Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or
the “Company”), a clinical stage regenerative medicine
biotechnology company developing cellular therapies for
life-threatening and chronic aging-related conditions, today
announced the closing of its previously announced registered direct
offering priced at-the-market under Nasdaq rules, for the issuance
and sale of an aggregate of 2,236,026 shares of its Class A common
stock (or common stock equivalents in lieu thereof) at a purchase
price of $4.025 per share of Class A common stock (or per common
stock equivalent in lieu thereof) in a registered direct offering
priced at-the-market under Nasdaq rules. In a concurrent private
placement, the Company issued unregistered warrants to purchase up
to an aggregate of 2,236,026 shares of Class A common stock. The
unregistered warrants have an exercise price of $3.90 per share and
are immediately exercisable for a period of twenty-four (24) months
following the date of issuance.
H.C. Wainwright & Co. acted as the exclusive
placement agent for the offering.
The gross proceeds to the Company from the
offering were approximately $9.0 million, prior to deducting
placement agent fees and other offering expenses payable by the
Company. The Company intends to use the net proceeds from the
offering for its ongoing clinical and regulatory development of
Lomecel-B™ for the treatment of several disease states and
indications, including HLHS and Alzheimer’s disease, obtaining
regulatory approvals, capital expenditures, working capital and
other general corporate purposes.
The shares of Class A common stock (or common
stock equivalents) offered in the registered direct offering (but
excluding the unregistered warrants offered in the concurrent
private placement and the shares of Class A common stock underlying
such unregistered warrants) were offered and sold by the Company
pursuant to a “shelf” registration statement on Form S-3
(Registration No. 333-264142), including a base prospectus,
previously filed with the Securities and Exchange Commission
(“SEC”) on April 5, 2022, and declared effective by the SEC on
April 14 2022. The offering of the shares of Class A common stock
(or common stock equivalents) in the registered direct offering
were made only by means of a prospectus supplement that forms a
part of the registration statement. A final prospectus supplement
and an accompanying base prospectus relating to the registered
direct offering were filed with the SEC and are available on the
SEC’s website located at http://www.sec.gov. Electronic copies of
the final prospectus supplement and accompanying base prospectus
may also be obtained by contacting H.C. Wainwright & Co., LLC
at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at
(212) 856-5711 or e-mail at placements@hcwco.com.
The offer and sale of the unregistered warrants
in the concurrent private placement were made in a transaction not
involving a public offering and have not been registered under
Section 4(a)(2) of the Securities Act of 1933, as amended (the
“Securities Act”), and/or Rule 506(b) of Regulation D promulgated
thereunder and, along with the shares of Class A common stock
underlying such unregistered warrants, have not been registered
under the Securities Act or applicable state securities laws.
Accordingly, the unregistered warrants offered in the private
placement and the underlying shares of Class A common stock may not
be reoffered or resold in the United States except pursuant to an
effective registration statement or an applicable exemption from
the registration requirements of the Securities Act and such
applicable state securities laws.
This press release does not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor
shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction.
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 separate and distinct FDA designations:
for the HLHS program - Orphan Drug designation, Fast Track
designation, and Rare Pediatric Disease designation; and, for the
Alzheimer’s Disease 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 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,
statements regarding the anticipated use of proceeds from the
offering. 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 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 SEC, including
Longeveron’s Annual Report on Form 10-K for the year ended December
31, 2023, filed with the SEC 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
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