Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a clinical-stage biopharmaceutical company dedicated to
the development of cellular therapies designed to reverse, not
manage, disease, today announced that it has entered into
definitive agreements with several institutional and accredited
investors for the issuance and sale of an aggregate of 2,084,850
shares of its common stock, at a purchase price of $2.0625 per
share, in a registered direct offering priced at-the-market under
Nasdaq rules. Caladrius has also agreed to issue to the investors
unregistered warrants to purchase up to an aggregate of 1,042,425
shares of common stock. The closing of the offering is expected to
occur on or about May 28, 2020, subject to the satisfaction of
customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive lead
placement agent for the offering.
The warrants have an exercise price equal to $2.0625 per share,
are exercisable immediately upon issuance and will expire five and
one-half years from the issuance date.
The gross proceeds from the offering are expected to be
approximately $4.3 million. The Company currently intends
to use the net proceeds from the offering for working capital and
general corporate purposes, including the advancement of its CD34+
technology-based clinical programs.
The shares of common stock described above (but not the warrants
or the shares of common stock underlying the warrants) are
being offered and sold by the Company in a registered direct
offering pursuant to a “shelf” registration statement on Form S-3
(Registration No. 333-226319), including an accompanying prospectus
previously filed with, and declared effective by the Securities and
Exchange Commission (the “SEC”) on August 2, 2018. The offering of
the shares of common stock will be made only by means of a
prospectus supplement that forms a part of the registration
statement. A final prospectus supplement and accompanying
prospectus relating to the registered direct offering will be filed
with the SEC and will be available on the SEC's website located at
http://www.sec.gov. Electronic copies of the prospectus supplement
and the accompanying 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 646-975-6996 or e-mail at
placements@hcwco.com.
The warrants described above were offered in a private placement
under Section 4(a)(2) of the Securities Act of 1933, as amended
(the "Act"), and Regulation D promulgated thereunder and, along
with the shares of common stock underlying the warrants, have not
been registered under the Act, or applicable state securities laws.
Accordingly, the warrants and the underlying shares of common stock
may not be offered or sold in the United States except pursuant to
an effective registration statement or an applicable exemption from
the registration requirements of the Act and such applicable state
securities laws.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of
these securities in any state or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage
biopharmaceutical company dedicated to the development of cellular
therapies designed to reverse, not manage, disease. We are
developing a first-in-class cell therapy product that is based on
the notion that our body contains finely tuned mechanisms for
self-repair. Our technology leverages and enables these mechanisms
in the form of specific cells, using formulations and modes of
delivery unique to each medical indication.
The Company's current product candidates include CLBS119, a
CD34+ cell therapy product candidate for the repair of lung damage
found in patients with severe COVID-19 infection who experienced
respiratory failure, for which the Company plans to initiate a
clinical trial in the coming months as well as three developmental
treatments for ischemic diseases based on its CD34+ cell therapy
platform: CLBS12, recipient of SAKIGAKE designation and eligible
for early conditional approval in Japan for the treatment of
critical limb ischemia ("CLI") based on the results of an ongoing
clinical trial; CLBS16, the subject of a recently completed
positive Phase 2 clinical trial in the U.S. for the treatment of
coronary microvascular dysfunction ("CMD"); and CLBS14, a
Regenerative Medicine Advanced Therapy ("RMAT") designated therapy
for which the Company has finalized with the U.S. Food and Drug
Administration (the "FDA") a protocol for a Phase 3 confirmatory
trial in subjects with no-option refractory disabling angina
("NORDA"). For more information on the company, please
visit www.caladrius.com.
Safe Harbor for Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements reflect management’s current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. All statements other than
statements of historical fact contained in this press release are
forward-looking statements including, without limitation, all
statements related to the completion of the registered direct
offering, the satisfaction of customary closing conditions related
to the registered direct offering and the intended use of net
proceeds from the registered direct offering as well as any
expectations of revenues, expenses, cash flows, earnings or losses
from operations, cash required to maintain current and planned
operations, capital or other financial items; any statements of the
plans, strategies and objectives of management for future
operations; any plans or expectations with respect to product
research, development and commercialization, including regulatory
approvals; any other statements of expectations, plans, intentions
or beliefs; and any statements of assumptions underlying any of the
foregoing. Without limiting the foregoing, the words “plan,”
“project,” “forecast,” “outlook,” “intend,” “may,” “will,”
“expect,” “likely,” “believe,” “could,” “anticipate,” “estimate,”
“continue” or similar expressions or other variations or comparable
terminology are intended to identify such forward-looking
statements, although some forward-looking statements are expressed
differently. Factors that could cause future results to differ
materially from the recent results or those projected in
forward-looking statements include the “Risk Factors” described in
the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (“SEC”) on March 5, 2020 and in the
Company’s other periodic filings with the SEC. The Company’s
further development is highly dependent on, among other things,
future medical and research developments and market acceptance,
which are outside of its control. You are cautioned not to place
undue reliance on forward-looking statements, which speak only as
of the date of this Press Release. Caladrius does not intend, and
disclaims any obligation, to update or revise any forward-looking
information contained in this Press Release or with respect to the
matters described herein, except as required by law.
Contact:
Investors: Caladrius Biosciences, Inc. John Menditto Vice
President, Investor Relations and Corporate Communications Phone:
+1-908-842-0084 Email: jmenditto@caladrius.com
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