Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a pooled interim analysis of 116 patients [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarkers and Predictive Indicators - Biomarkers such as the Neutrophil-to-Lymphocyte Ratio (NLR) have shown potential as predictors of clinical benefit, with favorable NLR values correlating with longer progression-free survival (PFS) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients compared to DTH- patients [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced immune activation [14][16]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][8]. - Ongoing analysis of the Phase 3 study aims to mature the understanding of overall survival data and the role of biomarkers in predicting patient response [11][12].

Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a focus on safety, biomarker correlations, and progression-free survival (PFS) [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarker Insights - Neutrophil-to-Lymphocyte Ratio (NLR) emerged as a potential predictive biomarker, with patients showing favorable NLR (0.7 – 2.3) experiencing longer PFS (4.4 months) compared to those with NLR <0.7 or >2.3 (2.6 months) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients (11.3 months) compared to DTH- patients (4.7 months) [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced T-cell activation and pro-inflammatory signaling [16][14]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][11]. - Ongoing analysis will continue as enrollment progresses and overall survival data matures, reinforcing the potential clinical benefits of the Bria-IMT regimen [8][11].

Core Insights - BriaCell Therapeutics Corp. is advancing its Phase 3 clinical study for Bria-IMT, having screened over 230 patients and enrolled over 160, with topline data expected in the first half of 2026 [1][9] Group 1: Clinical Study Progress - The Phase 3 study is evaluating Bria-IMT in combination with an immune checkpoint inhibitor against physician's choice therapy in patients with metastatic breast cancer [2][4] - An interim analysis will be conducted once 144 patient events (deaths) occur, focusing on overall survival as the primary endpoint [5][9] - The enrollment pace has exceeded expectations, indicating strong engagement from clinical sites and interest from patients [3][9] Group 2: Regulatory Status - The Bria-IMT combination regimen has received FDA Fast Track designation, which may facilitate its approval process [5][9] - Positive results from the study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [2][5] Group 3: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [7]

Core Insights - BriaCell Therapeutics Corp. is advancing its Phase 3 clinical study for Bria-IMT in metastatic breast cancer, having screened over 230 patients and enrolled over 160, with topline data expected in the first half of 2026 [1][9]. Group 1: Clinical Study Details - The pivotal Phase 3 study evaluates Bria-IMT combined with an immune checkpoint inhibitor against physician's choice therapy in advanced metastatic breast cancer [2][4]. - An interim analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint [5][9]. - The study has received FDA Fast Track designation, which may expedite the approval process for Bria-IMT if positive results are obtained [5][9]. Group 2: Company Statements and Expectations - Dr. William V. Williams, President & CEO, highlighted the strong engagement from clinical sites and patient interest, indicating that enrollment has exceeded expectations [3][9]. - The company is committed to sharing Phase 3 data with the U.S. FDA in the coming months, aiming to provide hope to patients with metastatic breast cancer [3][9].

Core Insights - BriaCell Therapeutics Corp. is set to present positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025, highlighting the potential of their novel immunotherapies in cancer treatment [1][7] Group 1: Presentation Details - The company will present three posters, including a pivotal Phase 3 trial analysis involving 116 patients, which shows an excellent safety profile and improved progression-free survival (PFS) in specific breast cancer subtypes [3][7] - A Phase II study on the Bria-IMT regimen combined with an anti-PD-1 checkpoint inhibitor demonstrated continued overall survival benefits in 54 metastatic breast cancer patients [4] - Analysis of blood cytokines from 30 patients suggests that Th1 biased cytokines may serve as predictive biomarkers for clinical responses to the Bria-IMT regimen [5] Group 2: Company Statements - The President & CEO of BriaCell expressed optimism about the survival and biomarker data, emphasizing the commitment to improving outcomes for cancer patients with unmet medical needs [2] - The Chief Medical Officer highlighted the significance of biomarker and patient subgroup data in identifying patients likely to benefit from their treatment [2]

