NASDAQ:LGVN Longeveron Q3 2024 Earnings Report $1.46 +0.05 (+3.55%) Closing price 04/17/2025 03:59 PM EasternExtended Trading$1.46 0.00 (0.00%) As of 04/17/2025 04:12 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Longeveron EPS ResultsActual EPS-$0.34Consensus EPS -$0.53Beat/MissBeat by +$0.19One Year Ago EPS-$2.80Longeveron Revenue ResultsActual Revenue$0.77 millionExpected Revenue$0.34 millionBeat/MissBeat by +$430.00 thousandYoY Revenue GrowthN/ALongeveron Announcement DetailsQuarterQ3 2024Date11/12/2024TimeAfter Market ClosesConference Call DateTuesday, November 12, 2024Conference Call Time4:30PM ETUpcoming EarningsLongeveron's Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Longeveron Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 12, 2024 ShareLink copied to clipboard.There are 7 speakers on the call. Operator00:00:00Ladies and gentlemen, greetings and welcome to the L'Ouvreux Third Quarter 2024 Earnings Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Operator00:00:35Please go ahead. Speaker 100:00:38Thank you, Zico. Good afternoon, everyone, and thank you for joining us today to review Longeveron's Q3 2024 financial results and business update. After the U. S. Markets closed today, we issued a press release with financial results for the Q3, which can be found under the Investors section of the Longeveron website. Speaker 100:00:57On the call with me today are Wael Hachad, Chief Executive Officer Natalia Agafanova, Chief Medical Officer Lisa Locklear, Chief Financial Officer and Joshua O'Hare, Co Founder, Chief Science Officer and Chairman of the Board. As a reminder, during this call, we will be making forward looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company's filings with the Securities and Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the questions from our analysts. Speaker 100:01:35With that, let me hand the call over to Wael Hassad, Chief Executive Officer. Wael? Speaker 200:01:41Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today. I'm very pleased to update you on our progress and accomplishments since the end of the last quarter, which I can sum it up again as continued strong execution across all aspects of the organization. Today, we also want to talk a little bit about the long term strategy. As a reminder for those of you newer to our story, loamtivirone is a regenerative medicine company developing cutting edge cellular therapies. Speaker 200:02:19Our development compound LAMASIL B represents a pipeline and a product opportunity that is being evaluated across 3 important treatment areas, addressing numerous unmet medical needs with U. S. Market potential opportunity of approximately $10,000,000,000 to $18,000,000,000 Before we get into our recent progress, I would like to ask Doctor. Joshua Hair, our Co Founder and Chief Science Officer to discuss an important milestone for launch of Veron. Josh? Speaker 300:02:56Thank you, Al, and good afternoon, everyone. As Al mentioned, we have just reached an important milestone for the company in our stem cell therapy research. This month marks the 10th anniversary of the founding of Lungevron. Our vision back at the time of founding was to apply stem cell research to deliver regenerative medical therapies for unmet medical needs and that remains our vision today. As you'll hear from the team, we are making great progress advancing cellular therapy research and our product candidate LomaCell B. Speaker 300:03:31Over the past decade, stem cell therapy has seen remarkable strides, transforming from a promising field into one delivering tangible clinical outcomes. We've seen the solidification of cell therapy's role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care. Speaker 200:03:56At the core Speaker 300:03:57of this progress is the increased understanding of different types of stem cells, including medicinal signaling cells or MSCs like our development candidate, Loma Cell B, embryonic stem cells, ESCs, adult stem cells and induced pluripotent stem cells. Key breakthroughs including the use of stem cells to treat degenerative diseases such as Parkinson's, diabetes, Alzheimer's disease and heart disease. In 2020, the FDA approved the 1st stem cell based treatment for spinal cord injuries, marking a significant milestone for the area of development. In regenerative medicine, stem cells have been used to create lab grown tissues and mini organs, which we call organoids. These open the door to personalized medicine and organ repair. Speaker 300:04:50Stem cell therapy has made significant advances in the development of new techniques, clinical applications and regulatory frameworks. While challenges remain, we've seen enhanced safety and precision of stem cell therapies. Governments and regulatory bodies like the FDA have begun to adapt more quickly to emerging stem cell technologies. More treatments are entering Phase II and III clinical trials with some therapies receiving breakthrough, fast track or regenerative medicine advanced therapy, RMAT designations for serious conditions. The stem cell market has expanded globally with collaborations between academia, biotech firms and government funded research programs. Speaker 300:05:36Longevron has been at the forefront of this evolution in medicine. A decade ago, our stem cell therapy vision was an academic idea. Today, LomaCell B, our product candidate, a proprietary, scalable, allogeneic cellular therapy, has been administered to over 540 patients, delivered positive initial results across 5 clinical trials in 3 indications. These include Phase 1 and 2 trials in Alzheimer's disease, Phase 1 and 2 trials in aging related frailty and a Phase 1 in hypoplastic left heart syndrome or HLHS, which is also currently being evaluated in a pivotal Phase 2 clinical trial for HLHS. LomusLB development programs have received 5 distinct and important U. Speaker 300:06:27S. FDA designations. For the HLHS program, we received orphan drug designation, fast track designation and rare pediatric disease designation. And for the AD program, the regenerative medicine advanced therapy designation or RMAT and fast track designation. We believe stem cell therapy has the potential to become a mainstream treatment for many conditions with significant unmet medical needs. Speaker 300:06:58The outlook for future breakthroughs is promising and we will continue to work towards our mission and hopefully support patients battling a range of diseases and conditions. As we do, we look forward to continuing to share our research, clinical and regulatory progress. Thank you and I will turn the call back over to Wael. Speaker 200:07:20Thank you, Josh. I am heartened to see the tremendous progress achieved both by the industry and specifically by Londevarone over the past decade. For Longevarone, this has been further accelerated with our recent accomplishments. As we have mentioned throughout the year, HLHS is the key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval across our pipeline. Speaker 200:07:57Our ongoing Phase 2b study, ELPHIS2, which is evaluating Lomacil B as a potential adjunct treatment for HLHS has now achieved more than 80% enrollment and we expect to complete enrollment for the end of this year or early next year. Very importantly, we recently completed a Type C meeting with the U. S. Children and Drug Administration, in which we were able to confirm that license application or a BLA submission for full traditional approval, as well as reaching alignment on ELPHIS-two primary and secondary endpoints. This significantly accelerates the potential regulatory and if supported by clinical data from ELVIS II would allow us to initiate a rolling submission of BLA for the Food and Drug Administration in year 2026. Speaker 200:09:00In support of that opportunity, I'm delighted to welcome Devin Glass to launch of her own as a Chief Technology Officer and a Senior Vice President of CMC. He will join us on December 2 to lead the company's technology and manufacturing strategy and execution. Devin