NASDAQ:LSTA Lisata Therapeutics Q3 2024 Earnings Report $2.37 -0.05 (-1.87%) As of 04:00 PM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Lisata Therapeutics EPS ResultsActual EPS-$0.59Consensus EPS -$0.75Beat/MissBeat by +$0.16One Year Ago EPS-$0.65Lisata Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ALisata Therapeutics Announcement DetailsQuarterQ3 2024Date11/12/2024TimeAfter Market ClosesConference Call DateTuesday, November 12, 2024Conference Call Time4:30PM ETUpcoming EarningsLisata Therapeutics' Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Lisata Therapeutics Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 12, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Welcome to the Lucetta Therapeutics Third Quarter 2004 Financial Results and Business Update Conference Call. As a reminder, this call is being recorded today, Tuesday, November 12, 2024. I would now like to turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lazada. Please go ahead, sir. Speaker 100:00:43Thank you, operator, and good afternoon, everyone. Welcome to Lazada's 3rd quarter 2024 conference call to discuss our financial results and to provide a business update. Joining me today from our management team are Doctor. David Mazzo, President and Chief Executive Officer Doctor. Kristin Buck, Executive Vice President of Research and Development and Chief Medical Officer and James Nisko, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Speaker 100:01:11Shortly before this call, we issued a press release announcing our Q3 2024 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or you'd like to be added to the company's e mail distribution list, please subscribe to our e mail alerts on the company website or e mail me at jmanditolasada.com to be added. Before we begin, I remind you that comments made by management during this conference call will contain forward looking statements that involve risks and uncertainties regarding the operations and future results of LASATA. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation its Forms 10Q, 8 ks and 10 ks, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward looking statements. Furthermore, the content of this conference call contains time sensitive information that is accurate as of the date of this live broadcast, Tuesday, November 12, 2024. Speaker 100:02:18LASATA Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I'll now turn the call over to Doctor. Mazzo. Dave? Speaker 200:02:32Thank you, John, and good afternoon, everyone. It is my pleasure to be here today to provide an overview of recent business highlights, discuss our Q3 2024 financial results and give an update on the progress of our development programs. Through the 1st 9 months of 2024, we continued our progress in advancing development of certepatide in combination with a variety of anticancer agents of differing modalities for the treatment of advanced solid tumors. The ongoing accumulation of both preclinical data and early clinical data support our belief that certepatide has the potential to become an integral part of a revised standard of care treatment regimen for advanced solid tumors including pancreatic, cholangiocarcinoma, glioblastoma, colon, appendiceal and melanoma. Additionally, we have initiated the preclinical investigation of certepatide as a potential therapeutic agent outside of oncology in the treatment of endometriosis, a disease which affects 100 of millions of women worldwide and for which there remains a pronounced unmet medical need. Speaker 200:03:38Doctor. Kristin Buck, our Chief Medical Officer and Head of R and D will provide a detailed update of our ongoing and planned clinical and preclinical programs following the review of our financial results. With that, I will now turn the call over to James Disco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James? Speaker 300:03:58Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our Q3 2024 financial results, Starting with operating expenses. For the 3 months ended September 30, 2024, operating expenses totaled $5,300,000 compared to $6,000,000 for the 3 months ended September 30, 2023, representing a decrease of $600,000 or 10.5%. Research and development expenses were approximately $2,500,000 for the 3 months ended September 30, 2024 compared to $3,400,000 for the 3 months ended September 30, 2023, representing a decrease of $800,000 or 24.8 percent. Speaker 300:04:52This was primarily due to a reduction in clinical research organization expenses associated with our Phase 2a bolster trial as a result of trial protocol modifications and lower equity expense. Also impacting this decrease were startup expenses in the prior year related to our glioblastoma multi form study. General and administrative expenses were approximately $2,800,000 for the 3 months ended September 30, 2024 compared to $2,600,000 for the 3 months ended September 30, 2023, representing an increase of $200,000 or 8.1%. This was primarily due to higher consulting expenses. Overall, net losses were $4,900,000 for the 3 months ended September 30, 2024 compared to $5,300,000 Speaker 200:05:56for Speaker 300:05:56the 3 months ended September 30, 2023. It is noteworthy that we continue to make progress according to our plans for our R and D and business activities, while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of September 30, 2024, LASATA had cash, cash equivalents and marketable securities of approximately 35,900,000 dollars Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. With that, I will now turn the call over to Doctor. Speaker 300:06:53Kristin Buck to provide an overview of the company's development programs. Kristin? Speaker 400:06:59Thank you, James, and good afternoon, everyone. Before I review our development portfolio, allow me to summarize some important background information, especially for those who are listening for the first time. Despite advances in cancer therapy, many solid tumors are still associated with poor patient outcomes. Advanced solid tumors such as pancreatic cancer, gastric cancer and glioblastoma multiforme are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies into the tumor. In addition, many solid tumors also harbor a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting the cancer. Speaker 400:07:44The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This coupled with the fact that most anti cancer therapies are not efficient in targeting only cancerous tissue defines the major challenges in the treatment of solid tumors. To overcome these obstacles, our investigational product certepatide leverages the naturally occurring SendR active transport system to selectively deliver anticancer drugs through the stroma into the tumor. Simultaneously, certepatide has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore increasing the tumors susceptibility to immunotherapy and our body's own immune system, while also inhibiting the metastatic cascade. For more specifics regarding certepatide's mechanism of action, I invite you to visit our website and view the animated video proceeding there too, as well as the relevant slides in the corporate presentation. Speaker 400:08:54Beyond our strategic clinical development plan, we have focused on optimizing our regulatory strategy. To date, our approach has yielded significant results for certepatide with multiple special regulatory designations across health authorities. These include orphan drug designation, fast track designation and rare pediatric disease designations. One such achievement occurred this past September when certepatide was granted orphan drug designation by the U. S. Speaker 400:09:22Food and Drug Administration for the treatment of cholangiocarcinoma. As mentioned, our regulatory and clinical development strategy for certepatide prioritizes rapid registration. We are actively evaluating certepatide's potential as a selective tumor targeting and penetrating enhancer and tumor microenvironment modifier in combination with a variety of standard of care therapies