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]

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].

Core Viewpoint - BRIACELL THERAP (BCTX) has experienced a bearish trend, losing 28.2% in the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottom formation, suggesting that selling pressure may be subsiding, which could lead to a bullish trend [2][4]. - A hammer pattern typically forms when a stock opens lower, makes a new low, but then closes near or above its opening price, indicating a shift in control from bears to bulls [3][4]. Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for BCTX, which is a bullish indicator as it often correlates with price appreciation [6]. - The consensus EPS estimate for BCTX has increased by 83.8% over the last 30 days, reflecting strong agreement among analysts regarding the company's improved earnings potential [7]. Zacks Rank - BCTX currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically indicates strong market performance [8]. - A Zacks Rank of 2 is a strong indicator of a potential trend reversal, as it helps investors identify when a company's prospects are improving [8].

Core Viewpoint - BRIACELL THERAP (BCTX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook driven by rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates in determining stock price movements, making it a valuable tool for investors [2][4]. - The correlation between earnings estimate revisions and stock price movements is strong, particularly due to institutional investors who adjust their valuations based on these estimates [4][6]. Company Performance Indicators - BRIACELL THERAP is projected to earn -$2.45 per share for the fiscal year ending July 2025, reflecting a year-over-year change of 43.7% [8]. - Over the past three months, the Zacks Consensus Estimate for BRIACELL THERAP has increased by 71.8%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - The upgrade of BRIACELL THERAP to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a likelihood of stock price appreciation in the near term [10].

Core Insights - BriaCell Therapeutics Corp. announced a significant clinical response in a metastatic breast cancer patient treated with Bria-OTS™, including complete resolution of lung metastasis after four injection cycles [1][5][7] - Bria-OTS™ is a personalized off-the-shelf immunotherapy currently in a Phase 1/2a dose escalation study for metastatic recurrent breast cancer, representing an advancement over BriaCell's previous candidate, Bria-IMT™ [2][6] - The initial patient in the study, a 78-year-old woman, had extensive metastases and showed stable disease elsewhere after treatment, indicating the potential effectiveness of Bria-OTS™ [5][6] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [8] - The company is exploring the therapeutic potential of Bria-OTS™ not only in metastatic breast cancer but also plans to extend its application to prostate cancer, melanoma, and lung cancer [6][8] Clinical Study Details - The Phase 1/2a clinical trial is designed to evaluate the safety and efficacy of Bria-OTS™ as a monotherapy initially, followed by combination therapy with an immune checkpoint inhibitor [6][7] - Key inclusion criteria for the study include recurrent metastatic breast cancer and at least two prior failed systemic therapy attempts [6]

Core Points - BriaCell Therapeutics Corp. completed a share consolidation on January 24, 2025, at a ratio of one post-Consolidation Common Share for every fifteen pre-Consolidation Common Shares to comply with Nasdaq listing requirements [1][3] - The post-Consolidation Common Shares will begin trading on the TSX and Nasdaq on January 29, 2025, under the symbols "BCT" and "BCTX" respectively, with a new CUSIP number: 107930208 [2] - The total number of Common Shares reduced from 44,204,061 to 2,946,940 as a result of the consolidation [3] - Fractional Common Shares less than one-half have been cancelled, while those at least one-half have been converted to one whole Common Share [4] - Shareholders holding physical share certificates must submit a Letter of Transmittal to receive post-consolidated shares, while those with book shares will have their pre-consolidated shares automatically rendered void [5] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [6]

