruce, and thanks to everyone for joining us for our first quarter, 2023 Bio-Atlop Premium. It's called.
Speaker 4: Before I provide an update on our first quarter progress, I would like to reiterate a few key points made on our last quarter call in March.
Speaker 4: As a reminder, BioAtlas is the inventor and leader of the development of novel therapies using a proprietary, conditionally active biologics, CABs, platform with improved selectivity for attacking tumor cells while avoiding healthy cells to address urgent unmet needs in oncology in order to improve patient's lives.
Speaker 4: We made significant progress last year across our multiple ongoing phase two trials for our two latest stage first-in-class cab ADC product candidates, BA3011 and BA3021, targeting solid tumor types with high unmet medical needs.
Speaker 4: As we are now a little over one-fold quarter into 2023, we continue our positive trajectory and our on track to achieve our recently guided milestones.
Speaker 4: We remain focused on further advancing the development of our innovative clinical programs, leveraging the broad applicability of our CAB technology across several clinical stage antibody types, including CAB, Axel, and CAB, WER2 ADCs, targeted CAB, CTA-A4.
Speaker 4: and immunoecology make it antibody, and our first dual-CAB by-specific F-CAM CD3 T-cell Engager. Additional details related to what I'm going to provide are available on our website as part of our updated company presentation that may be helpful to you.
Speaker 4: We have shared promising clinical responses to date that are so far meeting and in several cases exceeding our interim study.
Speaker 4: targeted responses. Last quarter, I shared our strategic shift in providing incremental data updates on small sample sizes to releasing more mature data sets across our programs. As a reminder, our goal is to provide sufficient data to allow us to set study parameters that maximize the company's likelihood of successful hour phase two potentially registrational studies.
Speaker 4: Additionally, last quarter I discussed the rationale for including the more frequent dose intensive regimens.
Speaker 4: A summary of these current dose regimens can be found in our updated corporate presentation on our website. Based on our exposure and response analyses, as well as our UPS-related FDA interactions, we aim to maximize the differentiated benefit risk profile of our cababities and our Phase to PURM-1 trials for potential further improvement.
Speaker 4: and anti-tool activity while having similar or even improved safety profiles. We continue to be excited about our lead asset, the A3011, for multiple indications.
Speaker 4: Previously, we shared the encouraging partial interim data on our BA-3011 Phase 2 Part 1 Sercoma Study, and our BA-3011 Phase 2 Part 1 Mounce Mulse Cell Lung Cancer Study. Let's now move to our clinical operational and financial updates for the first quarter 2023. First, I will reiterate our BA-3011 Phase 2 Sercoma Study and our overalls.
Speaker 4: Based on these results, together with the continued differentiated safety profile and encouraging feedback from the FDA around the study design, last year we initiated part two of the potentially-registerational portion of the trial. The first 40 patients with a TMPS greater than or equal to 50% are being randomized one to one between the 3Q-4W or 2Q-3W dosing regiments. Following this, we plan to enroll an additional 40 patients at the selected dose to complete the study. Overall, the primary efficacy endpoint will be based on approximately 60 patients treated at the selected dosing regimen.
Speaker 4: In addition to UPS, we continue to enroll in the Lyoma Sarkoma cohort using the 3Q4W DOSing Regimen and our own track with anticipated data readout in the second half of this year. With regards to the safety profile across our coma subtypes, BA3011 continues to be genuinely well tolerated with the Phase II Safety Portal file across all doses consistent with the profile we observed in Phase I. We also see real value in potentially expanding our Sarkoma footprint over time to include other Sarkoma subtypes.
Speaker 4: Ultimately, we believe VA 3011 has the potential to treat over 25,000 sarcoma patients per year and generate up to $2 billion in revenue worldwide in this area of high unmet need. Regarding our VA 3011 phase 2 study in actual positive multi-refractory non-small cell lung cancer, we continue to be enthusiastic about the
Speaker 4: and PFS rates of four months.
Speaker 4: As a reminder, part one of a phase two study of non-small cell lung cancer is ongoing in axial positive patients who have previously experienced failure of either PD-1, PD-L1, EGFR, or ALK inhibitors.
Speaker 4: So far in the study we have reported preliminary efficacy with an ORA 44% as monetary therapy and a PD1 failure population that I've seen on average three prior lines of therapy.