has over 15 years of distinguished experience in the development and manufacturing of advanced therapy. We look forward to working with him to advance Lomicil B across all of our indications. We also continue to advance our very important Alzheimer's disease program. Speaker 200:09:42We understand Alzheimer's disease has historically been difficult area for development. So we are only more encouraged with the results we have seen to date with Loma Tel B. Results from our CLEAR MIND Phase IIa clinical trial were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC. In the clinical trial, lomatilb treated patients showed an overall slowing or prevention of the disease worsening compared to placebo. Given the ClearMind Phase IIa clinical data, Empire Phase I of the FDA has granted LUMASIL B post regenerative medicine and therapy also known as RMAD designation and fast track designation for the treatment of mild Alzheimer disease. Speaker 200:10:41NOSL B appears to be the 1st cellular therapy candidate to receive RMAT designation for Alzheimer disease. With these data in hand, we anticipate meeting with the FDA in the Q1 of 2025 to view future clinical and regulatory strategy for continuing this important program. As we continue to for our development, optimizing our resources and being good stewards of shareholders' capital, while maintaining our investments in advancing our clinical pipeline and definitely BLA enabling activities. We have focused on expense control and program prioritization, leading to a total operating expenses through the 1st 9 months, declining 14% year over year. Our existing cash and cash equivalents are expected to be sufficient to fund the company through the Q4 of 2025. Speaker 200:11:52With that, I will turn the call to Doctor. Agathe Nova to provide updates on our clinical development program. Natalia? Speaker 400:12:02Thank you, Vael, and good afternoon, everyone. As Vael mentioned, our HLHS program is a primary focus for us with a near term pathway to potential approval and an area of clear unmet medical need. Our HLHS program begun with the LPISS-one Phase 1 clinical trial evaluating loneselfb in infants with HLHS, which produced positive encouraging results. Most recently, LPISS 2 5 year post treatment long term survival data was selected for presentation at the Congenital Heart Surgeons Society, CHSS 51st Annual Meeting. This data including the following: 5 year postglenn procedure Kaplan Meier survival was 100% in patients treated with Lorna Cell B in LPS I with non required heart transplant. Speaker 400:13:02This compared to 83% survival in the single ventricle reconstruction trial through 5 years postglance surgery and a 5.2% heart transplantation rate. No major cardiovascular adverse cardiovascular events were reported during the study. No Lonicel related safety issues also were reported. These findings support the use of Lonicel B as a potential adjunct to HLHS reconstruction surgery to improve transplant free survival. The LPIZ1 data served as the basis for LPIZ2, our ongoing Phase 2b clinical trial evaluating the potential of Lumicel B to improve right in cheek lower function and long term outcomes. Speaker 400:13:55LPISS-two is being conducted in collaboration with the National Heart, Lung and Blood Institute through grants from the National Institute of Health. This trial will enroll 38 pediatric patients and we have reached more than 80% enrollment. We have 12 leading pediatric cardiometritis institutions participated as a clinical trial site. The 3 of them have been joined in the last quarter. We could not be more pleased with the participating group and their the participating group and their enthusiasm for LPISS II and thank them for all the work they do for their patients and the patient's family. Speaker 400:14:36With this support, we are working towards completing enrollment of the trial by the end of this year, and there are patients in the queue that can make that timeline achievable. However, we obviously do not control scheduling from surgery, so we may see enrollment completion occurred in the Q1 of the next year. As Vael mentioned, we recently completed a Type C meeting with the FDA where we discussed HLHS, our development program, the data it has produced in our ongoing Phase 2 clinical trial. We reached alignment on LPISS 2 primary and secondary endpoints and very significantly we are able to confirm that LPISS 2 is pivotal and is positive acceptable for BLA submission. If results from LPISS-two are positive, we would be positioned to initiate a rolling submission with the FDA in 2026. Speaker 400:15:43Turning now to our Alzheimer disease program. Data from ClearMind Phase IIa clinical trial were selected for a future research oral presentation at the 2024 Alzheimer's Association International Conference held at the end of July. We are very excited about the trial positive results, which we have previewed previously. I would just reiterate that the trial achieved the primary safety and secondary efficacy endpoints. And also that in the clinical trial, lomicel B treated patients showed overall slowing prevention of disease worsening compared to placebo. Speaker 400:16:25Continued the positive data trend, Lonecel B data in Alzheimer disease was selected to be presented in a late break in poster presentation at the clinical trial on the ZYNER disease conference, CTAD 2024 in late October 2024. That data showed the following: Lonicell B capacity to inhibit MMNP-fourteen correlates with improved clinical and biomarker outcomes in mild Alzheimer disease. Pfizer offer potential mechanistic and clinical insights in the development of cellular based therapy for Alzheimer disease. We believe the results from ClearMind support the therapeutic potential of LomiSel B in the treatment of mild Alzheimer disease and provided evidence based support for future clinical development. Based on data generated in our Phase 1 and Phase 2 Alzheimer clinical trials in July, The FDA has granted Lonitzel B both Regeneron's Medicine Advanced Therapy, RMAT designation and Fast Track designation for the treatment of mild Alzheimer disease. Speaker 400:17:44We plan to meet with the FDA before in the end in the Q1 of the next year to review clinical trial and regulatory strategy for the Alzheimer program. I will hand the call over to Lisa O'Clair, our Chief Financial Officer, to discuss our financial results for the Q2. Lisa? Speaker 500:18:10Thank you, Natalia, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10 Q, both of which present our financial results in detail. So I will touch on some highlights. Revenues for the 9 months the 1st 9 months of 2024 were $1,800,000 up $1,100,000 or 177 percent when compared to the same period in 2023, mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue. Contract manufacturing revenue for the 9 months ended September 30, 2024 was $800,000 We believe the contract manufacturing business has the potential to expand our team's expertise and generate approximately $4,000,000 to $5,000,000 in annual revenues once it is up and running fully, helping offset our clinical development costs and reducing but not eliminating our additional capital need. Speaker 500:19:21This year, we have focused on prioritizing investments in our clinical programs and expense management, and we have successfully executed in both areas. Total operating expenses through the 1st 9 months of the year declined 14% year over year, with G and A expenses for the 9 month period ended September 30, 2024, decreasing to approximately $7,400,000 compared to $8,900,000 for the same period in 2023. This G and A expense decrease of approximately $1,500,000 or 16 percent is primarily due to lower personnel expenses as a result of reduced severance, legal and other administrative expenses, partially offset by higher stock compensation costs in 2024. R and D expenses for the 9 months ended September 30, 2024 also decreased approximately $800,000 or 11 percent to approximately $6,100,000 The