Full Press Release Details
NLS Pharmaceutics Ltd. and Kadimastem Ltd. Announce
Filing of F-4 Registration Statement with the SEC Ahead of Proposed Merger
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
ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL, December 30, 2024 - 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.TA"), 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.
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
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
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