Speaker 4: in Phase 2, Part 2. In addition, Part 1 of the Phase 2 study continues to enroll using the more frequent dose-intensity regimen with anticipated data readout for all dosing regimens on track for the second half of this year. We remain on track to submit a meeting request to the FDA for the potentially registrational BA3011 Phase 2, Part 2 non-small-cell lung cancer study design in the first half of this year with feedback anticipated in the second half of this year allowing us to initiate the Phase 2, Part 2 study in non-small-cell lung cancer with the most frequent dose-intensity regimen for all dosing regimens on track
Speaker 4: maintaining our overall timeline for development of the non-small cell lung cancer education.
Speaker 4: As we have previously mentioned approximately 35% of patients in this second line plus indication of mouse mouse on one cancer express axle. We estimate annually that there are over 100,000 actual positive addressable patients worldwide with the potential to add approximately 2.5 billion to 3 billion in worldwide revenue.
Speaker 4: at peak. Considering only the sarcoma and non-small cell 1 cancer indications, we continue to believe that BA3011 has the potential to become a significant commercial asset for bioatla.
Speaker 4: I've eaten greater importance is that BA3011 has the potential to be the best in class treatment for a significant number of patients who fail multiple lines of therapy, thus filling a significant unmathematical need.
Speaker 4: To round out our CABADC-B83011 program, we are supporting an ongoing multi-center investigator initiated or IIT Phase 2 clinical trial in patients with platinum-resistant ovarian cancer.
Speaker 4: The trial is on track and we anticipate interim data consisting of 10 patients in the second half of this year. Now, turning to our second lead CAB ADC product candidate, B-A-3-021, a CAB Ward 2 ADC.
Speaker 4: Currently, B-A30021 is the subject of phase two trials and the treatment of four indications. As a reminder, no other company has a therapy in the clinic targeting work to. So we have the potential to have a first-in-class treatment for solid tumors. We conducted a similar exposure response analysis of Rortu-
Speaker 4: I mentioned earlier.
Speaker 4: We are continuing to enroll patients in the more frequent dose intensity regimen of 3Q4W as planned with interim data readout on track for the second half of this year.
Speaker 4: Regarding the melanoma phase 2 trial in patients who have previously experienced failure of PD-1 therapy, following an additional complete response in an invaluable patient identified using our IHCSA, we are screening patients with the validated liquid biopsy.
Speaker 4: Since last quarter, we continue to enroll patients and the observed or two positivity rate is high over 50% and in line with our expectations. To round out our CABAEDC BA30021 program, we are also supporting the Phase II IIT study with BA30021 in patients with platinum resistance and ovarian cancer. The trial is on track and it anticipates interim data consisting of 10 patients of the second half of this year.
Speaker 4: Now I'd like to talk briefly about our Phase 12 trial for our CAHP CTA-4 antibody BA-3071.
Speaker 4: The FAS-12 trial is being conducted in tumors known to be responsive to CTLA for treatment, and we will evaluate safety and tolerability of B-A-3-0, Cepheid-1 and Monophobe and in combination with the Volumap. The trial is progressing as planned.
Speaker 4: Last quarter I shared that the DLT observation period was cleared for the fourth cohort at a dose of 210 mgs, or 3 mgs per kg, in combination with 3 mgs per kg of nivolumab. No DLTs were reported. As part of today's update, we are treating patients in the fifth cohort at 350 mgs, or 5 mgs per kg, as a monotherapy, or in combination with 3 mgs per kg of nivolumab, and are on track for a Phase 1 data readout in the second half of this year.
Speaker 4: We also remain on track for the initiation of our BA3071 Phase II study to commence in the second half of this year.
Speaker 4: Finally, on to our potentially first-in-class dual-CAB by specific T-cell Engager antibody. CAB, F-CAB, CV-3, or...
Speaker 4: in the first quarter we received FDA clearance of our IND for the treatment of advanced ad work.
Speaker 4: We anticipate first patient in for the Phase I study in the current quarter with the complete Phase I data readout anticipated next year. Similar to our other three clinical stage cap product candidates, this antibody holds much promise in view of the NVVO pre-clinical studies demonstrating
Speaker 4: has nine accepted recent and upcoming poster presentations since March.
Speaker 4: Additional abstracts have been submitted for several upcoming meetings and these will be updated as they are accepted. With that, I would now like to turn the call over to Rick to review the first quarter of 2023 financials. Rick? Thank you, Jay. As of March 31, 2023, we had $192.7 million in cash and cash equivalence compared to $215.5 million that the Semba 31 2022. We expect current cash and cash equivalence will be sufficient to fund planned operations.
