BioAtla Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 1, 2023

There are 11 speakers on the call.

Operator

Greetings, and welcome to the Bio Atlas Second Quarter 2023 Earnings Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr.

Operator

Bruce Mackle with LifeSci Advisors. 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. Jay Shorke, Chairman, CEO and Co Founder and Richard Waldron, Chief Financial Officer. Following today's call, Doctor. Eric Sievers, Chief Medical Officer And Sherry Lydic, Chief Commercial Officer will join Jay and Rick for a short Q and A.

Speaker 1

Earlier this afternoon, Bio Atlas released Results and a business update for the Q2 ended June 30, 2023. A copy of the press release and corporate Presentation are available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call We'll 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 it's clinical trials will be potentially registrational, Achievements of milestones, results, conduct, progress and timing of its research and development programs and clinical trials, Expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, Clinical trials, regulatory meetings and regulatory submissions, the potential regulatory approval path for its product candidates, Expectations about the sufficiency of its 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 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, August 1, 2023, And BioAtlet disclaims any obligation to update such statements to reflect future information, events or circumstances, except as required by law.

Speaker 1

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

Speaker 2

Thank you, Bruce, and thanks to everyone for joining us for our Q2 2023 BioAdla earnings call. BioLyla 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, Thereby addressing urgent unmet needs in oncology to improve patients' lives. We made significant progress last year across our For ongoing Phase 2 trials for our 2 latest stage 1st in class cab ADC product candidates, BA3011 and BA3011 targeting solid tumor types with high unmet medical needs. As we are now a little over halfway through 2023, we continue our positive trajectory and remain on track to achieve our recently guided milestones outlined On the Q1 call in May, 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 cabaxel And cab or 2 ADC's, cab CTLA-four immuno oncology naked antibody and our 1st 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.

Speaker 2

We remain excited about our lead asset BA-three thousand and eleven 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. We also shared additional insights on how we have Slide the learnings from our differentiated safety data and exposure response analyses as well as our UPS related FDA interactions We study more frequent dose intensity regimens more broadly across our AXA ADC and our Roar-two ADC programs. The goal of studying more frequent dose intensive regimens across programs is to provide data to allow us to set study parameters that maximize the company's likelihood of Successful. Our Phase 2 potentially registrational studies, a summary of our current dose regimens can be found in the updated corporate presentation on our website.

Speaker 2

Let's now move to our clinical, operational and financial updates for the Q2 2023. First, we are advancing BA3011 in our ongoing sarcoma Phase 2 studies, including a potentially registrational study at 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 to date. Based on these results, together with the continued differentiated safety An encouraging feedback from the FDA around the study design. Last year, we initiated Part 2 of the potentially registrational portion of the trial.

Speaker 2

The first 40 patients are being randomized 1 to 1 between the more frequent dose intensity regimens. Following the first 40 patients, we plan to enroll an Additional 40 patients at the selected dose to complete the study. The primary efficacy endpoint ORR Will be based on approximately 60 patients treated at the selected dosing regimen. As an update, we achieved 1st patient in and are actively enrolling In addition to UPS, we have completed enrollment of the Phase 2, Part 1 LYOMYOS sarcoma cohort using the 3Q4W dosing regimen and are on track with an anticipated data readout on 10 to 15 patients in the second half of this year. Further, the remaining bone sarcoma cohorts in Phase 2, Part 1 are on track to finish enrolling in the second half of twenty twenty three.

Speaker 2

With regards to safety profile across all sarcoma subtypes, there are no new safety signals to report. VA-three thousand and eleven continues to be generally well tolerated with a Phase 2 safety profile across all doses consistent with the profile we observed in Phase 1. Regarding our BA-three thousand and eleven Phase 2 study in axial Positive multi refractory non small cell lung cancer. We continue to be encouraged about the data from the Q2W dosing regimen. While we anticipate data from the more frequent dose intensive regimens, currently the scan treatment options in patients who progress on immune checkpoint inhibitors have Suboptimal overall response rates of approximately 10% to 20% and 4 month PFS rates.

