Full Press Release Details
Longeveron Provides Corporate Update
and Announces 2023 Strategic Priorities and Anticipated Milestones
- Expects to enroll first patient
clinical trial of Lomecel-B
for Aging-Related Frailty in Japan in 1Q23 -
- Extended cash runway into
Miami, Florida - January 6, 2023-
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative
medicines for unmet medical needs, today provided a corporate update highlighting the Company's strategic priorities and anticipated
milestones for 2023.
"This past year Longeveron made robust progress
advancing our lead investigational product Lomecel-BTM in multiple indications, achieving key regulatory and clinical development
milestones across our programs," said Chris Min, M.D., Ph.D., Longeveron's Interim Chief Executive Officer and Chief Medical
Officer. "In the first quarter, we look forward to enrolling the first patient in our Phase 2 Aging-Related Frailty trial in Japan,
where we believe we are in a strong position to help deliver a much-needed therapy to the country's aging population. In 2023, we
will focus our Aging-Related Frailty efforts in Japan, while continuing to build on our progress in HLHS and Alzheimer's Disease.
Additionally, we have extended our cash runway into the second half of 2024, placing us in a strong position to execute on our corporate
2023 Pipeline Updates and Anticipated Milestones
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company
developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is Lomecel-B ,
an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B
has multiple mechanisms of action encompassing pro-vascular, pro-regenerative, and anti-inflammatory, promoting tissue repair and healing
with broad potential applications across a spectrum of disease areas. Longeveron is advancing Lomecel-B through clinical trials
in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease, and Aging-Related Frailty. Additional information
about the Company is available at www.longeveron.com.
Cautionary Note Regarding Forward-Looking Statements
Certain 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 and other jurisdictions; the Company's plans and ability to obtain or
protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing
the intellectual property rights of others; the need to hire additional personnel and the Company's ability to attract and retain
such personnel; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
the Company's need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive
impact it may have on its investors; the Company's financial performance, and the period over which it estimates its existing cash
and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures requirements. Further information
relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the
Securities and Exchange Commission, including Longeveron's Annual Report on Form 10-K for the year ended December 31, 2021, filed
with the SEC on March 11, 2022. The forward-looking statements contained in this press release are made as of the date of this press release,
and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements,
whether as a result of new information, future events, or otherwise.
Source: Longeveron Inc