Earnings Call Transcript - BCAB Q2 2023

Operator, 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. 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, Host

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 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 BioAtla disclaims any obligation to update such statements to reflect future information, events, or circumstances, except as required by law. With that, I'd like to turn the call over to Jay Short. Jay?

Jay Short, CEO

Thank you, Bruce, and thanks to everyone for joining us for our second quarter 2023 BioAtla earnings call. BioAtla is a leader in developing new therapies using a proprietary conditionally active biologics CABS platform that targets tumor cells while sparing healthy cells, addressing critical unmet needs in oncology to enhance patient outcomes. We made substantial progress last year in our ongoing Phase II trials for our advanced CAB ADC product candidates, BA-3011 and BA-3021, aimed at solid tumors with significant medical needs. As we reach the midpoint of 2023, we maintain our positive momentum and are on track to meet the milestones we outlined in our first quarter call in May. We remain committed to advancing our innovative clinical programs using our CAP technology across various clinical-stage antibody types, including CAB axle and Cablor2ADCs CAB, as well as the CTLA-4 immuno-oncology naked antibody and our first bispecific CAB EpCAM CD3 T cell engager. More details are available on our website in our updated corporate presentation. We remain enthusiastic about our lead asset, BA-3011, for multiple indications. We previously shared encouraging interim results from our BA-3011 Phase II sarcoma study and the non-small cell lung cancer study. We've also provided insights on how we've utilized our safety data and exposure analysis, along with our FDA interactions, to explore more frequent dose intensity regimens across our axel ADC and ARI ADC programs. Our aim is to gather data that will help us optimize study parameters to enhance our chances of success in our Phase II potentially registrational studies. A summary of our current dosing regimens is available in the updated presentation on our website. Now, let’s proceed to our clinical, operational, and financial updates for the second quarter of 2023. We are making progress with BA-3011 in our ongoing sarcoma Phase II studies, which includes a potentially registrational study at UPS. Given that there are no specific approved treatments for UPS, this presents a significant commercial opportunity. We have demonstrated strong execution and promising results, showing continued antitumor activity and a favorable safety profile for BA-3011 in UPS. Based on these findings and the positive feedback from the FDA regarding our study design, we initiated part 2 of the potentially registrational trial. The first 40 patients are being randomized to receive more frequent dosing regimens. Following this, we will enroll another 40 patients at the determined dose to complete the study. The primary efficacy endpoint, overall response rate (ORR), will be assessed in approximately 60 patients treated according to the selected dosing regimen. We are currently enrolling patients and have achieved our first patient in. Additionally, we have completed enrollment in the Phase II Part I cohort for lyomyoarcoma using the 3Q FW dosing regimen and anticipate data from 10 to 15 patients in the latter half of this year. The remaining bone sarcoma cohorts in Phase II Part 1 are expected to finish enrollment in the second half of 2023. We have no new safety signals to report for BA-3011 across all sarcoma subtypes; it continues to be well tolerated, maintaining a Phase II safety profile consistent with what we observed in Phase I. Regarding the BA-3011 Phase II study in AXL-positive multi-refractory non-small cell lung cancer, we are optimistic about the data from the Q2W dosing regimen and look forward to results from the more frequent dosing regimens. Current treatment options for patients who progress after immune checkpoint inhibitors show response rates of only about 10% to 20%, with poor four-month progression-free survival rates. Part 1 of the Phase II study in non-small cell lung cancer is ongoing, enrolling AXL-positive patients who previously failed PD-1, PD-L1, EGFR, or ALK inhibitors. Anticipated data for all dosing regimens is still on track for the second half of this year, and we have submitted a request to the FDA regarding the study design for the potentially registrational BA-3011 Phase II Part II non-small cell lung cancer study, expecting feedback in the latter half of the year. Consequently, we are set to initiate the Phase II Part II study in non-small cell lung cancer in the second half of this year, keeping our development timeline on schedule for this indication. We continue to believe that BA-3011 can become a significant commercial asset for BioAtla and, importantly, a first-in-class treatment for many patients who have failed at least one prior treatment line, thereby addressing a substantial unmet medical need. In regard to 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 interim data readout from 10 patients in the second half of this year. Turning to our second CAB ADC asset, BA-3021, it is currently undergoing Phase II trials for four different indications. We performed an exposure response analysis of AR2 positive tumors to refine the dosing regimen for our Phase II ARII-positive non-small cell lung cancer study. We are actively screening and enrolling patients, and based on current activity, we anticipate having data this year to guide our clinical trial prioritization. In the melanoma Phase II trial for patients who have previously failed PD-1 therapy, we are continuing to screen patients using a validated IHC liquid biopsy assay and have successfully identified AR2-positive tumors, enabling us to enroll these patients. We are poised to begin dosing in the second half of this year. Our Phase II head and neck study is also ongoing and continuing to enroll patients after multiple have already been treated since the first patient was recorded earlier this year. Regarding the Phase I/II trial for our CAB CTLA-4 antibody, BA-3071, this trial is being conducted in tumors known to respond to CTLA-4 treatment, and we are assessing the safety and tolerability of BA-3071, both as a monotherapy and in combination with nivolumab. The trial is progressing as expected, and we reported last quarter that we began treating patients in the fifth cohort with a DLT observation period just cleared, reporting no DLTs. We are continuing to enroll patients in the sixth cohort and remain on track for a Phase I data readout anticipated in the latter half of this year. We are also on schedule to initiate the 371 Phase II study in the same timeframe. We recognize significant unmet medical needs with promising commercial opportunities across various tumor types where CTLA-4 can provide effective treatment while maintaining a manageable safety profile, allowing patients to remain on therapy longer to gain full benefits. Next, I’d like to discuss our potentially first-in-class dual CAB bispecific T-cell engager antibody, Cabaca and CAB CD3 or BA-3182. As previously mentioned, we received FDA clearance for our IND targeting advanced adenocarcinoma and are now actively enrolling patients in this Phase I study, with the full data readout expected next year. Similar to our other clinical stage CAB assets, this antibody has shown great promise in preclinical studies, demonstrating a notable improvement in therapeutic index due to the dual CAB design's combined selectivity. We believe that our dual CAB design can significantly address the substantial needs across several common adenocarcinoma subtypes, including colorectal, lung, breast, pancreatic, and prostate cancers. Lastly, we continue to seek opportunities to share our progress with the medical and scientific communities through additional trial abstracts, one for BA-3011 and another for BA-3021, accepted for presentations at the upcoming World Conference on Lung Cancer this September. This brings our confirmed presentations to 211 since the start of the year, with more abstracts submitted for upcoming meetings as well. Now, I'd like to turn the call over to Rick to discuss the second quarter 2023 financials. Rick?

