NeuroScientific Biopharmaceuticals (NSB) Q1 2027 TU earnings summary

Executive summary

• FDA feedback supported the proposed StemSmart Phase 2 trial design, with favourable responses to 6 of 7 key questions; no additional non-clinical studies were required, and release testing was acceptable for the trial.

• Southern Star Research was appointed after quarter-end to conduct the refractory Crohn’s disease Phase 2 trial in Australia and the US; initiation is targeted by end-CY2026.

Financial highlights

• Cash and cash equivalents were $3.911m at 30 September 2026, compared with $4.630m at the start of the quarter.

• Net cash used in operating activities was $719k; R&D spending was $409k, including $49k for the Q-Gen technology transfer.

Outlook and guidance

• StemSmart manufacturing technology transfer, TGA audit and Q-Gen licence expansion were anticipated before end-CY2026, subject to validation and audit.

• The milestone schedule targeted Australian Phase 2 ethics approval in Q4 2026, first patient treated in Q1 2027, FDA IND submission in Q2 2027 and first US patient treated in Q3/Q4 2027.

• Development of an open-label early-phase trial for fistulising Crohn’s continues; the trial may proceed independently or with research collaborators.