Core Insights - BriaCell Therapeutics Corp. will present positive biomarker and survival data at the 2025 San Antonio Breast Cancer Symposium, highlighting advancements in cancer immunotherapy [1][6] - The company emphasizes its commitment to improving survival and clinical outcomes for cancer patients with unmet medical needs through its innovative therapies [2] Clinical Data and Presentations - The company will showcase three poster presentations at the symposium, focusing on positive Phase 2 safety and efficacy signals, as well as biomarker findings from both Phase 2 and pivotal Phase 3 studies [6] - The pivotal Phase 3 study of Bria-IMT+CPI is ongoing, with an interim analysis expected in the first half of 2026 [6] - The Bria-IMT regimen has received Fast Track Designation from the US FDA, indicating its potential significance in cancer treatment [6] Leadership Statements - William V. Williams, MD, President & CEO, expressed confidence in the pivotal Phase 3 study in metastatic breast cancer, supported by positive clinical data and biomarker findings [2] - Miguel A. Lopez-Lago, PhD, Chief Scientific Officer, highlighted the importance of biomarker data in understanding the mechanism of action of their novel immunotherapy [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4]

Core Insights - BriaCell Therapeutics Corp. will present three clinical and one preclinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025, showcasing updated key biomarker data and survival data from its studies [1][2] Group 1: Poster Presentations - The presentations include two late-breaking clinical posters that are expected to have a significant impact on the field of breast cancer treatment [2] - The details of the poster presentations are as follows: - Late-Breaking Abstract Number: 3688, titled "Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial," scheduled for December 10, 2025, from 12:30 PM to 2:00 PM [3] - Late-Breaking Abstract Number: 3713, titled "Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine," also scheduled for December 10, 2025, from 12:30 PM to 2:00 PM [3] - Abstract Number: 1614, titled "Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer," scheduled for December 10, 2025, from 5:00 PM to 6:30 PM [3] Group 2: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4]

Core Insights - November is historically a strong month for stocks, prompting a focus on companies with steady earnings growth and earnings acceleration, which significantly impacts stock prices [1][9] Earnings Acceleration - Earnings acceleration refers to the incremental growth in a company's earnings per share (EPS), indicating an increase in quarter-over-quarter earnings growth rates [3] - Companies with earnings acceleration are often undervalued, leading to potential stock price rallies as investors take notice [4] Screening Parameters - The screening criteria for identifying stocks with earnings acceleration include: - Last two quarter-over-quarter EPS growth rates must exceed previous periods' growth rates [6] - Projected EPS growth rates for the upcoming quarter should exceed those of prior periods [6][7] - Additional criteria include a current price of at least $5 and an average 20-day volume of at least 50,000 [8] Identified Stocks - The screening process narrowed down to four stocks, with the top three being: - **Groupon, Inc. (GRPN)**: Expected earnings growth rate of 153% for the current year, operating a marketplace linking consumers to merchants [10] - **BriaCell Therapeutics Corp. (BCTX)**: Expected earnings growth rate of 81.6% for the current year, focused on developing immunotherapies for cancer [11] - **InnovAge Holding Corp. (INNV)**: Expected earnings growth rate of 209.1% for the current year, providing services to help seniors live independently [12]

Core Insights - BriaCell Therapeutics Corp. is expanding its pivotal Phase 3 clinical study by adding major cancer centers, which is expected to enhance patient enrollment and support the development of its immunotherapy, Bria-IMT [1][4][10] - The study is focused on advanced metastatic breast cancer, comparing Bria-IMT combined with an immune checkpoint inhibitor against physician's choice of treatment [3][5] - The company anticipates reporting top-line data as early as the first half of 2026, with interim data analysis planned after 144 patient events [1][6] Company Overview - BriaCell is a clinical-stage biotechnology company dedicated to developing novel immunotherapies aimed at transforming cancer care [8] - The company has received FDA Fast Track designation for the Bria-IMT combination regimen, which could lead to full approval and marketing authorization if positive results are achieved [6] Clinical Study Details - The pivotal Phase 3 study is currently enrolling patients at 79 clinical sites across 23 US states, with the addition of Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University [10] - The primary endpoint of the study is overall survival (OS) in patients treated with the Bria-IMT regimen compared to those receiving physician's choice treatment [6]

