BriaCell(BCTX) - 2025 Q4 - Annual Report

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].