BioAtla Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 11, 2023

There are 10 speakers on the call.

Operator

And welcome to the Bio Atlas 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. And as a reminder, this conference is being recorded. And it is now my pleasure to introduce to you, Bruce Mackle from LifeSci Advisors.

Operator

Thank you, Bruce. You may begin.

Speaker 1

Thank you, operator, and good afternoon, everyone. With me today on the phone from Bio Atlas are Doctor. To 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 Doctor. Eric Sievers, Chief Medical Officer and Sherry Lydic, Senior Vice President, Commercial Strategy will join Jay and Rick for a short Q and A.

Speaker 1

Earlier this afternoon, Bio Atlas 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 Bio Atlas' business plans and prospects, potential selective licensing collaborations and other strategic partnerships whether our clinical trials 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 and D and G and 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 Bio Atlas disclaims any obligation to update such statements to reflect future information, With that, I'd like to turn the call over to Jay Short.

Speaker 1

Jay?

Speaker 2

Thank you, Bruce, and thanks to everyone for joining us for our Q1 2023 Bio Atlas earnings call. Before I provide an update on our Q1 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, CAB's 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 2 trials for our 2 latest stage 1st in class CabADC product candidates, BA3011 and BA3011, 1 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 Axle and CAB war II ADCs, Targeted CAB CTLA-four and immuno oncology naked antibody and our 1st dual CAB bispecific EpCAM CD3 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 2

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 successful our Phase 2 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.

Speaker 2

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 CABADCs in our Phase 2, PARP-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 BA-three thousand and eleven Phase 2 Part 1 sarcoma study And our BA-three thousand and eleven Phase 2, Part 1 non small cell lung cancer study. Let's now move to our clinical, operational and financial updates for the Q1 2023. First, I will reiterate our BA-three thousand and eleven Phase 2 sarcoma study and our overall sarcoma strategy.

Speaker 2

We are advancing BA-three thousand and eleven in ongoing sarcoma Phase 2 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 septides with high recurrence 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 BA-three thousand and eleven in UPS today. 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 8 months.

Speaker 2

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 2 of the potentially registrational portion of the trial. The first forty patients with the TMPS greater than or equal to 50% are being randomized 1 to 1 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 of Bio Atlas as we plan for the transition into a commercial stage company.

Speaker 2

In addition to UPS, we continue to enroll in the lyo myosarcoma 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, BA-three thousand and eleven continues to be generally well tolerated with the Phase 2 safety profile across all doses consistent with the profile we observed in Phase 1. We also see real value in potentially expanding our sarcoma footprint over time to include other Ultimately, we believe BA-three thousand and eleven has the potential to treat over 25,000 sarcoma patients per year and generate up to $2,000,000,000 in revenue worldwide in this area of high unmet need. Regarding our VA-three thousand and eleven Phase 2 study In axial 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.

Speaker 2

These patients have suboptimal overall ORRs of approximately 10% to 20% and PFS rates of 4 months. As a reminder, Part 1 of the Phase 2 study in non small cell lung cancer is ongoing in axol positive Patients who have previously experienced failure of either PD-one, 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-one failure Population that have seen on average 3 prior lines of therapy. This response rate is highly competitive and exceeded our targeted response for moving forward to the Phase 2 potentially registrational part of the study. We continue to believe BA-three thousand and eleven 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.

Speaker 2

In addition, Part 1 of the Phase 2 study continues to enroll using the more frequent dose intensity regimen with Submit a meeting request to the FDA for the potential re registration of BA-three thousand and eleven 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 in the second half of 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 Axle. We estimate annually that there are over 100,000 Axle positive addressable patients worldwide with the potential to add approximately $2,500,000,000 to $3,000,000,000 in worldwide revenue at peak. Considering only the sarcoma non small cell lung cancer indications, we Of even greater importance is that BA-three thousand and eleven has the potential to be the best in class treatment for a significant number of patients To round out our CABADC BA-three thousand and eleven program, we are supporting an ongoing multicenter investigator initiated or IIT Phase to clinical trial in patients with platinum resistant ovarian cancer.

Speaker 2

The trial is on track and we anticipate interim data consisting of 10 patients in the second half Now turning to our 2nd lead CAB ADC product candidate, BA-three thousand and twenty one, Currently, BA-three thousand and twenty one is the subject of Phase 2 trials in the treatment of 4 indications. As a reminder, no other company has a therapy in the clinic targeting WER2. So we have the potential to have a 1st in class treatment for solid tumors. We conducted a similar exposure response analysis of LORD-two positive tumors to inform the more frequent dose intensity regimen in our Phase 2 LORD-two 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.

