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spk01: 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 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, May 11, 2023, 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 Jay Short. Jay?
spk05: Thank you, Bruce, and thanks to everyone for joining us for our first quarter 2023 BioAtlas earnings call. 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. As a reminder, BioAtlas is the inventor and leader in 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 patients' lives. 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. As we are now a little over one full quarter into 2023, we continue our positive trajectory and are on track to achieve our recently guided milestones. 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-AXL and CAB-WAR2 ADCs, targeted CAB-CTLA-4, an immuno-oncology naked antibody, and our first dual-cap bispecific EPCAM 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. We have shared promising clinical responses to date that are so far meeting and in several cases exceeding our interim study targeted responses. Last quarter, I shared our strategic shift from 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 success for our Phase II potentially registrational studies. Additionally, last quarter I discussed the rationale for including the more frequent dose-intensive regimens. A summary of these current dose regimens can be found in our updated corporate presentation on our website. Based on our exposure response analyses, as well as our UPS-related FDA interactions, we aim to maximize the differentiated benefit-risk profile of our CAB ADCs in our Phase II Part I trials for potential further improvement in antitumor activity while having similar or even improved safety profiles. We continue to be excited about our lead asset, BA3011, for multiple indications. Previously, we shared the encouraging partial interim data on our BA3011 Phase 2 Part 1 sarcoma study and our BA3011 Phase 2 Part 1 non-small cell lung cancer study. Let's now move to our clinical, operational, and financial updates for the first quarter of 2023. First, I will reiterate our BA3011 phase 2 sarcoma study and our overall sarcoma strategy. We are advancing BA3011 in ongoing sarcoma phase 2 studies, including a potentially registrational study in UPS. As a recap of the unmet need in UPS, it is one of the largest and most aggressive sarcoma subtypes with high reoccurrence rates, representing nearly 15% of all soft tissue sarcomas. Without specific treatments approved for UPS, there is a significant commercial opportunity as a standalone indication. We have shown strong execution and promising results with continued anti-tumor activity, lack of disease progression, and a differentiated safety profile of BA3011 in UPS to date. Additionally, we have observed an overall objective response rate, or ORR, of 50%. medium progression, free survival, or PFS of over 11 months, and a duration of response exceeding eight months. 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 registrational 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 3Q4W or 2Q3W dosing regimens. Following this, we plan to enroll an additional 40 patients at the selected dose to complete the study. Overall, the primary efficacy endpoint ORR will be based on approximately 60 patients treated at the selected dosing regimen. UPS represents a solid early indication for BioAtla as we plan for the transition into a commercial stage company. In addition to UPS, we continue to enroll in the Lyomyosarcoma cohort using the 3Q4W dosing regimen and are on track with anticipated data readout in the second half of this year. With regards to the safety profile across sarcoma subtypes, BA3011 continues to be generally well tolerated with a Phase II safety profile across all doses consistent with the profile we observed in Phase I. We also see real value in potentially expanding our sarcoma footprint over time to include other sarcoma subtypes. Ultimately, we believe VA3011 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 VA3011 Phase II study in axopositive multi-refractory non-small cell lung cancer, we continue to be enthusiastic about the data we presented earlier this year with the Q2W dosing regimen. Currently, the competitive landscape is scant for treatment options in patients who progress on immune checkpoint inhibitors, particularly in the second line and beyond settings. These patients have suboptimal overall ORRs of approximately 10% to 20% and PFS rates of four months. As a reminder, part one of a phase two study in 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. So far in the study, we have reported preliminary efficacy with an ORR of 44% as monotherapy in a PD-1 failure population that have seen, on average, three prior lines of therapy. This response rate is highly competitive and exceeded our targeted response for moving forward to the Phase II potentially registrational part of the study. We continue to believe BA3011 will be highly commercially relevant with a response well above those observed in a multi-refractory patient population, particularly in view of treating patients in earlier lines in Phase 2, Part 2. In addition, Part 1 of the Phase 2 study continues to enroll using the more frequent dose-intensive 