Full Press Release Details
NLS Pharmaceutics CEO Issues Letter to Shareholders
ZURICH, June 16,2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ: NLSP), a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders,
today issued a letter to its shareholders.
We are delighted to share a summary of NLS Pharmaceutics'
achieved milestones since the fourth quarter of 2024. Here's a snapshot of our progress and what lies ahead:
1. Completion of Major Financing Events
we first announced the proposed merger with Kadimastem, we have raised more than $6 million
in the aggregate to support the pending transaction and the combined company's clinical trials post-merger. Moreover, we have converted
all of the Company's
outstanding liabilities into equity ,
reflecting a strong balance sheet of a company free of debt. These
financing events have not only strengthened our balance sheet, but have extended our cash runway, enabling us to pursue continued research
& development efforts and proceed
with the execution of the merger.
2. Positive Clinical and Preclinical Developments
3. Merger with Kadimastem - Strategic
the merger process is progressing. We target completing the merger in early Q3 2025 ,
subject to requirements set forth by all regulatory agents.
Ronen Twito, Executive Chairman and Chief Executive
Officer of Kadimastem, said, "We are excited about the upcoming merger, which aligns with our strategic goals and will
enable us to provide comprehensive therapeutic options for patients. By joining forces, we can better serve those with diabetes and combat
its complexity. This merger demonstrates a commitment to innovation, patient care, and long-term value. Together, we aim to improve the
lives of diabetics and patients with related conditions. We are committed to ensuring a smooth integration process as we move forward,
following the completion of the merger. In addition to the equity investment, we believe the committed equity facility agreement of $25
million will enhance the combined company's balance sheet and could provide flexibility to support future pipeline development."
4. What the Combined Company Will Look Like
As we approach the anticipated closing of the
merger, we are preparing to rapidly initiate:
Our anticipated merger with Kadimastem is expected
to mark a transformational pivot-uniting our proprietary DOXA platform and the cell-therapy assets under one roof. With a fortified
capital structure, and a unified board guiding our research and development direction, we are strategically positioned for meaningful
Thanks to your trust and resilience, NLS stands
on the edge of a powerful new chapter. We anticipate the closing of the merger to occur in the near future, followed by an energized integration
phase and accelerated clinical momentum.
Thank you for your enduring support. Together,
we will accelerate development, diversify our pipeline, and enhance long-term shareholder value.
Chief Executive Officer
NLS Pharmaceutics (NASDAQ: NLSP)
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 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
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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 closing, and the timing of the closing, of the transaction and the potential benefits of the transaction
to NLS and Kadimastem and their respective shareholders, including value creation for shareholders, as well as the expected strategic
position of the combined company following the Merger, if completed, and the plan to prepare and initiate a Phase IIa multi-site clinical
trial of AstroRx , Kadimastem's product candidate for Amyotrophic Lateral Sclerosis (ALS). 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 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, including under the heading "Risk Factors" in NLS's
registration statement on Form F-4, filed with the SEC on December 27, 2024.
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
filed a registration statement on Form F-4 on December 30, 2023, including a proxy statement/prospectus, with the SEC (the "F-4
Registration Statement"), and subsequent Amendments to the F-4 Registration Statement on March 3, 2025, March 31, 2025, and June
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 (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