Ladies and gentlemen, welcome to the Longeveron Inc. 2020 Year-End Earnings Call. My name is Abby, and I’ll be coordinating your call today. [Operator Instructions] I will now hand over to our host, Natalya Rudman from Crescendo Communication. Please go ahead, Natalya..

Good morning and thank you for joining today’s conference call to discuss Longeveron’s corporate developments and financial results for 2020 fiscal year ended December 31, 2020. With us today are Geoff Green, the company’s CEO; Dr.

Joshua Hare, Co-Founder and Chief Executive Scientific Officer and Chairman; as well as James Clavijo, the company’s Chief Financial Officer. Today Longeveron released financial results for the fiscal year ended December 31, 2020. 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. 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, Tuesday, March 30, 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..

Thanks, Natalya. Good morning, everyone, and welcome to Longeveron’s year-end 2020 business update call. This will be our first as a publicly traded company. We’re excited to describe and share the tremendous progress we’ve made throughout 2020 and into 2021, and to layout the near-term milestones we are targeting in our various development programs.

Since some of you may be new to the company, since our IPO have just occurred in February of this year, I will give you a very brief history of Longeveron to provide some context as to how we arrived at, where we are today and where we’re headed. Longeveron was founded in 2014 by Dr.

Joshua Hare, a cardiologist at the University of Miami, Miller School of Medicine and a Co-Founder of the Interdisciplinary Stem Cell Institute, also at the University of Miami; and Don Soffer, a wealthy, retired real estate developer and philanthropists.

I’m sorry, can someone mute their phone, please? The company was founded on the premise with the very cells within our bodies whose primary function is to repair, restore and regenerate damaged tissue and organs maybe developed with safe and effective off-the-shelf cell therapy to treat chronic aging related diseases and other life-threatening conditions, to improve health span and substantially extent longevity.

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. When we’re young, we have an adequate supply of these cells and they function as intended.

Unfortunately, in both humans and in animals, there is a clear age-related decline in both the number and potency of these cells. And this is believed to be one of the primary reasons for age associated increase in chronic disease.

Longeveron’s lead therapeutic investigational product called Lomecel-B is produced from these specialized cells, which are sourced from the bone marrow of young healthy adult donors aged 18 to 45. These cells are the starting raw material used to produce Lomecel-B, which is being tested in multiple clinical trials for several indications.

Because the cells are donated from another individual, Lomecel-B is referred to as an allogeneic product. These cells have special characteristics that allow them to be transplanted from a donor to a host without triggering a harmful immune response in a recipient.

So far, we have tested Lomecel-B infusion or injection in over 260 subjects to date in our various clinical research programs. So we have assembled a fairly extensive body of evidence, documenting safety and tolerability.

To produce Lomecel-B, we operate a cGMP compliance, cell processing and product development facility, co-located with our corporate headquarters in Miami, Florida. Now, let me provide a little bit more detail on the clinical research status of Lomecel-B.

Since the beginning operations in late 2014, we have had five INDs filed and accepted by the USFDA, initiated five Phase 1 or 2 clinical trials, and completed three out of five of these trials. In addition, we have clinical programs in both Japan and The Bahamas, which I will highlight shortly. Starting with our Alzheimer’s disease program.

In the fall of 2020, we successfully completed our Phase 1 trial of Lomecel-B infusion in mild Alzheimer’s subjects. The trial value and the safety and tolerability of a single IV infusion of two different doses of Lomecel-B compared to placebo in a 52-week study.

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 society. With no cure, Alzheimer’s is currently the sixth leading cause of death in the United States.

In fact, the Alzheimer’s Association estimates that as many as 14 million Americans will be afflicted by 2050, barring significant medical breakthroughs.

Despite decades of research, the biotechnology and pharmaceutical industries have not succeeded in developing a safe and effective FDA approved treatment that can prevent, slow down or reverse the progression of Alzheimer’s and here’s where we come in.

We’re testing Lomecel-B as a potential treatment for Alzheimer’s based on the hypothesis that it’s multiple and possible mechanisms of actions can simultaneously address multiple features of the disease.

Preclinical studies show that MSCs can potentially reduce Alzheimer’s associated brain inflammation, improve the function of blood vessels in the brain and reduce brain damage to Alzheimer’s progression due to Alzheimer’s progression and promote regenerative responses.

As reported by the company earlier this year, we are extremely pleased with the safety and top line efficacy, exploratory efficacy results from our Phase 1 study. In that trial, which enrolled 33 subjects, Lomecel-B was well tolerated with no significant or serious adverse events that were considered related to our investigational products.

