BriaCell's Phase 3 Patient Enrollment on Track for 1H2026 Topline Data Readout

Executive Summary

• BriaCell Therapeutics reports that its pivotal Phase 3 study of Bria‑IMT + immune checkpoint inhibitor has screened >230 patients and enrolled >160, exceeding enrollment expectations.
• The company expects topline interim data in the first half of 2026, with the interim analysis to occur after 144 patient deaths (overall survival primary endpoint).
• The Bria‑IMT combination regimen continues under FDA Fast Track designation, positioning it for potential full approval and marketing authorization if results are positive.

Key Details

• Enrollment Milestones: >230 patients screened; >160 patients enrolled in the Phase 3 trial (Bria‑ABC) as of Dec 9 2025.
• Interim Analysis Trigger: Planned once 144 patient events (deaths) have occurred; will assess overall survival versus physician’s choice therapy.
• Topline Data Timeline: Anticipated readout in the first half of 2026 (1H2026).
• Regulatory Status: Bria‑IMT + CPI regimen holds FDA Fast Track designation for metastatic breast cancer.
• Study Design: Randomized comparison of Bria‑IMT plus checkpoint inhibitor versus physician’s choice therapy in advanced/metastatic breast cancer patients.
• ClinicalTrials.gov Identifier: NCT06072612 (link provided for additional study information).
• CEO Quote: Dr. William V. Williams highlighted “the pace of patient enrollment…exceeded expectations” and expressed confidence in delivering data to the FDA.

Notable Quotes

“The pace of patient enrollment in our pivotal Phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators,” – Dr. William V. Williams, President & CEO

Materiality Assessment: Material – Positive (significant progress in a late‑stage oncology trial that could lead to regulatory approval and commercial launch).