Accessibility StatementSkip Navigation ZURICH, Oct. 23, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (Nasdaq: NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on central nervous system ("CNS") disorders, and Kadimastem Ltd. (TASE: KDST) ("Kadimastem"), an advanced clinical-stage cell therapy company developing treatments for neurodegenerative diseases and diabetes, today announced an update regarding the proposed merger (the "Merger"). Ronen Twito, Ka ...

Core Viewpoint - The merger between NLS Pharmaceutics Ltd. and Kadimastem Ltd. has been approved by NLS shareholders, paving the way for the formation of NewCelX Ltd., which will be listed on Nasdaq under the ticker "NCEL" [1][6][7]. Group 1: Merger Details - The merger will create a Nasdaq-listed company named NewCelX, with governance and capital structure approvals completed [2]. - Kadimastem shareholders will own 84.4% of the combined company, while NLS shareholders will own 15.6%, reflecting the relative value contributions of each party [5][6]. - The combined company will integrate Kadimastem's advanced cell therapy programs with NLS's expertise in CNS small-molecule therapies [2][7]. Group 2: Leadership and Governance - The leadership team will be headed by Ronen Twito as Executive Chairman and CEO, with Prof. Michel Revel serving as Chief Scientific Officer and Director [3][6]. - A new Board of Directors will be elected, and various committees will be newly constituted to enhance governance and execution [6]. Group 3: Clinical Programs and Pipeline - The merger will unite Kadimastem's clinical programs, including a Phase 2a ALS trial of AstroRx® and the IsletRx diabetes product candidate, with NLS's CNS therapies [7]. - The combined company aims to build a diversified biotechnology portfolio with the potential to deliver transformative therapies to patients worldwide [7].

ZURICH and NESS ZIONA, Israel, Sept. 10, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (Nasdaq:Â NLSPW) ("NLS"), a Swiss clinical-stage biopharmaceutical company focused on central nervous system ("CNS") disorders, and Kadimastem Ltd. (TASE: KDST) ("Kadimastem"), an advanced clinical-stage cell therapy company progressing treatments for neurodegenerative diseases and diabetes, today announced that the U.S. Securities and Exchange Commission (the "SEC") has declared effective the registration st ...

Core Insights - Kadimastem has secured a patent in Hong Kong for its IsletRx technology, enhancing its global intellectual property (IP) portfolio, which already includes patents in Europe, the United States, and India [1][2][3] - The IsletRx platform aims to provide a scalable source of insulin-producing islet-like cells to address diabetes, a significant health challenge affecting millions globally [5][3] - The economic impact of diabetes in Hong Kong is substantial, with an estimated 706,000 adults affected, leading to lifetime healthcare costs averaging $125,000 per patient, translating to a potential economic burden of approximately $90 billion [3][4] Company Overview - Kadimastem Ltd. is a clinical-stage cell therapy company focused on developing allogeneic, "off-the-shelf" cell products for neurodegenerative diseases and diabetes [7] - NLS Pharmaceutics Ltd. is a Swiss-based biopharmaceutical company dedicated to innovative therapies for central nervous system disorders [6]

Core Insights - The announcement highlights the successful completion of a Type B Pre-IND meeting with the FDA, allowing NLS and Kadimastem to advance towards First-in-Human clinical trials of iTOL-102 [1][3] - The BIRD Foundation has approved a milestone payment of approximately NIS 564,400 ($166,000 USD), increasing total support to nearly NIS 3 million ($882,352 USD) [2] - The collaboration between Kadimastem and iTolerance is seen as promising, with the potential of iTOL-102 to redefine treatment for Type 1 diabetes [3] Company Developments - Kadimastem is developing IsletRx technology, which is a scalable, stem cell-derived source of insulin-producing islet-like cells, combined with iTolerance's iTOL-100 platform in iTOL-102 [3] - NLS Pharmaceutics is preparing for safety toxicology studies and clinical trial submissions based on FDA guidance [4] - Dr. Eric Konofal from NLS has been recommended for the Prix Galien, recognizing his contributions to pediatric sleep medicine [5] Industry Context - iTolerance is focused on developing immunomodulatory technologies to enable transplantation without chronic systemic immunosuppression, with iTOL-102 as its lead program [8] - Kadimastem is a clinical-stage biotechnology company with a focus on allogeneic cell therapies, including potential treatments for Type 1 diabetes [6] - NLS Pharmaceutics is a development-stage biopharmaceutical company targeting rare and complex central nervous system disorders [9]