Longeveron Inc.

Hello, and welcome to Longevron's call today to discuss the company's 2021 fourth quarter and year-end financial results. All participants are currently in a listen-only mode. Following the formal presentation, we will open the call up for a question and answer session. I would now like to turn the call over to Brendan Payne from Stern IR. Brendan, you may proceed.

Great. Thank you, Operator. Good morning, everyone, and welcome to Longevron's call today. to provide a business update and to discuss financial results for the fourth quarter 2021 and year end that were also contained in a press release we issued early this morning. You can access the press release by going to the investor section of our website at www.Longeviron.com. I'm joined on the call today with the following members of Longeviron's management team. Mr. Jeff Green, Chief Executive Officer, Dr. Joshua M. Hare, Co-Founder, Chief Science Officer and Chairman and James Clavijo, Chief Financial Officer. We'll begin with a brief general update and summary of recent events, followed by a recap of our 2021 fourth quarter and full year financial results, and then conclude with a Q&A period. 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 factors discussions in our filings with the FCC, including our most recent annual report on Form 10-K, which is being filed later today, 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 at Longeviron.

Jeff? Thank you, Brendan. Good morning, everyone, and thank you for attending Longeviron's fourth quarter 2021 business update and financial results call. For background, Longeviron is a leading clinical stage biotechnology company developing living cell therapies for chronic aging-related diseases and other specific life-threatening conditions. 2021 was a tremendous year for us, and I'm extremely proud of the progress the Longeviron team made during the period. During 2021, we announced clinical data in three different studies, and this data has provided additional meaningful insight into our lead product, Lomacil-B's potential mechanisms of action, contributed important safety and tolerability information, and provided the foundation for advancement into later stage trials. In the second half of 2021 and into the early part of 2022, we successfully advanced Lomacil-B into phase two trials in two indications, Alzheimer's disease and hypoplastic left heart syndrome. And this now places Lomacil-B squarely in phase two for three different indications. In addition, we achieved substantial regulatory milestones, having been granted both orphan drug designation and rare pediatric disease designation from the FDA in support of our HLHS program. Also from a regulatory standpoint, we have been given permission to proceed with our Japanese aging frailty phase two trial, from both the Japanese PMDA and the local IRB of the National Center for Geriatrics and Gerontology in Nagoya, with Jintendo University Hospital in Tokyo's IRB approval pending. Financially, we increased our year-end cash position to $35 million as a result of a private placement in December 2021, significantly strengthening the balance sheet and giving the company a cash runway into 2024 based on current estimates. We anticipate a very active 2022 and are financially and operationally poised to execute our plan. We expect to achieve several important milestones this year, which I will detail for you during this call. Just as a refresher, 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 age 18 to 45. These specialized multipotent cells that we call medicinal signaling cells, or MSCs, reside in different concentrations within various tissues in our body and are our endogenous or built-in repair mechanisms. MSCs are known to perform a number of complex functions, including the ability to form new tissue and home in on sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. Unfortunately, in both animals and in humans, there's a clear age-related decline in both the number and the potency of these cells, And this is believed to be one of the primary reasons for age-associated increase in chronic disease. It is our goal to increase health span and reverse or prevent chronic disease and other life-threatening conditions by harnessing the regenerative potential of MSCs. I'd like now to provide some updates specific to our various LOM cell B clinical programs, beginning with Alzheimer's disease. It is believed that a significant contributing factor to the pathology of Alzheimer's is early and substantial brain inflammation. leading to neurodegeneration and neuronal cell death, which then manifests in the hallmark symptoms of progressive dementia, among others, and in many cases, eventual death. In published studies of MSCs and Alzheimer's disease animal models, MSCs have been shown to cross the blood-brain barrier, decrease cytokines associated with harmful inflammation, and increase anti-inflammatory cytokines, leading to new neuron growth and improved vascular function. We are evaluating the potential anti-inflammatory, pro-regenerative, and pro-vascular effects of Lomacil-B for the purpose of learning whether the product may prevent, slow, or even reverse the progression of Alzheimer's disease. To that end, as we announced earlier this quarter, we have initiated a phase 2A trial in Alzheimer's, and I am very pleased to report that the first patient was treated on Friday, February 24th. The trial is a double-blind, randomized, placebo-controlled design investigating safety and tolerability as well as multiple secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of LOMA cell B compared to placebo in individuals with mild Alzheimer's disease. We will also be looking at changes in brain anatomy using MRI, as well as assessments of inflammatory and vascular systems function. The study consists of four treatment arms, 12 patients each, for a total target enrollment of 48 patients. Currently, we intend to activate up to 12 clinical sites for enrollment, including the Miami VA, which we expect to activate imminently. As more clinical sites open for screening, we plan to provide guidance on enrollment rates and trial