BriaCell’s Phase 3 Patient Enrollment on Track for 1H2026 Topline Data Readout

Rhea-AI Summary

BriaCell (Nasdaq: BCTX) reported that its pivotal Phase 3 study in metastatic breast cancer has screened >230 patients and enrolled >160, with enrollment exceeding expectations and strong site/patient interest.

The company expects a topline interim data readout as early as 1H2026; the interim analysis will occur once 144 patient events (deaths) are observed and will assess overall survival (OS) versus physician’s choice. The Phase 3 regimen retains FDA Fast Track designation and positive results could support full approval and marketing authorization for Bria-IMT.

Positive

• Enrollment >160 patients, exceeding expectations
• Topline interim readout targeted for 1H2026
• Study holds FDA Fast Track designation

Negative

• Interim analysis contingent on 144 patient events (deaths)
• Topline timing depends on reaching the 144-event threshold

Key Figures

Patients screened over 230 patients Pivotal Phase 3 metastatic breast cancer study

Patients enrolled over 160 patients Bria-IMT plus checkpoint inhibitor Phase 3 trial

Interim events trigger 144 patient events (deaths) Threshold for interim overall survival analysis

Topline timing 1H2026 Expected topline interim Phase 3 data readout

Current price $12.55 Pre-news close vs 52-week range $6–$190.5

1-day move 10.18% Price change in the 24h before this news

52-week high $190.5 Stock trading well below prior high

52-week low $6 Current price above the 1-year low

Market Reality Check

$12.55 Last Close

Volume Volume 49,397 vs 20-day average 50,098 (~in line), suggesting no major volume spike ahead of the news. normal

Technical Shares at 12.55, trading below the 200-day MA of 22.36 and well under the 190.5 52-week high.

Peers on Argus

BCTX was up 10.18% while key biotech peers like ADAP (-17.57%), NXTC (-8.2%), CYCC (-5.84%) and PRTG (-10.39%) were down, indicating a stock-specific move rather than a sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Clinical data update	Positive	+3.7%	Positive Phase 2 survival and Phase 3 biomarker data at SABCS.
Nov 25	Clinical data preview	Positive	+13.5%	Planned SABCS posters with positive Phase 2 and Phase 3 signals.
Nov 20	R&D partnership	Positive	-0.6%	AI-driven collaboration to expand small-molecule cancer pipeline.
Nov 18	Conference selection	Positive	-4.7%	Selection to present Phase 2 and 3 data at SABCS 2025.
Nov 07	Preclinical data	Positive	+15.1%	Robust anti-cancer activity for Bria-OTS+ platform at SITC 2025.

Pattern Detected

Clinical trial updates have often produced sizable but mixed price reactions, with several positive announcements met by both gains and pullbacks.

Recent Company History

Over the last two months, BriaCell has repeatedly highlighted progress for Bria-IMT in metastatic breast cancer, including Phase 2 survival signals, Phase 3 biomarker data, and expansion of clinical sites. Clinical trial news on Oct 21, Oct 22, Nov 18, Nov 25, and Dec 2 showed a mix of positive and negative single-day moves, suggesting investor reactions to trial milestones can be volatile even when the underlying data are favorable.

Market Pulse Summary

This announcement emphasizes strong momentum in BriaCell’s pivotal Phase 3 metastatic breast cancer trial, with over 230 patients screened and over 160 enrolled toward an interim overall survival analysis at 144 events. Topline data are anticipated in 1H2026 under FDA Fast Track designation. Investors may track future updates on enrollment, timing of the interim analysis, and any safety or efficacy signals relative to prior Phase 2 and Phase 3 readouts.

Key Terms

metastatic breast cancer medical

"pivotal Phase 3 study in metastatic breast cancer (MBC)Enrollment"

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.

Phase 3 medical

"pivotal Phase 3 study in metastatic breast cancer (MBC)Enrollment"

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.

Fast Track designation regulatory

"Phase 3 combination regimen continues under FDA Fast Track designation"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

overall survival (OS) medical

"This interim analysis will assess overall survival (OS) as the primary endpoint"

Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.

primary endpoint medical

"overall survival (OS) as the primary endpoint, comparing patients treated"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

ClinicalTrials.gov regulatory

"For additional information ... 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.

Fast Track regulatory

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

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

AI-generated analysis. Not financial advice.

• Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC)
• Enrollment exceeding expectations with strong clinical site and patient interest
• Topline interim data readout expected in 1H2026 
• Phase 3 combination regimen continues under FDA Fast Track designation

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce its Phase 3 clinical study has screened over 230 and enrolled over 160 patients. BriaCell anticipates reporting topline data as early as 1H2026.

Interim data will be analyzed once 144 patient events (deaths) occur. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT™ in patients with metastatic breast cancer.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).

“The pace of patient enrollment in our pivotal Phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We look forward to collecting, analyzing and sharing the Phase 3 data with the U.S. FDA in the coming months as we continue working to bring hope to patients with metastatic breast cancer who face an urgent medical need.”

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor in metastatic breast cancer will be analyzed once 144 patient events (deaths) occur. This interim analysis will assess overall survival (OS) as the primary endpoint, comparing patients treated with the Bria-IMT combination regimen to those receiving physician’s choice therapy. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has been granted FDA Fast Track designation.

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 the Company’s timeline for analyzing and reporting interim and topline data in its ongoing pivotal Phase 3 clinical study; the Company’s anticipated timeline for collecting, analyzing and sharing the Phase 3 data with the U.S. FDA; and the Company’s beliefs regarding Bria-IMT receiving full approval and marketing authorization for metastatic breast cancer patients, 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

How many patients has BriaCell enrolled in its Phase 3 (BCTX) study as of Dec 9, 2025?

BriaCell has enrolled over 160 patients and screened over 230 patients.

When does BriaCell expect topline interim data for BCTX Phase 3?

The company expects a topline interim data readout as early as 1H2026.

What triggers the interim analysis for BriaCell's BCTX Phase 3 study?

The interim analysis will be performed once 144 patient events (deaths) have occurred.

What is the primary endpoint assessed in the BCTX Phase 3 interim analysis?

The interim analysis will assess overall survival (OS) comparing the Bria-IMT combination regimen to physician’s choice.

Does BriaCell’s Phase 3 regimen have any regulatory designations?

Yes; the Bria-IMT combination regimen has been granted FDA Fast Track designation.