in advanced solid tumors. Now for an update on our individual development programs. The ASCEND trial is a 158 patient, double blind, randomized, placebo controlled clinical trial evaluating certepatide in combination with standard of care gemcitabine and nab paclitaxel chemotherapy and patients with metastatic pancreatic ductal adenocarcinoma or MPDAC. Speaker 400:10:17The trial is being conducted at 25 sites in Australia and New Zealand led by the Australasian Gastrointestinal Clinical Trials Group or AGITG in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney. As mentioned on prior calls, the ASCEND trial is an investigator initiated trial that LASATA inherited upon our acquisition of SEND Therapeutics. After the acquisition, LASATA collaborated with the sponsor of the trial, AGITG, to modify the trial to ensure it provided clinical outcomes that would best support the next steps in development of certepatide from a regulatory perspective. As such, the ASCEND protocol was amended to include another cohort of patients, Cohort B. Cohort B is designed to evaluate a second dose of intravenous certepatide given 4 hours after the first, thereby enabling further certepatide dose exploration and optimization. Speaker 400:11:21The ASCEND protocol was also amended to capture overall survival outcomes for both cohort A and cohort B. Given that the ASCEND protocol was amended following trial initiation, the outcome data from Cohort B will be delivered months after Cohort A data. Cohort A data, excuse me, Cohort A reached a predetermined number of events in September of this year, which prompted a preliminary analysis of the data. The results of that analysis were submitted as an abstract for ASCO GI, which takes place in January 2025. We just recently learned the abstract was accepted and the preliminary results of Cohort A will be presented by the study sponsor at the conference. Speaker 400:12:09As a reminder, the sponsor has sole ownership and control of the data dissemination. That said, we are in discussions with them to see if we could communicate any information from the preliminary analysis prior to the conference without diminishing the integrity of the abstract and presentation. As it stands right now, however, we will most likely need to wait until the time of the conference before communicating any preliminary results publicly. As noted, we anticipate cohort B is trailing cohort A in time and those data are expected to be mature and available mid-twenty 25 with a final analysis including both cohorts A and B available thereafter. The BOLSTER trial is our Phase 2a double blind placebo controlled multicenter randomized trial in the United States evaluating certepatide in combination with standard of care in first line and second line cholangiocarcinoma. Speaker 400:13:11Enrollment was completed in first line cholangiocarcinoma nearly 6 months ahead of time, accelerating the anticipated top line data readout to mid-twenty 25. A second cohort has been added to the bolster trial evaluating certepatide in subjects in second line cholangiocarcinoma on top of standard of care. We have now treated several patients in the second line cholangiocarcinoma cohort and enrollment completion is expected in the first half of twenty twenty five. Sendafox is a Phase 1b2a open label trial in the United States evaluating certepatide in combination with neoadjuvantfulfuronox based therapies in pancreatic, colon and appendiceal cancers. The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining 2 cohorts by the end of this quarter. Speaker 400:14:09Qilu Pharmaceutical, the licensee of certepatide in the Greater China Territory is also currently evaluating certepatide in combination with gemcitabine and nab paclitaxel as a treatment for metastatic pancreatic cancer. Chilo is currently treating patients in their Phase 2 placebo controlled trial in pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting. In collaboration with AstraZeneca Australia and the funding sponsor of the ILYSTA trial WARP-nine, we are evaluating certepatide in a Phase IbIIa randomized placebo controlled 3 arm single blind single center safety early efficacy and pharmacodynamic trial. The trial is being conducted in Australia evaluating certepatide in combination with a checkpoint inhibitor durvalumab plus standard of care gemcitabine and nab paclitaxel chemotherapy versus certepatide in combination with standard of care alone, no durvalumab versus standard of care alone in patients with locally advanced nonresectable pancreatic cancer. Speaker 400:15:29Enrollment completion is expected in the first half of twenty twenty five and preliminary results are expected to be announced at ASCO GI in January 2025. The study of certepatide in combination with temozolomide in glioblastoma multiforme or GBM has been initiated with several patients already enrolled and treated. This study is designed as a Phase 2a double blind placebo controlled randomized proof of concept study evaluating certepatide when added to standard of care temozolomide versus temozolomide alone and matching certepatide placebo in subjects with newly diagnosed GBM. This actively enrolling study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:one certepatide plus standard of care versus placebo plus standard of care. Enrollment completion is expected in the second half of twenty twenty five. Speaker 400:16:31FORTIFIED is a Phase 1b2a double blind placebo controlled 3 arm randomized study in the United States evaluating the safety, tolerability and efficacy of a 4 hour continuous intravenous infusion of certepatide in combination with standard of care in patients with second line metastatic pancreatic cancer who have previously progressed on Fulferonox. As part of this study, we have engaged Haystack Oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepatide. We expect to enroll the 1st patient in the study in the Q1 of 2025. Additionally, LASATA has recently entered into multiple preclinical research collaborations to broaden our understanding of certepatide therapeutic potential and identify new non oncologic opportunities for this development. These collaborations include a sponsored research agreement with the University of Cincinnati to assess certepatide in combination with bevacizumab, a VEGF inhibitor in a preclinical murine model for the treatment of endometriosis. Speaker 400:17:52This trial is the first exploration of certepatide in a non oncologic or cancer related indication. A partnership with Velo Therapeutics to investigate the benefits of combining certepatide with VALO's Peptocrad, a customizable oncolytic adenovirus platform technology and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma. Beyond the studies I've outlined, we are actively exploring additional opportunities to advance our development strategy. However, we remain focused on only initiating trials that can be funded through data and that can be executed within a reasonable period of time. As a reminder, several of the clinical studies I mentioned earlier are investigator initiated trials. Speaker 400:18:41And although we have great confidence in the investigators running these studies, LASATA has limited control and Operator00:18:51thus timelines and expectations may Speaker 200:18:51be subject Speaker 500:18:51to change. Speaker 400:18:51That said, we are extremely grateful to the investigators and especially to the patients participating in certepatide clinical trials around the world. For those who are interested, a more comprehensive description of each trial is available on the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are 2 slides that depict the anticipated timing and execution of key milestones and data readouts from our trials. As you will see, there are numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond. With that, I will now turn the call back to Dave. Speaker 200:19:31Thanks, Kristin. As you've heard, we have a lot going on and are looking forward to our data rich period starting in the very near