Longeveron® Lomecel-B™ Data in Alzheimer’s Disease Selected for Late Breaking Poster Presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24)
October 14 2024 - 8:05AM
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology
company developing regenerative medicines, today announced that its
submission entitled “Lomecel-B inhibition of MMP14 activity
predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s
disease” has been selected for a late breaking poster presentation
at the 17th edition of the Clinical Trials on Alzheimer’s Disease
Conference (CTAD24) to be held October 29 -November 1, 2024 in
Madrid, Spain.
“We are excited to have been selected to present
important Lomecel-B™ data at a leading forum for Alzheimer’s
research and clinical investigation,” said Wa’el Hashad, CEO of
Longeveron. “We believe the findings offer potential mechanistic
and clinical insights in the development of cellular-based therapy
for Alzheimer’s disease.”
Late Breaking Poster
Presentation
Date: |
|
Tuesday, October 29, 2024, 3:00 p.m. CEST to Wednesday, October 30,
5:00 p.m. CEST |
Theme: |
|
11. New Therapies and Clinical
Trials |
Title: |
|
LP029 “Lomecel-B inhibition of
MMP14 activity predicts Lomecel-B bioactivity in the treatment of
mild Alzheimer’s” |
|
The abstract of the poster will also be included
in the special CTAD edition of the Journal of Prevention of
Alzheimer’s Disease (JPAD), the official journal of the CTAD
conference.
About Lomecel-B™Lomecel-B™ is a
living cell product made from specialized cells isolated from the
bone marrow of young healthy adult donors. These specialized cells,
known as medicinal signaling cells (MSCs), are essential to our
endogenous biological repair mechanism. MSCs have been shown to
perform a number of complex functions in the body, including the
formation of new tissue. They also have been shown to respond to
sites of injury or disease and secrete bioactive factors that are
immunomodulatory and regenerative. We believe that Lomecel-B™ may
have multiple potential mechanisms of action that may lead to
anti-inflammatory, pro-vascular regenerative responses, and
therefore may have broad application for a range of rare and aging
related diseases.
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 (AD), 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
anticipated use of proceeds from recent offerings. 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 allogenic, 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 the 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 ColeInvestor
Relations Advisory Solutionsderek.cole@iradvisory.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d
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