decrease was primarily due to reduced expenses associated with the completed clear mind Alzheimer's disease clinical trial and reduced costs for the aging related frailty clinical trial following our decision to discontinue trial activities in Japan. Our net loss decreased 22% to approximately $11,900,000 for the 9 months ended September 30, 2024 from a net loss of $15,300,000 for the same period in 2023 for the reason I just explained. Speaker 500:20:59Our cash and cash equivalents as of September 30, 2024 were $22,800,000 The company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements through the Q4 of 2025 based on our current operating budget and cash flow forecast. It is important to note, however, that with our successful Type C meeting with the FDA with respect to the HLHS regulatory pathway, we have started to ramp up BLA enabling activities as we currently anticipate initiation of a rolling submission with the FDA in 2026, if the current ELPIS II trial is successful. To the extent that our operating expenses and capital expenditure requirements accelerate in calendar 2025 as a result of these activities, which includes CMC, chemistry manufacturing controls and manufacturing readiness, there will be a need to increase our current proposed spend and further increase our capital investments. We intend to seek additional financing, capital raises, non dilutive funding options to support these activities and current cash projections may be impacted by these ramped up activities as well as any financing transactions entered into. I will now hand the call back to Wael. Speaker 200:22:29Thank you, Lisa. The data generated to date in HLHS and Alzheimer disease support the broad potential for LomaSorb B as a regenerative medical therapy across multiple and significant indications. The strength of the data, our experienced and committed team and unwavering focus on patients give me confidence in the future of lamasolb and longeborone. Operator, we would like now to open the call for questions from covering analysts. Operator00:23:06Thank you. Ladies and gentlemen, we will now begin the question and answer The first question comes from the line of Raghuram Selvaraju with H. C. Wainwright. Please go ahead. Speaker 300:24:01Good afternoon. This is Dan on for Ram. Thanks for taking our questions and congratulations on your anniversary. So what would represent an appropriate benchmark from a performance standpoint in the Altice II trial that would catalyze the accelerated approval? And what's the current thinking with respect to the path forward for lung cell B and Alzheimer's disease? Speaker 300:24:23Is there a shorter term clinical design paradigm that could be applicable? For example, positioning it initially as a symptomatic rather than a disease modifying therapy? Thank you. So, Speaker 200:24:36Ram, I don't know the first part of the question. I hope I got it right, but if not, feel free to correct me as well. So regarding the plan, as you know, we met with the FDA. We confirmed a lot of the assumptions. So basically the current existing Phase 2b trial will be accepted for full approval and we also confirmed with them the GMC plan, the potency assay, the primary and secondary endpoints. Speaker 200:25:13So we have a confirmation. We have minutes from this one. We also have, as you know, fast track designation. And the fast track designation, by definition allow you to have rolling submission, which we intend to use once we finish the enrollment and get the top line results immediately. We actually started preparing from it assuming that we will have a positive data coming out of that trial. Speaker 200:25:38So I think a lot of this is not based on assumptions, but actually based on feedback with the agency and the current designation of what it allow us to do. I hope that this answer your question before I go to the Alzheimer's part? Speaker 300:25:53Yes, that was a great answer. Speaker 200:25:55All right. So regarding the Alzheimer's, so I think and Natalia and Doctor. Haire can jump in as well and weigh in on this one, but I'll give you my perspective here. We really believe that from and we actually had managed significantly most recently even at the CTAD meeting with a lot of the advisors and external thought leaders and these are the top Alzheimer's thought leaders around the world. And I think the unanimous feedback is you guys need to continue the development. Speaker 200:26:39There might be something very helpful for the patients here. Of course, we don't have the data to get approval today. However, as you know, there is over 140 programs is being developed right now in Alzheimer disease. Many of these programs are developed by small companies of our size. So we're really and we're all realized how big is the investment needed to advance this program and definitely partnership or a significant whether this is with a company or government entity or whatever would be very helpful. Speaker 200:27:14The question is, why these companies or these government entities really invest in your program and not any of the other 140 programs that are being developed. We're going to have to provide something very useful. So therefore, we really have been working on a proposed accelerated and streamlined the FDA at the beginning of next year. I'm not saying that this is the FDA, but if approved by the FDA or endorsed by the FDA, that will allow us to come to the market faster and more economical, which we believe will present a very good opportunity for us to be able to compete on these additional funds, whether public funds or partnership with companies and separate ourselves from other companies that operate in space. That is our strategy. Speaker 200:28:15That is our plan. And you're going to ask why do we do that? The simple answer is part of the RMAT designation, it's actually allow you if you read the RMAT guidelines, it actually allow you to have a streamlined path to approval. We just want to make sure that the FDA for this. And I want to also tell you one additional thing is that path that we are proposing, we have actually had the opportunity to spend time with some of the top advisors and Natalia have done this at the CTAD, where she really got their thoughts and we got very, very good positive feedback from our advisors about our proposed plan as well. Speaker 200:28:58Ataya and Josh, do you want to add anything for Ram's question? Speaker 400:29:02Sure, Raul. Guram, thank you for your question. I think you mentioned also the symptomatic DMT. I would like just to mention that CLEAR MIND study, which is proof of concept and Phase 1 study, which was placebo controlled, both were conducted on mild Alzheimer disease patient population. It is considered early, it's symptomatic and the advice we got recently on C TAD that we should continue our development as disease modifying treatment remaining in a mild Alzheimer disease patient population because there is a clear good signal on our prior development. Speaker 400:29:50So and this is where the plan to continue apply LomiSelb for this patient population. I hope we addressed your question, Graham. Speaker 200:30:03Yes. Thank you so much. Operator00:30:07Thank you. The next question comes from the line of Pupalan Pachupant with ROTH Capital Partners. Please go ahead. Speaker 600:30:17Good afternoon, team. Can you hear me okay? Speaker 200:30:21Yes. Speaker 400:30:21Yes. Operator00:30:22Yes, please go ahead. Speaker 600:30:24All right, great. So we have some questions and thanks so much for taking our questions. So firstly, with respect to LPISS-one trial long term follow-up, I see that you have 100% survival, which is really fantastic. So I was wondering whether you are able to measure additional cardiac parameters such as RVEF or tricuspid regurgitation at the end of 5 years that would have given you any indication that the ongoing LPs II trial might read out positive similar to LPs I? Or is this merely a 5 year safety follow-up? Speaker 400:31:00Wael, do you want me to