16 unchanged sentences
2 - Results of Operations.
−Removed: This section provides an analysis of our results of operations for the first half and second quarter
−Removed: of fiscal 2025 in comparison to the first half and second quarter of fiscal 2024.
+Added: This section provides an analysis of our results of operations for the first quarter of fiscal 2025
+Added: in comparison to the first quarter of fiscal 2024.
3 - Financial Liquidity and Capital Resources.
18 unchanged sentences
are not limited to, those described in our other SEC filings.
−Removed: Therapeutics Corp.
−Removed: (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to
−Removed: transform cancer care.
−Removed: Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune
−Removed: system to recognize and destroy cancer cells.
−Removed: The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination
−Removed: with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study (ClinicalTrials.gov
−Removed: NCT06072612 ) in metastatic breast cancer.
−Removed: The pivotal Phase 3 study of Bria-IMT™ is currently
−Removed: under Fast Track Designation by the U.S.
−Removed: FDA intended to accelerate the review process of novel treatments that address unmet medical
−Removed: Positive completion of the pivotal Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™
−Removed: plus an immune checkpoint inhibitor in metastatic breast cancer.
−Removed: is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
−Removed: Additionally,
−Removed: BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier:
−Removed: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS™,
−Removed: BriaCell’s personalized next generation immunotherapy, in metastatic breast cancer and other cancers.
−Removed: The study will investigate
−Removed: Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by
−Removed: BeiGene, Ltd.) for the treatment of metastatic breast cancer.
−Removed: Bria-OTS™/Bria-OTS+™, provides a platform technology to develop
−Removed: personalized off-the-shelf immunotherapies for numerous types of cancer.
−Removed: January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of
−Removed: the Company’s issued and outstanding common shares (the “Common Shares”) on the basis of one (1) post-Consolidation
−Removed: Common Share for every fifteen (15) pre-Consolidation Common Shares.
−Removed: The Consolidation is being implemented to ensure that the Company
−Removed: continues to comply with the listing requirements of The Nasdaq Capital Market (the “Nasdaq”).
−Removed: The effective date of the
−Removed: consolidation was January 29, 2025.
−Removed: February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor
−Removed: that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient treated with
−Removed: Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation
−Removed: study (ClinicalTrials.gov identifier:
−Removed: NCT06471673) in metastatic recurrent breast cancer.
−Removed: Bria-OTS™ represents a personalized,
−Removed: next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic
−Removed: breast cancer.
−Removed: February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate
−Removed: gross proceeds of approximately $3.05 million before deducting placement agent fees and other offering expenses (the “February
−Removed: 2025 Offering”).
−Removed: Each common share was sold at a public offering price of $4.00 per share.
−Removed: In addition, the Company issued 38,125
−Removed: agent warrants.
−Removed: The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price
−Removed: of $5.00 per share.
−Removed: April 10, 2025, the Company announced that its majority owned subsidiary, BriaPro Therapeutics Corp.
−Removed: (“ BriaPro ”),
−Removed: is developing novel, high affinity antibodies to B7-H3, a key player in cancer progression, using molecular modeling techniques.
−Removed: has filed provisional US patent applications for the corresponding technology and plans on filing an international patent application
−Removed: under the Patent Cooperation Treaty (PCT).
−Removed: both an immune checkpoint molecule that regulates T cell activity and a cell surface molecule expressed on many types of cancer cells,
−Removed: B7-H3 is a promising drug target.
−Removed: BriaPro plans on developing anti-B7-H3 antibodies for multiple cancer indications and plans to incorporate
−Removed: them into its Bria-TILsRx™ platform—a proprietary antibody platform designed to redirect and activate T cells within the
−Removed: tumor microenvironment.
−Removed: This platform integrates both T cell engagers, which promote T cell-mediated tumor killing, and tumor-targeted
−Removed: immune checkpoint modulators, which selectively block inhibitory signals on tumor infiltrating lymphocytes (TILs) to enhance their anti-tumor
−Removed: April 16, 2025, the Company announced new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI),
−Removed: outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.
−Removed: In BriaCell’s Phase 2 clinical
−Removed: study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+
−Removed: breast cancer.
−Removed: As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of
−Removed: care TRODELVY ® (14.4 months).
