LONGEVERON INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) – Marketscreener.com

In this document, the terms "Longeveron," "Company," "we," "us," and "our" referto Longeveron Inc. We have no subsidiaries.

This Quarterly Report on Form 10-Q (this "10-Q") contains forward-lookingstatements, within the meaning of the Private Securities Litigation Reform Actof 1995, that reflect our current expectations about our future results,performance, prospects and opportunities. This 10-Q contains forward-lookingstatements that can involve substantial risks and uncertainties. All statementsother than statements of historical facts contained in this report, includingstatements regarding our future results of operations and financial position,business strategy, prospective products, product approvals, research anddevelopment costs, future revenue, timing and likelihood of success, plans andobjectives of management for future operations, future results of anticipatedproducts and prospects, plans and objectives of management are forward-lookingstatements. These statements involve known and unknown risks, uncertainties andother important factors that may cause our actual results, performance orachievements to be materially different from any future results, performance orachievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as"anticipate," "believe," "contemplate," "continue," "could," "estimate,""expect," "intend," "may," "plan," "potential," "predict," "project," "should,""target," "will," or "would" or the negative of these terms or other similarexpressions, although not all forward-looking statements contain these words.Factors that could cause actual results to differ materially from thoseexpressed or implied in any forward-looking statements contained in this reportinclude, but are not limited to, statements about:

The forward-looking statements contained in this 10-Q are made on the basis ofthe views and assumptions of management regarding future events and businessperformance as of the date this 10-Q is filed with the Securities and ExchangeCommission (the "SEC"). In addition, we operate in a highly competitive andrapidly changing environment; therefore, new risk factors can arise, and it isnot possible for management to predict all such risk factors, nor to assess theimpact of all such risk factors on our business or the extent to which anyindividual risk factor, or combination of risk factors, may cause results todiffer materially from those contained in any forward-looking statement. We donot undertake any obligation to update these statements to reflect events orcircumstances occurring after the date this 10-Q is filed. In addition, thisdiscussion and analysis should be read in conjunction with our unauditedfinancial statements and notes thereto included in this 10-Q and the auditedfinancial statements and notes thereto included in our Annual Report on Form10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022("2021 10-K"). Operating results are not necessarily indicative of results thatmay occur in future periods.

Overview and Recent Developments

We are a clinical stage biotechnology company developing cellular therapies forspecific aging-related and life-threatening conditions. Our lead investigationalproduct is the LOMECEL-B cell-based therapy product ("Lomecel-B"), which isderived from culture-expanded medicinal signaling cells (MSCs) that are sourcedfrom bone marrow of young healthy adult donors. We believe that by using thesame cells that promote tissue repair, organ maintenance, and immune systemfunction, we can develop safe and effective therapies for some of the mostdifficult disorders associated with the aging process and other conditions.

We are currently sponsoring or have sponsored Phase 1 and 2 clinical trials inthe following indications: Aging Frailty, Alzheimer's disease (AD), theMetabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplasticleft heart syndrome (HLHS). Our mission is to advance Lomecel-B and othercell-based product candidates into pivotal Phase 3 trials, with the goal ofachieving regulatory approvals, subsequent commercialization and broad use bythe healthcare community.

Our philosophy is that healthy aging can be improved through regenerativemedicine approaches. Life expectancy has substantially increased over the pastcentury as a result of medical and public health advancements. However, thisincrease in longevity has not been paralleled by the number of years a person isexpected to live in relatively good health, with limited chronic disease anddisabilities of aging - a period known as healthspan. As we age, we experience:a decline in our own stem cells; a decrease in immune system function, known asimmunosenescence; diminished blood vessel functioning; chronic inflammation,known as "inflammaging"; and other aging-related declines. Our preliminaryclinical data suggest that Lomecel-B can potentially address these problemsthrough multiple mechanisms of action, or MOAs, that simultaneously target keyaging-related processes.

Improving healthspan is an imperative for governmental health agencies. TheNational Institute on Aging (NIA), an institute of the National Institutes ofHealth (NIH), has promoted the concept of geroscience - the idea that agingitself is the biggest risk factor for aging-related human diseases and thataging can be approached as a treatable disease to improve healthspan. Thegeroscience hypothesis provides a strong rationale for the approach of treatingunderlying biological processes contributing to aging as a way to reduce diseaseburden and advance global human health. Our investments into developing andtesting product candidates are aimed at reducing aging-related disease burdenand improving healthspan.