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 II Part II 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 II Part II study in non-small cell lung cancer in the second half of this year, maintaining our overall timeline for development of the non-small cell lung cancer indications. As we have previously mentioned, approximately 35% of patients in this second line plus indication of non-small cell lung cancer express axel. We estimate annually that there are over 100,000 axel-positive addressable patients worldwide with the potential to add approximately $2.5 billion to $3 billion in worldwide revenue at peak. Considering only the sarcoma non-small cell lung cancer indications, we continue to believe that BA3011 has the potential to become a significant commercial asset for Biolatla. Of even 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 unmet medical need. To round out our CAB ADC BA3011 program, we are supporting an ongoing multicenter investigator-initiated or IIT Phase II clinical trial in patients with platinum-resistant ovarian cancer. 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, BA3021, a CAB or two ADC. Currently, BA3021 is the subject of Phase II trials and the treatment of four indications. As a reminder, no other company has a therapy in the clinic targeting ROR2, so we have the potential to have a first-in-class treatment for solid tumors. We conducted a similar exposure response analysis of ROR2-positive tumors to inform the more frequent dose-intensity regimen in our Phase II ROR2-positive non-small-cell lung cancer study. Based on this analysis, which utilizes a similar strategy to our UPS Phase 2 Part 2 BA3011 study I mentioned earlier, 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. Regarding the melanoma Phase 2 trial in patients who have previously experienced failure of PD-1 therapy, Following an additional complete response in an evaluable patient identified using our IHC assay, we are screening patients with the validated liquid biopsy. Although we haven't enrolled additional patients to date, we have successfully identified more two positive tumors using the liquid biopsy assay, which is now allowing us to enroll more two positive patients. We anticipate an increased enrollment in the second half of this year. In addition, our Phase II head and neck study is ongoing in patients who have previously experienced failure of PD-1 therapy alone or in combination with Platinum therapy. Last quarter, we announced achievement of first patient in for this study. Since last quarter, we continue to enroll patients and the observed ROR2 positivity rate is high, over 50%, and in line with our expectations. To round out our CAB ADC BA3021 program, We are also supporting the Phase II IIT study with BA3021 in patients with platinum-resistant ovarian cancer. The trial is on track and we anticipate interim data consisting of 10 patients in the second half of this year. Now I'd like to talk briefly about our Phase I-II trial for our CAB CTLA-4 antibody, BA3071. As a reminder, the Phase I-II trial is being conducted in tumors known to be responsive to CTLA-4 treatment, and we will evaluate safety and tolerability of BA3071 in monotherapy and in combination with nivolumab. The trial is progressing as planned. Last quarter, I shared that the DLT observation period was cleared for the fourth cohort at a dose of 210 mg, or 3 mg per kg, in combination with 3 mg per kg of nivolumab. No DLTs were reported. As part of today's update, we are treating patients in the fifth cohort at 350 mg or 5 mg per kg as a monotherapy or in combination with 3 mg per kg of nivolumab and are on track for a Phase I beta readout in the second half of this year. We also remain on track for the initiation of our BA303 Phase 2 study to commence in the second half of this year. Finally, on to our potentially first-in-class dual-CAB bispecific T-cell engager antibody, CAB-FCAM-CAB-CD3, or BA3182. In the first quarter, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We anticipate first patient in for the phase one study in the current quarter with the complete phase one data readout anticipated next year. Similar to our other three clinical stage CAB product candidates, this antibody holds much promise in view of the in vivo preclinical studies demonstrating an over 100-fold improvement in the therapeutic index relative to the non-CAB variants due to the combined selectivity of the dual CAB design. Several of the most common subtypes of adenocarcinoma that have tremendous unmet need that we can potentially address include colon, lung, breast, pancreas, and prostate. BioATLA also continues to progress several candidates through IMD-enabling studies, including CAB-by specifics and next-generation ADC antibodies. And we still anticipate IMD submissions for additional candidates potentially in 2023 and through 2024. With respect to important ongoing communications, the company has nine accepted recent and upcoming poster presentations since March, including at the Asthma Sarcoma and Rare Cancers Congress, the European Lung Cancer Congress, AACR, and ASCO, the latter of which will include an online publication of the abstract related to exposure response analyses of BA3011. Additional asterisks 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.