take this one? Speaker 200:31:03Yes. Natalia or Josh can take that question. Okay. Speaker 400:31:08Thank you, Pupalan, for your question. It's a very important one and that we're basically aligned with our thinking. So initially LPS I protocol is Phase I was open label trial. And initially, we set up the trial that we are collecting only pass we call it passive follow-up. Basically, after completion of 1 year post Glenn procedure surgery, size call the patients with 2 questions, is the patient alive, yes or no and if patient had transplant heart transplant. Speaker 400:31:47However, you're absolutely right. If we have and beyond that, we have no additional data at this time. However, we do understand if we reach data by collecting more granular data on ejection fraction, on g auscultic regurgitation, basically on all ultrasound or MRI data exists that will help us to navigate BLA submission. It will help us to answer your question to answer your question, currently, we have only survival and transplant free survival data. However, we are entertaining this idea to gather more information on these patients retrospectively. Speaker 600:32:50So if you wanted to get that data in a retrospective manner, do you have to go back to agency and do some sort of trial protocol revision? Or do you need to get some additional approval from the participating clinical trials? Because I really feel because these patients were alive after 5 years, which is it's a new high watermark in HLHS, at least in my view. So I was curious whether additional parameters would make your case more convincing, not that it is less convincing now, but it would make it more convincing. Speaker 400:33:25Absolutely. And we don't have to go back to agency. We just need to revise our contracts with our sites. And this is actually ongoing efforts right now, but we don't have to go back to agency. And we are currently collaborating with one particular investigator who is very enthusiastic in this indication, who provides his guidance, cardiology guidance, what data we should collect in order to enrich our LPS II trial and get the package more complete. Speaker 400:34:03So, but yes, we don't have to go back to agency for that. Speaker 600:34:09Okay. That's very helpful. Go ahead, Vyral. Of course. Speaker 200:34:15Yes. Just for historical, I know we haven't talked about the L plus 1 for a long time. The good thing about L plus 1, it was conducted only on 3 sites. One of them almost half of the patients. So I don't think it is a major undertaking to work with the sites. Speaker 200:34:31It's not as big as the number of sites in the LPS II. So we're hopeful that we are able to be able to collect this data as Natayev said. Speaker 600:34:41Fantastic. All right. And then focusing your attention on LPS II, which is your pivotal trial. So speaking about the endpoint, which is RVEF, the right ventricular ejection fraction, Can you maybe provide some context in terms of the efficacy benchmark that will make you feel more comfortable given this is a pivotal trial? I understand no such benchmark exists to date and probably you will be a pioneer in this field. Speaker 600:35:11But nevertheless, based on your discussions with the agency and the feedback that you got and all of that, can you maybe provide some color? At least can you maybe tell us what's your current thinking? What would be the expected of the EF of HLHS patients at this juncture with Lomicil B and then what could be without the drug? Speaker 400:35:34Yes. Wael, do you want me to take this one? Speaker 200:35:39Yes, Natalya, Speaker 300:35:40you go ahead, Natalya. Speaker 200:35:42Yes. And Josh, Speaker 600:35:43I think Speaker 400:35:43it's Thanks, Pavalan. Yes, thanks, Pavalan. And Josh, please chime in if I may Speaker 200:35:48say anything. Yes, I'll Speaker 300:35:48add that. Speaker 400:35:51So, great question. And again, you're speaking as we thought. So, we did have a very meaningful conversation with FDA and they agree in principle that right ventricular ejection fraction would not be sufficient for 1 year after the Glenn procedure evaluation of the clinical response. So we are adding clinical points as well to the composite endpoint. And we're still flushing out the final simulations and final exercise to present to agency. Speaker 400:36:29But in principle, they did agree in addition of right ventricular ejection fraction, they will be clinical outcome measures as a primary endpoint. And Josh, if you want to speak about specifically right ventricular ejection fraction, I appreciate. Speaker 200:36:47Yes. Speaker 300:36:50The right ventricular ejection fraction is well established surrogate for outcome in HLHS patients. And really the important difference here will be between treated and the standard of care patients. I think if the number is higher, statistically significantly higher in the treated patients than in the standard of care, that would be considered a significant finding. But I do want to reiterate what Natalia has said that which is very important is that the agency was very supportive of the idea that we combine right ventricular ejection fraction with clinical endpoints as well, such as the survival. So I think that the survival difference that we see in the ALPUS-one is highly encouraging for what the ultimate finding will be in ALPUS-two. Speaker 600:38:00Okay, great. And then maybe one more question, if I may. So I just want to give you a high level thoughts whether you think the HLHS competitive landscape has meaningfully changed in the recent past. I was doing some quick search in clinical trials website. There's a product called Ventri Gel. Speaker 600:38:20I'm sure you might have heard of it, Josh. So I'm curious, do you think Ventri Gel could be at some point be competing with low Missal B? What are your preliminary thoughts? Speaker 200:38:34If Speaker 300:38:36I'm correct about VentriGel, it's basically an inert substance. It's a substance that you really what it does is it prevents remodeling. It prevents the heart from enlarging. I'm not sure if they even have Phase 1 data yet for the ventrogel. I am aware that a trial is being planned. Speaker 300:38:59I think the major difference between the ventrogel strategy and our strategy is that again the ventrogel isn't just an inert substance that affects the structural components of the ventricle, whereas Loma Cell B has a multifactorial action, which includes anti inflammatory, pro vascular, anti fibrotic and potentially pro regenerative effects, stimulating endogenous myocyte replication. So I think that the mechanism of action of the two strategies is very, very different. So I don't believe it would be a strong competitor. But of course, as you enter into these kind of novel strategies, you always have to be guided by the data. So we will see what the data shows. Speaker 300:39:53And we are obviously very excited about our data, particularly the new survival data from L plus-one. Speaker 600:40:02All right. That's it from us. Thanks so much once more for taking our questions. Speaker 200:40:08Thank you, Bill. Operator00:40:10Thank you. As there are no further questions, I would now like to hand the conference over to Wael Harshad for closing comments. Speaker 200:40:20Thank you, Mikhail. Thanks to all who attended our call today. We greatly appreciate your interest and support. And we look forward to updating you on our progress as we continue. Thank you, operator, and you may end the call right now. Operator00:40:40Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLongeveron Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) Longeveron Earnings HeadlinesLongeveron Stock Short Interest Report | NASDAQ:LGVN | BenzingaApril 18 at 3:37 PM | benzinga.comLGVN Announces Positive Alzheimer’s NewsMarch 20, 2025 | msn.comNow I look stupid. Real stupid... I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. April 20, 2025 | Porter & Company (Ad)Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s DiseaseMarch 20, 2025 | finance.yahoo.comLongeveron (LGVN) Receives a Buy from Roth MKMMarch 20, 2025 | markets.businessinsider.comRoth MKM Keeps Their Buy Rating on Longeveron (LGVN)March 12, 2025 | markets.businessinsider.comSee More Longeveron Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Longeveron? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Longeveron and other key companies, straight to your email. Email Address About LongeveronLongeveron (NASDAQ:LGVN), a clinical stage biotechnology company, develops cellular therapies for aging-related and life-threatening conditions in the United States and Japan. The company's lead investigational product is the LOMECEL-B, an allogeneic mesenchymal stem cell formulation sourced from the bone marrow of young and healthy adult donors. It is conducting Phase 1, Phase 1/2, Phase 2a, and Phase 2b clinical trials in various indications, such as aging-related frailty, alzheimer's disease, and hypoplastic left heart syndrome. 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There are 7 speakers on the call. Operator00:00:00Ladies and gentlemen, greetings and welcome to the L'Ouvreux Third Quarter 2024 Earnings Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Operator00:00:35Please go ahead. Speaker 100:00:38Thank you, Zico. Good afternoon, everyone, and thank you for joining us today to review Longeveron's Q3 2024 financial results and business update. After the U. S. Markets closed today, we issued a press release with financial results for the Q3, which can be found under the Investors section of the Longeveron website. Speaker 100:00:57On the call with me today are Wael Hachad, Chief Executive Officer Natalia Agafanova, Chief Medical Officer Lisa Locklear, Chief Financial Officer and Joshua O'Hare, Co Founder, Chief Science Officer and Chairman of the Board. As a reminder, during this call, we will be making forward looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company's filings with the Securities and Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the questions from our analysts. Speaker 100:01:35With that, let me hand the call over to Wael Hassad, Chief Executive Officer. Wael? Speaker 200:01:41Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today. I'm very pleased to update you on our progress and accomplishments since the end of the last quarter, which I can sum it up again as continued strong execution across all aspects of the organization. Today, we also want to talk a little bit about the long term strategy. As a reminder for those of you newer to our story, loamtivirone is a regenerative medicine company developing cutting edge cellular therapies. Speaker 200:02:19Our development compound LAMASIL B represents a pipeline and a product opportunity that is being evaluated across 3 important treatment areas, addressing numerous unmet medical needs with U. S. Market potential opportunity of approximately $10,000,000,000 to $18,000,000,000 Before we get into our recent progress, I would like to ask Doctor. Joshua Hair, our Co Founder and Chief Science Officer to discuss an important milestone for launch of Veron. Josh? Speaker 300:02:56Thank you, Al, and good afternoon, everyone. As Al mentioned, we have just reached an important milestone for the company in our stem cell therapy research. This month marks the 10th anniversary of the founding of Lungevron. Our vision back at the time of founding was to apply stem cell research to deliver regenerative medical therapies for unmet medical needs and that remains our vision today. As you'll hear from the team, we are making great progress advancing cellular therapy research and our product candidate LomaCell B. Speaker 300:03:31Over the past decade, stem cell therapy has seen remarkable strides, transforming from a promising field into one delivering tangible clinical outcomes. We've seen the solidification of cell therapy's role in regenerative medicine and its potential to treat a wide range of conditions, signaling an exciting future for both scientific innovation and patient care. Speaker 200:03:56At the core Speaker 300:03:57of this progress is the increased understanding of different types of stem cells, including medicinal signaling cells or MSCs like our development candidate, Loma Cell B, embryonic stem cells, ESCs, adult stem cells and induced pluripotent stem cells. Key breakthroughs including the use of stem cells to treat degenerative diseases such as Parkinson's, diabetes, Alzheimer's disease and heart disease. In 2020, the FDA approved the 1st stem cell based treatment for spinal cord injuries, marking a significant milestone for the area of development. In regenerative medicine, stem cells have been used to create lab grown tissues and mini organs, which we call organoids. These open the door to personalized medicine and organ repair. Speaker 300:04:50Stem cell therapy has made significant advances in the development of new techniques, clinical applications and regulatory frameworks. While challenges remain, we've seen enhanced safety and precision of stem cell therapies. Governments and regulatory bodies like the FDA have begun to adapt more quickly to emerging stem cell technologies. More treatments are entering Phase II and III clinical trials with some therapies receiving breakthrough, fast track or regenerative medicine advanced therapy, RMAT designations for serious conditions. The stem cell market has expanded globally with collaborations between academia, biotech firms and government funded research programs. Speaker 300:05:36Longevron has been at the forefront of this evolution in medicine. A decade ago, our stem cell therapy vision was an academic idea. Today, LomaCell B, our product candidate, a proprietary, scalable, allogeneic cellular therapy, has been administered to over 540 patients, delivered positive initial results across 5 clinical trials in 3 indications. These include Phase 1 and 2 trials in Alzheimer's disease, Phase 1 and 2 trials in aging related frailty and a Phase 1 in hypoplastic left heart syndrome or HLHS, which is also currently being evaluated in a pivotal Phase 2 clinical trial for HLHS. LomusLB development programs have received 5 distinct and important U. Speaker 300:06:27S. FDA designations. For the HLHS program, we received orphan drug designation, fast track designation and rare pediatric disease designation. And for the AD program, the regenerative medicine advanced therapy designation or RMAT and fast track designation. We believe stem cell therapy has the potential to become a mainstream treatment for many conditions with significant unmet medical needs. Speaker 300:06:58The outlook for future breakthroughs is promising and we will continue to work towards our mission and hopefully support patients battling a range of diseases and conditions. As we do, we look forward to continuing to share our research, clinical and regulatory progress. Thank you and I will turn the call back over to Wael. Speaker 200:07:20Thank you, Josh. I am heartened to see the tremendous progress achieved both by the industry and specifically by Londevarone over the past decade. For Longevarone, this has been further accelerated with our recent accomplishments. As we have mentioned throughout the year, HLHS is the key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval across our pipeline. Speaker 200:07:57Our ongoing Phase 2b study, ELPHIS2, which is evaluating Lomacil B as a potential adjunct treatment for HLHS has now achieved more than 80% enrollment and we expect to complete enrollment for the end of this year or early next year. Very importantly, we recently completed a Type C meeting with the U. S. Children and Drug Administration, in which we were able to confirm that license application or a BLA submission for full traditional approval, as well as reaching alignment on ELPHIS-two primary and secondary endpoints. This significantly accelerates the potential regulatory and if supported by clinical data from ELVIS II would allow us to initiate a rolling submission of BLA for the Food