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BriaCell(BCTX) - 2025 Q3 - Quarterly Report
2025-06-16 20:34
Financial Performance - BriaCell Therapeutics Corp. reported a net loss of $6.12 million for the three months ended April 30, 2025, compared to a net loss of $1.72 million in the same period of 2024[109]. - The company reported a loss of $6,224,929 for the three-month period ended April 30, 2025, compared to income of $1,692,242 in 2024, driven by a significant decrease in non-cash gains[117]. - The company reported a net loss of $18,392,033 for the nine-month period, compared to a loss of $3,682,796 in 2024, primarily due to a smaller gain on the fair value of the warrant liability[127]. Operating Expenses - Total operating expenses decreased to $6.33 million in Q2 2025 from $9.23 million in Q2 2024, primarily due to reduced research, development, and clinical trial expenses[109]. - Total research, development, and clinical trial costs for the three-month period ended April 30, 2025, were $4,810,196, down 37.8% from $7,657,632 in 2024[111]. - Clinical trial expenses for the same period were $3,190,751, a decrease of 26.9% from $4,359,850 in 2024, primarily due to the conclusion of the Bria-IMT™ Phase 1/2a trial[112]. - The Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,708,394, down 28.1% from $3,764,521 in 2024, reflecting a shift in spending focus[113]. - General and administrative expenses for the three-month period were $1,518,059, slightly down from $1,572,016 in 2024, indicating operational efficiencies[115]. - For the nine-month period ended April 30, 2025, total research, development, and clinical trial costs were $14,160,314, a 38.1% decrease from $22,772,344 in 2024[120]. - Clinical trial expenses for the nine-month period were $9,822,400, down 22.5% from $12,650,189 in 2024, reflecting the completion of the Bria-IMT™ Phase 1/2a trial[121]. Capital Raising and Financial Position - The company raised approximately $3.05 million from a public offering of 762,500 common shares at $4.00 per share in February 2025[94]. - In April 2025, BriaCell closed an underwritten public offering for 3,066,666 units, generating approximately $13.8 million in gross proceeds[105]. - The Company intends to raise additional capital through debt or equity financings to achieve its business objectives[131]. - Certain directors and officers agreed to defer payment of their fees until financing was completed, after which these fees were paid in full[131]. - As of April 30, 2025, the company had total assets of $17,001,798, significantly up from $5,872,261 in July 2024, indicating improved financial position[129]. - The Company achieved a positive working capital balance of $10,454,565 as of April 30, 2025, compared to a negative working capital balance of $3,807,303 on July 31, 2024[142]. - The Company's cash and cash equivalents increased by $11,598,164 from July 31, 2024, to April 30, 2025[132]. - Cash gained in financing activities for the period ended April 30, 2025, was $31,891,239, compared to nil for the period ended April 30, 2024[133]. Clinical Trials and Research Developments - The pivotal Phase 3 study of Bria-IMT™ has enrolled over 75 patients and is expected to complete enrollment by late 2025 or early 2026, with top-line data potentially available in H1 2026[99]. - Bria-OTS™ demonstrated a 100% resolution of lung metastasis in a patient after two months of therapy, confirmed at four months[100]. - BriaCell's Phase 2 study showed a median overall survival of 17.3 months for HR+ metastatic breast cancer patients treated with Bria-IMT™ plus checkpoint inhibitors, outperforming the standard of care, TRODELVY, which had a median survival of 14.4 months[97]. - The company is developing anti-B7-H3 antibodies for multiple cancer indications through its subsidiary, BriaPro Therapeutics Corp.[95]. - BriaCell's ongoing Phase 1/2 study of Bria-OTS™ has cleared safety evaluation and is now transitioning to combination therapy with an immune checkpoint inhibitor[108]. - Positive survival and clinical benefit data from the Phase 2 study were presented at ASCO 2025, indicating potential for FDA approval and commercialization[107]. Risk Management - The Company is exposed to foreign exchange risk due to transactions in Canadian Dollars, but a 5% change in the exchange rate would not have a material effect on total loss[145]. - Management believes that the credit risk concentration with respect to financial instruments is remote[141]. - The Company continues to focus on its Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer while reducing expenditure on non-core activities[131].
