Nls Pharmaceutics Ltd Stock Price, News & Analysis

NLS Pharmaceutics (NASDAQ:NLSP) and its merger partner Kadimastem have secured a significant patent in Hong Kong for their cell selection and enrichment technology used in developing IsletRx, a stem cell-derived therapy targeting insulin-dependent diabetes. The patent complements existing protections in Europe, the United States, and India.

The technology enables the selection of highly functional islet cells from differentiated cell populations to maximize therapeutic effect. Hong Kong represents a strategic market with approximately 706,000 adults living with diabetes (8.2% prevalence) and an estimated economic impact of $90 billion, based on average lifetime healthcare expenditures of $125,000 per patient.

NLS Pharmaceutics (NASDAQ:NLSP) announced that the BIRD Foundation has approved an additional milestone payment of $166,000 to Kadimastem and iTolerance for their iTOL-102 diabetes program. This brings total BIRD Foundation support to $882,352.

The milestone follows a successful Pre-IND meeting with the FDA regarding iTOL-102, a potential cure for Type 1 diabetes that combines Kadimastem's IsletRx technology with iTolerance's iTOL-100 immunomodulatory platform. The therapy aims to eliminate the need for life-long immunosuppression drugs.

Preclinical studies at the University of Miami's Diabetes Research Institute have shown promising results, demonstrating functional insulin secretion and disease reversal in diabetic animal models. The companies are now preparing for safety toxicology studies and clinical trial submissions.

NLS Pharmaceutics (NASDAQ: NLSP) has completed the second and final closing of its $1 million equity financing, bringing the total gross proceeds to $3 million. The company issued 606,061 preferred shares at a conversion price of $1.65 per share, representing a 10% premium to the market price as of March 28, 2025.

The funding will support NLS's pending merger with Kadimastem Ltd. (TASE: KDST), a clinical-stage cell therapy company developing treatments for ALS and diabetes. The combined entity plans to advance clinical trials, including a Phase IIa trial of AstroRx® for ALS and a Phase I study of IsletRx for diabetes. The merger remains subject to regulatory and shareholder approvals.

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.