BriaCell(BCTX)

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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 Closing of $13.8 million Public Offering
Globenewswire· 2025-04-28 20:05
Group 1 - BriaCell Therapeutics Corp. has completed an underwritten public offering of 3,066,666 units, raising approximately $13.8 million in gross proceeds at a price of $4.50 per unit [1][2] - Each unit consists of one common share (or a pre-funded warrant) and one warrant, with the warrants approved for listing on the Nasdaq Capital Market under the symbol "BCTXZ" [1] - The warrants are immediately exercisable at an exercise price of $5.25 per share and expire five years from the date of issuance [1] Group 2 - The net proceeds from the offering will be used for working capital requirements, general corporate purposes, and to advance business objectives [2] - ThinkEquity acted as the sole book-running manager for the offering [2] Group 3 - A registration statement on Form S-1 was filed with the SEC and became effective on April 24, 2025, allowing the offering to proceed [3]
BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+™ Development
Globenewswire· 2025-04-28 11:30
Core Insights - BriaCell Therapeutics Corp. is presenting positive data from its Phase 2 study of Bria-IMT™ in metastatic breast cancer and its preclinical Bria-OTS+ platform at the 2025 AACR Annual Meeting [1][2] - The company reports that Bria-IMT shows impressive survival and clinical efficacy in heavily treated patients who have failed multiple prior treatments [2][3] - The Phase 3 formulation of Bria-IMT has demonstrated a clinical benefit rate of 83% in evaluable patients [5][6] Phase 2 Study Findings - The Phase 2 study involved 54 metastatic breast cancer patients, with 37 receiving the Bria-IMT formulation currently used in the ongoing pivotal Phase 3 study [3] - Patients had a median of 6 prior treatments, including Antibody-Drug Conjugates (ADCs) and checkpoint inhibitors (CPIs) [3] - Overall survival (OS) for HR+ patients was reported at 17.3 months, while for triple-negative breast cancer (TNBC) patients, it was 11.44 months [6] Bria-OTS+ Platform - Bria-OTS+ is an enhanced immunotherapy platform that expresses multiple immune-activating cytokines and co-stimulatory molecules [8] - The platform aims to induce powerful and long-lasting immune activity against cancer [4][8] - The company anticipates that additional immune-activating factors will enhance the efficacy of the Bria-OTS+ platform [7] Future Developments - Phase 3 early biomarker data will be presented as a late-breaking abstract on April 30, 2025 [1][5] - The company plans to investigate Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer in upcoming Phase 1/2a clinical studies [8]
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
Core Insights - BriaCell Therapeutics Corp. has confirmed the complete resolution of lung metastasis in a patient with metastatic breast cancer after treatment with its Bria-OTS immunotherapy, marking a significant milestone in the ongoing Phase 1/2a study [1][6][8] Group 1: Treatment Efficacy - The Bria-OTS monotherapy resulted in a 100% resolution of lung tumors in a 78-year-old female patient after two months of therapy, with confirmation of this resolution at the four-month follow-up [2][5] - The patient had extensive metastases prior to treatment and showed stable disease in other areas after receiving Bria-OTS injections [5][6] - The treatment was well-tolerated, and the patient remains in the study with stable disease elsewhere [6][8] Group 2: Study Details - Bria-OTS is currently being investigated in a Phase 1/2a dose escalation study for metastatic recurrent breast cancer, with a focus on safety and efficacy as a monotherapy [9] - This study represents a next-generation advancement of BriaCell's lead candidate, Bria-IMT™, which is in a pivotal Phase 3 study for metastatic breast cancer [9] Group 3: Industry Context - The results from the Bria-OTS study are particularly significant given the limited treatment options available for patients with hormone receptor-positive metastatic breast cancer, despite advancements in antibody-drug conjugates and immune checkpoint inhibitors [8] - The initial data from the Bria-OTS study demonstrates promising anti-tumor activity, providing early validation for BriaCell's personalized immunotherapy approach [8][9]
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