Speaker 2

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-one 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 We identified MOR208 positive tumors using the liquid biopsy assay, which is now allowing us to enroll MOR208 positive patients. We anticipate an increased enrollment in the second half of this year. In addition, our Phase 2 head and neck study is ongoing in patients who have Previously experienced failure of PD-one therapy alone or in combination with platinum therapy.

Speaker 2

Last quarter, we announced achievement of 1st patient in for the Since last quarter, we continued to enroll patients and the observed VOR2 positivity rate is high, over 50% and in line with our expectations. To round out our CAB ADC BA-three thousand and twenty one program, we are also supporting the Phase 2 IIT study with BA-three thousand and twenty one in patients with platinum resistant ovarian cancer. The trial is Track and anticipate interim data consisting of 10 patients in the second half of this year. Now I'd like to talk briefly about our Phase onetwo trial for our CAB CTLA-four antibody BA-three thousand and seventy one. As a reminder, the Phase onetwo trial is being conducted in tumors known to be responsive to CTLA-four treatment and we will evaluate safety and tolerability of The trial is progressing as planned.

Speaker 2

Last quarter, I shared that the DLT observation period was cleared for the 4th cohort at a dose of 2 10 mgs For 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 5th cohort at 3 50 mgs or 5 mgs per kg as a monotherapy Or in combination with 3 mgs per gig of nivolumab and are on track for a Phase 1 data readout in the second half of this year. We also remain on track for the initiation of our BA-three thousand and seventy one Phase 2 study to commence in the second half of this year. Finally, on to our potentially 1st in class dual cab bispecific 2 cell engager antibody, cab, FCAM, cab CD3 or BA3,182.

Speaker 2

In the Q1, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We anticipate 1st patient in for the Phase 1 study in the current quarter with the complete Phase 1 data readout anticipated next year. Similar to our other 3 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 CAF variance due to the combined selectivity of the dual CAF 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 do IND enabling studies, including CAB bispecifics and next generation ADC antibodies, and we still anticipate IND submissions For additional candidates potentially in 2023 and through 2024.

Speaker 2

With respect to important ongoing communications, The company has 9 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-three thousand and eleven. 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 Q1 of 2023 Financials. Rick?

Speaker 3

Thank you, Jay. As of March 31, 2023, we had $192,700,000 in cash and Cash equivalents compared to $215,500,000 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.

Speaker 3

For the Q1 ended March 31, 2023, we reported a net loss of $27,500,000 compared to a net loss of $24,300,000 in the same period of 2022. Research and development expenses were $21,700,000 for the Q1 ended March 31, 2023, compared to $16,900,000 for the same period in 2022. The increase of $4,800,000 Expect our R and D expenses to remain variable from quarter to quarter and generally increase as we continue to invest General and administrative expenses were $7,200,000 for the Q1 ended March 31, 2023, compared to $7,400,000 for the same period in 2022. The $200,000 change was attributable to a decrease in various expenses for the 2023 period. We expect our G and 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 Net cash used in operating activities for the 3 months ended March 31, 2023, That's $22,700,000 compared to net cash used in operating activities of $25,100,000 for the same period in 2022.

Speaker 3

The decrease in net cash used in operating activities for the 1st 3 months of 2023 This 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.

Speaker 2

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 We are excited with the compelling clinical data that is emerging in treatment refractory UPS in Non small cell lung cancer and are eager to continue advancing the Phase 2 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. BioAdler remains confident about the future with the goal of pursuing indications of high unmet medical need that we feel We'll have significant impact for patients and our shareholders worldwide. With that, we will turn it back to the operator to take your questions.

Operator

Thank you, sir. We will now be conducting a question and answer session. A confirmation tone will indicate that your line is in the queue. And the first question comes from the line of Brian Chiang with JPMorgan. Please proceed with your question.

Speaker 4

Good afternoon, guys. Thanks for taking my question. A couple from me. Looking ahead into the data update 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?

Speaker 4

And then I have a couple of follow-up. Thank you.

Speaker 2

Yes. This is Jay, and thanks for your question, Brian. I think we'll expect to see the this is Best guess at this point, but we're expecting to see the ovarian readouts earlier than, let's say, the lung readouts. I would expect the Axle to be ahead of Roar 2. 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, lileomyosarcoma.

Speaker 2

And of course, CTLA-four will also Be somewhere in there as well. So, and there's kind of a couple updates, right? One may be completing the Phase 1 like in CTLA-four and then A follow-up a little later saying kicking off the Phase 2 study. So that's our intent. Same would happen with the XL1.

