BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven

Rhea-AI Summary

BriaCell Therapeutics (NASDAQ: BCTX) has expanded its pivotal Phase 3 clinical trial for advanced metastatic breast cancer treatment by adding two major cancer centers: Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven, contributing 30 additional satellite locations. The study now encompasses 58 active clinical sites across 15 states.

The trial evaluates BriaCell's lead candidate Bria-IMT™ plus immune checkpoint inhibitor versus physician's choice. Patient enrollment is expected to complete by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint will analyze overall survival after 144 patient events, with positive results potentially leading to full approval and marketing authorization.

Positive

• None.

Negative

• Study completion dependent on 144 patient deaths for endpoint analysis
• Final results not expected until H1-2026

News Market Reaction

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+2.45% News Effect

On the day this news was published, BCTX gained 2.45%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

• Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study
• BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center

PHILADELPHIA and VANCOUVER, British Columbia, July 02, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce the addition of two key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612): Los Angeles Cancer Network and Smilow Cancer Hospital at New Haven. Each has 15 satellite locations. BriaCell anticipates completing patient enrollment in late 2025 or early 2026 and may report top line data as early as H1-2026.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, plus immune check point inhibitor (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).

“Clinical investigator interest in our Phase 3 study has exceeded our expectations which has significantly expanded patient access to our treatment,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “This strong engagement reflects both the urgent unmet need in metastatic breast cancer and the dedication of our clinical partners.”

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently (ASCO 2025) announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the anticipated completion date of patient enrollment for the Company’s ongoing pivotal Phase 3 clinical study; the anticipated timeline for reporting top line data for the Company’s pivotal Phase 3 study; the timing and results of interim data; and the final results of the pivotal Phase 3 study, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com 

Investor Relations Contact:
investors@briacell.com

FAQ

How many clinical sites are involved in BriaCell's (BCTX) Phase 3 trial?

BriaCell's Phase 3 trial includes 58 active clinical sites across 15 states, with recent additions of Los Angeles Cancer Network and Smilow Cancer Hospital contributing 30 satellite locations.

When will BriaCell (BCTX) complete patient enrollment for its Phase 3 breast cancer trial?

BriaCell expects to complete patient enrollment in late 2025 or early 2026, with potential top-line data release in H1-2026.

What is the primary endpoint of BriaCell's (BCTX) Phase 3 breast cancer study?

The primary endpoint is overall survival (OS), comparing patients treated with the Bria-IMT combination regimen versus physician's choice, analyzed after 144 patient events.

What regulatory designations has BriaCell's (BCTX) Bria-IMT received?

The Bria-IMT combination regimen has received FDA Fast Track designation for metastatic breast cancer treatment.

What are the potential outcomes if BriaCell's (BCTX) Phase 3 trial is successful?

Positive results from the Phase 3 trial could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients.