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BriaCell Opens First Canadian Site – Sunnybrook – for Pivotal Phase 3 Trial in Metastatic Breast Cancer

(Moderate)
(Very Positive)

BriaCell (Nasdaq: BCTX) announced that Sunnybrook’s Odette Cancer Centre in Toronto has joined its ongoing pivotal Phase 3 Bria-ABC trial of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (NCT06072612). This is BriaCell’s first Canadian clinical site, adding to over 80 active U.S. sites across 15 states.

The randomized study compares the Bria-IMT combination to physician’s treatment of choice, with overall survival as the primary endpoint and an interim analysis planned after 144 patient deaths. According to BriaCell, the trial continues following a positive DSMB recommendation, builds on positive Phase 2 survival data presented at ASCO 2026, has FDA Fast Track designation, and was highlighted in Nature Medicine as one of “Eleven clinical trials that will shape medicine in 2026.”

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Positive

  • First Canadian Phase 3 site opened at Sunnybrook’s Odette Cancer Centre
  • Over 80 active U.S. clinical sites across 15 states for the Phase 3 study
  • DSMB issued positive recommendation to continue the pivotal Phase 3 trial
  • Positive Phase 2 survival data for Bria-IMT combination reported at ASCO 2026
  • FDA Fast Track designation for the Bria-IMT combination regimen
  • Phase 3 trial featured in Nature Medicine as a key 2026 clinical study

Negative

  • None.

News Market Reaction – BCTX

-2.28%
6 alerts
-2.28% Session close to close
-2.7% Trough in 1 hr 23 min
$32.19M Market Cap
0.5x Rel. Volume

In the Jul 16 session, BCTX declined 2.28%, reflecting a moderate negative market reaction. Argus tracked a trough of -2.7% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Viewed against an average -3.35% move on earlier clinical-trial news, the Sunnybrook site opening fi...
Analysis

Viewed against an average -3.35% move on earlier clinical-trial news, the Sunnybrook site opening fits ongoing Phase 3 execution rather than a new efficacy signal. With short interest characterized as low, future volatility may hinge more on funding progress and major data readouts than positioning swings.

Key Figures

Active U.S. sites: over 80 sites U.S. states: 15 states Interim analysis trigger: 144 patient deaths +1 more
4 metrics
Active U.S. sites over 80 sites Pivotal Phase 3 Bria-IMT plus checkpoint inhibitor study
U.S. states 15 states Coverage of active clinical sites in Phase 3 study
Interim analysis trigger 144 patient deaths Events required before planned interim overall survival analysis
Highlighted trials 11 clinical trials Nature Medicine list of trials expected to shape medicine in 2026

Previous Clinical trial Reports

5 past events · Latest: Jun 01 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 01 Clinical trial data Positive -9.1% Reported Phase 2 and ongoing Phase 3 data from Bria-IMT combination at ASCO 2026.
May 26 DSMB recommendation Positive -2.0% Independent DSMB issued another positive recommendation to continue pivotal Phase 3 Bria-ABC study.
May 22 Clinical data update Positive -6.2% Presented positive Bria-IMT clinical and biomarker data with favorable survival and safety at ASCO 2026.
May 13 Site addition Positive +2.5% Added Penn Medicine’s Abramson Cancer Center as a site in pivotal Phase 3 Bria-ABC study.
May 12 Enrollment milestone Positive -1.9% Reported Bria-ABC study had screened over 315 and enrolled over 230 metastatic breast cancer patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

On recent clinical trial headlines, the stock has more often traded down despite generally positive clinical messaging.

Key Terms

immune checkpoint inhibitor, overall survival, data safety monitoring board, fast track designation, +1 more
5 terms
immune checkpoint inhibitor medical
"Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer"
An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.
overall survival medical
"The study’s primary endpoint is overall survival (OS)."
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
data safety monitoring board regulatory
"received a positive recommendation from the independent Data Safety Monitoring Board"
A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.
fast track designation regulatory
"The Bria-IMT combination regimen has received FDA Fast Track designation."
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
clinicaltrials.gov regulatory
"metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612)."
clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • Sunnybrook’s Odette Cancer Centre, a world-class cancer center in Toronto, Ontario, Canada, joins BriaCell’s pivotal Phase 3 clinical trial in metastatic breast cancer
  • BriaCell Phase 3 trial featured in Nature Medicine as one of “Eleven clinical trials that will shape medicine in 2026”

PHILADELPHIA and VANCOUVER, British Columbia, July 16, 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, today announced that the Odette Cancer Centre at Sunnybrook Health Sciences Centre, a leading cancer center in Toronto, Ontario, Canada, has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).