spk04: As of March 31, 2023, we had $192.7 million in cash and cash equivalents compared to $215.5 million as of December 31, 2022. We expect current cash and cash equivalents will be sufficient to fund planned operations including all ongoing CAB product development programs into 2025. As a reminder, we control all CAB product market rights in the U.S., Europe, and Japan. 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 that could also provide to us development milestones and royalties upon regulatory approval and commercialization. and create additional value for stockholders. For the first quarter ended March 31, 2023, we reported a net loss of $27.5 million compared to a net loss of $24.3 million in the same period of 2022. Research and development expenses were $21.7 million for the first quarter ended March 31, 2023, compared to $16.9 million for the same period in 2022. The increase of $4.8 million was primarily driven by our preclinical 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. 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. The $0.2 million change was attributable to a decrease in various expenses for the 2023 period. We expect our G&A expenses to moderately increase to support development of our product candidates, advance our intellectual property portfolio, support focused pre-commercialization activities for our product candidate BA3011, and satisfy requirements as a public company. Net cash used in operating activities for the 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 2023 period compared to a decrease in accounts payable in the same period in 2022. And now, back to Jay.
spk05: Thank you, Rick. We are pleased with the progress we have made today and our cumulative results that continue to support both the preliminary efficacy and safety from our differentiated proprietary cap platform. We are excited with the compelling clinical data that is emerging in treatment refractory UPS and non-small cell lung cancer and are eager to continue advancing the Phase II studies with the addition of the more frequent dose-intensive regimens and providing clinical updates anticipated in the second half of this year. We also remain encouraged by the continued execution of our other promising CAB assets and 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 medical need that we feel will have significant impact for patients and our shareholders worldwide. With that, we will turn it back to the operator to take your questions.
spk11: 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.
spk07: One moment please while we poll for questions.
spk11: And the first question comes from the line of Brian Chang with JP Morgan. Please proceed with your question.
spk02: Good afternoon, guys. Thanks for taking my question. A couple from me. Looking ahead into the data updates in the second half this year, it seems that you have multiple interim data across a number of programs in the second half. How should we think about the cadence of each of these data updates? And I have a couple follow-up. Thank you.
spk05: Yeah. This is Jay, and thanks for your question, Brian. I think we'll expect to see the, you know, 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 axil to be ahead of ROR2. And I think that those are some of the key ones. And then we'll, of course, be giving progress reports on general progress reports in terms of in the area of sarcoma. in terms of UPS, leiomyosarcoma. And, of course, CTLA-4 will also be somewhere in there as well. And there's kind of a couple updates, right? One may be completing the Phase I, like in CTLA-4, and then a follow-up a little later saying kicking off the Phase II study. So that's our intent. Same would happen with the axial lung. Here's our data, hopefully tied in with a meeting or conference, and then followed by kicking off the, you know, describing 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 it, Brian.
spk02: Great. That was helpful. And for your actual program in non-small cell, what's your latest thoughts on the trial design for the potentially pivotal phase two, part two? And I think, you know, to more extent, I guess, have you decided on whether to focus on non-squamous versus squamous, whether you evaluate combo or single agents? And then the second part of that question is that if the part one data with the more frequent regimen looks better in the second half, will you have to revisit the trial protocol with the FDA? Thank you.
spk05: So first off, I can just say that we've decided to focus on the non-squamous 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-squamous. But I'm going to actually ask Philippe to potentially answer this one. Now, Philippe, the rest of the questions in this section.
spk06: Yeah, thank you, Jay. 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 whether to go with a single arm or our primary endpoints or go with the randomized study against a comparator, probably docetaxel, and it might still be an OR endpoint, but it could also be a TFS endpoint. So we'll make that decision post-meeting with FDA. Currently, we're focusing on the monotherapy, but we'll be getting more data for the combo later on this year. So we'll be able to make a decision whether to go with combo as well or to only focus on the monotherapy arm. And then with your last question about 324W, Would we have to re-discuss it with ABA? No, that would not be required. The dose selection is left to the sponsor to decide which doses to move forward with. So should we see a better benefit-risk profile with a 324W arm, we could just replace the Q2W with a 324W dosing regimen.
