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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) announced new in vitro study results showing that mazindol ER exhibits significant agonist activity at the Orexin-2 receptor, which is crucial for treating narcolepsy. The Phase 2 trials for Quilience (mazindol ER) met primary endpoints with high statistical significance, indicating its potential as a dual mechanism treatment for narcolepsy. The drug offers a unique profile as it targets orexin loss rather than merely treating symptoms. The Phase 3 program is set to begin mid-2023, with additional studies planned to further confirm efficacy and safety.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced an upcoming R&D Day on January 31, 2023, at 10:00 am EST to discuss its strategic pipeline for 2023, focusing on innovative therapies for rare CNS disorders. Key programs include NLS-13 for idiopathic hypersomnia, NLS-3 targeting ADHD, NLS-4 for chronic fatigue syndrome, NLS-8 addressing Alzheimer's amnesia, NLS-11 for Kleine-Levin Syndrome, and NLS-12 for Lewy body dementia. Promising preclinical results and orphan drug designations highlight the company's commitment to meeting unmet medical needs in CNS disorders.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced compliance with Nasdaq's minimum bid price requirement after a notification letter from Nasdaq on January 10, 2023. The company had initially been notified on June 10, 2022, of its non-compliance due to a share price falling below $1.00 for 30 consecutive business days. With a bid price meeting the requirement for 10 consecutive business days from December 20, 2022, to January 9, 2023, Nasdaq confirmed that NLS has regained compliance with Listing Rule 5550(a)(2).
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announces its participation in key upcoming investor conferences. CEO Alex Zwyer will provide a company update at the 2023 BIO CEO & Investor Conference on March 12-14, 2023, and will be available for one-on-one meetings. Additionally, he will participate in the 35th Annual Roth Conference during the same dates. NLS focuses on developing innovative therapies for rare and complex central nervous system disorders.
NLS Pharmaceutics Ltd. announced the grant of a patent for Mazindol ER in Hong Kong, covering its use for ADHD treatment. This patent is key to NLS's global strategy, enhancing its proprietary position in major markets like the U.S., Europe, and Canada. The company is advancing its lead product, Quilience® (Mazindol ER), aimed at treating narcolepsy and potentially ADHD, with Phase 2 clinical trials showing positive results. The ADHD market is projected to increase from $29 billion to nearly $45 billion by 2037.
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.
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