Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative
medicine biotechnology company developing cellular therapies for
life-threatening and chronic aging-related conditions, today
announced the launch of its contract development and manufacturing
business at the Company’s 15,000 square feet state-of-the-art Good
Manufacturing Practice (GMP) facility. 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. The Company
also announced the initiation of work under its first manufacturing
services contract with Secretome Therapeutics, a biotechnology
company developing first-in-class therapeutics from neonatal
mesenchymal stem cells (nMSC).
“We are delighted to partner with Secretome
Therapeutics to advance their portfolio of therapeutics in this,
our first contract manufacturing agreement in a new, revenue
generating business line,” said Wa’el Hashad, Chief Executive
Officer of Longeveron. “With cellular therapy manufacturing
expertise and capabilities in high demand, and Longeveron’s
strength in both, we see a significant opportunity to employ
currently unused capacity in our state-of-the-art GMP facility. We
have assembled a team of experts and proprietary technologies that
enable us 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. We believe this contract manufacturing
opportunity can expand our team’s experience and has the potential
to generate approximately $4-5 million in annual revenues once it
is up and running fully.”
“Our platform of neonatal stem cell-based
therapeutics has the potential to revolutionize treatment for a
wide range of chronic, inflammatory diseases,” said Vinny Jindal,
President and Chief Executive Officer of Secretome Therapeutics.
“As we move our lead product, STM-01, into clinical studies for
HFpEF and dilated cardiomyopathy this year, we look forward to
tapping into Longeveron’s extensive cellular therapy knowledge and
manufacturing expertise, which has supported the launch of multiple
clinical studies.”
Longeveron is primarily focused on advancing
development of its lead investigational therapeutic candidate,
Lomecel-BTM, a proprietary, scalable, allogeneic cellular therapy,
across multiple indications, including hypoplastic left heart
syndrome (HLHS) (Phase 2 on-going), Alzheimer’s disease (Phase 2
completed), and Aging-related Frailty (Phase 2 completed).
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. 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 and include, but are not limited to, the
potential demand for Longeveron’s contract manufacturing services
and its ability to enter into additional service agreements.
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, 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 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; 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;
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 Contact:Derek ColeInvestor Relations
Advisory Solutionsderek.cole@iradvisory.com
Photos accompanying this announcement are available at
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