Full Press Release Details
NLS Pharmaceutics and Kadimastem Unveil Multi-Target Approach to
Diabetes, Expanding Beyond GLP-1 Therapies
ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL
- February 10, 2025, 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.TA), 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
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
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:
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
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