BriaCell(US:BCTX)2022-12-13 16:00Clinical Trials and Research - BriaCell is advancing its targeted immunotherapy program with a Phase I/IIa clinical trial of Bria-IMT™ in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™[77] - In a recent study, 70% of patients showed either disease control or progression-free survival (PFS) benefits compared to their last therapy, with a disease control rate of 57% observed in evaluable patients[90] - The combination of Bria-IMT™ and Incyte's retifanlimab has shown evidence of clinical benefit, including tumor shrinkage and potential survival benefits in heavily pre-treated advanced breast cancer patients[87] - The Phase I/IIa study of Bria-IMT™ in combination with retifanlimab has received U.S. FDA fast track designation, indicating the potential for expedited development and review[92] - BriaCell's partnership with Caris Life Sciences aims to enhance patient identification for clinical trials, leveraging Caris' extensive clinical data and biomarker technology[85] - The company has developed next-generation off-the-shelf personalized immunotherapies, including Bria-OTS+™ and Bria-PROS™, designed to enhance immune activation for increased efficacy[93] - The median overall survival for patients with de novo stage IV metastatic breast cancer is reported to be 39.2 months, emphasizing the need for effective treatment options like Bria-IMT™[80] Market Opportunity - 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, with approximately 20% attributed to immuno-oncology drugs[78] - Approximately 287,500 women are estimated to be diagnosed with breast cancer in the U.S. in 2022, highlighting the significant market opportunity for BriaCell's therapies[78] Financial Performance - Research and development expenses for the three months ended October 31, 2022, were $3,255,215, a significant increase from $875,636 for the same period in 2021, reflecting expanded clinical trials and increased lab activity[95][96] - General and administrative expenses rose to $2,147,936 for the three months ended October 31, 2022, compared to $1,409,173 in 2021, primarily due to higher insurance premiums and increased personnel costs[97] - The company reported a net loss of $1,106,541 for the period ended October 31, 2022, a substantial decrease from a loss of $27,533,485 in the same period of 2021, largely due to a significant change in the fair value of warrant liability[100] - Financial income for the three months ended October 31, 2022, amounted to $4,296,610, a stark contrast to a financial expense of $25,248,676 in 2021, driven by a gain of $4,117,790 from the change in warrant liability[98] - As of October 31, 2022, the company had total assets of $38,450,320, down from $42,577,041 on July 31, 2022, with a positive working capital balance of $37,249,747[101][103] - The accumulated deficit as of October 31, 2022, was $61,456,378, compared to $60,349,837 on July 31, 2022[103] - The company plans to finance its research and development activities from existing and future working capital resources, believing that current capital will meet liquidity requirements for at least twelve months[102] - Cash used in operating activities for the period ended October 31, 2022, was $3,542,382, compared to $1,778,599 for the same period in 2021[104] Risk Factors - The company has no significant concentration of credit risk and believes that credit risk related to financial instruments is remote[108] - The company is exposed to foreign exchange risk due to transactions in Canadian Dollars, but a 5% fluctuation in the exchange rate would not materially affect total loss[110] Licensing and Collaborations - BriaCell has secured an exclusive license from UMBC to develop and commercialize Soluble CD80 (sCD80) as a biologic agent for cancer treatment[82]