Longeveron Inc.

Greetings and welcome to Long Everon's call today to discuss the results of the company's third quarter of 2021 financial results. All participants are currently in 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.

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 third quarter of 2021. And we're also contained in a press release issued earlier this morning. You can access the press release by going to the news section of our website at www.longevron.com. I'm joined on the call today by the following members of Longevron's management team. Mr. Jeff Green, Chief Executive Officer. Mr. Joshua Hare, Co-Founder, Chief Scientific Officer and Chairman. and James Clavio, Chief Financial Officer. We will begin with a general update and summary of recent events, followed by a recap of our financial results from the third quarter 2021, and then conclude with a question and answer 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 statements should be considered in conjunction with cautionary statements in our press releases and risk factor discussions in our filings with the SEC, including our last annual report and 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 Loggeveron. Jeff?

Yeah, thank you, Brendan. Good morning, everyone, and thank you for attending Longevron's third quarter 2021 business update and financial results call. We've had another busy and productive quarter, and let me get started on our progress with LomasLB clinical research. Following this, James Plavio, our CFO, will go through the financial performance for the quarter. Longeviron is a leading clinical stage biotechnology company developing living cell therapies for chronic aging-related diseases and other life-threatening conditions for which there are no approved treatments. Aging is the number one risk factor for chronic disease. Stem cell exhaustion, cellular senescence, chronic inflammation, together referred to as inflammation, compromises our ability to repair and regenerate damaged tissues and organs. Inflamma aging is linked to the rise of progressive chronic disease such as Alzheimer's and aging frailty. Our focus since day one has been to develop safe and effective allogeneic cell therapy solutions for the treatment and prevention of these diseases. Longevron's lead therapeutic investigational product called LomaCellB is a living cell biologic made from the specialized cells isolated from the bone marrow of young healthy adult donors aged 18 to 45. These specialized cells called medicinal signaling cells, or MSCs, reside within various tissues in our bodies and are considered to be the body's endogenous or built-in repair mechanism that promotes regeneration of damaged tissues and organs. It is our goal to increase healthspan and reverse or prevent chronic disease and other life-threatening conditions by harnessing the regenerative potential of MSCs. Now I'll provide an update on our LOMA Cell B clinical research program, beginning with our Alzheimer's disease. With Alzheimer's disease, it is believed that early and substantial inflammation in the brain leads to neurodegeneration and neuronal cell death, which is a significant contributor to the development and progression of this deadly disease. In animal models of Alzheimer's, MSCs, like the ones used in loma cell B, have been shown to cross the blood-brain barrier, decrease harmful inflammatory cytokines, and increase anti-inflammatory cytokines, which led to the generation of new neurons and improved blood vessel function. Our hypothesis is that the promascular, pro-regenerative, and anti-inflammatory properties of MSCs alleviates neuroinflammation in the brain, which may in turn prevent or reverse the clinical progression of Alzheimer's. In July, we presented data from our Phase I Alzheimer's Disease Clinical Trial as a poster presentation at the 2021 Annual Alzheimer's Association International Conference. This trial, funded in part by an Alzheimer's Association Park the Cloud Challenge on Neuroinflammation grant, used a randomized placebo-controlled double-blind design testing a single IV infusion of LomaCellB 20 million cells, we call this the low dose, LomaCellB 100 million cells, in this case the high dose or placebo. Key results from this trial include demonstrating tolerability in the target patient population of mild to moderate AD and a slow reduction in mini mental state exam score on average for the low dose LomaCellB group compared to the placebo group, as well as positive changes in various biomarkers of interest. The program is now transitioning to Phase 2, and we anticipate the initiation of a Phase 2 study by year-end or early 2022. The Phase 2 trial is anticipated to be a randomized placebo-controlled double-blind design to evaluate biomarkers, cognitive function, and other disease-specific endpoints. Further details about the trial design will be provided once the protocol is finalized. The protocol has already been filed as an amendment to our IRD. However, the design is undergoing some final adjustments. Now, transitioning now to our aging frailty research. On August 13th, we announced the top-line results of the Phase 2B U.S. Multi-Center Randomized Placebo-Controlled Aging Frailty Trial. The trial's primary objective was to evaluate whether LomaCell B infusion could improve walking distance in mild to moderately frail older adults with demonstrated mobility disability. Mobility disability, or the inability to walk a quarter mile, is a powerful predictor of future health and function. None of the subjects at screening could walk a quarter mile in six