BriaCell(US:BCTX)2021-10-28 16:00Company 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].