Company: NCEL
Filing Date: 2025-04-15
Form Type: 425
Source: 0001213900-25-031780
Chunk: 1

Company: NewcelX Ltd.
Filing Date: 2025-04-15
Form: 425
Chunk 1
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LS Pharmaceutics Announces Positive Results from
Study KO-943 Demonstrating Mazindol Reduces Fentanyl-
Induced Reward in Animal Models

Non-opioid, multi-mechanism profile positions Mazindol as a differentiated
asset in addiction therapeutics

Favorable results support potential expansion into high-value markets beyond
ADHD and narcolepsy</div>

Zurich, Switzerland – April 15, 2025 – NLS Pharmaceutics
Ltd. (Nasdaq: NLSP) (NASDAQ: NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company
focused on developing innovative therapies for central nervous system (CNS) disorders, today announced positive results from Study KO-943,
a preclinical investigation evaluating the efficacy of Mazindol in mitigating fentanyl-induced conditioned place preference (CPP) in mice.
The study, conducted by Key-Obs SAS, a leading preclinical CRO, provides evidence that Mazindol may offer a novel, non-opioid approach
for the treatment of fentanyl use disorder — a condition contributing to over 75% of opioid-related overdose deaths in the United
States.

As the United States continues to battle the
devastating effects of the fentanyl epidemic — now the leading cause of death for Americans aged 18–45 — the
urgency for effective, non-opioid treatment options has never been greater. Addressing the crisis has become a renewed national
priority, underscored by continued federal initiatives to combat the opioid epidemic and renewed efforts to thwart the flow of illegal opioids into the country. The U.S. opioid and broader substance use disorder treatment market, valued at over $35 billion in 2021, is projected to exceed $60 billion by 2029, driven
by the immediate demand for safer, more effective alternatives to traditional opioid-based therapies.

Study Design and Key Findings

Study KO-943 utilized a validated CPP paradigm in C57BL/6J mice to
measure the rewarding properties of fentanyl and the modulatory effects of Mazindol. Mice were divided into four groups: vehicle control,
fentanyl-only (0.1 mg/kg, s.c.), and fentanyl with Mazindol co-treatment (0.25 mg/kg or 0.5 mg/kg, i.p.). The primary outcome measured
was the change in time spent in the drug-paired compartment after conditioning.

| - | Fentanyl significantly increased place preference (