NeuroScientific Biopharmaceuticals (NSB) Q3 2026 TU earnings summary

Executive summary

• Achieved successful clinical responses in 3 of 4 patients with fistulising Crohn's disease using StemSmart under the TGA Special Access Scheme; the fourth patient showed partial improvement.

• Initiated technology transfer for StemSmart manufacturing to Q-Gen Cell Therapeutics, supporting scale-up for Phase 2 trials.

• Advanced regulatory and protocol planning for Phase 2 Crohn's study, leveraging real-world data from the Special Access Program.

• Engaged with key opinion leaders and clinical sites in Australia and the U.S., targeting Phase 2 trial initiation in 2H CY2026.

Financial highlights

• Cash and cash equivalents at 31 March 2026 were $5.68 million, supporting ongoing clinical and manufacturing activities.

• Research and development payments for the quarter were approximately $385k; staff costs $116k; administration and corporate costs $201k.

• Payments to related parties totaled $98k for the quarter, covering director fees, salaries, and superannuation.

• Net cash used in operating activities for the quarter was $672k.

• Estimated 8.46 quarters of funding available based on current cash and burn rate.

Outlook and guidance

• Phase 2 clinical trial for refractory Crohn's disease planned to start in the second half of CY2026, pending completion of manufacturing technology transfer and regulatory alignment.

• Pre-IND meeting with the U.S. FDA expected to provide critical feedback for final Phase 2 study design.

• Ongoing engagement with global clinical sites and opinion leaders to optimize trial execution and future commercial readiness.