−Removed: The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple
−Removed: negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2)
−Removed: receptors, was similar to TRODELVY ® but still markedly higher (70%) than those of chemotherapy.Table 1:
−Removed: Comparable Analysis
−Removed: of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™
−Removed: plus CPI versus other drugs in MBC patient subsets
−Removed: govitecan-hziy)
−Removed: agent chemotherapy
−Removed: govitecan-hziy)
−Removed: agent chemotherapy
−Removed: Patients treated with the Phase 3 formulation
−Removed: Number of prior chemotherapy-containing regimens
−Removed: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
−Removed: Abbreviations:
−Removed: hormone receptor-positive
−Removed: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth
−Removed: factor receptor 2 (HER2))
−Removed: April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612)
−Removed: has consented over 100 and has enrolled over 75 patients.
−Removed: BriaCell anticipates completing patient enrollment in late 2025 or early 2026,
−Removed: and may report top line data as early as H1-2026.
−Removed: April 24, 2025, BriaCell Confirmed 100% Resolution of Lung Metastasis with Bria-OTS (Figure 1).
−Removed: Complete resolution of lung metastasis
−Removed: confirmed at 4 months follow-up in a hormone receptor positive (HR+) breast cancer patient.
−Removed: Treatment well-tolerated and the patient
−Removed: remained on study with stable disease elsewhere.
−Removed: Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy
−Removed: approach in Phase 1/2a metastatic breast cancer study.
−Removed: Treatment with Bria-OTS monotherapy resulted in 100% resolution of
−Removed: tumor in the lung of the MBC patient following 2 months of therapy and confirmed at 4 months of therapy 1 (axial and coronal
−Removed: Note that the other white dots in the lungs are blood vessels.
−Removed: shown, the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months.
−Removed: images supersede those previously reported.
−Removed: April 28, 2025, the Company closed an underwritten public offering for the purchase and sale of 3,066,666 units for aggregate gross proceeds
−Removed: of approximately $13.8 million before deducting underwriting discounts, commissions, and other offering expenses (the “April 2025
−Removed: Of those units, 2,405,966 were “regular” units, each consisting of one common share and one five-year publicly
−Removed: traded warrant at a combined purchase price of $4.50 per unit, and 660,700 were “pre-funded” units, each consisting of one
−Removed: pre-funded warrant (at a $0.001 strike) and one five-year publicly traded warrant at a combined purchase price of $4.499 per unit.
−Removed: warrants have an exercise price of $5.25 per share, are immediately exercisable, and expire five years from the date of issuance (“April
−Removed: 2025 Warrants”).
−Removed: The April 2025 Warrants trade on the NASDAQ under the symbol “BCTXZ.”
−Removed: connection with the April 2025 Offering, the Company issued 153,333 representative’s warrants.
−Removed: The representative’s warrants
−Removed: are immediately exercisable at an exercise price of $5.625 per share and expire five years from the date of issuance.
−Removed: April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025.
−Removed: Positive tolerability profile and potential response
−Removed: biomarkers were identified.
−Removed: Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in
−Removed: Phase 2 study.
−Removed: Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits.
−Removed: Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were linked
−Removed: to longer progression-free survival (PFS) in Phase 3 patients.
−Removed: Presence of Circulating Tumor Cells (CTC) after patients’ initial
−Removed: Phase 3 treatment supports their role as negative prognostic marker (p = 0.04).
−Removed: The Bria-IMT Phase 3 regimen was well-tolerated with
−Removed: a preferred tolerability profile.
−Removed: May 23, 2025, BriaCell reported that its abstracts showcased positive survival and clinical benefit data at ASCO 2025.
−Removed: Phase 2 survival
−Removed: and clinical benefit data met or exceeded outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no
−Removed: treatment-related discontinuations.
−Removed: Successful completion of the pivotal Phase 3 study may support Biologics License Application, Priority
−Removed: Review, Full Approval, and Commercialization.
−Removed: May 27, 2025, BriaCell announced that the Bria-OTS Phase 1/2 Study cleared safety evaluation, and BriaCell dosed its first patient in
−Removed: Bria-OTS combination with an immune checkpoint inhibitor.