minutes prior to receiving Lomas LB or placebo. Six months after infusion, subjects in the three highest Lomas LB dose groups could, on average, walk statistically significantly further than they could at baseline, with an average increase of between 27 meters and 55 meters. By contrast, the placebo group could walk, on average, just nine meters further compared to baseline. Now, 90 days later, at nine months, the middle LOMOS-LB group and the highest LOMOS-LB group were still walking statistically significantly further compared to both baseline and to placebo, suggesting a durable, sustained improvement in exercise tolerance and endurance. At this stage, we are continuing to evaluate the clinical safety and efficacy data from this trial, as well as the blood-based biomarker data, in anticipation of determining the next step in this program. Results from Longeviron's other aging frailty trial, the Phase I-II HERA study, are anticipated in the first quarter of 2022. The primary objectives of the HERA study are to assess safety and tolerability and to explore the effect of LLB on the frail immune system and other frailty endpoints in subjects receiving the influenza vaccine. We plan to evaluate the results of the HERA study in the context of the results from the Phase IIb frailty trial as we plan the next steps in the U.S. Frailty Research Program. The planned Japanese Aging Frailty Phase II trial is currently on track to initiate by end of first quarter 2022. This investigator-initiated randomized placebo-controlled double-blind single infusion trial is being led by our clinical partners at the National Center for Geriatrics and Gerontology in Nagoya and Jintendo University Hospital in Tokyo. In Japan, where nearly one-third of the population is 65 or older, frailty's adverse outcomes and increased healthcare costs and use are already a significant public health concern. Japan has placed significant importance on the prevalence of frailty and implementing programs intended to prevent functional decline and to promote well-being. We anticipate and look forward to announcing the first subject pain roles in the Phase 2 trial. Excuse me. Related to – one second, please. Related to evaluating walking distance and mobility, in September, we announced our agreement with Kinesiometrics to provide a digital data-driven solution for objective real-time measurement of functional capacity and quality of life in Longevron's clinical studies. Kinesiometrics' mobile phone-based platform can collect not only years of historical data regarding a subject's activity levels via steps, distance walked, flights climbed, and energy expenditure, but also real-time response information for comparison of activity level changes pre- and post-Lomus LB infusion. The data may be used to understand and gauge outcomes of treatment regimens. Activity levels can be provided continuously rather than relying solely on single time points throughout the follow-up period. This could provide a rapid understanding of the effect of LomasLB and may have the potential to reduce the number of protocol-specific visits a research subject is asked to make to the clinic. And now, transitioning now to our hypoplastic left heart syndrome research program. This past third quarter, we announced the final results of our Phase I open-label safety study. The results from that trial showed that injection of LomasLB into the right ventricle during reconstructive surgery was well tolerated. Exploratory efficacy results show that, on average, the babies showed growth and development consistent with normal healthy babies and a transplant-free survival of all 10 babies one year post-surgery. We've continued to monitor the status of the children enrolled in this Phase 1 study and are very encouraged that all 10, as of September this year, remain alive and transplant-free two or more years after the surgery and administration of LOMUS-LB. Enrollment in the Phase II HLHS trial, referred to as ELPAS II, continues to progress nicely. Currently, five centers are open and actively recruiting subjects. Four babies have been enrolled and randomized as of today. ELPAS II has a target enrollment of 38 infants with one year of safety and efficacy follow-up per protocol. Currently, the ELPAS II team is projecting completion of enrollment in 2023. ELPAS II is being funded in part by a grant from the National Institute of Health, National Heart, Lung, and Blood Institute in collaboration with Longevron and is led by Principal Investigator Sanjay Kashal, Division Head, Cardiovascular Thoracic Surgery at the Lurie Children's Hospital of Chicago. Now moving on to our acute respiratory distress syndrome due to COVID-19 infection trial. The phase one trial continues to screen subjects at three participating centers in the U.S. We expect enrollment to continue into 2022. Enrollment in this trial has been slower than expected due to a number of factors that include a reduction in hospitalizations and increasing vaccination rates. The trial is funded in part by a Maryland Stem Cell Research TEDCO grant that goes through October of 2020-22. As a general note, we have a demonstrated track record of successfully applying for and receiving grant awards to help fund our research. With the new data coming out of our various trials and successful execution of said trials, we intend to continue to apply for grants as part of our funding strategy and to further our goal of commercializing LomasLB. With that, I'd like to turn the call over to James Cordejo, CFO, to discuss our financial results for the third quarter of 2021. James.