Notably, exploratory efficacy showed on average a slowing of the decline in cognitive function in the Lomecel-B treated subjects compared to the placebo treated subjects as measured by the commonly used Mini-Mental State Exam through 12 months with a statistical significant – statistically significant difference observed at nine months post treatment.

Additionally, MRI analysis indicated a significant difference in the average volume of the hippocampus at six months for Lomecel-B treated subjects compared to placebo treated subjects.

This is potentially very exciting because the hippocampus at the site of neurogenesis is responsible for memory formation, and is the area of the brain that atrophies in Alzheimer’s disease patients.

The results of the trial are being prepared for publication, and we anticipate the remainder of the data analysis, which includes a more extensive analysis of the efficacy, further MRI analysis and biomarker results will be announced by us in the second quarter of 2021.

Based on these results, we are actively planning for a larger Phase 2 study, which we expect to initiate in the second half of 2021. Now let’s turn to our Aging Frailty program. Aging Frailty is a clinically defined and extreme form of unsuccessful aging.

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

A diagnosis of Aging Frailty in the case of 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 the potential clinical and regulatory pathways for a future approval.

Leading geriatricians and epidemiologists from Johns Hopkins University estimate approximately 15% of the community dwelling individuals 65 years and older in the U.S. have Aging Frailty and another 45% are considered at risk for becoming frail or pre-frail. These equate to 8.1 million and 24.3 million people respectively.

In Japan, which is a considered a super aged society, approximately 29% of its population is over the age of 65, and caring for its frail elderly population represents a significant challenge for the government and its single payer healthcare system. There are an estimated 2.65 million Aging Frailty patients in Japan.

So we are evaluating Lomecel-B as a treatment for Aging Frailty because the potential mechanisms of action may address the biological underpinnings of this condition.

Foremost, Lomecel-B has the potential to reduce chronic inflammation associated with Aging Frailty and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which in turn could foster and promote regeneration of tissue and promote physiological restoration to a more healthful state.

As our early clinical data show, Lomecel-B may be able to improve aspects of physical functioning, as well as immune functions. We are currently conducting two multicenter trials in the U.S.

for Aging Frailty, have received Pharmaceuticals and Medical Devices Agency or PMDA approval to conduct a Phase 2 Aging Frailty clinical trial in Japan and have government approval to use Lomecel-B for Aging Frailty participants in a Registry Trial that is actively enrolling in The Bahamas. Our Phase 2 or U.S.

Phase 2b trial is our most advanced clinical trial in the frailty program. We completed the trial on February 2021 and the top line data are expected to be announced in the third quarter of 2021.

This 150 subject trial is evaluating the effect of Lomecel-B infusion compared to placebo on physical function and endurance by using the 6 Minute Walk Test at 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 to name a few. Our other U.S.

frailty trial is the Phase 1/2 HERA trial, which was designed to evaluate whether the Lomecel-B can improve immune response to influenza vaccine in frailty subjects, as well as to evaluate Lomecel-B’s possible effects on the frailty endpoints I’ve listed for the 150 subject U.S. frailty to 2b trial.

We expect the trial to be completed imminently and anticipate announcing top line data also in the third quarter of this year. The primary measure of efficacy in the HERA study is serum antibody production as measured by hemagglutination inhibition assay for treated subjects compared to placebo subjects.

In 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved the clinical trial notification, which is equivalent to U.S. IND, allowing an investigator initiated Phase 2 clinical study for Aging Frailty subjects in Japan, which we plan to initiate this year.

This trial will be led by the national center for geriatrics and gerontology, which is the Japanese equivalent of 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 PMDA and a hospital-based approval using a self-pay model.

We viewed this as a very significant opportunity for the company because of the potentially faster pathway to a marketing authorization. And finally, in both the frailty and the 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 participants 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 offset the cost of sponsoring the Registry Trial.

In 2020, despite the impact of the pandemic and travel restrictions into The Bahamas, which limited international visitors to just five months out of the year, the participation and revenue of this program for just those five months exceeded all of that of 2019.

As travel restrictions ease and vaccination rates increase in the elderly population, we hope to continue the momentum that was building in 2020 prior to the pandemic. This program has generated substantial amount of additional clinical data in addition to the trial data from our U.S. clinical studies.

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 reaching up to 40%.

These numbers are likely to increase as a result of COVID-19, which could become a seasonal epidemic. Older persons and those with Aging Frailty and those with 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 this randomized, double-blind, placebo-controlled trial and expect the trial to be completed in 2022.