future. We remain optimistic about the potential of certepatide to transform the lives of patients with cancer and have demonstrated our ability to design and execute a very capital efficient development plan. However, as I've mentioned before, we continue to be frustrated as I am sure all of you are with our share price and our market valuation. Considering our robust advancing clinical development portfolio, focused and rational development and regulatory strategy, continually growing library of supportive evidence and impeccable capital stewardship, trading at a negative enterprise value is irrational and misleading. Speaker 200:20:16We look forward to seeing a market reaction to our upcoming data that reflects what we see as the true value of our development candidate and company. We remain committed to advancing the setepatide program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year. And with that, operator, we're ready to take questions. Operator00:20:40Thank you. And our first question today will be coming from Joseph Panjianis of H. C. Wainwright. Your line is open. Speaker 600:21:04Hi, good afternoon. This is Sarah on for Joe. Thanks for taking the question. I had a question regarding enrollment in the GBM study. And in your last update, I believe you had mentioned you had enrolled 3 patients and I know more clinical sites have opened since. Speaker 600:21:22I was wondering if you can give any insight into maybe how many patients are currently enrolled in the study and how exactly it's progressing? Thank you. Speaker 200:21:30Thanks, Sarah. Appreciate you joining and thank you for the question. Our GBM trial has gotten off to a little bit slower start than we expected mostly because the sites in Latvia, which were intended to provide the lion's share of the patients ended up taking a bit longer, several months longer to initiate than was previously expected. The Estonian site though is now up to 5 patients and the Latvian sites should be coming online soon and we certainly hope to have enrollments meet our expectations for completion as indicated on our milestone slides. So thank you very much. Speaker 600:22:09Thank you. Operator00:22:12One moment for the next questions. And our next question will be coming from the line of Steve Brozak of WBB Securities. Your line is open. Speaker 700:22:27Yes. Hi. Thanks for taking the questions. You've alluded to an endometriosis potential here that I'm kind of curious too. And if you don't mind just going over the commonality with what you're looking at as far as certepatide and what the common characteristics are and why this is not just something that people should think about, but how it might extend to other things as well. Speaker 700:22:58So if you can provide as much detail in what the mechanisms are, what you're looking at, that would be greatly appreciated. And I've got a follow-up after that, please. Speaker 400:23:10Steve, this is Kristen. I will take that. Endometriosis is a tumor like disease. It's a disease of angiogenesis whereby menstrual material escapes the uterus and goes into the peritoneal cavity. We're targeting endometriosis, one, because it's a significant unmet medical need with over 190,000,000 women suffering from it worldwide for things like pain, discomfort and even infertility. Speaker 400:23:38But 2, because endometriosis has up regulated receptors required for certepatide selective targeting and penetration and that's the integrins and the norepoelin 1. And so we're trying to assess whether we can stop the angiogenesis of endometriosis by co administering certepatide with an anti vascular endothelial growth factor anti VEGF. In doing so, we hope that we can have a viable treatment option for these 190,000,000 people worldwide. Speaker 700:24:14Okay. I have a follow-up on that. I'd like to as long how you described it. What is the current standard of care that is used in dealing with endometriosis? And I've got one follow-up I was planning on after that, please. Speaker 400:24:31Sure, Steve. A lot of it starts with non steroidal anti inflammatories, analgesics, hormonal modulators and at worst case surgery to debulk the endometriotic lesions. There's really no cure for this disease. And as I said, it's very, very big unmet medical need. Speaker 700:24:52Okay. Thank you. Okay. Going back to on the trialing, I know that obviously the trials, what is released is specifically dictated by the clinicians, the lead investigators. But in terms of what you've seen as far as patient enrollment, because this is one thing that having done this for a long, long time, patient enrollment sometimes is a problem and other times it's you usually meet it. Speaker 700:25:21How would you explain the patient enrollment that you've seen on your on the major trials that you've got right now by comparison to the normal enrollment? And I'll hop back in the queue after that. Thank you. Speaker 200:25:38Well, thank you, Steve. I'll speak a little bit to ASCEND and then Kristen can speak to bolster and any others that she wishes to mention. But the ASCEND trial enrolled 158 patients over the course of about a year and a half, which was actually a pretty good enrollment rate considering that it was all done amongst about 20 sites in Australia and New Zealand. The investigators there, the AGITG consortium are enthusiastic and obviously the patients were convinced to not only join the trial, but to stay on treatment. So we take that as a positive sign that there's a great deal of both patient and investigator enthusiasm about the potential for the product. Speaker 200:26:29And I think it also speaks to certepatide's benign safety profile that while we hope it has significant impact on augmenting efficacy of the co administered drugs, it actually does not potentiate further adverse events. And I think that's very, very important for patients who are taking cytotoxics. Kristen, how about you speak to bolster, please? Speaker 400:26:54Sure. As I earlier spoke, bolster our first line cholangiocarcinoma cohort had 40 subjects and we recruited those within about 6 months of time, which is extremely fast, 6 months ahead of our projected recruitment timeline. The investigators were very eager and so much so that they requested that we continue to open that trial, make it larger and or add a second line cohort, which we have. The second line cohort for cholangiocarcinoma is recruiting as expected. It's slower than 1st line cholangiocarcinoma because it's a subset of patients who have progressed after first line and yet still have performance status capable of going on a new treatment regimen. Speaker 400:27:42So unfortunately, these patients who reach 2nd line often have very bad performance status and succumb to the disease very quickly. But to just answer your question succinctly, our first line recruited 6 months ahead of time, our second line in bolster is recruiting as expected. Speaker 700:28:01Got it. Thank you. I'll hop back in the queue. Thanks, Keith. Operator00:28:07Thank you. One moment for the next question. Our next question will be coming from Pete Enderlin of MAZ Partners. Your line is open. Speaker 500:28:22Thank you. Hello, everybody. Operator00:28:25Hi, Speaker 500:28:25Pete. I'd like to talk about the collaboration with Valotex. You mentioned you have multiple kind of collaborations and partnerships and joint efforts. So the first question is, how do you prioritize all those operations all those opportunities? And conceptually, you could say, take any kind of cancer and each of the different drugs that are in development for that and then each one of those is potentially an opportunity for enhancement with certapatide. Speaker 500:29:06So that's the first question. How do you prioritize pursuing those opportunities? And can you give us some sense of how many you see as realistic opportunities at this point? Speaker 200:29:22I'll start and then maybe Kristen can add some color commentary. But Pete, the way we look at this is it's sort of through a matrix. So first, as you said, in