Financial Performance - BriaCell reported total operating expenses of $9,829,446 for the three months ended January 31, 2024, compared to $4,486,323 for the same period in 2023, representing a 119% increase [86]. - The net loss for the three-month period ended January 31, 2024, was $11,294,603, a slight decrease from the loss of $11,881,762 reported in the same period in 2023 [94]. - The net loss for the period ended January 31, 2024, was $5,375,038, a reduction from $12,988,303 in the same period of 2023, indicating a 59% improvement [104]. - The company reported net financial income of $12,975,781 for the six-month period ending January 31, 2024, a significant turnaround from a loss of $3,098,829 in 2023 [102]. Research and Development - Research and development expenses increased to $8,257,455 in Q1 2024 from $3,053,357 in Q1 2023, primarily due to expanded clinical trials for Bria-IMT™ [86]. - Research and development expenses for the six-month period ending January 31, 2024, totaled $15,114,712, a significant increase from $6,308,572 in the same period of 2023, reflecting a 139% rise [97]. - Clinical trial costs surged from $1,288,577 in Q1 2023 to $6,200,980 in Q1 2024, reflecting higher patient enrollment and longer trial durations [91]. - Clinical trial expenses surged to $11,598,418 in 2024 from $3,330,516 in 2023, marking a 248% increase due to extended patient participation and higher setup costs for pivotal studies [100]. - BriaCell initiated its pivotal Phase 3 study of Bria-IMT™ on October 3, 2023, aiming to enroll 177 patients in both the treatment and control arms [84]. - The FDA has granted Fast Track Designation to Bria-IMT™, which could expedite the review process for this immunotherapy [79]. - The company expects ongoing communication with the FDA under its Fast Track status during the pivotal Phase 3 study [84]. Expenses - General and administrative expenses rose to $1,571,991 in Q1 2024 from $1,432,966 in Q1 2023, driven by increased shareholder communication costs [92]. - General and administrative expenses decreased to $3,217,762 in 2024 from $3,580,902 in 2023, primarily due to reduced non-cash share-based compensation expenses [101]. - Financial expenses, net, decreased significantly from $7,395,439 in Q1 2023 to $1,486,119 in Q1 2024, largely due to a reduction in warrant liability losses [93]. Assets and Working Capital - As of January 31, 2024, total assets were $12,231,047, down from $27,163,577 as of July 31, 2023, reflecting a 55% decrease [105]. - The company has a positive working capital balance of $7,817,634 as of January 31, 2024, compared to $25,147,050 on July 31, 2023, indicating a 69% decline [107]. - Cash used in operating activities for the six-month period ending January 31, 2024, was $15,006,564, compared to $7,494,122 in the same period of 2023, representing a 100% increase [109]. - The accumulated deficit as of January 31, 2024, was $85,945,291, up from $80,652,231 as of July 31, 2023, showing a 6% increase [107]. Capital and Risk Management - The company plans to finance its research and development activities through existing and future working capital resources while evaluating additional sources of capital [106]. - The Company does not have any interest-bearing debt, indicating minimal exposure to interest rate risk [114]. - 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 [115]. - The fair values of cash and cash equivalents, trade payables, and accrued expenses approximate their carrying values due to their short terms to maturity [116]. - Cash and cash equivalents are valued using quoted market prices in active markets [116]. - The fair value of the warrant liability is determined using quoted market prices for publicly traded warrants and the Black-Scholes pricing model for others [116].

Core Insights - BriaCell Therapeutics Corp. will present three posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting from April 5-10 in San Diego, CA [1] Group 1: Poster Presentations - Poster 1 focuses on the efficacy of the Bria-IMT regimen in inducing regression of CNS metastasis, scheduled for April 9, 2024 [1] - Poster 2 discusses the efficacy and safety of SV-BR-1-GM after progression on ADC in metastatic breast cancer patients, also on April 9, 2024 [1] - Poster 3 presents the Bria-OTS immunotherapy platform, which aims to harness gene-modified tumor cells for precision anti-tumor responses, scheduled for April 10, 2024 [1] Group 2: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies to transform cancer care [2]

Disease control rate of 61% observed in evaluable Phase 2 patients treated with the same formulation in BriaCell's pivotal Phase 3 study Disease control rate of 50% in evaluable patients treated with the Phase 3 formulation who failed prior antibody-drug conjugate (ADC) therapyNotable responder had failed 4 prior therapies including ADC therapy with metastatic liver tumor "no longer observed" following BriaCell treatment PHILADELPHIA and VANCOUVER, British Columbia, Feb. 07, 2024 (GLOBE NEWSWIRE) -- BriaCel ...