−Removed: Specifically, Bria-OTS has cleared its safety evaluation in the Phase 1/2 study
−Removed: monotherapy dosage setting.
−Removed: Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic
−Removed: breast cancer.
−Removed: The first Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis.
−Removed: of Operations for the Three Months Ended April 30, 2025 and 2024
−Removed: development, and clinical trial expenses
−Removed: and administrative expenses
+Added: BriaCell Therapeutics Corp.
+Added: or the “Company”) is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care.
+Added: Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize
+Added: and destroy cancer cells.
+Added: The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune
+Added: check point inhibitor (Retifanlimab) in a pivotal 1 Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov
+Added: as NCT06072612 ).
+Added: Bria-IMT™ is currently under Fast Track Designation by the U.S.
+Added: Food and Drug Administration
+Added: (the “FDA”) intended to accelerate the review process of novel treatments that address unmet medical needs.
+Added: Positive completion
+Added: of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination
+Added: in metastatic breast cancer.
+Added: BriaCell has reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer
+Added: with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer patients vs.
+Added: 6.7-9.8 months 2 for similar
+Added: patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab.
+Added: Additionally, BriaCell
+Added: reported median overall survival of 16.5 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint
+Added: inhibitor in patients treated with the Phase 3 formulation since 2022 (post-COVID).
+Added: A completed Bria-IMT™ Phase 1/2 combination
+Added: study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy (listed on ClinicalTrials.gov
+Added: as NCT03328026 ).
+Added: BriaCell Phase 1/2 Study of Bria-OTS™,
+Added: BriaCell’s personalized off-the-shelf immunotherapy, also known as Bria-BRES™, in metastatic breast cancer is ongoing (listed
+Added: on ClinicalTrials.gov as NCT06471673 ).
+Added: The first patient treated with 4 inoculations of cells (single agent) demonstrated
+Added: complete resolution of a lung metastasis.
+Added: BriaCell is currently developing Bria-OTS™ and its advanced form, Bria-OTS+™, as
+Added: a platform technology for personalized off-the-shelf immunotherapies for numerous types of cancer.
+Added: In September 2024, the Company announced
+Added: BriaCell had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™
+Added: for prostate cancer.
+Added: the period from August 1, 2025 through to the date of this report, we announced a number of corporate, financing and R&D developments.
+Added: On August 21, 2025, our board approved a consolidation of the Company’s issued and outstanding common shares on the basis of one
+Added: post-consolidation common share for every ten pre-consolidation common shares, primarily to help ensure continued compliance with Nasdaq
+Added: Capital Market listing requirements.
+Added: The consolidation became effective on August 25, 2025, with the post-consolidation common shares
+Added: commencing trading on the Toronto Stock Exchange and Nasdaq on that date.
+Added: also strengthened our non-dilutive funding and external collaborations.
+Added: On August 13, 2025, we announced acceptance into Memorial Sloan
+Added: Kettering Cancer Center’s (MSK’s) 2025 Therapeutics Accelerator Cohort program for the Bria-OTS+™ platform, which includes
+Added: the Bria-BRES+™ product candidate for breast cancer.
+Added: August 25, 2025, we reported that we had been awarded a US$2.0 million Small Business Innovation Research (SBIR) grant from the U.S.
+Added: National Cancer Institute (NCI) to advance Bria-PROS+™ in prostate cancer, providing non-dilutive funding to support manufacturing
+Added: and planned clinical evaluation activities for this program
+Added: October 21, 2025, we further announced a collaboration with MSK’s Therapeutics Accelerator program focused on the Bria-OTS+ platform.
+Added: The collaboration includes support for manufacturing, IND development and clinical protocol work for a planned Phase 1 study of Bria-BRES+
+Added: in breast cancer, and is intended to help accelerate clinical development of Bria-OTS+ across multiple cancer indications.
+Added: continued to advance our pivotal Phase 3 clinical study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) in metastatic breast
+Added: cancer (MBC).
