Longeveron’s CLEAR MIND Randomized Phase 2a Clinical Trial Evaluating Lomecel-B™ in Mild Alzheimer’s Disease Accepted for Featured Research Session Oral Presentation at the 2024 Alzheimer’s Association International Conference (AAIC)
15 Aprile 2024 - 2:30PM
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology
company developing regenerative medicines, today announced that it
has been accepted for a Featured Research Oral Presentation to
present the Company’s CLEAR MIND Phase 2a study results. CLEAR-MIND
is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in
mild Alzheimer’s Disease. In addition to the clinical study
results, the Company has been accepted for a poster presentation at
the 2024 Alzheimer’s Association International Conference (AAIC),
to be held July 28 – August 1, 2024 in Philadelphia, PA, USA and
online.
“We are extremely excited to share the full study results of our
CLEAR-MIND trial at the AAIC meeting this year, and have the
opportunity to present at the leading forum for Alzheimer’s disease
clinical investigation,” said Wa’el Hashad, CEO of Longeveron.
Oral Presentation |
Date: |
Sunday, July 28, 2024 |
Time: |
4:15pm – 5:45pm EDT |
Session: |
Featured Research Session,
1-32-FRS-B |
Title: |
“Results from a Phase 2a
Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial
of Lomecel-BTM in Mild Alzheimer’s Disease Dementia” |
|
|
Longeveron’s Kevin N. Ramdas, MD, MPH, Director of
Clinical Operations, was invited to chair this Featured Research
Session. |
|
|
Poster Presentation |
Date: |
Tuesday, July 30, 2024 |
Time: |
7:30am – 4:15pm EDT |
Session: |
In-Person Posters Tuesday;
Drug Development |
Topic: |
MRI Imaging results in the
CLEAR MIND phase 2a clinical trial of Lomecel-BTM |
|
|
Longeveron previously announced top-line results for the CLEAR
MIND Phase 2a clinical trial on October 5, 2023, and reported
additional clinical data and imaging biomarker results from CLEAR
MIND on December 20, 2023.
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
Mesenchymal Stem Cell (MSC) formulation sourced from the bone
marrow of young, healthy adult donors. Lomecel-B™ has multiple
potential mechanisms of action that promote tissue repair and
healing with broad potential applications across a spectrum of
disease areas. The underlying mechanism(s) of action that may lead
to the tissue repair programs include the stimulation of new blood
vessel formation, modulation of the immune system, reduction in
tissue fibrosis, and the stimulation of endogenous cells to divide
and increase the numbers of certain specialized cells in the body.
Longeveron is currently pursuing three pipeline indications:
Hypoplastic Left Heart Syndrome, Alzheimer’s disease, and
Aging-related Frailty. For more information, visit
www.longeveron.com or follow Longeveron on LinkedIn, X, and
Instagram.
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 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. 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, 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; a history of losses and may not be able to achieve
profitability going forward; no FDA-approved allogenic, cell-based
therapies for Aging-related Frailty, AD, or other aging-related
conditions, nor HLHS or other cardiac-related indications; ethical
and other concerns surrounding the use of stem cell therapy or
human tissue; the use of our product candidates or future products
in individuals may expose us to product liability claims, and we
may not be able to obtain adequate product liability insurance; if
our trade secret and patent position does not adequately 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; 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; 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 if our current share price
continues to decrease; 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 the 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 Contact:Derek ColeInvestor
Relations Advisory Solutionsderek.cole@iradvisory.com
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