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 ...

About NLS Pharmaceutics According to Kadimastem, the Hong Kong patent adds to previously granted patents in Europe, the United States and India, further strengthening the global protection around IsletRx. The patented process enables the selection and enrichment of highly functional islet cells from differentiated cell populations to help maximize therapeutic effect. Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, commented: "We congratulate Kadimastem on this important intellectual property ...

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]