Mr. Michal Efraty reports

NEUROTHERA LABS LAUNCHES PHASE IIB CLINICAL TRIAL AT YALE CHILD STUDY CENTER FOR FIRST-OF-ITS-KIND TREATMENT FOR TOURETTE SYNDROME

Neurothera Labs Inc. has initiated its phase IIb clinical trial site at the Yale Child Study Center, Yale School of Medicine, New Haven, Conn., U.S. The study, led by Dr. Michael H. Bloch, will evaluate SCI-110, Neurothera's proprietary cannabinoid-based drug candidate for the treatment of Tourette Syndrome (TS) in adults.

The trial is now progressing at the Yale Child Study Center, one of the study's key clinical sites. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in a single, innovative dosage form designed to reduce tics and associated comorbid symptoms in adults with TS while aiming to minimize side effects.

In addition to the Yale site, the phase IIb trial is also under way at Hannover Medical School in Hanover, Germany, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.

Dr. Adi Zuloff-Shani, chief technology officer of Neurothera, commented: "Launching a U.S. site at the Yale Child Study Center represents a significant milestone in our global development program for SCI-110. TS remains a major unmet medical need with limited therapeutic options, particularly in adults who continue to experience persistent, severe and often debilitating symptoms. We believe SCI-110 has the potential to introduce a novel, more effective and safer treatment approach. We are deeply committed to advancing this promising therapy and generating meaningful clinical data to support its future regulatory approval."

Building on the positive safety and efficacy results from the phase IIa study, which showed an average tic reduction of 21 per cent across the entire participants sample, as measured by the gold standard, Yale Global Tic Severity Scale Total Tic Score, the phase IIb study is a randomized, double-blind, placebo-controlled, crossover trial designed to evaluate the efficacy, safety and tolerability of daily oral SCI-110. Patients aged 18 to 65 will be randomized to receive either SCI-110 or placebo, with the primary efficacy end point being the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared with the baseline. Safety will be assessed through monitoring of adverse events.

About Neurothera Labs Inc.

Neurothera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.

We seek Safe Harbor.