Good morning and welcome to Longeveron’s 2021 First Quarter End Earnings and Business Update Conference Call. At this time, all participants are in a listen-only mode.

[Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for payback purposes. A replay of the call will be available approximately one hour after the end of the call through till May 21, 2021.

I would now like to turn the conference over to Brendan Payne with Stern Investor Relations, the company's Investor Relations firm. Please go ahead, sir..

Thank you, Bethany. Good morning, everyone and thank you for joining today’s conference call to discuss Longeveron’s corporate developments and financial results for 2021 first quarter ended March 31, 2021. With us today are Geoff Green, the company’s CEO; Dr.

Joshua Hare, Co-Founder, Chief Scientific Officer and Chairman; as well as James Clavijo, the company’s Chief Financial Officer. Today, Longeveron released financial results for the first quarter ended March 31, 2021. If you have not received Longeveron’s earnings release, please visit the company’s website at longeveron.com.

During this call, we will be making forward-looking statements regarding future events and the performance of Longeveron. The forward-looking statements are subject to risks and uncertainties that could cause actual events and results to differ materially from the forward-looking statements.

These risks are described in further detail in the company’s press releases and reports filed with the SEC.

These forward-looking statements represent the company’s judgment as of today, Friday, May 14, 2021, and we assume no obligation to update any of these forward-looking statements, unless we are required to do so by applicable law or by securities regulatory authority. I will now turn the call over to Geoff Green, Longeveron’s Chief Executive Officer.

Thank you, Geoff. You may begin..

Thank you, Brendan, and thank you, Bethany. Good morning, everyone. And welcome to Longeveron’s first quarter 2021 business update and earnings call. We're very excited to describe and share the tremendous progress we have made so far this year and to lay out near-term catalysts, we are targeting in our various clinical development programs.

As a high level summary, however, our Lomecel-B cell therapy program has three data readouts in three trials over the next two quarters. And we expect to initiate three new Phase 2 trials in the second half of 2021.

So needless to say, we are executing on our clinical plan as outlined in our IPO, and it will be an exciting and very active half year for the company.

Longeveron is a leading clinical stage biotechnology company developing 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, and chronic inflammation, together referred to as inflammaging, compromise our ability to repair and regenerate damaged tissues and organs. Inflammaging is linked to the rise of progressive chronic diseases such as Alzheimer’s disease 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.

Longeveron’s lead therapeutic investigational product called Lomecel-B 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 body and are considered to be the body's endogenous or built-in repair mechanism that promotes regeneration of damaged tissues and organs. When we're young, we have an adequate supply of these cells and they function as needed as intended.

Unfortunately, in both humans and in animals, there is a clear age-related decline in both number and potency of these cells. And this is believed to be one of the primary reasons for age associated increase in chronic disease. Now I'd like to provide an update on our Lomecel-B clinical research programs beginning with the Alzheimer's disease program.

This past April, we announced additional results from our Phase 1 Alzheimer's disease clinical study.

We are extremely excited about the preliminary efficacy results that showed that the low dose Lomecel-B treated subjects had a slower decline in cognitive function compared to the placebo treated subjects over 52 weeks as measured by the commonly used Mini-Mental State Exam.

At 13 weeks post-infusion, the Lomecel-B treated group's cognitive function score was nearly unchanged from baseline. By contrast, the placebo group had declined by nearly 2.7 points, which is statistically significantly worse than Lomecel-B group. We saw this statistically significant difference again at 39 weeks.

And by 52 weeks, the placebo group score declined by nearly six points compared to a drop of only two points in the low dose Lomecel-B group.

So with the initial safety hurdle overcome and the exciting results related to cognitive function as well as statistically significant results related to activities of daily living, quality of life assessments and various inflammation related biomarkers of interest, we are enthusiastically moving this program forward into a Phase 2 trial.

We are on track to initiate this Phase 2 trial in the second half of this year. Furthermore, we have submitted the data for publication and we plan to present at the upcoming Alzheimer's Association International Conference in July. Alzheimer's is the leading form of dementia.

And this disease affects nearly 6 million Americans annually, leads to early mortality and creates a tremendous burden on families and societies. With no cure, Alzheimer’s is currently the sixth leading cause of death in the U.S. so this transition to Phase 2 is a very important program.

And we look forward to enrolling the first patient in the Phase 2 trial. Now let's turn our attention to the Aging Frailty program. Aging Frailty is a clinically-defined and extreme form of unsuccessful aging.

It is readily recognized by a combination of hallmark clinical signs and symptoms, which can include involuntary muscle loss, weakness, slowing down, fatigue and unintentional weight loss and low activity levels, as well as being in a chronic inflammatory state.

A diagnosis of Aging Frailty indicates that the individual is at elevated risk for poor clinical outcomes, such as hospitalization, institutionalization, and death. Despite the pressing need for interventions, there are no FDA approved therapies that can slow down, reverse or prevent Aging Frailty.

