- Revolutionizing Diabetes Treatment: Introduction of
cutting-edge, multi-targeted innovation to transform diabetes
care.
- Diabetes more than just a Metabolic Disorder: Diabetes
is a multi-systemic disease impacting the central nervous system
(CNS), immune function, and cellular metabolism.
- Powerful Merger Synergies: Uniting the core competencies
of both organizations in order to create a holistic solution for
comprehensive diabetes management.
ZURICH and NESS ZIONA, Israel, Feb. 10,
2025 /PRNewswire/ -- NLS Pharmaceutics
Ltd. ("NLS") (Nasdaq: NLSP), a Swiss clinical-stage
biopharmaceutical company focused on the discovery and development
of innovative therapies for rare and complex central nervous system
disorders, and Kadimastem Ltd. ("Kadimastem") (TASE: KDST), a
clinical-stage cell therapy company developing and manufacturing
"off-the-shelf" allogeneic cell products for the treatment of
neurodegenerative diseases and potential cure for diabetes, are on
a mission to create a leading biotechnology entity. The upcoming
expected merger aims to transform the treatment landscape for
complex conditions such as diabetes. By uniting the core
competencies of both organizations, NLS and Kadimastem believe that
this merger is positioned to potentially create a holistic solution
that addresses the multifaceted challenges of diabetes
management.
While GLP-1 receptor agonists have brought significant
progress in diabetes care, they do not fully address
the systemic and neurological complications of the disease.
Their focus on glucose control and weight loss overlooks
key factors such as neuroinflammation, circadian rhythm
disruptions, and metabolic resilience. Furthermore, tolerance
issues, gastrointestinal side effects, and long-term safety
concerns underscore the need for alternative and
complementary therapeutic strategies. Diabetes is more than a
metabolic disorder—it is a multi-systemic
disease affecting the central nervous system (CNS),
immune function, and cellular metabolism. A growing body of
research highlights the connection between diabetes,
neurodegeneration, and sleep disorders, collectively known
as Diabetes-Associated Neurological and Sleep Disorders
(DANS). Addressing these complex interactions requires a
paradigm shift toward multi-target therapeutic strategies.
Introducing DOXA: A Multi-Target Innovation for
Diabetes
NLS is pioneering DOXA (Dual Orexin and Multi-Pathway
Modulation), a next-generation therapeutic
approach integrating orexin receptor agonism,
neuroprotective pathways, and metabolic
regulation to holistically manage diabetes and its
systemic complications.
Unlike conventional approaches that primarily
target incretin signaling, DOXA leverages multi-target
mechanisms to synchronize metabolic and neurological
pathways by acting on:
- Orexin Signaling (OX1R/OX2R): Aiming to
restore energy balance, cognitive function, and metabolic
stability, counteracting diabetes-related fatigue and
neurodegeneration.
- Sigma-1 Receptor (Sig-1R) Modulation: Aiming to
reduce oxidative stress, neuroinflammation, and insulin
resistance, critical factors in diabetes complications.
- Cathepsin Inhibition (CTSS/CTSL): Aiming to
protect neuronal integrity and β-cell survival, crucial for
long-term metabolic health.
- Sodium-Glucose Cotransporter-2 (SGLT2) Modulation: Aiming
to improve glucose metabolism while reducing neuropathic and
vascular damage.
- Adiponectin Receptor Activation: Aiming to
enhance insulin sensitivity and mitochondrial function,
addressing core metabolic dysfunctions.
Scientific Momentum: Breakthrough Findings to Be Presented at
ASCP 2025
Preclinical studies to be presented at the 2025 ASCP Annual
Meeting demonstrate that DOXA compounds:
- Restore orexinergic function, improving metabolic balance
and sleep-wake disturbances.
- Reduce inflammatory markers and neurodegeneration, preventing
diabetes-induced neuronal damage.
- Enhance β-cell survival and glucose metabolism, positioning
DOXA as a disease-modifying therapy rather than a
glucose-dependent intervention.
Beyond its individual potential, DOXA is expected to
significantly outperform existing treatments when combined with
Islet transplantation. By leveraging the ability of DOXA to
enhance metabolic regulation and insulin sensitivity,
the DOXA-Islet therapy combination is positioned to set a new
standard in diabetes care.
Positioning NLS Pharmaceutics and Kadimastem as Leaders in
Diabetes Innovation
The anticipated merger between NLS (Nasdaq: NLSP) and
Kadimastem (TASE: KDST) is intended to bring together two
complementary platform technologies—Kadimastem's expertise
in cell therapy and NLS's leadership
in pharmaceutical innovation. This strategic integration is
expected to strengthen their position in the diabetes
treatment landscape, offering a differentiated approach that
combines regenerative medicine with novel pharmaceutical
interventions.
By leveraging synergies in neurodegenerative and metabolic
disease research, the combined entity aims to position itself
to drive innovation in diabetes and beyond, establishing
itself as a key player in the evolving therapeutic space.
A New Era in Diabetes Treatment
While GLP-1 receptor agonists will continue to play a role
in diabetes care, we do not believe that they alone cannot
fully address the neurological and systemic complications of
diabetes. The DOXA multi-target strategy presents
a transformative, complementary approach, is aimed at
tackling not just glucose regulation, but also
neuroprotection, metabolic resilience, and long-term disease
modification. As diabetes research advances, multi-target
therapies are set to redefine the next generation of diabetes
treatments. By integrating breakthroughs in sleep-wake
regulation, neuroprotection, and metabolic health, NLS is
aiming to pioneer a new era of diabetes care—one that
offers comprehensive, long-lasting benefits for patients and
new investment opportunities for the future.
Dr Eric Konofal, M.D., PhD,
Chief Scientific Officer of NLS and inventor behind DOXA: "I
believe that this next-generation diabetes treatment must go beyond
glucose control. While GLP-1 therapies address part of the problem,
they fail to target the neurological and systemic disruptions
linked to the disease, including Diabetes-Associated Neurological
and Sleep Disorders (DANS). At NLS, our DOXA platform aims to
integrate neuroscience, metabolism, and regenerative medicine.
Combined with Islet transplantation, we anticipate a
breakthrough—enhancing insulin sensitivity, metabolic regulation,
and long-term disease modification."
Alex Zwyer, Chief Executive
Officer of NLS, "This planned merger represents a remarkable
opportunity to combine our strengths and expertise. Together,
believe that we will advance innovative solutions to better address
the challenges of diabetes and related disorders, delivering
enhanced value to patients."
Ronen Twito, Executive
Chairman and Chief Executive Officer of Kadimastem, added,
"We are thrilled about the upcoming merger, which aligns our
strategic goals and is aimed at empowering us to provide
comprehensive therapeutic options. By joining forces, we believe
that we will be well-equipped to tackle the complexities of
diabetes and improve outcomes for those we serve."
The upcoming merger reflects a commitment to innovation,
patient-centric care, and long-term value creation. As we move
forward, NLS and Kadimastem are dedicated to ensuring a smooth
integration process that maximizes the potential of both
organizations—bringing together expertise, resources, and vision to
improve the lives of patients impacted by diabetes and related
conditions.
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 of the transaction and the potential
benefits of the transaction to NLS and Kadimastem and their
respective shareholders, including value creation for shareholders,
the expected strategic position of the combined company following
the merger, if completed and the expected benefits of DOXA in the
treatment of diabetes. 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 Contacts:
Sarah
Bazak, Investors relations
s.bazak@kadimastem.com
www.kadimastem.com Social Media: Social Media: LinkedIn, X,
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SOURCE Kadimastem Ltd.; NLS Pharmaceutics Ltd.