principle, we could combine certapatide with any modality of anticancer agent, a chemotherapeutic and immunotherapeutic, even a radiopharmaceutical, an sRNA nor antisense pharmaceutical, etcetera. And so what we look for, well, first of all, as Kristen mentioned early on, we only want to start trials, whether they are preclinical or clinical that will yield the data in our current funding window. So there's no point in starting something that won't yield data until 2026 if we have cash until 2026. Speaker 200:30:11So we need to prioritize things that are likely to be completed in the 2025 timeframe so that we can use that data to further increase the enthusiasm around certapatide and there convert that into funding opportunities. We also look at what the unmet medical need would be in the indication of choice, whether the competition is too strong for us or not, whether the length or the duration of a clinical trial might take many, many years or be short. So we look for those places where the disease causes patients to progress and or succumb more quickly so that we can show an improvement in a shorter period of time. And we also look at the likelihood of the various mechanisms of action with certepatide and the co administered drugs are being complementary and yielding a much better approach. And so when we put things through that matrix or that funnel, many things fall out before they get to the end and the things that get to the end are the ones that we agree that are priority. Speaker 200:31:28We also obviously look for those things where the partner is either paying for most or all the collaboration and all we have to do is provide seteprotide, yet we still have access to the data. Kristen, would you like to add anything to that? Speaker 400:31:44I think you said it well, Dave. Speaker 500:31:46Let me just ask a little bit of a follow-up and that is looking at that matrix, you said some of them obviously drop out for obvious reasons. Can you give us any sense of how many are kind of live prospects at this point going forward? Speaker 200:32:02Well, I mean, you can see that we're working. We have ongoing trials in pancreatic cancer and appendiceal cancer, colon cancer, glioblastoma, cholangiocarcinoma, etcetera. There are a number of other cancers that we would like to do work in. And certainly, we have a growing body of evidence that indicates that the combination of certepatide with immunotherapies really will give those immunotherapies a much increased efficacy profile in comparison to those immunotherapies alone in these solid tumors. And so there are quite a few opportunities along those lines. Speaker 200:32:46And then as Kristen pointed out, we're looking at areas outside of oncology where the disease behaves like a tumor and or has the requisite receptors to allow for the setepatide mechanism of action to be effective. And so there are a bunch of things to be looking at there, including opportunities in osteosarcoma, even some veterinary applications, melanoma. There are quite a few possibilities. Right now, our ability to pursue all those is limited only by capital. Speaker 500:33:24Did you just sort of imply that in oncology, the opportunities in immunotherapy might be more promising than in chemotherapy as a broad statement? Speaker 200:33:37I think that's what I implied. Okay. Speaker 500:33:39And it's Speaker 200:33:39exactly the way I would. They might be, which early days yet, but we're seeing some really very, very compelling preclinical and early clinical data that might lead us to that final conclusion. Speaker 500:33:51Thanks. And then just in the format with Valitex, the collaboration, they do the test, you provide the drug sort of appetite. And so is that the preferred way to go about this and is that primarily for cash reasons or because it's just easier to have somebody else and has the bandwidth to do the clinical trials themselves? Speaker 200:34:16In the case of VALO, it's not a question of bandwidth as much as a question of both in house expertise and actually availability. So all of our preclinical work that's done, for example, in models with animals are done outside of LASADO. We do not have laboratories. We do not do animal testing in house and we don't have a preclinical group per se. So they're done with academic collaborations, universities or in some cases CROs. Speaker 200:34:47VALO actually has those capabilities in house. And so they're able to do the experiment straight away because they have everything they need. They don't have to order it. We don't have to set up contracts with CROs. We don't have to write a protocol. Speaker 200:35:02This is a model they have running all the time. They have the availability of the animals and the expertise. And so it was just simpler for them to do it. And that's also why it's less expensive because they're going to do it in house with existing resources. So we really don't have to pay them for that. Speaker 500:35:18Okay, great. Thank you very much for the information. Speaker 200:35:22Thanks, Pete. Operator00:35:24Thank you. And one moment for the next question. And our next question for the day will be coming from Will Hidalgo of Brookline Capital Markets. Your line is open. Speaker 800:35:40Hi, thank you for taking questions. I have one question. I know you don't have I know you can't say much about the Cohort A data for the ASCEND trial. But can you give us any idea what level of detail we should expect in the readout? Should we I'm assuming we're going to get some PFS data and what would you all like to see to continue development? Speaker 200:36:09Thanks, Will. Appreciate the question. So you're right. I'm not at liberty to say very much about the data because the data is not ours to divulge. But that said, you can look to the protocol, which is available publicly on clinicaltrials.gov. Speaker 200:36:27And from that protocol, you can see what were identified as the major endpoints. And so those are the endpoints or the data that you should expect to see or hear about. So that would be progression free survival at 6 months versus treatment versus placebo. Median progression free survival and median overall survival are at least three things that you should see. You should also expect to see a number the number numerical count of complete responses in each group and maybe partial responses and overall response rates as well. Speaker 200:37:06So I would expect those things out of a minimum and those are really important. I mean for us, we all know that any one of those pieces of data can be quite interesting, but there's a pretty, I would say, reasonable probability that the regulatory standards for ultimate approval will remain consistent going forward and that regulatory standard is overall survival. So we'll be paying very close attention to overall survival and also the number of complete responses in the treatment group versus the placebo group as we determine what would be the next steps. And hopefully there will be next steps in the development of certapatide in metastatic pancreatic ductal adenocarcinoma. Speaker 800:38:01Okay. Thank you. Operator00:38:05Thank you. And that does conclude today's Q and A session. And I would like to turn the call back over to Doctor. Maslow for closing remarks. Please go ahead. Speaker 200:38:16Again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Please stay well and have a good evening. Operator00:38:34That concludes today's conference call. You may all disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLisata Therapeutics Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Lisata Therapeutics Earnings HeadlinesLisata Therapeutics to Report First Quarter 2025 Financial Results and Provide a Business Update on Thursday, May 8, 2025May 1, 2025 | globenewswire.comLisata Therapeutics talks ADC breakthrough with Catalent – ICYMIApril 19, 2025 | proactiveinvestors.comYour Wealth is Being Erased – Save It Before It’s Gone ForeverWhat If America's Gold Reserves Are a Lie? 