and Drug Administration in year 2026. Speaker 200:09:00In support of that opportunity, I'm delighted to welcome Devin Glass to launch of her own as a Chief Technology Officer and a Senior Vice President of CMC. He will join us on December 2 to lead the company's technology and manufacturing strategy and execution. Devin has over 15 years of distinguished experience in the development and manufacturing of advanced therapy. We look forward to working with him to advance Lomicil B across all of our indications. We also continue to advance our very important Alzheimer's disease program. Speaker 200:09:42We understand Alzheimer's disease has historically been difficult area for development. So we are only more encouraged with the results we have seen to date with Loma Tel B. Results from our CLEAR MIND Phase IIa clinical trial were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC. In the clinical trial, lomatilb treated patients showed an overall slowing or prevention of the disease worsening compared to placebo. Given the ClearMind Phase IIa clinical data, Empire Phase I of the FDA has granted LUMASIL B post regenerative medicine and therapy also known as RMAD designation and fast track designation for the treatment of mild Alzheimer disease. Speaker 200:10:41NOSL B appears to be the 1st cellular therapy candidate to receive RMAT designation for Alzheimer disease. With these data in hand, we anticipate meeting with the FDA in the Q1 of 2025 to view future clinical and regulatory strategy for continuing this important program. As we continue to for our development, optimizing our resources and being good stewards of shareholders' capital, while maintaining our investments in advancing our clinical pipeline and definitely BLA enabling activities. We have focused on expense control and program prioritization, leading to a total operating expenses through the 1st 9 months, declining 14% year over year. Our existing cash and cash equivalents are expected to be sufficient to fund the company through the Q4 of 2025. Speaker 200:11:52With that, I will turn the call to Doctor. Agathe Nova to provide updates on our clinical development program. Natalia? Speaker 400:12:02Thank you, Vael, and good afternoon, everyone. As Vael mentioned, our HLHS program is a primary focus for us with a near term pathway to potential approval and an area of clear unmet medical need. Our HLHS program begun with the LPISS-one Phase 1 clinical trial evaluating loneselfb in infants with HLHS, which produced positive encouraging results. Most recently, LPISS 2 5 year post treatment long term survival data was selected for presentation at the Congenital Heart Surgeons Society, CHSS 51st Annual Meeting. This data including the following: 5 year postglenn procedure Kaplan Meier survival was 100% in patients treated with Lorna Cell B in LPS I with non required heart transplant. Speaker 400:13:02This compared to 83% survival in the single ventricle reconstruction trial through 5 years postglance surgery and a 5.2% heart transplantation rate. No major cardiovascular adverse cardiovascular events were reported during the study. No Lonicel related safety issues also were reported. These findings support the use of Lonicel B as a potential adjunct to HLHS reconstruction surgery to improve transplant free survival. The LPIZ1 data served as the basis for LPIZ2, our ongoing Phase 2b clinical trial evaluating the potential of Lumicel B to improve right in cheek lower function and long term outcomes. Speaker 400:13:55LPISS-two is being conducted in collaboration with the National Heart, Lung and Blood Institute through grants from the National Institute of Health. This trial will enroll 38 pediatric patients and we have reached more than 80% enrollment. We have 12 leading pediatric cardiometritis institutions participated as a clinical trial site. The 3 of them have been joined in the last quarter. We could not be more pleased with the participating group and their the participating group and their enthusiasm for LPISS II and thank them for all the work they do for their patients and the patient's family. Speaker 400:14:36With this support, we are working towards completing enrollment of the trial by the end of this year, and there are patients in the queue that can make that timeline achievable. However, we obviously do not control scheduling from surgery, so we may see enrollment completion occurred in the Q1 of the next year. As Vael mentioned, we recently completed a Type C meeting with the FDA where we discussed HLHS, our development program, the data it has produced in our ongoing Phase 2 clinical trial. We reached alignment on LPISS 2 primary and secondary endpoints and very significantly we are able to confirm that LPISS 2 is pivotal and is positive acceptable for BLA submission. If results from LPISS-two are positive, we would be positioned to initiate a rolling submission with the FDA in 2026. Speaker 400:15:43Turning now to our Alzheimer disease program. Data from ClearMind Phase IIa clinical trial were selected for a future research oral presentation at the 2024 Alzheimer's Association International Conference held at the end of July. We are very excited about the trial positive results, which we have previewed previously. I would just reiterate that the trial achieved the primary safety and secondary efficacy endpoints. And also that in the clinical trial, lomicel B treated patients showed overall slowing prevention of disease worsening compared to placebo. Speaker 400:16:25Continued the positive data trend, Lonecel B data in Alzheimer disease was selected to be presented in a late break in poster presentation at the clinical trial on the ZYNER disease conference, CTAD 2024 in late October 2024. That data showed the following: Lonicell B capacity to inhibit MMNP-fourteen correlates with improved clinical and biomarker outcomes in mild Alzheimer disease. Pfizer offer potential mechanistic and clinical insights in the development of cellular based therapy for Alzheimer disease. We believe the results from ClearMind support the therapeutic potential of LomiSel B in the treatment of mild Alzheimer disease and provided evidence based support for future clinical development. Based on data generated in our Phase 1 and Phase 2 Alzheimer clinical trials in July, The FDA has granted Lonitzel B both Regeneron's Medicine Advanced Therapy, RMAT designation and Fast Track designation for the treatment of mild Alzheimer disease. Speaker 400:17:44We plan to meet with the FDA before in the end in the Q1 of the next year to review clinical trial and regulatory strategy for the Alzheimer program. I will hand the call over to Lisa O'Clair, our Chief Financial Officer, to discuss our financial results for the Q2. Lisa? Speaker 500:18:10Thank you, Natalia, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10 Q, both of which present our financial results in detail. So I will touch on some highlights. Revenues for the 9 months the 1st 9 months of 2024 were $1,800,000 up $1,100,000 or 177 percent when compared to the same period in 2023, mainly as a result of increased participant demand for our frailty and cognitive impairment registry trial in the Bahamas and new contract manufacturing revenue. Contract manufacturing revenue for the 9 months ended September 30, 2024 was $800,000 We believe the contract manufacturing business has the potential to expand our team's expertise and generate approximately $4,000,000 to $5,000,000 in annual revenues once it is up and running fully, helping offset our clinical development costs and reducing but not eliminating our additional capital need. Speaker 500:19:21This year, we have focused on prioritizing investments in our clinical programs and expense management, and we have successfully executed in both areas. Total operating expenses through the 1st 9 months of the year declined 14% year over year, with G and A expenses for the 9 month period ended September 30, 2024, decreasing to approximately $7,400,000 compared to $8,900,000 for the