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NLS Pharmaceutics AG - NLSP STOCK NEWS

Welcome to our dedicated page for NLS Pharmaceutics news (Ticker: NLSP), a resource for investors and traders seeking the latest updates and insights on NLS Pharmaceutics 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.

Rhea-AI Summary

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.

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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.

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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.

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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.

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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.

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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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NLS Pharmaceutics received a delisting determination from Nasdaq due to failing to maintain a $1 bid price per share. The company plans to request a hearing to present a compliance plan and seek an extension to meet listing requirements. However, there is no guarantee of approval or regaining compliance.
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NLS Pharmaceutics announced the closing of a registered direct offering of 7,000,000 common shares at $0.25 per share, raising $1.75 million. The company also issued unregistered warrants for 3,500,000 common shares at the same price. The proceeds will be used for working capital and general corporate purposes.
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NLS Pharmaceutics announces a registered direct offering of 7,000,000 common shares at $0.25 per share, along with a private placement of unregistered warrants to purchase up to 3,500,000 common shares.
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NLS Pharmaceutics (NLSP) announces a groundbreaking exclusive worldwide license agreement with Aexon Labs, Inc., acquiring global rights to Dual Orexin Receptor Agonists for neurological disorders. The agreement aims to develop compounds targeting orexin receptors for narcolepsy, hypersomnia, and neurodegenerative diseases. NLS plans to focus on disease-modifying compounds to enhance its neuroscience pipeline in sleep medicine.
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FAQ

What is the main focus of NLS Pharmaceutics?

NLS Pharmaceutics specializes in developing innovative therapies for rare and complex central nervous system disorders.

Where is NLS Pharmaceutics headquartered?

NLS Pharmaceutics is headquartered in Zurich, Switzerland.

What are the company's leading products?

The company's leading products include Quilience for narcolepsy and Nolazol for ADHD.

What recent clinical trial success has NLS Pharmaceutics reported?

The company reported positive results from its Phase 2 clinical trial evaluating Mazindol ER for treating narcolepsy.

What strategic agreement did NLS Pharmaceutics recently enter?

NLS Pharmaceutics entered an exclusive worldwide option agreement with Aexon Labs for Dual Orexin Receptor Agonists.

How is NLS Pharmaceutics addressing financial challenges?

The company has submitted a compliance plan to regain its Nasdaq listing and secured funding through a share issuance agreement.

Who is the CFO of NLS Pharmaceutics?

Elena Thyen-Pighin is the Chief Financial Officer of NLS Pharmaceutics.

What new patent application was recently published?

A new patent application (PCT/WO2024115797) for dual orexin receptor agonists was published, targeting narcolepsy and neurodegenerative conditions.

What is the AMAZE program?

The AMAZE program is a Phase 3 clinical trial to evaluate the safety and efficacy of Mazindol ER in patients with narcolepsy type 1.

How does NLS Pharmaceutics plan to use the proceeds from its recent share issuance?

The proceeds will be used for working capital and general corporate purposes.

NLS Pharmaceutics AG

Nasdaq:NLSP

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8.64M
46.66M
31.54%
29.72%
0.49%
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