Dr. William Williams reports

BRIACELL RECEIVES FDA CLEARANCE TO INITIATE BRIA-BRES+™ CLINICAL STUDY IN BREAST CANCER

Briacell Therapeutics Corp. has received Food and Drug Administration clearance to initiate clinical evaluation of Bria-BRES+, its next-generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.

• FDA clearance of investigational new drug (IND) application opens path to commence phase 1/2a clinical study for Bria-BRES+ in metastatic breast cancer;
• Bria-BRES+ is Briacell's next-generation personalized immunotherapy for breast cancer, and features additional immune activating components designed to enhance clinical efficacy;
• Briacell has prepared clinical supplies of Bria-BRES+ and plans to initiate a phase 1/2a clinical study in metastatic breast cancer in the coming months.

"We are honoured to announce FDA clearance of the first IND for our next-generation personalized immunotherapy, Bria-BRES+," stated Dr. William V. Williams, Briacell's president and chief executive officer. "The unique design of Bria-BRES+ offers the potential for a favourable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options."

As reported in Briacell's recent AACR preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naive (resting) T-cells, dendritic cells and natural killer (NK) cells. Briacell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.

Briacell's Bria-BRES+ builds on its Bria-OTS breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100-per-cent) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at two months, was subsequently confirmed at four months, six months and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study and remains in survival follow-up.

About Briacell Therapeutics Corp.

Briacell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer.

We seek Safe Harbor.