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Longeveron Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results Miami, Florida

Key Takeaway: Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results Miami, Florida-March 30, 2021- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related

Full Press Release Details

Provides Corporate Update and Reports
Fourth Quarter and Full Year 2020 Financial Results
Miami, Florida-March
30, 2021- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company
developing cellular therapies for chronic aging-related and life-threatening conditions, today reported its financial results for the
quarter and full year ended December 31, 2020 and provided a business update.
Primary Accomplishments
of the significant progress made throughout 2020 and into 2021, including our successful IPO in February, which has positioned Longeveron
with a stronger balance sheet and the ability to continue to advance the diverse Lomecel-B pipeline of trials," stated Geoff Green,
Chief Executive Officer of Longeveron. "The Company was founded with the goal of developing safe and effective "off-the-shelf"
cell therapies that could be used to treat chronic aging-related disease, improve health span and potentially extend longevity. In 2020,
in conjunction with our funding partner, the Alzheimer's Association, we completed a Phase 1 Alzheimer's disease trial. We
are extremely pleased with the safety and preliminary efficacy results. We look forward to announcing the final results in the second
quarter of 2021 and initiating the planned Phase 2 multidose trial later this year. Additionally, both of our US Aging Frailty Phase
2 trials will have top line efficacy data available in the 3rd quarter of 2021. This will be very exciting year for Longeveron,
with several clinical trial and clinical data-driven catalysts on the near horizon."
Aging Frailty research program spans 5 clinical programs in 3 different countries, and includes two US randomized, placebo-controlled
Phase 2 trials, a sub-study of the effects of Lomecel-B in Aging Frailty subjects with Metabolic Syndrome, a Japanese Phase 2 study pending
initiation, and a Treatment Registry Trial in Nassau, The Bahamas.
PMDA has approved a Phase 2 clinical trial of Lomecel-B infusion in Japanese Aging Frailty subjects, which we expect to initiate in 2021.
This trial will be led by the National Center for Geriatrics and Gerontology, the Japanese equivalent to the National Institute on Aging
in the US. Similar to our US Phase 2b trial, the objective of this trial is to evaluate the ability for Lomecel-B infusion to improve
physical mobility and endurance in Aging Frailty subjects 70 to 85 years of age. Japan is a "super-aged" society and preventing
and treating frailty is a priority for the nation. With it's progressive and favorable regulatory framework for regenerative medicine
products, Japan offers several expedited pathways to market, including conditional marketing approval, at the option of Japanese health
regulators, after Phase 2, and a hospital-based approval that is a self-pay model known in Japan as the Act on the Safety of Regenerative
Medicine, or ASRM route."
the fact that travel into The Bahamas was only allowed for approximately 5 months due to COVID-19, the Company's Treatment Registry
Trial participation and revenue exceeded all of 2019. This reflects increased momentum and demand for participation in the Registry,
which the Company anticipates will continue as travel begins to return to normal activity.
current exception to its focus on chronic aging-related disease is the research program for children born with Hypoplastic Left Heart
Syndrome (HLHS), a rare congenital heart defect that affects about 1,000 babies per year. In that program, Lomecel-B is administered
via direct injection into the heart during pre-planned standard-of-care reconstructive surgery. In February 2021, the Company announced
the completion of a 10 subject Phase 1 safety study, funded in part by a Maryland Stem Cell Research Fund TEDCO grant, and preparation
for the Phase 2 randomized, placebo-controlled study are underway. The NHLBI is the funding partner for the Phase 2 study, and it will
be conducted through a consortium of leading pediatric cardiac surgeons in the US, led by Dr. Sunjay Kaushal at the Lurie Children's
Hospital in Chicago, Illinois.
from the recent IPO enable the Company to complete current ongoing clinical trials, and to initiate at least 4 additional Phase 2 clinical
trials, with 3 of those 4 trials expected to initiate this year: Japan Aging Frailty Phase 2 Trial; multidose Alzheimer's disease
Phase 2 trial, and HLHS Phase 2 trial.
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 is 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.
Expenses: 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.
Expenses: General and administrative expenses were $0.7 million for the fourth quarter of 2020 and 2019, respectively.
Loss: Net loss was $1.4 million for the fourth quarter of 2020, compared to $0.5 million for the fourth quarter of 2019.
Years Ended December 31, 2020 and
Total revenue, consisting of revenue from grants, clinical trials (from our Bahamas Registry Trial), and contract manufacturing,
was $5.6 million for the years ended December 31, 2020, and 2019. 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. 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.
Expenses: 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.
Expenses: 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.
Loss: Net loss was $3.7 million for the year ended December 31, 2020, compared to $3.0 million for the year ended December 31,
Cash as of December 31, 2020 was $0.8 million, compared to $1.9 million as of December 31, 2019.
first quarter of 2021 was increased by the $29.1 million (gross) in funds received from our IPO. As of March 30, 2021, our cash position
was $24.5 million. We believe, based on the current operating plan and financial resources, that our existing cash on hand will be sufficient
to cover expenses and capital requirements through at least the fourth quarter of 2022.
host a conference call today at 8:30 a.m. Eastern Time to discuss its fiscal 2020 financial results and provide a business update.
call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers
and using entry code 094408. You may also pre-register for the event. A webcast of the call may be accessed here or on the Company's
of the of the call will be available through April 6, 2021 and can be accessed here and by entering the access code: 40245, and will
remain online for one year through March 30, 2022.
clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company's
lead investigational product is the LOMECEL-B cell-based therapy product ("Lomecel-B"), which is derived from culture-expanded
medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using
the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies
for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring
Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer's disease, the Metabolic Syndrome, Acute Respiratory
Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company's mission is to advance Lomecel-B and other cell-based
product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad
use by the healthcare community. Additional information about the Company is available at www.longeveron.com
Regarding Forward-Looking Statements
in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions,
and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ
materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of
forward-looking terminology such as "believe," "expects," "may," "looks to," "will,"
"should," "plan," "intend," "on condition," "target," "see," "potential,"
"estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion
of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include,
but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates,
and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market
opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
Last updated: Mar 30, 2021