Full Press Release Details
Announces Fourth Quarter and Full Year 2021
Financial Results and Operational Progress
Enrolling Clinical Trials with Lomecel-B in Three Disease Indications:
Hypoplastic Left Heart Syndrome (Phase 2a), Alzheimer's Disease
and Covid-related Acute Respiratory Distress Syndrome (Phase 1)
Lomecel-B for HLSH Granted Rare Pediatric Disease
and Orphan Drug Designation by the US FDA
Japanese Phase 2 Aging Frailty Trial Expected
to Initiate in First Half of 2022
Multiple Clinical Data Publications Expected
- Conference Call Today at 8:30 a.m. EST -
Miami, Florida-March 11, 2022-
Longeveron Inc. (NASDAQ: LGVN) (the "Company," "Longeveron" or "we," "us," or "our"),
a clinical stage biopharmaceutical company developing cellular therapies for chronic, aging-related and life-threatening conditions, today
reported recent business highlights and key upcoming catalysts for 2022, and its financial results for the fourth quarter and full year
"For Longeveron, 2021 was a year defined
by effective execution, successful financings, and significant progress across our robust Lomecel-B pipeline of clinical trials,"
said Geoff Green, Chief Executive Officer at Longeveron. "Since our IPO in February of last year, important progress has been made
in advancing Lomecel-B into next phase trials, including initiation of Phase 2 trials in Alzheimer's and Hypoplastic Left Heart
Syndrome (HLHS), with the latter receiving both Orphan Drug and Rare Pediatric Disease designations from the FDA. Additionally, we successfully
closed a $20.5 million private placement of our common stock in the fourth quarter of 2021 to provide capital that we believe will be
sufficient to support our ongoing research and operations into 2024. We anticipate 2022 to be another eventful year as we continue to
work to demonstrate the potential therapeutic benefit of Lomecel-B across many life-threatening conditions."
Lomecel-B for Alzheimer's
Lomecel-B for Hypoplastic
Left Heart Syndrome (HLHS):
Lomecel-B for Aging Frailty:
Lomecel-B for Acute Respiratory
Distress Syndrome Due to COVID 19 Infection:
Financial Results for Full Year and Fourth
Quarter Ended December 31, 2021
Revenue: Revenue in the fourth
quarter 2021 was $0.2 million compared to $1.2 million in the same period in 2020. The difference was due to a decrease in clinical trial
revenue and grant revenue, as follows:
Revenue for full year 2021 was $1.3
million compared to $5.6 million in 2020. Clinical trial revenue was $0.7 million for 2021 compared to $1.3 million for 2020, a decrease
of $0.6 million, or 46%. Grant revenue was $0.6 million for 2021 compared to $4.3 million for 2020, a decrease of $3.7 million, or 86%.
The difference was due to same reasons outlined above with respect to our Bahamas Registry Trial and completion of grant-funded clinical
R&D Expenses: Research and
development expenses in the fourth quarter of 2021 were $1.7 million compared to $1.2 million for the same period in 2020. The increase
of $0.5 million, or 51%, was primarily due to an increase in research and development expenses related to the completion of clinical trials
that were not reimbursable by grants. R&D Expenses for full year 2021 were $7.1 million compared to $2.7 million for 2020. The increase
of $4.4 million, or 165% was primarily due to an increase in research and development expenses related to the completion of clinical trials
that were not reimbursable by grants; including $2.2 million of equity-based compensation recorded for Restricted Stock Units ("RSUs")
and stock options granted during the year.
G&A Expenses: General and
administrative expenses in the fourth quarter of 2021 were $2.3 million compared to $0.7 million for the same period in 2020. The increase
of approximately $1.6 million, or 225%, was primarily related to an increase in compensation, insurance and professional expenses incurred
during the current period; including $0.4 million of equity-based compensation recorded for RSUs and stock options granted during the
quarter. G&A Expenses for full year 2021 were $10.7 million compared to $2.7 million for 2020. The increase of $8.0 million, or 293%
was primarily due to an increase in compensation, insurance and professional expenses incurred during the current period; as well as $1.1
million in investor relation costs, and including $4.6 million of equity-based compensation expenses recorded during the year.
Net Loss: Net loss was $4.1
million in the fourth quarter of 2021 compared to $1.4 million for the same period in 2020. Net loss for full year 2021 was $17.0 million
compared to $3.7 million in 2020.
Per Share: Net loss per share
was $0.20 in the fourth quarter of 2021 compared to $0.08 for the same period in 2020. Net loss per share for full year 2021 was $0.90
compared to $0.23 in 2020.
Cash and Short Term Investments:
Cash and short-term investments was $35.0 million compared to $0.8 million as of December 31, 2021 and 2020, respectively. The increase
in cash period over period was the result of proceeds received from our initial public offering in February 2021 and our subsequent private
placement offering in December 2021.
Based on the Company's current operating
plan and financial resources, we believe that our existing cash and short-term investments will be sufficient to cover expenses and capital
requirements into 2024.
Conference Call and Webcast:
Management will host a conference call today at
8:30 a.m. Eastern Time to discuss the Company's fourth quarter and year end 2021 financial results and provide a business update.
The conference call will be available via telephone
by dialing toll free 1-844-200-6205 for U.S. callers; 1-646-904-5544 for local callers; or +1 929-526-1599 for international callers and
using entry code 770734. An audio replay of the call will be available through March 18, 2022.
A webcast of the call may be accessed from the
"Events & Presentations" page on the Longeveron website at https://investors.longeveron.com/events-and-presentations/default.aspx.
The recorded webcast will remain accessible for one year through March 11, 2022.
About Longeveron Inc.
Longeveron is a 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.
Forward-Looking Statements
Certain 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; our ability to obtain and maintain
regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions
of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others, and the period
over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure