Bioatla - Q1 2023
May 11, 2023
Transcript
Operator (participant)
Greetings, welcome to the BioAtla Q1 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce to you Bruce Mackle from LifeSci Advisors. Thank you, Bruce. You may begin.
Bruce Mackle (Investor Relations Advisor)
Thank you, operator. 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, Philippe Martin, Chief of Clinical Development and Operations, Dr. Eric Sievers, Chief Medical Officer, and Sheri Lydick, Senior Vice President, Commercial Strategy, will join Jay and Rick for a short Q&A. Earlier this afternoon, BioAtla released financial results and a business update for the Q1 ended March 31, 2023. A copy of the press release is 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 BioAtla's business plans and prospects, potential selective licensing, collaborations, 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, expectations with respect to enrollment and dosing in our clinical trials, 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, and expected R&D and G&A 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 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?
Jay Short (Chairman, CEO, and Co‑Founder)
Thank you, Bruce, thanks to everyone for joining us for our Q1 2023 BioAtla 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, BioAtla 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 II 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-ROR2 ADCs, targeted CAB-CTLA-4, an immuno-oncology naked antibody, and our first dual CAB 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 and 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 one 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 II part one sarcoma study and our BA3011 phase II part one non-small cell lung cancer study. Let's now move to our clinical, operational, and financial updates for the Q1 2023. I will reiterate our BA3011 phase II sarcoma study and our overall sarcoma strategy. We are advancing BA3011 in ongoing sarcoma phase II 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 antitumor 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%, median 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 TPS 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 leiomyosarcoma 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 BA3011 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 BA3011 phase II study in AXL-positive 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%-20% and PFS rates of four months. As a reminder, part one of the phase II study in non-small cell lung cancer is ongoing in AXL-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 II part two. In addition, part one of the phase II 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 II part two 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 two 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 indication. As we have previously mentioned, approximately 35% of patients in this second-line plus indication of non-small cell lung cancer express AXL. We estimate annually that there are over 100,000 AXL-positive addressable patients worldwide with the potential to add approximately $2.5 billion-$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 BioAtla. 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. 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 ROR2 ADC. Currently, BA3021 is the subject of phase II trials in the treatment of four indications.
As a reminder, no other company has a therapy in the clinic targeting ROR2. 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 II, part two 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 II 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 ROR2 positive tumors using the liquid biopsy assay, which is now allowing us to enroll ROR2 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 continued 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. 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 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 I data readout in the second half of this year. We also remain on track for the initiation of our BA3071 phase II 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 EpCAM CAB CD3, or BA3182. In the Q1, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. 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 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 IND-enabling studies, including CAB bispecifics and next generation ADC antibodies. We still anticipate IND 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 ESMO 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 BA.3011. 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 Q1 of 2023 financials. Rick?
Richard Waldron (CFO)
Thank you, Jay. 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 Q1 ended March 31, 2023, we re-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 Q1 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 Q1 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. Now back to Jay.
Jay Short (Chairman, CEO, and Co‑Founder)
Thank you, Rick. We are pleased with the progress we have made to date and our cumulative results that continue to support both the preliminary efficacy and safety from our differentiated proprietary CAB platform. We are excited with the compelling clinical data that is emerging in treatment refractory UPS and non-small cell lung cancer, are eager to continue advancing the phase II studies with the addition of the more frequent dose intensity 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 in multiple cancer indications, we are well poised to reach several value creating milestones and key inflection points in the next several months.
BioAtla 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.
Operator (participant)
Thank you, sir. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the queue. You may press star two if you would like to remove your question from the queue. 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. The first question comes from the line of Brian Cheng with JPMorgan. Please proceed with your question.
Brian Cheng (VP and Equity Research Analyst)
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? I have a couple follow-up. Thank you.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. This is Jay, 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 AXL to be ahead of ROR2. I think that those are some of the key ones. 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. Of course, CTLA-4 will also be somewhere in there as well. 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.
That's our intent. Same would happen with the AXL lung. Here's our data, hopefully tied in with a meeting or conference, followed by kicking off the, you know, describing the FDA feedback and kicking off the phase II portion of it. Last part two, phase II portion of that. Hopefully that gives you a sense of it, Brian.
Brian Cheng (VP and Equity Research Analyst)
Great. That was helpful. For your AXL program in non-small cell, what's your latest thoughts on the trial design for the potentially pivotal phase II, part two? I think, you know, to more extent, I guess, have you decided on whether to focus on non-squamous versus squamous, whether you'll evaluate combo or single agents? 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.
Jay Short (Chairman, CEO, and Co‑Founder)
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 gonna focus on the non-squamous. I'm gonna actually ask, Philippe to, potentially answer this one. Philippe, the rest of the questions in this section.
Philippe Martin (Chief of Clinical Development and Operations)
Yeah. Thank you, Jay. 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 R primary endpoint or go with a randomized study against a comparator, probably docetaxel and, it might still be an OR endpoint, but it could also be a PFS endpoint. We'll make that decision post post-meeting with FDA. Currently, we're focusing on the monotherapy, but we'll be getting more data for the combo later on in this year.
