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 has received patent approval in Japan for its lead product, Quilience® (mazindol ER), which is being developed for ADHD, narcolepsy, and idiopathic hypersomnia. This adds to existing patents in the U.S., Europe, Canada, and South Korea, strengthening the company's market position. CEO Alex Zwyer expressed optimism about the company's robust patent estate and ongoing Phase 2a clinical trials for Quilience®. The company also holds Orphan Drug Designations in key markets, enhancing treatment accessibility for patients.
NLS Pharmaceutics announced that the European Medicines Agency (EMA) has issued a positive opinion to grant Orphan Drug Designation (ODD) for Mazindol ER (Quilience) in treating idiopathic hypersomnia (IH). This designation acknowledges the unmet medical needs of IH, a rare sleep disorder affecting approximately 156,000 individuals in Europe. The company anticipates enrolling patients in an expanded access program, which may generate non-dilutive revenue. NLS plans to report final results from its ongoing Phase 2a narcolepsy trial in September 2022.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share. The company has 180 days, until December 5, 2022, to regain compliance. If the share price meets the requirement for ten consecutive business days, the compliance matter will be resolved. Should compliance not be achieved, NLS could face delisting, though an extension period is possible. The company is engaged in developing therapies for rare CNS disorders with its lead product Quilience® currently in Phase 2a trials for narcolepsy.
NLS Pharmaceutics (NASDAQ: NLSP, NLSPW) has appointed Chad C. Hellmann as the new Chief Financial Officer, succeeding Subhasis Roy, who will assist in the transition until June 30, 2022. Hellmann, previously CFO at Arcus Ventures, brings critical experience in operational strategies and capital markets for life sciences. The company is poised for significant developments with the upcoming Phase 2a results for Quilience, a treatment for narcolepsy, which is anticipated next quarter. NLS aims to enhance shareholder value through innovative strategies and product advancement.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announces successful completion of enrollment for its Phase 2a clinical trial of Quilience for narcolepsy treatment, exceeding its 60-patient target by 12%. Top-line results are anticipated at the European Sleep Research Society Congress in September 2022. Nearly 90% of participants are transitioning to the open label extension study, receiving Quilience monotherapy without additional treatments. The company is exploring strategic partnerships to expedite bringing Quilience to market.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced a significant milestone in its Phase 2a clinical trial for Quilience (Mazindol ER), with 90% of the 60 patients planned for the study having been randomized. Since the interim results were released in March, patient enrollment has nearly doubled, with 54 patients randomized and many more undergoing screening. Additionally, nearly 90% of patients who completed the trial have transitioned into the open label extension study, remaining on Quilience monotherapy without additional stimulant treatments.
NLS Pharmaceutics Ltd. announced the closing of its registered direct offering, raising approximately US$4.4 million through the sale of 4,200,000 common shares at $1.04 each. Health-care focused institutional investors participated, including the Company's Chairman, Ronald Hafner. Additionally, warrants for 3,150,000 common shares were issued at the same price, exercisable after six months and expiring in five years. The funds will be used for the development of Quilience® (Mazindol ER) for narcolepsy treatment and other corporate purposes.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced that CEO Alex Zwyer will join a fireside chat at the B. Riley Annual Neuro & Ophthalmology Investor Conference on April 28, 2022, at 4 PM EST.
This event will allow investors to gain insights into NLS's innovative therapies targeting rare central nervous system disorders, including the ongoing Phase 2a trial for Quilience, aimed at treating narcolepsy. Registration for the conference can be found here.
NLS Pharmaceutics Ltd. has announced a registered direct offering of 4,200,000 common shares at $1.04 per share, aiming to raise approximately US$4.4 million before expenses. The offering, expected to close around April 25, 2022, also includes warrants for 3,150,000 common shares. Funds will support the development of Quilience® for narcolepsy, alongside business development activities. This follows the effectiveness of a shelf registration statement filed with the SEC.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has received a notification from Nasdaq stating it is not in compliance with the minimum stockholders' equity requirement of at least $2,500,000.
Additionally, the company did not meet the alternative compliance standards concerning the market value of its securities or net income. NLS has 45 days until May 16, 2022, to submit a compliance plan to Nasdaq, which may grant an extension of up to 180 days if the plan is accepted. This notification does not immediately affect its Nasdaq listing.
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