BriaCell(US:BCTX)2025-12-11 21:05Clinical Trials 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[72]. - Research and development expenses rose to $6,683,643 for the three months ended October 31, 2025, up from $3,665,341 in 2024, primarily due to increased clinical trial costs[86]. - Clinical trial expenses for the pivotal Phase 3 study of Bria-IMT™ were $3,792,951 for the three months ended October 31, 2025, compared to $2,446,461 in 2024[87]. - The company is advancing its pivotal Phase 3 clinical study of Bria-IMT™ with 79 clinical sites across 23 U.S. states enrolling patients, with top-line data expected in the first half of 2026[79]. - The independent Data Safety Monitoring Board recommended the continuation of the Phase 3 trial without modification, indicating no safety concerns[79]. - BriaCell's Bria-OTS™ personalized immunotherapy platform is under development, with positive feedback received from the FDA for Bria-PROS+™ for prostate cancer[73]. - Bria-OTS™ Phase 1/2a expenses rose significantly to $988,038 compared to $77,588 in 2024, driven by expanded preclinical development and increased patient enrollment[90]. - BriaCell's collaboration with Receptor.AI aims to expand its small-molecule oncology pipeline using AI to design selective anti-cancer kinase inhibitors[82]. Financial Performance - Total operating expenses for the three months ended October 31, 2025, were $8,322,943, an increase from $5,152,832 in the same period of 2024[84]. - General and administrative expenses for the same period were $1,639,300, up from $1,487,491 in 2024, primarily due to higher shareholder communication costs and increased wages[92]. - The company reported a net loss of $8,278,328 for the three-month period ended October 31, 2025, compared to a loss of $5,829,276 in 2024, attributed to increased R&D spending[94]. - Financial income for the period was $158,646, significantly higher than $11,714 in 2024, due to increased interest income and unrealized gains on short-term investments[93]. - As of October 31, 2025, the company had total assets of $13,075,050, down from $21,649,706 on July 31, 2025, with a positive working capital balance of $8,030,634[96]. - The company experienced a decrease in cash and cash equivalents by $7,779,796 from July 31, 2025, with net cash used in operating activities amounting to $7,704,796[99]. - The company intends to raise additional capital through debt or equity financing to support its business plan objectives, although there are risks associated with this[98]. Grants and Funding - BriaCell received a $2.0 million SBIR grant from the U.S. National Cancer Institute to support the Bria-PROS+™ program in prostate cancer[78]. Shareholder and Compliance - The company announced a share consolidation of one post-consolidation common share for every ten pre-consolidation shares to comply with Nasdaq listing requirements[76]. - The company has no off-balance sheet arrangements or new accounting policies adopted during the period[101][104]. Risk Factors - The company is exposed to foreign exchange risk, particularly with transactions in Canadian Dollars, but a 5% fluctuation would not materially affect the total loss[112].