BriaCell(BCTX)
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BriaCell(BCTX) - 2022 Q4 - Annual Report
2022-10-27 16:00
Breast Cancer Statistics and Market Overview - In 2022, approximately 287,500 women in the U.S. were diagnosed with breast cancer, with over 43,000 projected deaths[15]. - About 12.9% of women will be diagnosed with breast cancer in their lifetime, with 81% of cases presenting as invasive breast cancer[17]. - The global market for cancer drugs is expected to reach nearly $269 billion by the end of 2025, growing at a CAGR of 10% from 2021 to 2025[16]. - The market for breast cancer drugs is a multibillion-dollar market, indicating a shortage of safe and effective treatments[26]. - The estimated 5-year survival rate for patients with metastatic breast cancer (MBC) at diagnosis is 27%[18]. - The company estimates that approximately 150,000 women in the U.S. are living with MBC, with 34,000 patients available for treatment based on HLA allele matching[27]. Treatment Efficacy and Clinical Trials - Current therapeutic options for breast cancer show response rates ranging from 6.9% to 59%, highlighting the opportunity for Bria-IMT™[29]. - The best response to Bria-IMT™ is observed in patients with 2+ HLA allele matches, which constitutes approximately 15-35% of cases[22]. - The median overall survival for patients with de novo stage IV MBC is 39.2 months, while for relapsed disease it is 27.2 months[18]. - The company proposes that Bria-IMT™ will target patients with MBC who have failed at least two lines of therapy[18]. - In a study, 241 out of 331 patients (72%) treated with trastuzumab progressed within 27 months, indicating a median survival of 13-14 months, highlighting the unmet need for effective therapies[34]. - The combination of PANVAC with docetaxel increased median progression-free survival (PFS) from 3.9 months to 7.9 months, supporting further clinical trials[35]. - The overall response rate (ORR) for docetaxel monotherapy at 100 mg/m2 was 36.0%, with a median overall survival (OS) of 12.3 months[30]. - The ORR for trastuzumab combined with paclitaxel was reported at 59%, with a median OS of 12.2 months[30]. - The ORR for ABI-007 (Nab paclitaxel) was 33%, with a median OS of 65 weeks[30]. - The median time to tumor progression was 144 days (range 64 – 223 days), with overall survival exceeding 33 months for most patients[48]. - The Bria-IMT™ regimen elicited cellular immune responses in 85% of evaluated patients and antibody responses in 58%[48]. - The median progression-free survival (PFS) was 5.7 months for monotherapy and 6.9 months for combination therapy[109]. - The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months[110]. - Seventy percent of patients who developed an immune response showed disease control, particularly in those with moderately-well differentiated tumors[109]. Immunotherapy Developments - Bria-IMT™ has shown potential to induce long-term remission in metastatic breast cancer (MBC) patients, especially when combined with immunotherapies[30]. - Bria-IMT™ is currently undergoing a Phase I/IIa clinical trial in combination with immune checkpoint inhibitors, including pembrolizumab and retifanlimab[39]. - A new Phase I/IIa study (BRI-ROL-001) is evaluating the combination of Bria-IMT™ with KEYTRUDA®, with 11 patients treated and a median of 3 cycles administered[54]. - The combination of Bria-IMT™ with immune system activators aims to enhance the immune response against breast cancer cells[58]. - The collaboration with Incyte Corporation will explore the combination of Bria-IMT™ with INCMGA00012 and epacadostat, shifting from the previous KEYTRUDA® combination[56]. - BriaCell achieved proof of concept for Bria-IMT™ in advanced breast cancer patients, showing that patients with specific HLA molecules had a higher likelihood of tumor regression[40]. - The company is developing Bria-OTS™, a personalized off-the-shelf immunotherapy, to cover over 99% of the breast cancer patient population using genetically engineered cell lines[60]. - BriaDx™, a diagnostic test, is being developed to identify patients most likely to respond to Bria-IMT™, focusing on HLA typing and specific biomarkers[62]. Financial Overview and Research Costs - For the year ended July 31, 2022, research costs amounted to $8,021,489, an increase from $2,020,899 for the year ended July 31, 2021, attributed to the recommencement of clinical trials and increased lab activity[98]. - For the year ended July 31, 2022, the company incurred $7,585,926 in net research and development expenses, a significant increase from $1,315,496 in the previous year[131]. - BriaCell incurred net losses of $26,838,903 and $13,816,200 in the fiscal years ended 2022 and 2021, respectively[195]. Regulatory and Market Strategy - The FDA approved the combination study of Bria-IMT™ with immune checkpoint