Longeveron Inc.

Good morning or good afternoon all and welcome to the Longevron Inc 2022 third quarter earnings call. My name is Adam and I'll be your operator today. If you'd like to ask a question during the Q&A portion of today's call, you may do so by pressing star followed by one on your telephone keypad. I would now like to turn the call over to Elsie Yao from Stern Investor Relations. Elsie, you may proceed.

Thank you, operator. Good morning, everyone, and welcome to Longevron's third quarter 2022 call. Today, we will provide a business update and discuss financial results for the third quarter of 2022. Earlier this morning, we issued a press release with these results, which can be found under the investor section of our website at www.Longevron.com. I'm joined on the call today by the following members of Longevron's management team. Dr. Chris Min, Interim Chief Executive Officer and Chief Medical Officer. Dr. Joshua M. Hare, Co-Founder, Chief Science Officer and Chairman. and James Covijo, Chief Financial Officer. Dr. Min will begin with a brief corporate overview, followed by a review of updates from Longevra's clinical programs in Alzheimer's disease, hypoplastic left heart syndrome, or HLHS, and aging frailty. Then Mr. Covijo will review our third quarter financials. Last, we will 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 statement should be considered in conjunction with cautionary statements in our press releases and risk factor discussions in our filings of the SEC, including our annual report on Form 10-K and cautionary statements made on 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 Dr. Chris Min, Interim Chief Executive Officer and Chief Medical Officer of Longevron. Chris?

Thank you, Elsie. Good morning, everyone, and welcome to Longevron's third quarter 2022 business update and financial results call. Longevron is a clinical stage biotechnology company developing regenerative medicines for unmet medical needs. At Longevron, our mission is to develop safe and effective cell-based therapies for some of the most challenging disorders associated with the aging process and other medical disorders. Our lead investigational product, called LomaCellB, is a living cell product made from specialized cells isolated from the bone marrow of young healthy donors ages 18 to 45. These specialized cells are known in the literature as medicinal signaling cells, or MSCs, and are essential to our endogenous or built-in repair mechanisms. MSCs are known to perform several complex functions, including the ability to form new tissue. They also home to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that LomaCellB has multiple mechanisms of action that may lead to anti-inflammatory, provascular, and regenerative responses, and therefore may have broad applications for a range of aging-related and rare diseases. In the third quarter of 2022, we continue to make progress advancing LomaCellB for our suite of aging and rare disease indications. We have ongoing trials in Alzheimer's disease and hypoplastic left heart syndrome, or HOHS, and have initiated patient screening in a phase two study evaluating LomaCellB for aging-related frailty in Japan. First, I'll begin with an update on Alzheimer's disease. Last week, we were pleased to announce the completion of enrollment for our Phase 2A trial. This represents an important milestone for Lung Gen 1 as we advance Lomasol B as a potential treatment for patients with mild Alzheimer's disease, a large area of unmet need where treatment options remain limited. Based on growing preclinical and clinical data, we believe Lomasol B may prevent, slow, or even reverse the clinical progression of Alzheimer's disease by reducing disease-related brain inflammation. Neuronal cell death caused by early and substantial neuroinflammation is a significant contributor to the pathogenesis of Alzheimer's disease. In preclinical models of Alzheimer's disease, MSCs like Lomacil-B have been shown to cross the blood-brain barrier, potentially with an anti-inflammatory effect, improving endothelial function and promoting neurogenesis, the process of how neuron formation occurs in the brain. In a previously completed Phase 1B study, we demonstrated the preliminary safety of Lomacil-B in patients with mild Alzheimer's disease. With the Phase 2A trial, we hope to build on this body of evidence. I'd like to remind you that this Phase 2A trial is a 48-patient, forearm, parallel design, randomized clinical trial of Lomacil-B designed to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild Alzheimer's disease. Our primary endpoint is safety, as measured by the occurrence of serious adverse events within the first 30 days after administration of Lumosome B. Secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging, or MRI, biomarkers relevant to inflammation and endothelial vascular systems, and measures of cognitive functions. Each patient is following the study for a duration of 12 months. With the trial fully enrolled, we expect to share the top-line results in 2024. Next, I'd like to move on to our HLHS program. This quarter, we were excited to announce that the FDA granted fast-track designation to LMS-LB for infants with this rare and life-threatening pediatric disease. As a reminder, HLHS is a rare congenital heart defect that affects approximately 1,000 infants a year in the United States. People born with HOHS have an underdeveloped or absent left ventricle impairing the heart's ability to pump blood. Left untreated, this condition is always fatal. Currently, the standard of care is comprised of three reconstructive operations before the age of five, an extraordinary treatment burden for these young pediatric patients. Further, even with these surgical interventions, Children with HLHS are at elevated risk of short-term mortality, delayed development, and long-term complications, including organ failure, with only somewhere between 50% to 60% of these patients surviving to adolescence. There exists a tremendous unmet need for additional interventions beyond the current standard of care. We believe LOMOS-LB, with its pro-regenerative, pro-vascular, and anti-inflammatory properties, when administered concurrently with surgical interventions, can fill that gap by improving cardiac performance in patients with HLHS. In combination with the previously announced rare pediatric disease and orphan drug designations, the new FAST-TRACK designation underscores the urgent unmet need for new treatments for HLHS. Enrollment remains ongoing in our ELPAS-2 trial of Lomacil-B for HLHS. All clinical sites have been activated. As a reminder, ELPAS-2 is a phase 2A clinical trial that intends to evaluate the safety and efficacy of intramarocardial injection of LOMOS-LB in infants with HLHS who are undergoing stage 2 reconstructive surgery. The primary endpoint is a change in right ventricular injection fraction, a key measure of cardiac function at 12 months post-treatment. We intend to provide further guidance on timelines for ELPAS-2 when a sufficient portion of the intended treatment population have been enrolled. Finally, I'd like to cover updates on our aging-related frailty program. Aging-related frailty is an age-associated decline and reversal in function across multiple physiologic systems that leads to an 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-related 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-related frailties, such as infection, falls, fractures, hospitalizations, and even death. At Longevron, we have been evaluating the effect of Lomus OB that it 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 and endothelial function to measure the effect. Our clinical development strategy in aging frailty is currently focused on Japan, which has one of the oldest populations in the world. After reevaluating our regulatory strategy in Japan last quarter to capitalize on near-term value-driving market opportunity, we initiated screening for our Phase II study, Evaluating Lobo Cell B in Patients with Aging-Related Feralty in Japan in partnership with the National Center for Geriatrics and Gerontology in Nagoya and Junten Do University Hospital in Tokyo. The Phase II clinical trial is a three-arm parallel design randomized, placebo-controlled, double-blind, single-infusion study of two different dose levels of LomaCell B versus placebo. The primary objective of the study is to evaluate the safety of LomaCell B as a treatment for aging-related frailty with an overarching goal of providing support for an eventual limited approval under the Act on the Safety of Regenerative Medicine, or ASRM, which recognizes tremendous therapeutic potential of cell therapies. Now, such an ASRM approval could enable us to enter the Japanese market based on demonstrated safety in Japanese patients with an expectation of efficacy, which can be established through the conduct of a small, well-controlled trial combined with our previous data in aging frailty. And such an approval will allow us to administer LOMOS-LB as a treatment for aging-related frailty at select clinical sites, addressing a crucial unmet need amongst the Japanese populations. We remain on track to enroll our first patient in the Phase II trial this quarter. With that, I'd like now to turn the call over to James Clavijo, our Chief Financial Officer, to discuss our financial results for the third quarter of 2022. James?