+Added: On October 13, 2025, we announced plans to present positive biomarker data from this ongoing trial at the ESMO 2025 Congress,
+Added: highlighting that biomarkers identified in our prior Phase 2 study showed similar trends in the Phase 3 setting, and that a delayed-type
+Added: hypersensitivity response appeared to be associated with longer progression-free survival in a blinded analysis of Phase 3 patients,
+Added: with no new safety or tolerability issues identified.globenewswire.com On October 21, 2025, we reported that 79 clinical sites across
+Added: states were enrolling patients in the Phase 3 study, including new participation by Dartmouth Cancer Center, Cedars-Sinai Medical
+Added: Center and Winship Cancer Institute of Emory University, and indicated that top-line data could be available as early as the first half
+Added: of 2026, subject to event accrual.globenewswire.com On October 22, 2025, we disclosed that the independent Data Safety Monitoring Board
+Added: (DSMB) had issued a fourth consecutive positive recommendation following review of safety data from the Phase 3 trial, identifying no
+Added: safety concerns and recommending that the study continue without modification;
+Added: the trial is being conducted under U.S.
+Added: FDA Fast Track
+Added: also expanded our clinical data-generation activities for Bria-IMT at major oncology conferences.
+Added: In November and December 2025, we announced
+Added: a series of forthcoming presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS®).
+Added: On November 18 and November 25, 2025,
+Added: we reported that three BriaCell posters had been accepted, which together will present updated overall survival data from the Phase 2
+Added: study of Bria-IMT plus CPI in MBC and positive biomarker findings from the pivotal Phase 3 study.app.researchpool.com+1 On December 2,
+Added: 2025, we confirmed that these SABCS presentations, scheduled for December 10, 2025, will highlight survival and clinical benefit data
+Added: from the Phase 2 program as well as key Phase 3 biomarker data, and reiterated that an interim overall survival analysis in the pivotal
+Added: Phase 3 trial is expected in the first half of 2026.
+Added: parallel, we continued to develop our next-generation Bria-OTS+™ off-the-shelf cell-based immunotherapy platform.
+Added: On October 3,
+Added: 2025, we announced plans to present preclinical data on Bria-OTS+ at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting,
+Added: followed on November 4, 2025 by a release describing a SITC poster to showcase anti-tumor activity of Bria-OTS+ in breast and prostate
+Added: cancer models, and the ongoing GMP manufacturing of lead candidates Bria-BRES+ and Bria-PROS+ in preparation for clinical trials.globenewswire.com+2BriaCell+2
+Added: On November 7, 2025, we reported preclinical results presented at SITC 2025 indicating that Bria-OTS+ induced rapid and durable anti-cancer
+Added: activity in preclinical models by engaging both innate and adaptive immune responses, and that both Bria-BRES+ and Bria-PROS+ increased
+Added: tumor cell cytotoxicity in these models.
+Added: we continued to broaden our pipeline beyond cell-based immunotherapies.
+Added: On November 20, 2025, we announced a collaboration between our
+Added: subsidiary BriaPro Therapeutics Corp.
+Added: and Receptor.AI to apply Receptor.AI’s artificial intelligence platform to design highly
+Added: selective anti-cancer kinase inhibitor candidates.
+Added: The collaboration is intended to expand BriaPro’s small-molecule oncology pipeline
+Added: and complements our existing cell-based programs, with the goal of accelerating development of next-generation cancer therapeutics with
+Added: improved efficacy and safety profiles.
+Added: of Operations for the Three Months Ended October 31, 2025, and 2024
+Added: Three months ended
Operating expenses:
−Removed: expenses, net
−Removed: in fair value of the warrant liability
−Removed: of loss on equity investments
−Removed: loss for the period
−Removed: loss attributable to non-controlling interest
−Removed: loss for the period attributable to BriaCell
−Removed: loss per share attributable to BriaCell – basic and diluted
−Removed: Development, and Clinical Trial Costs
−Removed: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development;
−Removed: clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our
−Removed: clinical trials.
−Removed: following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
−Removed: months ended April 30,
−Removed: trial sites and investigational drug costs
−Removed: the three-month period ended April 30, 2025, total research, development, and clinical trial costs amounted to $4,810,196 as compared
−Removed: to $7,657,632 for the three-month period ended April 30, 2024.
−Removed: This reduction was primarily driven by lower clinical trial sites and
−Removed: investigational drug costs, which decreased from $6,165,072 in 2024 to $3,175,543 in 2025.
−Removed: The decrease reflects the conclusion of the
−Removed: Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
−Removed: Wages and salaries increased considerably,
−Removed: from $1,090,902 in 2024 to $1,303,157 in 2025, reflecting the hiring of additional employees.
−Removed: Laboratory rent increased to $114,330 in
−Removed: 2025, up from $109,500 in 2024, due to expanded use of facilities to support ongoing research.
−Removed: Supplies decreased, from $165,264 in 2024
−Removed: to $157,184 in 2025, driven by lowered spending.
−Removed: Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in
−Removed: capital assets to support research activities.
−Removed: Professional fees increased to $650 in 2025, compared to $581 in 2024.
−Removed: Notably, share-based
−Removed: compensation expenses decreased significantly, from $126,313 in 2024 to $36,493 in 2025, contributing to the overall reduction in research,
−Removed: development, and clinical trial expenses.
−Removed: trial expenses for the period are as follows:
−Removed: months ended April 30,
−Removed: Bria-IMT™ Pivotal Phase 3
+Added: Research and development expenses
+Added: General and administrative expenses
+Added: Total operating expenses
+Added: Operating loss
+Added: Financial income, net
+Added: Change in fair value of the warrant liability
+Added: Share of loss on equity investment
+Added: Net loss for the period
+Added: $ (8,278,328 )
+Added: $ (5,829,276 )
+Added: Net loss attributable to non-controlling interest
+Added: Net loss for the period attributable to BriaCell
+Added: Net loss per share attributable to BriaCell – basic and diluted
+Added: Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
+Added: and Development Costs
+Added: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and (ii) clinical trials and investigational
+Added: drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
+Added: following is a breakdown of our research and development costs by nature of expenses:
+Added: months ended October 31,
+Added: Clinical trial sites and investigational
+Added: Wages and salaries
+Added: Laboratory Rent
+Added: Professional fees
+Added: Share-based compensation
+Added: the three-month period ended October 31, 2025, total research and development expenses were $6,683,643, compared to $3,665,341 for the
+Added: three-month period ended October 31, 2024.
+Added: The increase was primarily driven by higher clinical trial sites and investigational drug
+Added: costs, which rose from $2,439,667 in 2024 to $4,863,199 in 2025.
+Added: The increase reflects the progression of the pivotal Phase 3 trial,
+Added: including higher patient-related costs, expanded site activity, and increased investigational product usage.
+Added: Wages and salaries increased
+Added: from $949,089 in 2024 to $1,303,702 in 2025, reflecting higher headcount and additional personnel required to support clinical operations
+Added: and ongoing development programs.
+Added: Laboratory rent increased to $124,610 in 2025, compared to $114,330 in 2024, due to expanded utilization
+Added: of laboratory space and related facility charges.
+Added: Supplies increased from $99,430 in 2024 to $276,657 in 2025, reflecting increased consumable
+Added: usage driven by greater clinical and laboratory activity during the current period.
+Added: Depreciation expense was consistent year over year
+Added: at $22,839 for both periods.
+Added: Professional fees increased from $7,268 in 2024 to $9,205 in 2025, primarily due to higher consulting, regulatory,
+Added: and scientific support related to advancing clinical development.
+Added: Share-based compensation increased from $32,718 in 2024 to $83,431
+Added: in 2025, reflecting a higher level of equity-based awards outstanding during the period.
+Added: clinical trial expenses are broken down as follows:
+Added: Three months ended
+Added: Bria-IMT™ Pivotal Phase 3 study
Bria-IMT™ Phase 1/2a
−Removed: Bria-OTS™ Phase
−Removed: trial expenses for the three months ended April 30, 2025, were $3,190,751, compared to $4,359,850 during the same period in 2024.
−Removed: slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting
−Removed: in lower associated costs.
−Removed: As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly directed toward
−Removed: the pivotal Phase 3 study, which remains our primary focus.
−Removed: At the same time, we have begun incurring costs related to the Bria-OTS™
−Removed: Phase 1/2a trial, which commenced in August 2024.
−Removed: the three-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,708,394, a decrease from $3,764,521
−Removed: This decrease reflects the planned phasing of expenditures within the pivotal study;
−Removed: the prior-year quarter included higher
−Removed: up-front activities, whereas current spending is concentrated on ongoing patient recruitment, treatment, and data-management costs as
−Removed: we push toward key milestones.