inhibitors in advanced breast cancer, marking a significant step in the company's clinical research efforts[95]. - The FDA has granted "Fast Track" status to Bria-IMT™ for the treatment of metastatic breast cancer, facilitating potential accelerated approval[112]. - The company must navigate extensive regulatory requirements, which require substantial time and financial resources for product approval[138]. - The FDA review process for a Biologics License Application (BLA) typically aims for a ten-month review period, or six months for serious unmet medical needs[149]. - Fast Track designation allows for rolling review of a BLA, potentially reducing the review period to six months if priority review is granted[153]. - Under the Accelerated Approval program, the FDA may approve a BLA based on surrogate endpoints, requiring post-marketing studies to verify clinical benefits[154]. - The company anticipates needing additional capital for ongoing research and development, which may dilute current shareholder holdings[212]. - The company is heavily reliant on third-party manufacturers for product development and marketing, with no in-house capabilities expected[201]. - The company lacks internal marketing capabilities and plans to establish strategic partnerships for marketing and distribution[203]. Clinical Trial Management and Partnerships - BriaCell has added multiple clinical trial sites, including Mayo Clinic and Hoag Memorial Hospital, to enhance patient enrollment for its studies[181][192]. - The partnership with Caris Life Sciences aims to accelerate patient enrollment in clinical trials through efficient patient identification[190][191]. - The company entered into a Cooperative Research and Development Agreement with the U.S. Department of Health and Human Services, providing funding of $433,400 over three years for preclinical studies[90]. - The company has entered into a License Agreement with Faller-Williams Technology, which includes milestone payments totaling up to $30 million upon FDA approvals[118]. - The company is developing multi-specific binding reagents designed to activate the immune system against cancer cells, with a focus on reducing toxicity compared to current therapies[89].
BriaCell(BCTX) - 2022 Q3 - Quarterly Report
2022-06-12 16:00
Exhibit 99.1 BriaCell Therapeutics Corp. Condensed Interim Consolidated Financial Statements For the Three and Nine Months Ended April 30, 2022 Expressed in United States Dollars (Unaudited) | --- | --- | |-------------------------------------|-------------------------------------| | | | | Corporate Office- Canada | | | Suite 300 - Bellevue Centre | Corporate Office- US | | 235 -15th Street | 2929 Arch Street, 3rd Floor | | West Vancouver, BC V7T 2X1 | Philadelphia, PA 19104 | | Tel : 604-921-1810 | Tel : 1 ...
BriaCell(BCTX) - 2022 Q1 - Quarterly Report
2021-10-28 16:00
Company Overview - BriaCell Therapeutics Corp. is developing a new therapy for advanced breast cancer, with its common shares listed on TSX Venture Exchange under the symbol "BCT" and on Nasdaq under "BCTX" and "BCTXW" [23]. - The company has two wholly owned subsidiaries: BriaCell Therapeutics Corp. and Sapientia Pharmaceuticals Inc., which focus on novel targeted therapeutics for multiple indications including cancers [24]. - The company operates under International Financial Reporting Standards and all financial information is prepared in US dollars [3]. - BriaCell's corporate structure includes a registered agent in the United States and corporate offices in both Canada and the U.S. [23]. Financial Performance - BriaCell has faced a history of operating losses and is in the early stages of development, which presents inherent risks and uncertainties [7]. - The company reported net losses of $4,712,789, $4,024,536, and $428,334 for the fiscal years ended July 31, 2019, 2020, and 2021, respectively, showing a significant reduction in losses in 2021 [171]. - The company incurred net research and development expenses of $1,315,497 for the year ended July 31, 2021, down from $2,425,838 in 2020, indicating a 45.8% decrease [163]. - The company has identified the need for additional capital and access to capital markets as a significant factor for its operations [8]. - The independent registered public accounting firm expressed substantial doubt about the company's ability to continue as a going concern, which could impair investor perceptions and financing options [194]. - The company does not expect to generate revenues from product sales for the foreseeable future, facing challenges in completing product development and obtaining market approvals [195]. Research and Development - The acquisition of Sapientia included rights to a novel therapeutic technology platform known as protein kinase C delta (PKCδ) inhibitors, aimed at treating cancer and boosting the immune system [24]. - The Company has a patent for SV-BR-1-GM (Bria-IMT™), a whole-cell targeted immunotherapy for cancer, and is advancing its clinical trial program [49]. - The Company plans to use the net proceeds from the U.S. Private Offering to further advance its research and development pipeline [47]. - The company anticipates IND filings for new immunotherapy cell lines starting in 2022 [111]. - The company plans to develop additional immunotherapy cell lines for other cancers, including prostate, non-small cell lung, and melanoma [111]. Clinical Trials and Results - The Bria-IMT™ regimen showed promising results in a study with 23 patients, confirming its ability to induce regression of metastatic breast cancer in patients matching at least one HLA allele [49]. - In the Phase I/IIa studies, 85% of evaluated patients exhibited delayed-type hypersensitivity (DTH) responses, indicating a robust immune response [84]. - The overall survival for patients treated with Bria-IMT™ was more than 33 months, except for one patient who had 7 months [84]. - The combination of Bria-IMT™ with pembrolizumab (KEYTRUDA®) is being evaluated, with 11 patients treated showing a median of four prior systemic therapy regimens [88]. - The second proof of concept trial showed a median overall survival of 35 months for late-stage treatment-refractory patients using Bria-IMT™ [102]. Market Potential - The global market for cancer drugs, including immunotherapy, is projected to reach nearly $269 billion by the end of 2025, growing at a CAGR of 10% from 2021 to 2025 [51]. - The market for breast cancer drugs is a multibillion-dollar market, indicating a significant demand for safe and effective treatments [59]. - Approximately 281,550 women are estimated to be diagnosed with breast cancer in the U.S. in 2021, with over 43,600 projected deaths [50]. Risks and Challenges - The company relies on third parties for certain operations and is subject to competition and regulatory challenges [8]. - The outbreak of COVID-19 could disrupt the development of product candidates and impact clinical trial timelines, with delays expected of at least one quarter [200]. - The company may face challenges in establishing adequate sales, marketing, and distribution channels for its products [195]. - The company faces potential product liability lawsuits as its drug candidates enter clinical trials, which could result in substantial liabilities [197]. Corporate Strategy - The company plans to evaluate strategic partnerships and distribution arrangements as it approaches product approval [168]. - BriaCell's future commercial strategy may include establishing its own sales force or partnering with distributors [168]. - The company may pursue acquisitions to complement its existing business, but such acquisitions carry risks that could harm financial conditions [190].
BriaCell Therapeutics (BCTXF) Presents At 38th Annual J.P. Morgan Healthcare Conference - Slideshow
2020-01-16 20:11
Company Overview - BriaCell Therapeutics Corp is a clinical-stage immunotherapy company focused on developing treatments to boost the body's cancer-fighting cells to destroy cancerous tumors, including BriaIMT™ for advanced breast cancer[4] - The company has recruited 35 patients showing robust response and is developing next-generation HLA-type matching therapies from a saliva test[4] - BriaCell's CEO has been involved in eleven drug approvals[5, 13, 62] Clinical Pipeline and Strategy - BriaCell is developing Bria-IMT™ combined with immune checkpoint inhibitors and Incyte's selected compounds for advanced breast cancer[4] - BriaCell is also developing Bria-OTS™ "Off-The-Shelf Personalized" immunotherapy based on patient's HLA-type[4] - The company believes tumor regression is most pronounced in patients who match Bria-IMT™ at specific HLA-types and develop an immune response[36] - BriaCell is engineering 15 unique HLA types (molecules), collectively referred to as Bria-OTS™, allowing for treatment of over 99% of patients[53] Clinical Trial Data - In a Phase I/IIa study, 23 patients were dosed with Bria-IMT™ monotherapy, showing similar or superior data to other advanced breast cancer drugs at a similar stage[34] - In HLA-matched patients (N=6, ≥ 2 matches), tumor shrinkage was observed in 50% of patients, and 75% in immune responders[35] - In a combination therapy study with checkpoint inhibitors, all 3 patients with Grade I/II tumors had clinical benefit (100%)[48] Financials and Ownership - As of January 3, 2020, the recent share price was C$12.00, with basic shares outstanding of 722,000 and fully diluted shares outstanding of 936,500[57] - Basic market capitalization was C$8.7 million, with insider ownership at 33.5%[57] - Jamieson Bondarenko holds 119,856 shares (16.6%), Dr William Williams holds 67,064 shares (9.3%), and Dr Charles Wiseman holds 44,604 shares (6.2%)[58]