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NLS Pharmaceutics and Kadimastem Unveil Multi-Target Approach to Diabetes, Expanding Beyond GLP-1 Therapies
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 ß-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 ß-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,
The GidDy uP Kid
5 월 전
.1369...
NLSP…
"AMENDMENT TO THE
NLS PHARMACEUTICS LTD.
COMMON STOCK PURCHASE WARRANTS
September 16, 2024
“This Amendment No. 1, dated September 16, 2024 (the “Effective Date”), to each of the following four common stock purchase warrants (the “Amendment”), issued by NLS Pharmaceuticals Ltd, a Swiss corporation (the “Company”), and each issued on or about (a) January 29, 2021, to Armistice Capital Master Fund Ltd. (“ACMF” or the “Holder” or the “Investor”) to purchase 500,000 shares of the Company’s common stock, par value CHF 0.02 (“Common Stock”), containing an exercise price of $4.15 per share (the “January 2021 Warrant”); (b) April 25, 2022, to ACMF to purchase 2,163,462 shares of Common Stock, containing an exercise price of $1.04 per share (the “April 2022 Warrant”); (c) March 22, 2024, to AMCF, to purchase 1,750,000 shares of Common Stock, containing an exercise price of $0.25 per share (the “March 2024 Warrant”); and (d) July 1, 2024, to ACMF to purchase 2,500,000 shares of Common Stock, containing an exercise price of $0.24 per share (the “June 2024 Warrant”, and together with the January 2021 Warrant, April 2022 Warrant and March 2024 Warrant, the “Existing Warrants”, and each a “Warrant”).”
https://www.otcmarkets.com/filing/html?id=17845694&guid=G2L-kWrdbxRXB3h
On September 18, 2024, NLS Pharmaceutics Ltd., or the Registrant, convened an extraordinary shareholders’ meeting, or the Meeting. At the Meeting, a quorum was present, and the shareholders of the Registrant approved all agenda items as originally proposed.
The Report on Form 6-K is incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File No. 333-262489, and 333-268690 and 333-269220), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.”"
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