Frailty would be considered a new indication from a regulatory standpoint and thus will require discussions with FDA and other health authorities as to potential clinical and regulatory pathways for a future approval.

So we're evaluating Lomecel-B as a treatment for Aging Frailty because the potential mechanisms of action may address the biological underpinnings of this condition. Our goal is to improve health, independence, and quality of life in these individuals were at-risk for becoming dependent and disabled.

In the first quarter of 2021, we completed our two U.S. clinical studies and we plan to announce the data from these trials in the third quarter of this year. Our U.S. Phase 2 trial is our most advanced clinical trial in Aging Frailty program.

This 149 subject trial is evaluating the effect of Lomecel-B infusion compared to placebo on physical function and endurance by using the six-minute walk test as the primary efficacy endpoint.

In addition to walking distance, some of the other endpoints in the trial include grip strength, walking speed, balance, fear, and risk of falling, sexual function, patient questionnaires and biomarkers of inflammation. Our other U.S.

Frailty trial, which will be read out in the third quarter is the Phase 1/2 HERA trial, which was designed to evaluate whether Lomecel-B can improve immune response to influenza vaccine in Aging Frailty subjects, as well as to evaluate Lomecel-B’s possible effects on the frailty endpoints, I just listed for the larger 149 subject trial.

The primary measure of efficacy in this study is serum antibody production as measured by hemagglutination inhibition assay, which is a measure of the amount of circulating antibodies that would be considered protective against the flu virus.

And then finally, in our Aging Frailty program, our Japanese Phase 2 Aging Frailty clinical study is on track to initiate this year. This trial will be led by the National Center for Geriatrics and Gerontology, which is the Japanese equivalent to the National Institute on Aging in the U.S.

Japan has a progressive and favorable regulatory framework for regenerative medicine products and offer several expedited pathways to market, including potentially a conditional approval after Phase 2, which is solely at the discretion of the Japanese PMDA as well as a hospital-based approval using a self-pay model.

We view this as a very significant opportunity for the company because of the potentially faster pathway to marketing authorization. And finally, in the frailty and dementia research program, we sponsor a Registry in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee.

The Bahamas Registry Trial administers Lomecel-B to eligible patients at two private clinics in Nassau for a variety of indications.

While Lomecel-B is considered an investigational product in The Bahamas under the approval terms from the National Stem Cell Ethics Committee, we are permitted to charge a fee to participants, which offsets the cost of sponsoring the Registry Trial.

Participation in the Registry has slowed over the past year as a result of COVID-19, but it's possible that as travel restrictions ease and vaccination rates increase in the elderly population, we will see an increase in interest in the Registry Trial. Now let's touch upon our Acute Respiratory Distress Syndrome or ARDS program.

In 2020, we were approved by the USFDA to conduct a Phase 1 study in ARDS caused by either COVID-19 or influenza virus. Approximately 200,000 people suffer from all-cause ARDS in the U.S. annually, with a mortality rate of roughly 40%. These numbers are likely to increase as a result of the COVID-19 pandemic, which could become a seasonal epidemic.

Older persons, those with Aging Frailty and those with the Metabolic Syndrome are at significantly increased risk for severely poor outcomes from ARDS due to viral infection, including prolonged hospitalization and death.

We are currently enrolling subjects in our Phase 1 randomized, double-blind, placebo trial, and expect this trial to be completed with data in 2022. Lastly, I’d like to discuss our Hypoplastic Left Heart Syndrome or HLHS program.

HLHS is a severe congenital birth defect in which the left ventricle of the heart is either severely underdeveloped or is missing altogether. Babies born with HLHS now undergo a complex three stage heart reconstruction over the course of years, which improves the survival rates of the babies.

Unfortunately, the need for heart transplant is still high in this population due to right ventricular failure, as such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.

To that end, we have completed our 10 patient multi-center open-label Phase 1 clinical trial, and we inspect Phase 1 top-line results in the second quarter of this year. The Phase 2 trial is on track to initiate in the second half of 2021.

And so to close, I want to summarize the near-term milestones that we believe will drive significant shareholder value, including one initiate phase – our Phase 2 clinical trial in Alzheimer's disease.

We will announce Phase 1 results from the HLHS trial in the second quarter, and announce the results of two Phase 2 Aging Frailty trials in the third quarter. We plan to initiate our Phase 2 Japanese Aging Frailty trial in the second half of this year, as well as initiate the Phase 2 HLHS trial in the second half of this year.

As I hope you will agree where we are working aggressively to advance LOMECEL-B through clinical trials in various indication.

As evidenced by our progress thus far, our core business strategy is to become a world-leading regenerative medicine company through development and commercialization of novel cell therapy products for unmet medical needs with an emphasis on aging-related indications.

With that, I will now turn the discussion over to James Clavijo, who will provide detailed information about our financial results for the quarter ended March 31, 2021.