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Email Address About Lisata TherapeuticsLisata Therapeutics (NASDAQ:LSTA), a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other diseases. Its product candidates include LSTA1, which is in Phase 2a and 2b clinical studies for the treatment of solid tumor, including metastatic pancreatic ductal adenocarcinoma (mPDAC), in combination with a range of anti-cancer regimens; XOWNA that is in Phase IIa clinical trial for the treatment of coronary microvascular dysfunction; and CD34+ cell therapy for the treatment of chronic kidney disease. Lisata Therapeutics, Inc. was incorporated in 1980 and is headquartered in Basking Ridge, New Jersey.View Lisata Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Palantir Stock Drops Despite Stellar Earnings: What's Next?Is Eli Lilly a Buy After Weak Earnings and CVS-Novo Partnership?Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2 Upcoming Earnings ARM (5/7/2025)AppLovin (5/7/2025)Fortinet (5/7/2025)MercadoLibre (5/7/2025)Cencora (5/7/2025)Carvana (5/7/2025)Walt Disney (5/7/2025)Emerson Electric (5/7/2025)Johnson Controls International (5/7/2025)Lloyds Banking Group (5/7/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 9 speakers on the call. Operator00:00:00Welcome to the Lucetta Therapeutics Third Quarter 2004 Financial Results and Business Update Conference Call. As a reminder, this call is being recorded today, Tuesday, November 12, 2024. I would now like to turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lazada. Please go ahead, sir. Speaker 100:00:43Thank you, operator, and good afternoon, everyone. Welcome to Lazada's 3rd quarter 2024 conference call to discuss our financial results and to provide a business update. Joining me today from our management team are Doctor. David Mazzo, President and Chief Executive Officer Doctor. Kristin Buck, Executive Vice President of Research and Development and Chief Medical Officer and James Nisko, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Speaker 100:01:11Shortly before this call, we issued a press release announcing our Q3 2024 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or you'd like to be added to the company's e mail distribution list, please subscribe to our e mail alerts on the company website or e mail me at jmanditolasada.com to be added. Before we begin, I remind you that comments made by management during this conference call will contain forward looking statements that involve risks and uncertainties regarding the operations and future results of LASATA. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation its Forms 10Q, 8 ks and 10 ks, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward looking statements. Furthermore, the content of this conference call contains time sensitive information that is accurate as of the date of this live broadcast, Tuesday, November 12, 2024. Speaker 100:02:18LASATA Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I'll now turn the call over to Doctor. Mazzo. Dave? Speaker 200:02:32Thank you, John, and good afternoon, everyone. It is my pleasure to be here today to provide an overview of recent business highlights, discuss our Q3 2024 financial results and give an update on the progress of our development programs. Through the 1st 9 months of 2024, we continued our progress in advancing development of certepatide in combination with a variety of anticancer agents of differing modalities for the treatment of advanced solid tumors. The ongoing accumulation of both preclinical data and early clinical data support our belief that certepatide has the potential to become an integral part of a revised standard of care treatment regimen for advanced solid tumors including pancreatic, cholangiocarcinoma, glioblastoma, colon, appendiceal and melanoma. Additionally, we have initiated the preclinical investigation of certepatide as a potential therapeutic agent outside of oncology in the treatment of endometriosis, a disease which affects 100 of millions of women worldwide and for which there remains a pronounced unmet medical need. Speaker 200:03:38Doctor. Kristin Buck, our Chief Medical Officer and Head of R and D will provide a detailed update of our ongoing and planned clinical and preclinical programs following the review of our financial results. With that, I will now turn the call over to James Disco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James? Speaker 300:03:58Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our Q3 2024 financial results, Starting with operating expenses. For the 3 months ended September 30, 2024, operating expenses totaled $5,300,000 compared to $6,000,000 for the 3 months ended September 30, 2023, representing a decrease of $600,000 or 10.5%. Research and development expenses were approximately $2,500,000 for the 3 months ended September 30, 2024 compared to $3,400,000 for the 3 months ended September 30, 2023, representing a decrease of $800,000 or 24.8 percent. Speaker 300:04:52This was primarily due to a reduction in clinical research organization expenses associated with our Phase 2a bolster trial as a result of trial protocol modifications and lower equity expense. Also impacting this decrease were startup expenses in the prior year related to our glioblastoma multi form study. General and administrative expenses were approximately $2,800,000 for the 3 months ended September 30, 2024 compared to $2,600,000 for the 3 months ended September 30, 2023, representing an increase of $200,000 or 8.1%. This was primarily due to higher consulting expenses. Overall, net losses were $4,900,000 for the 3 months ended September 30, 2024 compared to $5,300,000 Speaker 200:05:56for Speaker 300:05:56the 3 months ended September 30, 2023. It is noteworthy that we continue to make progress according to our plans for our R and D and business activities, while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of September 30, 2024, LASATA had cash, cash equivalents and marketable securities of approximately 35,900,000 dollars Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. With that, I will now turn the call over to Doctor. Speaker 300:06:53Kristin Buck to provide an overview of the company's development programs. Kristin? Speaker 400:06:59Thank you, James, and good afternoon, everyone. Before I review our development portfolio, allow me to summarize some important background information, especially for those who are listening for the first time. Despite advances in cancer therapy, many solid tumors are still associated with poor patient outcomes. Advanced solid tumors such as pancreatic cancer, gastric cancer and glioblastoma multiforme are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies into the tumor. In addition, many solid tumors also harbor a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting the cancer. Speaker 400:07:44The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This coupled with the fact that most anti cancer therapies are not efficient in targeting only cancerous tissue defines the major challenges in the treatment of solid tumors. To overcome these obstacles, our investigational product certepatide leverages the naturally occurring SendR active transport system to selectively deliver anticancer drugs through the stroma into the tumor. Simultaneously, certepatide has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore increasing the tumors susceptibility to immunotherapy and our body's own immune system, while also inhibiting the metastatic cascade. For more specifics regarding certepatide's mechanism of action, I invite you to visit our website and view the animated video proceeding there too, as well as the relevant slides in the corporate presentation. Speaker 400:08:54Beyond our strategic clinical development plan, we have focused on optimizing our regulatory strategy. To date, our approach has yielded significant results for certepatide with multiple special regulatory designations across health authorities. These include orphan drug designation, fast track designation and rare pediatric