−Removed: the three-month period ended April 30, 2025, Bria-IMT™ Phase 1/2a costs were $300,013, a significant decline from $898,528 in 2024,
−Removed: as the trial has now concluded.
−Removed: The remaining expenses primarily relate to final data analysis and study close-out activities.
−Removed: the three-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $182,344, compared to $nil in 2024.
−Removed: is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
+Added: Bria-OTS™ Phase 1/2a
+Added: Clinical trial expenses for the three months ended October 31, 2025, were
+Added: $4,944,193, compared to $2,708,091 during the same period in 2024.
+Added: The increase reflects higher spending across both the Bria-IMT™
+Added: pivotal Phase 3 program and the Bria-OTS™ Phase 1/2a program.
+Added: Phase 3 costs increased as the study advanced, enrolled more patients, and required greater clinical
+Added: support, while Bria-OTS™ expenses rose substantially as the program moved into the clinic.
+Added: Together, these programs account for the majority of the year-over-year increase in clinical trial expenses.
+Added: For the three-month period
+Added: ended October 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs were $3,792,951, compared to $2,446,461 in 2024.
+Added: reflects the study moving into a more cost-intensive stage, with higher charges related to CRO services, enrolling and treating more
+Added: patients, central lab work, and clinical supply management.
+Added: Several scheduled billing milestones also fell within the current
+Added: quarter, contributing to the higher spend as the Phase 3 program progresses.
+Added: For the three-month period ended October 31, 2025, Bria-IMT™ Phase
+Added: 1/2a expenses were $163,204, compared to $184,042 in 2024.
+Added: The decrease reflects the continued wind-down of the program following its
+Added: completion in fiscal 2024, with current-period activity limited to residual close-out and data-related tasks.
+Added: Costs remain modest and
+Added: are expected to taper further as final wrap-up items are completed.
+Added: For the three-month period
+Added: ended October 31, 2025, Bria-OTS™ Phase 1/2a expenses were $988,038, compared to $77,588 in 2024.
+Added: The substantial increase
+Added: reflects the rapid advancement of the OTS program as we move into the clinic.
+Added: Current-period costs include expanded preclinical
+Added: development activities, enrolling and treating more patients, GMP manufacturing of Bria-BRES+ and Bria-PROS+, and increased
+Added: regulatory, analytical, and operational work needed to support the next-generation Bria-OTS+ platform.
+Added: The investment aligns with
+Added: the program’s progression toward first-in-human evaluation and the broader expansion of OTS across multiple solid tumor
and Administrative Expenses
−Removed: the three-month period ended April 30, 2025, general and administrative expenses amounted to $1,518,059, compared to $1,572,016 for the
−Removed: same period in 2024.
−Removed: The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
−Removed: in overall stable general and administrative expenses quarter over quarter.
+Added: For the three-month period ended October 31, 2025, general and administrative
+Added: expenses were $1,639,300, compared to $1,487,491 for the same period in 2024.
+Added: The increase was driven primarily by higher shareholder
+Added: communications costs and increased wages and salaries, partly offset by lower professional fees, consulting, insurance, and travel expenses.
income (expenses), net
−Removed: the three-month period ended April 30, 2025, financial expense amounted to $9,762, compared to income of $13,215 for the three-month
−Removed: period ended April 30, 2024.
−Removed: Financial expense for the 2025 period consisted of $26,632 in interest income offset by $585 foreign exchange
−Removed: loss and interest expense of $36,979 .
−Removed: In comparison, financial income for the 2024 period included $15,606 in interest income and a
−Removed: $2,391 foreign exchange loss.
−Removed: The decrease in financial income to a loss from 2024 to 2025 was primarily due to higher interest expense
−Removed: in 2025 compared to nil in 2024.
−Removed: for the period
−Removed: Company reported a loss of $6,224,929 for the three-month period ended April 30, 2025, compared to income of $1,692,242 for the same
−Removed: period in 2024.
−Removed: The swing to a net loss was primarily driven by a significantly smaller non-cash gain from the change in fair value of
−Removed: the warrant liability, which declined from $10,945,672 in 2024 to $175,826 in 2025.
