Dr. William Williams reports

BRIACELL INITIATES PIVOTAL PHASE 3 STUDY OF BRIA-IMT(TM) IN ADVANCED METASTATIC BREAST CANCER

Briacell Therapeutics Corp.'s registration-enabling pivotal phase 3 study of its lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, is fully approved by the institutional review board (IRB) and will soon enroll patients with advanced metastatic breast cancer.

"Timely initiation of our pivotal study is a key milestone for us further confirming our expedited timeline for FDA approval of our immunotherapy," stated Dr. William V. Williams, Briacell's president and chief executive officer. "Based on our recently announced benchmark-beating survival data, we strongly believe that our novel immunotherapy may transform the way we treat advanced metastatic breast cancer patients, and we look forward to sharing additional development milestones in the coming months."

The study will evaluate the efficacy and safety of the Bria-IMT combination regimen in patients who have failed at least two approved therapies for the disease.

Bria-IMT is currently under fast-track designation by the U.S. Food and Drug Administration intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT immune checkpoint inhibitor combination in advanced metastatic breast cancer.

The FDA has agreed that improvement in overall survival in the Bria-IMT combination arm as compared with the physician's choice of treatment arm will be the primary end point of the study. The study will enroll 177 patients in the Bria-IMT combination therapy arm and 177 patients in the treatment of physician's choice arm. To gather additional information on the Bria-IMT regimen alone, 50 patients will be enrolled in this regimen and will be eligible for combination therapy following their initial posttreatment evaluation. Briacell expects frequent and responsive FDA communication under its fast-track status during its pivotal phase 3 study.

The successful completion of the pivotal study would allow Briacell to subsequently submit a biologics licence application and accelerate the path to commercialization.

About Briacell Therapeutics Corp.

Briacell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care.

We seek Safe Harbor.