BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

Rhea-AI Summary

BriaCell Therapeutics (NASDAQ: BCTX) has announced the addition of UCLA Health Jonsson Comprehensive Cancer Center as a key site for its pivotal Phase 3 clinical study (Bria-ABC). The study evaluates Bria-IMT™ combined with a checkpoint inhibitor versus physician's choice in advanced metastatic breast cancer patients.

The trial's interim analysis will be conducted after 144 patient events, with overall survival as the primary endpoint. Building on positive Phase 2 survival data presented at ASCO 2025, the study has received FDA Fast Track designation. BriaCell expects to share top-line data in 2026.

Positive

• FDA Fast Track designation granted for Bria-IMT combination therapy
• Positive Phase 2 survival data supports the Phase 3 study design
• Partnership with prestigious UCLA Health expected to accelerate trial enrollment
• Clear timeline for top-line data release in 2026

Negative

• Phase 3 results dependent on 144 patient deaths for interim analysis
• Final results not expected until 2026, indicating a lengthy trial period

News Market Reaction – BCTX

-7.15%

4 alerts

-7.15% News Effect

-$992K Valuation Impact

$13M Market Cap

0.6x Rel. Volume

On the day this news was published, BCTX declined 7.15%, reflecting a notable negative market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $992K from the company's valuation, bringing the market cap to $13M at that time.

Data tracked by StockTitan Argus on the day of publication.

PHILADELPHIA and VANCOUVER, British Columbia, July 31, 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 the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT™ in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC).

“The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer,” stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. “We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site.”

“The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution,” said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We remain confident in our timeline for sharing top-line data in 2026.”

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO 2025, which evaluated the same combination in a similar MBC patient population. Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

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 BriaCell’s Phase 3 study representing an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer; the Company’s anticipated strong patient enrollment through their large multi-center clinical site; the Company’s anticipated timeline for sharing top-line data; and the Company’s timeline for its analysis of interim data 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

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

The primary endpoint is overall survival (OS), with interim analysis planned after 144 patient events (deaths) occur.

When will BriaCell (BCTX) release top-line data for its Phase 3 breast cancer trial?

BriaCell expects to share top-line data in 2026 for its Phase 3 trial evaluating Bria-IMT combination therapy.

What is the significance of UCLA Health joining BriaCell's (BCTX) Phase 3 trial?

UCLA Health's participation as a key site is expected to accelerate trial enrollment and execution through their large multi-center clinical site.

What regulatory designation has BriaCell (BCTX) received for its breast cancer therapy?

The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential to address a serious unmet medical need in metastatic breast cancer.

What patient population is targeted in BriaCell's (BCTX) Phase 3 trial?

The trial targets patients with advanced metastatic breast cancer (MBC), comparing Bria-IMT combination with immune checkpoint inhibitor against physician's choice.