Welcome to our dedicated page for Nls Pharmaceutic news (Ticker: NLSPW), a resource for investors and traders seeking the latest updates and insights on Nls Pharmaceutic stock.
NLS Pharmaceutics Ltd. (NLSPW) is a Swiss clinical-stage biopharmaceutical company advancing novel therapies for central nervous system disorders. This page provides investors and medical professionals with timely updates on the company’s research milestones, regulatory developments, and strategic initiatives.
Key resources include: press releases detailing clinical trial progress, partnership announcements with leading research institutions, and updates on intellectual property advancements. Users will find verified information on narcolepsy/ADHD treatment pipelines, R&D methodologies, and patient-centered therapeutic innovations.
Bookmark this page to stay informed about NLS Pharmaceutics’ contributions to neurotherapeutics. Check regularly for authoritative updates directly from corporate communications and verified industry sources.
NLS Pharmaceutics (NLSP) has announced positive results from Study KO-943, evaluating Mazindol's effectiveness in reducing fentanyl-induced reward in mice. The preclinical study demonstrated that Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced conditioned place preference (CPP), bringing behavior close to baseline.
The study utilized four test groups: vehicle control, fentanyl-only, and two fentanyl with Mazindol co-treatment groups. Key findings showed that fentanyl increased place preference (p ≤ 0.05 vs. vehicle), while Mazindol demonstrated a dose-dependent effect in reducing this preference.
Mazindol's mechanism of action includes:
- Partial mu-opioid receptor modulation
- 5-HT1A receptor interaction
- OX2R activity
NLS Pharmaceutics (NASDAQ:NLSP) has secured a $2 million equity financing through preferred shares at $1.65 per share, with potential for an additional $1 million subject to shareholder approval. The company also signed a $25 million committed equity facility agreement.
The funding will support NLS's planned merger with Kadimastem, a clinical-stage cell therapy company focusing on neurodegenerative diseases and diabetes. The merged entity plans to conduct a Phase IIa multi-site clinical trial for AstroRx® in Amyotrophic Lateral Sclerosis (ALS) and a Phase I trial for IsletRx in type 1 diabetes patients post-merger.
The financing, closed on March 28, 2025, was secured at a 10% premium to the market share price. The securities were issued through a private placement under Section 4(a)(2) of the Securities Act and Regulation D. The merger remains subject to regulatory and shareholder approvals.
NLS Pharmaceutics (NLSP) has announced new preclinical findings for AEX-2, their non-sulfonamide dual orexin receptor agonist (DOXA). The research demonstrates promising results in treating narcolepsy and related neurological disorders.
Key findings from preclinical studies show that AEX-2 (20 mg/kg, IP) significantly enhanced wakefulness while maintaining stable wake architecture, preserved REM sleep patterns, and effectively reduced cataplexy episodes in narcolepsy type 1.
The company is expanding its therapeutic potential beyond sleep disorders, with AEX-2 and AEX-41 showing promise in treating neuroinflammation, ALS, Parkinson's disease, and diabetes-associated neurological disorders through Sigma-1 receptor modulation. NLS plans to advance both compounds into IND-enabling studies in 2025, targeting first-in-human clinical trials by 2026.
NLS Pharmaceutics (NASDAQ: NLSP) has submitted three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), scheduled for May 27-30, 2025, in Scottsdale, Arizona. The submissions include:
1. A study on Mazindol ER for fentanyl dependence, exploring its potential as a non-opioid alternative for addiction treatment.
2. Research on AEX-41 and AEX-2, novel dual orexin receptor agonists (DOXA), showing promising results for narcolepsy treatment without traditional stimulants' adverse metabolic effects.
3. A comprehensive study on managing diabetes-associated neurological and sleep disorders using dual orexin receptor agonists, neuropeptide-based preconditioning, and metabolic modulators.
NLS Pharmaceutics (NASDAQ: NLSP) has launched a preclinical program to evaluate Mazindol ER as a treatment for fentanyl dependence. The program, designated Study KO-943, comes amid a major global health crisis, with CDC reporting 105,007 drug overdose deaths in 2023, 90% involving synthetic opioids like fentanyl.
Mazindol ER, protected by patents until September 2038, offers a non-opioid alternative through multiple mechanisms: 5-HT1A receptor modulation, mu-opioid receptor interaction, and orexin-2 receptor partial agonist activity. The preclinical study will evaluate safety, efficacy, and pharmacokinetics, with completion expected within 12-18 months.
The company holds key patents, including US Patent No. 11,207,271 for oral formulations and No. 11,596,622 for heroin dependence treatment. The development program aims to address the limitations of traditional treatments like methadone and buprenorphine.
NLS Pharmaceutics (NLSP) CEO Alex Zwyer issued a shareholder letter highlighting recent developments and future strategies. The company has made progress with its Dual Orexin Receptor Agonist (DOXA) platform, developing AEX-41 and AEX-2 compounds for narcolepsy treatment. Preliminary results from AEX-41 studies showed promising outcomes in managing sleep-wake disturbances.
The company regained Nasdaq compliance and strengthened its financial position through two private placements: a $3.2 million placement in October and an announced $1 million placement at $3.10 per share in December. These funds extend the runway to approximately 18 months.
NLSP announced a merger with Kadimastem, expected to close by January 2025. Post-merger, Kadimastem will own DOXA program, while NLSP shareholders will retain rights to benefit from potential sale of legacy assets, including Mazindol, through a CVR agreement.
NLS Pharmaceutics (Nasdaq: NLSP) announced a private placement offering of up to 322,580 common shares at $3.10 per share, representing a 15% premium to market price, for total gross proceeds of up to $1.0 million. The offering will be executed in two tranches: an initial closing of $500,000 expected by January 10, 2025, and a potential subsequent closing of another $500,000 within 15 days following specific conditions, including shareholder approval and maintaining share price above $3.10 for ten consecutive trading days. The company plans to use proceeds for general corporate purposes.
NLS Pharmaceutics (NASDAQ:NLSP) announced promising preclinical data for its dual orexin receptor agonist (DOXA) platform. The study focuses on AEX-41 and AEX-2, first-in-class non-sulfonamide DOXAs targeting both orexin-1 and orexin-2 receptors while inhibiting cathepsins. In orexin knockout mice, AEX-41 showed significant increase in wakefulness and reduced REM sleep duration, with efficacy comparable to existing OX2R agonists. The company plans to expand research in 2025 to study neuroinflammation impact, with an IND application planned for 2026-2027. The dual-action mechanism could potentially address both sleep-wake regulation and neurodegenerative processes.
NLS Pharmaceutics has provided insights into its preclinical program evaluating dual orexin receptor agonist (DOXA) platform. The company is developing AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs targeting both orexin-1 and orexin-2 receptors while inhibiting cathepsins. The ongoing studies at the Centre for Neuroscience Research of Lyon use an orexin knockout mouse model to evaluate wakefulness promotion, sleep quality enhancement, and cataplexy suppression. The study employs EEG/EMG technology and includes stress condition testing. First results are expected in early December 2024, with potential applications extending to other conditions like ALS.
NLS Pharmaceutics (Nasdaq: NLSP) announced it has regained full compliance with Nasdaq listing requirements. The company received notice from Nasdaq confirming compliance with both the bid price requirement (Rule 5550(a)(2)) and equity requirement (Rule 5550(b)(1)). The compliance was achieved through balance sheet improvements, including capital raising and implementation of a reverse share split.
