ADDED
As of October 15, 2025, 1,883,906 shares of the registrant s common shares, no par value per share, were issued and outstanding.
Changes in legislation and regulations may affect our revenue and profitability There is substantial doubt about our ability to continue as a going concern We are highly dependent on our key personnel; We have an unproven market for our product candidates; We are a pre-revenue clinical stage company; Short sellers may be manipulative and may drive down the market price of our common shares; Future issuance of our common shares could dilute the interests of existing shareholders 3 PART I ITEM BUSINESS BUSINESS Overview of the Company BriaCell Therapeutics Corp.
The Company is currently advancing its Bria-IMT targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal 1 Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ).
6.7-9.8 months 2 for similar patients reported in the literature in its Phase 2 study of Bria-IMT combination study with retifanlimab.
A completed Bria-IMT Phase 1/2 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy (listed on ClinicalTrials.gov as NCT03328026 ).
BriaCell Phase 1/2 Study of Bria-OTS , BriaCell s personalized off-the-shelf immunotherapy, also known as Bria-BRES , in metastatic breast cancer is ongoing (listed on ClinicalTrials.gov as NCT06471673 ).
The first patient treated with 4 inoculations of cells (single agent) demonstrated complete resolution of a lung metastasis.
BriaCell is currently developing Bria-OTS and its advanced form, Bria-OTS+ , as a platform technology for personalized off-the-shelf immunotherapies for numerous types of cancer.
Market It is estimated by the National Cancer Institute Cancer Facts and Figures that in 2025, approximately 319,750 people (316,950 women and 2,800 men) will be diagnosed with breast cancer in the United States.
That means that every two minutes an American woman is diagnosed with breast cancer and more than 42,170 are projected to die in 2025.
REMOVED
As of October 28, 2024, 36,183,161 shares of the registrant s common shares, no par value per share, were issued and outstanding.
( BriaPro ) may not generate revenue as expected; Clinical trials involve a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results; Future issuance of our common shares could dilute the interests of existing shareholders; and We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital.
BUSINESS BUSINESS Overview of the Company BriaCell Therapeutics Corp.
The Company is currently advancing its Bria-IMT targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal 1 Phase 3 study in metastatic breast cancer.
6.7-9.8 months 2 for similar patients reported in the literature in its Phase 2 study of Bria-IMT combination study with retifanlimab at the 2023 San Antonio Breast Cancer Symposium.
A completed Bria-IMT Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy.
BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS and Bria-OTS+ , which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer.
Market It is estimated by the National Cancer Institute Cancer Facts and Figures that in 2024, approximately 310,720 women will be diagnosed with breast cancer in the United States.
That means that every two minutes an American woman is diagnosed with breast cancer and more than 42,250 are projected to die in 2024.
It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the American Cancer Society estimates that approximately 2,790 new cases of invasive male breast cancer will be diagnosed and approximately 530 men will die from breast cancer in 2024.