16 unchanged sentences
2 - Results of Operations.
−Removed: This section provides an analysis of our results of operations for the first quarter of fiscal 2024
−Removed: in comparison to the first quarter of fiscal 2023.
+Added: This section provides an analysis of our results of operations for the first half and second quarter
+Added: of fiscal 2025 in comparison to the first half and second 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: BriaCell is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care.
−Removed: Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize
−Removed: and destroy cancer cells.
−Removed: The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune
−Removed: check point inhibitor (Retifanlimab) in a pivotal Phase 3 study in metastatic breast cancer.
−Removed: Bria-IMT™ is currently under Fast Track
−Removed: Designation by the U.S.
−Removed: Food and Drug Administration(the “FDA”) intended to accelerate the review process of novel treatments
−Removed: that address unmet medical needs.
−Removed: Positive completion of the pivotal study, following review by FDA, could lead to full approval of the
−Removed: Bria-IMT™ immune checkpoint inhibitor combination in metastatic breast cancer.
−Removed: BriaCell reported benchmark-beating patient survival
−Removed: and clinical benefit in metastatic breast cancer with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer
−Removed: 6.7-9.8 months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study
−Removed: with retifanlimab at the 2023 San Antonio Breast Cancer Symposium.
−Removed: A completed Bria-IMT™ Phase 1 combination study with retifanlimab
−Removed: (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy.
−Removed: BriaCell is also developing personalized
−Removed: off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf
−Removed: immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system
−Removed: as well as an immune checkpoint inhibitor.
+Added: Therapeutics Corp.
+Added: (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to
+Added: transform cancer care.
+Added: Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune
+Added: system to recognize and destroy cancer cells.
+Added: The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination
+Added: with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study in metastatic
+Added: breast cancer.
+Added: The pivotal Phase 3 study of Bria-IMT™ is currently under Fast Track Designation by the U.S.
+Added: FDA intended to accelerate
+Added: the review process of novel treatments that address unmet medical needs.
+Added: Positive completion of the pivotal Phase 3 study, following
+Added: review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer.
+Added: Additionally,
+Added: BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier:
+Added: NCT06471673 ) to evaluate the safety and efficacy
+Added: of Bria-OTS™, BriaCell’s personalized next generation immunotherapy.
+Added: The study will investigate Bria-OTS™ alone and
+Added: in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by BeiGene, Ltd.)
+Added: for the treatment of metastatic breast cancer.
+Added: Bria-OTS™/Bria-OTS+™, provides a platform technology to develop personalized
+Added: off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of
+Added: the immune system as well as an immune checkpoint inhibitor.
+Added: is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
+Added: September 10, 2024, BriaCell announced it had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND)
+Added: meeting with the FDA for Bria-PROS+™ in prostate cancer.
+Added: The meeting provides a clear path towards filing an IND and
+Added: conducting a Phase 1/2 study of Bria-PROS+™
+Added: September 11, 2024, BriaCell reported positive overall survival (OS) in metastatic breast cancer in its Phase 2 study of the Bria-IMT™
+Added: regimen in combination with an immune checkpoint inhibitor.
+Added: Median overall survival of 15.6 months in patients treated with the phase
+Added: 3 formulation of Bria-IMT™ since 2022 was reported.
+Added: OS of 15.6 months compared favorably with 5.9-9.8 months reported for similar
+Added: patients in the literature.
+Added: Ongoing Phase 3 study investigates Bria-IMT™ in similar metastatic breast cancer population.
+Added: related discontinuations were reported.
+Added: September 12, 2024, BriaCell announced closing of $8.5 million offering.
+Added: The Company announced the closing of its previously announced
+Added: best-efforts offering priced at-the-market under Nasdaq rules for 821,666 common shares.
+Added: Each common share was sold at an offering price
+Added: of $10.35 per share, for gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses.
+Added: All the shares in the offering were offered by the Company.
+Added: The Company announced its intention to use the net proceeds from the offering
+Added: for working capital requirements, general corporate purposes, and the advancement of business objectives.
+Added: ThinkEquity acted as sole placement
+Added: agent for the offering.
+Added: The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement
+Added: on Form S-3 (File No.
+Added: 333-276650), including a base prospectus, filed with the U.S.
+Added: Securities and Exchange Commission (the “SEC”)
+Added: on January 22, 2024 and declared effective on January 31, 2024.
+Added: The offering was made by means of a prospectus supplement and prospectus
+Added: which have been filed with the SEC and available on the SEC’s website at www.sec.gov.
+Added: September 18, 2024, BriaCell announced an FDA-authorized expanded access policy for metastatic breast cancer patients.
