Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius”) and Cend
Therapeutics, Inc. (“Cend”) today announced that the proposed
merger of the two companies has closed following the approval of
Caladrius’ stockholders on September 13, 2022. The merged company
will operate as Lisata Therapeutics, Inc. (“Lisata”) and will focus
primarily on advancing its CendR Platform™ technology product
candidates in a range of oncology indications, in addition to
Caladrius’ existing development programs. Lisata will commence
trading on The Nasdaq Capital Market today, September 15, 2022,
under the ticker symbol “LSTA”.
“The completion of the merger of Caladrius and Cend
is an extraordinary milestone for our companies, our employees, our
stockholders and, it is our fervent hope, for patients,” stated
David J. Mazzo, Ph.D., Chief Executive Officer of Lisata. “The
entire Lisata team is driven by the goal of helping patients who
suffer from difficult-to-treat cancers via our CendR platform™ as
well as other devastating diseases, and we are committed to the
development of innovative products to treat such conditions. Based
on our strong balance sheet, advancing mid-late stage clinical
development pipeline and our Tumor-Penetrating Nanocomplex™ (“TPN”)
platform that holds potential to enable effective treatment of
solid tumor cancers with RNA-based medicines, we expect to reach
important development milestones over the next 24 months.”
Following the closing of the merger, David J.
Mazzo, Ph.D., current President and Chief Executive Officer of
Caladrius will continue as the Chief Executive Officer of Lisata,
David Slack, MBA, current President and Chief Executive Officer of
Cend, will be Lisata’s President and Chief Business Officer, and
Kristen K. Buck, M.D., current Executive Vice President of R&D
and Chief Medical Officer of Caladrius, will continue in those
roles with Lisata. Lisata’s cash and investments, as of immediately
following the closing of the merger, are approximately $76 million.
Prior to the closing of the merger, Caladrius effected a 1-for-15
reverse split of its common stock. Post-merger and post-reverse
split, Lisata has approximately 7.8 million shares of common stock
issued and outstanding, with prior Caladrius stockholders
collectively owning approximately 52% of the combined company and
prior Cend stockholders collectively owning approximately 48% of
the combined company.
Lisata’s Board of Directors
Pursuant to the merger agreement and upon the
closing of the merger, three former Cend directors, including Erkki
Ruoslahti, M.D., Ph.D., Heidi Henson, and David Slack, MBA, were
appointed as directors. Gregory Brown, M.D., former Chairman of
Caladrius, will continue in the role as Chairman of Lisata, and
three Caladrius directors, including David Mazzo, Ph.D., Cynthia
Flowers, and Steve Klosk, will continue as directors on Lisata’s
Board.
Additionally, Lisata is pleased to announce that
Mohammad Azab, M.D., M.Sc., MBA has been appointed to the Lisata
Board of Directors. Dr. Azab possesses more than 30 years of
experience in worldwide drug development, and almost 20 years as
board director. He led the development of several FDA and EMA
approved drugs, including six in oncology. Previously, Dr. Azab
served as Chairman of the Board of Directors, President, and Chief
Medical Officer of Astex Pharmaceuticals, Inc. (previously Supergen
Inc.). Prior to joining Astex Pharmaceuticals in July 2009, Dr.
Azab served as President and CEO of Intradigm Corporation in Palo
Alto, California, before it was acquired by Silence Therapeutics, a
company developing siRNA cancer therapeutics. Previously, Dr. Azab
served as executive vice president of Research and Development, and
Chief Medical Officer of Vancouver, British Columbia-based QLT
Inc., where he led clinical development for now-approved drugs in
oncology, gastrointestinal and ophthalmologic indications. He also
served as Oncology Drug Team leader at UK-based Zeneca
Pharmaceuticals, now AstraZeneca, where he held responsibilities in
global clinical development. In this capacity, he managed the
development of now approved drugs for prostate, breast, lung, and
colorectal cancer indications. Before Zeneca, Dr. Azab was an
international medical manager in oncology at Sanofi
Pharmaceuticals, in Gentilly, France.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage
biopharmaceutical company dedicated to the discovery, development,
and commercialization of innovative therapies for the treatment of
advanced solid tumors and other major diseases. Lisata’s lead
investigational product candidate, LSTA1 (formerly known as
CEND-1), is designed to modify the tumor microenvironment by
activating a novel uptake pathway that allows anti-cancer drugs to
penetrate solid tumors more effectively. LSTA1 actuates an active
transport system in a tumor-specific manner, resulting in
systemically co-administered anti-cancer drugs more efficiently
penetrating and accumulating in the tumor, while normal tissues are
not affected. LSTA1 has demonstrated favorable safety,
tolerability, and activity in clinical trials to enhance delivery
of standard-of-care chemotherapy for pancreatic cancer. Lisata and
its collaborators have also amassed significant non-clinical data
demonstrating enhanced delivery of a range of emerging anti-cancer
therapies, including immunotherapies and RNA-based therapeutics.
Lisata is exploring the potential of LSTA1 to enable a variety of
treatment modalities to treat a range of solid tumors more
effectively. In addition, Lisata also has clinical development
programs based on its autologous CD34+ cell therapy technology
platform.
Forward-Looking Statements
This communication contains “forward-looking
statements” that involve substantial risks and uncertainties for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. All statements, other than
statements of historical facts, included in this communication
regarding strategy, future operations, future financial position,
future revenue, projected expenses, prospects, plans and objectives
of management are forward-looking statements. In addition, when or
if used in this communication, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to Lisata or its management, may identify forward-looking
statements. Examples of forward-looking statements include, but are
not limited to, statements relating to the long-term success of
Lisata’s recently completed merger (the “Merger”) with Cend
Therapeutics, Inc. (“Cend”), including the ongoing integration of
Cend’s operations; Lisata’s continued listing on the Nasdaq Capital
Market; expectations regarding the capitalization, resources and
ownership structure of Lisata; the approach Lisata is taking to
discover and develop novel therapeutics; the adequacy of Lisata’s
capital to support its future operations and its ability to
successfully initiate and complete clinical trials; and the
difficulty in predicting the time and cost of development of
Lisata’s product candidates. Actual results could differ materially
from those contained in any forward-looking statement as a result
of various factors, including, without limitation: the ongoing
COVID-19 pandemic on Lisata’s business, the safety and efficacy of
Lisata’s product candidates, decisions of regulatory authorities
and the timing thereof, the duration and impact of regulatory
delays in Lisata’s clinical programs, Lisata’s ability to finance
its operations, the likelihood and timing of the receipt of future
milestone and licensing fees, the future success of Lisata’s
scientific studies, Lisata’s ability to successfully develop and
commercialize drug candidates, the timing for starting and
completing clinical trials, rapid technological change in Lisata’s
markets, the ability of Listata to protect its intellectual
property rights; unexpected costs, charges or expenses resulting
from the Merger; potential adverse reactions or changes to business
relationships resulting from the completion of the Merger;
potential underperformance of Lisata’s business following the
Merger as compared to management’s initial expectations; and
legislative, regulatory, political and economic developments. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in Lisata’s Annual Report on Form 10-K filed with the SEC
on March 22, 2022 and in the proxy statement/prospectus filed by
Lisata with the Securities and Exchange Commission relating to the
Merger. Except as required by applicable law, Lisata undertakes no
obligation to revise or update any forward-looking statement, or to
make any other forward-looking statements, whether as a result of
new information, future events or otherwise.
Contact:
Investors and Media:Caladrius Biosciences, Inc.John
MendittoVice President, Investor Relations and Corporate
CommunicationsPhone: 908-842-0084Email: jmenditto@caladrius.com
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