Speaker 2

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 2 portion of that last Part 2, Phase 2 portion of that. So hopefully that gives you a sense of it, Brian.

Speaker 4

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 2, Part 2. And I think to more extent, I guess, have you decided on Whether you're focused on non squamous versus squamous, whether your Evelate combo are single agents? And then the second part of that question is that if the Part 1 data With the more frequent regimen looks better in the second half, will you have to revisit the trial protocol with the FDA?

Speaker 4

Thank you.

Speaker 2

So first off, I can just say that we're 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. Philippe, the rest of the questions in this section.

Speaker 5

Yes. 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 which whether to go with a single arm or our primary endpoint or go with the randomized study I guess the comparator, probably docetaxel and it might still be an ORR endpoint, but it could also be a PFS 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 in this year, so we'll be able to make a decision Whether to go with combo as well, which will only focus on the monotherapy arm.

Speaker 5

And then with your last question about 3Q4W, should we would we have to be discussing with the FDA? No, that would not be required. The dose selection is left to the sponsor to decide which dose to move or doses to move forward with. So should we see a better benefit risk profile than the 3 24W arm, we could Just replace the Q2W with the Q4W dosing regimen.

Speaker 4

Okay. If I can squeeze one more in on CAPCTL-four, that would be great. How does the 350 dose that you're dosing now with the Capsid TiA4 correlate to the target engagement that you're seeing with the currently approved CTLA-four agents that you're Seeing in the market space. Thank

Speaker 3

you. Well, we've done a

Speaker 2

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 of different antibodies and the different sequence, But their origin was very similar in 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.

Speaker 4

Great. Thanks for taking my questions today.

Speaker 2

Yes.

Operator

And the next question comes from the line of Kelly Hsieh with Jefferies. Please proceed with your question.

Speaker 6

Hi, everyone. This is Dave from Jefferies. Kelly is traveling to Asia, so I'm here on behalf of just one quick question for me. In last update in March, you mentioned there were 6 patients enrolled in LMS So, Hord, just wondering how many new patients are added since then? And when do you expect to complete 10 to 15 patient enrollment?

Speaker 6

And Any comment on pace of any?

Speaker 2

Yes. 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 We have that it won't be timely in terms of being able to report out on that in the fall. But I don't know, Philippe, if you have any other nuance on it.

Speaker 5

No, we are on schedule, 10 to 15 patients in the second half. Currently, based on the pace of enrollment, it might be more inclusive of 15 than 10, But we're on target.

Speaker 6

Okay. Thank you for taking my question.

Operator

And the next question comes from the line of Kaveri Pullman with BTIG. Please proceed with your question.

Speaker 7

Yes. 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?

Speaker 2

Yes. No, that's a good question. And Filip, I think since we've discussed this before, you should grab that one.

Speaker 5

Yes. I think what would be meaningful in patients that have failed, remember the patients that we dosing are patients that Sales not only PD-one, but they've failed generally a first round of chemo and then docetaxel or gemcitabine after that. So they are highly refractory. Durability of response anywhere above 4 months would be positive. As we said before, we are targeting 6 months Plus and the latest data we had reported

Speaker 7

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 late line?

Speaker 5

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 will respond at this point. So We'll need to generate that data before we start enrolling squamous patient or decide to go further with squamous patient.

Speaker 2

Yes. There's just a lot more announcement in these patients coming into the study.

Speaker 7

Got it. And maybe one last 1 on the other sarcoma types that you have besides UPS and LMS. Do you plan to test more frequent regimens? They are Just the way you're doing for UPS and LMS before you decide to move forward?

Speaker 2

Well, I think we're going to wait on the Lylemione data because there are strategies around that. Obviously, we're also want to drive UPS as it is, I 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 at we have an awful lot of indications, a lot of Phase 2 studies going on. So we'll be prioritizing at that time on which ones We'll prioritize over others in the fall. And so but we do believe ultimately There will be several other sarcoma types to add and a couple of them Still getting data, Lyle Myo as well as some of the bone sarcomas, but others have already Past 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, sarcoma is also, but I think we have to Balance, which one is to go first, and we'll be looking at that carefully in the fall.

Speaker 7

That's helpful. Thank you.

Operator

And the next question comes from the line of Rene Benjamin with JMP Securities. Please proceed with your question.

Speaker 8

Hey, good afternoon guys. Thanks for taking the questions.

Speaker 2

Maybe just to start off, can

Speaker 8

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 World War II, but Is this something that can be further expanded? And as we think about this, how does this get, I guess, further fine tuned and ready for commercialization as part of the development program.