Richard Waldron, CFO

Thank you, Jay. 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. 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 BA-3011, 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, CEO

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 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 BA-3071-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. We remain 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.

Operator, Operator

Thank you. We will now take questions. Our first question is from Kelly Shi with Jefferies.

Unidentified Analyst, Analyst

This is Dave from Jefferies. I have a question on the request that you submitted to FDA. Can you talk a little bit more about what kind of data have you provided to the FDA? And does it include enough data to make a decision on RP2D?

Jay Short, CEO

Yes. I mean I think what we really approached the FDA with is questions related to 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, CMO

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, and some of those features. We anticipate preparing more information regarding our dosing regimens in the briefing book.

Unidentified Analyst, 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, CEO

Eric, do you want to start with that one?

Eric Sievers, CMO

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, CEO

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, Operator

And our next question is from Brian Cheng with JPMorgan.

Brian Cheng, Analyst

Just a couple from us. Maybe first on 3021. 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, CEO

Yes. When making these decisions, Brian, we will evaluate the entire portfolio. We need to consider the axle indications, specifically our involvement with a lone axle and multiple lung indications, and determine how many lung indications we can pursue simultaneously. This evaluation will be data-driven and will also involve safety considerations. Overall, we're feeling quite confident across all indications. Personally, I'm very interested to see how the head data will turn out. We are still gathering data for lung as well, and we anticipate receiving ovarian cancer data from both the axle and MORE2 indications. Additionally, at the time of writing this, we hadn’t yet dosed a melanoma patient, but we have now, which is promising and gives us a clearer picture moving forward. I believe we have more indications and drug opportunities than most companies, allowing us to choose the best ones to advance and providing us with flexibility for partnerships. This may be a broad response, but if Sheri has anything to add, she can, although she’s not obligated.

Sheri Lydick, CCO

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

Brian Cheng, Analyst

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, CEO

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'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 an 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.

Operator, Operator

Our next question is from Kaveri Pohlman with BTIG.

Kaveri Pohlman, Analyst

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, CEO

We anticipate having sufficient data for more frequent dosing to inform our plans for a registrational study later this year. We have identified a medical meeting where we will update on our data concerning both biweekly dosing and more frequent dosing, and we will share details after our acceptance to the meeting. We believe this is on track for communication this year. Regarding our axle in lung, the UPS is the registration or potential registration, but we will not report on that until late next year as we progress further. For the ovarian studies, we plan to share outcomes for both the Asan ROI, and we are hopeful to have enough data on the MORE2 asset to guide our portfolio prioritization, determining what to advance and explore partnerships. While we may not report efficacy data on ORI this year, we will provide insights on prioritization. Additionally, we will give regular updates on CTLA-4 as we move into Phase 1 and will offer guidance on the Phase II study. The timing for our readouts will align with medical meetings, and we are working to incorporate as many as possible this year.

