Full Press Release Details
NLS Pharmaceutics CEO Issues Letter to Shareholders
Z RICH, Switzerland, March
10, 2025 - 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 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
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
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
Our commitment to addressing critical health challenges
Financial Resilience and Growth
We have fortified our financial foundation through
strategic initiatives:
Nasdaq & Strong Financial Position
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
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.
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
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