Bria-Pros+ is based on BriaCell's next generation personalized immunotherapy platformBria-Pros+ is capable of activating multiple types of immune cells, including helper T cells, cytotoxic (killer) T cells and natural killer cellsInitiation of GMP manufacturing represents a major milestone for BriaCell's off-the-shelf personalized cellular cancer vaccines PHILADELPHIA and VANCOUVER, British Columbia, Feb. 06, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW))) (TSX:BCT) ("BriaCell" o ...

Core Points - BriaCell Therapeutics Corp. held its annual general meeting of shareholders on January 30, 2024, with 5,375,071 common shares voted, representing 33.63% of the total issued and outstanding shares [1][2]. Shareholder Resolutions - Shareholders voted overwhelmingly in favor of all proposed resolutions, including the re-appointment of MNP LLP as auditors and the election of directors [2]. - The following directors were elected with significant support: - Dr. William V. Williams: 3,487,704 votes (99.71% for) - Mr. Jamieson Bondarenko: 3,302,543 votes (94.41% for) - Mr. Marc Lustig: 3,221,128 votes (92.09% for) - Dr. Jane A. Gross: 3,491,308 votes (99.81% for) - Dr. Rebecca Taub: 3,491,351 votes (99.81% for) - Mr. Vaughn C. Embro-Pantalony: 3,489,398 votes (99.76% for) - Mr. Martin E. Schmieg: 3,486,913 votes (99.68% for) [3]. Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4].

Financial Performance - For the three-month period ended October 31, 2023, total operating expenses amounted to $8,503,028, a significant increase from $5,403,151 in the same period of 2022[80] - Net financial income for the three-month period was $14,461,900, a substantial increase from $4,296,610 in 2022, driven by a gain of $14,282,078 from changes in warrant liability[87] - The Company reported a profit of $5,958,872 for the three-month period ended October 31, 2023, compared to a loss of $1,106,541 in the same period of 2022[88] - The Company's net cash used in operating activities for the period ended October 31, 2023, was $7,605,245, compared to $3,542,382 for the same period in 2022[93] Research and Development - Research and development costs for the same period were $6,857,257, up from $3,255,215 in 2022, primarily due to increased clinical trial expenses[82] - Clinical trial expenses surged to $5,397,438 in 2023 from $2,041,939 in 2022, reflecting the expansion of the Bria-IMT™ trial[85] - BriaCell is advancing its Bria-IMT™ targeted immunotherapy in a pivotal Phase 3 study, reporting a median overall survival of 13.5 months for patients, compared to 6.7-9.8 months in literature[74] Assets and Capital - As of October 31, 2023, total assets were $18,619,235, down from $27,163,577 on July 31, 2023, with a positive working capital balance of $17,361,478[89] - The Company has working capital of $17,361,478, down from $25,147,050 on July 31, 2023[91] - The accumulated deficit as of October 31, 2023, is $74,560,688, reduced from $80,652,231 on July 31, 2023[91] - The Company intends to raise additional capital through debt or equity financing to support its business plan objectives[92] Cash Flow - Cash and cash equivalents decreased by $7,605,245 from the previous year, reflecting a significant cash outflow[93] Ownership and Transactions - The Company completed a spinout transaction on August 31, 2023, resulting in a 2/3rd ownership of BriaPro Therapeutics Corp., which holds certain pipeline assets[75] Risk Management - The Company does not use derivative instruments to mitigate foreign currency risk, which arises from transactions in Canadian Dollars[96] - A 5% fluctuation in the Canadian dollar against the US dollar would not have a material effect on the total loss and comprehensive loss as of October 31, 2023[100] - The Company has no significant concentration of credit risk arising from operations, indicating a remote credit risk concentration[97] Accounting Policies - The Company has not adopted any new accounting policies during the period ended October 31, 2023[95] General and Administrative Expenses - General and administrative expenses decreased to $1,645,771 in 2023 from $2,147,936 in 2022, mainly due to lower non-cash share-based compensation[86]

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, 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 Number: 001-40101 BRIACELL THERAPEUTICS CORP. (Exact name of registrant as specified in its charter) British Columbia 47-1099599 (State or othe ...