Kaveri Pohlman, Analyst

Got it. That's very helpful. And then I believe for ovarian cancer results, you mentioned that you have completed 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, CEO

These studies began some time ago, and I think Eric could provide better insights on the timeline. I want to remind everyone that these are IIT studies, and we are currently awaiting the data. We know that the results are not too far off because we've been informed that they are fully enrolled, so we expect to have a good overview soon. Eric, could you share more about when the studies started, considering that all the patients joined at different times? It's difficult to provide a specific number, but maybe you can add more details.

Eric Sievers, CMO

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 ROI asset and the other for AXL. We are looking forward to seeing these data as well.

Jay Short, CEO

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

Kaveri Pohlman, Analyst

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, CEO

I believe the companion diagnostics process is going well. Earlier in the year, we reported at least one partial response at the 1% TMPS score level in lung cancer. We are looking into this further without going into too much detail right now. This is definitely on our radar, and we are assessing our options.

Operator, Operator

Thank you. Our next question is from Arthur He with H.C. Wainwright.

Arthur He, Analyst

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, CEO

It can't be very long because I think we reported out that we were just losing them in our kind of May timeframe, 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, Analyst

Okay.

Jay Short, CEO

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, Analyst

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, CEO

I think we don't have precise information. I know one has been made, but I don't have much more to share and I'm unsure of the status. That's about all we can provide right now. We'll just wait to see how it plays out.

Unidentified Analyst, Analyst

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 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, CEO

Well, the remit 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-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, 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, Analyst

Congrats on the progress.

Operator, Operator

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

Tony Butler, Analyst

Jay, I have two questions regarding 371. First, at a dose of 700 mg Q3W, will you have sufficient durability data from the 3 to 6 patients to determine whether you should advance with the cohorts you plan to pursue? Secondly, you mentioned that you've conducted extensive work on each of the 7 cohorts. Are you restricted to just 2 cohorts, as indicated in your corporate presentation?

Jay Short, CEO

What do you mean limited to 2 comments?

Tony Butler, Analyst

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

Jay Short, CEO

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, Analyst

Within that statement, is there any reason to assume, even though we don't know, that a 2x 30.71 dose, 350 to 700, really provides added efficacy despite the side effect profile?

Jay Short, CEO

Well, I think we know it from other 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 much the case with PD-1. And with CTLA-4, there is support for that. And that actually was the original 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 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, Analyst

Very helpful.

Operator, Operator

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

Reni Benjamin, Analyst

You mentioned that you identified the AXL2 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 AXL2 patients in the real world versus kind of epidemiological studies and the numbers we get from that?

Jay Short, CEO

It's interesting to note that in melanoma, we observed about a 7% positivity rate for AXL2 using an IHC histochemical assay. As we move to liquid biopsy, while we haven't provided an exact number, I can confirm that we're seeing a positivity rate in the double digits. This transition to liquid biopsy, supported by extensive validation of the assay, suggests increased sensitivity, allowing us to identify more AXL2 positive patients at potentially lower levels. This is beneficial not only because the assay is easier to perform but also because each assay has a specific sensitivity. In our studies, we had only one evaluable patient in Phase I and one in Phase II due to the previously low positivity rate. However, increasing this rate should attract more patients to participate in the study, particularly since taking a blood sample is much simpler than obtaining a tumor biopsy. The remaining question is determining the threshold that indicates activity. With ADCs, there's considerable evidence of a broad range of reactions; for instance, we observed a response in the teens TPS score in our head and neck studies right from the first dose. In summary, liquid biopsy is enabling us to identify a greater number of patients with positive results. The next question we need to address is whether we can sustain a strong response rate in this group, and we anticipate that we will have answers in the near future.

Reni Benjamin, Analyst

Got it. I think I've asked you this before, but now that you're treating the melanoma patients, do you wait to see the results before testing the other indications with this liquid biopsy? In the past, you mentioned that for these other indications, you have a strong AXL2 expression, so the assay may not be necessary.

Jay Short, CEO

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 AXL, 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, Analyst

Got it. One final question for me. In the Phase II investigator-sponsored ovarian study involving platinum, are you recruiting the 10 patients? What type of data do you need to see or would prefer to achieve so that it could potentially be developed in-house under a corporate IND rather than maintaining it as an IST? Or is this an indication that you would prefer to have someone else, even an academic partner, develop?

Jay Short, CEO

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, 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, CEO

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, Operator

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