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NLS Pharmaceutics Ltd. (Nasdaq: NLSP) is a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system (CNS) disorders. Founded in 2015 and headquartered in Zurich, Switzerland, NLS Pharmaceutics is committed to designing affordable, safe, and effective therapeutics aimed at safeguarding and empowering the brain throughout all stages of life.
The company's core mission is to serve patients by developing life-improving drug therapies, particularly targeting rare and complex neurobehavioral and neurocognitive conditions. NLS Pharmaceutics' leading products include Quilience, which is being developed for the treatment of narcolepsy, and Nolazol, aimed at treating ADHD.
Recent Achievements:
- Positive results from Phase 2 clinical trials (NLS-1021) demonstrating the efficacy, tolerability, and safety of Quilience (Mazindol ER) in treating narcolepsy.
- Initiation of a Phase 3 clinical trial program (AMAZE) for Mazindol ER in patients with narcolepsy type 1, following IRB and FDA green light.
- Exclusive worldwide option agreement with Aexon Labs to acquire global development and commercialization rights for Dual Orexin Receptor Agonists, with potential applications in treating narcolepsy, idiopathic hypersomnia, and neurodegenerative disorders like Parkinson’s and Alzheimer’s disease.
- Secured a definitive agreement for the issuance and sale of common shares to generate $1.75 million for working capital and general corporate purposes.
- Publication of a new patent application (PCT/WO2024115797) by Aexon Labs covering dual orexin receptor agonists targeting narcolepsy and neurodegenerative conditions.
- Appointment of Elena Thyen-Pighin as Chief Financial Officer to further strengthen the company's leadership team.
Financial Condition and Market Position:
NLS Pharmaceutics operates in a challenging financial environment but continues to demonstrate resilience through strategic partnerships, clinical trial successes, and innovative research. Despite facing compliance issues with Nasdaq's minimum stockholders' equity requirement, the company has submitted and received approval for a compliance plan to regain its standing.
Leadership and Vision:
The company is led by an experienced management team with a proven track record in developing and commercializing therapeutic products. CEO Alex Zwyer emphasizes a patient-first approach, valuing partnership, integrity, and innovation. NLS Pharmaceutics remains committed to advancing its pipeline and maximizing shareholder value through strategic actions and partnerships aligned with its core mission.
For more information, please visit NLS Pharmaceutics.
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.
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.
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