For the purpose of facilitating enrollment and adjusting to evolving conditions related to COVID-19 and the influenza season, we recently announced that the enrollment criteria for the Phase 1 ARDS RECOVER trial have been expanded to include mild ARDS in addition to moderate and severe ARDS.

The protocol amendment allows for the inclusion of milder cases in addition to those who are on mechanical ventilation. The goal here is to use Lomecel-B to potentially reduce the cytokine storm involved in ARDS, and thus possibly to improve clinical health outcomes in these patients.

And 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 missing altogether.

Babies born with HLHS now undergo a complex three stage heart reconstruction over the course of years, which improves the survival rates.

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 which may improve short-term and long-term outcomes.

We are evaluating intramyocardial injection of Lomecel-B as a potential combinatorial therapy with HLHS surgery to improve these short and long-term clinical outcomes. We are evaluating whether a direct injection into the heart can improve right ventricular function by promoting regenerative and repair responses.

To that end, we have completed a 10 patient multicenter open-label Phase 1 clinical trial, and we expect Phase 1 top line data in the second quarter of this year. And for the Phase 2 study to initiate in the second half of 2021.

This month, we announced that Lomecel-B was approved by the FDA for compassionate use for the treatment of a child with HLHS, FDA has expanded access program also called compassionate use provides a pathway for patients to gain access to investigational drugs, biologics and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of a clinical trial.

So we are very pleased that FDA has granted Lomecel-B compassionate use, and we are hoping this therapy will be a game changer for this child and others in the future.

As you can see, we are aggressively advancing our clinical trials and we haven’t reached this level alone, since our founding in 2014, our programs have been awarded – approximately $16 million in grant funding from various organizations that include the National Institute on Aging, the National Heart, Lung and Blood Institute, the Alzheimer’s Association and the Maryland Stem Cell Research Fund from the TEDCO grant.

Since 2015, we have received approximately $56.1 million in equity financing, have been awarded the $16 million in non-dilutive grant funds for our programs and have generated approximately $3.8 [ph] million in non-grant revenue, primarily from clinical trial revenue and strategic contract manufacturing agreements.

Furthermore, earlier this month, we announced expanding and amending our exclusive license agreement related to the Lomecel-B technology rights and entered into a collaborative research and development agreement with the University of Miami.

In February, 2021, we completed our initial public offering and raised $29.1 million, which includes a partial exercise of the overlapping option. This marked a significant milestone for Longeveron and the net proceeds from our IPO allows us to complete current ongoing clinical trials as well as allows us to initiate additional clinical trials.

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

To close, I want to summarize the near-term milestones that we believe will drive significant shareholder value, including full clinical trial results from four Phase 1 and 2 trials expected this year, which include Phase 1 Alzheimer’s disease, two Phase 2 Aging Frailty trials, and a Phase 1 HLHS trial.

And the initiation of at least three Phase 2 trials for Alzheimer’s disease, Aging Frailty and Hypoplastic Left Heart Syndrome.

We are working aggressively to advance Lomecel-B through clinical trials in these various indications and we remain extremely encouraged by the outlook for the company, I believe we are well positioned to execute on a corporate strategy, especially following our IPO.

With that, I will now turn the discussion over to James Clavijo, CFO, who will provide detailed information about our financial results for the year ended December 31, 2020..

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 discussion and analysis, operations for the year ended December 31, 2020 and 2019, which has been filed today.

For the quarter ended December 31, 2020 and 2019, total revenue consisting of revenue from grants and clinical trials from our Bahamas Registry Trial was $1.2 million for the fourth quarter of 2020, compared to revenue of $1.8 million for the fourth quarter of 2019.

This decrease was a result of a decrease in grant revenue of $0.8 million for 2020 as compared to the same period in 2019, which was expected and a function of the pre-planned timing of release of funds according to the terms of the various grants.

Revenue from our Bahamas Registry Trial increased by $0.3 million or 119% for 2020 as compared to the same period in 2019; despite international travel being severely negatively impacted by COVID-19. Research and development expenses were $1.2 million for the fourth quarter of 2020, compared to $0.3 million for the fourth quarter of 2019.

The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants. General and administrative expenses were $0.7 million for the fourth quarter of 2020 and 2019, respectively. Our net loss was $1.4 million for the fourth quarter of 2020, compared to $0.5 million for the fourth quarter of 2019.

For the year ended December 31, 2020 and 2019, our total revenue, consisting of revenues from grants and clinical trials and contract manufacturing was $5.6 million for the years, both years ended 2020, and 2019 respectively.

