BriaCell(BCTX) - 2026 Q2 - Quarterly Report

Clinical Efficacy and Research - BriaCell reported a median overall survival of 13.4 months for metastatic breast cancer patients treated with Bria-IMT™, compared to 6.7-9.8 months for similar patients in literature[91]. - The ongoing pivotal Phase 3 study of Bria-IMT™ has over 230 patients screened and more than 160 patients enrolled, with topline data expected in the first half of 2026[99]. - BriaCell's Phase 2 study showed that 9 out of 25 patients treated since 2022 survived over 18-47 months, significantly exceeding benchmarks for standard therapies[104]. - The Phase 2 study of Bria-IMT™ demonstrated a median overall survival of 15.6 months, with 52% of patients surviving one year and 32% surviving two years[107]. - BriaCell's Bria-OTS™ platform is being developed for personalized off-the-shelf immunotherapies across multiple cancer types, with positive feedback from the FDA[93]. - The company highlighted positive Phase 2 data at the San Antonio Breast Cancer Symposium, emphasizing the clinical benefit and safety of the Bria-IMT regimen[103]. - BriaCell reported a sustained complete resolution of lung metastasis in a patient after 11 months of treatment with Bria-OTS, confirming the efficacy of the therapy[125]. - BriaCell's collaboration with Memorial Sloan Kettering Cancer Center aims to accelerate clinical development of Bria-OTS+ across various cancer indications[97]. - No toxicity-related discontinuations were reported in the ongoing Phase 3 study, indicating a favorable safety profile for the Bria-IMT regimen[103]. Financial Performance - For the three months ended January 31, 2026, total operating expenses were $7,531,266, compared to $7,169,443 for the same period in 2025, reflecting an increase of approximately 5.1%[138]. - Research and development expenses for the three-month period ended January 31, 2026, were $6,053,689, up from $5,684,777 in 2025, representing an increase of about 6.5%[138]. - Clinical trial expenses for the three months ended January 31, 2026, were $5,008,171, compared to $3,923,559 during the same period in 2025, indicating a year-over-year increase of approximately 27.7%[142]. - The Bria-IMT™ Pivotal Phase 3 Study costs were $3,874,242 for the three months ended January 31, 2026, compared to $3,642,650 in 2025, reflecting an increase of about 6.4%[143]. - The Bria-OTS™ Phase 1/2a expenses were $936,726 for the three months ended January 31, 2026, compared to $65,608 in 2025, showing a significant increase of approximately 1,326%[145]. - The net loss for the period attributable to BriaCell was $7,221,820 for the three months ended January 31, 2026, compared to $6,291,420 in 2025, representing an increase of about 14.8%[139]. - The Company reported a net loss of $7,296,893 for the three-month period ended January 31, 2026, compared to a loss of $6,337,828 for the same period in 2025, driven by increased operating expenses[148]. - For the six-month period ended January 31, 2026, total operating expenses were $15,854,209, up from $12,322,275 in 2025, with research and development expenses rising to $12,737,332 from $9,350,118[149]. - Clinical trial expenses for the six months ended January 31, 2026, were $9,952,363, compared to $6,631,649 in 2025, reflecting significant investment in clinical programs[152]. Capital and Funding - BriaCell received a US$2.0 million Small Business Innovation Research grant from the U.S. National Cancer Institute to support the Bria-PROS+™ program in prostate cancer[98]. - The Company intends to raise additional capital through debt or equity financings to support its business plan objectives[163]. - Cash gained in financing activities for the period ended January 31, 2026, was $27,874,441, compared to $17,176,863 for the same period in 2025[165]. Assets and Liabilities - As of January 31, 2026, the Company had total assets of $33,594,454, up from $21,649,706 as of July 31, 2025, and a positive working capital of $28,993,334[161]. - The accumulated deficit as of January 31, 2026, was $127,174,949, an increase from $111,755,564 as of July 31, 2025[161]. - The Company’s net cash used in operating activities during the period ended January 31, 2026, was $15,672,094, compared to $12,875,298 for the same period in 2025[164]. Shareholder Information - The weighted average number of shares used in computing net basic and diluted earnings per share of common stock was 2,802,337 for the three months ended January 31, 2026, compared to 269,957 in 2025, indicating a substantial increase in share count[139]. - BriaPro has agreed to purchase BriaCell's exclusive license to develop and commercialize Soluble CD80, with BriaCell receiving approximately C$1.18M in common shares as part of the transaction[129][133]. General and Administrative Expenses - General and administrative expenses for the six-month period ended January 31, 2026, amounted to $3,116,877, compared to $2,972,157 in 2025, primarily due to higher wages and regulatory fees[156]. Valuation and Financial Instruments - Cash and cash equivalents are valued using quoted market prices in active markets[179]. - The fair value of the warrant liability is determined based on the nature of the warrant[179]. - For publicly traded warrants, the quoted market price is used[179]. - For all other warrants, the Black-Scholes pricing model is applied[179].