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spk05: Hello and welcome to the BioAlta second quarter 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. I now would like to turn the conference over to your host today, Bruce Mackel. Bruce Mackel, please go ahead.
spk07: Thank you, Operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, Chairman, CEO, and Co-Founder, Scott Smith, President, Philippe Martin, Chief of Clinical Development and Operations, Sherry Lydick, Senior Vice President, Commercial Strategy, and Richard Waldron, Chief Financial Officer. Earlier this afternoon, BioAtla released financial results and a business update for the quarter ended June 30, 2022. A copy of the press release is available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements, including but not limited to statements regarding BioAtla's business plans and prospects, financial and operating performance and expectations, operating costs and expenses, product pipeline, clinical trial and regulatory timing and associated resource requirements, its programs and potential partnerships, and the advancement of its CAB technology and product candidates. These statements are subject to various risks, assumptions, and uncertainties, that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 9, 2022, 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?
spk10: Thank you, Bruce. Thanks to everyone for joining us for our second quarter 2022 BioAtlas earnings call. The broad applicability of BioAtlas CAP technology has allowed us to continue advancing the development of our innovative clinical and preclinical programs. The second quarter was marked by strong execution with promising results across five potentially registration-enabling ongoing phase two trials for our two latest stage CAB-ADC product candidates, Mecbotimab-vidotin, or BA3011, and Ozu-Riftimab-vidotin, or BA3021, across multiple solid tumor types for these first-in-class therapeutic candidates. But before I go any further, I'd like to remind everyone that additional details related to what we are going to present are available on our website as part of our updated company presentation that may be helpful to you. We have several additional upcoming catalysts this year for both our lead assets, including important results to be covered in today's discussion. We previously shared interim data on our BA3011 Phase II sarcoma study, And we now look forward to enrolling multiple sarcoma subtypes into part two of that study. Further, on today's call, we will discuss new results for additional sarcoma subtypes and important initial interim data for the non-small cell lung cancer study for BA3011. BA3021 studies also continue to advance, and we anticipate an interim update for non-small cell lung cancer in the fourth quarter. We also expect that our successful validation of the liquid biopsy will accelerate the melanoma study for an enrollment update later this year. In addition, we are actively screening in our head and neck study with the first patient anticipated to be dosed shortly. Our Phase I-II basket trial for our CAB CTLA-4 antibody, BA3071, is currently ongoing with the first patient dose completed. We also remain on track for our pre-IND meeting and IND filing for our dual-cAB bispecific antibody, EPCAM CD3, or BA3182, this year. We are pleased with our cumulative results that continue to support both the efficacy and safety from our differentiated proprietary CAB platform thus far in 2022, and I believe we are well-positioned to continue with strong execution. Most importantly, we are excited to share the updates of our ongoing clinical programs with you today, in particular, observations from our Phase II non-small cell lung cancer study with our lead asset, BA3011. With that, I would now like to turn the call over to Philippe for additional details. Philippe?