+Added: FDA authorized
+Added: the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need of novel treatments.
+Added: The expanded access policy will
+Added: provide Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s pivotal Phase 3 clinical trial.
+Added: October 1, 2024, BriaCell reported 100% Resolution of brain metastasis in breast cancer patient with “eye-bulging” tumor.
+Added: The dramatic anti-tumor response included complete resolution of right temporal lobe brain metastasis.
+Added: Heavily pre-treated, this patient
+Added: had failed 8 prior regimens including antibody-drug conjugate ( ADC) therapy and continues to receive Bria-IMT™ treatment.
+Added: October 2, 2024, BriaCell announced closing of $5 million offering.
+Added: The Company announced the closing of its previously announced best-efforts
+Added: offering of 341,900 common shares and warrants to purchase up to 341,900 common shares at a combined offering price of $14.63 per share
+Added: and associated warrant, priced at-the-market under Nasdaq rules.
+Added: The warrants had an exercise price of $12.75 per share and are immediately
+Added: exercisable upon issuance for a period of five years following the date of issuance.
+Added: Total gross proceeds from the offering, before deducting
+Added: the placement agent’s fees and other offering expenses, are approximately $5 million.
+Added: The Company announced its intentions to use
+Added: the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.
+Added: ThinkEquity acted as sole placement agent for the offering.
+Added: The securities were offered and sold pursuant to the Company’s currently
+Added: effective shelf registration statement on Form S-3 (File No.
+Added: 333-276650), including a base prospectus, filed with the U.S.
+Added: and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024.
+Added: The offering was made
+Added: by means of a prospectus supplement and prospectus which have been filed with the SEC and available on the SEC’s website at www.sec.gov.
+Added: You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering.
October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main
15 unchanged sentences
This rate exceeds the survival data of the current standard of care for
−Removed: similar patients (see Table 1).
+Added: similar patients (see Table 1 below).
Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.
+Added: Comparable Analysis of 1 year survival for the BriaCell Phase 2 study
+Added: Breast Cancer Type
+Added: Median prior lines of therapy
+Added: Median OS (months)
+Added: Percent Survival at 1 year
+Added: Bria-IMT™ plus CPI
+Added: Cortes et al.
+Added: Bardia et al.
+Added: Patients treated with the Phase 3 formulation
+Added: Patients treated with the Phase 3 formulation since 2022
+Added: Annals of Oncology 2018
+Added: Breast Cancer Res Treat.
+Added: J Clin Oncol.
+Added: Abbreviations:
+Added: hormone receptor-positive
+Added: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal
+Added: growth factor receptor 2 (HER2))
+Added: Human epidermal growth factor receptor 2 positive
+Added: hormone receptor-positive and human epidermal growth factor receptor 2 negative
+Added: Treatment of Physicians Choice
November, 21, 2024, the Company announced that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier:
6 unchanged sentences
November 23, 2024, Marc Lustig resigned from the board of directors of the Company.
+Added: December 2, 2024, BriaCell received green-light from Data Safety Monitoring Board for its Phase 3 Study in metastatic breast cancer.
+Added: The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study
+Added: of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer.
+Added: December 11, 2024, BriaCell presented unprecedented overall survival data in metastatic breast cancer in Spotlight Poster at 2024 SABCS®.
+Added: Median overall survival (OS) of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated
+Added: since 2022), was ~double that of comparable patients in the literature.
+Added: Final Phase 2 OS calculation was pending as many patients remain
+Added: alive well over 1 year after starting the study.
+Added: Median OS of 13.7 months was reported in breast cancer patients with central nervous
+Added: system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI).
+Added: Five BriaCell posters were presented that showcased robust survival and clinical benefit data, plus key biomarker data from the Phase
+Added: 2 trial of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer (MBC).
+Added: identify patients who benefit from treatments with the Bria-IMT™ regimen.
+Added: No toxicity-related discontinuations were reported.
December 13, 2024, the Company closed a public offering for the purchase and sale of 493,333 common shares of the Company and warrants
−Removed: to purchase up to an aggregate of 7,400,000 common shares of the Company for aggregate gross proceeds of approximately $5.55 million
−Removed: before deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”).
−Removed: share was sold together with one warrant to purchase one common share at a combined purchase price of $0.75.
+Added: to purchase up to an aggregate of 493,333 common shares of the Company for aggregate gross proceeds of approximately $5.55 million before
+Added: deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”).
+Added: Each common share
+Added: was sold together with one warrant to purchase one common share at a combined purchase price of $11.25.
