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BriaCell(BCTX) - 2023 Q3 - Quarterly Report
2023-06-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended April 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-40101 BRIACELL THERAPEUTICS CORP. (Exact name of registrant as specified in its charter) | --- | --- | |------------------------------ ...
BriaCell(BCTX) - 2023 Q2 - Quarterly Report
2023-03-15 16:00
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]
BriaCell(BCTX) - 2023 Q1 - Quarterly Report
2022-12-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common shares, no par value BCTX The Nasdaq Stock Market LLC Warrants to purchase common shares, no par value BCTXW The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE S ...
BriaCell(BCTX) - 2022 Q4 - Annual Report
2022-10-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended July 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from [●] to [●] Commission File Number: 001-40101 | --- | --- | |-------------------------------------------------------------------------------------------------------------- ...
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
Exhibit 99.3 BRIACELL THERAPEUTICS CORP. Annual Information Form FOR THE YEAR ENDED JULY 31, 2021 DATED AS OF OCTOBER 28, 2021 TABLE OF CONTENTS | --- | --- | |--------------------------------------------------------------------------|-------| | | | | ANNUAL INFORMATION FORM | 1 | | FORWARD-LOOKING STATEMENTS | 1 | | GLOSSARY OF TERMS | 3 | | CORPORATE STRUCTURE | 6 | | GENERAL DEVELOPMENT OF THE BUSINESS | 7 | | DESCRIPTION OF THE BUSINESS | 11 | | RISK FACTORS | 36 | | DESCRIPTION OF SECURITIES | 55 | | D ...