Speaker 2

Part 1 of a Phase 2 study in non Small cell lung cancer is ongoing in axial positive patients who have previously experienced failure of either PD-one, PD L1, EGFR We're ALK inhibitors and continues to enroll patients. Anticipated data for all dosing regimens With the study design for the potentially registrational portion of the trial remains on track for the second half of this year. We have submitted a meeting request to the FDA for potentially registrational VA-three thousand and eleven Phase 2 Part 2 non small cell lung cancer Study design and anticipate feedback in the second half of this year. And as a result, remain on track to initiate the Phase 2 Part 2 study In non small cell lung cancer also in the second half of this year, maintaining our overall timeline for development of the non small cell lung cancer indication. We continue to believe BA-three thousand and eleven has the potential to become a significant commercial asset for BioAtma and that even greater importance, A first in class treatment for a significant number of patients who fail at least one prior line of therapy, thus addressing a significant unmet medical need.

Speaker 2

Regarding the ongoing multicenter investigator initiated IIT Phase 2 clinical trial in patients with platinum resistant ovarian The trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year. Now turning to our 2nd CAB ADC asset, BA-three021, a CAB OR2 ADC. Currently, VA3,021 is the subject of Phase 2 trials in the treatment of 4 different indications. We conducted a similar exposure response analysis of WR2 positive tumors to inform the more frequent dose intensity regimen of 3q4w in our Phase 2 war II positive non small cell lung cancer study. Based on this analysis, which is a similar strategy to our UPS Phase 2 Part 2 BA-three zero one study, I mentioned earlier, we are screening and enrolling patients.

Speaker 2

Based on the activity to date, we believe that we remain on track to obtain data this year to permit clinical trial prioritization across our portfolio. Regarding the melanoma Phase 2 trial in patients who have previously experienced failure of PD-one therapy, We are continuing to screen patients with the validated IHC liquid biopsy assay. As we stated last quarter, we have successfully identified OR2 positive Tuners using the liquid biopsy assay, which is allowing us to enroll WR2 positive patients and we are on track to dose patients 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. Earlier this year, we announced achievement of 1st patient in for the study.

Speaker 2

Since that time, multiple patients have been dosed and we continue to enroll patients. Regarding the ongoing multicenter investigator initiated Phase 2 clinical trial in patients with platinum resistant ovarian cancer, The trial is fully enrolled and remains on track for the interim data readout consisting of 10 patients in the second half of this year. Now turning to 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 We are continuing to evaluate safety and tolerability of BA-three thousand and seventy one in monotherapy and in combination with nivolumab. The trial is progressing as planned.

Speaker 2

Last quarter, we shared that we started treating patients in the 5th cohort 350 milligrams or 5 mgs per kg as monotherapy and in combination with 3 mgs per kg nivolumab. As part of today's update, I'm happy to report that the DLT observation period was cleared for the 5th cohort and no DLTs were reported. We are currently enrolling patients in the sick cohort at 700 milligrams or 10 mgs per kg as the monotherapy or in combination With 3 mgs per kg of dolomab and remain on track for Phase 1 data readout anticipated in the second half of this year. We also remain on track to initiate BA371 Phase 2 study also in the second half of this year. We believe there are significant unmet medical needs with sizable commercial opportunities across multiple tumor types where CTLA-four can deliver efficacy With a manageable safety and tolerability profile that allows patients to stay on therapy for longer and thus achieve The full benefit of this important therapy.

Speaker 2

Next on to our potentially 1st in class dual cab bispecific T cell engager antibody, CABPAPCAM and CAB CD3 or BA3182. As mentioned During last quarter's call, we received FDA clearance of our IND for the treatment of advanced adenocarcinoma. We are now actively enrolling patients in this Phase 1 study with the full data readout remaining on track for next year. Similar to our other 3 clinical stage cab assets, this antibody has shown significant promise in in vivo preclinical studies Demonstrating an over 100 fold improvement in the therapeutic index relative to the non cab variance due to the combined selectivity of the dual cab design. We believe that our dual cab design has the potential to address the tremendous unmet need across several of the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas and prostate.

Speaker 2

Finally, we continue to pursue opportunities Share our progress with the medical and scientific communities with an additional 2 trial in progress abstracts, one for BA-three thousand and eleven and another for BA-three 3021, which were accepted for poster presentations at the upcoming World Conference on Lung Cancer this September. This brings the total confirmed medical meeting presentation talent to 11 since the beginning of the year. Additional abstracts have been submitted for several upcoming meetings as With that, I would now like to turn the call over to Rick to review the Q2 2023 financials. Rick?

Speaker 3

Thank you, Jane. As of June 30, 2023, we had $168,700,000 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 TAB 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 collective licensing of product rights In certain territories, all 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 Q2 ended June 30, 2023, we reported a net loss of $35,800,000 Compared to a net loss of $28,900,000 in the same period of 2022. Research and development expenses were $31,000,000 for the Q2 ended June 30, 2023, compared to $20,700,000 for the same period in 2022. The increase of $10,300,000 was primarily driven by our preclinical and clinical product development efforts. We expect our R and D Tremendous remain variable from quarter to quarter and generally increase as we continue to invest in R and D activities expenses were $6,200,000 for the quarter ended June 30, 2023, compared to $8,300,000 for the same quarter in 2022. The $2,100,000 change was attributable to a decrease in various administrative expenses For the 2023 period, we expect our G and A expenses to moderately increase to development of our product candidates, advance our intellectual property portfolio, support focused pre commercialization activities For asset BA3011 and satisfy requirements as a public company, Net cash used in operating activities for the 6 months ended June 30, 2023 Was $46,700,000 compared to net cash used in operating activities of $42,100,000 For the same period in 2022, the increase in net cash used in operating activities for the 1st 6 months Of 2023 is primarily due to an increase in research and development expenses related to our program development efforts as compared to the 1st 6 months of 2022.

Speaker 3

And now back to Jay.

Speaker 2

Thank you, Rick. We are pleased with the progress we have made to date and cumulative results that continue to support both the preliminary efficacy and safety from our differentiated We are encouraged with the compelling clinical profile that is emerging in treatment refractory UPS in non small cell lung cancer And are eager to start evaluating data from our Phase 2 studies with the addition of the more frequent dose intensity regimens. We're also excited by the continued clinical execution of our other promising CAB assets, in particular, our BA3071 Cab CTLA-four, clearing the 5th cohort with no DLTs observed and are well positioned to reach several value creating milestones and key inflection BioIsland remains confident about the future with the goal of pursuing indications of high unmet medical needs 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. We will now be conducting a question and answer And our first question is from Kelly Hsieh with Jefferies. Please proceed with your question.

Speaker 4

I have a question on the request that you submitted to FDA. Can you talk a little bit more what kind of Data have you provided to the FDA? And does it include Enough data to make a decision on RP2D?

Speaker 2

Yes. I mean, I think what we've Really approach the FDA with these questions related to a study design and basically both With respect to whether it's a randomized trial, single arm trial, and we've provided a basic update of Things that we have to date and maybe Eric, you might want to add a little bit more on that.

Speaker 5

Sure. Your question was about whether we've provided data regarding a recommended Phase 2 dose, I believe. And presently, we've submitted questions to the agency, just as Jay had mentioned about the overall study design, Randomization, some of those features. We anticipate preparing more information regarding our dosing regimens in the briefing book.

Speaker 4

All right. And one more thing, how many patient data do you expect to include And the follow-up, and do you have any internal bar to move forward for both ORR or PFS?

Speaker 2

Eric, you want to start with that one?

Speaker 5

Sure. We are evaluating patients as Shown in our corporate deck, at multiple dose levels, including more dose intensive regimens. And I anticipate we'll have a fulsome Analysis of those data by the end of the year that we can provide to the agency as a part of the Project Optimus.

