Q3 2024 Longeveron Inc Earnings Call
Speaker Change: Ladies and gentlemen, greetings and welcome to the Longeviron 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. If anyone should require operator assistance during the conference, please press star and zero on a telephone keypad.
Please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead.
Derek Cole: Thank you, Zico. Good afternoon, everyone, and thank you for joining us today to review Longeveron's third quarter 2024 financial results and business update.
Derek Cole: After the U.S. markets closed today, we issued a press release with financial results for the third quarter, which can be found under the Investors section of the Longevron website.
Derek Cole: On the call with me today are Wael Hashad, Chief Executive Officer, Nataliya Agafonova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Joshua Hare, Co-Founder, Chief Science Officer, and Chairman of the Board.
Derek Cole: As a reminder, during this call, we will be making forward-looking statements.
Derek Cole: These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements.
Derek Cole: Any such statement 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.
Speaker Change: Following the company's prepared remarks, we will open the questions from our analysts. With that, let me hand the call over to Wael Hashad, Chief Executive Officer. Wael?
Wael Hashad: Thank you, Derek. Good afternoon, everyone. And thank you very much for joining us today.
Wael Hashad: 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.
Wael Hashad: Today, we also want to talk a little bit about the long-term strategy.
Wael Hashad: As a reminder for those of you newer to our story, Bloom Chaperone is a regenerative medicine company developing cutting-edge cellular therapies.
Wael Hashad: Our development compound, Lomacell-B, represents a pipeline and a product opportunity that is being evaluated across three important treatment areas.
Wael Hashad: addressing numerous unmet medical needs with the U.S. market potential opportunity of approximately 10 to 18 billion dollars.
Speaker Change: Before we get into our recent progress, I would like to ask Dr. Joshua Hare, our co-founder and chief science officer, to discuss an important milestone for large-scale development.
Josh.
Thank you. Thank you.
Thank you. Thank you.
Speaker Change: Thank you, Al, and good afternoon, everyone. As Al mentioned, we have just reached an important milestone for the company and our stem cell therapy research.
Speaker Change: This month marks the 10th anniversary of the founding of Longevron.
Speaker Change: 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.
Speaker Change: As you'll hear from the team, we are making great progress advancing cellular therapy research and our product candidate, Lomacel B.
Speaker Change: Over the past decade, stem cell therapy has seen remarkable strides.
Speaker Change: transforming from a promising field into one delivering tangible clinical outcomes.
Speaker Change: 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 Change: At the core of this progress is the increased understanding of different types of stem cells.
Speaker Change: including medicinal signaling cells, or MSCs, like our development candidate, Lomacell B.
Speaker Change: embryonic stem cells, ESCs, adult stem cells, and induced pluripotent stem cells.
Speaker Change: Key breakthroughs including the use of stem cells to treat degenerative diseases such as Parkinson's, diabetes, Alzheimer's disease, and heart disease.
Speaker Change: In 2020, the FDA approved the first stem cell-based treatment for spinal cord injuries, marking a significant milestone for the area of development.
Speaker Change: In regenerative medicine, stem cells have been used to create lab-grown tissues and mini-organs, which we call organoids.
These opened the door to personalized medicine and organ repair.
Speaker Change: Stem cell therapy has made significant advances in the development of new techniques, clinical applications, and regulatory frameworks.
Speaker Change: While challenges remain, we have seen enhanced safety and precision of stem cell therapies.
Speaker Change: Governments and regulatory bodies like the FDA have begun to adapt more quickly to emerging stem cell technologies.
Speaker Change: More treatments are entering phase two and three clinical trials, with some therapies receiving breakthrough, fast-track, or regenerative medicine advanced therapy, ARMET, designations for serious conditions.
Speaker Change: The stem cell market has expanded globally with collaborations between academia, biotech firms, and government-funded research programs.
Speaker Change: Longevron has been at the forefront of this evolution in medicine.
