Benitec Biopharma Receives Green Light To Advance BB-301 Trial After Safety Review; Cohort 2 Enrollment Set For Q4 2025

-In April 2025 the Sixth and Final Subject of Cohort 1 was Safely Treated with the Low Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study (NCT06185673)-

-Independent Data Safety Monitoring Board Review Has Been Completed for All Six Subjects Enrolled into Cohort 1, and the Data Safety Monitoring Board Recommended Continuation of Subject Enrollment for the Phase 1b/2a Clinical Treatment Study-

-Following the Positive Data Safety Monitoring Board Recommendation, Enrollment of Cohort 2 is Expected to Begin in Q4 2025-

HAYWARD, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ:BNTC) ("Benitec" or "Company"), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary "Silence and Replace" DNA-directed RNA interference ("ddRNAi") platform, today announced the recommendation of the independent Data Safety Monitoring Board (DSMB) to continue enrollment of the Phase 1b/2a Clinical Treatment Study (NCT06185673) following completion of the comprehensive review of safety information for all six Subjects enrolled into Cohort 1. Following the positive DSMB recommendation, enrollment of Cohort 2 is expected to begin in Q4 2025.

In accordance with the Protocol for the BB-301 Phase 1b/2a Clinical Treatment Study, a meeting of the DSMB was convened following the completion of the 28-day post BB-301 dosing visit for the sixth Subject enrolled into Cohort 1. The DSMB recommended the continuation of Subject enrollment for the Phase 1b/2a Clinical Treatment Study. Following the positive DSMB recommendation, enrollment of Cohort 2 is expected to begin in Q4 2025.