FDA Approves BriaCell's Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce a partnership with New York Cancer & Blood Specialists (NYCBS), a group of leading community cancer centers in the United States, to evaluate the Bria-IMT™ combination with a checkpoint inhibitor in its pivotal Phase 3 registration study in advanced breast cancer patients in New York.

"Cancer is complex. It takes a village to care for a cancer patient. At NYCBS, our mission is to offer cancer patients access to state-of-the-art treatments close to their homes, families, and support networks at convenient locations across Long Island, New York City, and Upstate New York," stated Dr. Jeffrey Vacirca, CEO of NYCBS. "We were impressed with the survival data of the Bria-IMT™ regimen to date and look forward to working with the BriaCell team to make these novel therapeutics available to our patients."

• The randomized pivotal Phase 3 study is expected to enroll a total of 354 patients in either Bria-IMT™ combination or physician's choice therapy (1:1)
• Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™
• The study's primary endpoint is overall survival in patients treated with the Bria-IMT™ combination regimen versus those treated with physician's choice
• The study initiation follows FDA Fast Track designation and earlier supportive Phase 2 safety and efficacy data in the same patient population

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announces that its registration-enabling pivotal Phase 3 study of its lead clinical candidate, Bria-IMT™, in combination with an immune check point 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 CEO. "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."

• Median overall survival of 13.5 months in BriaCell's advanced metastatic breast cancer patients (vs. 6.7-9.8 months for similar patients reported in the literature)
  
• 21 out of 29 patients treated since 2022 are still alive suggesting a strong survival benefit for BriaCell's combination regimen
• No dose limiting toxicities to date
  

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announces the completion of patient enrollment in its Phase 2 clinical study and reports clinical data showing strong patient survival benefit and clinical benefit in advanced metastatic breast cancer patients.

"The promising survival data of BriaCell's combination regimen suggests the potential for an industry-shaping leap in advanced metastatic breast cancer treatment," stated Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ plus check point inhibitors study. "The overall safety profile and survival data in advanced metastatic breast cancer is extremely encouraging in this heavily pre-treated patient population."

• briacell therapeutics corp. closes Arrangement effecting the distribution described in the plan of arrangement.

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announces that the Company has closed the previously announced plan of arrangement spinout transaction (the " Arrangement ") pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the " SpinCo Assets "), were spun-out to BriaPro Therapeutics Corp. (" SpinCo "), resulting in a 23 rd owned subsidiary of the Company with the remaining 13 rd held by BriaCell shareholders (" BriaCell Shareholders ").

briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties' plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell's novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting.