“Eleven clinical trials that will shape medicine in 2026” – BriaCell Phase 3 Trial Featured in Nature Medicine

Rhea-AI Summary

BriaCell (Nasdaq: BCTX) announced its Phase 3 Bria-IMT trial in metastatic breast cancer (BRIA-ABC) was highlighted in Nature Medicine’s "Eleven clinical trials that will shape medicine in 2026."

The company said the trial has screened more than 230 patients and enrolled over 160 patients, with an interim analysis scheduled once 144 patient events (deaths) occur. BriaCell anticipates reporting topline data as early as H1-2026. The Bria-IMT combination has FDA Fast Track designation. The primary endpoint at interim is overall survival comparing Bria-IMT plus checkpoint inhibitor versus physician’s choice.

Positive

• Screened >230 patients to date
• Enrolled >160 patients to date
• Interim analysis triggered at 144 patient events
• Bria-IMT has FDA Fast Track designation

Negative

• Interim analysis timing depends on occurrence of 144 deaths
• Topline data timing remains an estimate ("as early as H1-2026")

Key Figures

Trials to watch 11 clinical trials Nature Medicine Year In Review feature list

Screened patients >230 patients Bria-ABC Phase 3 trial screening count

Enrolled patients Over 160 patients Bria-ABC Phase 3 trial enrollment to date

Interim events trigger 144 patient events Deaths required before interim OS analysis

Top-line timing H1-2026 Anticipated Phase 3 top-line data window

Trial phase Phase 3 Bria-IMT pivotal metastatic breast cancer study

Market Reality Check

$0.0576 Last Close

Volume Volume 24,837 is below the 20-day average of 55,209 ahead of this positive trial highlight. low

Technical Shares at $8.73 are trading below the 200-day MA of $21.37, reflecting a weak longer-term trend pre-news.

Peers on Argus

Peers show mixed moves: ADAP -17.57%, NXTC -5.49%, CYCC -5.84%, PRTG -10.39%, while IMNN +1.04%, suggesting this largely reflects stock-specific dynamics rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 10	SABCS data update	Positive	-7.9%	Presented Phase 2 survival and Phase 3 biomarker data from Bria-ABC trial.
Dec 09	Phase 3 enrollment	Positive	-2.1%	Reported >230 screened, >160 enrolled and confirmed 1H 2026 interim readout plan.
Dec 02	Upcoming SABCS posters	Positive	+3.7%	Announced three SABCS posters with positive Phase 2 survival and Phase 3 signals.
Nov 25	SABCS data preview	Positive	+13.5%	Highlighted positive Phase 2 and Phase 3 data; reiterated H1 2026 interim analysis.
Nov 20	AI collaboration	Positive	-0.6%	Announced AI-driven small-molecule collaboration via BriaPro and Receptor.AI.

Pattern Detected

Recent clinically positive headlines have often seen negative or muted price reactions, with several divergences between upbeat trial updates and next-day performance.

Recent Company History

Over the last month, BriaCell has repeatedly highlighted progress in its Bria-IMT program, including SABCS® 2025 data, strong Phase 2 survival signals, and an on-track Phase 3 enrollment targeting an interim OS readout in 1H 2026. Despite generally positive clinical messaging, price reactions varied, with some updates drawing declines of up to -7.9% and others gains above +13%. Today’s Nature Medicine recognition fits this pattern of increasing clinical visibility around the pivotal Bria-ABC trial.

Market Pulse Summary

This announcement underscores BriaCell’s Bria-ABC Phase 3 trial in metastatic breast cancer, now featured by Nature Medicine among clinical trials expected to influence medicine in 2026. It reiterates that more than 230 patients have been screened, over 160 enrolled, and an interim overall survival analysis is planned once 144 events occur, targeting top-line data in H1 2026. Investors may watch enrollment progress, timing of the interim OS readout, and any further Phase 3 efficacy or safety updates as key catalysts.

Key Terms

metastatic breast cancer medical

"The BRIA-ABC trial is an exciting study focused on people living with 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.

immunotherapies medical

"a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care"

Immunotherapies are medical treatments that strengthen or guide the body's own immune system to recognize and fight disease cells, such as cancer or chronic infections. They matter to investors because they can produce long-lasting patient responses, command premium prices, and reshape standard care—similar to installing a smarter security system that prevents repeat break-ins—creating significant commercial upside but also clinical and regulatory risk.

cell-based immunotherapy medical

"to see if a new cell-based immunotherapy, called Bria-IMT, can actually improve outcomes"

A therapy that uses living immune cells, often taken from a patient or donor and modified in a lab, to seek out and destroy disease such as cancer. Think of it as training and equipping a person’s own soldiers to better recognize and fight a specific enemy; for investors it matters because these treatments can command high prices and large market demand but also carry substantial development costs, regulatory hurdles, and variable clinical success that affect company value.

brain metastases medical

"including patients who cannot work but are able to take care of themselves — and those with brain metastases"

Cancer cells that have spread from another part of the body to the brain, forming new tumors there. Think of it like weeds from one garden taking root in another; the behavior and treatment needs can change significantly once cancer reaches the brain. For investors, brain metastases matter because they often drive different clinical trial designs, higher healthcare costs, and urgent demand for effective therapies, all of which can materially affect a biotech or healthcare company’s prospects.

immune check point inhibitor medical

"evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice"

A drug that lifts the natural “brakes” the body uses to keep the immune system from attacking healthy cells, allowing immune cells to recognize and destroy cancer cells. Think of it as removing restraints on security guards so they can chase down intruders; success or failure in clinical trials, approvals, and patient use can quickly change a drugmaker’s revenue prospects and therefore its stock value.

overall survival (OS) medical

"This interim analysis will evaluate 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.

Fast Track designation regulatory

"The Bria-IMT combination regimen has been granted 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.

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. Not financial advice.

• Nature Medicine asked leading researchers to name their top clinical trial for 2026, from long-awaited vaccines for infectious diseases to new treatments for advanced cancers and long COVID
• BriaCell’s Phase 3 clinical trial in metastatic breast cancer featured as “clinical trial to watch in 2026”
• BriaCell anticipates reporting top line data as early as H1-2026
  

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 18, 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 Bria-IMT™ clinical trial in metastatic breast cancer has been prominently and independently featured in the Nature Medicine Year In Review’s publication, “Eleven clinical trials that will shape medicine in 2026”¹, linked here.

As quoted in the Nature Medicine feature, Dr. Sara A. Hurvitz, MD, FACP, stated: “The BRIA-ABC trial is an exciting study focused on people living with metastatic breast cancer. Even though cancer care has come a long way, metastatic breast cancer is still rarely curable, and only a small fraction of patients benefit long-term from current immunotherapy or targeted treatments. That is why this trial was designed — to see if a new cell-based immunotherapy, called Bria-IMT, can actually improve outcomes for people who have already gone through many prior treatments.”

“What really sets BRIA-ABC apart is how inclusive it is. It welcomes individuals with all breast cancer subtypes, including patients who cannot work but are able to take care of themselves — and those with brain metastases and people who have already had extensive prior treatments, even antibody–drug conjugates or checkpoint inhibitors. Plus, it uses a real-world comparator arm, making the results much more meaningful for everyday clinical practice.” Dr. Sara A. Hurvitz holds the Smith Family Endowed Chair in Women’s Health at the Fred Hutchinson Cancer Center, Seattle, WA, USA.

BriaCell anticipates reporting top line data as early as H1-2026.

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

BriaCell recently reported its Phase 3 clinical study has screened more than 230 patients and enrolled over 160 patients to date. Interim data will be analyzed once 144 patient events (deaths) occur. This interim analysis will evaluate 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 for 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 anticipated timelines for data reporting, interim analysis, regulatory submissions, and the results and conclusions contained in this press release, 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

¹ May, M. Eleven clinical trials that will shape medicine in 2026. Nat Med 31, 3943–3947 (2025)

FAQ

What is BriaCell announcing about the BRIA-ABC Phase 3 trial (BCTX) dated Dec 18, 2025?

BriaCell said BRIA-ABC was featured in Nature Medicine and has screened >b230 patients, enrolled >b160, with topline data anticipated as early as H1-2026.

When will BriaCell (BCTX) report BRIA-ABC interim or topline data?

The company anticipates reporting topline data as early as H1-2026, with an interim analysis once 144 patient events occur.

How many patients has the Bria-IMT Phase 3 trial (BCTX) enrolled and screened?

BriaCell reported the study has screened more than 230 patients and enrolled over 160 patients to date.

What is the primary endpoint for BriaCell’s BRIA-ABC Phase 3 trial (BCTX)?

The interim analysis will evaluate overall survival (OS) as the primary endpoint comparing Bria-IMT combination versus physician’s choice.

Does Bria-IMT have any regulatory designations that could affect approval timelines for BCTX?

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