Nls Pharmaceutic Stock Price, News & Analysis

NLS Pharmaceutics (Nasdaq: NLSP, NLSPW) announced on November 11, 2022, that it successfully appealed a Nasdaq delisting notice. The Nasdaq Hearings Panel granted a continuation of the company's listing, contingent on providing updated financial statements by January 19, 2023, and demonstrating compliance with stockholders' equity requirements by February 28, 2023. Failure to meet these conditions may lead to delisting. NLS focuses on developing therapies for rare CNS disorders, with its lead candidate, Quilience®, showing promising results for narcolepsy during clinical trials.

NLS Pharmaceutics Ltd. announced positive interim results from the Open Label Extension (OLE) study for Quilience® (Mazindol ER) in narcolepsy treatment. Of 60 patients from the Phase 2 trial, 52 (87%) opted for the OLE, showing a significant improvement in excessive daytime sleepiness (EDS) scores by 1.8 points, reaching a mean of 9.2. Patients receiving placebo in the Phase 2 trial also showed comparable EDS improvements when starting Quilience® in the OLE. Weekly cataplexy episodes declined to 2.1 on average from 17.5 at baseline, indicating strong efficacy and safety of Quilience®.

NLS Pharmaceutics Ltd. has received Orphan Drug Designation (ODD) from the FDA for its product candidate, Quilience® (Mazindol ER), aimed at treating Idiopathic Hypersomnia (IH). Currently, there is only one approved drug for IH in the U.S., highlighting a significant unmet medical need. The ODD provides NLS with seven years of marketing exclusivity and financial incentives. Quilience® has shown promising Phase 2a results in promoting wakefulness in narcolepsy patients, similar to IH, positioning the company to enhance shareholder value through its Mazindol-based solutions.

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) received a delisting determination letter from Nasdaq on September 29, 2022, due to failure to meet the minimum stockholders' equity requirement. The company plans to request a hearing before the Nasdaq Hearings Panel, which could grant an extension to regain compliance by March 28, 2023. NLS Pharmaceutics is focused on developing therapies for central nervous system disorders, with its lead candidate, Quilience, showing positive results in clinical trials for narcolepsy.

NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) has announced a private placement for 5,194,802 common shares and warrants to purchase up to 2,597,401 common shares, raising approximately $4 million. The shares are priced at $0.77, a 20% premium over the previous closing price. The company plans to utilize the funds for the development of its lead product, Quilience®, for narcolepsy, and for general corporate purposes. The offering is expected to close by October 7, 2022. Existing short-term notes will convert into common shares and additional warrants.

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.