BioAtla, Inc. (NASDAQ:BCAB) Q2 2023 Earnings Call Transcript

BioAtla, Inc. (NASDAQ:BCAB) Q2 2023 Earnings Call Transcript August 1, 2023

BioAtla, Inc. misses on earnings expectations. Reported EPS is $-0.77 EPS, expectations were $-0.64.

Operator: Greetings, and welcome to the BioAtla 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. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Bruce Mackle with LifeSci Advisors. Thank you, Bruce. You may begin.

Bruce Mackle: Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, Chairman, CEO and Co-Founder; and Richard Waldron, Chief Financial Officer. Following today’s call, Dr. Eric Sievers, Chief Medical Officer; and Sheri Lydick, Chief Commercial Officer, will join Jay and Rick for a short Q&A. Earlier this afternoon, BioAtla released financial results and a business update for the second quarter 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 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 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&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 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 BioOutlet 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: Thank you, Bruce, and thanks to everyone for joining us for our second quarter 2023 BioAtla earnings call. BioAlta 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, thereby addressing urgent unmet needs in oncology to improve patients’ lives. We made significant progress last year across our multiple ongoing Phase II trials for our 2 latest-stage first-in-class cab ADC product candidates, BA-3011 and BA-3021, 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 first quarter call in May.

We remain focused on further advancing the development of our innovative clinical programs, leveraging the broad applicability of our CAP technology across several clinical stage antibody types, including cab axle and Cablor2ADCs cab, CTLA-4 immuno-oncology naked antibody and our first deal 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 remain excited about our lead asset, BA-3011 for multiple indications. Previously, we shared the encouraging partial interim data on our BA3011 Phase II Part 1 sarcoma study and our BA-3011 Phase II Part I non-small cell lung cancer study. We also shared additional insights on how we have applied the learnings from our differentiated safety data and exposure resource analysis as well as our UPS-related FDA interactions to study more frequent dose intensity regimens more broadly across our axle ADC and our ARI ADC programs.

The goal of selling 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 success for our Phase II potentially registrational studies. A summary of our current dose regimens can be found in the updated corporate presentation on our website. Let’s now move to our clinical operational and financial updates for the second quarter 2023. First, we are advancing BA3011 in our ongoing sarcoma Phase II studies, including a potentially registrational study at UPS. Without specific treatments approved for UPS, there is a significant commercial opportunity as a stand-alone indication. We have shown strong execution and promising results with continued antitumor activity, lack of disease progression and a differentiated safety profile of BA-3011 in UPS to date.

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 40 patients are being randomized one-to-one 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 first patient in and are actively enrolling patients. In addition to UPS, we have completed enrollment of the Phase II Part I lyomyoarcoma cohort using the 3Q FW 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 II Part 1 are on track to finish enrolling in the second half of 2023. With regards to safety profile across all sarcoma subtypes, there are no new safety signals to report. 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 — regarding our BA3011 Phase II study in AXL-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 scar 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.

Part 1 of a 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 and continues to enroll patients. Anticipated data for all dosing regimens, assisting 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 BA-3011 Phase II Part II non-small cell lung cancer study design and anticipate feedback in the second half of this year. And as a result, we remain on track to initiate the Phase II Part II study in non-small cell lung cancer also in the second half of this year, maintaining our overall timeline for development of the nonsmall-cell lung cancer indication.

We continue to believe DA3011 has the potential to become a significant commercial asset for BioAtla and of 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. Regarding the ongoing multicenter investigator-initiated IIT Phase II 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 second cab ADC asset, BA-3021, a cab or to ABC. Currently, BAA-3021 is a subject of Phase II trials in the treatment of 4 different indications. We conducted a similar exposure response analysis of AR2sitive tumors to inform the more frequent dose-intensity regimen of Q4W in our Phase II WARII-positive non-small cell lung cancer study.

Based on this analysis, which is a similar strategy to our UPS Phase II Part II BA3011 study, I mentioned earlier, we are screening and enrolling patients. 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 II trial of patients who have previously experienced failure of PD-1 therapy, we are continuing to screen patients with the validated IHC liquid biopsy assay. As we stated last quarter, we have successfully identified AR2positive tumors using the liquid biopsy assay, which is allowing us to enroll ARI positive patients, and we are on track to dose patients 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.

Copyright: iggyphoto / 123RF Stock Photo

Earlier this year, we announced the achievement of first patient in for the study. Since that time, multiple patients have been dosed, and we continue to enroll patients. Regarding the ongoing multicenter investigator-initiated Phase II 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 I/II trial for our CAB CTLA-4 antibody, BA-3071. As a reminder, the Phase I/II trial is being conducted in tumors known to be responsive to CTLA-4 treatment, and we are continuing to evaluate safety and tolerability of VA-3071 in monotherapy and in combination with nivolumab. The trial is progressing as planned.

Last quarter, we shared that — we started treating patients in the fifth cohort at 350 milligrams or 5 mgs per kg as monotherapy and in combination with 3 mg/kg nivolumab. As part of today’s update, I’m happy to report that the DLT observation period was cleared for the fifth cohort, and no DLTs were reported. We are currently enrolling patients in the SiC cohort at 700 milligrams or 10 mg per kg as the monotherapy or in combination with 3 mg/kg of nivolumab and remain on track for Phase I data readout anticipated in the second half of this year. We also remain on track to initiate the 371 Phase II 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-4 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.

Next, on to our potentially first-in-class dual cab bispecific T-cell engager antibody, Cabaca and cab CD3 or BA-3182. 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 I 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-GAAP variance due to the combined selectivity of the dual cab design. We believe that our dual CAD design has the potential to address the tremendous suite need across several of the most common subtypes of adenocarcinoma, including colon, lung, breast, pancreas and prostate.

Finally, we continue to pursue opportunities to share our progress with the medical and scientific communities with an additional 2 trial and progress abstracts, one for BA-3011 and another for D8-3021, 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 211 since the beginning of the year. Additional abstracts have been submitted for several upcoming meetings as well. With that, I would now like to turn the call over to Rick to review the second quarter 2023 financials. Rick?

Richard Waldron: Thank you, Jane. As of June 30, 2023, we had $168.7 million in cash and cash equivalents compared to $215.5 million as of December 31, 2022. The — 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 to stockholders.

For the second quarter ended June 30, 2023, we reported a net loss of $35.8 million compared to a net loss of $28.9 million in the same period of 2022. Research and development expenses were $31 million for the second quarter ended June 30, 2023, compared to $20.7 million for the same period in 2022. The increase of $10.3 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 $6.2 million for the quarter ended June 30, 2023 compared to $8.3 million for the same quarter in 2022.

The $2.1 million change was attributable to a decrease in various administrative 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 activity for our asset BA3011 and satisfy requirements as a public company. Net cash used in operating activities for the 6 months ended June 30, 2023, was $46.7 million compared to net cash used in operating activities of $42.1 million for the same period in 2022. The increase in net cash used in operating activities for the first 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 first 6 months of 2022.

And now, back to Jay.

Jay Short: 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 of safety from our differentiated proprietary CAD platform. 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 II studies with the addition of the more frequent dose intensive regimens. We’re also excited by the continued clinical execution of our other promising cab assets, in particular, our BA3071-CABCTLA4, clearing the fifth cohort with no DLTs observed and are well positioned to reach several value-creating milestones and key inflection points by year-end.

Hiyremains confident about the future with the goal of pursuing indications of high unmet medical needs 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.

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Q&A Session

Operator: Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] And our first question is from Kelly Shi [ph] with Jefferies.

Unidentified Analyst: This is Dave on from Jefferies. 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?

Jay Short: Yes. I mean I think what we really approached the FDA with is questions related to a study design and basically both with respect to whether it’s a randomized trial, a 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.

Eric Sievers: Sure. Your question was about whether we’ve provided data regarding a recommended Phase II 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.

Unidentified Analyst: All right. And one more thing. How many patient data do you expect to include in the follow-up? And do you have any internal bar to move forward for both ORR or PFS?

Jay Short: Eric, do you want to start with that one?

Eric Sievers: 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 Optimis.

Jay Short: And I would add that we’re testing basically 3 different doses every other week and then the 2Q 3W as well as the 3Q debut. And so we’ll have a little bit more data on the Q2, but 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.

Operator: And our next question is from Brian Cheng with JPMorgan.

Brian Cheng: Just a couple from us. Maybe first on 30 21. Given the number of potential opportunities here for the molecule, how do you think of the factors to consider when making a prioritization decision. What is your latest thoughts on collaboration or partnership that could potentially built in this consideration?

