Briacell Therapeutics Corp Stock Price, News & Analysis

BriaCell Therapeutics (NASDAQ: BCTX) has expanded its pivotal Phase 3 clinical trial for advanced metastatic breast cancer treatment by adding two major cancer centers: Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven, contributing 30 additional satellite locations. The study now encompasses 58 active clinical sites across 15 states.

The trial evaluates BriaCell's lead candidate Bria-IMT™ plus immune checkpoint inhibitor versus physician's choice. Patient enrollment is expected to complete by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint will analyze overall survival after 144 patient events, with positive results potentially leading to full approval and marketing authorization.

BriaCell Therapeutics (NASDAQ: BCTX) has received a positive safety review recommendation from the independent Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. This marks the third consecutive positive recommendation from the DSMB, which found no safety concerns and recommended the study continue without modifications.

The study is being conducted under FDA Fast Track Designation, highlighting the significant unmet medical need in metastatic breast cancer patients. The DSMB reviews occur quarterly as per study protocol, and this latest recommendation further validates the favorable safety profile of BriaCell's immunotherapy treatment.

BriaCell Therapeutics Corp. (Nasdaq: BCTX), a clinical-stage biotechnology company focused on innovative cancer immunotherapies, has announced two upcoming virtual investor presentations. The events are scheduled for Thursday, June 12, and Thursday, June 26, 2025, both at 12:00 PM EDT. The presentations, organized by Renmark Financial Communications Inc., will be accessible to stakeholders, investors, and other interested parties through online registration. While live event participation may be limited, replays will be available on the Company's Investor website. Participants are advised to use the latest version of Google Chrome for optimal connectivity.

BriaCell Therapeutics (NASDAQ: BCTX) presented robust clinical data at ASCO 2025, showcasing impressive results from their Bria-IMT and Bria-OTS studies in metastatic breast cancer. The Phase 2 study demonstrated a median Overall Survival of 17.3 months for patients treated with the Phase 3 formulation since 2022, surpassing comparable literature outcomes. The treatment showed clinical benefit across all breast cancer subtypes with a 55% overall clinical benefit rate, including 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer patients. Notably, the Phase 3 formulation patients experienced significantly improved survival (13.9 vs 6.93 months) compared to alternate formulation. The therapy demonstrated strong safety with no treatment-related discontinuations, and efficacy data matched or exceeded FDA-approved therapies in similar patient populations. The company continues its pivotal Phase 3 study and has initiated combination therapy in its Bria-OTS program.

BriaCell Therapeutics (NASDAQ: BCTX) has announced significant progress in its Phase 1/2 study of Bria-OTS, a personalized immunotherapy for metastatic breast cancer. The therapy has successfully cleared its safety evaluation in the monotherapy setting and has now begun dosing patients in combination with checkpoint inhibitors. Notably, the first monotherapy patient showed complete resolution of lung metastasis and remains in the study.

The study will evaluate Bria-OTS with checkpoint inhibitors in up to 12 patients with metastatic breast cancer, focusing on safety and objective response rate as primary endpoints. This follows a successful three-patient monotherapy safety run-in. BriaCell also plans to evaluate Bria-OTS+, an optimized version, for multiple cancer types including breast and prostate cancers.

BriaCell Therapeutics (NASDAQ: BCTX) has announced positive Phase 2 survival and clinical benefit data for its Bria-IMT™ immunotherapy treatment for metastatic breast cancer. The study's Phase 3 formulation (n=37) demonstrated significant improvements in median overall survival (13.4 vs 6.9 months, P=0.01) and progression-free survival (3.6 vs 2.6 months, P=0.01) compared to alternate formulation. The treatment achieved a Clinical Benefit Rate of 61% and an Objective Response Rate of 14%, meeting or exceeding outcomes of FDA-approved therapies despite treating more heavily pre-treated patients. Notably, Bria-IMT showed strong safety with no treatment-related discontinuations. The company will present these results in three clinical poster presentations and one publish-only abstract at ASCO 2025, with 22% of patients still in active survival follow-up.

BriaCell Therapeutics (NASDAQ: BCTX) has provided significant updates on their cancer immunotherapy programs. Their lead candidate Bria-IMT™ is progressing well in a pivotal Phase 3 study for metastatic breast cancer, with over 75 patients enrolled across 54 clinical sites. The treatment has received Fast Track designation from the FDA. Phase 2 survival data has shown superior results compared to standard care treatments like TRODELVY® in hormone receptor positive (HR+) metastatic breast cancer patients, with 83% of evaluable patients showing clinical benefit. Additionally, their personalized Bria-OTS™ platform has demonstrated promising early results, including complete resolution of lung metastasis in their first treated breast cancer patient at 4-month follow-up. The company recently raised US$13.8 million through a public offering to support their clinical programs and operations.

BriaCell Therapeutics has reported promising Phase 3 data for its Bria-IMT™ treatment in metastatic breast cancer at AACR 2025. The study identified key biomarkers that could predict patient response to treatment, including positive delayed-type hypersensitivity (DTH) and favorable Neutrophil-to-Lymphocyte Ratio (NLR).

Early clinical data (n=62) showed median progression-free survival of 3.67 months across all arms. Notably, positive DTH correlated with better PFS (4.5 vs 2.5 months), while favorable NLR and lower Circulating Tumor Cells showed significant survival benefits. The Bria-IMT regimen demonstrated excellent tolerability with no treatment discontinuations.

The ongoing multicenter randomized study involves 57 US clinical sites, evaluating overall survival with Bria-IMT plus checkpoint inhibitor versus standard treatment. The trial, which received FDA Fast Track designation, will analyze interim data after 144 patient events, potentially leading to full approval for metastatic breast cancer treatment.

BriaCell Therapeutics, a clinical-stage biotech company focused on cancer immunotherapy, has successfully closed its public offering raising $13.8 million in gross proceeds. The offering consisted of 3,066,666 units, including 399,999 units from the full exercise of the underwriter's option.

Each unit, priced at $4.50, includes one common share (or pre-funded warrant) and one warrant. The warrants, trading under symbol BCTXZ on Nasdaq, allow holders to purchase one common share at $5.25 and expire in five years.

• ThinkEquity served as the sole book-running manager
• Offering was registered with SEC (Form S-1 File No. 333-286670)
• Funds will support working capital, corporate purposes, and business objectives

The transaction utilized the TSX Company Manual Section 602.1 exemption for eligible Nasdaq-interlisted issuers. The offering was conducted through a prospectus available via ThinkEquity and the SEC website.