Speaker 2

And I would add that we're testing basically 3 different doses that would be every other week and then 2Q, 3W as well as the 3Q, 4W. And so we'll have a little bit more data on the Q2 W, we believe we'll have sufficient data for all of the doses for our go forward decision and how we're going to approach it.

Speaker 4

Great. Thank you for taking our question.

Operator

Thank you. And our next question is from Brian Chiang with JPMorgan. Please proceed with your question.

Speaker 6

Hey, guys. Thanks for taking my question this morning this afternoon. Just a couple from us. Maybe first on 3021, What is your latest thoughts on collaboration or partnership that could potentially built in this consideration?

Speaker 2

Yes. When we're making these kind of decisions, Brian, I think we're going to be looking across the entire portfolio. We have to weigh The axle indications were the fact that we're in a lung axle and also in a MOR2 Well, how many lung indications should we take forward at the same time? We'll be evaluating that. That's going to be related to data.

Speaker 2

And also where things are safety wise, I think we're across the board feeling very comfortable across all the indications. So I think I know personally I'm very interested to see how they head in that reads out. We're still accumulating data. Likewise in lung and of course on both of the AXA and WER2, we're seeing we expect to see On track to see ovarian cancer data as well. And by the way, just as a footnote, at the time of our Right up on the script, we hadn't dosed the melanoma patient yet, but at least we crossed that line today.

Speaker 2

And so I think that's truly going And that's going to give us a nice picture there as well, which we expected, but it's nice to see it's maybe a little ahead. So Overall, I think we have more indications and more drug opportunities than most companies have. So you've got an opportunity to really Pick the best ones to advance and that also gives us some freedom for partnering as well. And so I don't know that's Maybe a high level response and maybe, I don't know if Sherry, you want to add anything else to it, but don't feel obligated.

Operator

No, I think you covered it, Jay. Thank you.

Speaker 6

Yes. Maybe just one more on 3,701. Any color on clinical activity so far with the 5th cohort dosing? And just how should we think about the potential indications for the Phase 2 dose expansion cohort?

Speaker 2

Yes. I mean, safety wise, and we're very happy with that. We're So very encouraged without getting into any specifics, but with the data and readouts that we're seeing already. And so I would say, As we said in the script, we're excited about that asset and we continue to be. And I think You'll recall that we're testing this across 8 different indications, all known to have Some responsiveness to CTLA-four.

Speaker 2

And so we're we've done a fair bit of analysis on which ones we are likely to take forward. But I think we're going to see how the next cohort Reach out and tighten that view. But I think at this point, I certainly wouldn't be ruling out any indications. However, There would be some that I think that have a great opportunity and I would prefer not to list them now because this is An evolving asset and I really like the data we're seeing with the combination with PD-one PD-one to 3 mgs per kg and clearing the 5 mgs per kg and we're already dosed the patients at I should have added, Brian, that one nice thing about CTLA-four is that it also opens up the door For future combination therapies and just like in analogous way that PD-one has done with so many different other therapies. So One can't help but sit back and think about those possibilities in addition to just combining with PD-one.

Operator

Our next question is from Kaveri Pullman with BTIG. Please proceed with your question.

Speaker 7

Yes. Good evening and thanks Phase 2 trial, it's a relatively small sample size. Any color on when do you think you'll be able to complete the frequent dosing And will you be reporting efficacy data from these cohorts after selection of the right schedule or that won't be allowed Since some patients will be part of the pivotal trial.

Speaker 2

Well, if we're talking about lung, We do anticipate, well, we'll have the data, enough data for the more frequent dosing to make our Plan for going forward into a registrational study this half of this year. We are and have identified A medical meeting where we intend to provide an update on our data both for the every other week dosing as well as the more Frequent dosing. We're going to report on that meeting after we formally get accepted at that meeting. But we believe that's on track for Communication this year, that's with Axle in lung. The UPS, of course, is registration or potentially now and we'll not be reporting on that until later next year once we get further down the line on that.