Speaker Change: 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.
Speaker Change: delivered positive initial results across five clinical trials in three indications.
Speaker Change: These include Phase I and II trials in Alzheimer's disease, Phase I and II trials in aging-related frailty, and a Phase I in hypoplastic left heart syndrome, or HLHS.
Speaker Change: which is also currently being evaluated in a pivotal phase 2 clinical trial for HLHS.
Speaker Change: Lomasel B development programs have received five distinct and important U.S. FDA designations.
Speaker Change: For the HLHS program, we received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. And for the AD program,
Speaker Change: The Regenerative Medicine Advanced Therapy Designation, or RMAT, and Fast-Track Designation.
Speaker Change: We believe stem cell therapy is the potential to become a mainstream treatment for many conditions with significant unmet medical needs.
Speaker Change: The 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.
Speaker Change: As we do, we look forward to continuing to share our research, clinical, and regulatory progress.
Speaker Change: Thank you and I will turn the call back over to YL.
Thank you, Josh.
I am heartened to see the tremendous progress.
Speaker Change: achieved both by the industry and specifically by Longeverone over the past decade.
Speaker Change: With Algebra On, this has been further accelerated with our recent accomplishments.
Speaker Change: And we have mentioned throughout the year, HLHS is the key strategic priority for us.
Speaker Change: We believe the Edge LHS program has high probability of success.
and Ashutosh Bas for potential regulatory approval across our pipeline.
Speaker Change: which is evaluating Lomato-B as a potential adjunct treatment for HLHS has now achieved more than 80% enrollment and we expect to complete enrollment toward the end of this year or early next year.
Speaker Change: Very importantly, we recently completed a Type C meeting with the U.S. Food and Drug Administration in which we were able to confirm that Alpha-2 is a pivotal and a positive acceptable for biological license application or a BLA submission for full traditional approval.
Speaker Change: as well as reaching alignment on LPS2 primary and secondary endpoints.
This significantly accelerates the potential regulatory
Speaker Change: In support of that opportunity, I'm delighted to welcome Devin Blass to Longeverone as a Chief Technology Officer and a Senior Vice President of CMC.
Speaker Change: He will join us on December 2nd to lead the company's technology and manufacturing strategy and execution.
Speaker Change: Devin has over 15 years of distinguished experience in the development and manufacturing of advanced therapies.
Speaker Change: We look forward to working with him to advance LAMICL-B across all of our indications.
Speaker Change: We also continue to advance our very important Alzheimer's disease program. We understand Alzheimer's disease has been a difficult area for development.
Speaker Change: So we are only more empowered with the results we have seen to date with Llamasel-B.
Speaker Change: Results from our ClearMind Phase 2A clinical trial were presented in a featured research overall presentation at the 2024 Alzheimer Association International Conference, AAIC.
Speaker Change: In the clinical trial, vomito B treated patients showed an overall slowing or prevention of the disease worsening compared to placebo.
Speaker Change: This month, a clear mind is to a clinical data and prior phase one, the FDA has granted Lomis-O-Vee.
Speaker Change: Most Regenerative Medicine and Therapy, also known as RMAD designation, and Fast-Track designation for the treatment of mild Alzheimer's disease.
Speaker Change: NOSLB appears to be the first cellular therapy candidate to receive RMAT designation for Alzheimer's disease.
Speaker Change: With these data in hand, we anticipate meeting with the FDA in the first quarter of 2025 to view future clinical and regulatory strategies for continuing this important program.
Speaker Change: As we continue today's conversation, I would like to thank you for joining us for our discussion.
Speaker Change: We focus on optimizing our resources and being good stewards of shareholder's capital.
Thank you.
Speaker Change: while maintaining our investments in advancing our clinical pipeline and definitely BLA-enabling activities.
Speaker Change: We have focused on expense control and program prioritization, leading to a total operating expenses through the first nine months declining 14% year over year.
