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Longeveron Inc. Provides Corporate Update and Reports Second Quarter 2022 Financial Results -Longeveron's Phase 2a trial of Lomecel-B for patients with mild Alzheimer's Disease proceeding on schedule, currently at 50% en

Key Takeaway: Inc. Provides Corporate Update and Reports Second Quarter 2022 Financial Results -Longeveron's Phase 2a trial of Lomecel-B for patients with mild Alzheimer's Disease proceeding on schedule, currently at 50% enrollment Japanese Pharmaceuticals and Medical Devices Agency Accepts

Full Press Release Details

Inc. Provides Corporate Update and Reports Second Quarter 2022 Financial Results
-Longeveron's Phase 2a trial of Lomecel-B for patients with mild Alzheimer's Disease proceeding on schedule,
currently at 50% enrollment
Japanese Pharmaceuticals and Medical Devices Agency Accepts Amended Aging Frailty study design August 8, 2022, allowing the trial to
Top-line findings from the second phase of the Phase1/2 HERA trial show that the primary endpoint for safety was met in the randomized
placebo-controlled portion of the study
million in cash, cash equivalents and short-term investments as of June 30, 2022, expected to be sufficient to fund operations into 2024
call scheduled for 8:30 a.m. ET today-
Florida - August 12, 2022- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage
biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today provided a business
update and reported its financial results for the second quarter ended June 30, 2022.
has made steady progress advancing Lomecel-B, our lead medicinal signaling cell (MSC) therapy product, through clinical trials for four
different indications," said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer. "Today I
am proud to announce multiple updates on all of our projects. First, we have enrolled 50% of our planned patient population of 48 in
our Phase 2a trial of Lomecel-B in patients with mild Alzheimer's Disease. Furthermore, a pre-planned total of 89 patients have
been consented to undergo eligibility screening, and we expect to fully enroll the study on schedule."
addition, on August 8, 2022, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an amendment to our Japanese Aging
Frailty Trial. We reevaluated our Aging Frailty strategy in Japan given the large unmet need there, and the supportive regulatory framework
including the pathway recognizing the therapeutic potential of cell therapies through the Act on the Safety of Regenerative Medicine
(ASRM). ASRM approval, if granted, could allow Longeveron to provide Lomecel-B in Japan at selected sites, permitting us to enter the
market in that country on an accelerated basis. We have increased confidence in the near-term, value-driving opportunity in Japan."
also announced that we met the primary safety endpoint in the randomized phase of our Phase 1/2 HERA' Aging Frailty trial.
In that study, Lomecel-B does not appear to interfere with the potency of vaccines such as HD Fluzone in the adult
population with aging frailty."
the remainder of 2022 through early 2023, we expect to publish manuscripts for the ELPIS 1 trial and for the previously completed Phase
2b study in Adult Frailty in quality peer-reviewed journals, enroll the first Japanese patient with aging frailty in our Phase 2 study
in that country, as well as complete enrollment of our Phase 2a trial in Alzheimer's Disease."
Quarter Business Updates:
for Alzheimer's Disease:
for Hypoplastic Left Heart Syndrome (HLHS):
first phase of the study was open label, enrolled 22 subjects, and was previously reported in the S1 during the Initial Public Offering
in February 2021. The second phase was randomized and placebo controlled. A total of 40 subjects were enrolled over two flu seasons.
The trial measured exploratory biomarkers designed to assess whether Lomecel-B augmented immune responses following influenza
vaccination. This biomarker evaluation was performed with descriptive statistics and the study was not powered to make definitive conclusions
regarding these biomarkers.
a result of these findings, Longeveron plans to pursue additional studies of the immune system and will be making highly sophisticated
measures of B-cell responses using samples obtained in the study. B-cells are the cells that mount the antibody responses to vaccination.
These new study findings continue to broaden Longeveron's database regarding the potential impact of Lomecel-B in diseases
of aging, such as Aging Frailty and Alzheimer's Disease. Longeveron plans to publish the full study results once all study assessments
any intervention to be applied in older adults, proving safety of Lomecel-B is the critical and necessary first step, and this trial
has achieved that," said Dr. Sean Leng, a board-certified geriatrician, Professor of Medicine, Molecular Microbiology and Immunology
