This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk02: Hello everyone and welcome to the Longevity Run in 2022 first quarter earnings call. My name is Juan and I will be coordinating your call today. All participants have been placed on mute to prevent any background noise. There will be a question and answer session at the end of the presentation. If you would like to ask a question at that time, please press star followed by number one on your telephone keypad. I would now like to turn the call over to Elsie Zhao from Stern Investor Relations. Please, Elsie, you may proceed.
spk00: Thank you, Operator. Good morning, everyone, and welcome to Longevira's first quarter 2022 call. Today, we'll provide a business update and discuss financial results for the first quarter of 2022. Earlier this morning, we issued a press release with these results, which can be found under the Investors section of our website at www.longevira.com. I'm joined in the call today by the following members of Longeviron's management team, Jeff Green, Chief Executive Officer, Dr. Joshua M. Hare, Co-Founder, Chief Science Officer and Chairman, Dr. Chris Min, Chief Medical Officer, and James Covijo, Chief Financial Officer. Mr. Green will begin with a brief corporate overview, followed by Dr. Min, who will provide updates to our clinical pipeline, And finally, Mr. Colvijo will review our 2022 first quarter financial results. We will then open the call for Q&A. As a reminder during this call, we will be making forward-looking statements which are subject to various risks and uncertainties that could cause our 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 factor discussions in our filings of the FTC including our annual report on Form 10-K and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now, I'd like to turn the call over to Jeff Green, Chief Executive Officer of Longeviron. Jeff?
spk05: Thank you, Elsie. Good morning, everyone. It's my pleasure to welcome you to Longeviron's first quarter 2022 business update and financial results call. Longevron is a leading clinical stage biotechnology company developing living cell therapies for chronic aging-related diseases and other specific life-threatening conditions. We are driven by our mission to develop safe and effective cell-based therapies for some of the most challenging disorders associated with the aging process and other medical disorders. In the first quarter of 2022, we continue to make progress advancing our lead investigational cell therapy product, LomaCellB, through clinical development for multiple indications. with ongoing trials in Alzheimer's disease, hypoplastic left heart syndrome, or HLHS, and acute respiratory distress syndrome, or ARDS. As a reminder, our lead investigational product called LomaCellB is a living cell product made from the specialized cells isolated from the bone marrow of young, healthy adult donors aged 18 to 45. These specialized multipotent cells, known in the literature as medicinal signaling cells, or MSCs, reside in different concentrations within various tissues in our bodies and are our endogenous or built-in repair mechanism. MSCs are known to perform a number of complex functions, including the ability to form new tissue and home to sites of injury or disease, and to create bioactive factors that are immunomodulatory and regenerative. We believe that Loma cell B may have multimodal mechanisms of action that leads to anti-inflammatory, provascular, or improved vascular and endothelial function, and regenerative and repair responses. Through clinical testing, we hope to show that Lomacil-B could be a potential clinical therapy for a range of aging-related and rare diseases. Now, before turning the call over to Dr. Min, I'd like to take a moment to address the announcement we made on Monday, May 9th regarding the CEO transition to occur on June 1st. After more than six years with Longeviron at a variety of leadership positions that included senior vice president, president and chief executive officer, I made the decision to step down as CEO in order to pursue new opportunities. My time with Longevron has been a very rewarding experience, participating in fantastic growth and progress, an initial public offering, raising nearly $50 million in 2021, and expanding Longevron's executive management team. At the request of our board of directors, Dr. Chris Min, current chief medical officer, has agreed to serve as interim CEO while the company engages in a nationwide search for a permanent CEO. I have full confidence in Dr. Min and know this will be a smooth transition. I'll miss all my fantastic colleagues at Longevron. It has been an eventful and rewarding journey for me, but it is time to let someone else take the helm. The company has dedicated and hardworking employees, a seasoned executive leadership team, a strong board, an exciting lead therapeutic in LomasLB, promising preliminary clinical data, and a healthy balance sheet, and I look forward to following the company's path and progress closely. Now, for specific updates regarding our clinical programs, I turn it over to Dr. Chris Min, Chief Medical Officer and future interim CEO. Chris? Thank you, Jeff.