spk06: Thank you, Jay, and good afternoon, everyone. I would like to provide initial interim observations on part one of our phase two study in non-small cell lung cancer and an update on part one of our phase two study in sarcoma. First, I will go over our preliminary data in non-small cell lung cancer and start with a brief introduction of the study design. Our ongoing potential year registration enabling phase two trial of BA3011 is designed to evaluate the efficacy and safety of BA3011 monotherapy and in combination with nivolumab in axial expressing patients with refractory non-small cell lung cancer that have failed either ALK, EGFR, or PD-1 inhibitors. We do not restrict the number of prior lines of therapy or restrict any particular type of non-small cell lung cancer in available patients with either non-squamous or squamous cell carcinoma. Therefore, the interim data will be presented accordingly. There are two parts to the non-smoke cell lung cancer phase two portion of the trial. In part one, interim analysis will be conducted after 20 and up to 40 patients, with the potential to be followed for at least three months. Our predefined goal criteria for the interim analysis is to achieve an overall response rate of approximately 20%. As of a data cutoff of July 15, 2022, we had enrolled 15 patients with nine efficacy-evaluable patients. Four patients are currently on treatment but did not have yet the opportunity to be followed for three months, and two additional patients were not deemed efficacy-evaluable. Importantly, all patients are PD-1 failure patients and have failed on average 2.5 cryo lines of systemic therapy for metastatic disease. Of the nine evaluable patients, seven were non-sequamous adenocarcinoma patients, and two were squamous cell carcinoma patients. So far, we observed a total of one complete response and two partial response for a combined objective response rate of 33%. All response were observed in non-squamous group, representing an OR of 43%, or three out of seven patients. Four out of seven of these non-squamous patients were administered BA3011 monotherapy, while three received BA3011 in combination with nebulumabin. The two PRs were observed in the non-squamous monotherapy group, representing an OR of 50% for this group, and the CR was observed in the non-squamous combination group, representing an OR of 33% for this group. Of the two evaluable patients in the squamous cohort, we have not yet observed a response with either BA3011 monotherapy or BA3011 in combination with nivolumab. All patients enrolled were Axle positive with a TMPS of 1% or more. The rate of Axle positivity in the non-small cell lung cancer population continues to be high. We estimate it to be approximately 35% for the non-squamous population and approximately 30% for the squamous population based on over 200 non-small cell lung cancer patients tested so far for Axle expression. As of the latest safety data cutoff, the safety and tolerability profile from the Phase 2 non-small cell lung cancer study continues to be differentiated from other MMAE ADCs. No new signals have been identified from Phase 1, no treatment-related deaths, and very few grade 3, 4 AEs were reported. To put this data into perspective, and notwithstanding the preliminary nature and small sample size of our data set, The efficacy observed in this study, and in particular the efficacy observed for the BA3011 monotherapy non-squamous and BA3011 monotherapy non-squamous and squamous combined, is so far highly competitive in this PD-1 refractory population and supportive of moving forward to the registrational part of this study. We are continuing to enroll patients in Pac-1 to help us better define which population and which treatment cohort or cohorts we will be advancing to the registrational part of the study. With now close to 20 patients enrolled in the part one of the study, we anticipate we'll be able to present interim results of approximately 20 patients in the fourth quarter of this year. I will now present the sarcoma data. During our last quarterly call, we presented interim data from our ongoing part one of the potentially registration enabling phase two trial of BA3011. which was designed to evaluate the efficacy and safety of BA3011 in adults and adolescent patients with refractory soft tissue and bone sarcomas. We enrolled patients across seven different sarcoma subtypes to receive BA3011 monotherapy, and across all sarcoma subtypes to receive BA3011 in combination with nivolumab, equally between CD20 positive and CD20 negative tumor expression. The purpose of part one was to identify sarcoma subtypes that do not respond to BA3011 treatment and eliminate the subtypes from moving forward into part two of the study. Predefined go-no-go criteria for the interim analysis determine which subtype may advance to part two of the study. The threshold for a good decision is either at least one partial response or complete response for subtype or progression-free survival. or PFS rate of at least 40% at pre-month. Patients were selected based on actual expression using a TMPS of greater than or equal to 50% in each sarcoma subtype. The subtypes in soft tissue sarcoma included leiomyosarcoma, synovial sarcoma, liposarcoma, other soft tissue sarcoma such as UPS. In bone sarcoma, the subtypes included osteosarcoma, Ewing sarcoma, and other bone sarcoma, which includes chordoma and chondral sarcoma. The interim results presented previously in UPS and osteosarcoma satisfied our predefined goal criteria in 2.2 of the Phase 2 BA3011 study. UPS and osteosarcoma are advancing as separate cohorts to registration studies. Additional details for these registration studies will become available following FDA written response. Today, we are sharing data from additional cohorts based on an efficacy data cutoff of July 25th, 2022. In the post-arcoma, we've enrolled six patients and observed the PFS rate of 60%, which exceeded our predefined goal criteria to part two of phase two. These patients have progressed on two or more prior lines of systemic therapies. For context, Recent studies have shown that for the earlier first and second line metastatic lymphosarcoma patients, the PFS rate for placebo at three months was around 30%, and approximately 50% for ribolin and trabectinib. In synovial sarcoma, we removed five patients. These patients had progressed on three or more lines of systemic therapy. The PFS rate at three months was 50%, which also exceeded our predefined goal criteria to part two of phase two. For context, The PFS rate for pazopanib at three months is 49% for the earlier first and second line metastatic synovial patients. With regards to safety profile across sarcoma subtypes, BA3011 continues to be generally safe and well tolerated with a Phase II safety profile consistent with the profile observed in Phase I. We are currently evaluating the clinical and commercial opportunities for these subtypes and will decide on the path forward in the near future. We are continuing to enroll patients in the Ewing sarcoma cohort and the Bone-Other cohort, mostly made of chordoma and chondrosarcoma. Thank you for your attention. Sherry will now highlight the significant admit need and commercial opportunity in non-small cell lung cancer. Sherry?