same period in 2023. This G and A expense decrease of approximately $1,500,000 or 16 percent is primarily due to lower personnel expenses as a result of reduced severance, legal and other administrative expenses, partially offset by higher stock compensation costs in 2024. R and D expenses for the 9 months ended September 30, 2024 also decreased approximately $800,000 or 11 percent to approximately $6,100,000 The decrease was primarily due to reduced expenses associated with the completed clear mind Alzheimer's disease clinical trial and reduced costs for the aging related frailty clinical trial following our decision to discontinue trial activities in Japan. Our net loss decreased 22% to approximately $11,900,000 for the 9 months ended September 30, 2024 from a net loss of $15,300,000 for the same period in 2023 for the reason I just explained. Speaker 500:20:59Our cash and cash equivalents as of September 30, 2024 were $22,800,000 The company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements through the Q4 of 2025 based on our current operating budget and cash flow forecast. It is important to note, however, that with our successful Type C meeting with the FDA with respect to the HLHS regulatory pathway, we have started to ramp up BLA enabling activities as we currently anticipate initiation of a rolling submission with the FDA in 2026, if the current ELPIS II trial is successful. To the extent that our operating expenses and capital expenditure requirements accelerate in calendar 2025 as a result of these activities, which includes CMC, chemistry manufacturing controls and manufacturing readiness, there will be a need to increase our current proposed spend and further increase our capital investments. We intend to seek additional financing, capital raises, non dilutive funding options to support these activities and current cash projections may be impacted by these ramped up activities as well as any financing transactions entered into. I will now hand the call back to Wael. Speaker 200:22:29Thank you, Lisa. The data generated to date in HLHS and Alzheimer disease support the broad potential for LomaSorb B as a regenerative medical therapy across multiple and significant indications. The strength of the data, our experienced and committed team and unwavering focus on patients give me confidence in the future of lamasolb and longeborone. Operator, we would like now to open the call for questions from covering analysts. Operator00:23:06Thank you. Ladies and gentlemen, we will now begin the question and answer The first question comes from the line of Raghuram Selvaraju with H. C. Wainwright. Please go ahead. Speaker 300:24:01Good afternoon. This is Dan on for Ram. Thanks for taking our questions and congratulations on your anniversary. So what would represent an appropriate benchmark from a performance standpoint in the Altice II trial that would catalyze the accelerated approval? And what's the current thinking with respect to the path forward for lung cell B and Alzheimer's disease? Speaker 300:24:23Is there a shorter term clinical design paradigm that could be applicable? For example, positioning it initially as a symptomatic rather than a disease modifying therapy? Thank you. So, Speaker 200:24:36Ram, I don't know the first part of the question. I hope I got it right, but if not, feel free to correct me as well. So regarding the plan, as you know, we met with the FDA. We confirmed a lot of the assumptions. So basically the current existing Phase 2b trial will be accepted for full approval and we also confirmed with them the GMC plan, the potency assay, the primary and secondary endpoints. Speaker 200:25:13So we have a confirmation. We have minutes from this one. We also have, as you know, fast track designation. And the fast track designation, by definition allow you to have rolling submission, which we intend to use once we finish the enrollment and get the top line results immediately. We actually started preparing from it assuming that we will have a positive data coming out of that trial. Speaker 200:25:38So I think a lot of this is not based on assumptions, but actually based on feedback with the agency and the current designation of what it allow us to do. I hope that this answer your question before I go to the Alzheimer's part? Speaker 300:25:53Yes, that was a great answer. Speaker 200:25:55All right. So regarding the Alzheimer's, so I think and Natalia and Doctor. Haire can jump in as well and weigh in on this one, but I'll give you my perspective here. We really believe that from and we actually had managed significantly most recently even at the CTAD meeting with a lot of the advisors and external thought leaders and these are the top Alzheimer's thought leaders around the world. And I think the unanimous feedback is you guys need to continue the development. Speaker 200:26:39There might be something very helpful for the patients here. Of course, we don't have the data to get approval today. However, as you know, there is over 140 programs is being developed right now in Alzheimer disease. Many of these programs are developed by small companies of our size. So we're really and we're all realized how big is the investment needed to advance this program and definitely partnership or a significant whether this is with a company or government entity or whatever would be very helpful. Speaker 200:27:14The question is, why these companies or these government entities really invest in your program and not any of the other 140 programs that are being developed. We're going to have to provide something very useful. So therefore, we really have been working on a proposed accelerated and streamlined the FDA at the beginning of next year. I'm not saying that this is the FDA, but if approved by the FDA or endorsed by the FDA, that will allow us to come to the market faster and more economical, which we believe will present a very good opportunity for us to be able to compete on these additional funds, whether public funds or partnership with companies and separate ourselves from other companies that operate in space. That is our strategy. Speaker 200:28:15That is our plan. And you're going to ask why do we do that? The simple answer is part of the RMAT designation, it's actually allow you if you read the RMAT guidelines, it actually allow you to have a streamlined path to approval. We just want to make sure that the FDA for this. And I want to also tell you one additional thing is that path that we are proposing, we have actually had the opportunity to spend time with some of the top advisors and Natalia have done this at the CTAD, where she really got their thoughts and we got very, very good positive feedback from our advisors about our proposed plan as well. Speaker 200:28:58Ataya and Josh, do you want to add anything for Ram's question? Speaker 400:29:02Sure, Raul. Guram, thank you for your question. I think you mentioned also the symptomatic DMT. I would like just to mention that CLEAR MIND study, which is proof of concept and Phase 1 study, which was placebo controlled, both were conducted on mild Alzheimer disease patient population. It is considered early, it's symptomatic and the advice we got recently on C TAD that we should continue our development as disease modifying treatment remaining in a mild Alzheimer disease patient population because there is a clear good signal on our prior development. Speaker 400:29:50So and this is where the plan to continue apply LomiSelb for this patient population. I hope we addressed your question, Graham. Speaker 200:30:03Yes. Thank you so much. Operator00:30:07Thank you. The next question comes from the line of Pupalan Pachupant with ROTH Capital Partners. Please go ahead. Speaker 600:30:17Good afternoon, team. Can you hear me okay? Speaker 200:30:21Yes. Speaker 400:30:21Yes. Operator00:30:22Yes, please go ahead. Speaker 600:30:24All right, great. So we have some questions and thanks so much for taking our questions. So firstly, with respect to LPISS-one trial long