Speaker 2

Philippe or Eric, if you

Speaker 5

just want to handle that one. Yes, I'll start and then Eric wants to add more, So it's not confined to Roche. We have developed a liquid biopsy for AXO Not small cell lung as well. And we are 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 So we'll be able to correlate the IHC data to the CTC data Once we've demo all the patients, once we have all the results from this first part of the study.

Speaker 5

So it's ongoing for O2 and Axle, and we're just waiting to generate more data. In melanoma, because we had The difficulty in moving as we discussed before, we prioritize that and are now Using this assay in Novartis, we've been able to identify patients that were Both positive leaving 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 liquid biopsy over time.

Speaker 8

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.

Speaker 2

Yes. Philippe, you may as well go ahead on the axle lung. You want to give an update on that

Speaker 5

Yes. So on Lon, the target is to have approximately 20 patients Mono, the Q2W, 20 patients combo with a Q2W and then 20 patients 3Q4W And 20 patients with the 2Q3W dosing regimen. So that's the target that we set For ourselves, we've already enrolled the Q2W cohorts. We are currently enrolling the 3Q4 and the 2Q3W cohorts. So that's the that's our target for Axle non small cell lung cancer.

Speaker 5

Yes.

Speaker 2

And whether we hit exactly 20 on the more frequent dose intensity regimens, 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, Felix described what we're targeting.

Speaker 8

And that was for BA-three thousand and eleven,

Speaker 9

if I'm thinking about it right. What about BA-three thousand and eleven?

Speaker 2

Yes, 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 VA-three thousand and twenty one. Philippe, you want to add to that?

Speaker 5

Yes. So our target is 20 Q2W Monotherapy 20 Q2W combo and 20 Q4W. These are The number of patients we're looking to have by the end of the year, obviously, it is approximately, and so it might be Shire a couple of patients there or maybe above in some other cohorts, the 20 patients target, but the current target is correct.

Speaker 8

Thanks, guys.

Speaker 2

And I would also add, depending when we read these out, with Roar two, it's more of an issue potentially than For Axl, to hit those, the question is, if we're getting that date in December, are we just going to push that into early Conference in January or do we try to give a sense at one of the upcoming meetings or also at our earnings For 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. So please keep that in mind.

Speaker 8

You got it. Thank you very much.

Operator

And the next question comes from the line of Arthur He with H. C. Wainwright. Please proceed with your question.

Speaker 9

Hi, good afternoon, J. A. Henric. This is Arthur from HC Wainwright. So I just want to follow-up on the 3,011 and 3,021, the data updating So when you look at those data, besides the safety and the I presume that the ORR, what other criteria you could look into For you to make the decision, choose the optimal dosing for the pivotal study potentially?

Speaker 2

Well, I think ultimately, you've got to have a duration And Philippe already mentioned what we're targeting there 6 months or greater. And I think that's something that we care about and we'll be looking at and I think that's the other key feature. Obviously, I think in these PD-one failure Groups and especially with AXA, you got 35% of the patients are positive. We really could open up some efficacy for patients that really don't have any 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 been seeing been encouraged with the data that we have already

Speaker 9

Okay, great. Thanks for that. And for the 3,701 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 you're going to including mono Yes.

Speaker 2

So, yes,

Speaker 5

I mean, our focus is mostly Combination, okay, because that's how ipilimumab has been used or is generally used in combination with PD-one. So that's our primary focus. That being said, we are looking at monotherapy data as well. In terms of dose selection, we will be looking at efficacy and safety in patients that we've treated, But we'll also be looking at certain markers or efficacy that and as well as the PK characteristics of the dose we're looking at. So it's an overall assessment of the data that will lead us to choose 1 or Two doses to go forward.

Speaker 5

We reserve the right again to go with mono and combo, but Our primary focus will be combo for the expansion of data.

Speaker 9

Got you. Thanks, Philippe. 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 for the 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.

Speaker 5

Yes. So these are platinum failure patients, and it's in combination with a TD1 inhibitor. We see that the dose the more intensive dosing regimen is well tolerated And generate more efficacy and the indications we're looking at currently, we'll be translating that to the other indications 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 regimen. We may decide to take 2 doses forward, but we wouldn't have a problem taking forward the more intensive dosing regimen.

Speaker 9

Okay. Thanks for taking my question and congrats on the progress this quarter.

Speaker 5

Thank you. Thank you.

Operator

And at this time, there are no further questions. Now, I'd like to turn the floor back over to Jay for any closing comments.

Speaker 2

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.

Operator

And thank you everyone. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

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