Speaker Change: Our existing cash and cash equivalents are expected to be sufficient to fund the company through the fourth quarter of 2025.
Speaker Change: With that, I will turn the call to Dr. Agafonova to provide updates on our clinical development program.
Thank you.
Thank you, Vailen. Good afternoon, everyone.
Speaker Change: 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.
Speaker Change: Our HLHS program began with the LPS-1 Phase 1 clinical trial, evaluating low-SLB in infants with HLHS, which produced positive encouraging results.
Speaker Change: Most recently, LPS-2 five-year post-treatment long-term survival data was selected for presentation at the Congenital Heart Surgeons Society, CHSS, 51st annual meeting.
This data includes the following.
Speaker Change: Five-year post-gland procedure Kaplan-Mayer survival was 100% in patients treated with Lomis-LB in LPS1 with non-required heart transplant.
Speaker Change: This compared to 83% survival in the single ventricle reconstruction trial through 5 years port gland surgery and a 5.2% heart transplantation rate.
Speaker Change: No major adverse cardiovascular events were reported during the study. No long-cell-related safety issues also were reported.
Speaker Change: The findings support the use of lomicel B as a potential adjunct to HLHS reconstruction surgery to improve transplant-free survival.
Speaker Change: The LPS-1 data serves as the basis for LPS-2, our ongoing Phase 2b clinical trial evaluating the potential of Lomacell-B to improve right ventricular function and long-term outcomes.
Speaker Change: LTIS-2 is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institute of Health.
Speaker Change: This trial will enroll 38 pediatric patients, and we have reached more than 80% enrollment.
Speaker Change: We have 12 leading pediatric cardiothoracic institutions participating as clinical trial sites, with three of them having joined in the last quarter.
Speaker Change: We could not be more pleased with the participating group and their enthusiasm for LTIF2 and thank them for all the work they do for their patients and the patient's family.
Speaker Change: With their support, we are working towards completing enrollment of the trial by the end of this year.
Speaker Change: And there are patients in the queue that can make that timeline achievable. However, we obviously do not control scheduling for surgery, so we may see enrollment completion occurred in the first quarter of the next year.
Speaker Change: 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, and our ongoing phase 2 clinical trial.
Speaker Change: We reached alignment on LPS-II primary and secondary endpoints and, very significantly, we are able to confirm that LPS-II is pivotal.
And if positive, acceptable for BLA submission.
Speaker Change: If results from LPS-2 are positive, we would be positioned to initiate a rolling submission with the FDA in 2026.
Turning now to our Alzheimer's disease program.
Speaker Change: Data from CLEARMIND Phase 2a clinical trial will be selected for a future research oral presentation at the 2024 Alzheimer's Association International Conference, held at the end of July.
Speaker Change: We are very excited about the trial-positive results, which we have previewed previously.
Speaker Change: I would just reiterate that the trial achieved the primary safety and secondary efficacy endpoints, and also that in the clinical trial, long-excel B-treated patients show an overall slowing prevention of disease worsening compared to placebo.
Speaker Change: was selected to be presented in a late breaking poster presentation at the clinical trial on Alzheimer's disease conference.
CSTART 2024 in late October 2024.
Speaker Change: That data showed the following, Lomicell-B capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild Alzheimer's disease.
Speaker Change: FINDIAN offers potential mechanistic and clinical insights in the development of cellular-based therapy for Alzheimer's disease.
Speaker Change: We believe the results from ClearMind support the therapeutic potential of long SLD in the treatment of mild Alzheimer's disease and provide evidence-based support for future clinical development.
Speaker Change: Based on data generated in our Phase 1 and Phase 2 Alzheimer's clinical trials in July, the FDA has granted Lomid Cell B both Regenerative Medicine Advanced Therapy, RMAT designation, and FAST drug designation for the treatment of mild Alzheimer's disease.