Clinical Trials and Efficacy - BriaCell's Bria-IMT™ regimen in combination with Incyte's retifanlimab showed that 70% of patients experienced disease control or progression-free survival benefits compared to their last therapy[81]. - In a cohort of 12 advanced breast cancer patients, 9 of 11 (82%) patients remained alive, indicating strong survival benefits from the Bria-IMT™ regimen[94]. - The combination of Bria-IMT™ and retifanlimab produced evidence of disease control and tumor shrinkage in heavily pre-treated advanced breast cancer patients[81]. - The Phase II clinical trial of Bria-IMT™ in combination with retifanlimab is ongoing, with positive initial efficacy data reported[81]. - BriaCell's End of Phase II meeting with the FDA confirmed agreement on the primary endpoint and study design for the upcoming pivotal clinical study in advanced metastatic breast cancer[92]. - The median progression-free survival (PFS) for patients in the study was 3.5 months, with one subject ongoing, indicating favorable outcomes compared to other recent studies[95]. - 15 of 18 patients recruited since the study reopened in 2021 remained alive, demonstrating the tolerability and clinical effectiveness of BriaCell's combination treatment[97]. Financial Performance - The company reported a net loss of $4,895,436 for the three months ended April 30, 2023, compared to a loss of $10,015,573 for the same period in 2022, indicating a significant reduction in losses[108]. - For the nine months ended April 30, 2023, total operating expenses were $15,566,503, up from $10,054,878 in the same period in 2022[109]. - Research costs for the nine months ended April 30, 2023, amounted to $10,169,140, compared to $4,852,620 for the same period in 2022, marking a substantial increase[111]. - The company experienced a gain of $539,427 in the change in fair value of warrant liability for the three months ended April 30, 2023, compared to a loss of $5,928,528 in the same period in 2022[107]. - General and administrative expenses decreased to $1,816,461 for the three months ended April 30, 2023, from $1,854,455 in the same period in 2022, primarily due to reduced non-cash share-based compensation[106]. - For the nine-month period ended April 30, 2023, general and administrative expenses increased to $5,397,363 from $5,202,258 in the same period of 2022, primarily due to higher insurance premiums, professional fees, and salaries[116]. - The net financial expenses for the nine-month period ended April 30, 2023, were $2,317,236, a significant decrease from $16,333,673 in the prior year, largely due to a loss of $2,972,285 from the warrant liability compared to a loss of $16,384,676 in the previous period[117]. - The company recorded a loss of $17,883,739 for the period ended April 30, 2023, an improvement from a loss of $26,388,551 in the same period of 2022[118]. Research and Development - Research and development expenses for the three months ended April 30, 2023, totaled $3,860,568, a 70.2% increase from $2,268,805 in the same period in 2022[99]. - Clinical trial expenses increased from $1,364,090 in 2022 to $2,469,105 in 2023, reflecting the expansion of the Bria-IMT™ trial[105]. - The company is developing next-generation off-the-shelf personalized immunotherapies, Bria-OTS+™ and Bria-PROS™, which activate naïve T cells for enhanced immune responses[85]. Regulatory and Licensing - The FDA provided guidance for the Bria-OTS™ clinical-grade cell lines, with an expected initiation of the study under an Investigational New Drug Application (IND) in the second half of 2023[90]. - BriaCell has secured an exclusive license to develop and commercialize Soluble CD80 (sCD80) for cancer treatment, with royalties payable upon commercialization[75]. - The company received an Issue Notification for a patent covering its personalized off-the-shelf cell-based immunotherapy, extending protection until May 25, 2040[86]. Company Operations and Management - BriaCell's partnership with Caris Life Sciences aims to accelerate patient enrollment in clinical trials through efficient patient identification[78]. - The company plans to accelerate the path to commercialization for its lead clinical candidate Bria-IMT™ following positive FDA feedback on its pivotal study[97]. - The company plans to finance its operations through existing and future working capital resources and is evaluating additional sources of capital[119]. - As of April 30, 2023, the company had total assets of $29,721,868, down from $42,577,041 as of July 31, 2022, with a positive working capital balance of $28,119,886[120]. - The accumulated deficit as of April 30, 2023, was $78,233,576, compared to $60,349,837 as of July 31, 2022[121]. - The net cash used in operating activities during the nine-month period ended April 30, 2023, was $12,825,853, an increase from $9,158,647 in the same period of 2022[122]. - Cash used in financing activities for the nine-month period ended April 30, 2023, was $45,700, significantly lower than $3,582,874 in the prior year[123]. - As of April 30, 2023, the company has no significant concentration of credit risk arising from operations, and liquidity risk is managed to ensure sufficient liquidity to meet liabilities[126]. - As of April 30, 2023, the company's disclosure controls and procedures were deemed ineffective due to material weaknesses in internal control over financial reporting[130]. - The company is implementing plans to improve material weaknesses, including hiring additional personnel and segregating duties among the team[130]. - There have been no material changes in internal control over financial reporting during the quarter ended April 30, 2023, except for ongoing remediation efforts[131]. Foreign Exchange and Risk Management - The company is exposed to foreign exchange risk due to transactions in Canadian Dollars, but a 5% fluctuation in the exchange rate would not have a material effect on total loss[128].

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]

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 ...