Our core business strategy is to become a world leading regenerative medicinecompany through the development and commercialization of novel cell therapyproducts for unmet medical needs, with emphasis on aging-related indications.Key elements of our business strategy are as follows.

? Advance Lomecel-B and other regenerative medicine products to market. We are

advancing Lomecel-B into later stage clinical trials for the purpose of

achieving commercialization in one or more indications. Our studies throughout

the clinical development process are intended to generate safety and efficacy

data needed to advance these programs, and establish foundations for subsequent

development and expansion into new areas. We will continue to leverage our

technical and clinical expertise, and relationships with clinical

investigators, treatment centers, and other key stakeholders, to explore new

? Expand our manufacturing capabilities to commercial-scale production. We

operate a good manufacturing practice (GMP) - compliant manufacturing facility

and produce our own product candidates for testing. We continue to improve and

expand our capabilities with the goal of achieving cost-effective manufacturing

that may potentially satisfy future commercial demand should Lomecel-B achieve

? Non-dilutive funding. Our clinical programs have received over $16.0 million in

competitive extramural grant awards ($11.9 million which has been directly

awarded to us and which are recognized as revenue when the performance

obligations are met) from the NIH, Alzheimer's Association, and Maryland Stem

Cell Research Fund (MSCRF). These prestigious funding awards are non-dilutive

and allow us to collaborate with state and federal partners in pursuing safe

and effective therapeutics for disorders that have few, if any, available

? Continue to develop our existing international programs. We have selected Japan

as our first non-U.S. territory for a randomized, double-blinded,

placebo-controlled clinical trial to evaluate Lomecel-B for Aging Frailty. We

may explore other indications in Japan, and potentially pursue Aging Frailty

and other indications in additional international locations for further

development and commercialization.

? Collaboration arrangements and out-licensing opportunities. We will be

opportunistic and consider entering into co-development, out-licensing,

commercialization or other collaboration agreements for the purpose of

commercializing Lomecel-B and other products domestically and internationally.

? Product candidate development pipeline through internal research and

development, and in-licensing. Through our research and development program,

and through strategic in-licensing agreements, or other business development

arrangements, we continue to actively explore promising potential additions to

our pipeline of product candidates.

? Continue to expand our intellectual property portfolio. Our intellectual

property is vitally important to our business strategy, and we take significant

steps to develop this property and protect its value. Results from our ongoing

research and development efforts are intended to add to our existing

intellectual property portfolio.

We continue to monitor how the COVID-19 pandemic is affecting our employees,business, and clinical trials. During the initial stages associated with thespread of COVID-19, we instructed all employees who could perform theiressential employment duties from home to do so. Our laboratory scientists, cellprocessing scientists and other manufacturing personnel continued to work fromour GMP facility and headquarters on a day-to-day basis, and as such cellproduction has been minimally impacted. When the pandemic began to emerge in theU.S., most of our ongoing clinical trials had completed enrollment. However, afew subjects that were currently on study and in follow-up experienced somedifficulties in adhering to the protocol schedule. Because we primarily enrollelderly subjects in our trials, who are at particular risk for poor outcomesrelated to COVID-19 infection, we experienced some disruption in executing thefollow-up visits in our protocols. These disruptions were due to a number ofreasons that include an unwillingness of the subject to leave their residence tovisit the hospital or clinic, the inability to leave their residence due toregional "stay-at-home" orders, and temporary clinical site closures. We haveattempted to mitigate this disruption by conducting remote visits where feasible(telemedicine), arranging for in-home visits for phlebotomy in order to collectblood samples and perform protocol-specific assessments if feasible, andamending protocols to increase the window of time for follow-up visits. In spiteof these efforts, several subjects either missed their scheduled follow upvisit, had their follow up visit outside of the protocol-defined window of time,or dropped out of the trial prior to completing. While we believe the number ofinstances where a visit was missed completely is small, we cannot predictwhether this will have a material impact on our clinical results until the datafrom the trials are analyzed. If too many subjects drop-out or the protocol isno longer effective, we may have to restart the clinical trial entirely.