Speaker Change: We plan to meet with the FDA before in the first quarter of the next year to review clinical trial and regulatory strategy for the Alzheimer's program.
Speaker Change: I will hand the call over to Lisa Locklear, our Chief Financial Officer, to discuss our financial results for the second quarter. Lisa?
Lisa Locklear: Thank you Natalya and good afternoon everyone. This afternoon we issued a press release and filed our quarterly report on Form 10-2, both of which present our financial results in detail, so I will touch on some highlights.
Lisa Locklear: Revenues for the first nine months of 2024 were $1.8 million.
Lisa Locklear: up $1.1 million or 177% 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.
Lisa Locklear: Contract manufacturing revenue for the nine months ended September 30, 2024 was $0.8 million.
Lisa Locklear: We believe the contract manufacturing business has the potential to expand our team's expertise
Lisa Locklear: and generate approximately $4 to $5 million 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.
Lisa Locklear: This year we have focused on prioritizing investments in our clinical programs and expense management, and we have successfully executed in both areas.
Lisa Locklear: Total operating expenses through the first nine months of the year declined 14% year-over-year. With G&A, expenses for the nine-month period ended September 30, 2024, decreasing to approximately $7.4 million.
compared to $8.9 million for the same period in 2023.
Lisa Locklear: This GNA expense decrease of approximately $1.5 million, or 16%, was 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.
Lisa Locklear: R&D expenses for the nine months ended September 30, 2024 also decreased approximately $0.8 million or 11% to approximately $6.1 million.
Lisa Locklear: 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.
Lisa Locklear: Our net loss decreased 22% to approximately $11.9 million for the nine months ended September 30, 2020-2024, from a net loss of $15.3 million for the same period in 2023, for the reason I just explained.
Lisa Locklear: Our cash-in-cash equivalents as of September 30, 2024 were $22.8 million.
Lisa Locklear: The company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements through the fourth quarter of 2025, based on our current operating budget and cash flow forecast.
Lisa Locklear: It is important to note, however, that with our successful Type C meeting with the FDA,
Lisa Locklear: 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.
Lisa Locklear: To the extent that our operating expenses and capital expenditure requirements accelerate in calendar 2025, as a result of these activities,
Lisa Locklear: which includes CMC, Chemistry, Manufacturing and Controls, and Manufacturing Readiness, there will be a need to increase our current proposed spend and further increase our capital investments.
Lisa Locklear: 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 Wayo.
Thank you, Lisa.
Wayo: The data generated to date in HLHS and Alzheimer's disease supports a broad potential for Loma Sabi as a regenerative medical therapy across multiple and significant indications.
Wayo: In terms of the data, our experienced and committed team, and unwavering focus on patients.
Wayo: Give me the confidence in the future of Llamas Lobby and Longevero.
Speaker Change: Operator, we would like now to open the call for questions from covering analysts.
Thank you.
Thank you.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on a telephone keypad. A confirmation tone will indicate your line is in the question queue.
Speaker Change: You may press star and 2 if you would like to remove your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: Ladies and gentlemen, we will wait for a moment while we poll for questions.
Speaker Change: The first question comes from the line of Raghuram Selvaraju with HC Wainwright. Please go ahead.
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Speaker Change: Good afternoon. This is Dan Ansbouron. Thanks for taking our questions and congratulations on your anniversary.
Speaker Change: So, what would represent an appropriate benchmark from a performance standpoint in the ELPIS-2 trial that would catalyze the accelerated approval? And what's the current thinking with respect to the path forward for Lone Cell B and Alzheimer's disease? Is 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.
Speaker Change: So, Ram, 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.
Speaker Change: So, basically, the current existing Phase 2b trial will be accepted for full approval and we also confirmed with them.
Speaker Change: the GMC plan, the potency assay, the primary and secondary endpoints. So we have a confirmation, we have minutes.
Speaker Change: 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
Speaker Change: that we will have a positive data coming out of that trial. So I think a lot of this is not based on assumption, but actually based on feedback with the agency and the current designation and what it allows us to do. I hope that this answers your question before I go to the Alzheimer part.
Yes, that was a great answer.
Speaker Change: So regarding the Alzheimer's, so I think, and Natalia and Dr. Hare can jump in as well and weigh in on this one, but I'll give you my perspective here. We really believe that
from Charlie Sunway that went very quickly to get it.
and Mark. Thank you.
Speaker Change: And we actually met most recently, even at the CTAD meeting, with a lot of the advisors and external thought leaders. And these are the top.
Speaker Change: Alzheimer's leaders around the world. And I think it's a unanimous feedback. If you guys need to continue the development, there might be something very helpful for the patients here. Of course, we don't have the data to get approval today. However,
Speaker Change: As you know, there are over 140 programs being developed right now on Alzheimer's disease.
Speaker Change: Many of these programs are developed by small companies of our size.
Speaker Change: So we really, and we all realize how big is the investment needed.
Speaker Change: 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. The question is, why these companies or these government entities?
Speaker Change: really invest in your program and not any of the other 140 programs that are being developed. You're going to have to provide something very useful.
Speaker Change: Therefore, we really have been working on a proposed, accelerated, and a streamlined approach.
Speaker Change: I'm Dr. Steven Wilson on behalf of USDA Anniversary Innovation Team.
Thank you.
Speaker Change: 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.
from other companies that are operating.
Thank you.
Thank you for joining today's event.
Speaker Change: that is our plan. And you're gonna 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 wanna make sure that the FDA is doing this. And I wanna also tell you one additional thing is,
That path that we are proposing
Speaker Change: We have actually had the opportunity to spend time with some of the top advisors. Nataliya 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 Change: Nataliya and Josh, do you want to add anything for Ram's question?
Speaker Change: The advice, we got recently when she thought that we should continue our development is disease modifying treatment.
Speaker Change: Mainly in that mild Alzheimer's disease patient population because there is a clear good signal on our prior development. So and this is where a good plan.
Speaker Change: To continue Oh.
Speaker Change: Fly Lagerfeld before this patient population.
I hope we addressed your question Graham.
Speaker Change: Yes. Thank you so much.
Speaker Change: Mhm.
Speaker Change: Thank you.
Speaker Change: The next question comes from the line of.
Speaker Change: Well, Brandon, but she happened with Roth capital Partners. Please go ahead.
Good afternoon, Tim can you hear me okay.
Speaker Change: Yeah, Yeah, Yes. Please go ahead.
Speaker Change: Alright, great. So.
Have some questions and thanks, so much for taking our questions. So firstly with respect to Altice, one trial long term follow up I see that you're 100% survival, which is really fantastic.
Speaker Change: So I was wondering whether you were able to measure additional cardiac parameters such as our V. F. R. Tricuspid regurgitation at the end of five years that would have given you any indication that the lp's ongoing phase two trial, Mike read out positive similar to phase one or is this merely a.
Speaker Change: Fire safety fall off.
Well, you'll do you want me to take a disciplined yeah and Italia or Josh can take that question and then I'm okay.
Speaker Change: Thank you for balance for your question, it's a very important one.
Speaker Change: Basically aligned with our thinking so initially a L. P. S. One protocol as phase one open label trial.
Speaker Change: And and you shouldn't be the set up the trial to be a collection only partially be call. It starts to fall off basically after completion of one year fourth Glenn procedure.
Speaker Change: <unk>.
Speaker Change: The sites called the patients with two questions is the patient alive, yes, or no and if patient had transplant heart.
Speaker Change: A heart transplant.
Speaker Change: However, you are absolutely right I E. If we fast and a bit beyond that he had no additional we have no additional data at this time. However, we do understand it's been reach beat that by collecting more.
