BriaCell Phase 3 Bria-IMT™ Study Enrollment Surpasses 230 Patients

BriaCell (Nasdaq:BCTX) reported that its pivotal Phase 3 Bria-ABC study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer has screened over 315 and enrolled over 230 patients.

Rhea-AI Summary

BriaCell (Nasdaq:BCTX) reported that its pivotal Phase 3 Bria-ABC study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer has screened over 315 and enrolled over 230 patients. The trial’s primary endpoint is overall survival, with interim topline data expected in 2026 after 144 events. The Bria-IMT regimen holds FDA Fast Track status and has attracted growing interest from leading cancer centers, including independent highlight in a Nature Medicine article on trials expected to shape medicine in 2026.

Positive

• Over 230 patients enrolled and more than 315 screened in Phase 3 Bria-ABC trial
• Interim topline overall survival data expected in 2026
• Trial design targets full approval of Bria-IMT in metastatic breast cancer if OS is positive
• Bria-IMT combination regimen has FDA Fast Track designation
• Increased interest from leading cancer centers supports ongoing enrollment
• Independent inclusion among “Eleven clinical trials that will shape medicine in 2026” in Nature Medicine

Negative

• Regulatory approval depends on future positive overall survival results not yet available
• Interim analysis requires 144 death events, reflecting the severity of metastatic disease and time to readout

Argus May 12 session

-1.92% close to close Open Argus

Details

News Market Reaction – BCTX

In the May 12 session, BCTX declined 1.92%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights tangible progress in Bria‑IMT’s pivotal Phase 3 Bria‑ABC trial, with ov...

Analysis

This announcement highlights tangible progress in Bria‑IMT’s pivotal Phase 3 Bria‑ABC trial, with over 315 patients screened and more than 230 enrolled toward an interim overall survival analysis at 144 events expected in 2026. Compared with prior clinical‑trial headlines featuring QOL, biomarker, and survival data, this update focuses on trial execution and momentum. Investors may track enrollment pace, timing of interim OS readout, and how upcoming data align with prior Phase 2 signals.

Key Figures

Patients screened: over 315 patients Patients enrolled: over 230 patients Interim analysis events: 144 patient events +1 more

Patients screened

over 315 patients

Phase 3 Bria-ABC Bria-IMT + checkpoint inhibitor trial

Patients enrolled

over 230 patients

Phase 3 Bria-ABC Bria-IMT + checkpoint inhibitor trial

Interim analysis events

144 patient events

Deaths required for interim overall survival analysis

Topline data timing

2026

Expected interim topline overall survival data

Previous Clinical trial Reports

5 past events · Latest: May 07

Same Type 5 events

1. May 07

   Site expansion update

   24h Move

   -1.2%

   Added NYU Perlmutter Cancer Center as Phase 3 Bria-ABC clinical site.

2. Apr 27

   ASCO data preview

   24h Move

   +3.9%

   Announced six metastatic breast cancer data presentations at ASCO 2026.

3. Apr 20

   QOL/biomarker data

   24h Move

   -9.3%

   Presented Phase 3 quality-of-life and Phase 2 biomarker findings at AACR.

4. Dec 18

   Nature Medicine feature

   24h Move

   +3.2%

   Nature Medicine highlighted Bria-IMT Phase 3 as shaping medicine in 2026.

5. Dec 10

   SABCS 2025 data

   24h Move

   -7.9%

   Presented Phase 2 survival and interim Phase 3 biomarker data at SABCS 2025.

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

Key Terms

phase 3, immune checkpoint inhibitor, metastatic breast cancer, overall survival, +2 more

6 terms

phase 3 medical

"Over 315 patients screened and over 230 patients enrolled in BriaCell’s pivotal Phase 3 Bria-ABC study"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

immune checkpoint inhibitor medical

"Phase 3 Bria-ABC study of Bria-IMT plus 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.

metastatic breast cancer medical

"Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer"

Metastatic breast cancer is breast cancer that has spread beyond the breast and nearby lymph nodes to other organs, such as bones, liver, lungs or brain. For investors it matters because these advanced-stage cases often require long-term, complex and costly treatments, drive demand for specialty drugs and diagnostics, and influence regulatory approvals, pricing negotiations and the long-term revenue potential of companies developing therapies aimed at slowing spread or improving quality of life. An everyday analogy: it’s like a weed that has taken root in multiple beds rather than just one garden patch, requiring broader and more sustained effort to manage.

overall survival medical

"Overall survival (OS) is the primary endpoint, and positive results could support full approval"

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.

fda fast track designation regulatory

"The Bria-IMT combination regimen has received FDA Fast Track designation."

FDA Fast Track designation is a U.S. regulatory status that gives a drug or treatment a faster, more interactive path through development and review because it targets a serious condition with unmet medical need. Think of it as a “fast lane” at the agency that can speed up testing and paperwork, potentially shortening the time to market; for investors, that can lower development risk and accelerate potential revenue, though it does not guarantee approval.

clinicaltrials.gov regulatory

"For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov 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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Add on Google Not now

• Over 315 patients screened and over 230 patients enrolled in BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor in metastatic breast cancer 
• Enrollment momentum continues with strong clinical site and patient interest
• Interim topline data expected in 2026
• Positive interim overall survival results could support potential approval of Bria-IMT in metastatic breast cancer
• BriaCell’s Bria-IMT combination regimen continues under FDA Fast Track designation
  

PHILADELPHIA and VANCOUVER, British Columbia, May 12, 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 its pivotal Phase 3 Bria-ABC study has screened over 315 and enrolled over 230 patients. BriaCell anticipates reporting topline data in 2026.

BriaCell has received increased interest from leading cancer centers and continued enrollment momentum following the independent inclusion of its Phase 3 clinical trial in Nature Medicine’s article, “Eleven clinical trials that will shape medicine in 2026”. The Phase 3 Bria-ABC study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor versus physician’s choice of treatment in advanced breast cancer.

The interim analysis will be conducted after 144 patient events, defined as deaths, have occurred. Overall survival (OS) is the primary endpoint, and positive results could support full approval of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has received FDA Fast Track designation.

“Sustained and new interest from world class institutions and their patients continues to drive remarkable patient engagement,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We remain on track to report the interim analysis in 2026 while continuing to enroll patients and advance preparations for potential commercialization, with the goal of bringing our novel immunotherapy regimen to patients with metastatic breast cancer as efficiently as possible.”

For additional information on BriaCell’s pivotal Phase 3 study, 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 ongoing patient enrollment in the pivotal Phase 3 clinical study of Bria‑IMT, the expected timing of interim analysis and topline data readout, and the potential for full approval and marketing authorization of the Bria‑IMT combination regimen, 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 about enrollment in its Phase 3 Bria-IMT trial?

BriaCell announced that its Phase 3 Bria-ABC study has enrolled over 230 patients and screened more than 315. According to BriaCell, this pivotal trial evaluates Bria-IMT plus an immune checkpoint inhibitor in advanced breast cancer versus physician’s choice of treatment.

When is BriaCell (BCTX) expecting interim topline data from the Phase 3 Bria-ABC study?

BriaCell expects interim topline data from the Phase 3 Bria-ABC study in 2026. According to BriaCell, the interim analysis will occur after 144 patient events, defined as deaths, with overall survival serving as the trial’s primary endpoint in metastatic breast cancer.

What is the primary endpoint of BriaCell’s (BCTX) Phase 3 Bria-IMT metastatic breast cancer trial?

The primary endpoint of BriaCell’s Phase 3 Bria-ABC trial is overall survival. According to BriaCell, the interim analysis will be triggered after 144 death events, and positive overall survival results could support potential full approval of Bria-IMT in metastatic breast cancer.

How could positive Phase 3 Bria-IMT results impact BriaCell (BCTX) and metastatic breast cancer patients?

Positive interim overall survival results could support potential approval of Bria-IMT in metastatic breast cancer. According to BriaCell, the company is preparing for possible commercialization while continuing patient enrollment, aiming to bring its immunotherapy regimen to eligible patients as efficiently as possible.

What does FDA Fast Track designation mean for BriaCell’s (BCTX) Bria-IMT combination regimen?

BriaCell’s Bria-IMT combination regimen has received FDA Fast Track designation for metastatic breast cancer. According to BriaCell, this designation is intended to facilitate development and expedite review of therapies addressing serious conditions with unmet medical needs, potentially accelerating regulatory interactions and timelines.

Why is BriaCell’s (BCTX) Phase 3 Bria-ABC trial considered notable for 2026?

BriaCell’s Phase 3 Bria-ABC trial was independently highlighted in a Nature Medicine article on trials shaping medicine in 2026. According to BriaCell, this recognition aligns with growing interest from leading cancer centers and ongoing enrollment momentum in the metastatic breast cancer study.

What treatment comparison is used in BriaCell’s (BCTX) Phase 3 Bria-ABC metastatic breast cancer study?

The Phase 3 Bria-ABC study compares Bria-IMT plus an immune checkpoint inhibitor against physician’s choice of treatment. According to BriaCell, this design evaluates its lead immunotherapy candidate in an advanced breast cancer setting, with overall survival as the primary efficacy endpoint.