Speaker 2

And then the ovarian studies, we intend to Poured out on those, both for the absolute war II and we're certainly hopeful that we'll have sufficient data Well, the Ward 2 asset to allow us to effect the prioritization across our portfolio, Those from the standpoint of what we want to take forward, what we might want to partner, etcetera. I'm not sure that we're going to report out on efficacy data on OR This year, but we'll certainly have some sense of the prioritization. And of course, CTLA-four, I think also we're going to be we'll be giving updates, routine updates on as we progress through Phase 1, but I think is, we'll also guide a little bit on where we're going to head with the Phase 2 study as well. The actual readout on that is probably most of our plan, as we've reported earlier in the year is to align with medical meetings for Our readouts, but we're trying to bring in as many of those as we can into this year.

Speaker 7

Got it. That's very helpful. And then I believe for ovarian cancer results, you mentioned that you have completed the enrollment. But can you tell us How long these patients have been on treatment and will you be able to provide any results on durability?

Speaker 2

Well, these started some time ago and I maybe allow Eric to give some better feedback on the timeline. But I'll just remind everyone, these are IIT studies. So the actual we're waiting on the data ourselves. So we hope we know it is not too far off in the future. We've been told by IT studies.

Speaker 2

We know they're fully enrolled, so we should have a nice snapshot. But Eric, maybe you want to get a sense when things started. Keeping in mind, all the patients have come on board at different times. So it's hard to give a specific number. Eric, you want to add some more color to it?

Speaker 5

Jay, I think you've characterized that really well. We started working with the Canadian Clinical Trials Group back in 2020 about this. Then we had a mature protocol and started enrolling patients at different times in the 2 different protocols, I mean the 2 different regimens, one for the ROAR-two asset and the other for AXAL. We are looking forward to seeing these data as well.

Speaker 2

I think we'll get some insight on durability. Obviously, the latter Patients in that study will have a little less than the earlier ones, but that's the way it works.

Speaker 7

Got it. And maybe a last one. Besides exploring the dosing schedule, do you also plan to continue to explore XL Question score for each tumor type to confirm the patient population that responds best to the treatment And any changes you expect or need to make in terms of your companion diagnostic test?

Speaker 2

I think the companion diagnostics path forward was in good I would just say though, I think we reported out earlier in the year that we had At least 1 PR at the 1% TNPS score level at lung. So we are exploring a bit further Without getting into too many details at this point, but yes, that's certainly on our mind and we're evaluating things.

Speaker 7

Thanks for taking my questions.

Operator

And our next question is from Arthur He with H. C. Wainwright. Please proceed with your question.

Speaker 8

Hi, good afternoon, Jay, Eric, Eric and Sherry. Thanks for taking my question. Hi, Heather. So for the 3,071 data update, so Could you tell us what the current 5 mgkg in combo, what's the average Cycles of this 3,701 being dosed?

Speaker 2

It can't be very long because I think We reported out that we were just dosing them in our kind of May timeframe, Something like that. And May, June, I think also at some of the conferences we may have mentioned in June. So you can only expect it to be a couple a few months. But I think in general, We're encouraged with what we're seeing.

Speaker 8

Okay. Thanks for that. And

Speaker 2

By the way, Arthur, I should add though, but we have earlier dose at those levels That just happened to be earlier, and several of those have gone on for quite some time, well over the 3 to 4 cycles that are normally attainable.

Speaker 8

I see. I see. Yes. And for the 10 megapiloten megapiloten megapiloten megapiloten megapiloten, is still in the monotherapy dosing stage or it's already reached the

Speaker 2

I think it's we don't have a precise I know one has made it, but I don't have much more information. I don't know the status, but so let's that's about all I'm going to give right now. Let's just see how it plays out here.

Speaker 8

Sure. No worries. And my second question is on the SCCAM program. So congrats on the progress. And So for the data update we expect for the next year, could you first give some Update on the enrollment status for the study?