−Removed: Additionally, research, development, and clinical
−Removed: trial expenses decreased from $7,657,632 in 2024 to $4,810,196 in 2025, mainly due to lower clinical-trial and investigational-drug costs
−Removed: following the completion of the Bria-IMT™ Phase 1/2a trial, partially offsetting the impact of the reduced warrant-liability gain.
−Removed: of Operations for the Nine Months Ended April 30, 2025 and 2024
−Removed: development, and clinical trial expenses
−Removed: and administrative expenses
−Removed: operating expenses
−Removed: expenses, net
−Removed: in fair value of the warrant liability
−Removed: of loss on equity investments
+Added: For the three-month period ended
+Added: October 31, 2025, the Company recorded net financial income of $158,646, compared to $11,714 in the same period of 2024.
+Added: is mainly attributable to higher interest income and an unrealized gain on short-term investments during the current period.
+Added: three-month period ended October 31, 2025, financial income was comprised of $48,482 of interest income, an $89,487 unrealized gain on
+Added: short-term investments, and a $20,677 foreign exchange gain.
+Added: For the three-month period ended October 31, 2024, financial income consisted
+Added: of $13,050 of interest income and a $1,336 foreign exchange loss.
+Added: The year-over-year increase reflects higher cash and cash equivalents
+Added: available for investment, resulting in increased interest income, as well as unrealized gains recognized on the Company’s short-term
+Added: investment portfolio during the current quarter.
(loss) for the period
−Removed: loss attributable to non-controlling interest
−Removed: loss for the period attributable to BriaCell
−Removed: loss per share attributable to BriaCell – basic and diluted
−Removed: Development, and Clinical Trial Costs
−Removed: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;
−Removed: and (ii) Clinical trials and investigational
−Removed: drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
−Removed: following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
−Removed: months ended April 30,
−Removed: trial sites and Investigational drug costs
−Removed: the nine-month period ending April 30, 2025, research, development and clinical trial costs amounted to $14,160,314, a significant decrease
−Removed: from the $22,772,344 incurred during the same period in 2024.
−Removed: This reduction was primarily driven by lower clinical trial sites and investigational
−Removed: drug costs, which decreased from $17,763,490 in 2024 to $9,732,786 in 2025.
−Removed: The decrease reflects the conclusion of the Bria-IMT™
−Removed: Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
−Removed: Wages and salaries increased slightly, from $3,513,306
−Removed: in 2024 to $3,544,267 in 2025, reflecting the hiring of additional employees.
−Removed: Laboratory rent increased to $342,990 in 2025, up from
−Removed: $305,980 in 2024, due to expanded use of facilities to support ongoing research.
−Removed: Supplies decreased, from $566,830 in 2024 to $341,878
−Removed: in 2025, driven by lowered spending.
−Removed: Depreciation expenses of $68,517 were recognized in 2025, reflecting investments in capital assets
−Removed: to support research activities.
−Removed: Professional fees increased to $9,826 in 2025, compared to $4,363 in 2024, primarily due to consulting
−Removed: and support for clinical operations.
−Removed: Notably, share-based compensation expenses decreased significantly, from $618,375 in 2024 to $120,050
−Removed: in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
−Removed: trial expenses for the period are as follows:
−Removed: months ended April 30,
−Removed: Pivotal Phase 3 study
−Removed: trial expenses for the nine-month period ended April 30, 2025, were $9,822,400, compared to $12,650,189 during the same period in 2024.
−Removed: This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the planned phasing of expenditures within the pivotal
−Removed: Phase 3 study, which remains our primary focus.
−Removed: While resources have been increasingly directed toward Phase 3, we have also begun incurring
−Removed: costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
−Removed: the nine-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $8,797,505, up from $8,651,728 in 2024.
−Removed: The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, treatment,
−Removed: site activation, and data-management activities to support the study’s advancement.
−Removed: Phase 1/2a costs declined to $699,356, a sharp reduction from $3,998,461 in 2024, reflecting the trial’s conclusion.
−Removed: The remaining
−Removed: costs are tied to final reporting, regulatory submissions, and study close-out activities.
