NLS Pharmaceutics AG engages in the discovery and development of drug therapies to treat rare and complex central nervous systems disorders. These disorders include narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as ADHD. The company was founded by Ronald Hafner and Alexander Zwyer in August 2015 and is headquartered in Stans, Switzerland.
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- The SEC has declared effective the registration statement for the merger between Kadimastem and NLS Pharmaceutics, marking the final U.S. federal regulatory hurdle for the transaction. - The combined company, NewCelX Ltd., will trade on Nasdaq under ticker "NCEL" and unite Kadimastem's cell therapy platforms with NLS's small-molecule expertise. - Kadimastem is preparing to initiate a Phase 2a clinical trial of AstroRx for ALS treatment and continues advancing IsletRx for insulin-dependent diabetes. - The merger creates a diversified pipeline targeting CNS disorders and metabolic diseases, with completion expected following a September 29 shareholder meeting.
- Kadimastem has been granted a Hong Kong patent covering its proprietary cell selection and enrichment technology for IsletRx, a stem cell-derived therapy candidate intended to treat and potentially cure insulin-dependent diabetes. - The Hong Kong patent adds to previously granted patents in Europe, the United States and India, strengthening global intellectual property protection for the IsletRx platform. - Hong Kong represents a significant diabetes market with approximately 706,000 adults living with diabetes, representing an 8.2% prevalence and potential economic impact of $90 billion. - IsletRx aims to provide scalable, stem cell-derived insulin-producing islet-like cells capable of secreting insulin and glucagon in response to glucose levels.
- The BIRD Foundation approved a fifth milestone payment of approximately $166,000 USD to support continued development of iTOL-102, a potential cure for Type 1 diabetes that would eliminate the need for lifelong immunosuppression. - The funding follows a successful Type B Pre-IND meeting with the FDA in February 2025, where the agency provided constructive guidance on the clinical development pathway for First-in-Human trials. - iTOL-102 combines Kadimastem's IsletRx stem cell-derived insulin-producing islet-like cells with iTolerance's iTOL-100 immunomodulatory platform, demonstrating functional insulin secretion and disease reversal in preclinical diabetic animal models. - The companies are currently preparing for safety toxicology studies and clinical trial submissions based on FDA guidance, with total BIRD Foundation support reaching nearly $882,352 USD to date.
- NLS Pharmaceutics' preclinical study demonstrates Mazindol ER significantly reduces both fentanyl's rewarding effects and withdrawal symptoms in rodent models, suggesting potential as a novel non-opioid treatment for opioid addiction. - The drug's multi-receptor mechanism targets partial mu-opioid receptor agonism, 5-HT1A receptor activation, and orexin-2 receptor modulation, offering a unique approach compared to traditional addiction treatments. - These findings will be presented at the 2025 ASCP Annual Meeting in Arizona, with researchers highlighting Mazindol's potential advantages over conventional ADHD medications that show limited efficacy for opioid dependence.
• NLS Pharmaceutics has closed a $2 million equity financing at a 10% premium to market price, with potential for an additional $1 million, alongside a $25 million committed equity facility to support its planned merger with Kadimastem. • The funding will enable the merged company to advance Kadimastem's AstroRx® Phase IIa clinical trial for Amyotrophic Lateral Sclerosis (ALS) and IsletRx Phase I trial for type 1 diabetes following the merger completion. • The strategic merger aims to create a leading regenerative medicine company combining NLS's CNS expertise with Kadimastem's cell therapy platform for neurodegenerative diseases and diabetes.
• NLS Pharmaceutics has filed a $75 million mixed securities shelf, signaling potential capital raising activities to support its clinical development pipeline in the near future. • NewAmsterdam Pharma has filed a significantly larger $500 million mixed securities shelf, positioning the company for substantial financing flexibility as it advances its cardiovascular therapeutics. • These strategic financial moves by both pharmaceutical companies indicate preparation for expanded research operations, clinical trials, or possible acquisitions in a competitive biotech funding landscape.
- Kadimastem and iTolerance have submitted a request for a Pre-IND meeting with the FDA for iTOL102, a novel treatment for Type 1 Diabetes. - iTOL102 combines allogeneic stem cell-derived pancreatic islets with an immunomodulator to potentially cure Type 1 Diabetes. - Preclinical studies of iTOL102 at the Diabetes Research Institute showed functional insulin release and disease reversal in animal models. - NLS Pharmaceutics anticipates its merger with Kadimastem will enhance its pipeline with valuable assets, pending shareholder approval.
• Kadimastem and NLS Pharmaceutics are merging to advance their respective drug portfolios, including AstroRx for amyotrophic lateral sclerosis (ALS). • A Phase 2a clinical trial of AstroRx is planned in the U.S. after January 2025, following FDA clearance of the investigational new drug application. • The merger will also support the development of NLS's dual orexin receptor agonists (DOXA) platform for neurodegenerative conditions. • Previous Phase 1/2a trial results showed AstroRx significantly reduced disease progression in ALS patients, with repeat dosing to be tested in the upcoming trial.
