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]

Financial Performance - BriaCell reported a net loss of $1,715,759 for the three-month period ended April 30, 2024, compared to a net loss of $4,895,436 for the same period in 2023, indicating a significant improvement[88]. - The net loss for the period decreased to $3,682,796 in 2024 from $17,883,739 in 2023, indicating a reduction of approximately 79%[1]. - The company reported a net financial income of $23,934,668 for the nine-month period ending April 30, 2024, a significant turnaround from a net loss of $2,317,236 in the same period of 2023[4]. Operating Expenses - Total operating expenses for the three-month period ended April 30, 2024, were $9,229,648, up from $5,677,029 in the same period of 2023, reflecting increased research and development activities[88]. - For the nine-month period ending April 30, 2024, total operating expenses increased to $27,562,122, up from $15,566,503 in the same period of 2023, representing a 77% increase[1]. - General and administrative expenses decreased to $1,572,016 for the three-month period ended April 30, 2024, from $1,816,461 in the same period of 2023[94]. Research and Development - Research and development expenses rose to $7,657,632 for the three-month period ended April 30, 2024, compared to $3,860,568 in the same period of 2023, driven by expanded clinical trials[88]. - Research and development expenses rose significantly to $22,772,344, compared to $10,169,140 in 2023, marking a 124% increase, driven by higher clinical trial costs[1]. - Clinical trial expenses surged to $17,763,490 in 2024 from $5,799,621 in 2023, reflecting a 206% increase due to extended patient participation and higher setup costs for pivotal studies[2]. Clinical Trials - The company initiated its pivotal Phase 3 study of Bria-IMT™ on October 3, 2023, aiming to enroll 177 patients in both the treatment and control arms[85]. - BriaCell's Bria-IMT™ showed a median overall survival of 13.4 months in advanced metastatic breast cancer patients, compared to 6.7-9.8 months reported in literature[80]. - Clinical trial costs specifically increased from $2,469,105 in 2023 to $6,165,072 in 2024, highlighting the escalation in the Bria-IMT™ trial[93]. Financial Position - As of April 30, 2024, the company had total assets of $6,203,266, down from $27,163,577 as of July 31, 2023, indicating a decrease of approximately 77%[7]. - The company has a negative working capital of $1,227,767 as of April 30, 2024, compared to a positive working capital of $25,147,050 as of July 31, 2023[7]. - The accumulated deficit increased to $84,229,532 as of April 30, 2024, from $80,652,231 as of July 31, 2023[9]. Cash Flow - Cash used in operating activities for the nine-month period ending April 30, 2024, was $20,090,398, compared to $12,825,853 in the same period of 2023, reflecting an increase of 56%[11]. Capital Management - The company plans to finance its research and development activities through existing and future working capital resources while evaluating additional sources of capital[8]. Risk Management - The Company does not believe it is exposed to material interest rate risk as it has no interest-bearing debt[116]. - A 5% depreciation or appreciation of the Canadian dollar against the US dollar would not have a material effect on the total loss and comprehensive loss[117]. - The Company does not use derivative instruments to reduce its exposure to foreign currency risk[113]. - Management believes that the credit risk concentration with respect to financial instruments is remote[114]. - The overall objective of the Board is to set policies that seek to reduce risk without unduly affecting the Company's competitiveness and flexibility[113]. - The Company has no significant concentration of credit risk arising from operations[114]. - Price risk is considered remote as the Company has no revenues[116].

Core Insights - BriaCell Therapeutics Corp. has entered into a clinical supply agreement with BeiGene, Ltd. to evaluate the safety and efficacy of Bria-OTS™ in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for advanced heavily pretreated metastatic breast cancer [1][2] - The Bria-OTS™ platform is positioned as a next-generation off-the-shelf therapy with enhanced potency, building on the success of Bria-IMT™, which has shown clinical benefits in patients resistant to checkpoint inhibitors [2] Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [3]

83% intracranial objective response rate (iORR) with Bria-IMT™ in heavily pretreated advanced breast cancer patients with CNS metastasesMedian progression free survival (PFS) of 4.1 months in ADC resistant patients - double the PFS of patients in similar studies1,2,3Clinical benefit rate of 55% in evaluable patients includes HR+, HER2+ and TNBC disease - much higher than comparable studies1,2,3 PHILADELPHIA and VANCOUVER, British Columbia, May 24, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ ...

PHILADELPHIA and VANCOUVER, British Columbia, May 17, 2024 (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, today announced it has closed its previously announced registered direct offering with healthcare-focused institutional investors and a certain existing investor and a director of the Company for the purchase and sale of 2,402,935 common sh ...

Core Viewpoint - BriaCell Therapeutics Corp. has announced a securities purchase agreement to raise approximately $5.0 million through the sale of common shares and warrants, aimed at funding working capital and research initiatives, including a Phase 3 study in advanced breast cancer [1][2]. Group 1: Offering Details - The company will sell 2,402,935 common shares and warrants at a price of $2.00 per share for institutional investors and $2.215 for an existing investor and a director [1]. - The warrants will have an exercise price of $2.11 per share, becoming exercisable six months post-issuance and expiring five years from the initial exercise date [1]. - The closing of the offering is expected around May 17, 2024, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital, general corporate purposes, research and development studies, and legal costs associated with the Phase 3 study in advanced breast cancer [2]. - The company may also consider repurchasing certain issued shares and warrants with the proceeds [2]. Group 3: Regulatory and Compliance Information - The offering is being conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission on January 22, 2024, and declared effective on January 31, 2024 [3]. - A prospectus supplement detailing the offering terms will be filed with the SEC and made available on their website [3]. - The company is relying on exemptions from certain prospectus requirements under Canadian securities laws for the offering [3]. Group 4: Related Party Transactions - A director of the company may participate in the offering, which is classified as a "related party transaction" under Multilateral Instrument 61-101 [5]. - The company is exempt from the formal valuation requirement as the director's participation is not expected to exceed 25% of the market capitalization [5].

Oral presentation by Mayo Clinic Professor and Principal Investigator, Saranya Chumsri, MDTwo poster presentations include Drs. Hurvitz (Fred Hutchinson Cancer Center), Brufsky (UPMC), and Cristofanilli (Weill Cornell) as authors PHILADELPHIA and VANCOUVER, British Columbia, April 24, 2024 (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 pleas ...