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

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

Outcomes of advanced/metastatic breast cancer (aMBC) treated with BRIA-IMT, an allogeneic whole cell immunotherapy. (ASCO 2024) - P1/2, P3 | " Analysis of the phase 1 with expansion phase 2 cohort randomized by sequence using SV-BR-1-GM, checkpoint inhibitor (pembrolizumab or retifanlimab), low dose cyclophosphamide (Day –2) and post-dose local pegylated interferon α, with cycles every 3 weeks. BRIA-IMT has shown a favorable safety profile while providing benefits to heavily treated aMBC patients. Superior outcomes and survival were seen in patients treated with the phase III formulation and regimen now being used in the ongoing Ph3 trial, confirming the improvement in efficacy of the novel regimen. The results from this randomized phase 2 study informed the study design of the ongoing Ph3 trial comparing BRIA-IMT to standard of care physician choice treatments (NCT06072612)."

IO biomarker • Metastases • Breast Cancer • Cardiovascular • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • PGR

Overall Survival Results of Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine. (SABCS 2024) - P1/2, P3 | "Methods This phase I/II study evaluated the Bria-IMT regimen consisting of low-dose cyclophosphamide (Day –2) followed by SV-BR-1-GM and CPI (pembrolizumab or retifanlimab), then low-dose local peg- interferon α, all given every 3 wks. In heavily pretreated MBC patients, the Bria-IMT regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles. There was no significant difference in OS among patients treated with immediate vs. delayed CPI."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

Data Safety Monitoring Board (DSMB) Recommends Continuing BriaCell’s Phase 3 Metastatic Breast Cancer Study (GlobeNewswire) - "Independent DSMB reports no safety concerns to date and recommends continuing BriaCell's pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor; Seventh consecutive positive DSMB recommendation reinforces the favorable safety and tolerability of BriaCell's novel immunotherapy approach; Phase 3 study is being conducted under FDA Fast Track designation, underscoring the substantial unmet need in metastatic breast cancer."

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

BriaCell Therapeutics Corp…announced that Memorial Sloan Kettering Cancer Center (MSK) has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (GlobeNewswire) - "BriaCell’s Phase 3 study now has more than 80 active clinical sites across 15 states, including Penn Medicine’s Abramson Cancer Center, 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

Allogeneic, antigen-presenting, GM-CSF-secreting, SV-BR-1-GM whole cell therapeutic vaccine in advanced metastatic breast cancer (SABCS 2022) - P1/2 | " SV includes cyclophosphamide 300 mg/m2 i.v. 48-72 hours prior to SV-BR-1-GM (20 x 106 cells) intradermally followed by interferon-alpha-2b at the SV-BR-1-GM inoculation sites on days 2 and 4. SV-BR-1-GM demonstrated promising activity in patients with MBC. Treatment was well tolerated with no concerning AEs. The PFS ratio compares favorably with prior penultimate standards of care, more notably in patients with matched HLA."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2

BriaCell Therapeutics…announced that the Odette Cancer Centre at Sunnybrook Health Sciences Centre…has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (GlobeNewswire) - "BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor (CPI), compared with physician’s treatment of physician’s choice in patients with advanced metastatic breast cancer (the Bria-ABC study)."

Trial status • Breast Cancer

Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Medical College of Wisconsin | N=20 ➔ 0 | Initiation date: Mar 2026 ➔ Jun 2026 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial initiation date • Trial withdrawal • Oncology • Solid Tumor

Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months. (ASCO 2026) - P3 | " Phase I/II evaluating the Bria-IMT regimen (SV-BR-1-GM with CPI (pembrolizumab or retifanlimab). In heavily pretreated MBC, Bria-IMT demonstrated a tolerable safety profile and the emergence of a long-term survivor cohort. Durable survival was observed beyond 12 and 24 months. Differential survival favoring Ph3 formulation, DTH positivity, lower baseline CTC burden, and early CPI sequencing was observed."

IO biomarker • Metastases • Breast Cancer • Immunology • Oncology • Solid Tumor • CSF2 • CTCs • IFNG

Cell-based second-generation immunotherapy BC1 in metastatic breast cancer. (ASCO 2026) - P1/2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT06471673 Background: BC1 (BC-OTS-001; BriaCell Inc) is an allogeneic cancer cell line derived from invasive ductal carcinoma, engineered to secrete GM-CSF; part of the personalized off-the-shelf platform technology currently under development, which builds on the clinical and scientific observations from Bria-IMT (Bria-ABC trial)...Phase 1 Part 2: one patient received BC1 @20M + tislelizumab with cyclophosphamide 300 mg/m² day −2/−3 and peginterferon 18 μg day 0 q3wk... Dose escalation from 20M to 60M and combination with CPI showed tolerable intradermal BC1 and potential clinical benefit in refractory MBC. One patient received 17 cycles with 12 mo of disease control. Expansion cohorts will assess HLA match, DTH, dose optimization, and combination activity."