spk01: Thank you, Philippe, and good afternoon, everyone. Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80 to 85% classified as non-small cell lung cancer. Upon further breakdown, non-squamous subtype accounts for approximately 75%, while squamous cell accounts for the remaining 25% of non-small cell lung cancer cases. There are over 540,000 people in the U.S. living with lung cancer and approximately 200,000 newly diagnosed patients per year, majority of which are diagnosed with advanced or metastatic disease. The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic non-small cell lung cancer. Chemotherapy plus immune checkpoint inhibitors has become standard of care in the frontline setting in patients with metastatic disease. Despite advances in first-line care, the majority of patients eventually progress and experience worsening outcomes after each line of subsequent therapy. There are limited options for these patients who progress on immune checkpoint inhibitors, and available treatments in the second-line setting and beyond have suboptimal overall objective response rates of 10 to 20%. While the data Philippe just shared are early observations, the signal is encouraging, particularly when we think about this multi-refractory non-small cell lung cancer population. And we believe that BA3011 has the potential to fill a significant unmet medical need for these patients. Turning to the commercial opportunity, Non-small cell lung cancer is one of the largest oncology therapy markets, valued at approximately $20 billion in 2020 in major markets and projected to grow 9% annually, reaching $48 billion by 2030. We estimate that there are approximately 40,000 to 50,000 actual positive non-small cell lung cancer patients per year in the U.S. and over 100,000 per year worldwide. We estimate that this represents a significant global commercial opportunity of approximately $2.5 to $3 billion. With respect to sarcoma, we remain energized about the continued opportunity for BA3011 in soft tissue and primary bone sarcomas, even when considering only UPS and osteosarcoma, given the significant unmet medical need and lack of approved treatments for these patients. Combined, there are approximately 5,000 to 7,000 actual positive addressable UPS in osteosarcoma patients per year in the U.S., and over 12,000 globally, which we estimate to be a worldwide commercial opportunity of up to a billion dollars. Taken together, our preliminary observations in non-small cell lung cancer and our Phase II sarcoma study data, our lead CAB ADC asset BA3011 has the potential to be a best-in-class therapeutic treatment for patients who have failed frontline regimens with an estimated total global commercial opportunity of approximately $4 billion. We are excited for the upcoming near-term catalyst this year in our BA3011 program and for the potential of this asset to fill significant unmet needs for refractory patients across a variety of cancers. Now I would like to turn the call over to Scott Smith, president at BioATLA, to provide an overview and updates to other ongoing clinical programs. Scott?
spk08: Thank you, Sherry, and good afternoon, everyone. Before I review our key operational updates from the quarter, I want to share my excitement around the preliminary observations from part one of our phase two non-small cell lung study. Given the significant unmet medical need and commercial opportunity in refractory non-small cell lung, we are very excited to see an early signal in the non-squamous population, albeit with a small number of evaluable patients today. Plenary observations in the non-squamous cohort validate the signal observed from our phase one study. We will wait for the full interim data analysis before making detailed study determinations, but we are thrilled to see a trend in a positive direction thus far with 3011 in this initial cohort, The early observations in part one of our phase two non-small cell line study exceed our internal predefined go-no criteria. And we will begin preparations for discussions with the FDA for part two of the study. In the interim, we will continue to enroll and dose patients in both subtypes and anticipate a full interim data set of approximately 20 patients through multiple scans in the fourth quarter of this year. the non-small cell lung Phase II preliminary observations further strengthened 3011 as a potential best-in-class therapeutic treatment for a variety of cancers given the clinical outcomes from our other studies in sarcoma. As reported last quarter, the interim Phase II analysis at three months in axial positive sarcomas demonstrated meaningful anti-tumor activity, and we met our predefined GO criteria for two very important sarcoma subtypes, UPS, and osteosarcoma. As discussed earlier, we are very pleased to note that two additional cohorts, liposarcoma and synovial sarcoma, now qualify to move to part two of the study based on our predefined criteria. We are currently evaluating the clinical and commercial opportunities for these subtypes and will decide on the path forward in the near future. With respect to UPS and osteosarcoma, we have submitted a request to the FDA for written feedback regarding the study designed to support registration. For UPS, we have proposed a single-arm trial with ORR as the primary endpoint in a sample size of approximately 60 patients. For osteosarcoma, we have proposed a double-blind randomized placebo-controlled trial with PFS as the primary endpoint in a sample size of approximately 120 patients. We anticipate written feedback in the coming weeks, and we'll begin enrollment shortly thereafter. Now turning to our second lead CAB ADC product candidate, BA3021, a CAB War II ADC. As a reminder, there are no other therapies targeting War II in the clinic, so we have the potential to have a first-in-class treatment for solid tumors. In phase one, we saw impressive responses in ROR2 positive patients refractory to PD-1 therapy, including two PRs in non-small cell lung, one PR in head and neck cancer, and a complete response in a melanoma patient who remains in complete remission off treatment for over two years. To date, we have three phase two trials ongoing with 3021, and I'm happy to provide an update as to where we are with each, beginning with non-small cell lung. The non-small cell lung trial in refractory patients is enrolling as planned and currently dosing with an interim update of the preliminary cohort of up to 20 patients, followed by at least three months of therapy anticipated in the second half of this year. Turning to the melanoma trial, which is being conducted in patients refractory to PD-1 therapy, as previously discussed, we ran into challenges with trial recruitment, which we believe was due to lower WART2 positivity rate than anticipated and challenges obtaining invasive tissue biopsies in these patients. However, after working on a liquid biopsy with our partner RareSite, we are happy to report that we now have a validated non-invasive liquid biopsy assay and that we are implementing this part of study protocol this quarter. As a reminder, we previously mentioned that one melanoma enrolled in the phase two as of last quarter achieved a complete response. Together with the complete response we observed in one patient in the phase one study, we have two out of two war two positive PD-1 refractory patients with a complete response, which is quite remarkable. We remain very excited about the potential of 3021 in melanoma patients, particularly with potential acceleration of enrollment following validation and implementation of the liquid biopsy. The third phase two study that we've initiated with 3021 is in refractory patients with head and neck cancer, and the first patient is anticipated to be dosed very soon. To round out our CAB ADC programs, we are supporting a multicenter investigator-initiated phase two clinical trial of 3011 or 3021 in patients with platinum-resistant ovarian cancer. This trial is ongoing, and to date, five patients have been dosed. Now I'd like to talk briefly about updates for our CAB CTLA-4 antibody, BA3071. The Phase I-II trial that will examine safety and tolerability of 3071 on monotherapy and in combination with nivolumab is ongoing, and the first patient has been dosed. We believe there's a tremendous unmet need and commercial opportunity for a safer and better tolerated CTLA-4. Turning now to our preclinical pipeline, BioAtla has several candidates in IND-enabling phase that include CAB bispecifics and second-generation ADC antibodies. We remain on track for a pre-IND meeting and IND filing for our CAB-EPCAM, CAB-CD3 bispecific antibodies later this year, as well as for potential additional IND filings for preclinical next-generation CAB-ADC candidate and a second cab by specific in 2023. With that, I'd like to hand the call over to Rick to review the second quarter 2022 financials. Thank you, Scott.
spk04: As of June 30, 2022, we had $202.3 million in cash and cash equivalents compared to $245 million as of December 31, 2021. We expect cash and cash equivalents will be sufficient to fund planned operations including all ongoing CAB product development programs into the second half of 2024. As a reminder, we control all CAB product rights in the U.S., Europe, and Japan. Our business strategy includes advancing commercial preparations in key global markets while exploring opportunities to extend our cash runway by generating upfront cash through the selective licensing of product rights in certain territories or collaborations with other biopharmaceutical companies that could also provide to us development milestones and royalties upon regulatory approval and commercialization and create additional value for stockholders. When the second quarter ended June 30, 2022, we reported a net loss of $28.9 million compared to a net loss of $30.4 million in the same quarter of 2021. Research and development expenses increased from $14.9 million in Q2 of 2021 to $20.7 million in Q2 of 2022, primarily driven by expansion of our product development efforts, including clinical development for CAB CTLA-4 and preclinical development of additional CAB candidates. 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 clinical programs. General and administrative expenses were $8.3 million for the second quarter of 2022 compared to $15.9 million for the same quarter of 2021. The $7.6 million change was attributable to a decrease in stock-based compensation for the 2022 period. We expect our G&A expenses to moderately increase to support development of our product candidates. advance our intellectual property portfolio, support focused pre-commercialization activities for our product candidate BA3011, and meet all requirements as a public company. Net cash used in operating activities for the six months ended June 30, 2022, was $42.1 million compared to net cash used in operating activities of $28.5 million for the same period in 2021. The increase in net cash used in operating activities for the first six months of 2022 is primarily due to an increase in research and development expense related to our program development efforts as compared to the first six months of 2021. And now, back to Scott.
spk08: Thank you, Rex. We are very pleased with the progress we've made this year, and with a cash runway into the second half of 2024, we are well poised to reach several milestones and key inflection points with our innovative CAB assets. BioAval will remain acutely focused on prioritizing the programs and indications we view have the highest probability of therapeutic success and market potential to maximize the value for our shareholders, while being prudent with our strong balance sheet to ensure development and execution support of our robust clinical and preclinical pipeline. We're very excited about the future of our innovative CAB antibodies and the potential impact on patients across multiple tumor types. BioAlla looks forward to creating long-term, sustainable value in transformative cancer therapy. And with that, we will turn it back to the operator to take your questions.
spk05: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using a speaker phone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble the roster. And the first question comes from Kelly Shee with Jefferies.
spk03: Congrats on the great progress and thank you for taking my questions. My first question is for the non-small cell lung cancer program, so the actual cutoff has been lower to 1%. I'm just curious with this new cutoff, what percentage of the non-small cell lung cancer patients are eligible for the enrollment criteria? And also in the three responders, How does the EXO expression level look like? Are they fairly like a broader range of EXO level or more of like high expressors? And also, I mean, even though it's a very small number, just curious whether you saw a trend. There's a correlation between the EXO level and the depth of the response. Thanks.
spk08: So, Kelly, thank you very much for that question. So at the axial positivity rate, with axial greater than 1%, is approximately 35 to 40% of non-small cell lung patients in the area that we're studying. The three patients, I don't know that we have disclosed the three patients that responded with their axial positivity rates, but I'll ask Philippe if there's anything that we can report on that at this time, or is that part of the bigger data set once we get that?
spk03: Okay, great.
spk06: Yeah, I think it's a little early to report any, to make any comments about any trends. We want to get a little bit more patience before we do that.
spk03: Great. And I also have a follow-up. So as you're evaluating both the PD-1 combo and monotherapy in the lung cancer patients, I'm just curious, for the monotherapy, what what kind of ORR rate maybe will incentivize you to prioritize the monotherapy first instead of a PD-1 combo, given that they might add additional tox to the patient?