Grant revenue was $4.3 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. Revenue from the Bahamas Registry Trial was $1.3 million for the year ended December 31, 2020, compared to $1.2 million for the year ended December 31, 2019.

And contract manufacturing revenue was $0.1 million for the year ended December 31, 2020, compared to $0.3 million for the year ended December 31, 2019. This decrease was primarily due to COVID-19 related decrease in travel, which restricted the business development and marketing of these services.

Research and development expenses were $2.7 million for the year ended December 31, 2020, compared to $1.8 million for the year ended December 31, 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants.

We expect that our research and development expenses will increase in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.

General and administrative expenses were $2.7 million for the year ended December 31, 2020, compared to $2.8 million for the year ended December 31, 2019. Expenses remained relatively consistent for 2020 compared to 2019.

General and administrative expenses consisted primarily of rent, professional fees, insurance, and paid and accrued compensation costs. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support increased administrative activities relating to our becoming a public company.

We also expect to incur additional expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Our net loss for December 31, 2020 was $3.7 million, compared to $3.0 million for the year ended December 31, 2019. And finally our cash of December 31, 2020 was $0.8 million, compared to $1.9 million as of December 31, 2019. Our financial outlook. Our cash in 2021 was increased by the funds received from our IPO, with gross $29.1 million from our IPO.

As of March 30, 2021, our cash was $24.5 million. We believe that based on our current operating plan and financial resources that our cash 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 to Geoff..

Thank you, James. We’ll now take the time to open the conference call for questions.

Operator?.

[Operator Instructions] So we have a question come through here from, let me just check, sorry, Nicole Kaufmann [ph] from Black Ridge Capital [ph]. Nicole, your line is now open, please go ahead..

Hi, good morning. Congratulations on your recent IPO.

Do you mind expanding a bit on the impact of COVID and the expectations for the Bahamas Registry Trial after the pandemic?.

Hey, good morning, Nicole. Thanks for joining the call, this is Geoff Green. So the impact was primarily a restriction of international visitors and it’s restricted to a five month period, primarily in the beginning of 2020, after the spring it was locked down for the most part, the remainder of the year.

I believe it opened towards the end of the year under certain rules and restrictions. And so, the company was building momentum throughout the beginning part of the year in 2020.

And now that travel is open to the Bahamas, we’re not seeing an increase necessarily yet of back to normal levels, but we’re hoping that we see normal levels of travel and we hope that, that will be a positive impact on the participation in the Bahamas Registry in the future..

All right, great. I have a follow-up question. This is regarding the Alzheimer’s trial program that you have.

And can you let me know how many other approaches to Alzheimer’s have not been successful and why you guys are confident in the outlook for your program?.

I could not guess at the number of attempts at Alzheimer’s, I know it’s a very large number of investigational agents have been tried in clinical trials in the United States and throughout the world, it’s a very difficult disease to treat.

And to-date the approved products, I believe are – you are approved to treat the symptoms associated with the disease.

And so Longeveron is taking an approach where the Mesenchymal Stem Cells or medicinal signaling cells that we make, we need to have very potent anti-inflammatory properties and the goal would be to use a systemic peripheral IV infusion, where the cells would travel systemically throughout the body and impact not only the body but the brain, primarily as through the anti-inflammatory pathways that we believe are core to the mechanisms of action of these cells.

And so the preclinical evidence is supporting the approach, we’re one of the few companies in the clinic that are attempting this and we’ve just gotten over the first significant hurdle, which is to establish a safety profile in a Phase 1 program.

And so, now the program is transitioning to Phase 2, where it will be designed to look more carefully at efficacy. And we’re excited about the preliminary efficacy from the Phase 1 study, and we’ll expand the trial to make it larger and larger sample size, so that we can focus more on the efficacy endpoints..

Well, thank you very much and thanks for taking my questions. Congratulations so far and looking forward to your success. If I have more questions, I’ll jump in the queue. Thanks again..

Thank you..

[Operator Instructions] So I can assume we don’t have any further questions on the line at this moment. So I hand back over to the management team for any closing remarks..

This is Geoff Green; Dr. Hare is there, did you want to do any follow-up on the question about Alzheimer’s with Nicole? I think he is on mute. Okay, well no further remarks.

Thank you for taking the time for everyone to listening in our conference call and for your continued support and interest in Longeveron and we look forward to updating you again when we discuss the first quarter 2021 results..

Ladies and gentlemen, this concludes today’s call. Thank you for joining. You may now disconnect your lines..