Metastases • Breast Cancer • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • HER-2

Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer. (ASCO 2026) - P3 | "The phase 3 Bria-ABC trial (NCT06072612) evaluates Bria-IMT + retifanlimab vs physician's choice in MBC w/ no meaningful therapeutic options. Heavily pretreated MBC pts in Bria-ABC demonstrated stable global health and key functional domains. Findings support sustained QoL in advanced disease. TWiST demonstrates meaningful benefit w/o significant toxicity."

HEOR • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • HER-2

Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC phase 3 trial for advanced metastatic breast cancer: An ongoing analysis. (ASCO 2026) - P3 | "The Bria-IMT consists of cyclophosphamide, irradiated SV-BR-1-GM cells, micro-dose pegylated α IFN at each inoculation site. In an ongoing analysis of a heavily treated mBC pts, we observed that in the entire blinded population, 65% of pts had stability/drop in CAMLs significantly correlated with better PFS. Treatment arm specific comparisons will not be unblinded until completion of the designated milestone (144 mortalities)."

Biomarker • Clinical • IO biomarker • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • PD-L1

BriaCell Receives Positive Recommendation from Data Safety Monitoring Board for Phase 3 Study in Metastatic Breast Cancer (Investing News Network (INN)) - "Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol."

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

Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer (GlobeNewswire) - "BriaCell Presentations highlight positive clinical data for Bria-IMT at ASCO 2026....Heavily pretreated MBC patients in the pivotal Bria-ABC demonstrated stable global health and key functional domains. Measurements included quality of life (QOL) and time without symptoms or toxicity (TWiST). Blinded data indicated that QOL was largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure. Clinical data demonstrates meaningful benefits without significant toxicity. Ongoing follow up will further characterize durability of patient-reported outcomes and clinical correlation. Data further supports decentralized care and potential home self-administration of the Bria-IMT+CPI regimen."

P3 data • Patient reported outcomes • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC Phase 3 trial for advanced metastatic breast cancer: An ongoing analysis (GlobeNewswire) - "BriaCell Presentations Highlight Positive Clinical Data for Bria-IMT at ASCO 2026....In an ongoing analysis of heavily treated MBC patients, we observed that in the entire blinded population, 65% of patients had stability/drop in Cancer-Associated Macrophage-Like cells (CAMLs) and this significantly correlated with better progression free survival (PFS). Treatment arm specific comparisons will not be unblinded until completion of the designated milestone (144 mortalities)."

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

Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months (GlobeNewswire) - "BriaCell presentations highlight positive clinical data for Bria-IMT at ASCO 2026....32 Phase 2 Bria-IMT patients were randomized to receive immune checkpoint inhibitor (CPI) in the first cycle or delayed to the second cycle....Median overall survival (OS) was 13.3 vs. 7.4 months for starting CPI in cycle 1 versus cycle 2. In patients who developed an immune response as measured by delayed-type hypersensitivity (DTH) positive vs. negative, OS was 11.9 vs. 4.7 months, with 48% 12-months survival vs 0.0% 12-month survival. Patients with circulating tumor cells (CTCs) 5 at baseline had median OS of 16.6 vs. 5.5 months. Median OS was 16.6 months for the formulation selected for the Phase 3 study with 52% of patients surviving at 12-months."

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

BriaCell Adds NYU Langone Health’s Perlmutter Cancer Center as Clinical Site in Pivotal Phase 3 Breast Cancer Study (BriaCell Press Release) - "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."

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

BriaCell Therapeutics…announces that its pivotal Phase 3 Bria-ABC study has screened over 315 and enrolled over 230 patients (GlobeNewswire) - "BriaCell anticipates reporting topline data 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."

P3 data: top line • Trial status • Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer

Efficacy of Bria-IMT regimen in inducing CNS metastasis regression (AACR 2024) - "Bria-IMT (SV-BR-1-GM ~20x106 cells, intradermally 48-72 hours after cyclophosphamide 300 mg/m2, followed by interferon-alpha at the inoculation sites 2 days later) was administered q3wks...After 2 additional cycles of SV-BR-1-GM + ICI (retifanlimab) and 1 cycle of SV-BR-1-GM (ICI was skipped on final cycle due to grade 2 AE), patient achieved CR of a left orbital mass observed at baseline (24mm ➔ 0m)...Pt 06-007 (ER-/PR-, HER2 1+ (IHC)) demonstrated significant reductions in CNS lesions after 3 cycles of SV-BR-1-GM + ICI (pembrolizumab): a 67% reduction in a right frontal lobe lesion, 29% in the right parietal, 30% in the right thalamus, and 67% in the right precentral gyrus lesions... This review consolidates evidence for the efficacy of the Bria-IMT regimen in CNS metastasis regression, both alone and with ICIs. The consistent regression seen across all breast cancer subtypes among heavily pretreated patients highlights the potential of SV-BR-1-GM in managing CNS..."