Financial Performance - BriaCell reported a net loss of $5,802,175 for the three months ended October 31, 2024, compared to a net income of $6,001,543 in the same period of 2023, reflecting a significant change in financial performance [102]. - For the three-month period ending October 31, 2024, the Company reported a loss of $5,829,276 compared to a gain of $5,958,872 for the same period in 2023, primarily due to a significant change in the fair value of the warrant liability [112]. - Net financial income for the three-month period ending October 31, 2024, was $11,714, a significant decrease from $179,822 in the same period of 2023, driven by lower interest income [111]. - The Company has an accumulated deficit of $91,245,872 as of October 31, 2024, up from $85,443,697 as of July 31, 2024 [115]. Operating Expenses - Total operating expenses decreased to $5,152,832 in Q1 2024 from $8,503,028 in Q1 2023, primarily due to reduced research and development costs [102]. - General and administrative expenses decreased to $1,487,491 in Q1 2024 from $1,645,771 in Q1 2023, reflecting cost management efforts [110]. - Research and development expenses for the three months ended October 31, 2024, were $3,665,341, down from $6,857,257 in the same period of 2023, indicating a 46% reduction [102]. Cash Flow and Financing - The Company’s net cash used in operating activities during the period ended October 31, 2024, was $6,955,076, a decrease from $7,605,245 for the same period in 2023 [117]. - Cash gained in financing activities for the period ended October 31, 2024, was $11,960,252, compared to nil for the same period in 2023 [118]. - The Company intends to raise additional capital through debt or equity financings to achieve its business plan objectives, although there is no assurance of success [117]. - The Company’s overall position of cash and cash equivalents increased by $4,930,176 from the period ended July 31, 2024 [117]. Assets and Working Capital - As of October 31, 2024, the Company had total assets of $10,414,330, an increase from $5,872,261 as of July 31, 2024, and a positive working capital of $3,230,459 compared to a negative balance of $3,807,303 [115]. Clinical Studies and Developments - The Bria-IMT™ pivotal Phase 3 study costs amounted to $2,185,543, remaining consistent with the prior year's $2,278,258, highlighting strategic spending optimization [107]. - The one-year survival rate for patients treated with the Bria-IMT™ regimen in the Phase 2 clinical study was reported at 55%, exceeding the current standard of care [98]. - BriaCell is advancing its Bria-IMT™ targeted immunotherapy in a pivotal Phase 3 study for metastatic breast cancer, with 35 clinical sites actively enrolling patients [97]. - The Company has received FDA Fast Track designation for the Bria-IMT™ combination regimen, which could lead to full approval upon positive study results [95]. - The Phase 1/2 study for Bria-OTS™ commenced with the first patient dosed, evaluating its safety and efficacy in combination with an immune checkpoint inhibitor [99]. Foreign Exchange and Investment Strategy - The Company is exposed to foreign exchange risk due to transactions occurring in Canadian Dollars, but a 5% fluctuation would not have a material effect on total loss [132]. - The Company’s investment strategy focuses on capital preservation and supporting liquidity requirements, primarily through cash and cash equivalents [116].

Core Insights - BriaCell Therapeutics Corp. reports significant infiltration of CD8+ "killer" T cells into metastatic breast cancer tumors and lymphatic tissues, indicating a positive response to the Bria-IMT™ plus immune checkpoint inhibitor (CPI) treatment [1][6][7] - The use of CD8 ImmunoPET imaging technology has been validated as a precision diagnostic tool to monitor immune responses in patients, correlating with clinical benefits and tumor marker reductions [2][7] Group 1: Treatment Efficacy - The Bria-IMT™ plus CPI regimen led to the transformation of "cold" tumors into "hot" tumors, suggesting enhanced immune activity against cancer cells [6][7] - In a study involving six patients, 50% showed a decrease in the neutrophil/lymphocyte ratio, indicating immune system activation after treatment [6] Group 2: Imaging Technology - CD8 ImmunoPET imaging was utilized to document the mechanism of action of the Bria-IMT™ regimen, providing insights into its effectiveness in cancer treatment [3][4] - The imaging technology is crucial for identifying pseudo progression in patients who exhibit clinical benefits, distinguishing them from those with actual tumor progression [2][7] Group 3: Clinical Presentation - The findings were presented at the 2024 San Antonio Breast Cancer Symposium, highlighting the potential of the Bria-IMT™ regimen in improving patient outcomes [5][7] - The poster presentation included details such as the abstract number SESS-1069 and emphasized the importance of CD8+ T cells in cancer detection and destruction [5]

Core Viewpoint - BriaCell Therapeutics Corp. has announced a public offering of 7,400,000 common shares and warrants, aiming to raise approximately $5.55 million to support its business objectives and working capital needs [1][2]. Group 1: Offering Details - The public offering price is set at $0.75 per share, with warrants having an exercise price of $0.9375, immediately exercisable for five years [1]. - The offering is expected to close on December 13, 2024, pending customary closing conditions [1]. - ThinkEquity is acting as the sole book-running manager for the offering [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital requirements, general corporate purposes, and advancing business objectives [2]. Group 3: Regulatory Information - The offering is conducted under a shelf registration statement on Form S-3, filed with the U.S. SEC, and a final prospectus supplement will be made available [4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended July 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from [●] to [●] Commission File Number: 001-40101 BRIACELL THERAPEUTICS CORP. (Exact name of registrant as specified in its charter) British Columbia 47-1099599 (State or othe ...