We'll be able to make a decision whether to go with combo as well, which will only focus on the monotherapy arm. With your last question about 3Q4W, would we have to re-discuss it with FDA? No, that would not be required. The dose selection is left to the sponsor to decide which dose or doses to move forward with. Should we see a better benefit risk profile with the 3Q4W arm, we could just replace the 2Q2W with the 3Q4W dosing regimen.
Brian Cheng (VP and Equity Research Analyst)
Okay. If I can squeeze one more in on CAB-CTLA-4, that would be great. How does the 350 dose that you're dosing now, with the CAB-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.
Jay Short (Chairman, CEO, and Co‑Founder)
Well, you know, we've done a lot of work with ipilimumab. We do a lot of comparisons. 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. Because they're different, you know, they're different antibodies, and they're different sequence, but we, you know, but their origin was very similar in all of our comparison studies. I think that's a nice general guideline with the caveat of some PK alignment at the end of the study.
Brian Cheng (VP and Equity Research Analyst)
Great. Thanks for taking my questions today.
Jay Short (Chairman, CEO, and Co‑Founder)
Yep.
Operator (participant)
The next question comes from the line of Kelly Shi with Jefferies. Please proceed with your question.
David Steinberg (Senior Equity Research Analyst)
Hi, everyone. This is David from Jefferies. Kelly is traveling to Asia, I'm here in on behalf of her. Just one quick question for me. In last update in March, you mentioned there were six patient enrolled in LMS cohort. Just wondering how many new patient are added since then? When do you expect to complete 10-15 patient enrollment? Any comment on pace of enrollment? Thank you.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. 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. 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. I don't know, Philippe, if you have any other nuance on it, but.
Philippe Martin (Chief of Clinical Development and Operations)
No, we're on schedule. 10 to 15 patients in the second half. I think, currently based on the pace of enrollment, it might be more closer to 15 than 10. We're on target.
David Steinberg (Senior Equity Research Analyst)
Okay. Thank you for taking my question.
Operator (participant)
The next question comes from the line of Kaveri Pohlman with BTIG. Please proceed with your question.
Kaveri Pohlman (Director and Biotechnology Analyst)
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 these late line patients from the data you're collecting?
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. No, that's a good question. Philippe, I think, since we've discussed this before, you should grab that one.
Philippe Martin (Chief of Clinical Development and Operations)
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. 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 have reported led us to believe that we'll be able to achieve that.
Kaveri Pohlman (Director and Biotechnology Analyst)
I got it. That's helpful. 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-based regimen in the first line. Does that make it less susceptible to respond to MMAE in late line?
Philippe Martin (Chief of Clinical Development and Operations)
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. We'll need to generate that data before we start enrolling, squamous patients or decide to go further with squamous patients.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. There's just a lot more non-squamous patients coming into the study.
Kaveri Pohlman (Director and Biotechnology Analyst)
Got it. Maybe, one last one on the other sarcoma types that you have besides UPS and LMS. Do you plan to test more frequent regimens, there just the way you're doing for UPS and LMS before you decide to move forward?
Jay Short (Chairman, CEO, and Co‑Founder)
Well, I think we're gonna wait on the leiomyo data, because there's strategies around that. Obviously, we're also, wanna drive UPS as it is, move that down the line and, we'll be doing. I mean, we have an awful lot of indications, a lot of phase II 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, leiomyo as well as some of the bone sarcomas.
Others have already passed our criteria. When we will actually load those other ones, I think that's yet to be determined. We have some very large indications and great opportunities. I mean sarcomas also, I think we have to balance which ones to go first. We'll be looking at that carefully in the fall.
Kaveri Pohlman (Director and Biotechnology Analyst)
That's helpful. Thank you.
Operator (participant)
As a reminder, if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the queue. The next question comes from the line of Reni Benjamin with JMP Securities. Please proceed with your question.
Reni Benjamin (Equity Research Analyst)
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 ROR2, but is this something that could be further expanded? 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?
Jay Short (Chairman, CEO, and Co‑Founder)
Philippe or Eric, if you guys wanna handle that one?
Philippe Martin (Chief of Clinical Development and Operations)
Yeah. I'll start it, and if Eric wants to add more, please do so. It's not confined to ROR2. We have developed a liquid biopsy for AXL non-small cell lung as well. And we're currently generating data. 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 CTC or the liquid biopsy. We'll be able to correlate the IHC data to the CTC data once we've enrolled the patients or once we have all the results from this first part of the study. It's ongoing for ROR2 and AXL, 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 melanoma, and we've been able to identify patients that were ROR2 positive using the CTC assay. 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.
Reni Benjamin (Equity Research Analyst)
Got it. Okay. I think, you know, you, you have several readouts, you know, coming out in the second half. You mentioned about 10 patients worth for the ovarian, 10-15 patients worth for LMS. Can you give us a sense just based on current enrollment trends? You know, how many patients worth of, you know, data we might see from the anticipated readout for non-small cell lung and anything else I'm, I might be missing that's not coming to the top of my head right now.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah, Philippe, you may as well go ahead on the AXL lung. You wanna give an update on that one, estimate?
