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].

Breast Cancer Statistics and Market Overview - In 2024, approximately 310,720 women are expected to be diagnosed with breast cancer in the United States, with over 42,250 projected deaths[7]. - The global market for cancer drugs is anticipated to reach nearly $375 billion by the end of 2027, growing at a CAGR of 17% from 2023 to 2027, with about 20% attributed to immuno-oncology drugs[7]. - Approximately 83% of breast cancer cases present as invasive, with 6% being Stage IV metastatic breast cancer[8]. - It is estimated that over 150,000 women in the US were living with metastatic breast cancer in 2015, projected to increase to over 240,000 by 2030[8]. - The lifetime risk of men developing breast cancer is estimated at 1 in 1,000, with approximately 2,790 new cases expected in 2024[7]. Treatment Efficacy and Clinical Trials - The median overall survival for patients with de novo Stage IV metastatic breast cancer is 39.2 months, while for relapsed disease it is 27.2 months[8]. - The overall response rates (ORR) for current breast cancer treatments range from 2.7% to 59%, with a median of 24%[12]. - Progression-free survival (PFS) for existing therapies varies from 8 weeks to 12 months, with a median of 5 months[12]. - The clinical trial data indicates that Bria-IMT™ has the potential to improve upon the current median PFS of 5 months[12]. - The Phase 1/2 clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors reported a median overall survival of 13.5 months, compared to 6.7-9.8 months for similar patients in literature[21]. - The combination therapy with retifanlimab demonstrated 70% disease control in evaluable patients, highlighting the efficacy of Bria-IMT™[21]. Company Financials and Risks - The company has a history of losses and may incur future losses, raising substantial doubt about its ability to continue as a going concern[5]. - The company must obtain additional capital to continue operations, indicating potential liquidity challenges[5]. - Clinical trials involve lengthy and expensive processes with uncertain outcomes, which may affect the company's ability to commercialize its products[5]. - The company faces significant risks, including a history of losses and reliance on third parties for operations[5]. - The company has issued a significant number of options and warrants, which may complicate future capital raising efforts[5]. Product Development and Market Potential - Bria-IMT™ has a potential market opportunity of $2-5 billion specifically in breast cancer and up to $25 billion across broader indications[10]. - The company is developing novel technologies for the treatment of metastatic breast cancer, targeting patients with no approved alternative therapies available[8]. - The competitive landscape shows that existing therapies have unpredictable response rates, reinforcing the opportunity for Bria-IMT™[12]. - The company is actively pursuing clinical trials to validate the efficacy of Bria-IMT™ against established treatments[11]. - The introduction of new therapeutic options is expected to drive market uptake and improve patient outcomes in breast cancer treatment[10]. Regulatory Approvals and Designations - The FDA has granted Fast Track Designation to Bria-IMT™, which could accelerate the review process for the treatment[20]. - The pivotal study aims to demonstrate improvement in overall survival as the primary endpoint, with an interim evaluation for efficacy that may allow for early completion[20]. - The FDA's goal is to review a Biologics License Application (BLA) within ten months, or six months for serious unmet medical needs, after acceptance for filing[44]. - The FDA has waived the requirement for animal studies for Bria-IMT™, Bria-BRES™, and Bria-PROS+™, as they are human cellular vaccines[42]. Competitive Landscape and Market Position - The worldwide sales figures for key competitors in breast cancer treatments include KISQALI® at $2.1 billion, LYNPARZA® at $2.8 billion, and KEYTRUDA® at $25.0 billion[10]. - BriaCell faces significant competition from larger companies with greater financial and technical resources in the cancer immunotherapy market[20]. - The company is targeting oncologists for marketing Bria-IMT™, focusing on patients with late-stage breast cancer who have failed at least two prior treatments[34]. - BriaCell has secured numerous US and international patents for its immunotherapy technologies, enhancing its competitive position in the market[25]. Research and Development Investments - BriaCell incurred net research and development expenses of $26,442,821 for the year ended July 31, 2024, compared to $14,264,048 for the previous year, representing an increase of approximately 85%[40]. - The company is developing additional immunotherapy cell lines for breast cancer, prostate cancer, lung cancer, and melanoma, with IND filings anticipated starting in 2025[28]. - BriaCell has entered into a manufacturing service agreement with Waisman Biomanufacturing for Bria-Pros™, aimed at clinical studies, ensuring compliance with FDA regulations[24]. Clinical Outcomes and Patient Responses - BriaCell reported a disease control rate of 61% in evaluable Phase 2 patients treated with Bria-IMT™, with a notable responder case showing no metastatic liver tumor after treatment[52]. - The median progression-free survival (PFS) for patients treated with Bria-IMT™ was reported at 4.1 months, which is double that of similar studies[54]. - A clinical benefit rate of 55% was observed in evaluable patients across all breast cancer subtypes treated with Bria-IMT™[59]. - BriaCell reported a 100% resolution of brain metastasis in a breast cancer patient after treatment with the Bria-IMT™ regimen, with no detectable lesions at 8 and 11 months[64].

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BRIACELL THERAP (BCTX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a cha ...

Core Insights - BriaCell Therapeutics' stock (BCTX) experienced a significant increase, trading at $1.94, up 213.1% with a session volume of 113.08 million compared to the average volume of 366.19 thousand [1][2] Clinical Study Results - The company announced overall survival data from its Phase 2 clinical study of Bria-IMT in combination with an immune checkpoint inhibitor for late-stage metastatic breast cancer, reporting a median overall survival of 15.6 months for recent patients treated since 2022 [1] - This median overall survival of 15.6 months shows a substantial improvement over the previously reported 13.4 months in December 2023 [1] - The patients in the study had a median of 6 prior treatments, indicating they were heavily pre-treated metastatic breast cancer patients [2] Treatment Efficacy - The Bria-IMT regimen is noted as the only investigational drug demonstrating impressive survival rates in heavily pre-treated metastatic breast cancer patients who have failed multiple prior treatments, including immune checkpoint inhibitors and antibody-drug conjugates [2]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common shares, no par value BCTX The Nasdaq Stock Market LLC Warrants to purchase common shares, no par value BCTXW The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended April 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...