Speaker 5: including all ongoing CADB product development programs into 2025.
Speaker 5: As a reminder, we control all cab product motor rights in the US, Europe , and Japan.
Speaker 5: Our business strategy includes advancing commercial preparations in key global markets while exploring opportunities to extend our cash runway by generating upfront cash through the selective licensing of product rights in certain territories or collaborations with other biopharmaceutical companies.
Speaker 5: that could also provide to us development milestones and royalties upon regulatory approval and commercialization and create additional value for stockholders.
Speaker 5: For the first quarter ended March 31, 2023.
Speaker 5: compared to $16.9 million for the same period in 2022. The increase of $4.8 million was primarily driven by our pre-clinical and clinical product development efforts. We expect our R&D expenses to remain variable from quarter to quarter and generally increase as we continue to invest in R&D activities to advance our product candidates and our clinical programs.
Speaker 5: General and administrative expenses were $7.2 million for the first quarter ended March 31, 2023 compared to $7.4 million for the same period in 2022.
Speaker 5: The $0.2 million change was attributable to a decrease in various expenses for the 2023 period. The $0.2 million change was attributable to a decrease in various expenses for the 2023
Speaker 5: Net cash used in operating activities for three months ended March 31, 2023, was $22.7 million compared to net cash used in operating activities of $25.1 million for the same period in 2022. The decrease in net cash used in operating activities for the first three months of 2023 is primarily due to an increase in accounts payable and accrued expenses in the 2020 period compared to a decrease in accounts payable in the same period in 2022.
Speaker 5: And now back to Jay.
Speaker 4: from our differentiated proprietary cap platform.
Speaker 4: We are excited with the compelling clinical data that is emerging in treatment, refractory UPS and non-small-solling cancer, and are eager to continue advancing the phase two studies with the addition of the more frequent dose intensive regimens and providing clinical updates anticipated in the second half of this year.
Speaker 4: We also remain encouraged by the continued execution of our other promising CAV assets of multiple cancer indications and we are well poised to reach several value-creating milestones and key inflection points in the next several months. BioAdler remains confident about the future with the goal of pursuing indications of high unmet e advocates and clinical professionals and help update the practices taken to promote arena endocrinology. st. Louis center ways to invest in and introduce all clinical professionals toUpmarket and
Speaker 2: With that, we will turn it back to the operator to take your questions. Thank you, sir. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. And the first question comes from the line of Brian Chang with JP Morgan. Please proceed with your question.
Speaker 6: Good afternoon, guys. Thanks for taking my question. A couple from me.
Speaker 6: Looking ahead into the data update in a second half this year, I think that you have multiple interim data across a number of programs in a second half. How should we think about the cadence of each of these data updates and then have a couple of all up? Thank you.
Speaker 4: This is Jay and thanks for your question, Brian . I think we'll expect to see the, this is a best guess at this point, but I'm expecting to see the ovarian readouts earlier than let's say the lung readouts. I would expect the axial to be ahead of ROR2 and I think that those are some of the key learnings in what we've beenIXT-14 known as the
Speaker 4: And there's kind of a couple updates, right? One may be completing the phase one, like in CTA-4, and then follow up a little later, saying kicking off the phase two study. So that's our intent. Same would happen with the axle one. Here's our data, hopefully tied in with the meeting or conference, and then followed by kicking off the...
Speaker 4: you know, describe in the FDA feedback and kicking off the phase two portion of it. Last, part two, phase two portion of that. So hopefully that gives you a sense of a brine.
Great. That was helpful. And for your axial program in non-small cell, what's your latest thoughts on the trial design for the potentially pivotal phase II, part 2? And I think, you know, to more extent, I guess, have you decided on whether to focus on non-SQAMIS versus SQAMIS, whether you'll evaluate combo or single agents.
Will you have to revisit the trial protocol with the FDA? Thank you.
first off I can just say that we've decided to focus on the non-Squamish going forward even though I think there's more to learn on the squamous side but I think we're going to focus on the non-Squamish but I'm going to actually ask
answer this one naturally. The rest of the questions in this section.
