Bria-IMT (SV-BR-1-GM) / BriaCell - LARVOL DELTA

Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer (GlobeNewswire) - "BriaCell presents positive clinical data...at the San Antonio Breast Cancer Symposium....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."

Biomarker • Retrospective data • Breast Cancer

Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine (GlobeNewswire) - "BriaCell presents positive clinical data...at the San Antonio Breast Cancer Symposium....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."

Late-breaking abstract • P2 data • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial (GlobeNewswire) - "BriaCell presents positive clinical data...at the San Antonio Breast Cancer Symposium....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....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)....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 2.3."

Biomarker • Late-breaking abstract • P3 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

BriaCell’s Phase 3 Patient Enrollment on Track for 1H2026 Topline Data Readout (GlobeNewswire) - "Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC)...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."

Enrollment status • P3 data: top line • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer

Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine (SABCS 2025) - P1/2, P3 | "Coadministration w/ an anti-PD-1 CPI, the vaccine response is reinforced, counteracting the immuno-suppressive tumor microenvironment.MethodsThis phase I/II study evaluated the Bria-IMT regimen: low-dose cyclophosphamide (Day –2) followed by SV-BR-1-GM and CPI (pembrolizumab or retifanlimab), then low-dose local peg- interferon α. On basis of these results, a randomized phase III trial comparing the Bria-IMT regimen to physician's choice is ongoing (NCT06072612). Trial information: NCT03328026."

IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Triple Negative Breast Cancer • CTCs • HER-2 • IFNG • PD-L1 • PGR

Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial (SABCS 2025) - P3 | "The Bria-IMT regimen includes Day -2 cyclophosphamide (300 mg/m²), Day 0 intradermal SV-BR-1-GM (20x106 irradiated cells), and Day 2 pegylated α interferon (0.1 mcg/site). Patients in this late stage, phase III trial maintained functional status w/o evidence of decline. This early prospective RCT in late stage metastatic breast cancer following recent drug approvals offers an emerging benchmark with results that may inform future trial design and guide care for pts who have exhausted standard options."

Biomarker • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer • CSF2 • HER-2

Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer. (SABCS 2025) - P1/2, P3 | "SV-BR1-GM induces a cytokine profile consistent with a Th1-polarized immune response, marked by elevated IL-2 and IL-15 in patients with clinical benefit (SD and PR). These cytokines, along with increased levels of MCP-1 and IP-10, reflect enhanced activation and recruitment of cytotoxic T cells, NK cells, and antigen-presenting cells. In contrast, there was no induction of Th2- or regulatory-associated cytokines such as IL-4, IL-10, or IL-13, suggesting that the vaccine does not promote an immunosuppressive or tolerogenic environment."

Biomarker • Clinical • IO biomarker • Breast Cancer • Oncology • Solid Tumor • CCL2 • CD4 • CD8 • CSF2 • CXCL10 • IL10 • IL13 • IL15 • IL2 • IL4

The pivotal Phase 3 study of Bria-IMT+CPI is ongoing with an interim analysis expected in H1-2026 (GlobeNewswire)

P3 data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell Selected to Present Phase 2 & 3 Clinical Data at SABCS 2025 (GlobeNewswire) - "Three BriaCell poster presentations include updated key biomarker data from BriaCell’s pivotal Phase 3 study and updated survival data from the Phase 2 study of Bria-IMT plus immune check point inhibitor (CPI) in metastatic breast cancer."

Clinical data • Breast Cancer

Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Medical College of Wisconsin

New P1 trial • Oncology • Solid Tumor

Feasibility and biomarker validation of an international randomized phase 3 trial of bria-IMT cell therapy in late stage MBC (Bria-ABC) (ESMO 2025) - P3 | "Bria-IMT regimen consists of: Day –2, Cyclophosphamide 300 mg/m 2; Day 0, 20M irradiated SV-BR-1-GM cells; Day +2, 0.1 mcg pegylated α interferon at inoculation sites. OS, CNS event free survival and others will be monitored as data becomes available. Enrollment expected to close by 2025, w/ final analyses planned for 2026."

Biomarker • Clinical • P3 data • Oncology • HER-2

Phase III Pivotal Trial of Bria-IMT + CPI vs Physician's Choice in Advanced Metastatic Breast Cancer (BRIA-ABC) [WITHDRAWN] (ESMO 2025) - No abstract available

Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor

BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer (GlobeNewswire) - "Independent DSMB has identified no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune check point inhibitor; Fourth consecutive positive DSMB recommendation supports the favorable safety profile observed to date."

DSMB • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell Adds Key Clinical Sites in Phase 3 Metastatic Breast Cancer Study (GlobeNewswire) - "79 clinical sites across 23 US states are currently enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC). Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University have now joined BriaCell’s extensive national network....BriaCell anticipates reporting top line data as early as H1-2026."

