Nls Pharmaceutics Ltd Stock Price, News & Analysis

NLS Pharmaceutics (NASDAQ: NLSP) has announced significant progress in Q1 2025, including successful financing events totaling $2.5M at premium share prices and a $25M equity facility commitment. The company completed two equity financings at $3.10 and $1.65 per share, representing 48% and 10% premiums respectively. A transformative merger with Kadimastem (TASE: KDST) is expected to close in early Q3 2025, creating NewcelX, a combined entity focusing on neurodegenerative diseases and diabetes treatments. The company reported positive preclinical data for AEX-2 and encouraging results for Mazindol ER in fentanyl-related studies. Post-merger plans include initiating a Phase IIa trial for AstroRx in ALS treatment, Phase I study for IsletRx in Type I diabetes, and advancing preclinical development of AEX-2/AEX-41 for narcolepsy and neurodegeneration. The company has converted all outstanding liabilities to equity, achieving a debt-free status.

NLS Pharmaceutics (NASDAQ: NLSP) will present new preclinical data on Mazindol ER at the 2025 ASCP Annual Meeting in Scottsdale, Arizona. The study (KO-943) demonstrates Mazindol's dual efficacy in reducing both fentanyl reward effects and withdrawal symptoms in rodent models.

Key findings show that Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced conditioned place preference in mice, while doses of 0.5 and 1.0 mg/kg decreased withdrawal symptoms in rats. The drug's multiple-target profile, including partial mu-opioid receptor agonist, 5-HT1A receptor agonist, and orexin-2 receptor modulation, suggests potential as a novel non-opioid therapeutic for opioid addiction.

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

This development follows the company's recent $3 million fundraising and $25 million committed equity facility agreement as part of a planned merger with Kadimastem

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 (NASDAQ: NLSP) announced significant developments in their shareholder letter dated March 10, 2025. The company highlighted its planned merger with Kadimastem (TASE: KDST), expected to close in Q2 2025, creating a Nasdaq-traded biotechnology company under the name 'NucelX ' (future ticker: NCEL).

Key developments include a successful pre-IND meeting with the FDA for iTOL-102, a potential Type 1 Diabetes treatment developed in collaboration with iTolerance Inc. The company plans to initiate a Phase IIa multi-site clinical trial of AstroRx® for ALS post-merger.

Financially, NLSP maintains zero long-term debt and raised approximately $4.2 million through private placements in October and December 2024, extending their operational runway to approximately 18 months. The company is advancing its Dual Orexin Receptor Agonist (DOXA) platform with AEX-41 and AEX-2 compounds for sleep-wake disorders, and launched a preclinical program evaluating Mazindol ER for fentanyl dependence treatment.

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 (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression.

The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials.

IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.

NLS Pharmaceutics (NLSP) and Kadimastem have announced their planned merger to revolutionize diabetes treatment through a multi-targeted approach. The companies are introducing DOXA (Dual Orexin and Multi-Pathway Modulation), a next-generation therapeutic platform that goes beyond traditional GLP-1 therapies by addressing both metabolic and neurological aspects of diabetes.

DOXA targets multiple pathways including orexin signaling, sigma-1 receptor modulation, cathepsin inhibition, SGLT2 modulation, and adiponectin receptor activation. Preclinical studies, to be presented at ASCP 2025, show DOXA's ability to restore orexinergic function, reduce inflammation, and enhance β-cell survival.

The merger combines Kadimastem's cell therapy expertise with NLS's pharmaceutical innovation, particularly focusing on Diabetes-Associated Neurological and Sleep Disorders (DANS). The companies believe their combined approach, especially when DOXA is paired with Islet transplantation, could set new standards in diabetes care.

NLS Pharmaceutics (NLSP) and Kadimastem have achieved a significant milestone in their merger process as Kadimastem's shareholders approved the merger during a special general meeting. The merger aims to create a combined Nasdaq-traded biotechnology company focusing on advanced therapies for neurodegenerative diseases and diabetes.

NLS, a Swiss clinical-stage biopharmaceutical company specializing in rare and complex central nervous system disorders, plans to convene its own shareholder meeting for final merger approval. Kadimastem, a clinical-stage cell therapy company, develops 'off-the-shelf' allogeneic cell products for neurodegenerative diseases and diabetes treatment.

Both companies view this merger as an opportunity to leverage their combined biotechnology strengths and advance innovative solutions in the biopharmaceutical sector.