−Removed: the nine-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $325,539, compared to $nil in 2024.
−Removed: is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
−Removed: remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources
−Removed: strategically to ensure its successful execution.
−Removed: and Administrative Expenses
−Removed: the nine-month period ended April 30, 2025, general and administrative expenses amounted to $4,490,216, compared to $4,789,778 for the
−Removed: same period in 2024.
−Removed: The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
−Removed: in overall stable general and administrative expenses period over period.
−Removed: income (expenses), net
−Removed: the nine-month period ended April 30, 2025, financial income amounted to $69,310, compared to $274,665 for the nine-month period ended
−Removed: April 30, 2024.
−Removed: Financial income for the 2025 period consisted of $86,514 in interest income and a $19,775 foreign exchange gain offset
−Removed: by interest expense of $36,979.
−Removed: In comparison, financial income for the 2024 period included $288,016 in interest income, offset by a
−Removed: $13,351 foreign exchange loss.
−Removed: The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting
−Removed: reduced cash and cash equivalents available for investment in interest-bearing funds.
−Removed: for the period
−Removed: Company reported a loss of $18,392,033 for the nine-month period ended April 30, 2025, compared to $3,682,796 in 2024.
−Removed: The increase was
−Removed: primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $366,024 in 2025 compared to $23,660,003
−Removed: This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $22,772,344
−Removed: in 2024 to $14,160,314 in 2025, mainly due to lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™
−Removed: Phase 1/2a trial.
+Added: For the three-month period ended October 31, 2025, the Company reported
+Added: a net loss of $8,278,328, compared to $5,829,276 for the same period in 2024.
+Added: The higher loss primarily reflects increased research and
+Added: development spending as the Company continued to advance its pivotal Phase 3 trial, including higher clinical-site activity, investigational
+Added: product costs, and supporting operational infrastructure.
+Added: These increased development expenses were partially offset by improved financial
+Added: income during the period.
Capital Resources and Going Concern Uncertainty
3 unchanged sentences
upon its ability to continue to raise adequate financing and to commence profitable operations in the future.
−Removed: of April 30, 2025, and a positive working capital balance of $10,454,565 (July 31, 2024 negative balance of $3,807,303).
−Removed: of April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261), a positive working capital of $10,454,565
−Removed: (July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $103,664,194 (July 31, 2024 - $85,443,697).
−Removed: of April 30, 2025, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
+Added: of October 31, 2025, and a positive working capital balance of $8,030,634 (July 31, 2025 positive balance of $15,948,588).
+Added: of October 31, 2025, the Company has total assets of $13,075,050 (July 31, 2025 - $ 21,649,706), a positive working capital of $8,030,634
+Added: (July 31, 2025 – positive balance of $15,948,588) and an accumulated deficit of $119,953,129 (July 31, 2025 - negative balance
+Added: of $ 111,755,564).
+Added: of October 31, 2025, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
of cash on deposit with banks, investments in money market funds, investments in U.S.
24 unchanged sentences
our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.
−Removed: the period ended April 30, 2025, the Company’s overall position of cash and cash equivalents increased by $11,598,164 from the
+Added: the period ended October 31, 2025, the Company’s overall position of cash and cash equivalents decreased by $7,779,796 from the
period ended July 31, 2025 (including effects of foreign exchange).
−Removed: This increase in cash can be
+Added: This decrease in cash can be
attributed to the following:
−Removed: Company’s net cash used in operating activities during the period ended April 30, 2025, was $20,038,075 as compared to $20,090,398
−Removed: for the period ended April 30, 2024.
−Removed: gained in financing activities for the period ended April 30, 2025, was 31,891,239 as compared to nil for the period ended April 30,
+Added: Company’s net cash used in operating activities during the period ended October 31, 2025, was $7,704,796 as compared to $6,955,076
+Added: for the period ended October 31, 2024.
+Added: gained in financing activities for the period ended October 31, 2025, was nil as compared to 11,960,252 for the period ended October
Sheet Arrangements
4 unchanged sentences
Accounting Policies Adopted
−Removed: Company did not adopt any new accounting policies during the period ended April 30, 2025.
+Added: Company did not adopt any new accounting policies during the period ended October 31, 2025.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.