disease designations. One such achievement occurred this past September when certepatide was granted orphan drug designation by the U. S. Speaker 400:09:22Food and Drug Administration for the treatment of cholangiocarcinoma. As mentioned, our regulatory and clinical development strategy for certepatide prioritizes rapid registration. We are actively evaluating certepatide's potential as a selective tumor targeting and penetrating enhancer and tumor microenvironment modifier in combination with a variety of standard of care therapies in advanced solid tumors. Now for an update on our individual development programs. The ASCEND trial is a 158 patient, double blind, randomized, placebo controlled clinical trial evaluating certepatide in combination with standard of care gemcitabine and nab paclitaxel chemotherapy and patients with metastatic pancreatic ductal adenocarcinoma or MPDAC. Speaker 400:10:17The trial is being conducted at 25 sites in Australia and New Zealand led by the Australasian Gastrointestinal Clinical Trials Group or AGITG in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney. As mentioned on prior calls, the ASCEND trial is an investigator initiated trial that LASATA inherited upon our acquisition of SEND Therapeutics. After the acquisition, LASATA collaborated with the sponsor of the trial, AGITG, to modify the trial to ensure it provided clinical outcomes that would best support the next steps in development of certepatide from a regulatory perspective. As such, the ASCEND protocol was amended to include another cohort of patients, Cohort B. Cohort B is designed to evaluate a second dose of intravenous certepatide given 4 hours after the first, thereby enabling further certepatide dose exploration and optimization. Speaker 400:11:21The ASCEND protocol was also amended to capture overall survival outcomes for both cohort A and cohort B. Given that the ASCEND protocol was amended following trial initiation, the outcome data from Cohort B will be delivered months after Cohort A data. Cohort A data, excuse me, Cohort A reached a predetermined number of events in September of this year, which prompted a preliminary analysis of the data. The results of that analysis were submitted as an abstract for ASCO GI, which takes place in January 2025. We just recently learned the abstract was accepted and the preliminary results of Cohort A will be presented by the study sponsor at the conference. Speaker 400:12:09As a reminder, the sponsor has sole ownership and control of the data dissemination. That said, we are in discussions with them to see if we could communicate any information from the preliminary analysis prior to the conference without diminishing the integrity of the abstract and presentation. As it stands right now, however, we will most likely need to wait until the time of the conference before communicating any preliminary results publicly. As noted, we anticipate cohort B is trailing cohort A in time and those data are expected to be mature and available mid-twenty 25 with a final analysis including both cohorts A and B available thereafter. The BOLSTER trial is our Phase 2a double blind placebo controlled multicenter randomized trial in the United States evaluating certepatide in combination with standard of care in first line and second line cholangiocarcinoma. Speaker 400:13:11Enrollment was completed in first line cholangiocarcinoma nearly 6 months ahead of time, accelerating the anticipated top line data readout to mid-twenty 25. A second cohort has been added to the bolster trial evaluating certepatide in subjects in second line cholangiocarcinoma on top of standard of care. We have now treated several patients in the second line cholangiocarcinoma cohort and enrollment completion is expected in the first half of twenty twenty five. Sendafox is a Phase 1b2a open label trial in the United States evaluating certepatide in combination with neoadjuvantfulfuronox based therapies in pancreatic, colon and appendiceal cancers. The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining 2 cohorts by the end of this quarter. Speaker 400:14:09Qilu Pharmaceutical, the licensee of certepatide in the Greater China Territory is also currently evaluating certepatide in combination with gemcitabine and nab paclitaxel as a treatment for metastatic pancreatic cancer. Chilo is currently treating patients in their Phase 2 placebo controlled trial in pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting. In collaboration with AstraZeneca Australia and the funding sponsor of the ILYSTA trial WARP-nine, we are evaluating certepatide in a Phase IbIIa randomized placebo controlled 3 arm single blind single center safety early efficacy and pharmacodynamic trial. The trial is being conducted in Australia evaluating certepatide in combination with a checkpoint inhibitor durvalumab plus standard of care gemcitabine and nab paclitaxel chemotherapy versus certepatide in combination with standard of care alone, no durvalumab versus standard of care alone in patients with locally advanced nonresectable pancreatic cancer. Speaker 400:15:29Enrollment completion is expected in the first half of twenty twenty five and preliminary results are expected to be announced at ASCO GI in January 2025. The study of certepatide in combination with temozolomide in glioblastoma multiforme or GBM has been initiated with several patients already enrolled and treated. This study is designed as a Phase 2a double blind placebo controlled randomized proof of concept study evaluating certepatide when added to standard of care temozolomide versus temozolomide alone and matching certepatide placebo in subjects with newly diagnosed GBM. This actively enrolling study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:one certepatide plus standard of care versus placebo plus standard of care. Enrollment completion is expected in the second half of twenty twenty five. Speaker 400:16:31FORTIFIED is a Phase 1b2a double blind placebo controlled 3 arm randomized study in the United States evaluating the safety, tolerability and efficacy of a 4 hour continuous intravenous infusion of certepatide in combination with standard of care in patients with second line metastatic pancreatic cancer who have previously progressed on Fulferonox. As part of this study, we have engaged Haystack Oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepatide. We expect to enroll the 1st patient in the study in the Q1 of 2025. Additionally, LASATA has recently entered into multiple preclinical research collaborations to broaden our understanding of certepatide therapeutic potential and identify new non oncologic opportunities for this development. These collaborations include a sponsored research agreement with the University of Cincinnati to assess certepatide in combination with bevacizumab, a VEGF inhibitor in a preclinical murine model for the treatment of endometriosis. Speaker 400:17:52This trial is the first exploration of certepatide in a non oncologic or cancer related indication. A partnership with Velo Therapeutics to investigate the benefits of combining certepatide with VALO's Peptocrad, a customizable oncolytic adenovirus platform technology and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma. Beyond the studies I've outlined, we are actively exploring additional opportunities to advance our development strategy. However, we remain focused on only initiating trials that can be funded through data and that can be executed within a reasonable period of time. As a reminder, several of the clinical studies I mentioned earlier are investigator initiated trials. Speaker 400:18:41And although we have great confidence in the investigators running these studies, LASATA has limited control and Operator00:18:51thus timelines and expectations may Speaker 200:18:51be subject Speaker 500:18:51to change. Speaker 400:18:51That said, we are extremely grateful to the investigators and especially to the patients participating in certepatide clinical trials around the world. For those who