Speaker 8

And regarding the update, what kind of data set we could expect? Thanks.

Speaker 2

Well, the enrollment is active across many centers, which we had to roll out across. And so we're happy that that's Rolling and I think it fits our timeline and we should be able to I don't know when we're going to give the first update on that. It will certainly be we're just basically would be a little bit similar To how we're handling CTLA-four, but I don't think we would give too much insight on the early doses, because they're probably Less relevant. But as we start to march up toward, I would say, EC50 where we start seeing efficacy expectations and I But clearly, we're on track for next year as everything looks right now. So and that's an exciting Asset, no question.

Speaker 8

Awesome. Thank you. Thank you for taking my question and congrats on the progress.

Speaker 2

Thank you.

Operator

And our next question is from Tony Butler with E. F. Hutton. Please proceed with your question.

Speaker 9

Thanks very much. Jay, two questions on 3,071, please. One is, at 700 mgs Q3, W, do you will you have enough durability in the 3 to 6 patients that actually tells you That you need to move forward with whatever 2 ish or 3 ish cohorts you wish to move forward with? Question 1. Number 2 is, Though you said you've done a lot of work on each of those 7 cohorts, the notion that Any one may be better than another.

Speaker 9

I guess, would you are you limited to 2 is really what I'm saying, which is what you state in your corporate presentation. Thank you.

Speaker 2

What do you mean limited to 2? 2

Speaker 9

Well, it says selected to 2 for potential Phase 2 dose expansion.

Speaker 10

No, no, no. And so it could be,

Speaker 9

for example, an RCC or whatever.

Speaker 2

Okay. Yes. Yes. I think we have a lively discussion around that exact point, Tony. I'm kind of glad you asked it.

Speaker 2

I think the reason we set up that 2 was because we're confident we're doing 2. I don't mean that and I don't Meaning that to say we're not going to couldn't do more than 2. But for now, I think 2 looks pretty solid and there's There could be a decent argument to consider more. I think with respect to What dose we end up with and durability, I think that remains to be seen. But One's got to love the fact that you're at 5 mgs per kg with a plus 3 on the PD-one side and you haven't got a DLT and now We're able to at least dose the people and we'll just see where patients and where it goes at the 10 mg per kg with 3 mgs per kg on PD-one.

Speaker 2

This is close to uncharted territory. Adjust for PK and adjust for a few other things. We really like where this It's going and I think it's going to I'm hopeful it will highlight what I think is the powerful advantage of CAP Technology.

Speaker 9

Within that statement, and thank you for it, we do too. But the real notion is, is there added Is there any reason to assume even though you may for the sake of discussion, we don't know. Any notion to say that 2x 3,071 dose, 350 to 700, let's say, really gives you added efficacy despite the fact that the side effect profile.

Speaker 10

Well, I think you know it from other

Speaker 9

Let's say management.

Speaker 2

Yes, I think you know from past studies with other C24s, if you can Two things, if you could potentially increase the dose or and or if you could keep patients on more cycles, You do translate to better outcomes, if you can manage the safety. And I think there's a fair bit of literature around that. That's not quite as much the case with PD-one. And with CTLA-four, there There is support for that. And that actually was the original objective.

Speaker 2

Could we, number 1, get to a higher dose in combination with PD-one? That's The second question was, could we get beyond 3 to 4 cycles in the combination therapy with CTLA-four and PD-one? And the third question is, could we do both? And that's what we're on the precipice of answering. And I think we've already answered a portion of it With the 5 mgs plus 3 mgs that we cleared and of course, we'd like to see a readout for a few more months.

Speaker 2

So all of these things going forward here are additive that we're at the right timeframe to look at it.

Operator

Thank you. And our next question is from Reni Benjamin with JMP Securities, please proceed with your question.

Speaker 10

Hey, guys. Thanks for taking the questions. You mentioned that you identified the ROAR-two positive tumors using liquid biopsy. Can you talk a little bit about how many patients were identified? And what does this kind of tell you about the proportion of Row 2 patients in the real world versus kind of epidemiological studies and the numbers we get from that.

