BriaCell(BCTX) - 2023 Q3 - Quarterly Report

Clinical Trials and Efficacy - BriaCell's Bria-IMT™ regimen in combination with Incyte's retifanlimab showed that 70% of patients experienced disease control or progression-free survival benefits compared to their last therapy[81]. - In a cohort of 12 advanced breast cancer patients, 9 of 11 (82%) patients remained alive, indicating strong survival benefits from the Bria-IMT™ regimen[94]. - The combination of Bria-IMT™ and retifanlimab produced evidence of disease control and tumor shrinkage in heavily pre-treated advanced breast cancer patients[81]. - The Phase II clinical trial of Bria-IMT™ in combination with retifanlimab is ongoing, with positive initial efficacy data reported[81]. - BriaCell's End of Phase II meeting with the FDA confirmed agreement on the primary endpoint and study design for the upcoming pivotal clinical study in advanced metastatic breast cancer[92]. - The median progression-free survival (PFS) for patients in the study was 3.5 months, with one subject ongoing, indicating favorable outcomes compared to other recent studies[95]. - 15 of 18 patients recruited since the study reopened in 2021 remained alive, demonstrating the tolerability and clinical effectiveness of BriaCell's combination treatment[97]. Financial Performance - The company reported a net loss of $4,895,436 for the three months ended April 30, 2023, compared to a loss of $10,015,573 for the same period in 2022, indicating a significant reduction in losses[108]. - For the nine months ended April 30, 2023, total operating expenses were $15,566,503, up from $10,054,878 in the same period in 2022[109]. - Research costs for the nine months ended April 30, 2023, amounted to $10,169,140, compared to $4,852,620 for the same period in 2022, marking a substantial increase[111]. - The company experienced a gain of $539,427 in the change in fair value of warrant liability for the three months ended April 30, 2023, compared to a loss of $5,928,528 in the same period in 2022[107]. - General and administrative expenses decreased to $1,816,461 for the three months ended April 30, 2023, from $1,854,455 in the same period in 2022, primarily due to reduced non-cash share-based compensation[106]. - For the nine-month period ended April 30, 2023, general and administrative expenses increased to $5,397,363 from $5,202,258 in the same period of 2022, primarily due to higher insurance premiums, professional fees, and salaries[116]. - The net financial expenses for the nine-month period ended April 30, 2023, were $2,317,236, a significant decrease from $16,333,673 in the prior year, largely due to a loss of $2,972,285 from the warrant liability compared to a loss of $16,384,676 in the previous period[117]. - The company recorded a loss of $17,883,739 for the period ended April 30, 2023, an improvement from a loss of $26,388,551 in the same period of 2022[118]. Research and Development - Research and development expenses for the three months ended April 30, 2023, totaled $3,860,568, a 70.2% increase from $2,268,805 in the same period in 2022[99]. - Clinical trial expenses increased from $1,364,090 in 2022 to $2,469,105 in 2023, reflecting the expansion of the Bria-IMT™ trial[105]. - The company is developing next-generation off-the-shelf personalized immunotherapies, Bria-OTS+™ and Bria-PROS™, which activate naïve T cells for enhanced immune responses[85]. Regulatory and Licensing - The FDA provided guidance for the Bria-OTS™ clinical-grade cell lines, with an expected initiation of the study under an Investigational New Drug Application (IND) in the second half of 2023[90]. - BriaCell has secured an exclusive license to develop and commercialize Soluble CD80 (sCD80) for cancer treatment, with royalties payable upon commercialization[75]. - The company received an Issue Notification for a patent covering its personalized off-the-shelf cell-based immunotherapy, extending protection until May 25, 2040[86]. Company Operations and Management - BriaCell's partnership with Caris Life Sciences aims to accelerate patient enrollment in clinical trials through efficient patient identification[78]. - The company plans to accelerate the path to commercialization for its lead clinical candidate Bria-IMT™ following positive FDA feedback on its pivotal study[97]. - The company plans to finance its operations through existing and future working capital resources and is evaluating additional sources of capital[119]. - As of April 30, 2023, the company had total assets of $29,721,868, down from $42,577,041 as of July 31, 2022, with a positive working capital balance of $28,119,886[120]. - The accumulated deficit as of April 30, 2023, was $78,233,576, compared to $60,349,837 as of July 31, 2022[121]. - The net cash used in operating activities during the nine-month period ended April 30, 2023, was $12,825,853, an increase from $9,158,647 in the same period of 2022[122]. - Cash used in financing activities for the nine-month period ended April 30, 2023, was $45,700, significantly lower than $3,582,874 in the prior year[123]. - As of April 30, 2023, the company has no significant concentration of credit risk arising from operations, and liquidity risk is managed to ensure sufficient liquidity to meet liabilities[126]. - As of April 30, 2023, the company's disclosure controls and procedures were deemed ineffective due to material weaknesses in internal control over financial reporting[130]. - The company is implementing plans to improve material weaknesses, including hiring additional personnel and segregating duties among the team[130]. - There have been no material changes in internal control over financial reporting during the quarter ended April 30, 2023, except for ongoing remediation efforts[131]. Foreign Exchange and Risk Management - The company is exposed to foreign exchange risk due to transactions in Canadian Dollars, but a 5% fluctuation in the exchange rate would not have a material effect on total loss[128].