are interested, a more comprehensive description of each trial is available on the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are 2 slides that depict the anticipated timing and execution of key milestones and data readouts from our trials. As you will see, there are numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond. With that, I will now turn the call back to Dave. Speaker 200:19:31Thanks, Kristin. As you've heard, we have a lot going on and are looking forward to our data rich period starting in the very near future. We remain optimistic about the potential of certepatide to transform the lives of patients with cancer and have demonstrated our ability to design and execute a very capital efficient development plan. However, as I've mentioned before, we continue to be frustrated as I am sure all of you are with our share price and our market valuation. Considering our robust advancing clinical development portfolio, focused and rational development and regulatory strategy, continually growing library of supportive evidence and impeccable capital stewardship, trading at a negative enterprise value is irrational and misleading. Speaker 200:20:16We look forward to seeing a market reaction to our upcoming data that reflects what we see as the true value of our development candidate and company. We remain committed to advancing the setepatide program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year. And with that, operator, we're ready to take questions. Operator00:20:40Thank you. And our first question today will be coming from Joseph Panjianis of H. C. Wainwright. Your line is open. Speaker 600:21:04Hi, good afternoon. This is Sarah on for Joe. Thanks for taking the question. I had a question regarding enrollment in the GBM study. And in your last update, I believe you had mentioned you had enrolled 3 patients and I know more clinical sites have opened since. Speaker 600:21:22I was wondering if you can give any insight into maybe how many patients are currently enrolled in the study and how exactly it's progressing? Thank you. Speaker 200:21:30Thanks, Sarah. Appreciate you joining and thank you for the question. Our GBM trial has gotten off to a little bit slower start than we expected mostly because the sites in Latvia, which were intended to provide the lion's share of the patients ended up taking a bit longer, several months longer to initiate than was previously expected. The Estonian site though is now up to 5 patients and the Latvian sites should be coming online soon and we certainly hope to have enrollments meet our expectations for completion as indicated on our milestone slides. So thank you very much. Speaker 600:22:09Thank you. Operator00:22:12One moment for the next questions. And our next question will be coming from the line of Steve Brozak of WBB Securities. Your line is open. Speaker 700:22:27Yes. Hi. Thanks for taking the questions. You've alluded to an endometriosis potential here that I'm kind of curious too. And if you don't mind just going over the commonality with what you're looking at as far as certepatide and what the common characteristics are and why this is not just something that people should think about, but how it might extend to other things as well. Speaker 700:22:58So if you can provide as much detail in what the mechanisms are, what you're looking at, that would be greatly appreciated. And I've got a follow-up after that, please. Speaker 400:23:10Steve, this is Kristen. I will take that. Endometriosis is a tumor like disease. It's a disease of angiogenesis whereby menstrual material escapes the uterus and goes into the peritoneal cavity. We're targeting endometriosis, one, because it's a significant unmet medical need with over 190,000,000 women suffering from it worldwide for things like pain, discomfort and even infertility. Speaker 400:23:38But 2, because endometriosis has up regulated receptors required for certepatide selective targeting and penetration and that's the integrins and the norepoelin 1. And so we're trying to assess whether we can stop the angiogenesis of endometriosis by co administering certepatide with an anti vascular endothelial growth factor anti VEGF. In doing so, we hope that we can have a viable treatment option for these 190,000,000 people worldwide. Speaker 700:24:14Okay. I have a follow-up on that. I'd like to as long how you described it. What is the current standard of care that is used in dealing with endometriosis? And I've got one follow-up I was planning on after that, please. Speaker 400:24:31Sure, Steve. A lot of it starts with non steroidal anti inflammatories, analgesics, hormonal modulators and at worst case surgery to debulk the endometriotic lesions. There's really no cure for this disease. And as I said, it's very, very big unmet medical need. Speaker 700:24:52Okay. Thank you. Okay. Going back to on the trialing, I know that obviously the trials, what is released is specifically dictated by the clinicians, the lead investigators. But in terms of what you've seen as far as patient enrollment, because this is one thing that having done this for a long, long time, patient enrollment sometimes is a problem and other times it's you usually meet it. Speaker 700:25:21How would you explain the patient enrollment that you've seen on your on the major trials that you've got right now by comparison to the normal enrollment? And I'll hop back in the queue after that. Thank you. Speaker 200:25:38Well, thank you, Steve. I'll speak a little bit to ASCEND and then Kristen can speak to bolster and any others that she wishes to mention. But the ASCEND trial enrolled 158 patients over the course of about a year and a half, which was actually a pretty good enrollment rate considering that it was all done amongst about 20 sites in Australia and New Zealand. The investigators there, the AGITG consortium are enthusiastic and obviously the patients were convinced to not only join the trial, but to stay on treatment. So we take that as a positive sign that there's a great deal of both patient and investigator enthusiasm about the potential for the product. Speaker 200:26:29And I think it also speaks to certepatide's benign safety profile that while we hope it has significant impact on augmenting efficacy of the co administered drugs, it actually does not potentiate further adverse events. And I think that's very, very important for patients who are taking cytotoxics. Kristen, how about you speak to bolster, please? Speaker 400:26:54Sure. As I earlier spoke, bolster our first line cholangiocarcinoma cohort had 40 subjects and we recruited those within about 6 months of time, which is extremely fast, 6 months ahead of our projected recruitment timeline. The investigators were very eager and so much so that they requested that we continue to open that trial, make it larger and or add a second line cohort, which we have. The second line cohort for cholangiocarcinoma is recruiting as expected. It's slower than 1st line cholangiocarcinoma because it's a subset of patients who have progressed after first line and yet still have performance status capable of going on a new treatment regimen. Speaker 400:27:42So unfortunately, these patients who reach 2nd line often have very bad performance status and succumb to the disease very quickly. But to just answer your question succinctly, our first line recruited 6 months ahead of time, our second line in bolster is recruiting as expected. Speaker 700:28:01Got it. Thank you. I'll hop back in the queue. Thanks, Keith. Operator00:28:07Thank you. One moment for the next question. Our next question will be coming from Pete Enderlin of MAZ Partners. Your line is open. Speaker 500:28:22Thank you. Hello, everybody. Operator00:28:25Hi, Speaker 500:28:25Pete. I'd like to talk about the collaboration with Valotex. You mentioned you have multiple kind of collaborations and partnerships and joint efforts. So the first question is, how do you prioritize all those operations all those opportunities? And conceptually, you could say, take any