spk06: I wish a sincerely thank you for the dedication, hard work, and leadership you have provided, and I speak for the entire company and board of directors when I say we wish you the best of luck in your future endeavors. As for our program updates, I'll begin with an overview of our work in Alzheimer's disease. Neuronal cell death caused by early and substantial neuroinflammation is a significant contributor to the pathogenesis of Alzheimer's disease. We are continuing to evaluate whether loma cell B infusions may prevent, slow, or even reverse the clinical progression of Alzheimer's disease by reducing disease-related brain inflammation, improving the function of blood vessels in the brain and body, and thereby potentially decreasing or slowing disease-related brain damage. Our hypothesis is supported by published preclinical studies showing that in animal models of Alzheimer's, MSCs can cross the blood-brain barrier, potentially with an anti-inflammatory effect, improving endothelial function, and promoting neurogenesis, or the process of new neuron formation in the brain. Both the previous Phase I and the current Phase IIa study explore specific biomarkers related to inflammation, as well as endothelial and vascular function. Last year, we announced positive data from our Phase I study of LOMO cell B, demonstrating the preliminary safety of LOMO cell B in patients with mild to moderate Alzheimer's disease. While one should exercise caution interpreting results from a small, underprivileged study such as this, The data did show a slower decline in mini mental state exam score, a tool used to assess cognitive function in patients who received a low dose of lumbosol B compared to placebo, in addition to an improvement trend in quality of life measures. This quarter, we are pleased to announce the publication of the full phase one results in the Alzheimer's and Dementia, the Journal of the Alzheimer's Association. Building on the Phase I data, in January of this year, we initiated a 48-patient, four-arm, parallel-designed, randomized Phase IIa clinical trial of LomaCellB infusion in patients with mild Alzheimer's disease. The primary endpoint of this Phase IIa study is the safety of both single and multiple infusions of LomaCellB at two different dose levels. We also plan to evaluate secondary and exploratory endpoints, which include cognitive function, activities of daily living, specific biomarkers relevant to inflammation in endothelial and vascular systems, as well as brain volume. We have already enrolled several patients in the trial, and there are 10 of the 12 planned clinical sites open for enrollment, including the Miami VA. And we anticipate providing updates on enrollment rates and will provide trial completion guidance at a later date. Next, I'd like to move to our hypoplastic left heart syndrome or HLHS clinical program. As a reminder, HLHS is a rare congenital heart defect that affects approximately 1,000 infants per year in the United States. People born with HLHS have an underdeveloped or absent left ventricle impairing the heart's ability to pump blood. The current standard of care for HLHS typically consists of three reconstructive operations before the age of five. However, over the long term, patients remain at continued risk of death from heart failure and or require a heart transplant. When used in combination with surgical intervention, we and our partners are exploring the potential for LomasLB to improve cardiac function in patients with HLHS. We believe LomasLB may have pro-regenerative, pro-vascular, and anti-inflammatory properties that have the potential to contribute to improved cardiac performance. Our uncontrolled open label, meaning it wasn't blinded, ELPIS-1 trial results show that intramyocardial injection of LOMOS-LB was well tolerated with no major adverse cardiac events and or treatment-related infections related to LOMOS-LB. We currently expect to submit the complete results of that trial to a peer-reviewed journal, and we anticipate acceptance and publication this year. The HLHS program has advanced into a phase two trial called ELPAS-2. ELPAS-2 is a randomized, blinded, and controlled trial designed to evaluate the safety and efficacy of level cell B for patients with HLHS undergoing stage two reconstructive cardiac surgery. The primary endpoint is a change in right ventricular ejection fraction, a key measure of cardiac function, at 12 months post-treatment. All seven target centers are activated for enrollment, and we anticipate that enrollment will continue well into 2023. Finally, I'd like to cover our aging frailty program. Aging frailty is an age-associated decline in reserve and function across multiple physiologic systems leading to inability to cope with stressors. This is common among the elderly, affecting millions of individuals in the United States and up to 15% of the population over the age of 65, depending on the specific clinical definition used. Aging frailty manifests typically as a combination of several signs and symptoms