The proposed transaction will create a
Nasdaq-traded, biotechnology company with product candidates in
advanced stages of clinical development and a focus on advancing
its allogeneic cell therapy platform
ZURICH and NESS ZIONA, Israel, Dec. 30,
2024 /PRNewswire/ -- NLS Pharmaceutics Ltd. ("NLS")
(Nasdaq: NLSP), a Swiss clinical-stage biopharmaceutical company
focused on the discovery and development of innovative therapies
for patients with rare and complex central nervous system
disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a
clinical-stage cell therapy company developing and manufacturing
"off-the-shelf" allogeneic cell products for the treatment of
neurodegenerative diseases and potential cure of diabetes,
announced today that NLS has filed a Registration Statement on
Form F-4 ("Registration Statement") with the U.S. Securities and
Exchange Commission ("SEC") regarding the previously announced
merger between NLS and Kadimastem.
The Registration Statement contains a prospectus in connection
with the proposed merger transaction pursuant to the definitive
agreement entered between the companies, as well as a proxy
statement for the meeting of NLS shareholders related to certain
approvals required in connection with the merger. As part of the
share exchange process related to the merger, NLS is providing
information about NLS's securities offering to Kadimastem
shareholders.
This announcement follows the Report on Form 6-K dated
November 5, 2024, which detailed the
signing of a binding merger agreement alongside the terms governing
the completion of the merger transaction. The closing of the merger
is subject to approval by the shareholders of each of NLS and
Kadimastem, the declaration of the Registration Statement as
effective by the SEC and other customary requirements and closing
conditions. As previously announced, Kadimastem intends to become a
publicly traded company on Nasdaq through the merger.
According to Ronen Twito,
Chairman of the Board and Chief Executive Officer of
Kadimastem, "We are making significant strides toward achieving
our strategic objectives at Kadimastem. The submission of NLS's
Registration Statement related to the merger with the SEC marks a
crucial milestone in our journey to conclude the merger. We believe
the pending merger will empower us to further unlock the potential
of our innovative technologies. Our commitment remains steadfast in
delivering value to our shareholders while making a meaningful
impact in the field of cell therapy."
Alex Zwyer, Chief Executive
Officer of NLS, stated, "We are excited about the momentum
building around the merger. We believe that this strategic
partnership is set to strengthen our market position and enhance
shareholder value through expanded growth opportunities. We are
focused on executing the merger effectively, as we move forward
together in the biotechnology sector."
About the Proposed Transaction
The proposed Transaction will be affected through a reverse
triangular structure in which Kadimastem will become a wholly owned
subsidiary of NLS. In consideration, NLS will issue common
shares to the Kadimastem shareholders who, after completing the
Transaction, will hold approximately 85% of the issued and
outstanding shares of NLS, and the existing shareholders of NLS
will hold the remaining 15% of NLS following completion of the
merger.
Following the Transaction, the parties expect to continue
developing NLS's promising, first-in class Dual Orexin Agonist
platform within the merged company. The remaining NLS assets are
expected to be divested subject to a contingent value rights
agreement, the proceeds of which will be distributed entirely to
the current shareholders of NLS.
The merger has been approved by the boards of directors of both
companies. Each of Kadimastem and NLS has received commitments of
support with respect to voting for the matters related to the
merger from shareholders representing more than 40% of its
outstanding shares.
About NLS Pharmaceutics Ltd.
NLS is a global development-stage biopharmaceutical company,
working with a network of world-class partners and internationally
recognized scientists, focused on the discovery and development of
innovative therapies for patients with rare and complex central
nervous system disorders who have unmet medical needs.
Headquartered in Switzerland and
founded in 2015, NLS is led by an experienced management team with
a track record of developing and commercializing product
candidates. For more information, please visit
www.nlspharma.com.
About Kadimastem
Kadimastem is a clinical stage cell therapy company, developing
"off-the-shelf", allogeneic, proprietary cell products based on its
technology platform for the expansion and differentiation of Human
Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the
company's lead product, is an astrocyte cell therapy in clinical
development for the treatment for ALS and in pre-clinical studies
for other neurodegenerative indications.
IsletRx is the company's treatment for diabetes. IsletRx is
comprised of functional pancreatic islet cells producing and
releasing insulin and glucagon, intended to treat and potentially
cure patients with insulin-dependent diabetes. Kadimastem was
founded by Professor Michel Revel,
Chief Scientific Officer of Kadimastem and Professor Emeritus of
Molecular Genetics at the Weizmann Institute of Science. Professor
Revel received the Israel Prize for the invention and development
of Rebif®, a multiple sclerosis blockbuster drug sold worldwide.
Kadimastem is traded on the Tel Aviv Stock Exchange (TASE:
KDST).
Social Media: LinkedIn, X, Facebook, Instagram
Safe Harbor Statement
This press release contains expressed or implied forward-looking
statements pursuant to U.S. Federal securities laws. For example,
NLS and Kadimastem are using forward-looking statements when they
discuss the expected timing of the closing, and benefits of, the
merger agreement, the expected closing of the transaction and the
potential benefits of the transaction to NLS and Kadimastem and
their respective shareholders. These forward-looking statements and
their implications are based on the current expectations of the
management of NLS and Kadimastem and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to
differ materially from those described in the forward-looking
statements: risks related to the companies' ability to
complete the merger on the proposed terms and schedule, including
risks and uncertainties related to the satisfaction of the closing
conditions related to the merger agreement and risks and
uncertainties related to the failure to timely, or at all, obtain
shareholder approvals for the transaction; unexpected costs,
charges or expenses resulting from the transaction and potential
adverse reactions or changes to business relationships resulting
from the announcement or completion of the proposed merger; changes
in technology and market requirements; either or both companies may
encounter delays or obstacles in launching and/or successfully
completing their clinical trials; the companies' products may not
be approved by regulatory agencies; their technologies may not be
validated as they progress and their methods may not be accepted by
the scientific community; either of both of the companies may be
unable to retain or attract key employees whose knowledge is
essential to the development of their products; unforeseen
scientific difficulties may develop with the products being
advanced by the companies; their products may wind up being more
expensive than anticipated; results in the laboratory may not
translate to equally good results in real clinical settings;
results of preclinical studies may not correlate with the results
of human clinical trials; the companies' patents may not be
sufficient; their products may harm recipients; changes in
legislation may adversely impact either or both of the companies;
inability to timely develop and introduce new technologies,
products and applications; and loss of market share and pressure on
pricing resulting from competition, which could cause the actual
results or performance of candidate products to differ materially
from those contemplated in such forward-looking statements.
Except as otherwise required by law, neither Kadimastem nor
NLS undertakes any obligation to publicly release any revisions to
these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events. More detailed information about the risks and uncertainties
affecting NLS is contained under the heading "Risk Factors" in
NLS's annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and
Exchange Commission ("SEC"), which is available on the SEC's
website, www.sec.gov, and in subsequent filings made by NLS with
the SEC.
No Offer or Solicitation
This communication is not intended to and shall not constitute
an offer to buy or sell or the solicitation of an offer to buy or
sell any securities, or a solicitation of any vote or approval, nor
shall there be any sale of securities in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made, except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Additional Information about the Transaction and Where to
Find It
In connection with the proposed transaction, NLS has filed a
Registration Statement on Form F-4, including a proxy
statement/prospectus, with the SEC. NLS may also file other
relevant documents with the SEC regarding the proposed transaction.
This document is not a substitute for the proxy
statement/prospectus or any other document that NLS may file with
the SEC. The proxy statement (if and when available) will be mailed
or delivered to shareholders of NLS and Kadimastem. INVESTORS AND
SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS
AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS
WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY
AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE
THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
PROPOSED TRANSACTION. Investors and security holders will be able
to obtain free copies of the proxy statement/prospectus (if and
when available) and other documents containing important
information about NLS and Kadimastem and the proposed transaction,
once such documents are filed with the SEC through the website
maintained by the SEC at http://www.sec.gov. Copies of the
documents filed with the SEC by the Company will be available free
of charge on NLS's website at www.nlspharma.com.
Participants in the Solicitation
NLS, Kadimastem, and certain of their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from NLS and Kadimastem shareholders in
respect of the proposed transaction. Information about the
directors and executive officers of NLS, including a description of
their direct or indirect interests, by security holdings or
otherwise, is set forth in NLS's Annual Report on Form 20-F for the
fiscal year ended December 31, 2023,
which was filed with the SEC on May 15,
2024. Other information regarding the participants in the
proxy solicitation and a description of their direct and indirect
interests, by security holdings or otherwise, will be contained in
the proxy statement/prospectus and other relevant materials to be
filed with the SEC regarding the proposed merger when such
materials become available. Investors should read the proxy
statement/prospectus carefully when it becomes available before
making any voting or investment decisions. You may obtain free
copies of these documents from NLS Pharmaceutics using the sources
indicated above.
NLS Pharmaceutics Contacts:
InvestorRelations@nls-pharma.com
www.nlspharma.com
Kadimastem Contacts:
Sarah Bazak, Investors
relations
s.bazak@kadimastem.com
www.kadimastem.com
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SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.
