Company Overview - NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders [1] - The company is positioned for a transformative future in the biotechnology sector [1] Strategic Merger - NLS Pharmaceutics announced a definitive merger agreement with Kadimastem Ltd., a clinical-stage cell therapy company specializing in "off-the-shelf" allogeneic cell products for neurodegenerative diseases and diabetes [2] - The merger aims to create a Nasdaq-traded biotechnology company with a robust portfolio of advanced therapies, with both boards of directors unanimously approving the transaction [2] - The merger is anticipated to close in the second quarter of 2025, pending regulatory approvals and customary closing conditions [2][3] Regulatory Filings - A Registration Statement on Form F-4 has been filed with the SEC, detailing the proposed merger with Kadimastem [3] - An application has been submitted to list the merged company on Nasdaq under the name "NucelX Ltd." with the future ticker of NCEL [3] Advancements in Diabetes Treatment - Kadimastem has completed a pre-Investigational New Drug meeting with the FDA for iTOL-102, a potential breakthrough therapy for Type 1 Diabetes [4] - The innovative approach combines Kadimastem's IsletRx cells with iTolerance's immunomodulator, aiming to cure Type 1 Diabetes without lifelong immune suppression [4] - The diabetes treatment landscape has seen significant growth, highlighted by notable mergers and acquisitions in the sector [5] Expansion of Treatment Strategies - The company is expanding its diabetes treatment strategies beyond GLP-1 therapies to address challenges in diabetes management, including neuroinflammation and metabolic resilience [6] Advancements in Neurodegenerative Disease Treatment - Post-merger, NLS Pharmaceutics plans to initiate a Phase IIa multi-site clinical trial of AstroRx®, a product candidate for Amyotrophic Lateral Sclerosis (ALS) [7] Leadership and Expertise - Kadimastem contributes an experienced international leadership team, including key figures with a track record in developing medicines from laboratory to market [8][9] Research and Development Initiatives - The company is advancing its Dual Orexin Receptor Agonist platform, with promising results from preliminary studies on compounds AEX-41 and AEX-2 for sleep-wake disorders [10] - A preclinical program evaluating Mazindol ER as a treatment for fentanyl dependence has been launched [14] Financial Position - NLS Pharmaceutics has zero long-term debt and raised approximately $4.2 million through private placements, extending its operational runway to approximately 18 months [14] - This financial stability allows the company to accelerate clinical development and pursue strategic partnerships [14]
NLS Pharmaceutics CEO Issues Letter to Shareholders