NLS Pharmaceutics Ltd. Warrant - NLSPW STOCK NEWS

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced positive results from its Phase 2a trial of Quilience® (Mazindol ER) for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients. The trial achieved its primary endpoint, showing a mean reduction of 7.1 points in EDS, significantly better than the 3.2 points for placebo (p=0.0081). The drug demonstrated rapid action and safety, with no serious adverse events reported. An open-label extension study indicated strong patient interest in continuing treatment, with interim results expected by year-end 2022.

NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced a Virtual Key Opinion Leader (KOL) Event to discuss top-line results from its Phase 2a clinical trial of Quilience (Mazindol ER) for excessive daytime sleepiness and cataplexy in narcolepsy patients. The event is scheduled for September 30, 2022. The Phase 2a trial enrolled 67 patients, evaluating the drug’s efficacy and safety. The primary endpoint assessed changes in excessive daytime sleepiness using the Epworth Sleepiness Scale, crucial for patients with narcolepsy types 1 and 2.

NLS Pharmaceutics Ltd. announced the appointment of Dr. George Apostol as Chief Medical Officer and Global Head of R&D, effective immediately. Dr. Apostol brings extensive experience in drug development from his previous role at Endo Pharmaceuticals. He expressed enthusiasm for overseeing the upcoming Phase 2a results of Quilience for narcolepsy treatment. Additionally, the company confirmed Sylvia Panigone will depart as COO on November 30, 2022. This leadership change aligns with NLS's objectives to advance Quilience towards pivotal trials and expand its CNS disorder pipeline.

NLS Pharmaceutics has received patent approval in Japan for its lead product, Quilience® (mazindol ER), which is being developed for ADHD, narcolepsy, and idiopathic hypersomnia. This adds to existing patents in the U.S., Europe, Canada, and South Korea, strengthening the company's market position. CEO Alex Zwyer expressed optimism about the company's robust patent estate and ongoing Phase 2a clinical trials for Quilience®. The company also holds Orphan Drug Designations in key markets, enhancing treatment accessibility for patients.

NLS Pharmaceutics announced that the European Medicines Agency (EMA) has issued a positive opinion to grant Orphan Drug Designation (ODD) for Mazindol ER (Quilience) in treating idiopathic hypersomnia (IH). This designation acknowledges the unmet medical needs of IH, a rare sleep disorder affecting approximately 156,000 individuals in Europe. The company anticipates enrolling patients in an expanded access program, which may generate non-dilutive revenue. NLS plans to report final results from its ongoing Phase 2a narcolepsy trial in September 2022.

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share. The company has 180 days, until December 5, 2022, to regain compliance. If the share price meets the requirement for ten consecutive business days, the compliance matter will be resolved. Should compliance not be achieved, NLS could face delisting, though an extension period is possible. The company is engaged in developing therapies for rare CNS disorders with its lead product Quilience® currently in Phase 2a trials for narcolepsy.

NLS Pharmaceutics (NASDAQ: NLSP, NLSPW) has appointed Chad C. Hellmann as the new Chief Financial Officer, succeeding Subhasis Roy, who will assist in the transition until June 30, 2022. Hellmann, previously CFO at Arcus Ventures, brings critical experience in operational strategies and capital markets for life sciences. The company is poised for significant developments with the upcoming Phase 2a results for Quilience, a treatment for narcolepsy, which is anticipated next quarter. NLS aims to enhance shareholder value through innovative strategies and product advancement.

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announces successful completion of enrollment for its Phase 2a clinical trial of Quilience for narcolepsy treatment, exceeding its 60-patient target by 12%. Top-line results are anticipated at the European Sleep Research Society Congress in September 2022. Nearly 90% of participants are transitioning to the open label extension study, receiving Quilience monotherapy without additional treatments. The company is exploring strategic partnerships to expedite bringing Quilience to market.

NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced a significant milestone in its Phase 2a clinical trial for Quilience (Mazindol ER), with 90% of the 60 patients planned for the study having been randomized. Since the interim results were released in March, patient enrollment has nearly doubled, with 54 patients randomized and many more undergoing screening. Additionally, nearly 90% of patients who completed the trial have transitioned into the open label extension study, remaining on Quilience monotherapy without additional stimulant treatments.