Speaker Change: Granular data on ejection traction on GE of course between the patient basically on all which was found the MRI data that will help us to navigate BLA submission that will help us actually so we are entertaining and right now this idea to Richard.
Speaker Change: Effectively a go back and God. There is these data may support of our investigators for Lps wanting this to get there. So to answer. Your question. Currently we have only about survival and transplant free survival data. However, we are interacting and this idea to gather more information on.
These patients are just spectacular.
So if you wanted to get the data I noticed but introspect demand or do you have to go back to agency and do some sort of trial protocol the tradition or do you need to get some additional approvals.
Speaker Change: Approval from the participating clinical trial, because I really feel because these patients are alive after five years, which is.
Speaker Change: It's a new high watermark in <unk> at least in my view. So I was just curious you know whether additional parameters would make your case more convincing.
But it is less convincing hold but it would make it more convincing.
Speaker Change: Absolutely and.
Speaker Change: We don't have to go back to urgency they just need to revise how contract.
Speaker Change: With all the sites and Oh. This is actually ongoing efforts right now, but we don't have to go back to at Juicy.
Speaker Change: And we are currently co collaborations one one particular investigator who was very enthusiastic in this indication who provide keeps.
Speaker Change: Guidance cardiology guidance, what they thought they should collect in order to enrich our lp's two trial and get the package more complete so but yeah. We don't have to go back to agency for that.
Speaker Change: Okay, that's very helpful.
Speaker Change: Or go ahead go ahead by.
Speaker Change: Just for historical I know, we haven't talked about to help us one for a long time that the good thing about it up is one that was conducted only on three sites.
Speaker Change: One of them almost half.
Speaker Change: Half of the patients so I don't think it is.
Speaker Change: Taking workload decides it's not as big as the number of sites and the Apis do so we're hopeful that we are able to to be able to collect this data is not that you're upset.
Speaker Change: Fantastic Alright.
Speaker Change: And then.
Speaker Change: Focusing our attention or LP stool, which is your pivotal trial or not so speaking about the endpoint, which is R. V E F. The right ventricular ejection fraction can you maybe provide some context in terms of the efficacy benchmark that would make you feel more comfortable given this is a pivotal trials I understand no.
Speaker Change: Such a benchmark exist to date and probably you'll be a pioneer in this field, but nevertheless, based on your discussions with the agency and the feedback that you got all of that you know can you maybe provide some color at least can you.
Speaker Change: Maybe tell us what's your current thinking what would be the expected all the E S.
Speaker Change: At your largest stations or.
Speaker Change: At this juncture the lummus there'll be and then what could be without the drug.
Speaker Change: Yep.
Speaker Change: They want me to take this one.
Speaker Change: Yeah.
Speaker Change: Go ahead Ms O'neill.
Speaker Change: Yeah, and Jonathan Thanks, Paul Yeah. Thanks for the London, Josh Please chime in if you all are.
Andrew.
Speaker Change: Uh-huh. So great question and again are you speaking just got so.
Speaker Change: These have a very meaningful conversation gets M D and they agreed in principle. They tried to ensure equal ejection fraction would not be sufficient for one here after the Glen procedure evaluation of the clinical response, so we our avion our cleanup call.
Speaker Change: <unk> says well.
Speaker Change: The composite endpoint and the skills washing out there finally simulation and final exercise to present, so ajay but in principle. They did agree in addition of priced vehicle ejection fraction, they they'll be clinical outcome measures as a primary endpoint.
Speaker Change: And Josh if you wanted to speak about specifically ripened decicco.
Speaker Change: Injection traction I appreciate it.
Speaker Change: Yes.
Speaker Change: The right ventricular ejection fraction is is well established a well established surrogate for outcome and HL Hs patients.
Speaker Change: And really the the important difference here will be between.
Speaker Change: Treated in the standard of care patients I think if the.
Speaker Change: If the number is as 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.
Speaker Change: Is that the agency was very supportive of the idea that we combine.