completion for this study. The results of our phase one study have been submitted to a peer-reviewed journal, and we anticipate acceptance and publication in the first half of 2022. Transitioning now to our hypoplastic left heart syndrome, or HLHS program. As a reminder, HLHS is a congenital heart defect that affects approximately 1,000 babies per year in the United States. Babies 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 child is five years old. However, despite this, there still remains a roughly 30% mortality rate at three years. Last year we announced results of our phase one open label safety study with LomasLB in HLHS patients. That trial in which 10 infants received LomasLB during stage two surgery met its primary endpoint demonstrating that intraventricular injection of LomasLB was well tolerated with no major adverse cardiac events nor any infections considered related to the product. In addition, we observed that all 10 infants were alive and transplant free between two to three and a half years post Stage 2 surgery, a transplant-free survival rate exceeding that which had been previously reported in a published study. The results of our Phase 1 study have been submitted to a peer-reviewed journal, and we anticipate acceptance and publication in 2022. The Phase 2 HLHS trial, referred to as ELPAS-2, was open for enrollment in July of 2021 and now has all seven clinical sites open for enrollment. ELPAS 2 has a target enrollment of 38 infants with one year of safety and efficacy follow-up per protocol. ELPAS 2 is being funded in part by a grant from the National Heart, Lung, and Blood Institute and is projected to complete enrollment in 2023. Now that all pre-identified sites are open for enrollment, we intend to provide more specific enrollment rates and trial completion guidance as that trial progresses. In the fourth quarter of 2021, we were granted both rare pediatric disease and orphan drug designations from the US FDA for LomasLB. Both designations confer specific potential benefits, which may include market exclusivity upon approval for this indication and eligibility to receive a priority review voucher. These benefits are available only if all statutory and regulatory requirements and conditions are met. Moving on now to our aging frailty research program. Aging frailty is an age-associated decline in reserve and function across multiple physiologic systems, leading to an inability to cope with stressors. This is a common geriatric condition that affects up to 15% of the population over the age of 65, depending on the definition used, and manifests clinically, typically, as a combination with several signs and symptoms that may include sarcopenia or involuntary loss of muscle, associated weakness, fatigue, weight loss, slowness, and low activity levels. Older frail individuals are more vulnerable to poor clinical outcomes such as infection, falls, fractures, hospitalizations, and death. So the planned Japanese phase two aging frailty trial is currently on track to initiate in the first half of 2022. This is an investigator-initiated, randomized, placebo-controlled, double-blind, single-infusion study being conducted by our clinical partners at the National Center for Geriatrics and Gerontology and the Gintendo University Hospital. Results from the Phase I-II HERA aging frailty trial are expected to be announced in the first half of 2022. The HERA trial is a multicenter, randomized, placebo-controlled study intended to evaluate safety and to explore the effect LomaCellB may have on biomarkers and immune system function in aging frailty subjects receiving the influenza vaccine, as well as other signs and symptoms of aging frailty. In the fall of 2021, we announced results of the Phase IIb Multi-Center Randomized Placebo-Controlled Aging Frailty Trial. That trial demonstrated that at six months post-infusion, Patients in the three highest loma cell B dosing groups could, on average, walk statistically significantly further than they could at baseline. And by nine months, two of the four loma cell B dose groups showed statistically significant increases in walking distance compared to both baseline and the placebo group, which we believe may suggest a durable, sustained improvement in exercise tolerance and endurance. On January 12th, 2022 Longevron announced publication of the LOMAS-LB Phase 2B Aging Frailty Trial Design in the Journal of Aging Frailty. In addition to this publication, we anticipate submitting a manuscript of the Phase 2B trial results to a peer-reviewed journal that we anticipate acceptance and publication in 2022. We plan to evaluate the results of the Phase I-II Harris study independently as well as in the context of the results from the Phase IIb trial as we plan the next steps in the U.S. Frailty Research Program. And then rounding out our clinical program with LomaSelb, our Phase I trial on subjects experiencing acute respiratory distress syndrome due to COVID-19 infection continues to screen subjects at three participating centers in the U.S., and we expect enrollment to continue to run through 2022. Transitioning now over to the leadership front, we made several key additions to the Longevron team in 2021, including the appointment of four new directors, as well as Dan Gensler, the Senior Vice President for Strategic Collaborations and Scientific Affairs. Our most recent addition to our board of directors, announced last month, is seasoned biotech executive Todd Girolamo. Todd brings to Longevron an extensive body of experience in SEC and FDA compliance, corporate finance, M&A, and licensing activities, as well as intellectual property litigation and drug development. Todd is currently Chief Legal Officer, Senior Vice President of Corporate Development, and Corporate Secretary of Caladrius Biosciences, and also spent 12 years on Wall Street where he specialized in therapeutic healthcare equity securities, and served as an analyst and a portfolio manager for biopharma and med tech equities. And with that, now I'd like to turn the call over to James Clavio, CFO, to discuss our financial results for the fourth quarter of 2021 and full year 2021. James?