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BriaCell(BCTX) - 2023 Q4 - Annual Report
2023-10-24 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, 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 ...
BriaCell(BCTX) - 2023 Q3 - Quarterly Report
2023-06-13 16:00
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].
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
Company 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].
BriaCell Therapeutics (BCTXF) Presents At 38th Annual J.P. Morgan Healthcare Conference - Slideshow
2020-01-16 20:11
Company Overview - BriaCell Therapeutics Corp is a clinical-stage immunotherapy company focused on developing treatments to boost the body's cancer-fighting cells to destroy cancerous tumors, including BriaIMT™ for advanced breast cancer[4] - The company has recruited 35 patients showing robust response and is developing next-generation HLA-type matching therapies from a saliva test[4] - BriaCell's CEO has been involved in eleven drug approvals[5, 13, 62] Clinical Pipeline and Strategy - BriaCell is developing Bria-IMT™ combined with immune checkpoint inhibitors and Incyte's selected compounds for advanced breast cancer[4] - BriaCell is also developing Bria-OTS™ "Off-The-Shelf Personalized" immunotherapy based on patient's HLA-type[4] - The company believes tumor regression is most pronounced in patients who match Bria-IMT™ at specific HLA-types and develop an immune response[36] - BriaCell is engineering 15 unique HLA types (molecules), collectively referred to as Bria-OTS™, allowing for treatment of over 99% of patients[53] Clinical Trial Data - In a Phase I/IIa study, 23 patients were dosed with Bria-IMT™ monotherapy, showing similar or superior data to other advanced breast cancer drugs at a similar stage[34] - In HLA-matched patients (N=6, ≥ 2 matches), tumor shrinkage was observed in 50% of patients, and 75% in immune responders[35] - In a combination therapy study with checkpoint inhibitors, all 3 patients with Grade I/II tumors had clinical benefit (100%)[48] Financials and Ownership - As of January 3, 2020, the recent share price was C$12.00, with basic shares outstanding of 722,000 and fully diluted shares outstanding of 936,500[57] - Basic market capitalization was C$8.7 million, with insider ownership at 33.5%[57] - Jamieson Bondarenko holds 119,856 shares (16.6%), Dr William Williams holds 67,064 shares (9.3%), and Dr Charles Wiseman holds 44,604 shares (6.2%)[58]