term follow-up, I see that you have 100% survival, which is really fantastic. So I was wondering whether you are able to measure additional cardiac parameters such as RVEF or tricuspid regurgitation at the end of 5 years that would have given you any indication that the ongoing LPs II trial might read out positive similar to LPs I? Or is this merely a 5 year safety follow-up? Speaker 400:31:00Wael, do you want me to take this one? Speaker 200:31:03Yes. Natalia or Josh can take that question. Okay. Speaker 400:31:08Thank you, Pupalan, for your question. It's a very important one and that we're basically aligned with our thinking. So initially LPS I protocol is Phase I was open label trial. And initially, we set up the trial that we are collecting only pass we call it passive follow-up. Basically, after completion of 1 year post Glenn procedure surgery, size call the patients with 2 questions, is the patient alive, yes or no and if patient had transplant heart transplant. Speaker 400:31:47However, you're absolutely right. If we have and beyond that, we have no additional data at this time. However, we do understand if we reach data by collecting more granular data on ejection fraction, on g auscultic regurgitation, basically on all ultrasound or MRI data exists that will help us to navigate BLA submission. It will help us to answer your question to answer your question, currently, we have only survival and transplant free survival data. However, we are entertaining this idea to gather more information on these patients retrospectively. Speaker 600:32:50So if you wanted to get that data in a retrospective manner, do you have to go back to agency and do some sort of trial protocol revision? Or do you need to get some additional approval from the participating clinical trials? Because I really feel because these patients were alive after 5 years, which is it's a new high watermark in HLHS, at least in my view. So I was curious whether additional parameters would make your case more convincing, not that it is less convincing now, but it would make it more convincing. Speaker 400:33:25Absolutely. And we don't have to go back to agency. We just need to revise our contracts with our sites. And this is actually ongoing efforts right now, but we don't have to go back to agency. And we are currently collaborating with one particular investigator who is very enthusiastic in this indication, who provides his guidance, cardiology guidance, what data we should collect in order to enrich our LPS II trial and get the package more complete. Speaker 400:34:03So, but yes, we don't have to go back to agency for that. Speaker 600:34:09Okay. That's very helpful. Go ahead, Vyral. Of course. Speaker 200:34:15Yes. Just for historical, I know we haven't talked about the L plus 1 for a long time. The good thing about L plus 1, it was conducted only on 3 sites. One of them almost half of the patients. So I don't think it is a major undertaking to work with the sites. Speaker 200:34:31It's not as big as the number of sites in the LPS II. So we're hopeful that we are able to be able to collect this data as Natayev said. Speaker 600:34:41Fantastic. All right. And then focusing your attention on LPS II, which is your pivotal trial. So speaking about the endpoint, which is RVEF, the right ventricular ejection fraction, Can you maybe provide some context in terms of the efficacy benchmark that will make you feel more comfortable given this is a pivotal trial? I understand no such benchmark exists to date and probably you will be a pioneer in this field. Speaker 600:35:11But nevertheless, based on your discussions with the agency and the feedback that you got and all of that, can you maybe provide some color? At least can you maybe tell us what's your current thinking? What would be the expected of the EF of HLHS patients at this juncture with Lomicil B and then what could be without the drug? Speaker 400:35:34Yes. Wael, do you want me to take this one? Speaker 200:35:39Yes, Natalya, Speaker 300:35:40you go ahead, Natalya. Speaker 200:35:42Yes. And Josh, Speaker 600:35:43I think Speaker 400:35:43it's Thanks, Pavalan. Yes, thanks, Pavalan. And Josh, please chime in if I may Speaker 200:35:48say anything. Yes, I'll Speaker 300:35:48add that. Speaker 400:35:51So, great question. And again, you're speaking as we thought. So, we did have a very meaningful conversation with FDA and they agree in principle that right ventricular ejection fraction would not be sufficient for 1 year after the Glenn procedure evaluation of the clinical response. So we are adding clinical points as well to the composite endpoint. And we're still flushing out the final simulations and final exercise to present to agency. Speaker 400:36:29But in principle, they did agree in addition of right ventricular ejection fraction, they will be clinical outcome measures as a primary endpoint. And Josh, if you want to speak about specifically right ventricular ejection fraction, I appreciate. Speaker 200:36:47Yes. Speaker 300:36:50The right ventricular ejection fraction is well established surrogate for outcome in HLHS patients. And really the important difference here will be between treated and the standard of care patients. I think if the number is higher, statistically significantly higher in the treated patients than in the standard of care, that would be considered a significant finding. But I do want to reiterate what Natalia has said that which is very important is that the agency was very supportive of the idea that we combine right ventricular ejection fraction with clinical endpoints as well, such as the survival. So I think that the survival difference that we see in the ALPUS-one is highly encouraging for what the ultimate finding will be in ALPUS-two. Speaker 600:38:00Okay, great. And then maybe one more question, if I may. So I just want to give you a high level thoughts whether you think the HLHS competitive landscape has meaningfully changed in the recent past. I was doing some quick search in clinical trials website. There's a product called Ventri Gel. Speaker 600:38:20I'm sure you might have heard of it, Josh. So I'm curious, do you think Ventri Gel could be at some point be competing with low Missal B? What are your preliminary thoughts? Speaker 200:38:34If Speaker 300:38:36I'm correct about VentriGel, it's basically an inert substance. It's a substance that you really what it does is it prevents remodeling. It prevents the heart from enlarging. I'm not sure if they even have Phase 1 data yet for the ventrogel. I am aware that a trial is being planned. Speaker 300:38:59I think the major difference between the ventrogel strategy and our strategy is that again the ventrogel isn't just an inert substance that affects the structural components of the ventricle, whereas Loma Cell B has a multifactorial action, which includes anti inflammatory, pro vascular, anti fibrotic and potentially pro regenerative effects, stimulating endogenous myocyte replication. So I think that the mechanism of action of the two strategies is very, very different. So I don't believe it would be a strong competitor. But of course, as you enter into these kind of novel strategies, you always have to be guided by the data. So we will see what the data shows. Speaker 300:39:53And we are obviously very excited about our data, particularly the new survival data from L plus-one. Speaker 600:40:02All right. That's it from us. Thanks so much once more for taking our questions. Speaker 200:40:08Thank you, Bill. Operator00:40:10Thank you. As there are no further questions, I would now like to hand the conference over to Wael Harshad for closing comments. Speaker 200:40:20Thank you, Mikhail. Thanks to all who attended our call today. We greatly appreciate your interest and support. And we look forward to updating you on our progress as we continue. Thank you, operator, and you may end the call right now. Operator00:40:40Thank you. This concludes today's teleconference. 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