BriaCell Therapeutics Announces Pricing of $13.8 million Public Offering
Newsfilter· 2025-04-25 00:00
Core Points - BriaCell Therapeutics Corp. announced a public offering of 3,066,666 units at a price of $4.50 per unit, aiming for gross proceeds of approximately $13.8 million [1][2] - Each unit consists of one common share (or Pre-Funded Warrant) and one Warrant, with the Warrants approved for listing on the Nasdaq Capital Market under the symbol "BCTXZ" [1] - The offering is expected to close on April 28, 2025, subject to customary closing conditions [2] - The net proceeds will be used for working capital, general corporate purposes, and advancing business objectives [3] - A registration statement related to the securities was filed with the SEC and became effective on April 24, 2025 [4] Company Information - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care [6]
BriaCell Confirms 100% Resolution of Lung Metastasis with Bria-OTS™
Newsfilter· 2025-04-24 11:30
(IMAGES BELOW) Complete resolution of lung metastasis confirmed at 4 month follow-up in hormone receptor positive (HR+) breast cancer patientTreatment well-tolerated and patient remains on study with stable disease elsewhereSustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study PHILADELPHIA and VANCOUVER, British Columbia, April 24, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW)) (TSX:BCT) ("Bri ...
BriaCell Announces Four Clinical Data Presentations at ASCO 2025
Newsfilter· 2025-04-23 11:30
PHILADELPHIA and VANCOUVER, British Columbia, April 23, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW)) (TSX:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL. The details ...
BriaCell Enrollment Pace Accelerating in Phase 3 Clinical Study in Advanced Metastatic Breast Cancer (Bria-ABC)
Newsfilter· 2025-04-22 11:30
Over 75 patients enrolled in BriaCell's pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer (MBC)54 clinical sites across 15 states currently enrolling patients including Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center PHILADELPHIA and VAN ...
BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer
Newsfilter· 2025-04-16 11:30
Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patientsSurvival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY® No Bria-IMT related discontinuations reported to date PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (GLOBE NEWSWIRE) -- ...
BriaCell's Subsidiary, BriaPro, Develops Novel Antibodies to Anti-Cancer Target B7-H3
Newsfilter· 2025-04-10 12:00
BriaPro is developing novel antibodies to B7-H3, a key cancer antigen and immune checkpointHighly expressed on the cell surfaces of both tumor and immune cells, B7-H3 is a promising anti-cancer target for drugs both effecting cancer cells and blocking immune checkpoint activityBriaPro expects to advance anti-B7-H3 antibodies into development of proprietary antibody-drug conjugates, T cell engagers, and targeted immune checkpoint inhibitors with potential applications in multiple cancer indicationsBriaPro ha ...
BriaCell to Present Clinical and Preclinical Data at the 2025 AACR Conference
Newsfilter· 2025-03-26 12:00
Core Insights - BriaCell Therapeutics Corp. will present three posters at the 2025 American Association for Cancer Research (AACR) Annual Meeting from April 25th to 30th in Chicago, IL [1][2] Group 1: Poster Presentations - Poster 1: Title is "Bria-ABC1 vs physician choice in late-stage MBC; early biomarker correlates of the randomized registration trial," scheduled for April 30, 2025, from 9:00 AM to 12:00 PM CST [2] - Poster 2: Title is "Survival outcomes in a randomized phase 2 of Bria-IMT: An allogeneic whole cell cancer vaccine," scheduled for April 28, 2025, from 2:00 PM to 5:00 PM CST [2] - Poster 3: Title is "Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity," scheduled for April 28, 2025, from 2:00 PM to 5:00 PM CST [2] Group 2: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [3]
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell's Phase 3 Study in Metastatic Breast Cancer
Newsfilter· 2025-03-20 12:00
Core Insights - BriaCell Therapeutics Corp. has received a positive recommendation from the external Data Safety Monitoring Board (DSMB) to continue its pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer without modifications [1][6] - The study is currently under Fast Track Designation with the FDA, indicating its potential significance in addressing an urgent medical need [1][6] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [3] - The company emphasizes the importance of its research in improving survival and quality of life outcomes for patients with metastatic breast cancer [2] Clinical Study Details - The pivotal Phase 3 study is designed to evaluate the safety and efficacy of Bria-IMT in combination with CPI for patients with metastatic breast cancer [1][6] - The DSMB's second safety data review found no safety concerns, allowing for the continuation of patient enrollment in the clinical trial [2][6]
BriaCell(BCTX) - 2025 Q2 - Quarterly Report
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 $65,608 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 $11,294,603 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 $8,257,455 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 $2,519,420 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 $15,114,712 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 $1,571,991 in 2024, attributed to operational efficiencies[121]. - Financial income for the three-month period ended January 31, 2025, was $67,358, down from $81,628 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 $1,567,747 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 $10.64 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 $5,375,038 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 $3,217,762 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 $261,450 in 2024, primarily due to lower interest income[133]. - The accumulated deficit increased to $97,537,292 as of January 31, 2025, from $85,443,697 as of July 31, 2024[136]. - The company had total assets of $9,363,567 as of January 31, 2025, compared to $5,872,261 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 $3,807,303 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 $12,875,298 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 $8.5 million offering for 821,666 common shares at $10.35 per share, intended for working capital and business objectives[94]. - The company closed a $5 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].