Philippe Martin (Chief of Clinical Development and Operations)
Yeah. On lung, the target is to have approximately 20 patients mono, 20 with 2Q2W, 20 patients combo with a 2Q2W, and then 20 patients, 3Q4W, and 20 patients with the 2Q3W dosing regimen. That's the target that we've set for ourselves. We've already enrolled the 2Q2W cohorts. We are currently enrolling the 3Q4W and the 2Q3W cohorts. That's the that's our target for AXL non-small cell lung cancer.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. Whether we hit exactly 20 on the, you know, more frequent dose-intensive 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. Certainly Philippe's described what we're targeting.
Reni Benjamin (Equity Research Analyst)
That was for BA3011, if I'm thinking about it right. What about BA3021?
Jay Short (Chairman, CEO, and Co‑Founder)
I think we're gonna be behind 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 and with our discussions, future discussions with the FDA with regard to BA3021. Philippe, you wanna add to that?
Philippe Martin (Chief of Clinical Development and Operations)
Yeah. Our target is 20 2Q2W monotherapy, 20 2Q2W 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, we might be shy of a couple patients there or maybe above in some of the cohorts. Some of the cohorts, the 20 patients target, the current target is 20.
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah.
Reni Benjamin (Equity Research Analyst)
Thanks, guys.
Jay Short (Chairman, CEO, and Co‑Founder)
I would also add, you know, with ROR2 it's more of an issue potentially than it is for AXL, to hit those, you know. The question is, if we're getting that data in December, are we just gonna push that into early conference in January? Do we try to give a sense at one of the upcoming meetings or also at our earnings, for the Q3? 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. Please, keep that in mind.
Reni Benjamin (Equity Research Analyst)
You got it. Thank you very much.
Operator (participant)
The next question comes from the line of Arthur He with H.C. Wainwright. Please proceed with your question.
Arthur He (VP in Equity Research)
Hi, good afternoon, Jay and Rick. This is Arthur from H.C. Wainwright. Thanks for taking my question. I just want to follow up on the BA3011 and BA3021, the data updating the lung cancer. When you look at those data, besides the safety and the presumably ORR, what other criteria you could looking to for you to make the decision choose the optimal dosing for the pivotal study potentially?
Jay Short (Chairman, CEO, and Co‑Founder)
Well, I think ultimately you've got to have a duration of response. Philippe already mentioned what we're targeting there, you know, six months or greater. I think that's something that we care about and we'll be looking at. you know, I think that's the other key feature. Obviously, I think in these PD-1 failure groups, and especially with AXL, you got 35% of the patients are positive. We, you know, 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 coming, 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 seen, been encouraged with the data that we have already obtained to date.
Arthur He (VP in Equity Research)
Okay. Great. Thanks for that. For the 3071 program, when we're looking for the data from the initial dose escalation part, how could we get the idea about for the RP2D for both monotherapy and the combo, when we see the data? Another question is for the expansion study, are you planning to go straight for the combo study or you going including mono and combo together?
Jay Short (Chairman, CEO, and Co‑Founder)
Yeah. Philippe, go ahead. Philippe.
Philippe Martin (Chief of Clinical Development and Operations)
I mean, our focus is mostly combination, okay? Because that's how ipilimumab is, has been used or is generally used in combination with the PD-1. That's our primary focus. That being said, we are looking at monotherapy data as well. In terms of dose selection, we'll be looking at efficacy and safety in the patients that we've treated. We'll also be looking at certain markers or efficacy that and as well as the PK characteristics of the dose we are looking at. It's an overall 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, our primary focus will be combo for the expansion data.
Arthur He (VP in Equity Research)
Gotcha. Thanks, Philippe. My last question is on the ovarian cancer study. Could you remind us the inclusion and the exclusion criteria for that study? If you see good data from the more intensive dosing regimen from the either the lung cancer and the sarcoma, is there a way to do the dose optimization as well for the ovarian cancer study? Thanks.
Philippe Martin (Chief of Clinical Development and Operations)
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-tolerated and generate more efficacy in the indication we're looking at currently, we'll be translating that to the other indications as well. In the case of ovarian, we would be able to move forward with a study that would most likely be a registration study with the higher dosing regimen. We might decide to take two doses forward, but we wouldn't have a problem taking forward the more intensive dosing regimen.
Arthur He (VP in Equity Research)
Okay, thanks. thanks for taking my question, and congrats on the progress this quarter.
Philippe Martin (Chief of Clinical Development and Operations)
Thank you.
Jay Short (Chairman, CEO, and Co‑Founder)
Thank you.
Operator (participant)
At this time, there are no further questions. Now let's turn the floor back over to Jay for any closing comments.
Jay Short (Chairman, CEO, and Co‑Founder)
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 quarters. Thank you.
Operator (participant)
Thank you everyone. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.