ZURICH, March 10,
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.
Dear Shareholders,
We are thrilled to share the significant progress and strategic
milestones NLS Pharmaceutics has achieved, positioning our company
for a transformative future in the biotechnology sector.
Strategic Merger with Kadimastem
In November 2024, we announced a
definitive merger agreement with Kadimastem Ltd. (TASE: KDST)
("Kadimastem"), a clinical-stage cell therapy company specializing
in "off-the-shelf" allogeneic cell products for neurodegenerative
diseases and diabetes. This merger aims to create a Nasdaq-traded
biotechnology company with a robust portfolio of advanced
therapies. Both companies' boards of directors have unanimously
approved the transaction, with Kadimastem's shareholders recently
voting in favor and NLS major shareholders holding approximately
40% of NLSs' common shares having signed support letters for the
NLS shareholders' meeting to be convened soon. We currently
anticipate closing the merger in the second quarter of 2025,
pending effectiveness of NLSs' pending registration statement filed
with the Securities and Exchange Commission ("SEC"), Nasdaq
approval, NLSs' shareholders' approval and customary closing
conditions.
Regulatory Filings and Approvals
We filed a Registration Statement on Form F-4 and subsequent
amendment with the SEC, detailing the proposed merger with
Kadimastem. This filing is a necessary step toward finalizing the
merger and creating a combined entity focused on innovative
therapies. In addition, we have submitted an application to
list the merged company on Nasdaq under the name of "NucelX Ltd.",
with the future ticker of NCEL.
Advancements in Diabetes Treatment
In collaboration with iTolerance Inc., Kadimastem has
successfully completed a pre-Investigational New Drug ("pre-IND")
meeting with the U.S. Food and Drug Administration ("FDA") for
iTOL-102, a potential breakthrough therapy for Type 1 Diabetes.
This innovative approach combines Kadimastem's IsletRx cells with
iTolerance's immunomodulator, aiming to cure Type 1 Diabetes
without the need for lifelong immune suppression.
The diabetes treatment landscape has experienced significant
growth, underscored by notable mergers and acquisitions. For
instance, Novo Nordisk's acquisition of Inversago Pharma for up to
$1.075 billion highlights the
strategic emphasis on developing novel therapies for obesity,
diabetes, and related metabolic disorders. Similarly, Roche's
$2.7 billion acquisition of Carmot
Therapeutics reflects their concerted effort to expand into the
diabetes and obesity markets. Additionally, Sana Biotechnology has
made significant advancements in the diabetes space, with early
clinical data suggesting their hypo immune platform could enable
insulin production without immunosuppression, positioning them as a
potential leader in developing transformative treatments for type 1
diabetes. We believe that these developments underscore the
sector's robust growth and the immense potential it holds for
innovative treatments.
Furthermore, we are expanding our diabetes treatment strategies
beyond GLP-1 therapies. By integrating complementary
approaches, we aim to address the multifaceted challenges of
diabetes management, including neuroinflammation and metabolic
resilience.
Advancements in Neurodegenerative Disease Treatment
Post-merger, we plan to prepare and initiate a Phase IIa
multi-site clinical trial of AstroRx®, Kadimastem's product
candidate for Amyotrophic Lateral Sclerosis (ALS). This trial is
slated to commence following the merger's completion, marking
significant progress in our neurodegenerative disease treatment
pipeline.
Experienced International Leadership Team
We believe that Kadimastem contributes to the merger with its
experienced international leadership team and board of directors,
and with the teams prior experience developing medicine from the
laboratory to the market. For example, Rebif®, a
blockbuster drug invented by Professor Michel Revel, Chief Scientist at Kadimastem, in
his capacity as a scientific investigator at the world-renowned
Weizmann Institute of Science, was acquired by Merck Serono. In
addition, Ronen Twito, Kadimastem's
Executive Chairman and Chief Executive Officer, brings extensive
experience working in the U.S. capital market and M&A
international market.
Advancements in DOXA R&D Programs
Our promising Dual Orexin Receptor Agonist ("DOXA") platform has
made significant strides. The development of AEX-41 and AEX-2
compounds showcases our dedication to addressing unmet needs in
sleep-wake disorders. Preliminary studies have yielded promising
results, reinforcing our confidence in these compounds' potential
to transform patient care.
Additional Pipeline Expansion and Research
Initiatives
Our commitment to addressing critical health challenges remains
steadfast:
- Fentanyl Dependence Treatment: We have launched a
preclinical program evaluating Mazindol ER as a treatment for
fentanyl dependence, aiming to offer a non-opioid alternative in
combating the opioid crisis.
- Advancing Scientific Research: Our recent
submissions to and upcoming poster presentation at the American
Society of Clinical Psychopharmacology's 2025 Annual Meeting
highlight our commitment to innovative therapeutic strategies and
groundbreaking research.
Financial Resilience and Growth
We have fortified our financial foundation through strategic
initiatives:
Nasdaq & Strong Financial Position
- We carry zero long-term debt, a rarity among biopharmaceutical
companies. This strong financial position provides us with
flexibility to execute our strategic goals without financial
constraints.
- We raised approximately $4.2
million pursuant to private placements in October and
December 2024, at a premium to market
price. We currently believe that the amounts raised in these
private placements has extended our operational runway to
approximately 18 months.
- This financial stability empowers us to accelerate clinical
development, pursue strategic partnerships, and advance our
innovative pipeline with confidence.
Looking Ahead
The momentum generated by these developments underscores our
commitment to delivering life-changing therapies. We aim to
capitalize on emerging opportunities within the dynamic
biotechnology landscape, driving NLS Pharmaceutics toward a future
of unparalleled success.
As we embark on this exciting new chapter, we remain
laser-focused on:
- Building an international, strong, well-balanced pipeline and
top-notch biotechnology company
- Delivering life-changing therapies for patients worldwide
- Expanding our pipeline through innovation & strategic
collaborations
- Maximizing shareholder value by maintaining a strong financial
position
We extend our deepest gratitude to our shareholders, partners,
and supporters for your trust and commitment. Together, we are
building a future of unparalleled success for NLS
Pharmaceutics.
Sincerely,
Alex Zwyer
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.
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 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 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 Contacts:
InvestorRelations@nls-pharma.com
www.nlspharma.com
Kadimastem Contact:
Sarah
Bazak, Investors relations
s.bazak@kadimastem.com
www.kadimastem.com
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