Full Press Release Details
Kadimastem and NLS Pharmaceutics Announce
of SEC Registration Statement in
Connection with Proposed Merger
Zurich, Switzerland and Ness Ziona, Israel
- September 10, 2025 - NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS"), a Swiss clinical-stage biopharmaceutical
company focused on central nervous system ("CNS") disorders, and Kadimastem Ltd. (TASE: KDST) ("Kadimastem"),
an advanced clinical-stage cell therapy company progressing treatments for neurodegenerative diseases and diabetes, today announced that
the U.S. Securities and Exchange Commission (the "SEC") has declared effective the registration statement on Form F-4 related
to the companies' previously announced merger. The Form F-4 became effective on September 9, 2025, at 4:00 p.m. Eastern Time.
This marks the final U.S. federal securities regulatory
hurdle required for closing the merger. Upon completion, the combined company - to be known as NewCelX Ltd. - will
remain a publicly traded biotechnology company listed on Nasdaq under the ticker "NCEL", uniting Kadimastem's
proprietary cell therapy platforms with NLS's expertise in small-molecule therapies.
Clinical and Strategic Highlights
"We are thrilled to announce this pivotal
milestone. The SEC clearance of our F-4 filing marks the final step on the U.S. federal regulatory path toward closing our merger with
Kadimastem," said Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics. "We believe this combination represents
a transformational opportunity to build a next-generation biotechnology company with a diversified pipeline and global reach. Following
the upcoming extraordinary general meeting on September 29, we look forward to uniting our teams under the new company and advancing our
mission of delivering innovative therapies to patients with high unmet medical needs."
Ronen Twito, Executive Chairman and CEO of
Kadimastem, commented: "We are proud to reach this milestone and to be so close to completing the merger with NLS. Kadimastem
is entering an advanced stage in its clinical journey, with a Phase 2a ALS trial for AstroRx on the horizon and meaningful progress
in our IsletRx diabetes program. We believe the merger strengthens our global position, provides access to U.S. capital markets, and reinforces
our mission to develop transformative therapies for patients suffering from some of the most challenging diseases."
About NLS Pharmaceutics
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) is a Swiss-based
biopharmaceutical company focused on the development of innovative therapies for central nervous system disorders and related indications.
For more information, visit www.nlspharma.com.
Kadimastem Ltd. (TASE: KDST) is a clinical-stage
cell therapy company developing allogeneic, "off-the-shelf" cell products for neurodegenerative diseases and diabetes. For
more information, visit www.kadimastem.com.
Forward-Looking Statements
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 closing of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their
respective shareholders, the advancement of the clinical trials related to AstroRx and IsletRx and the combined company's pipeline
and global reach. 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, 2024, 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, including under the heading "Risk Factors" in NLS's registration statement on Form F-4, filed with
the SEC on September 3, 2025.
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, which was declared effective on
September 9, 2025. 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 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 may obtain free copies of the proxy statement/prospectus and other documents containing important information
about NLS and Kadimastem and the proposed transaction through the website maintained by the SEC at http://www.sec.gov. Copies of the documents
filed with the SEC by the Company are 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, And other information regarding the participants in the proxy solicitation
and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the proxy statement/prospectus
filed with the SEC regarding the proposed merger. Investors should read the proxy statement/prospectus carefully before making any voting
or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above.
Investor & Media Contacts
Kadimastem Contacts:
Sarah Bazak, Investors relations
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