spk08: Yeah. Thank you, Kelly, for the follow-up. And again, we want to enroll the full cohort. We have doses, you know, close to the 20 patients. And so You know, once we get everybody through two scans, we'll have a bigger cohort to make some of those assessments on. We were very pleased with what we saw in this initial group of valuable patients. You know, we have said from the beginning that we believe in this PD-1 failure population. And again, I think Philippe reported the average number of prior treatments was two and a half in the group that we've studied so far. So refractory population for sure, difficult to treat population. You know, we were thinking that the 20% and above is approvable. We were thinking 25%, 30% is, you know, really something that would be very commercially viable. I think that goes for the mono and the combo. And, again, we want to take a look at the full data and decide do we want to prioritize one over the other. You know, we did have a complete response in the combination group. Very nice response in that difficult-to-treat patient. And so, you know, we don't have enough information to decide one or the other at this point in time. Or maybe there, you know, once we get the fullness of the data, it will dictate that, you know, one patient type and characteristic is better for mono and one for combo. But we're pleased we're seeing responses both in mono and in combo. And we could take both forward potentially into the registration phase.
spk03: Okay, good enough. And thank you very much. Looking forward to your next update.
spk05: Thank you. Thank you. And once again, please press star, then 1 if you would like to ask a question. And the next question comes from Arthur He with HC Wainwright.
spk09: Hey, good afternoon, everyone. Congrats on the progress. I just want to follow up on these lung cancer data. Could you give us about the disease control rate for these nine available patients?
spk08: Yeah, thank you. Thank you, Arthur. And, you know, I will, you know, again, I'll ask us early to comment on the specifics here.
spk06: Yeah, I think it's too early to give you the disease control rate for these patients. We, all the responders are still on treatment and are still ongoing. And then we have a number of patients that are are going through their first scan as well. So once we have all patients at least going through two scans, we'll be able to disclose that kind of information.
spk09: All right. Thanks for the comment. And for the further clinical development, if these kind of the ORR level rates are holding up, How do you think for the agents who could use the OR as the endpoint for a registration of study? Or do you think you could register for the PFS for a randomized study to get the registry?
spk08: Thank you for the follow-up, Arthur. Again, I think we're very pleased with what we're seeing in this population. If you take a look at the swine population, you're seeing 40-plus percent ORR in this initial group, which was, you know, well over our go-no-go criteria. I think if that holds up, I think hugely relevant. I think likely for us. This is always a part of a, you know, of a discussion, you know, with the agency. You know, available treatments today are something, you know, for second-line plus are in the 10% to 20% ORR range, and we're seeing, you know, much, much better than that early. So, you know, always a discussion with the agency. I believe the overall response rate could be an endpoint in a registrational study if things hold up, yes.
spk09: Oh, that's great. Thanks, Scott. And my last question is regarding the sarcoma study of clinical pathway. So when you guys are waiting for the recent feedback from the FDA, could that be served as an FPA or just purely feedback and to tune up your clinical design?
spk08: I think what we have done here is we have proposed, in sarcoma, we have proposed for UPS a certain study design, which will be response rate at approximately 60 patients. We're taking a look at the osteo, we're proposing back to them, you know, more in the 120 range in a PFS endpoint, and we're looking for written feedback from them. you know, giving us green light, not green light suggestions, modifications for what those studies should look like. So we can have any discussions with the FDA and can have a dialogue if there's things that we agree or don't agree with. But, you know, part of requesting written feedback is to get, you know, very clear feedback. We think we are proposing a very strong way forward and hopefully we're looking to hear formally back from them. And then just, you know, a comment, as we mentioned, you know, we were very pleased in just the last few days to get some more data and see that now synovial and liposarcoma both qualify to move forward into part two of the study. We'll take our time while we're waiting on written feedback on UPS and osteosarcoma to evaluate the clinical path forward, the commercial possibilities and things in lipo and synovial. see if now is the time to do that or whether we would move forward with the registration studies with UPS and osteo and add those, you know, sort of post-approval. But it was very gratifying for us to see, you know, two more cohorts in sarcoma qualify, I think showing the overall potential utility of this drug in the sarcoma space where there is really very little.