Yes, thank you, Jack. So in terms of study design, I think clearly this will be the focus of the conversation with the FDA around the end of this quarter. We haven't landed. Based on their feedback, we'll decide which whether to go with a signal on or off.
with the VA. Currently, we're focusing on the monopathy, but we'll be getting more data for the combo later on in
this year so we'll be able to make a decision whether to go with combo as well to only focus on on the monocarity
And then would be a last question about 324W, should we have to be discussing with them, they know that you're not required. The dose selection is left to the sponsor to decide which dose to be, or do so.
to move forward with. So should we see a better benefit with profile than the trick before the W-Larm, we could just replace the Q2W with the Q2W, the same way, you know? Okay, if I can squeeze one more in on Capsity.04, that would be great. How does the 350 dose that you're dosing now?
with the CAHPS CTLA-4 correlate to the target engagement that you're seeing with the currently approved CTLA-4 agents that you're seeing out in the market space. Thank you.
Well, you know, we've done a lot of work with ipilimumab, and so we do a lot of comparisons. So we believe that our antibody is most comparable to IPI when you start to think about these.
doses. Of course, there will be new offices in PK and so forth, but for the most part, because they're different, you know, they're different antibodies in a different sequence, but you know, that their origin was very similar and all of our comparisons. So I think that's a nice
general guideline with the caveat of some PK alignment at the end of the study.
Thanks for taking my question today. And the next question comes from the line of Kelly Shee with Jefferies. Please proceed with your question.
In last update in March you mentioned there were six patient enrolled in LMS cohort. Just wondering how many new patients are added since then and when do you expect to complete 10 to 15 patient enrollment and any comments?
Yeah, I don't think we, I don't have an update on additional patients, but we believe it's readily going to be available in the second half and will be completed there. So there's no indication that we have that it won't be timely in terms of being able to report out on that in the fall.
might be more closer to 15 than 10, but we're on target. Thank you for taking my question. And the next question comes from the line of Caveri Pullman with BTIG.
than 10, but we're on target. Thank you for taking my question. And the next question comes from the line of Kaveri Polman with BTIG. Please proceed with your question.
Yeah, good evening and thanks for taking my questions. For non-small cell lung cancer, can you tell us what's the bar for durability here? What would be clinically meaningful to see in the late-line patients from the data you're collecting? Yeah, now that's a good question and Philly, I think since we've discussed this before.
try to be an after that. So they're highly refractory. A durability of response anywhere about four months would be positive. As we said before, we are targeting six months plus and
And the place may be there, but I have the courage, let us to believe that we will be able to achieve that.
I got it. That's helpful. And I believe you just mentioned that you're moving forward with non-squamous. I was just wondering, I believe squamous type is treated with taxane, a base regimen in the first line. Does that make it less susceptible to respond to MMA in dateline?
I don't think that's the case. I think it's just we're not moving with claimants because we were not able to enroll new square mass patients so we don't know how this patient will respond at this point. So we'll need to generate that data before we start anew on square mass patient. We'll decide to go further with square mass patient.
Yeah, it's just a lot more non-squating as patients come into the study.
Got it. And maybe one last one on the other sarcoma types that you have besides UPS and LMS. Do you plan to test more frequent regimens? They're just the way you're doing for UPS and LMS before you decide to move forward?
Well, I think we're going to wait on the LOMO data because there's strategies around that. Obviously we also want to drive UPS as it is. Move that down the line. And we'll be doing, I think we had mentioned this in our end of March call, that we'll be looking across, we have an awful lot of indications, a lot of phase two studies going on.
getting data, Lyle-Mio, as well as some of the bone sarcomas, but others have already passed our criteria. But when we will actually load those other ones, I think that's yet to be determined because we have some very large indications and great opportunities. I mean sarcomas also, but I think we have to...
question comes from the line of Rene Benjamin with JMP Securities. Please proceed with your question. Hey, good afternoon, guys. Thanks for taking the questions. Maybe just to start off, can you just take us through your latest thoughts on the liquid biopsy assay?
Kind of its potential use across all the programs. I know right now It appears to be confined to the war too, but is this something that could be further expanded? And as we think about this, you know how does this get I guess further fine-tuned and and ready for commercialization as part of the development program.
Billy or Eric, if you want to handle that one?
Yeah, I'll start if any tech Eric wants to add more. So, so it's not confined to go through. We have a developed a liquid biocipal axol, not small so long as well. And we're currently generating data. So every patient that we have an early in the current study.
but we have all the results from this first part of the study. So it's ongoing for Rho2 and Axo and we're just waiting to generate more data in melanoma because we have some difficulty as we discussed before. We prioritize that and are now using the Sasa in melanoma and we've been able to identify patients that were both reposited using the CTC assets. So right now in the future our assumption is we're going with IC but should CTC continue to perform we could...
switch to an equal biopsy of a doctor. Got it. Okay. And I think you have several readouts coming out in the second half. You mentioned about 10 patients worth for the ovarian, 10 to 15 patients worth for LMS.
