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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 its participation at the American Society of Clinical Psychopharmacology (ASCP) annual meeting from May 30 to June 2, 2023, in Miami, Florida. The company's Chief Scientific Officer, Dr. Eric Konofal, will present new preclinical data on four pipeline compounds targeting chronic fatigue and memory issues associated with CNS disorders. The presentations include:
- NLS-4: Effects on chronic severe fatigue - June 1, 2023
- NLS-8: Effects on memory in Alzheimer's model - June 1, 2023
- NLS-11: Effects on memory - May 31, 2023
- NLS-12: Effects on memory - May 31, 2023
The company emphasizes its commitment to developing innovative therapies for patients with rare CNS disorders.
NLS Pharmaceutics Ltd. announced results from its six-month Open Label Extension (OLE) study for Quilience® (Mazindol ER) in treating narcolepsy. Of the 60 patients completing the Phase 2 trial, 87% continued into the OLE, showing increased effectiveness in managing excessive daytime sleepiness and cataplexy episodes. Patients previously on placebo also achieved similar results after switching to Mazindol ER. Overall, the safety and tolerability profile remained consistent, with no serious adverse events reported. The Phase 3 program is set to begin mid-2023 after an FDA meeting in late April.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced that CEO Alex Zwyer will present at the 35th Annual Roth Conference on March 13, 2023, at 10:00 AM PT (1:00 PM ET) in Dana Point, CA.
The conference will include small group meetings, analyst-led fireside chats, and company presentations from around 400 private and public companies across various sectors.
Live audio webcasts and replays will be available in the investor relations section of the Company's website.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has completed the six-month Open Label Extension (OLE) study for Mazindol ER, a treatment for narcolepsy. The study included patients who previously participated in the POLARIS Phase 2 study. Notably, 87% of the patients opted to continue Mazindol ER treatment rather than switch therapies. The OLE aims to assess long-term safety, tolerability, and efficacy for Excessive Daytime Sleepiness (EDS) and cataplexy, showing promising results in interim data. Full results are expected in Q1 2023 and will be presented at a scientific meeting.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced on January 25, 2023, that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies to maintain a minimum stockholders' equity of $2,500,000. This follows a notification letter from the Nasdaq Hearings Panel confirming the company's adherence to the rule. NLS was first notified of its non-compliance on April 1, 2022, but through an appeal process, it received approval to continue its Nasdaq listing. The Panel's recent confirmation resolves all outstanding compliance issues.
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