Core Insights - BriaCell Therapeutics Corp. is conducting a pivotal Phase 3 clinical study for its lead candidate, Bria-IMT, in advanced metastatic breast cancer, with over 75 patients enrolled and more than 100 consented [1][2][9] - The company expects to complete patient enrollment by late 2025 or early 2026 and may report top-line data as early as the first half of 2026 [1][5] - The study is being conducted at 54 clinical sites across 15 states in the US, with a focus on evaluating overall survival compared to physician's choice treatment [4][5][9] Company Statements - Dr. William V. Williams, President & CEO, expressed optimism about the expanding patient enrollment and the potential of Bria-IMT to transform cancer care for metastatic breast cancer patients [3] - Dr. Giuseppe Del Priore, Chief Medical Officer, noted that the enrollment pace and clinical investigator interest are higher than previously observed, highlighting the dedication of clinical investigators and patients [3] Study Details - The primary endpoint of the study is overall survival, with interim data analysis planned once 144 patient events occur [5] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential for expedited development and review [5] - Positive results from the Phase 3 study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5]
BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer
Newsfilter· 2025-04-16 11:30
Core Insights - BriaCell Therapeutics Corp. announced positive survival data from its Phase 2 study of Bria-IMT combined with checkpoint inhibitors, showing better outcomes than current ADC drugs for HR+ metastatic breast cancer patients [1][2][4] Clinical Study Results - In the Phase 2 study, 25 out of 37 patients with HR+ breast cancer treated with Bria-IMT had a median overall survival of 17.3 months, surpassing the 14.4 months seen with TRODELVY® [2][4] - For triple-negative breast cancer (TNBC) patients, the survival data with Bria-IMT was comparable to TRODELVY® but significantly higher (70%) than traditional chemotherapy [2][4] - The study included 54 heavily pre-treated metastatic breast cancer patients, with a median of 6 prior treatments [5] Company Statements - Dr. William V. Williams, President and CEO of BriaCell, expressed confidence in the survival benefit data and the tolerability of Bria-IMT, looking forward to further confirmation in the ongoing Phase 3 study [3][4] - Dr. Giuseppe Del Priore, Chief Medical Officer, highlighted the potential of Bria-IMT + CPI to meet the unmet medical needs of HR+ and TNBC patients, who have limited treatment options [3][4] Additional Information - No discontinuations related to Bria-IMT have been reported to date, indicating a favorable safety profile [4][5] - The ongoing pivotal Phase 3 study is listed on ClinicalTrials.gov as NCT06072612 [5]
BriaCell's Subsidiary, BriaPro, Develops Novel Antibodies to Anti-Cancer Target B7-H3
Newsfilter· 2025-04-10 12:00
Core Viewpoint - BriaCell Therapeutics Corp. and its subsidiary BriaPro are advancing the development of novel high-affinity antibodies targeting B7-H3, a significant player in cancer progression, with plans for patent applications and multiple cancer indications [1][2][8]. Group 1: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing innovative immunotherapies to transform cancer care [5]. - BriaPro is a pre-clinical stage immunotherapy company aiming to enhance the body's cancer-fighting capabilities [6]. Group 2: Technology Development - BriaPro is utilizing molecular modeling techniques to develop anti-B7-H3 antibodies, which are expected to be incorporated into the Bria-TILsRx™ platform designed to activate T cells in the tumor microenvironment [2][8]. - The B7-H3 target is overexpressed in various solid tumors, including prostate, lung, breast, pancreatic, and ovarian cancers, while showing limited expression in normal tissues, making it an ideal target for selective activation of tumor infiltrating lymphocytes [3][8]. Group 3: Market Potential - Antibodies targeting B7-H3 are in high demand among pharmaceutical and biotechnology companies, indicating a strong market interest [5]. - The development of anti-B7-H3 antibodies is expected to synergize with BriaCell's existing cell-based immuno-oncology platform, which includes novel cell-based immunotherapy approaches [5].
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]