In the United States, BriaCell’s Phase 3 study now has over 80 active clinical sites across 15 states, including Penn Medicine's Abramson Cancer Center, Mayo Clinic, Smilow Cancer Hospital at Yale New Haven, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Sylvester Comprehensive Cancer Center (University of Miami), Texas Oncology-Baylor Charles A. Sammons Cancer Center, and the University of Arizona.

“There are a limited number of effective treatment options for patients with metastatic breast cancer and, unfortunately for most patients, standard treatments eventually stop working,” commented Katarzyna Jerzak, MD, MSc, FRCPC, Medical Oncologist and Clinician Investigator at Sunnybrook’s Odette Cancer Centre, and Associate Professor in the Department of Medicine, University of Toronto. “We are excited to evaluate BriaCell’s innovative immunotherapy approach and to offer these patients the opportunity to access a potentially effective new treatment.”

“Opening our first Canadian clinical site for BriaCell’s pivotal Phase 3 study is an important milestone,” stated Dr. William V. Williams, BriaCell’s President & Chief Executive Officer. “Sunnybrook is a world-class cancer center, and its participation expands access to our Bria-IMT regimen to patients in Canada, as we work to accelerate development of this our novel immunotherapy for patients with metastatic breast cancer.”

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor (CPI), compared with physician’s treatment of physician’s choice in patients with advanced metastatic breast cancer (the Bria-ABC study). The study’s primary endpoint is overall survival (OS). An interim analysis is planned after 144 patient deaths have occurred, comparing mortality in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice.

BriaCell recently received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase 3 Study in metastatic breast cancerAt ASCO 2026, BriaCell reported positive Phase 2 survival data in a similar metastatic breast cancer 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 checkpoint 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 regarding the participation of Sunnybrook’s Odette Cancer Centre in BriaCell’s ongoing pivotal Phase 3 study, the continued enrollment, advancement and outcomes of the Phase 3 study, the continued development and potential commercialization of Bria-IMT, and the potential benefits of Bria-IMT 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 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 (NASDAQ:BCTX) announce on July 16, 2026 about its breast cancer trial?

BriaCell announced that Sunnybrook’s Odette Cancer Centre joined its pivotal Phase 3 Bria-ABC trial in metastatic breast cancer. According to BriaCell, this is its first Canadian site for evaluating Bria-IMT plus an immune checkpoint inhibitor compared with physician’s treatment of choice.

How is BriaCell’s Phase 3 Bria-IMT trial in metastatic breast cancer (BCTX) designed?

The pivotal Phase 3 Bria-ABC study evaluates Bria-IMT with an immune checkpoint inhibitor versus physician’s treatment of choice in advanced metastatic breast cancer. According to BriaCell, the primary endpoint is overall survival, with an interim analysis planned after 144 patient deaths occur.

How many clinical sites are participating in BriaCell’s Phase 3 metastatic breast cancer trial (BCTX)?

BriaCell reports over 80 active clinical sites across 15 U.S. states, plus the newly opened Sunnybrook site in Toronto, Canada. According to BriaCell, these include major cancer centers such as Penn Medicine, Mayo Clinic, Yale’s Smilow Cancer Hospital, and others.

What is the primary endpoint and interim analysis plan for BriaCell’s Phase 3 trial (NASDAQ:BCTX)?

The primary endpoint is overall survival in patients with advanced metastatic breast cancer. According to BriaCell, an interim analysis will be conducted after 144 patient deaths, comparing mortality between the Bria-IMT combination arm and the physician’s treatment-of-choice arm.

What prior clinical data support BriaCell’s Bria-IMT regimen in metastatic breast cancer (BCTX)?

BriaCell reported positive Phase 2 survival data in a similar metastatic breast cancer population treated with the same Bria-IMT combination regimen. According to BriaCell, these data were presented at ASCO 2026 and help support the rationale for the current pivotal Phase 3 trial.

Does BriaCell’s Bria-IMT combination have FDA Fast Track designation and other recognitions (BCTX)?

Yes. BriaCell states that the Bria-IMT combination regimen has received FDA Fast Track designation. According to BriaCell, the Phase 3 trial also received a positive DSMB recommendation to continue and was highlighted by Nature Medicine as a 2026 trial to watch.

Where can investors find more details on BriaCell’s Phase 3 Bria-IMT trial in metastatic breast cancer (NASDAQ:BCTX)?

Investors can review the trial under identifier NCT06072612 on ClinicalTrials.gov. According to BriaCell, this listing provides further information on study design, participating centers, and eligibility criteria for the pivotal Phase 3 Bria-IMT plus checkpoint inhibitor study.