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Data Safety Monitoring Board (DSMB) Recommends Continuing BriaCell’s Phase 3 Metastatic Breast Cancer Study

Key Takeaway: BriaCell Therapeutics Corp. received a positive recommendation from the Data Safety Monitoring Board (DSMB) for its Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer. This marks the seventh consecutive positive review, affirming the treatment's safety and tolerability. The study is being conducted under FDA Fast Track designation, addressing significant unmet medical needs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Seventh consecutive positive recommendation from DSMB.
  • No safety concerns reported, indicating favorable tolerability.
  • Study conducted under FDA Fast Track designation, highlighting unmet need.
  • Encouraging progress in developing novel immunotherapies for cancer.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+44%
120-day peak, hindsight
Typical move
12.2%
average across 6 past catalysts
Cash runway
~7 mo
Medium dilution risk
Lead asset
SV-BR-1-GM
Phase 3 · Breast Cancer

Full Press Release Details

• Independent DSMB reports no safety concerns to date and recommends continuing BriaCell's pivotal Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor
• Seventh consecutive positive DSMB recommendation reinforces the favorable safety and tolerability of BriaCell's novel immunotherapy approach
• Phase 3 study is being conducted under FDA Fast Track designation, underscoring the substantial unmet need in metastatic breast cancer
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 14, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces that the independent Data Safety Monitoring Board (DSMB) has issued its seventh consecutive positive recommendation following review of clinical data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).
Following its review, the DSMB raised no safety or other clinical concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.
“We are very encouraged by the DSMB’s seventh consecutive positive recommendation to continue BriaCell’s pivotal Phase 3 Bria-ABC study,” said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. “This milestone represents continued progress in developing BriaCell’s novel immunotherapies for patients with urgent unmet medical needs.”

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 DSMB’s seventh consecutive positive recommendation, the favorable safety and tolerability profile of Bria-IMT™ plus an immune checkpoint inhibitor, the continued advancement of BriaCell’s pivotal Phase 3 Bria‑ABC study under FDA Fast Track designation, and Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer, 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, such as those 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.

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

Investor Relations Contact: investors@briacell.com

Frequently Asked Questions

What is the DSMB's recommendation for BriaCell's study?

The DSMB recommended continuing BriaCell's Phase 3 study without modifications.

How many positive recommendations has the DSMB given?

The DSMB has issued seven consecutive positive recommendations.

What is the focus of BriaCell's Phase 3 study?

The study focuses on Bria-IMT plus an immune checkpoint inhibitor for metastatic breast cancer.

What designation has the FDA granted to this study?

The study is being conducted under FDA Fast Track designation.

Last updated: Sep 14, 2026