• Successful Clinical Results from Special Access Program: 3 of 4 patients with fistulising Crohn's disease achieved 'Clinical Response'
• Initiation of Manufacturing Technology Transfer: First tech transfer manufacturing run for StemSmart™ commenced with Q-Gen Cell Therapeutics
• Phase 2 Preparation Progressing: Advanced protocol and regulatory planning, completed gap assessment, and commenced pre-IND meeting preparations

NeuroScientific Biopharmaceuticals reported a successful quarter, with highlights including positive interim clinical results from the StemSmart™ Special Access Scheme (SAS) Program for fistulising Crohn's disease, the initiation of the first technology transfer manufacturing run at Q-Gen Cell Therapeutics, and continued progress in preparations for the upcoming Phase 2 clinical trial. The SAS Program saw 3 of the initial 4 patients achieve a 'Clinical Response', defined as a greater than or equal to 50% reduction in fistula openings or discharge, with the fourth patient showing a partial response. These results reinforce earlier Phase 2 trial findings and validate the StemSmart™ platform. The technology transfer to Q-Gen, a large-scale GMP contract manufacturer, is a critical milestone in scaling production for late-stage trials and commercialization. The company also advanced its regulatory pathway, including a gap assessment with its advisor Scendea and preparations for a pre-IND meeting with the FDA to align on the Phase 2 study design. Early engagement with key opinion leaders and trial sites in Australia and the U.S. is also underway, with the Phase 2 study in refractory Crohn's disease targeted for initiation in the second half of 2026.