at Johns Hopkins University School of Medicine and Bloomberg School of Public Health, and Director of Johns Hopkins Center on Aging and
Immune Remodeling (JH CAIR). "The result suggestive of potential boosting effect on heterotypic antibody response to HD Fluzone
is very encouraging. The planned in-depth B cell studies including plasmablast response to the vaccine is an extremely important
next step as it will provide further insights into potentially beneficial impact of Lomecel-B on the aging immune system with significant
clinical relevance to senior health."
for Acute Respiratory Distress Syndrome (ARDS) caused by either Covid-19 or Influenza Infection:
Results for Second quarter Ended June 30, 2022
Revenue for each of the second quarters of 2022 and 2021 was $0.5 million. Revenue consisted of:
Expenses: Research and development expenses in the second quarter 2022 were $1.7 million compared to $2.0 million for the same period
in 2021. The decrease of $0.3 million, or 12%, was primarily due to a decrease in equity-based compensation allocated to research and
development expenses which decreased from $0.8 million for the three months ended June 30, 2021, to $0.1 million for the same period
in 2022. However, this was offset by an increase of $0.5 million in research and development expenses that were not reimbursable by grants.
Expenses: General and administrative expenses in the second quarter 2022 were $2.4 million compared to $3.2 million for the same
period in 2021. The decrease of approximately $0.8 million, or 26%, was primarily related to a decrease of $0.7 million in equity-based
compensation expenses allocated to general and administrative expenses. However, expenses related to legal and consulting services increased
by $0.2 million in the three months ended June 30, 2022, compared to the same period in 2021.
Lawsuit expense: Non-operating Lawsuit expense for the three months ended June 30, 2022, was approximately $1.4 million. Additional
detail can be found in Part II, Item 1 "Legal Proceedings" of this Quarterly Report on Form 10-Q. Legal expenses incurred
in ordinary business activities are reported within general and administrative expenses.
Loss: Net loss was $5.6 million in the second quarter 2022 compared to $5.0 million for the same period in 2021.
Share: Net loss per share was $0.27 in the second quarter 2022 compared to $0.26 for the same period in 2021.
and short-term investments: Cash and short-term investments was $27.0 million and $35.0 million as of June 30, 2022, and December
31, 2021, respectively.
believe, based on the current operating plan and financial resources, that our existing cash and short-term investments will be sufficient
to cover expenses and capital requirements into the first half of 2024.
will host a conference call today at 8:30 a.m. Eastern Time to discuss the Company's second quarter 2022 financial results and
provide a business update.
Dial-in Number: 844-200-6205
Dial-in Number: 833-950-0062
Other Locations Dial-in Number: 929-526-1599
Replay Dial-in Number: 866-813-9403
Replay Dial-in Number: 226-828-7578
Other Locations Dial-in Number: 44-204-525-0658
audio webcast of the call may also be accessed from the Investors' page of the Longeveron website at www.longeveron.com.
A replay of the call will be available on the Longeveron website shortly after completion of the call.
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, 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: Alzheimer's Disease, hypoplastic left heart syndrome (HLHS), Aging
Frailty, and Acute Respiratory Distress Syndrome (ARDS). Additional information about the Company is available at www.longeveron.com.
Note Regarding Forward-Looking Statements
statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995, which 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. Factors that could cause actual results to differ materially from those expressed
or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron's
clinical trials to demonstrate safety and efficacy of the Company's product candidates, and other positive results; the timing
and focus of the Company's ongoing and future preclinical studies and clinical trials and the reporting of data from those studies
and trials; the size of the market opportunity for the Company's product candidates, including its estimates of the number of patients
who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics,
safety, efficacy and therapeutic effects of the Company's product candidates; the Company's ability to obtain and maintain
regulatory approval of its product candidates; the Company's plans relating to the further development of its product candidates,
including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan
Last updated: Aug 8, 2022