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BriaCell(BCTX) - 2025 Q2 - Quarterly Report
BCTXBriaCell(BCTX)2025-03-12 20:22

Clinical Trials and Research - BriaCell Therapeutics is advancing its Bria-IMT™ targeted immunotherapy in a pivotal Phase 3 study for metastatic breast cancer, currently under Fast Track Designation by the U.S. FDA[90]. - The Phase 2 study of Bria-IMT™ reported a median overall survival (OS) of 15.6 months, significantly higher than the 5.9-9.8 months reported for similar patients in the literature[93]. - The ongoing Phase 3 study has 35 clinical sites active and enrolling patients, with interim data analysis planned after 144 events (deaths) occur[99]. - In the Phase 2 study, patients treated with the Bria-IMT™ regimen had a one-year survival rate of 55%, exceeding the current standard of care[100]. - BriaCell received positive feedback from the FDA for its Pre-IND meeting regarding Bria-PROS+™ in prostate cancer, paving the way for a Phase 1/2 study[93]. - The FDA authorized an expanded access policy for Bria-IMT™ to provide treatment to metastatic breast cancer patients beyond the clinical trial scope[95]. - The Bria-OTS™ Phase 1/2a trial costs totaled 65,608forthethree−monthperiodendedJanuary31,2025,reflectingthetrial′sinitiationinAugust2024[120].−ThecompanyremainscommittedtoadvancingthepivotalPhase3studyofBria−IMT™inadvancedbreastcancer[131].FinancialPerformance−Forthethree−monthperiodendedJanuary31,2025,thenetlossattributabletoBriaCellwas65,608 for the three-month period ended January 31, 2025, reflecting the trial's initiation in August 2024[120]. - The company remains committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer[131]. Financial Performance - For the three-month period ended January 31, 2025, the net loss attributable to BriaCell was 6,291,420, a decrease from 11,294,603inthesameperiodof2024,reflectingareductioninresearch,development,andclinicaltrialexpenses[123].−Totalresearch,development,andclinicaltrialcostsforthethreemonthsendedJanuary31,2025,were11,294,603 in the same period of 2024, reflecting a reduction in research, development, and clinical trial expenses[123]. - Total research, development, and clinical trial costs for the three months ended January 31, 2025, were 5,684,777, down from 8,257,455in2024,primarilyduetolowerclinicaltrialcosts[117].−TheBria−IMT™PivotalPhase3studycostsincreasedto8,257,455 in 2024, primarily due to lower clinical trial costs[117]. - The Bria-IMT™ Pivotal Phase 3 study costs increased to 3,642,650 in the three months ended January 31, 2025, compared to 2,519,420in2024,indicatingintensifiedeffortsinpatientrecruitmentandtrialexecution[119].−Forthesix−monthperiodendedJanuary31,2025,totalresearch,development,andclinicaltrialcostswere2,519,420 in 2024, indicating intensified efforts in patient recruitment and trial execution[119]. - For the six-month period ended January 31, 2025, total research, development, and clinical trial costs were 9,350,118, significantly lower than 15,114,712in2024,drivenbyreducedclinicaltrialexpenses[127].−Generalandadministrativeexpensesforthethree−monthperiodendedJanuary31,2025,were15,114,712 in 2024, driven by reduced clinical trial expenses[127]. - General and administrative expenses for the three-month period ended January 31, 2025, were 1,484,666, a slight decrease from 1,571,991in2024,attributedtooperationalefficiencies[121].−Financialincomeforthethree−monthperiodendedJanuary31,2025,was1,571,991 in 2024, attributed to operational efficiencies[121]. - Financial income for the three-month period ended January 31, 2025, was 67,358, down from 81,628in2024,primarilyduetolowerinterestincome[122].−Thechangeinfairvalueofthewarrantliabilityresultedinagainof81,628 in 2024, primarily due to lower interest income[122]. - The change in fair value of the warrant liability resulted in a gain of 806,841 in the three-month period ended January 31, 2025, compared to a loss of 1,567,747in2024,contributingtoimprovedfinancialresults[123].−ThecompanyreportedanetlosspershareattributabletoBriaCellof1,567,747 in 2024, contributing to improved financial results[123]. - The company reported a net loss per share attributable to BriaCell of 2.33 for the three-month period ended January 31, 2025, compared to 10.64in2024[114].−Forthesix−monthperiodendedJanuary31,2025,thecompanyreportedalossof10.64 in 2024[114]. - For the six-month period ended January 31, 2025, the company reported a loss of 12,167,104, an increase from the loss of 5,375,038inthesameperiodof2024[134].−Generalandadministrativeexpensesdecreasedto5,375,038 in the same period of 2024[134]. - General and administrative expenses decreased to 2,972,157 for the six-month period ended January 31, 2025, compared to 3,217,762forthesameperiodin2024,reflectingoperationalefficiencies[132].−Financialincomedecreasedto3,217,762 for the same period in 2024, reflecting operational efficiencies[132]. - Financial income decreased to 79,072 for the six-month period ended January 31, 2025, down from 261,450in2024,primarilyduetolowerinterestincome[133].−Theaccumulateddeficitincreasedto261,450 in 2024, primarily due to lower interest income[133]. - The accumulated deficit increased to 97,537,292 as of January 31, 2025, from 85,443,697asofJuly31,2024[136].−Thecompanyhadtotalassetsof85,443,697 as of July 31, 2024[136]. - The company had total assets of 9,363,567 as of January 31, 2025, compared to 5,872,261asofJuly31,2024,indicatingimprovedfinancialposition[136].−Thecompanyachievedapositiveworkingcapitalbalanceof5,872,261 as of July 31, 2024, indicating improved financial position[136]. - The company achieved a positive working capital balance of 1,931,735 as of January 31, 2025, a significant improvement from a negative balance of 3,807,303asofJuly31,2024[136].−CashgainedinfinancingactivitiesfortheperiodendedJanuary31,2025,was3,807,303 as of July 31, 2024[136]. - Cash gained in financing activities for the period ended January 31, 2025, was 17,176,863, compared to nil for the same period in 2024[140]. - The company’s net cash used in operating activities was 12,875,298fortheperiodendedJanuary31,2025,comparedto12,875,298 for the period ended January 31, 2025, compared to 15,006,564 for the same period in 2024[139]. Capital Raising Activities - BriaCell closed an 8.5millionofferingfor821,666commonsharesat8.5 million offering for 821,666 common shares at 10.35 per share, intended for working capital and business objectives[94]. - The company closed a 5millionofferingfor341,900commonsharesandwarrants,withgrossproceedsintendedforworkingcapitalandbusinessadvancement[98].−ThecompanyclosedapublicofferingonFebruary5,2025,raisingapproximately5 million offering for 341,900 common shares and warrants, with gross proceeds intended for working capital and business advancement[98]. - The company closed a public offering on February 5, 2025, raising approximately 3.05 million from the sale of 762,500 common shares at a price of $4.00 per share[112]. Corporate Governance - The board approved a consolidation of common shares on a 1-for-15 basis to comply with Nasdaq listing requirements, effective January 29, 2025[110].