Can you give us a sense, just based on current enrollment trends, you know, how many patients' worth of data we might see from the anticipated readout for non-small cell lung and anything else I might be missing that's not coming to the top of my head right now?
just based on current enrollment trends, you know, how many patients' worth of data we might see from the anticipated readout for non-small cell lung and anything else I might be missing that's not coming to the top of my head right now.
Yeah, feel if you guys will go ahead on the axle alone, you want to get an update on that one. Yeah, so on long, the target is to have approximately 20 patients, mono 20 with a Q2W and then 20 patients, 324 W.
and 20 patients with the 2Q3WU dosing regimen. So that's the target that we set for ourselves. We've already enrolled the Q2W records. We're currently innovating the Q2Q4 and the 2Q3W records. So that's the...
that's our target for axial non-smoke cell lung cancer. Yeah, and whether we hit exactly 20 on the more frequent dose-intensive regimens, I think we'll get a good feeling even if we're a few, happen to be a few patients shy of that.
a little bit but in terms of the more the more frequent dose intensity but hopefully enough to give us a nice sense of things and certainly how we at the end of the year would like to go in with our discussions future discussions with the FDA with regard to the A3021. Philippe you want to add to that? yeah so our target is 22 W...
of the courts, the 20 patients target, but the current target is 20. Thanks, guys. And I would also add, you know, depending when we read these out, you know, with more too, it's more than issue-particularly than it's for axle to hit those, you know, the question is.
If we're getting that date in December , we're just going to push that into early conference in January or do we try to give a sense that one of the upcoming meetings or also at our early, for the third quarter. I mean, all of those things have yet to be decided. It's just a little early in the year to have that kind of precision. So, please keep that in mind.
Thank you very much.
And the next question comes in the line of Arthur, he with H.C. Wainwright, please proceed with your question.
Hi, good afternoon, Jay and Rick. This is Arthur from HCRE-RIGHT. Thanks for taking my question. So I just wanted to follow up on the 3011 and 3012, the data updating the lung cancer.
So when you look at those data, besides the safety and the presumably ORR, what other criteria are you looking to for you to make the decision to choose the optimal dosing for the pivotal study potentially? Well, I think ultimately you've got to have a duration of response and so we're...
I think in these PD-1 cellular groups, especially with actually got 35% of the patients are positive, we really could open up some efficacy for patients that really don't have any other choices. Even potentially with some of the new therapies that could be arriving in 2024.
we think we're still in a very strong position to there with what we are looking for and what we've been encouraged with the data that we have already obtained to date.
In terms of those selection, we will be looking at efficacy and safety in the patients that were treated, but we will also be looking at certain markers or efficacy as well as the PKK Act as well as those we are looking at. So it's another assessment of the data that we will need us to choose one or two doses to go forward. We reserve the right again to go with Mono and Congo, but our final focus will be Congo for the expansion data. Gotcha, thanks for it. My last question is on the on the O'Rinn Cancer study.
Could you remind us the inclusion and exclusion criteria for that study? And if you see good data from the more intensive dosing regimen for the year
from either the lung cancer and the sarcoma. Is there a way to do the dose optimization as well for the ovarian cancer study? Thanks. Yeah, so these are platinum failure patients and it's in combination with a PD-1 inhibitor.
If we see that the more intensive building regimen is well tolerated and generates more strategic implications, we will be translating that to the other implications as well. So in the case of ovarian, we will be able to move forward with the study.
That would most likely be a registration study with the higher dosing regime. We might decide to take two doses forward, but we wouldn't have a problem taking forward the more intensive dosing regime.
that would most likely be a registration study with the higher dosing regime. We might decide to take two doses forward but we wouldn't have a problem taking forward the more intensive dosing regime.
Thanks for taking my question and congrats on the program at this quarter. Thank you. Thank you. And at this time there are no further questions. Now let's turn the floor back over to Jay for any closing comments. Well, I want to thank everyone for their time and attention today. We're really looking forward to a lot of readouts coming up in the next couple of quarters. So thank you. Thank you.
Thank you everyone, this does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation and have a great day.