NLS Pharmaceutics Ltd. Warrant - NLSPW STOCK NEWS

NLS Pharmaceutics Ltd. announced the closing of an initial $10 million tranche with BVF Partners, securing cash runway beyond pivotal studies for Quilience (Mazindol ER) in narcolepsy. BVF may invest up to $30 million based on meeting conditions, including an FDA phase 2 meeting. The funding aims to accelerate clinical development and business activities, with operations supported until 2025. Quilience has met primary endpoints in clinical trials and received Orphan Drug Designation.

NLS Pharmaceutics Ltd. received a notification from Nasdaq stating it failed to meet the minimum bid price of $1.00, a requirement for continued listing. The company has 180 days to regain compliance, but by December 6, 2022, it received a notice indicating potential delisting. NLS has presented its plan to the Nasdaq Hearings Panel and has been granted until February 28, 2023, to rectify the issue. NLS is a clinical-stage biopharmaceutical company focused on therapies for complex CNS disorders, notably its product Quilience for narcolepsy.

NLS Pharmaceutics Ltd. has entered a definitive agreement with BVF Partners L.P. to raise up to $30 million through a private placement. The initial closing of $10 million will provide 11,494,253 common shares at $0.87 per share, with an option for an additional $20 million following a successful end of phase 2 meeting with the FDA. The funds will support the clinical development of Quilience for narcolepsy and other business activities, ensuring operational funding through 2025.

NLS Pharmaceutics Ltd. (NASDAQ NLSP, NLSPW) has received a Notice of Allowance from the USPTO for a patent covering Mazindol as a treatment for opioid dependence and substance use disorders. This patent could be issued within months and will expire no earlier than 2038. The opioid market is projected to grow to nearly $5 billion by 2028, with over 100,000 overdose deaths annually in the U.S. Mazindol, classified as a Schedule IV controlled substance, presents a non-addictive alternative to current treatments like methadone.

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has launched a Named Patient Program (NPP) for idiopathic hypersomnia (IH), allowing access to Mazindol ER in regions without approved treatments. The program began in the UK and will expand to other countries. CEO Alex Zwyer expressed excitement about providing a treatment option for IH, which affects about 156,000 individuals in the EU. Additionally, the FDA granted Orphan Drug Designation for Mazindol ER on November 2, 2022. This initiative marks a significant step in addressing unmet medical needs in sleep disorders.

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.