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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 and Kadimastem have announced a binding term sheet for a merger, creating a Nasdaq-traded biotechnology company focused on advancing Kadimastem's allogeneic cell therapy platform. The proposed transaction will result in Kadimastem becoming a wholly owned subsidiary of NLS, with Kadimastem's shareholders acquiring an 85% interest in NLS. The combined company is expected to operate under the name Kadimastem and trade on the Nasdaq Capital Market. Both companies have received commitments of support from shareholders representing over 40% of their respective outstanding shares. The merger aims to create a company with product candidates in advanced stages of clinical development, particularly in the areas of neurodegenerative diseases and potential diabetes cure.
NLS Pharmaceutics, a Swiss clinical-stage biopharmaceutical company specializing in treatments for rare and complex CNS disorders, announced a registered direct offering of 3,277,750 common shares at $0.24 per share. This offering is expected to close around July 1, 2024, subject to customary conditions. Additionally, NLS will issue unregistered warrants for the same number of shares, exercisable immediately at $0.24 per share and expiring in five years. The gross proceeds of $786,660 will support working capital, R&D, and strategic expansion. H.C. Wainwright & Co. is acting as the exclusive placement agent.
NLS Pharmaceutics (NASDAQ:NLSP) has announced promising preclinical results from in vitro studies targeting alpha-synuclein (A53T mutation) to treat Parkinson's Disease (PD). Utilizing the 'Alpha-Synuclein (A53T) Genetic Cell-Based Agonist Neurite Outgrowth Assay' by Eurofins, various compounds demonstrated positive effects on neurite outgrowth, indicating potential neuronal health benefits.
AEX-23 showed significant OX1R agonist activity and positive neurite outgrowth. AEX-19 showed benefits at low concentrations, increasing CTSD activity and imparting neuroprotective effects. AEX-24 enhanced CTSD activity, suggesting a role in alpha-synuclein degradation.
NLS plans to develop AEX-230 and AEX-231, targeting cathepsins involved in neurodegenerative disorders. Further preclinical and in vivo studies are needed to optimize dosing and assess long-term safety and efficacy.
NLS Pharmaceutics announced that the Nasdaq Hearings Panel has granted the company an extension until October 14, 2024, to meet listing requirements for the Nasdaq Capital Market. The company must comply with a minimum bid price of $1.00 per share and maintain at least $2,500,000 in stockholders' equity, as per Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1). Previously, NLS received notification from Nasdaq that it failed to meet these criteria, prompting a hearing on June 4, 2024. Despite the extension, there are no guarantees that NLS will achieve compliance by the deadlines.
NLS Pharmaceutics, a clinical-stage biopharmaceutical company, has announced a new patent application for dual orexin receptor agonists (DOXA), developed with Aexon Labs, targeting narcolepsy and neurodegenerative diseases like Parkinson's. These non-sulfonamide compounds are designed to reduce side effects and improve patient safety. The molecules enhance neurotransmitter release and protect neuronal health by modulating orexin receptors and inhibiting cathepsin H (CTSH), offering potential therapeutic benefits for sleep regulation and neurodegeneration. This patent represents a significant advancement in addressing unmet medical needs in both narcolepsy and neurodegenerative diseases.
NLS Pharmaceutics announced promising results from study KO-874, presented at the American Society of Clinical Psychopharmacology. The study evaluated mazindol's neuroprotective effects in a narcoleptic-like rat model. Key findings showed that a 3 mg/kg dose of mazindol significantly mitigated circadian activity reduction caused by OX-B-SAP lesions and restored activity levels to normal. Lower doses were less effective. The study highlights mazindol's potential utility in treating disorders like narcolepsy. Further clinical development is supported by these results.
NLS Pharmaceutics (NASDAQ: NLSP) announced it received an additional staff determination letter from Nasdaq on May 22, 2024, notifying the company of its non-compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing. This additional delinquency serves as a separate basis for potential delisting. Previously, on April 19, 2024, NLS was informed of potential delisting due to failing to maintain a $1 bid price per share. The company has requested a hearing before a Nasdaq Hearings Panel, scheduled for June 4, 2024, to appeal the delisting determination and present its plans to regain compliance.
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