Clinical Efficacy and Survival Rates - BriaCell's Bria-IMT™ showed a median overall survival of 13.4 months in metastatic breast cancer patients, compared to 6.7-9.8 months reported in literature[13]. - The company reported a median overall survival of 16.5 months for patients treated with the Phase 3 formulation of Bria-IMT™ since 2022[13]. - The survival rate for patients with metastatic breast cancer at diagnosis is only 30% over five years[19]. - Current therapeutic options for metastatic breast cancer show response rates of only 3-5% and overall survival of approximately 7 to 14 months[26]. - In a Phase 2 study, 25 of 37 patients with HR+ metastatic breast cancer treated with Bria-IMT™ plus CPI had a median OS of 17.3 months, exceeding the current ADC standard of care TRODELVY at 14.4 months[69]. - The overall response rate for patients treated with Bria-IMT™ in the Phase 2 study was 9.5%, with a clinical benefit rate of 55%[72]. - The intracranial overall response rate (iORR) for patients with measurable intracranial metastatic disease treated with Bria-IMT™ is 71%, significantly higher than the typical iORR of <20% in comparable patients[80][83]. - For patients with MBC who have received 2 or more prior lines of therapy, median survival is between 5.9 to 9.8 months[19]. Market Opportunity and Growth - The global market for cancer drugs, including immunotherapy, is projected to reach nearly $441 billion by the end of 2029[16]. - Approximately 319,750 people are expected to be diagnosed with breast cancer in the U.S. in 2025, with over 42,170 projected deaths[15]. - In 2015, over 150,000 women in the US were living with metastatic breast cancer (MBC), projected to increase to over 240,000 by 2030[19]. - There is a significant market demand for new therapeutic drugs, as MBC treated with second or higher lines of therapy has a very poor prognosis[27]. Product Development and Clinical Trials - BriaCell is developing Bria-OTS™ and Bria-OTS+™ as personalized off-the-shelf immunotherapies for various cancers[14]. - The Phase 1/2 study of Bria-OTS™ in metastatic breast cancer is ongoing, with the first patient showing complete resolution of a lung metastasis[14]. - Bria-IMT™ is undergoing pivotal Phase 3 clinical testing for advanced metastatic breast cancer, with safety and efficacy data expected in 2025[45]. - The ongoing Phase 3 clinical trial (Bria-ABC) is expected to enroll 177 patients in both the Bria-IMT™ combination therapy arm and the treatment of physician's choice arm[86]. - The first interim analysis of the Phase 3 study will occur at 144 events, with a hazard ratio (HR) target of ≤ 0.6 for potential Biologics Licensing Application submission[88]. Regulatory and Approval Processes - The FDA has granted Fast Track Designation to Bria-IMT™, which could accelerate the review process for full approval following positive study results[85]. - The FDA's Fast Track designation allows for rolling review of product candidates intended to treat serious conditions, potentially expediting the approval process[149]. - Priority Review can reduce the FDA's action target date to six months if the product shows significant improvement over existing therapies[149]. - The Accelerated Approval program permits BLA approval based on surrogate endpoints that predict clinical benefit, with post-marketing studies required to verify benefits[150]. - Breakthrough Therapy designation may expedite development and review for therapies showing substantial improvement over existing treatments[151]. Financials and Investments - BriaCell incurred net research and development expenses of $21,150,628 for the year ended July 31, 2025, compared to $26,442,821 for the previous year, representing a decrease of approximately 20%[133]. - Prevail Partners invested $4 million in the company at a 20% premium to the trailing thirty trading day volume-weighted average price[95]. - The Company raised approximately $50.9 million in gross proceeds during the fiscal year ended July 31, 2025, enhancing its capital position for ongoing clinical trials[181]. Intellectual Property and Patents - BriaCell was awarded a US patent on January 24, 2023, covering its personalized off-the-shelf cell-based immunotherapy for cancer, with the patent term extending to May 25, 2040[127]. - The company has secured numerous U.S. and international patents for Bria-OTS™, enhancing its intellectual property portfolio[105][124]. - The company filed an international patent application under the PCT on March 2, 2023, to expand its intellectual property portfolio for innovative immunotherapeutic strategies[129]. - The company has filed for additional patents related to engineered mammalian dendritic cells in collaboration with the National Cancer Institute on March 29, 2024[130]. Competitive Landscape - Competitors in the cancer immunotherapy market include large companies with substantial financial resources, which may impact market share for BriaCell[33][35]. - The development of cancer vaccines for breast cancer indicates a competitive landscape, with potential implications for Bria-IMT™[28]. Corporate Structure and Operations - The Company completed a spinout transaction on August 31, 2023, resulting in BriaPro Therapeutics Corp. being a two-thirds owned subsidiary, with a valuation of $1.75 million for BriaPro assets[175][181]. - BriaCell's corporate offices in Canada are located in West Vancouver, while its research offices in the United States are in Philadelphia, PA[133]. - The company does not own any real property and considers its current office and laboratory space sufficient for its anticipated needs[134].