James?.

Thank you, Geoff. Good morning everyone and thank you for joining us. Most of what I'll be covering this morning has been presented in more detail in our consolidated financial statements and in our management and discussion analysis of operations for the three months ended March 31, 2021 and 2020, which has been filed or will be filed today.

First quarter ended March 31, 2021 and 2020. Revenues for the three months ended March 31, 2021 and 2020 were approximately $0.4 million and $1.7 million respectively.

Revenues for the three months ended March 31, 2021 were approximately $1.3 million or 78% lower when compared to the same period in 2020, primarily due to a decrease in clinical trial revenue year-over-year and grant revenue compared to that recorded in 2020.

Grant revenue for the three months ended March 31, 2021 and 2020 was $0.2 million and $0.9 million respectively. Grant revenue for the three months ended March 31, 2021 was approximately $0.7 million or 78% lower when compared to the same period in 2020.

This resulted from less research grant funds being available as various company clinical trial programs concluded in the quarter. Clinical trial revenue, which comes from the company's Bahamas Registry Trial for the three months ended March 31, 2021 and 2020 was approximately $0.6 million or 78% lower when compared to the same period in 2020.

During the first quarter of 2021, clinical trial revenue which has comprised of the Bahamas Registry Trial was negatively impacted by the COVID-19 travel restrictions as participants continue to have concerns with respect to for international travel.

Research and development expenses for the three months ended March 31, 2021 increased to approximately $1.4 million from approximately $0.3 million for the same period in 2020.

This increase of $1.1 million or 367% was primarily due to an increase in research and development expenses that were not reimbursable by grants, including also a $0.4 million charge for equity-based compensation recorded from RSUs granted.

General and administrative expenses for the three months ended March 31, 2021 increased to approximately $2.2 million compared to $0.7 million for the same period in 2020.

The increase of approximately $1.5 million or 221% was primarily related to an increase for compensation insurance and professional expenses incurred during this current period, including $0.8 million of equity-based compensation recorded for RSUs granted.

Net loss increased approximately $3.1 million for the three months ended March 31, 2021 from a net loss of $0.2 million for the same period in 2020. Our cash as of March 31, 2021 was $24.5 million compared to $0.8 million as of December 31, 2020.

The increase in cash period over the period was a result of the completion of the company's IPO in February of this year. Our cash in the first quarter of 2021 had increased by $29.1 million in funds received from our IPO.

Therefore, we believe are based on our current operating plan and financial resources that are existing cash on hand will be sufficient to cover expenses and capital requirements through at least the fourth quarter of 2022. With that, I will turn the call back over to Geoff. Thank you..

Thank you, James. At this time, I think we will open the conference call for questions, and turn it back over to Bethany..

[Operator Instructions] We don't appear to be having any questions coming through on the telephone. So I will hand it back to Brendan..

Perfect. Well, thank you everyone for joining us today.

We did have one question submitted online for management with show many events to look forward to in this coming year, which of the milestones upcoming do you think will be most significant from an investor’s standpoint in terms of value inflection?.

Super, thank you for the question. The value driving events for all companies in this space for biotech companies that are conducting clinical research has always – the ability to generate both compelling data and data that allows you to transition into later stage trials. So the company is deep into Phase 1 and Phase2 trials.

And having the ability to go from Phase 1 into Phase 2 and launch a larger trial in such a difficult disease, such as Alzheimer's, for us, it is a very significant event. And I think you'll see that in the industry when companies are able to advance programs to the next stage towards commercialization in that disease.

There is a lot of enthusiasm around that, so I think that's a major step for the company.

The fact that there isn't a single drug approved or a therapeutic approved anywhere in the world for the indication of Aging Frailty, those two trials are events that we really look forward to, we've been working on aging frailty research for almost four years, now we have partners in the national institutes on aging.

We have a program that's ready to roll in Japan, which is a super aged society. So I think everybody out there should be looking forward to the data and looking forward to see if there is a potential treatment on the horizon that can prevent or reverse these sort of progressive degenerative and devastating syndromes like aging related frailties.

So it's the release of data and the transition to these new phases of development that for us are really the catalyst that we're looking forward to. I would ask our Chief Science Officer, Joshua Hare to maybe add to that..

Thanks, Geoff.

Yes, I would completely agree that we face a very exciting upcoming two quarters, where we'll be releasing a substantial amounts of new clinical information and disseminating that information at important venues, such as the Alzheimer's association, national meeting in July and the international society for Sarcopenia and frailty research.

So the timing is very fortunate in that we have a large amount of data being released in a short amount of time, that together will catalyze the future directions of the company, and allow us to optimize the development strategies that we'll be using to take this product from where it is now through to approval in major venues like the United States and/or Japan..

Excellent. Thank you..

This concludes today's conference call. Ladies and gentlemen, thank you for joining us; and you may now disconnect your lines..