Clinical • Brain Cancer • Breast Cancer • CNS Tumor • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • PGR

Survival outcomes in a randomized phase 2 ofBria-IMT: An allogeneic whole cell cancer vaccine (AACR 2025) - P1/2, P3 | "11 pts received pembrolizumab, 44 retifanlimab, w/ 1 pt transitioning from pembrolizumab to retifanlimab. Randomized phase 2 Bria-IMT demonstrated efficacy and safety in heavily pretreated MBC. Post-progression survival exceeding median OS in pts still undergoing survival follow-up suggests long-term benefit extending beyond treatment period. C1 vs C2 CPI initiation showed no statistical or clinically significant difference in OS."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

QOL outcomes in Bria-ABC late stage metastatic phase 3 trial (AACR 2026) - P3 | "The ongoing multicenter phase 3 Bria-ABC trial (NCT06072612) evaluates Bria-IMT + Retifanlimab vs physician's choice in pts with metastatic breast cancer who have exhausted standard therapies. These observations and AE profile support decentralized clinical trial initiatives including home self-administration. Ongoing follow up will further characterize the durability of pt reported outcomes and their relationship w/ clinical status."

Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • HER-2

QOL Outcomes in Bria-ABC Late-Stage Metastatic Phase 3 Trial (BriaCell Press Release) - "QOL largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Survey showed: Global health status stable through early and mid-treatment; Emotional and cognitive functioning maintained; symptom burden stable; Safety profile and time-to-deterioration analyses support durable tolerability in a late-line setting."

P3 data • Breast Cancer

Bria-ABC vs physician choice in late stage MBC: Early biomarker correlates of the randomized registration trial (AACR 2025) - P3 | "The Bria-IMT™ regimen includes preconditioning w/ cyclophosphamide (300 mg/m²) on day -2/-3, intradermal SV-BR-1-GM inoculations (x4) on day 0, and interferon at inoculation sites (Days 1-3). CPI (retifanlimab 375 mg) may be given between days -2 to 2...Future analyses will assess OS, PFS, ORR, CBR, QoL, and CNS event-free survival as data becomes available. Expected to close to enrollment by 2025, with final analyses planned for 2026."

Biomarker • Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTCs • HER-2

Efficacy and safety of SV-BR-1-GM after progression on ADC in metastatic breast cancer patients (AACR 2024) - "Bria-IMT™ (irradiated SV-BR-1-GM ~20x106 cells, intradermally 48-72 hours after cyclophosphamide (300 mg/m2), followed by interferon-alpha at the inoculation sites 2 days later) was administered q3wks with a CPI...Prior ADCs included: 4 ado-trastuzumab emtansine, 14 trastuzumab deruxtecan, 13 sacituzumab govitecan; 8 pts received > 1 ADC... The retrospective analysis of the Bria-IMT™ regimen in ADC refractory MBC patients suggests a potential treatment option for this patient population. The absence of serious AEs, notably ILD, and no toxicity-related treatment discontinuations, underscores the regimen's favorable safety profile. Future studies are warranted to confirm these results and explore the potential of Bria-IMT™ in broader clinical settings."

ADC • Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • HER-2

Bria-OTS immunotherapy platform: Harnessing gene-modified tumor cells to reinvigorate the cancer immunity cycle for precision anti-tumor responses (AACR 2024) - "Our initial version, SV-BR-1-GM, a breast cancer cell line expressing GM-CSF, demonstrates promising clinical outcomes by directly activating CD4+ T-cells in an antigen-specific, HLA-restricted manner. The Bria-OTS cell lines will offer the following key features: 1) multimodal mechanisms of action including thwarting some mechanisms of cancer immune escape. 2) Precision Therapy; Bria-OTS will be precisely matched to individual patients based on their HLA alleles, encompassing over 99% of the U.S. population. 3) rapid, cost-effective treatment as our 'off-the-shelf' cell lines eliminate the need for personalized manufacturing."

IO biomarker • Tumor cell • Breast Cancer • Oncology • Solid Tumor • CD40 • CD80 • CD86 • CSF2 • IFNA1 • IL12A • IL7