Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative
medicine biotechnology company developing cellular therapies for
life-threatening and chronic aging-related conditions, today
announced that it will participate in the Alliance for Regenerative
Medicine’s Cell & Gene Meeting on the Mesa taking place October
7-9, 2024 in Phoenix, Arizona.
At the conference, members of the Longeveron
management team will host meetings with global pharmaceutical
company executives to explore potential partnership and strategic
opportunities for the Company’s cellular therapy program in
Alzheimer’s disease (AD), which has generated positive data in
successful Phase 1 and Phase 2a clinical trials, and to highlight
the Company’s contract development and manufacturing business at
its 15,000 square feet facility with 8 current Good Manufacturing
Practice (cGMP) cleanroom suites.
To schedule a meeting with the Longeveron team
during the conference, please use the conference partnering system,
or email info@longeveron.com.
Alzheimer’s Disease
ProgramLongeveron’s lead investigational therapeutic
candidate is Lomecel-B™, a proprietary, scalable, allogeneic
cellular therapy. In a completed Phase 2a clinical trial (CLEAR
MIND) in mild Alzheimer’s disease, Lomecel-B™ treated patients
showed an overall slowing/prevention of disease worsening compared
to placebo. The trial achieved the primary safety and secondary
efficacy endpoints and showed statistically significant
improvements in pre-specified clinical and biomarker endpoints in
specific Lomecel-B™ groups compared to placebo. These results
support the therapeutic potential of Lomecel-B™ in the treatment of
mild Alzheimer’s disease and provided evidence-based support for
further clinical development.
Full results from the CLEAR MIND study were presented in a
featured research oral presentation at the 2024 Alzheimer's
Association International Conference (AAIC). Longeveron previously
announced top-line results for CLEAR MIND on October 5, 2023, and
reported additional clinical data and imaging biomarker results
from CLEAR MIND on December 20, 2023.
The U.S. FDA has granted Lomecel-B™ both
Regenerative Medicine Advanced Therapy (RMAT) designation and Fast
Track designation for the treatment of mild Alzheimer’s
disease.
Contract Development and
ManufacturingLongeveron provides contract development and
manufacturing services to pharmaceutical company clients at its
15,000 square feet current Good Manufacturing Practice (cGMP)
facility in Miami, Florida. This facility contains 3,000 square
feet of cleanroom space, including eight ISO 7 cleanrooms and
ancillary areas, as well as 1,150 square feet of process
development, quality control and warehousing space.
Longeveron has assembled a team of experts and
proprietary technologies that enable it to take a systematic
approach to rapidly develop improved cell therapies. Longeveron’s
manufacturing expertise, capabilities and facility provide other
pharmaceutical organizations the ability to advance their
development programs without building their own manufacturing
facility.
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 potential mechanisms of action encompassing pro-vascular,
pro-regenerative, anti-inflammatory, and tissue repair and healing
effects with broad potential applications across a spectrum of
disease areas. Longeveron is currently pursuing three pipeline
indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s
disease, and Aging-related Frailty. Lomecel-B™ development
programs have received five distinct and important U.S. FDA
designations: for the HLHS program - Orphan Drug designation, Fast
Track designation, and Rare Pediatric Disease designation; and, for
the AD program - Regenerative Medicine Advanced Therapy (RMAT)
designation and Fast Track designation. For more information, visit
www.longeveron.com or follow Longeveron on LinkedIn, X, and
Instagram.
Forward-Looking
StatementsCertain 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 operations,
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 and include, but are not limited to, the
potential for Lomecel-B™ to be an effective treatment for
hypoplastic left heart syndrome or achieve U.S. FDA approval under
the Orphan Drug designation, Fast Track designation, and Rare
Pediatric Disease designation programs, or any approval. 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, market and other
conditions, our limited operating history and lack of products
approved for commercial sale; adverse global conditions, including
macroeconomic uncertainty; inability to raise additional capital
necessary to continue as a going concern; our history of losses and
inability to achieve profitability going forward; the absence of
FDA-approved allogeneic, cell-based therapies for Aging-related
Frailty, Alzheimer’s Disease, or other aging-related conditions, or
for HLHS or other cardiac-related indications; ethical and other
concerns surrounding the use of stem cell therapy or human tissue;
our exposure to product liability claims arising from the use of
our product candidates or future products in individuals, for which
we may not be able to obtain adequate product liability insurance;
the adequacy of our trade secret and patent position to protect our
product candidates and their uses: others could compete against us
more directly, which could harm our business and have a material
adverse effect on our business, financial condition, and results of
operations; if certain license agreements are terminated, our
ability to continue clinical trials and commercially market
products could be adversely affected; the inability to protect the
confidentiality of our proprietary information, trade secrets, and
know-how; third-party claims of intellectual property infringement
may prevent or delay our product development efforts; intellectual
property rights do not necessarily address all potential threats to
our competitive advantage; the inability to successfully develop
and commercialize our product candidates and obtain the necessary
regulatory approvals; we cannot market and sell our product
candidates in the U.S. or in other countries if we fail to obtain
the necessary regulatory approvals; final marketing approval of our
product candidates by the FDA or other regulatory authorities for
commercial use may be delayed, limited, or denied, any of which
could adversely affect our ability to generate operating revenues;
we may not be able to secure and maintain research institutions to
conduct our clinical trials; ongoing healthcare legislative and
regulatory reform measures may have a material adverse effect on
our business and results of operations; if we receive regulatory
approval of Lomecel-B™ or any of our other product candidates, we
will be subject to ongoing regulatory requirements and continued
regulatory review, which may result in significant additional
expense; being subject to penalties if we fail to comply with
regulatory requirements or experience unanticipated problems with
our therapeutic candidates; reliance on third parties to conduct
certain aspects of our preclinical studies and clinical trials;
interim, “topline” and preliminary data from our clinical trials
that we announce or publish from time to time may change as more
data become available and are subject to audit and verification
procedures that could result in material changes in the final data;
the volatility of price of our Class A common stock; we could lose
our listing on the Nasdaq Capital Market; provisions in our
certificate of incorporation and bylaws and Delaware law might
discourage, delay or prevent a change in control of our company or
changes in our management and, therefore, depress the market price
of our Class A common stock; we have never commercialized a product
candidate before and may lack the necessary expertise, personnel
and resources to successfully commercialize any products on our own
or together with suitable collaborators; and in order to
successfully implement our plans and strategies, we will need to
grow our organization, and we may experience difficulties in
managing this growth. 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, 2023, filed with the Securities and
Exchange Commission on February 27, 2024, as amended by the Annual
Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports
on Form 10-Q, and its Current Reports on Form 8-K. 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.
Investor and Media Contact:Derek Cole Investor
Relations Advisory Solutions derek.cole@iradvisory.com
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