Jay Short: 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 where the fact that we’re in a lone axle and also in more to lung, how many lung indications should we take forward at the same time. We’ll be evaluating that and that’s going to be related to data 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 the head reads out. We’re still accumulating data. Likewise, in lung. And of course, on both of the axle and MORE2 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 a write-up on the script, we haven’t dosed a melanoma patient yet, but at least we crossed that line today. 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 that 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 it does. So I don’t know that’s maybe a high-level response, and maybe I don’t know if Sheri, you want to add anything else to it, but you don’t feel obligated.

Sheri Lydick: No, I think you covered it, Jay. Thank you.

Brian Cheng: Yes. Maybe just one more on 371. Any color on clinical activity so far with the fifth cohort dosing? And just how should we think about the potential indications for the Phase II dose expansion cohort?

Jay Short: Yes. I mean, the safety wise, and we’re very happy with that. We’re also 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-4. 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 reads 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 better, 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-1 or 3 mg per kg and clearing the 5 mg per kg and then we already have dosed the patients at this next level.

So it’s ongoing. I should add it, Brian, one nice thing about CTLA-4 is that it also opens up the door for future combination therapies. And just like in analogous way that PD-1 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-1 [ph].

Operator: Our next question is from Kaveri Pohlman with BTIG.

Kaveri Pohlman: Thanks. Phase II trial; it’s a relatively small sample size. Any color on when do you think you’ll be able to complete the frequent dosing study? 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?

Jay Short: Well, if we’re talking about loans, we do anticipate — well, we’ll have the data, enough data for the more frequent dosing to make our plan for going forward to 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 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 the axle in lung. The UPS, of course, is the registration or potentially registrational now, and we’ll not be reporting on that until later next year once we get further down the line on that.

And then the ovarian studies, we intend to report out on those, both for the Asan ROI, and we’re certainly hopeful that we’ll have sufficient data on the MORE2 asset to allow us to affect the prioritization across our portfolio, both from the standpoint of what we want to take forward what we might want to partner, et cetera. I’m not sure that we’re going to report out on efficacy data on ORI this year, but we’ll certainly have some sense of the prioritization – and of course, CTLA-4, I think also we’re going to be – we’ll be giving a routine updates on as we progress to Phase 1. But I think as we’ll also guide a little bit on where we’re going to head with the Phase II study as well. The actual readout on that is probably – most of our plan, as we’ve reported earlier in the years 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.

Kaveri Pohlman: 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?

Jay Short: Well, these have started some time ago, and I maybe allow Eric to give 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’re — we know it is not too far off in the future. We’ve been told by IT studies. 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 that all the patients have come on board at different times. So it’s hard to give a specific number. But Eric, do you want to add some more color to it?

Eric Sievers: 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 RORI asset and the other for AXL. We are looking forward to seeing these data as well.

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

Kaveri Pohlman: Got it. And maybe a last one. Besides exploring the dosing schedule, do you also plan to continue to explore Axel expression 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 tests?

Jay Short: I think the companion diagnostics path forward was in good shape. I would just say though, we — I think we reported out earlier in the year that we had at least 1 PR at the 1% TMPS 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.

Kaveri Pohlman: Thank you.

Operator: And our next question is from Arthur He with H.C. Wainwright.

Arthur He: I had a – so for the 371 data update. So could you give us the current 5 mg per kilo in combo? What’s the average cycle of the 3 that we want to be dosed?

Jay Short: It can’t be very long because I think we reported out that we were just losing them in our kind of May time frame, something like that. And June, I think also at some of the conferences we may have mentioned in June. So can only expect it to be a few months. But I think that in general, we’re encouraged with what we’re seeing.

Arthur He: Okay.

Jay Short: And by the way, Arthur, I should add, though, but we have earlier 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.

Arthur He: I see. I see, yes. And for the 10 mg per kilo, is there in the monotherapy dosing stage or it’s already reached the combo dosing?

Jay Short: I think it’s — we don’t have a precise — I know one has made it, but I don’t have much more information and I don’t know the status. But so let’s — that’s about all we’re going to give right now. We just see how plays here.

Arthur He: Sure. No worries. And then my second question is on the SCM program. So congrats on the progress. And so for the data update that we expect for the next year, could you first give some update on the enrollment that for the study? And regarding the update, what kind of data set we could expect?

Jay Short: Well, the remits 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-4, 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 towards, I would say, EC50 where we start seeing efficacy expectations, and I think we’ll communicate more on it. But clearly, we’re on track for next year as everything looks right now. So – and that’s an exciting asset, no question.

Arthur He: Congrats on the progress.

Jay Short: Thank you.

Operator: Thank you. And our next question is from Tony Butler with E.F. Hutton.

Tony Butler: Jay, two questions on 471, please. One is at 700 mg Q3W. — 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 one. Number two is, though, you said you’ve done a lot of work on each of those 7 cohorts. The notion that anyone may be better than another, I guess, would you — are you limited to 2 is really what I’m saying, which is what you stated in your corporate presentation.

Jay Short: What do you mean limited to 2 comments?

Tony Butler: That selected the 2 for potential expansion for example, in RCC or whatever.

Jay Short: Okay. Yes. I think we have a lively discussion around that exact point, Tony. I’m kind of glad you asked it. I think the reason we set up that too was because we’re confident we’re doing too. I don’t mean that – and I don’t mean that to say we’re not going to – couldn’t do more than 2. But for now, I think 2 looks pretty solid. And the – 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 mg per kg with a plus 3 on the PD-1 side and you haven’t got a DLT and now we’re able to at least dose the people and we’ll just see patients and where it goes at the 10-meg with 3 mgs per kg on PD-1.

This it’s close to uncharted territory. You adjust for PK and adjust for a few other things. We really like where this asset is going. And I think it’s going to – I’m hopeful it will highlight what I think is the powerful advantage of CAP technology.

Tony Butler: Within that statement, but the real notion is — is there a — 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 30.71 dose, 350 to 700, let’s say, really gives you added efficacy despite the fact that the side effect profile…

Jay Short: Well, I think we know it from other…

Tony Butler: Manage [ph]?

Jay Short: Yes. I think you know from past studies with other C24, if you could – 2 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 mal objective. Could we, number one, get to a higher dose in combination with PD-1. That’s one question. The second question was, could we get beyond 3 to 4 cycles in the combination therapy with C24 PD-1? 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 mg plus 3 mgs that we cleared. And of course, we’d like to see a readout for a few more months. So all of these things going forward here are additive, but we’re at we’re the right time frame to look at it. And I think we’re going to have a great encouraging answer. I’m hopeful later this year.

Tony Butler: Very helpful.uch the case with PD-1. And with CTLA-4, there is support for that. And that actually was the origin

Operator: Thank you. And our next question is from Reni Benjamin with JMP Securities.

Reni Benjamin: You mentioned that you identified the RORE 2 positive tumors using the 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 ROI patients in the real world versus kind of epidemiological studies and the numbers we get from that?

Jay Short: Yes, it’s kind of interesting. In melanoma, you’ll recall that we sold approximately 7% positivity rate for RORI in melanoma using an IHC 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 or to positive but at a lower — probably a more sensitive 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. So I think the lesson here is that every assay has a certain sensitivity.

And of course, the only patients that we had studied — we had 1 patient in evaluable patients in Phase I. We had one valuable patient that had come across in the Phase II 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 blood draw than 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 that activity. But with ADCs, there’s a lot of history saying that there can be a wide range of reaction. And so like in our head and neck, we saw something in the teens, as TPS score in the teens that we saw a PR right on the first dose.

So long story short, this liquid biopsy is allowing us to see a larger number of patents from a positivity standpoint. The next question we’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.

Reni Benjamin: 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 or to expression. And so we don’t really need to use the assay.

Jay Short: Well – 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 want to put behind the companion or need to put behind the 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, and we’re forecasting to get into 2025. Well, that means you got to be prudent on how you do things.

Reni Benjamin: Got it. One final one for me. The Phase II investigator-sponsored ovarian study in platinum is an ovarian gas, are you getting the 10 patients. What kind of data do you need to see or 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 keeping it as an IST? Or is this something — is this an indication that you would really just like to be seeing developed by somebody else, even if it’s an academic partner?

Jay Short: 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 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 is still being debated. But beyond that, it’s hard to answer at this particular second. We have our own – so I mean I would say I’ll just throw out, I think 20% still quite viable if you’re seeing responses in that. Keeping 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. So we have to keep all of these various aspects of 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. And it’s in combination with PD-L1. So it’s going to be an interesting read out one way or the other.

Operator: Thank you. We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to CEO, Dr. Jay Short for closing comments.

Jay Short: 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 go forward; but thank you for your attention today.

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