kind of cancer and each of the different drugs that are in development for that and then each one of those is potentially an opportunity for enhancement with certapatide. Speaker 500:29:06So that's the first question. How do you prioritize pursuing those opportunities? And can you give us some sense of how many you see as realistic opportunities at this point? Speaker 200:29:22I'll start and then maybe Kristen can add some color commentary. But Pete, the way we look at this is it's sort of through a matrix. So first, as you said, in principle, we could combine certapatide with any modality of anticancer agent, a chemotherapeutic and immunotherapeutic, even a radiopharmaceutical, an sRNA nor antisense pharmaceutical, etcetera. And so what we look for, well, first of all, as Kristen mentioned early on, we only want to start trials, whether they are preclinical or clinical that will yield the data in our current funding window. So there's no point in starting something that won't yield data until 2026 if we have cash until 2026. Speaker 200:30:11So we need to prioritize things that are likely to be completed in the 2025 timeframe so that we can use that data to further increase the enthusiasm around certapatide and there convert that into funding opportunities. We also look at what the unmet medical need would be in the indication of choice, whether the competition is too strong for us or not, whether the length or the duration of a clinical trial might take many, many years or be short. So we look for those places where the disease causes patients to progress and or succumb more quickly so that we can show an improvement in a shorter period of time. And we also look at the likelihood of the various mechanisms of action with certepatide and the co administered drugs are being complementary and yielding a much better approach. And so when we put things through that matrix or that funnel, many things fall out before they get to the end and the things that get to the end are the ones that we agree that are priority. Speaker 200:31:28We also obviously look for those things where the partner is either paying for most or all the collaboration and all we have to do is provide seteprotide, yet we still have access to the data. Kristen, would you like to add anything to that? Speaker 400:31:44I think you said it well, Dave. Speaker 500:31:46Let me just ask a little bit of a follow-up and that is looking at that matrix, you said some of them obviously drop out for obvious reasons. Can you give us any sense of how many are kind of live prospects at this point going forward? Speaker 200:32:02Well, I mean, you can see that we're working. We have ongoing trials in pancreatic cancer and appendiceal cancer, colon cancer, glioblastoma, cholangiocarcinoma, etcetera. There are a number of other cancers that we would like to do work in. And certainly, we have a growing body of evidence that indicates that the combination of certepatide with immunotherapies really will give those immunotherapies a much increased efficacy profile in comparison to those immunotherapies alone in these solid tumors. And so there are quite a few opportunities along those lines. Speaker 200:32:46And then as Kristen pointed out, we're looking at areas outside of oncology where the disease behaves like a tumor and or has the requisite receptors to allow for the setepatide mechanism of action to be effective. And so there are a bunch of things to be looking at there, including opportunities in osteosarcoma, even some veterinary applications, melanoma. There are quite a few possibilities. Right now, our ability to pursue all those is limited only by capital. Speaker 500:33:24Did you just sort of imply that in oncology, the opportunities in immunotherapy might be more promising than in chemotherapy as a broad statement? Speaker 200:33:37I think that's what I implied. Okay. Speaker 500:33:39And it's Speaker 200:33:39exactly the way I would. They might be, which early days yet, but we're seeing some really very, very compelling preclinical and early clinical data that might lead us to that final conclusion. Speaker 500:33:51Thanks. And then just in the format with Valitex, the collaboration, they do the test, you provide the drug sort of appetite. And so is that the preferred way to go about this and is that primarily for cash reasons or because it's just easier to have somebody else and has the bandwidth to do the clinical trials themselves? Speaker 200:34:16In the case of VALO, it's not a question of bandwidth as much as a question of both in house expertise and actually availability. So all of our preclinical work that's done, for example, in models with animals are done outside of LASADO. We do not have laboratories. We do not do animal testing in house and we don't have a preclinical group per se. So they're done with academic collaborations, universities or in some cases CROs. Speaker 200:34:47VALO actually has those capabilities in house. And so they're able to do the experiment straight away because they have everything they need. They don't have to order it. We don't have to set up contracts with CROs. We don't have to write a protocol. Speaker 200:35:02This is a model they have running all the time. They have the availability of the animals and the expertise. And so it was just simpler for them to do it. And that's also why it's less expensive because they're going to do it in house with existing resources. So we really don't have to pay them for that. Speaker 500:35:18Okay, great. Thank you very much for the information. Speaker 200:35:22Thanks, Pete. Operator00:35:24Thank you. And one moment for the next question. And our next question for the day will be coming from Will Hidalgo of Brookline Capital Markets. Your line is open. Speaker 800:35:40Hi, thank you for taking questions. I have one question. I know you don't have I know you can't say much about the Cohort A data for the ASCEND trial. But can you give us any idea what level of detail we should expect in the readout? Should we I'm assuming we're going to get some PFS data and what would you all like to see to continue development? Speaker 200:36:09Thanks, Will. Appreciate the question. So you're right. I'm not at liberty to say very much about the data because the data is not ours to divulge. But that said, you can look to the protocol, which is available publicly on clinicaltrials.gov. Speaker 200:36:27And from that protocol, you can see what were identified as the major endpoints. And so those are the endpoints or the data that you should expect to see or hear about. So that would be progression free survival at 6 months versus treatment versus placebo. Median progression free survival and median overall survival are at least three things that you should see. You should also expect to see a number the number numerical count of complete responses in each group and maybe partial responses and overall response rates as well. Speaker 200:37:06So I would expect those things out of a minimum and those are really important. I mean for us, we all know that any one of those pieces of data can be quite interesting, but there's a pretty, I would say, reasonable probability that the regulatory standards for ultimate approval will remain consistent going forward and that regulatory standard is overall survival. So we'll be paying very close attention to overall survival and also the number of complete responses in the treatment group versus the placebo group as we determine what would be the next steps. And hopefully there will be next steps in the development of certapatide in metastatic pancreatic ductal adenocarcinoma. Speaker 800:38:01Okay. Thank you. Operator00:38:05Thank you. And that does conclude today's Q and A session. And I would like to turn the call back over to Doctor. Maslow for closing remarks. Please go ahead. Speaker 200:38:16Again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Please stay well and have a good evening. Operator00:38:34That concludes today's conference call. You may all disconnect.Read morePowered by