Welcome to our dedicated page for NLS Pharmaceutics Ltd. Ordinary Shares news (Ticker: NLSP), a resource for investors and traders seeking the latest updates and insights on NLS Pharmaceutics Ltd. Ordinary Shares stock.
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) provides updates in a letter to shareholders from CEO Alex Zwyer, highlighting significant progress in clinical development for Quilience, an innovative narcolepsy treatment. Key achievements include entering Phase 2 clinical trials, successful patent applications in the U.S., Europe, and Canada, and positive pre-clinical data on NLS-4 for chronic fatigue syndrome. The company anticipates reporting interim results from the POLARIS trial in Q1 2022, and plans to explore additional market opportunities for Quilience beyond narcolepsy.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has announced promising preclinical data for its next-generation drug candidate, NLS-4 (Lauflumide), targeting chronic fatigue associated with Long-COVID. In a study, rats treated with NLS-4 exhibited improved nighttime activity and greater motor-stimulating behavior compared to those treated with modafinil. The results suggest NLS-4 may effectively combat symptoms of fatigue and sleep disturbances related to COVID-19. The company is committed to advancing NLS-4 into clinical development to alleviate chronic fatigue in Long-COVID patients.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW), a Swiss clinical-stage pharmaceutical company, is set to present at The Micro Cap Rodeo Fall Harvest Conference from October 5-8, 2021. CEO Alex Zwyer will provide a corporate overview on October 5 at 9:00 am ET. The presentation is accessible through a provided link, and a replay will be available on the company's website. NLS's lead candidate, Quilience, is in phase 2 studies for narcolepsy treatment and has received Orphan Drug Designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced a $20 million Standby Equity Distribution Agreement (SEDA) with YA II PN, Ltd., allowing the company to issue common shares over 36 months at an 8% discount. A $2.5 million immediate investment at $1.90 per share is also included. Proceeds will be used for advancing pipeline assets and general working capital. Quilience®, the company's lead product, is in Phase 2 trials for narcolepsy. The shares will only be sold following SEC registration. Risks include potential clinical trial delays and market acceptance issues.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) will participate in the Benzinga Healthcare Small Cap Conference on September 29-30, 2021. CEO Alex Zwyer is scheduled for a live interview on September 29 from 1:55 PM to 2:15 PM ET. Attendees can access the interview here, with a replay available on the company website. NLS focuses on developing therapies for rare CNS disorders and is advancing its lead candidate, Quilience, for narcolepsy, which has Orphan Drug Designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. has initiated a Phase 2 clinical trial for its drug Quilience (mazindol ER) targeting excessive daytime sleepiness and cataplexy in narcolepsy patients. Enrolling around 60 patients across 30 centers in the U.S. and Europe, the trial aims to assess its efficacy over 28 days. Primary endpoints include changes in the Epworth Sleepiness Scale and cataplexy attack frequency. Successful completion could lead to significant advancements in treatment options for narcolepsy, addressing an unmet medical need.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NASDAQ:NLSPW) announces that CEO Alex Zwyer will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Investors can access the presentation online starting September 13 at 1:00 PM CET / 7:00 AM ET. This conference includes six industry tracks, highlighting Healthcare & Biotechnology, and offers networking opportunities. NLS is focused on innovative therapies for central nervous system disorders, with its lead candidate, Quilience, targeting narcolepsy and receiving Orphan Drug Designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced a Notice of Allowance from the USPTO for patent application No. 16/083,131.
This patent will cover oral formulations with immediate-release and sustained-release layers of mazindol for treating attention deficit disorders (ADD, ADHD), narcolepsy, and excessive daytime sleepiness.
The patent is expected to issue in Q4 2021, expiring no earlier than March 2037. NLS aims to include it in the FDA's Orange Book if market approval is obtained.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced that CEO Alex Zwyer will present at the Canaccord Genuity 41st Annual Growth Conference from August 10-12, 2021. Zwyer's presentation is scheduled for August 12, 2021, at 10:00 AM ET and will be available for live streaming and replay on the company's website. NLS focuses on innovative therapies for rare central nervous system disorders, with its lead product, Quilience, developed for narcolepsy treatment and holding orphan drug designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. has appointed Eric Konofal, M.D., Ph.D., as Chief Scientific Officer. Dr. Konofal, a co-founder with over 30 years of experience in CNS disorders, will focus on advancing the company’s drug pipeline, which includes Quilience® for narcolepsy and five other patented compounds. His leadership is expected to enhance drug development efforts, particularly against disorders like ADHD and Parkinson’s disease. The company recently submitted multiple patent applications, which could strengthen its market position.
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