Nls Pharmaceutics Ltd Stock Price, News & Analysis

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced significant progress in its clinical pipeline focused on rare CNS disorders in a letter from CEO Alex Zwyer to shareholders. Key achievements for 2022 include successfully completing the Phase 2a clinical program for Quilience (Mazindol ER) in narcolepsy, securing up to $30 million in funding, and launching a Named Patient Program for idiopathic hypersomnia. The company established a strong leadership team and anticipates a fruitful 2023 with ongoing developments in its product pipeline and regulatory efforts.

NLS Pharmaceutics Ltd. has received an Israeli patent for Mazindol, which is recognized as a treatment for Attention Deficit/Hyperactivity Disorder (ADHD) and various sleep disorders, including narcolepsy. The patent is effective until at least 2037. NLS is advancing the clinical development of its lead product, Mazindol ER, with expected funding through 2025, anticipating a new drug application submission in late 2024 or early 2025. The ADHD therapeutics market is currently valued at over $29 billion and expected to increase to nearly $45 billion by 2037.

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®.