BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

Rhea-AI Summary

BriaCell (NASDAQ: BCTX) said an independent Data Safety Monitoring Board issued its fourth consecutive positive recommendation after reviewing safety data from the pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). The DSMB identified no safety concerns and recommended the study continue without modifications. The study is conducted under FDA Fast Track designation. DSMB meetings occur quarterly; this is the fourth positive quarterly review. Management highlighted confidence in the regimen's safety and tolerability and reiterated commitment to advancing the trial for patients with urgent unmet needs.

Positive

• Fourth consecutive positive DSMB safety recommendation
• DSMB raised no safety concerns and recommended continuation
• Study conducted under FDA Fast Track designation

Negative

• No efficacy or interim efficacy results disclosed in this update
• Phase 3 study is ongoing; pivotal efficacy readout and timing not provided

• Independent DSMB has identified no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor
• Fourth consecutive positive DSMB recommendation supports the favorable safety profile observed to date
• Phase 3 study is being conducted under FDA Fast Track Designation, reflecting the significant unmet need in metastatic breast cancer
  

PHILADELPHIA and VANCOUVER, British Columbia, Oct. 22, 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, announces that the independent Data Safety Monitoring Board (DSMB) has issued its fourth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

Following its review, the DSMB raised no safety 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.

“Repeated consecutive DSMB positive recommendations further strengthen our confidence in the excellent safety and tolerability profile of the BriaCell regimen,” commented Dr. William V. Williams, BriaCell’s President & CEO. “We strongly believe in Bria-IMT’s potential to transform cancer care and remain determined to make it a reality for patients with metastatic breast cancer who face urgent 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 Bria-IMT’s safety and tolerability profile; 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.

Contact Information

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

Investor Relations Contact:
investors@briacell.com

FAQ

What did BriaCell (BCTX) announce on October 22, 2025 about its Phase 3 study?

An independent DSMB issued its fourth consecutive positive recommendation, finding no safety concerns and recommending the study continue without modifications.

Does the October 22, 2025 BriaCell update include efficacy results for Bria-IMT (BCTX)?

No; the update reports safety recommendations only and does not disclose any efficacy or interim efficacy results.

What is the regulatory status of BriaCell’s Phase 3 trial (BCTX) as of October 22, 2025?

The Phase 3 study is being conducted under FDA Fast Track designation.

How often does the DSMB review safety data for BriaCell’s Phase 3 trial (BCTX)?

DSMB meetings occur quarterly in accordance with the study protocol.

What does a positive DSMB recommendation mean for BriaCell shareholders (BCTX)?

A positive DSMB recommendation indicates regulators’ independent reviewers found no safety concerns and the trial can continue as designed.