P3 data: top line • Trial status • Breast Cancer

BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025 (GlobeNewswire) - "As of the time of the poster submission, pooled data was available in 113 patients, with a median of 6 prior lines of treatment (2–13). Evaluable only pertains to imaging. All 113 are evaluated for safety, PFS, etc....Neutrophil to Lymphocyte Ratio (NLR) continues to be a potential biomarker of clinical benefit as progression free survival (PFS) was significantly higher in patients with NLR of 0.7 – 2.3 (4.5 months) vs those with NLR 2.3 (2.5 months) {(HR) of 0.5 (95% CI 0.3–0.8, p=0.005)}."

Biomarker • P3 data • Breast Cancer

[10-K] BriaCell Therapeutics Corp. Files Annual Report (StockTitan.net) - "The company’s lead immunotherapy, Bria-IMT, is in a pivotal Phase 3 study in metastatic breast cancer...As of April 22, 2025, the study had consented over 100 and enrolled over 75 patients, with top-line data anticipated as early as H1‑2026."

P3 data: top line • Trial status • Breast Cancer

BriaCell to Present Positive Clinical Biomarker Data of Phase 3 Study at ESMO 2025 (GlobeNewswire) - "Treatment arm agnostic biomarker positive subgroups showed significant improvement in progression free survival in patients who developed an immune response to Bria-IMT (as measured by delayed type hypersensitivity) (p=0.0002)...Bria-IMT was well tolerated with no treatment-related discontinuations due to adverse events (AEs)."

Biomarker • P3 data • Breast Cancer

BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study (GlobeNewswire) - "BriaCell Therapeutics...announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC)....'We remain confident in our timeline for sharing top-line data in 2026'. Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint."

P3 data: top line • Trial status • Breast Cancer

BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer (The Manila Times) - "BriaCell Therapeutics Corp...is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612) in metastatic breast cancer. BriaCell’s Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona."

Trial status • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell's Bria-IMT(TM) Demonstrates Survival Advantage over Trodelvy and Control Group in Metastatic Breast Cancer (BriaCell Press Release) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "BriaCell Therapeutics Corp...announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI)....Triple negative breast cancer (TNBC): median overall survival (OS) of 13.9 months vs. 11.8 months for antibody drug conjugate Trodelvy (sacituzumab govitecan-hziy) and 6.9 months single agent chemotherapy data. Hormone receptor positive (HR+): median overall survival (OS) of 17.3 months vs. 14.4 months for Trodelvy and 11.2 months in single agent chemotherapy data....No Bria-IMT related discontinuations have been reported to date."

P2 data • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell Phase 2 Survival Achievement: 52% of Patients Surpass One-Year Milestone in Metastatic Breast Cancer (GlobeNewswire) - P2 | N=54 | "BriaCell...has reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer...BriaCell’s most recent Phase 2 study cohort of 25 patients* achieved a 52% one-year survival rate (i.e. 52% of patients remained alive at least one year after starting on the study); 11 of these patients remain alive as of most recent contact, including one patient at 38.3 months and another at 30.3 months; Survival rate exceeds the survival expectations with the current standard of care therapies in similar patient populations; Notably, many patients had very advanced metastatic breast cancer, having already failed multiple prior lines of therapy including check point inhibitors (CPIs) and antibody-drug conjugates (ADCs) such as TRODELVY...and ENHERTU....BriaCell’s Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6)..."

P2 data • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven (The Manila Times) - "BriaCell Therapeutics Corp...is pleased to announce the addition of two key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612): Los Angeles Cancer Network and Smilow Cancer Hospital at New Haven. Each has 15 satellite locations. BriaCell anticipates completing patient enrollment in late 2025 or early 2026 and may report 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 (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC)."

P3 data: top line • Trial status • Breast Cancer

BriaCell Announces Positive Recommendation from Data Safety Monitoring Board for Pivotal Phase 3 Study in Metastatic Breast Cancer (GlobeNewswire) - "BriaCell Therapeutics...is pleased to report that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612). Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date."

DSMB • Breast Cancer

Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer. (ASCO 2025) - P1/2, P3 | " 54 pts (22 Ph I, 32 Ph II) enrolled; 11 received pembrolizumab, 44 retifanlimab (1 crossover). The Bria-IMT Ph 3 formulation cohort OS was comparable to ASCENT and TROPiCS-02 (13.43 vs 11.8, 14.4 mos), exceeding TPC arms (6.9, 11.2 mos). CBR (61%) compared favorably to ASCENT (40%) and TROPiCS-02 (34%); ORR (14%) matched or exceeded TPC arms (4%, 14%). These outcomes were observed in a more heavily pretreated population, demonstrating Bria-IMT's clinical activity."

Checkpoint inhibition • IO biomarker • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

Impact of HLA matching on clinical outcomes in a phase 2 trial of Bria-IMT plus anti PD1 in advanced breast cancer. (ASCO 2025) - P1/2, P3 | "Matching at Class I seemed to decrease PFS & OS, but did not have a similar effect on ORR and CBR. Both matched and non matched pts demonstrated favorable OS and response rates. These findings support further investigation into specific mechanisms and the clinical significance of HLA matching in immunotherapy response."

Clinical • Clinical data • IO biomarker • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • CSF2