spk02: Okay, if I can squeeze one more in on CAHPS CTLA-4, 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.
spk05: 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 nuances in PK and so forth. But for the most part, because they're different antibodies in a different sequence, but their origin was very similar in all of our comparison studies. So I think that's a nice general guideline with the caveat of some PK alignment at the end of the study.
spk07: Great. Thanks for taking my questions today.
spk11: And the next question comes from the line of Kelly Shee with Jefferies. Please proceed with your question.
spk03: Hi, everyone. This is Dave from Jefferies. Kelly is traveling to Asia, so I'm here on behalf of her. Just one quick question for me. In last update in March, you mentioned there were six patients enrolled in LMS cohort. Just wondering how many new patients are added since then? When do you expect to complete the 10 to 15 patient enrollment and any comment on pace of enrollment?
spk05: 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 at 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 up on that in the fall. but I don't know, Philippe, if you have any other nuance on it.
spk06: No, we're on schedule. 10 to 15 patients in the second half. Currently, based on the pace of enrollment, it might be more closer to 15 than 10, but we're on target.
spk03: Thank you for taking my question.
spk11: And the next question comes from the line of Kaveri Pullman with BTIG. Please proceed with your question.
spk10: Yeah, good evening, and thanks for taking my question. 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 these late-line patients from the data you're collecting?
spk05: Yeah, no, that's a good question. And, Philippe, I think since we've discussed this before, you should grab that one.
spk06: Yeah, I think what would be meaningful in patients that have failed, remember the patients that we're dosing are patients that have failed not only PD-1, but they've failed generally a first round of chemo, and then docetaxel or gemcitabine after that. So they're highly refractory. Durability of response anywhere above four months. would be positive. As we said before, we are targeting six months plus and the latest data we had reported led us to believe that we'll be able to achieve that.
spk10: 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 base regimen in the first line. Does that make it less susceptible to respond to MMA in late line?
spk06: I don't think that's the case. I think it's just we're not moving with squamous because we were not able to enroll new squamous patients, so we don't know how these patients would respond at this point. So we'll need to generate that data before we start enrolling squamous patients or decide to go further with squamous patients.
spk05: Yeah, there's just a lot more non-squamous patients coming into the study.
spk10: 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?
spk05: Well, I think we're going to wait on the wild mile data because there's strategies around that. Obviously, we're 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 March, 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, so we'll be prioritizing at that time on which ones we'll prioritize over others in the fall. But we do believe, ultimately, there will be several other sarcoma types to add. And a couple of them still getting data, Lyle Mayo, 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 –
spk11: balance which ones to go first and we'll be looking at that carefully in the fall that's helpful thank you and as a reminder 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 and the next 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
spk08: 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 II, but is this something that can be further expanded? And as we think about this, you know, how does this get, I guess, further fine-tuned and ready for commercialization as part of the development program?
spk07: Eric, if you just want to handle that one.
spk06: Yeah, I'll start. Eric wants to add more. So it's not confined to Rothschild. We have developed a liquid biopsy for Axel not so long as well. and we're currently generating data. So every patient that we are enrolling in the current study, we're testing them obviously for IHC because that's the entry criteria, but we're also testing them for the CCC or the liquid biopsy. So we'll be able to correlate the IHC data to the CTC data once we have all the results from this first part of the study. So it's ongoing for Rho2 and Axel, and we're just waiting to generate more data. In melanoma, because we had some difficulty enrolling, as we discussed before, We prioritized that and are now using this assay in Milanoma, and we've been able to identify patients that were both positive using the CTC asset. So right now, in the future, our assumption is we're going with IHC, but should CTC continue to perform, we could switch to a liquid biopsy over time.
spk08: 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, 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?
spk05: Yeah, Philippe, you might as well go ahead on the axolung. You want to give an update on that estimate?
spk06: Yeah, so on lung, the target is to have approximately 20 patients mono, Q2W, 20 patients combo with a Q2W, and then 20 patients 3Q4W, and 20 patients with a 2Q3W dosing regimen. Um, so that's the, the, the target, um, that we've set for ourselves. We've already enrolled the Q2W cohorts. We are currently enrolling the 3Q4 and the 2Q3W cohorts. Um, so that's the, that's the, uh, that's our target for, uh, actual non-small cell lung cancer.
spk05: Yeah. And whether we hit exactly 20 on the, on the, you know, uh, more frequent dose intensity regimens, you know, I think we'll get a good feeling even if we're a few, happen to be a few patients shy of that. But certainly, if you'll each describe what we're targeting.
spk08: And that was for BA3011, if I'm thinking about it right. What about BA3011?
spk05: Yeah, I think we're going to be behind that a little bit, but in terms of 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 VA3021. Philippe, you want to add to that?
spk06: Yeah, so our target is 20 Q2W monotherapy, 20 Q2W combo, and 20 3Q4W. These are the number of patients we're looking to have by the end of the year. Obviously, it is approximately, and so we might be shy of a couple patients there or maybe above in some of the cohorts, the 20 patients target, but the current target is 20.
spk05: Thanks, guys. And I would also add, you know, depending when we read these out, you know, with Roar 2, it's more of an issue potentially than it is for Axel. To hit those, you know, the question is, if we're getting that data in December, are we 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 earnings for 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.
spk07: You got it. Thank you very much.
spk11: And the next question comes from the line of Arthur He with HC Wainwright. Please proceed with your question.
spk09: Good afternoon, Jay and Rick. This is Arthur from HCV, right? Thanks for taking my question. So I just wanted to follow up on the 3011 and 3021, the data updating the lung cancer. So when you look at those data, besides the safety and the presumably ORR, what other criteria you could look into for you to make the decision, choose the optimal, uh, dosing for the pivotal study potentially.
spk05: Well, I think ultimately you've got to have a duration of response. And so we're, and we already, and Philippe already mentioned what we're targeting there, you know, six months or greater. And, uh, I think that's something that we care about and, uh, we'll be looking at. And, uh, you know, uh, I think that's the other key feature. Uh, obviously, um, I think in these PD-1 failure groups, and 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 there with what we are looking for and what we've been encouraged with the data that we have already obtained to date. Okay, great.
spk09: Thanks for that. And for the 3071 program, when we're looking for the data from the initial dose escalation part, so how could we get the idea about for the RP2D for both monotherapy and the combo when we see the data? And another question is, for the expansion study, are you planning to go straight for the combo study, or are you going to include mono and combo together?
spk05: Philip, go ahead.
spk06: Yeah, so yeah, I mean, our focus is mostly combination, okay, because that's how epidemimab has been used, or is generally used in combination with the PD-1. So that's our focus. primary focus. That being said, we are looking at immunotherapy data as well. In terms of dose selection, we will be looking at efficacy and safety in the patients that we've treated. but we'll also be looking at certain markers or efficacy as well as the PK characteristics of the dose we're looking at. So it's a novel assessment of the data that will lead us to choose one or two doses to go forward. We reserve the right, again, to go with mono and combo, but our primary focus will be combo for the expansion data.
spk09: Gotcha. Thanks, Philip. And my last question is on the ovarian cancer study. Could you remind us the inclusion and the exclusion criteria for that study? And if you see good data from the more intensive dosing regimen 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.
spk06: Yeah, so these are platinum failure patients. and it's in combination with a PD-1 inhibitor. If we see that the dose, the more intensive dosing regimen is well-treated and generate more efficacy in the indication we're looking at currently, we'll be translating that to the other indications as well. So in the case of the variant, we would 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.
spk09: Okay, thanks. Thanks for taking my question, and congrats on the progress this quarter.
spk00: Thank you.
spk09: Thank you.
spk11: And at this time, there are no further questions. Now let's turn the floor back over to Jay for any closing comments.
spk05: Well, I want to thank everyone for their time and attention today, and we're really looking forward to a lot of readouts coming up in the next couple of quarters. So thank you.
spk11: And 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.
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