NLS Pharmaceutics AG
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- NLS Pharmaceutics AG, a clinical-stage biopharmaceutical company headquartered in Zurich, Switzerland and founded in 2015, develops innovative therapies for rare and complex central nervous system disorders including narcolepsy, idiopathic hypersomnia, attention deficit hyperactivity disorder, and other sleep and neurodevelopmental conditions. The company offers a pipeline of product candidates such as Quilience (mazindol extended-release) for narcolepsy treatment, Nolazol for ADHD, lauflumide (NLS-4) as a wake-promoting agent for chronic fatigue including long-COVID symptoms, and early-stage programs including non-sulfonamide dual orexin receptor agonists (DOXA) like AEX-635 for narcolepsy and neurological disorders; it also advances preclinical efforts in fentanyl dependence and expanded applications of mazindol ER. NLS Pharmaceutics operates primarily in Switzerland with a global focus on CNS and neurodegenerative markets targeting patients worldwide through clinical trials and regulatory pathways in the United States, Europe, and Asia. In recent developments, the company completed a merger with Kadimastem Ltd. on October 30, 2025, forming NewCelX Ltd. (Nasdaq: NCEL) with Kadimastem shareholders owning 84.4% and NLS retaining 15.6%, integrating cell therapy platforms such as AstroRx for ALS Phase 2a trials and IsletRx/iTOL-102 for type 1 diabetes in partnership with iTolerance; it secured up to $3 million in equity financing plus a $25 million equity facility in 2025 to support the merger and clinical programs, implemented a 1-for-10 reverse share split effective October 30, 2025, regained full Nasdaq compliance, reported positive Phase 2 top-line results for Quilience in narcolepsy, obtained key patents including for mazindol ER in Japan and Hong Kong for cell therapy technologies, and entered an MOU with TargetGene for next-generation gene-edited therapies under NewCelX.
NewcelX Provides Business and Strategic Roadmap Update Following Closing of Merger with NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. and Kadimastem Ltd.
NLS Pharmaceutics Expands CNS Pipeline With AEX-6xx Series Developed by Aexon Labs
NLS Pharmaceutics and Kadimastem Highlight Continued BIRD Foundation Support for ITOL-102 Diabetes Program Following Merger
NLS Pharmaceutics Ltd. Announces 1-for-10 Reverse Share Split and Name Change in Connection with Proposed Merger with Kadimastem
NLS Pharmaceutics and Kadimastem Announce Completion of Material Conditions Precedent for Merger Transaction and Delisting Date of Kadimastem's Shares
NLS Pharmaceutics and Kadimastem Announce Strategic Collaboration between Kadimastem and TargetGene to Advance Next-Generation Gene-Edited Cell Therapies
NLS and Kadimastem Announce Receipt of Nasdaq Approval; Merger Expected to Close on October 30, 2025
NLS Pharmaceutics Shareholders Approve Merger with Kadimastem and Related Proposals at Extraordinary General Meeting
Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger
NLS Pharmaceutics and Kadimastem announce a Hong Kong Patent Covering Cell-Selection and Enrichment Technology for IsletRx for Diabetes Patients
NLS Pharmaceutics Highlights Continued Progress in iTOL-102 Diabetes Program as BIRD Foundation Approves Additional Milestone Payment to Kadimastem and iTolerance for Continued Co-Development of Type 1 Diabetes Cell Therapy
NLS Pharmaceutics and Kadimastem Announce Pricing and Closing of $1 Million Equity Financing
NLS Pharmaceutics CEO Issues Letter to Shareholders
NLS Pharmaceutics to Present New Data on the Dual Efficacy of Mazindol ER in Fentanyl Reward and Withdrawal at the 2025 ASCP Annual Meeting
NLS Pharmaceutics Announces Positive Results from Study KO-943 Demonstrating Mazindol Reduces Fentanyl-Induced Reward in Animal Models
NLS Pharmaceutics and Kadimastem Announces Up to $3 Million Equity Financing and $25 Million Equity Facility Agreement
NLS Pharmaceutics CEO Issues Letter to Shareholders
NLS Pharmaceutics Announces New Preclinical Data for AEX-2, Expanding the Therapeutic Potential of its Non-Sulfonamide Dual Orexin Receptor Agonist Platform
Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment