BriaCell Presents Outstanding Phase 2 Survival & Promising Phase 3 Clinical Data at SABCS® 2025

Rhea-AI Summary

BriaCell (Nasdaq: BCTX) presented Phase 2 survival and Phase 3 biomarker data across three posters at SABCS® 2025 (Dec 9-12, 2025). A pooled interim analysis (116 patients) from the Bria-ABC Phase 3 trial showed a favorable safety profile with no treatment-related discontinuations, early PFS signals by subtype (median PFS: HR+/HER2- 3.7 months; HER2-Low 3.9 months) and a potential predictive Neutrophil-to-Lymphocyte Ratio (NLR) signal (favorable NLR 0.7–2.3: PFS 4.4 vs 2.6 months). Phase 2 data (n=54) reported DTH+ patients with higher median OS (11.3 vs 4.7 months, P=0.0001) and Th1-biased cytokine signatures correlated with clinical benefit in biomarker analyses (n=30). Further analysis planned as enrollment and OS mature.

Positive

• No treatment-related discontinuations reported in Phase 3 pooled interim analysis
• Phase 2 DTH+ median OS 11.3 months vs 4.7 months (P=0.0001)
• Favorable NLR (0.7–2.3) associated with PFS 4.4 vs 2.6 months
• Th1-biased cytokine signatures linked to better clinical responses and OS

Negative

• Pooled interim analysis is blinded, limiting definitive efficacy conclusions
• Phase 2 cohort small (n=54), reducing statistical generalizability
• CNS metastasis subgroup very small (6 patients) for subgroup inference
• Early median PFS values are short (3.7–3.9 months by subtype)

Key Figures

Phase 3 pooled patients 116 patients Interim analysis with MHC subtyping in pivotal Phase 3 trial

Prior therapies Median 6 prior treatments Metastatic breast cancer patients in Bria-IMT Phase 3 study

Median PFS (favorable NLR) 4.4 months Patients with NLR 0.7–2.3 in Phase 3 pooled analysis

Median PFS (other NLR) 2.6 months Patients with NLR <0.7 or >2.3 in Phase 3 analysis

Median OS DTH+ 11.3 months Phase 1/2 Bria-IMT + anti–PD-1 in DTH+ patients

Median OS DTH- 4.7 months Phase 1/2 Bria-IMT + anti–PD-1 in DTH- patients

OS significance P=0.0001 Difference in median OS between DTH+ and DTH- groups

Clinical benefit rate 75% Overall CBR in evaluable CNS metastasis patients (CR/PR/SD)

Market Reality Check

$0.3606 Last Close

Volume Volume 61,799 is 1.18x the 20-day average of 52,247, indicating modestly elevated trading interest pre-data. normal

Technical Shares trade below the 200-day MA, with price at 12.28 versus the 22.19 200-day moving average, reflecting a longer-term downtrend.

Peers on Argus

BCTX’s -2.15% move contrasted with mixed peers: ADAP -17.57%, CYCC -5.84%, PRTG -10.39% and NXTC -1.5% were weak, while IMNN gained 2.58%, pointing to company-specific trading rather than a uniform sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Clinical data preview	Positive	+3.7%	Preview of positive Phase 2 survival and Phase 3 biomarker data for SABCS.
Nov 25	Clinical data highlight	Positive	+13.5%	Announcement of positive Phase 2/3 data to be highlighted at SABCS 2025.
Nov 20	AI collaboration deal	Positive	-0.6%	Research collaboration with Receptor.AI to expand small‑molecule pipeline.
Nov 18	Conference selection	Positive	-4.7%	Selection to present multiple Phase 2/3 and preclinical posters at SABCS.
Nov 07	Preclinical data SITC	Positive	+15.1%	Robust preclinical anti‑cancer activity for Bria‑OTS+ at SITC 2025.

Pattern Detected

Clinical and preclinical updates have often been framed positively, but share reactions have alternated between strong rallies and notable selloffs, indicating inconsistent alignment between news tone and price.

Recent Company History

Over the last two months, BriaCell has repeatedly highlighted progress for its Bria-IMT platform. Clinical‑trial news on Oct 21 and Oct 22 detailed Phase 3 site expansion and positive DSMB feedback, while November releases focused on SABCS® 2025 Phase 2/3 data and preclinical Bria‑OTS+ activity. Prior SABCS‑related clinical updates on Nov 18, Nov 25, and Dec 2 emphasized positive survival, safety, and biomarker signals, with mixed but sometimes strong price reactions.

Market Pulse Summary

This announcement details mature Phase 2 survival results and ongoing Phase 3 biomarker data for Bria‑IMT in heavily pretreated metastatic breast cancer, including patients with CNS metastases and a median of 6 prior therapies. Predictive markers such as NLR, DTH status, and Th1‑biased cytokine signatures are emphasized. Historically, BriaCell’s trial updates and regulatory filings, including FDA Fast Track designation, have been key milestones to monitor.

Key Terms

immune check point inhibitor medical

"Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI)"

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.

neutrophil-to-lymphocyte ratio medical

"Neutrophil-to-Lymphocyte Ratio (NLR) as a potential predictive biomarker"

The neutrophil-to-lymphocyte ratio (NLR) is a simple number calculated from a routine blood test that compares two types of white blood cells: neutrophils (first responders in inflammation) and lymphocytes (cells tied to long-term immune response). Like measuring the relative sizes of two teams in a tug-of-war, a higher NLR often signals more systemic inflammation or stress and can predict disease severity or treatment response — information investors use to gauge the likely success, market potential, or regulatory risk of medical therapies and clinical trials.

delayed type hypersensitivity medical

"Positive Delayed Type Hypersensitivity (DTH) may be key predictor"

A delayed type hypersensitivity is an immune reaction that appears hours to days after exposure to a substance, driven by certain immune cells rather than immediate allergic antibodies. Think of it like a slow-acting alarm that triggers later, producing redness, swelling or tissue changes at the exposure site. Investors care because these responses are measured in vaccine and drug development to assess safety, effectiveness and potential regulatory or market impacts.

progression-free-survival medical

"assessed safety, biomarker correlations and progression-free-survival (PFS) per imaging"

Progression-free survival (PFS) is the length of time during and after a treatment that a patient’s disease does not get worse. For investors, PFS is a key measure in clinical trials because longer PFS can indicate a treatment is working and may speed regulatory reviews or adoption, similar to how longer battery life makes a gadget more attractive to buyers. PFS is a useful early sign of value but does not guarantee longer overall survival.

overall survival medical

"median overall survival (OS) was significantly (P=0.0001) higher"

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.

central nervous system metastasis medical

"Six patients had Central Nervous System (CNS) metastasis."

Cancer cells that have spread from their original site to the brain and/or spinal cord are called central nervous system metastasis; think of it as weeds from one garden taking root in another room of a house. It matters to investors because such spread often makes disease harder to treat, changes clinical trial goals, increases the need for specialized therapies or tests, and can significantly affect a drug’s market size, regulatory hurdles, and reimbursement prospects.

cytokines/chemokines medical

"Analysis of 35 different blood cytokines/chemokines from 30 patients"

Cytokines and chemokines are small proteins the body’s cells use to send signals that control immunity and inflammation; cytokines are broader messengers while chemokines are a subset that guide cells to specific locations. For investors, their levels and behavior are important because they serve as measurable indicators of how well drugs or vaccines work and whether treatments cause harmful inflammation, making them key biomarkers and drug targets in biotech and pharmaceutical valuations.

Th1-biased cytokine signatures medical

"Th1-biased cytokine signatures as biomarkers of clinical benefit"

A TH1-biased cytokine signature describes a pattern of immune signaling molecules that indicates the body is favoring a cell-focused immune response led by T helper 1 (TH1) cells, which helps clear viruses and infected cells. For investors, this matters because such a signature is often used as a biomarker to show that vaccines or immunotherapies are producing the desired type of immune activity and can influence clinical trial outcomes, regulatory review, and perceived product effectiveness or safety.

AI-generated analysis. Not financial advice.

• BriaCell presents positive clinical data in three posters at the San Antonio Breast Cancer Symposium (SABCS^®)
• Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI) continues to support biomarkers to identify patients who benefit from treatment with BriaCell’s regimen
• Maturing Phase 2 study data continues to support meaningful clinical benefit of the Bria-IMT regimen with outstanding long-term survival
• No toxicity related discontinuations in Phase 3

PHILADELPHIA and VANCOUVER, British Columbia, Dec. 10, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, presents positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS^®) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

“We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses in patients treated with the Bria-IMT regimen early in their treatment course,” stated Kelly E. McCann, MD, PhD, breast medical oncologist at UCLA Health Jonsson Comprehensive Cancer Center, and lead investigator at UCLA for the Bria-ABC pivotal Phase 3 study. “These biomarkers could serve as highly valuable tools for clinicians, helping them inform treatment decisions for metastatic breast cancer, a complex disease in which many patients have limited or no remaining treatment options.”

“BriaCell’s data shows the promise of the Bria-IMT regimen to address major unmet needs in the treatment of metastatic breast cancer, including in patients with CNS metastasis who have progressed on several lines of therapy – median 6 prior treatments,” stated Chaitali S. Nangia, MD, Partner, Hoag Medical Group and first author of the poster.

“Our findings support further evaluation of cytokine and chemokine biomarkers as potential predictors of survival and clinical benefit with our Bria-IMT regimen, establishing a path towards more personalized therapeutic strategies in metastatic breast cancer patients with limited treatment options,” commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

The details of the poster presentations are listed below.

Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM - 2:00 PM CST

Summary
In BriaCell’s pivotal Phase 3 study in metastatic breast cancer, patients are randomized 1:1:1 to receive Bria-IMT plus an immune check point inhibitor (CPI), Bria-IMT monotherapy or Treatment of Physician’s Choice (TPC). A pooled interim analysis of 116 patients with available MHC subtyping and median 6 prior lines of therapy assessed safety, biomarker correlations and progression-free-survival (PFS) per imaging. All data remains blinded to date.

Key Findings

• Favorable safety profile: The Bria-IMT regimen was well tolerated with no treatment-related discontinuations due to adverse events (AEs). The most common AEs were fatigue, anemia, and nausea and were predominantly low grade.
• Early PFS signals by subtype: Median PFS values appeared highest in patients with HR+/HER2- disease (3.7 months) and HER2-Low disease (3.9 months).
• Neutrophil-to-Lymphocyte Ratio (NLR) as a potential predictive biomarker: Consistent with findings from the Phase 2 study, the Neutrophil to Lymphocyte Ratio (NLR) continues to show potential as a biomarker of clinical benefit. Patients with favorable NLR of 0.7 – 2.3 demonstrated longer PFS with a median of 4.4 months vs 2.6 months in those with NLR <0.7 or >2.3.
  

Conclusion
Biomarkers previously associated with PFS and overall survival (OS) in BriaCell’s phase 2 study continue to show a direct relationship with PFS in this ongoing phase 3 study. Further analysis is planned as enrolment progresses, and as OS data mature.

Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM - 2:00 PM CST

The data analysis of Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer is presented below. Six patients had Central Nervous System (CNS) metastasis.

Summary
Positive Delayed Type Hypersensitivity (DTH) may be key predictor of clinical benefit as median overall survival (OS) was significantly (P=0.0001) higher in patients who were DTH+ (11.3 months) vs those who were DTH- (4.7 months).

In four evaluable patients with CNS metastasis, best clinical benefit Rate (CBR) including complete response (CR), partial response (PR), or stable disease (SD) in patients was 100% in HER2+ patients, 100% in HR+ patients, 50% in patients with TNBC, and 75% overall.

Conclusion
Maturing positive Phase 2 data continue to support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further evaluating this immunotherapy and the role of biomarkers in predicting patient response.

Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM - 6:30 PM CST

Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI).

Summary

• Bria-IMT immunotherapy produced Th1 biased cytokine and chemokine changes consistent with immune activation suggesting their use as potential biomarkers to predict clinical responses of cancer patients to Bria-IMT regimen.
• Patients with Stable Disease (SD) or PR (Partial Response) showed significantly higher levels of immune activating factors including IL-2, IL-15, IL-27, TNF-α, CXCL10, CCL2, CCL13, CCL26, and IL-17Apost-treatment, suggesting enhanced T-cell activation and pro-inflammatory signaling.
• No induction of Th2- or regulatory-associated cytokines was observed suggesting that the Bria-IMT regimen did not suppress immune activation.
• Elevated post-treatment levels of IL-1β, IL-6, IL-8, TNF-α, and MCP-4 were associated with better Overall Survival (OS).

Conclusion
BriaCell’s data suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer.

Copies of the posters will be made available at https://briacell.com/scientific-publications/.

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 presenting at the 2025 SABCS^®, the contents of such presentations, 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

FAQ

What Phase 3 interim safety findings did BriaCell (BCTX) report at SABCS 2025?

The pooled interim analysis (116 patients) showed a favorable safety profile with no treatment-related discontinuations and mainly low-grade adverse events like fatigue, anemia, and nausea.

How did BriaCell’s Phase 2 DTH result affect overall survival in the BCTX study?

Patients who were DTH+ had median OS of 11.3 months versus 4.7 months in DTH- patients (P=0.0001).

What biomarker predicted progression-free survival in BriaCell’s Bria-ABC Phase 3 interim data?

Neutrophil-to-Lymphocyte Ratio (NLR) showed potential predictive value: favorable NLR 0.7–2.3 had median PFS 4.4 months vs 2.6 months for others.

What were the reported median PFS values by subtype in BriaCell’s interim Phase 3 data?

Median PFS appeared highest in HR+/HER2- patients at 3.7 months and in HER2-Low patients at 3.9 months.

Are BriaCell’s cytokine biomarker findings (BCTX) mature enough to guide treatment decisions?

Cytokine analyses (n=30) showed Th1-biased signatures associated with benefit, but further analysis is planned as enrollment increases and OS data mature.