In July 2020 the Bahamian government halted travel from the U.S. into TheBahamas, which resulted in the temporary cessation of participation in TheBahamas Registry Trial. While this travel restriction has now been lifted,participation in the Registry Trial remains lower than anticipated, due in partto pandemic-related effects on international travel.

Presently, several Longeveron employees continue to work from home either fulltime, or through a hybrid schedule, and we anticipate that this will continuefor the foreseeable future. We expect that the COVID-19 pandemic may continue toimpact our business, results of operations, clinical development timelines andfinancial condition. At this time, there is significant uncertainty relating tothe trajectory of the COVID-19 pandemic and impact of related responses. Theimpact of COVID-19 on our future results will largely depend on futuredevelopments, which are highly uncertain and cannot be predicted withconfidence, such as the ultimate geographic concentration and continued spreadof the disease, the duration of the pandemic, travel restrictions to and socialdistancing within the United States and other countries, business closures orbusiness disruptions, the continued impact on financial markets and the globaleconomy, and the effectiveness of the global response to contain and treat thedisease.

Lomecel-B for Alzheimer's Disease:

? In January 2022, we initiated enrollment of a 48-patient, 4-arm, parallel

design, randomized (1:1:1:1) Phase 2a clinical trial of Lomecel-B infusion in

patients with mild Alzheimer's disease. This study is intended to evaluate the

safety of single and multiple administrations of Lomecel-B compared to placebo

according to the following treatment groups:

o Group 1 (n=12): Placebo infusion (zero cells) on day 0, weeks 4, 8 and 12

o Group 2 (n=12): Lomecel-B infusion (25 million cells) on day 0, followed by

placebo infusions at Weeks 4, 8 and 12

o Group 3 (n=12): Lomecel-B infusion (25 million cells) on day 0, weeks 4, 8, and

12

o Group 4 (n=12): Lomecel-B infusion (100 million cells) on day 0, weeks 4, 8,

and 12

? Other endpoints in the Phase 2a trial include brain volumetry by MRI,

biomarkers relevant to inflammation and endothelial/vascular systems, and

measures of cognitive function. We currently plan to activate up to 12 clinical

sites to facilitate enrollment, and intend to provide updates on anticipated

enrollment rates as additional sites are activated, as well as trial completion

guidance at a later date. Further details about the trial design can be found

on clinicaltrials.gov by entering trial identifier NCT05233774.

? On March 31, 2022, we announced the publication of a manuscript in Alzheimer's

& Dementia: The Journal of the Alzheimer's Association detailing the

previously completed and announced Phase 1 Alzheimer's disease trial results.

Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS):

? The ELPIS II trial (Phase 2a) continues to enroll infants in the 38-patient,

2-arm, parallel design, randomized (1:1), blinded controlled trial intended to

evaluate the safety and efficacy of Lomecel-B injection into the right

ventricle of children born with HLHS who are undergoing Stage II reconstructive

cardiac surgery. All seven planned clinical sites have now been activated for

screening and enrollment and additional sites are being considered.

? We anticipate that a manuscript detailing the full Phase 1 ("ELPIS I") trial

results (the top-line data having been previously announced on September 9,

2021), to be submitted to a peer-reviewed journal, with acceptance and

publication currently anticipated in 2022.

Lomecel-B for Aging Frailty:

? The planned Japanese Aging Frailty Phase 2 trial is currently on track to

initiate in the first half of 2022. This is an investigator-initiated 3-arm,

parallel design, randomized (1:1:1), placebo-controlled, double-blind single

infusion study of two different dose levels of Lomecel-B being conducted by our

clinical partners at the National Center for Geriatrics & Gerontology (NCGG;

Nagoya), and Juntendo University Hospital (Tokyo).

? Top-line results from the Phase 1/2 "HERA" Aging Frailty trial are currently

expected to be disclosed in the first half of 2022. The HERA Trial is a small

multicenter, randomized, placebo-controlled study intended primarily to

evaluate safety, and to explore the effect Lomecel-B may have on specific

biomarkers of immune system function in older individuals with mild to moderate

Aging Frailty who received the high dose influenza vaccine, as well as evaluate

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LONGEVERON INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - Marketscreener.com