BriaCell(BCTX) - 2023 Q2 - Quarterly Report

Clinical Trial Results and Patient Outcomes - BriaCell's Bria-IMT™ regimen combined with Incyte's retifanlimab showed disease control, tumor shrinkage, and potential survival benefit in 70% of 12 advanced breast cancer patients, who had been heavily pre-treated with at least 2 prior therapy regimens[82][83] - BriaCell's Bria-IMT™ regimen was evaluated in 23 patients with advanced breast cancer in 2017-2018, showing regression of metastatic breast cancer in patients matching Bria-IMT™ at HLA alleles or with grade I/II tumors[71] - 9 of 11 (82%) patients remain alive from 2021/2022 dosing, showing strong survival benefits[96] - 7 of 11 (64%) patients showed disease control or progression-free survival benefits[96] - Median PFS of 3.5 months compares favorably with other studies in advanced disease[96] - 9 additional patients have been screened/enrolled, bringing the total to 21 patients[98] Market and Industry Trends - The global market for cancer drugs, including immunotherapy, is expected to reach $269 billion by 2025, with a CAGR of 10% from 2021 to 2025, and immuno-oncology drugs accounting for about 20% of the market[72] - Approximately 287,500 women were diagnosed with breast cancer in the US in 2022, with 43,000 deaths, and the lifetime risk for women is about 12.9%[72][73] Intellectual Property and Licensing - BriaCell secured an exclusive license from UMBC to develop and commercialize Soluble CD80 (sCD80) as a biologic agent for cancer treatment, with strong anti-tumor activity reported in multiple tumor types[75][76] - BriaCell received a US patent (No. 11,559,574) for its personalized off-the-shelf cell-based immunotherapy, extending intellectual property protection through May 25, 2040, with potential for an additional 5-year extension[89][90] - BriaCell was awarded an Australian patent (No. 2017224232) for its whole-cell cancer immunotherapy technology, extending protection through February 27, 2037[89][91] Partnerships and Collaborations - BriaCell partnered with Caris Life Sciences to leverage its Right-In-Time Clinical Trial Network, which includes over 495 oncology sites, to accelerate patient enrollment for its Phase I/II clinical trial in advanced metastatic breast cancer[79][81] - BriaCell added Mayo Clinic, Jacksonville, Florida as a clinical site in its Phase I/II study of Bria-IMT™ with Incyte's retifanlimab in advanced breast cancer[82] Financial Performance and Expenses - Research and development expenses increased to$ 3,053,357 in Q1 2023, up from $1,708,179 in Q1 2022[103] - Clinical trial expenses increased to$ 1,438,231 in Q1 2023, up from $635,195 in Q1 2022[105] - Wages and salaries for R&D increased to$ 1,282,441 in Q1 2023, up from $524,108 in Q1 2022[108] - Total operating expenses for Q1 2023 were$ 4,486,323, compared to $3,646,809 in Q1 2022[103] - Net loss for Q1 2023 was$ 11,881,762, compared to a net profit of $11,160,507 in Q1 2022[103] - Clinical trial expenses increased to$ 3,041,327 in 2023, up from $960,804 in 2022, driven by the expansion of the Bria-IMT™ trial and preparation for the Bria-OTS™ trial[116] - Pre-clinical project costs rose to$ 1,608,402 in 2023, compared to $906,067 in 2022, due to hiring more staff and adding the sCD80 program[117] - CMC costs increased to$ 741,608 in 2023 from $269,264 in 2022 to support additional patients in trials[117] - Total research and development costs for the six-month period ended January 31, 2023, were$ 6,308,572, up from $2,583,815 in the same period in 2022[120] - Clinical trial and investigational drug costs surged to$ 3,330,516 in 2023 from $1,497,780 in 2022[120] - Wages and salaries for lab employees increased to$ 1,998,985 in 2023 from $809,648 in 2022[120] - Share-based compensation expenses rose to$ 575,347 in 2023 from $109,453 in 2022[120] - The company reported a loss of$ 12,988,303 for the period ended January 31, 2023, compared to $16,372,978 in the same period in 2022[124] - As of January 31, 2023, the company had total assets of$ 34,161,267 and a positive working capital balance of $33,268,148[125] - The company's net cash used in operating activities for the six-month period ended January 31, 2023, was$ 7,494,122, compared to $4,334,808 in the same period in 2022[128] - Total assets as of January 31, 2023, were$ 34,161,267, a decrease from $42,577,041 on July 31, 2022[135] - Positive working capital balance as of January 31, 2023, was$ 33,368,149, down from $41,405,613 on July 31, 2022[135] Risk Management and Financial Controls - The company is exposed to foreign exchange risk due to transactions in Canadian Dollars, but a 5% fluctuation in the Canadian dollar against the US dollar would not materially affect total loss[137] - The company has no significant concentration of credit risk and believes credit risk related to financial instruments is remote[134] - The company does not use derivative instruments to mitigate foreign currency risk[133] - The company has no interest-bearing debt and is not exposed to material interest rate risk[136] - The company has no revenues, making price risk remote[136] - Disclosure controls and procedures were not effective as of January 31, 2023, due to material weaknesses in internal control over financial reporting[140] Legal and Regulatory Matters - The company is involved in a legal dispute with Alpha Capital Anstalt, with no estimated value of claims or damages at this time[142] - The company believes it is more likely than not that it will not have to pay Alpha in the litigation[143] Product Development and Pipeline - BriaCell's next-generation off-the-shelf personalized immunotherapies, Bria-OTS+™ and Bria-PROS™, demonstrated strong immune responses by activating naïve T cells and producing immune-activating molecules[86][87] - BriaCell expects to initiate the Bria-OTS™ study under an IND in the first half of 2023[92]