Speaker 2

Yes, it's kind of interesting. In melanoma, you'll recall that we saw approximately 7% Positivity rate for VOR2 in melanoma using an IHC assay, a histochemical assay. As we transition to the liquid biopsy, we haven't given a definitive number, but I can tell you it's certainly double digit positivity rate. So it's Clear that the liquid biopsy because we've done a lot of validation around this assay has it seems to be more sensitive Being able to pick up patients that are WRO2 positive, but at a lower, Probably a more associate level, so we're seeing more patients. So that's an advantage that goes beyond the fact that it's much easier to perform that assay.

Speaker 2

So I think the lesson here is that every assay has a certain sensitivity. And of The only patients that we had studied we had 1 patient in evaluable patient in Phase 1, we had one Valuable patient that had come across in the Phase 2 study, partly only 1 in 1 that were valuable because of the low Positivity rate. Well, if you can start to move the positivity rate up, then you're going to get a lot more patients wanting to come on board to do the study. It's a lot easier to take a Draw that it is to go and get a tumor biopsy from the patient. The question remaining is what is that threshold that allows you to see But with ADCs, there's a lot of history saying that there could be a wide range of The reaction is so like in our head and neck, we saw something in the teens, it was TNPS score in the teens that we saw A PR right on first dose.

Speaker 2

So long story short, this liquid biopsy is allowing us to See a larger number of patients from a positivity standpoint. The next question they're hoping to answer is, Do we maintain a strong response rate in this group? And we should be able to answer that in the near future.

Speaker 10

Got it. And I think I've asked you this before, but now that you're dosing the melanoma patients, do you kind of wait to see How this reads out before testing the other indications with this liquid biopsy? Or do you Kind of I think in the past you may have said that with these other indications you have quite a robust ROAR-two expression and so we don't really need to use the assay.

Speaker 2

Well, we yes, I think, rolling it out, we definitely are working at the research level To make sure we have it covered in these other areas, including Axle, if we need it. However, to roll it out With the expense that you might have want to put behind a companion or need to put behind a companion diagnostic, no, we wouldn't do that until we got more Confirmation beyond what we have at the moment, because we're keep in mind, we're also wanting to manage our Capital, we're forecasting to get into 2025. Well, that means you got to be prudent on how you do things.

Speaker 10

Got it. One final one for me. The Phase 2 investigator sponsored ovarian study In platinum resistant ovarian cancer, you're getting the 10 patients. What kind of data do you need to see or bow you would like to hit So that I don't know, it would be kind of brought back in house and developed under a corporate IND versus giving it As an IST or is this something is this an indication that you would really just like to be seen developed by somebody else even if it's an academic quarter?

Speaker 2

Well, we've had corporate we've had companies Ask us about the ovarian cancer. So, there's interest out there. And what the exact cutoff is, is interesting because it It depends on how that whole field is emerging a little bit, but I think the bar is fairly low at the moment in terms of what you need to see To advance this, but I think how we'll take that forward is going to be linked to the data. What that exact cutoff will be It's still being debated. But beyond that, it's hard to answer at this particular second.

Speaker 2

We have our own Well, so I mean, I would say I'll just throw out, I think 20% is still quite viable if you're seeing responses in that. Keep in mind though, A lot of these drugs get approved on PFS and not ORR. So I just we have to keep all as well as overall survival. We have to keep all of these various aspects in mind, but we'll keep an eye on it and We look at it as an upside. It's a study that we wouldn't have been able to fund ourselves at that time.

Speaker 2

And It's in combination with PD L1. So it's going to be an interesting readout one way or the other. Got it. Thanks for taking the questions.

Operator

Closing comments.

Speaker 2

Well, I just appreciate everyone's attendance and we've got a very active Fall here coming up and we really look forward to speaking with everyone at meetings and other venues as we

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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Earnings Conference Call
BioAtla Q2 2023
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