spk09: Okay. Thank you. Thank you for taking my question and talking to you guys. Thank you, Arthur.
spk05: Thank you. And the next question, Constantine Butler with Roth Capital.
spk02: Yes, sorry, forgive me. Three specific questions, if I may. One, they're all related to the 3011 in SCLC. The first is, correct me if I'm wrong, there was a scan at three months. Correct. And then the next scan, which you're discussing, would be at six months. So could you just talk about the cadence of scans? That's question one. Number two is do you have information or could you share that information on time to response? Would you have an idea about that? The monotherapy and the combo, I just wondered if, in fact, the combo led to a time to response that was more rapid. And the third is if you consider what duration one would like to see from a registration perspective, what might that be? Thanks very much.
spk08: So thank you, Tony, for the questions, and I'll give a sort of top-line overview, and I'll pass it over to go into some more detail with you. These patients are getting scanned at six weeks and at 12 weeks, for example. in the three-month period, and that six-week scan cadence continues as we move forward. I don't believe we can see or make any conclusions on time for response between mono and combo at this point in time, although I will, you know, ask Philippe to comment on that. But I think we saw responses on the first scan for all three of these patients, I believe. And again, I'll let Philippe correct me if I'm wrong there. And then, you know, in terms of duration of response, you'd like to see, I believe, you know, sort of six months of the average regulatory response that you would look for somewhere in that range. And, you know, I will say when you take a look at the phase one study and the patients have responded in lung, you see a very long duration of response in that lung patient. And you saw that in sarcoma as well. So, Again, Philippe, do you want to address sort of the last two in a little more detail, the time to respond and the durability that we could hope to see?
spk06: Yeah, so I agree that it is early to make any types of determination, but I will say that the complete response was particularly fast in the combination arm. And as with the second question, The third question, sorry, I don't remember what the question was, the third question.
spk08: What an appropriate durability of response would be as we mentioned.
spk06: Oh, yes. So you answered six months, which is what we've answered before. Data from others show that it could be as low as four months, but we're going to shoot for six months.
spk02: And may I actually ask one follow-up, and it would be of patients that I have not responded, but I assume are still being followed. Are there any characteristics of those patients, be it bulk of disease, I could think of others, that may be characteristic of those patients that did not respond? Thanks very much.
spk08: Well, certainly I will say, no, just let me make a quick comment, Philippe, and then you can, certainly, you know, in the end, we want to wait until we see sort of the the full 20 patient data set through, you know, multiple scans, but, you know, we saw responses in the non-squamous population and then so far in the squamous population. So there's a clear differentiation, right? We had three responses, two parses, and a complete in seven patients with non-squamous, which is, you know, a pretty remarkable response rate. So that's one characteristic. I don't know, Philippe, if you noticed anything else about the patients that would help predict response.
spk06: No, so far we've had patients that are all PG1 failure patients. I think generally speaking, the number of prior lines of therapy usually is a factor in how well or how quickly a patient can respond to treatment. So we'll keep an eye on that and All the patients we've enrolled so far were also all smokers or prior smokers or current smokers. So that generally is a negative factor for these patients, but they all had the same similar baseline when it comes to smoking. So nothing extremely different from patient to patient.
spk02: Thank you, Philippe. Thank you, Scott. Thank you.
spk05: Thank you. And this does conclude the question and answer session. I would like to turn the floor to Scott Smith for any closing comments.
spk08: No, I just would like to thank everybody for joining on the call. I think, you know, a quarter of real important progress for us on non-small cell lung, but also a lot of progress in sarcoma. You know, we want to continue to accelerate the clinical programs and, you know, have more to report on as we get into the Q3 call and Just again, thank you all very much for listening. I'm very, very excited to continue these programs and continue to show the use of the differentiation that we believe these CAB assets can have in the clinic. So thank you all for your attention.
spk05: Thank you. The conference is now concluded. Thank you for attending today's presentation. We now disconnect your lines.
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