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NLS Pharmaceutics

NLS Pharmaceutics logo
🇨🇭Switzerland
Ownership
Public
Employees
4
Market Cap
-
Website
http://www.nlspharma.com
Introduction

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.

Mazindol ER Shows Promising Dual Action Against Fentanyl Addiction in Preclinical Studies

• 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 Secures $28 Million in Financing to Advance Merger with Kadimastem and Cell Therapy Pipeline

• 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.

Kadimastem and iTolerance Seek FDA Input for Novel Type 1 Diabetes Therapy, iTOL102

• 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 Merge to Advance ALS Therapy AstroRx

• 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.
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