that may include sarcopenia or involuntary loss of muscle, associated weakness, fatigue, weight loss, slowness, and low activity. Unfortunately, elderly frail individuals are more vulnerable to poor clinical outcomes related to aging frailty, such as infection, falls, fractures, hospitalizations, and death. At Longevron, we have been evaluating the effect LOMAS-LB may have on the health and function of elderly frail patients, particularly on their physical and immune system function. In early stage exploratory trials, we have been using biomarkers of inflammation and vascular endothelial function to measure that effect. To that end, we remain on track to initiate our Japanese aging frailty phase two trial in the first half of 2022. This is an investigator-initiated, randomized, placebo-controlled, double-blind study of a single infusion of two different dose levels of Lomacil-B compared to placebo. and it's being conducted by our clinical partners at the National Center for Geriatrics and Gerontology in Nagoya and Jutendo University Hospital in Tokyo. In conjunction with our program evaluating Lomacil-B as a treatment for aging frailty, we have a concurrent early stage study exploring primarily the safety of Lomacil-B infusion as an adjuvant to high dose influenza vaccine in older frail individuals. This study, called the HERA study, is an exploratory trial that enrolled patients over several flu seasons and was partially funded through grants from the NIH and Maryland's Stem Cell Research Fund. As a small exploratory trial that is not robust with power for efficacy, however, we are analyzing an extensive panel of biomarkers to look for potential effects on the aging immune system as well as other endpoints related to physical function and frailty. We are currently analyzing the results of the trial and we anticipate reporting top line data in the first half of this year. In summary, we have made meaningful steps to advance our three ongoing clinical trials and look forward to providing updates to these programs throughout the year. With that, I'd now like to turn the call over to James Clavijo, our Chief Financial Officer, to discuss our financial results for the first quarter of 2022. James?
spk07: Thanks, Chris. Good morning, everyone. Most of what I'll be covering this morning will be presented in more detail in our condensed financial statements and in our management's discussion and analysis of operations for the quarter ended March 31st, 2022, and our quarterly report on Form 10Q, which will be filed today. For the first quarter ended March 31st, 2022, revenues for each of our first quarters of 2022 and 2021 were approximately $0.4 million. The difference was due to an increase in clinical trial revenue and grant revenue as follows. Clinical trial revenue, which derives from our Bahamas registry trial, was 0.3 million in the first quarter of 2022 compared to 0.2 million in the same period in 2021, an increase of 0.1 million, or 88%. While COVID-19-related travel concerns continue to negatively impact registry trial revenue, we believe this impact was lessened during the first quarter. First quarter 2022 grant revenue was less than 0.1 million compared to 0.2 million in the same period in 2021, a decrease of 0.1 million or 72%. The decrease in grant revenue is primarily due to a reduction in grant funds available due to the completion of the grant funded clinical trials. Research and development expenses in the first quarter of 2022 were 1.4 million compared to 1.3 million for the same period in 2021. The small decrease of 0.1 million or 6% was primarily due to an increase in research and development expenses that were not reimbursable by grants related to the completion of clinical trials. General administrative expenses for the first quarter of 2022 were 2 million compared to 1.7 million for the same period in 2021. The increase of approximately 0.3 million or 16% was primarily related to 0.8 million increase in compensation, insurance, and professional expenses incurred during the current period despite a $0.5 million decrease in equity-based compensation reported for RSUs and stock options granted during the quarter. Net loss was $3.5 million in the first quarter of 2022 compared to $3.1 million for the same period in 2021. Cash and short-term investments was $30.6 million compared to $35 million as of March 31, 2022, and 2021 respectively. The decrease in cash period over period was a result of operating expense and prepayments for insurance. Based on the company's current operating plan and financial resources, we believe that our existing cash and short-term investments will be sufficient to cover expenses and capital requirements into the first half of 2024. With that, thank you, and I will turn the call back over to Jeff.
spk05: Thank you, James. So as you've heard today, I think we've made some strong progress in the first quarter, and we look forward to providing additional updates throughout the year. Now I believe we'd like to open the call for questions. Operator?
spk02: Thank you. If you would like to ask a question at this point, please press the star followed by number one on your telephone keypad. If you would like to withdraw your question, please press the star followed by number two. When preparing to ask a question, please ensure your phone is unmuted locally. And the first question comes from the line of Michael Okunich from Maxim Group. Please, Michael, your line is now open.
spk08: I guess I'd like to first start off kind of broad here and see if you could provide a bit more color on what differentiates LomaCell from the other MSCs being developed out there.
spk05: Sure. Good morning, Michael. Thanks for being on the call and thanks for the question. I'd like to ask our Chief Science Officer, Dr. Hare, to address the question, please.
spk09: Thank you, Jeff, and thank you for the question. MSC products can be differentiated from one another based on the production process. The adage in the field is that the product is the process. So our process has been refined by us. The formulas we use are our trade secrets. And our potency assays are also protected information. Potency assays are the critical element that is required to take a cell-based therapeutic through FDA approvals. So while products may appear on the surface to be similar to one another in different companies, really they are each judged very uniquely by regulatory authorities based on where they're produced, how they're produced, and what the potency assays associated with their use are. Thank you. All right.
spk08: Yeah, thank you very much. I appreciate that. The other thing I'd like to ask about the HERA trial, and more specifically, what are you using as an evaluate when you're evaluating LomaCell as an adjuvant? Are you primarily looking at how LomaCell B will impact the immunity produced by vaccines? And then what is the underlying mechanism in this population that you're looking to leverage?
spk05: Yeah, sure. So this is Jeff. I'll give sort of a brief overview and let Dr. Moon and Dr. Hare kind of get specific on this. So this study spanned over multiple flu seasons and enrolled older or frail individuals who received a flu vaccine at specific times shortly after the Lomacil-B infusion. So it's a rather complex study, hypothesis generating regarding the potential for Lomacil-B to improve immune status. in older frail individuals who typically have diminished immune systems or something called immunosemescence. So the primary objective was to evaluate the safety of LOMA cell B infusion in advance of receiving the flu vaccine, but also to evaluate impact on adaptive immunity. And adaptive immunity measures included antibody production, hemagglutin inhibition, or HAI assays, as well as changes in B and T cell production. So beyond that, the study was designed to evaluate the potential impact of LOMA cell B you know, various measures of frailty since we were, you know, enrolling a frail population. And this would allow us to kind of compare these results to the findings we've already announced from our completed Phase 2B aging frailty study. Dr. Hare, you know, elaborate on that and more specific to Michael's question.
spk09: Yes. Hi. Thanks for the question. Let me address one of the issues you asked about mechanism of action. The issues of the mechanism of action of these types of cell-based therapies can be complex to pin down to a single event because the cells as a living cell have pleiotropic mechanisms of action. They do at least four things that we're aware of and possibly more. They receive, they release cytokines and growth factors that are immunomodulatory. They form heterosellular coupling interactions with host cells. They release exosomes, and they form tunneling nanotubes with host cells with which they transmit organelles such as mitochondria, which can re-energize the host tissues. These four mechanisms form the basis for our studies and our choice of indications using LOMA cell B. With regard to the immune system specifically, we know that older individuals with frailty have diminished immune responses to vaccination. This is well studied. And through a combination of those four mechanisms, we believe that LomaCellB can enhance immune responses. And the purpose of the study in an exploratory fashion is to try to identify which specific features of the immune system are responsive to an infusion of loma cell B. All right.
spk08: Thank you very much. I appreciate the additional color.
spk02: Thank you. Our next question comes from the line of Chad Jan from Maxine Group. Please, Chad, your line is now open.
spk04: Hi, guys. Thanks for taking the question. So for Alzheimer's, I know you guys looked at TNF-alpha in the aging frailty study. I was just wondering if you had any discussions to look at the biomarker in Alzheimer's going forward. Thanks.
spk06: So I'm sorry, just to make sure I understood the question. The question is, are we continuing to measure TNF-alpha in subsequent studies in Alzheimer's? This is Chris Min, by the way, CMO.
spk04: Yeah. Hey, Chris. Yeah, correct.
spk06: Yes, we are continuing to do this in the phase two, in our currently enrolling phase two setting. There are challenges with TNF-alpha, so we don't, we haven't made a decision to pin everything in development to that specific biomarker, but we are continuing to use that as a measure.
spk04: Okay, great. Thank you. And for the aging frailty study in Japan, Will the dosing be similar or more or less the same as the U.S. study?
spk05: Yeah, so this is Jeff. So the doses are going to be 50 million and 100 million. So they're similar. These are doses that were tested in our U.S. trial. We, in collaboration and discussion with the partners in Japan, made the decision not to go as high in the upper range as we did in the U.S. And this was based, that decision was based mainly on basically the differences in body mass and physiology of the subjects in Japan versus those in the United States. So same dose range, but not quite as, we're not going quite as high.
spk04: Thanks.
spk02: Makes a lot of sense. Appreciate the question. Thank you. As a reminder, to ask any further question, please press the star followed by number one on your telephone keypad now. The next question comes from the line of Constantine Davides from EF Hudson. Please, Constantine, your line is now open.
spk03: Hey, guys. Good morning. Just a quick one. Apologies if I missed this. For HLHS, for ELPAS 2, can you just talk about the enrollment expectations there? I think I caught something about that extending into 2023, but just expand upon that a little bit in terms of how the enrollment experience is comparing to ELPAS 1, and then when we could expect a readout from that program.
spk05: Hey, Constantine. Thanks for the call. Thanks for the question as well. So we have, as you know, we're conducting this trial in collaboration with the partners at the NHLBI, Lurie Children's Hospital in Chicago, and the University of Texas Health Center Coordinating Center. I may have not got that name exactly right, but the grant has specifically seven tertiary hospitals that are part of the consortium that is responsible for the enrollment of these patients, obviously the care of the patients and the conducting of the trial. So all seven centers have been activated for enrollment. The target for enrollment for that trial as provided by the coordinating centers and the PI is into 2023, well into 2023. And so we are kind of monitoring the speed at which it's enrolling based on all seven centers. We'd like to see all seven centers a few quarters worth of enrollment to really understand how quickly they're going to be able to get all 38 of these infants enrolled. But at this stage, what we understand is that we should expect enrollment to continue well into 2023. And each infant, therefore, has a year of observation. You know, so depending on when that last infant is enrolled, you can expect another year of observation and then, you know, hopefully shortly thereafter the data. So we'll stop short at sort of predicting when you would see a readout. But that's what we understand right now in terms of the guidance that this trial will enroll.
spk03: But it's a 2024 event, basically.
spk05: I think that's a reasonable assumption at this point.
spk03: Okay. Thanks for the color there. And then, Chris, maybe this is a similar question to one that was asked previously, but ask it a different way. You know, there's a lot of cell therapy platforms out there, cell therapy programs. I'm just wondering, you know, what specifically attracted you to Longeviron? Is it, you know, that is to say, is it something about a particular program or something that You saw in the technology as an outsider. I'm just curious if you can articulate that a little bit.
spk06: Yeah, sure, happy to. You know, the fact is that I have seen, like, the history, and I'm sure you're aware that there have been a number of MSC companies that have come and gone already. And when I was first approached by Longevron, I was kind of curious about that. And as I got to know specifically Dr. Hare's work, I was really impressed by the careful way in which the investigations have been conducted and the way that he has built a clinical platform. And particularly, I thought the adult frailty study that was reported last year was impressive, although the pre-specified endpoint may not have achieved the statistical significance that was generated as a pre-study hypothesis. The ad hoc analysis of the differences in six minute walk time at nine months I thought was really impressive and the dose response. And I thought this was something that while we all know that therapeutics development is very difficult and despite the best things one can end up not getting the efficacy results you need for final approval, I thought the early clinical results demonstrated with LomasLB were really quite promising and something I wanted to be a part of. I hope that answers your question.
spk03: No, that's great. Thank you.
spk02: Thank you. We currently have no further questions, so we'll hand over back to Geoff Green for any final remarks.
spk05: Great. Just wanted to say thank you, and on behalf of the company, we'd like to thank everyone for their continued interest and support in Longevron, and I'd like to wish everyone a great day and a great weekend.
spk02: This concludes today's conference call. Thank you so much for joining. You may now disconnect your lines.
Disclaimer