The warrants have an exercise
2 unchanged sentences
issued 24,666 agent warrants.
−Removed: The agent warrants are immediately exercisable for a period of five years from the closing date at an
−Removed: exercise price of $0.9375.
−Removed: of Operations for the Three Months Ended October 31, 2024, and 2023
+Added: The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise
+Added: price of $14.06.
+Added: January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of
+Added: the Company’s issued and outstanding common shares (the “Common Shares”) on the basis of one (1) post-Consolidation
+Added: Common Share for every fifteen (15) pre-Consolidation Common Shares.
+Added: The Consolidation is being implemented to ensure that the Company
+Added: continues to comply with the listing requirements of The Nasdaq Capital Market (the “Nasdaq”).
+Added: The effective date of the
+Added: consolidation was January 29, 2025.
+Added: February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer
+Added: tumor that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient
+Added: treated with Bria-OTS™.
+Added: Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a
+Added: Phase 1/2a dose escalation study (ClinicalTrials.gov identifier:
+Added: NCT06471673) in metastatic recurrent breast cancer.
+Added: Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is
+Added: currently in a pivotal Phase 3 study for metastatic breast cancer.
+Added: February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate
+Added: gross proceeds of approximately $3.05 million before deducting placement agent fees and other offering expenses (the “February
+Added: 2025 Offering”).
+Added: Each common share was sold at a public offering price of $4.00 per share.
+Added: In addition, the Company issued 38,125
+Added: agent warrants.
+Added: The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price
+Added: of $5.00 per share.
+Added: of Operations for the Three Months Ended January 31, 2025 and 2024
+Added: Three months ended
Operating Expenses:
−Removed: development expenses
−Removed: and administrative expenses
+Added: Research, development, and clinical trial expenses
+Added: General and administrative expenses
Total operating expenses
Operating loss
−Removed: Financial income, net
−Removed: Change in fair value of
−Removed: the warrant liability
−Removed: of loss on equity investment
−Removed: Net income (loss) for the
+Added: Financial expenses, net
+Added: Change in fair value of the warrant liability
+Added: Share of loss on equity investments
+Added: Net loss for the period
$ (6,337,828 )
−Removed: loss attributable to non-controlling interest
−Removed: income (loss) for the period attributable to BriaCell
−Removed: income (loss) per share attributable to BriaCell – basic
−Removed: income (loss) per share attributable to BriaCell – diluted
−Removed: Weighted average number of shares used in computing
−Removed: net basic earnings per share of common stock
−Removed: Weighted average number
−Removed: of shares used in computing net diluted earnings per share of common stock
−Removed: and Development Costs
−Removed: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory 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 and development costs by nature of expenses:
−Removed: months ended October 31,
−Removed: Clinical trial sites and investigational
+Added: $ (11,333,910 )
+Added: Net loss attributable to non-controlling interest
+Added: Net loss for the period attributable to BriaCell
+Added: (11,294,603 )
+Added: Net loss per share attributable to BriaCell – basic and diluted
+Added: Development, and Clinical Trial Costs
+Added: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development;
+Added: clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our
+Added: clinical trials.
+Added: following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
+Added: Three months ended January 31,
+Added: Clinical trial sites and investigational drug costs
Wages and salaries
2 unchanged sentences
Share-based compensation
−Removed: the three-month period ending October 31, 2024, research costs amounted to $3,665,341, a significant decrease from the $6,857,257 incurred
−Removed: during the same period in 2023.
+Added: the three-month period ended January 31, 2025, total research, development, and clinical trial costs amounted to $5,684,777 as compared to $8,257,455 for the three-month
+Added: period ended January 31, 2024.
This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which
6 unchanged sentences
2024, due to expanded use of facilities to support ongoing research.
−Removed: Supplies also increased, from $89,023 in 2023 to $99,430 in 2024, driven
−Removed: by higher operational needs.
−Removed: Depreciation expenses of $22,839 were recognized in 2024, reflecting investments in capital assets to support
−Removed: research activities.
−Removed: Professional fees increased to $7,268 in 2024, compared to $3,782 in 2023, primarily due to consulting and support
−Removed: for clinical operations.
−Removed: Notably, share-based compensation expenses decreased significantly, from $257,809 in 2023 to $32,718 in 2024,
−Removed: contributing to the overall reduction in research and development expenses.
−Removed: clinical trial expenses are broken down as follows:
−Removed: months ended October 31,
−Removed: Bria-IMT™ Pivotal Phase 3
−Removed: Bria-IMT™ Phase 1/2a
−Removed: Indirect research and
−Removed: development expenses allocated to trials
−Removed: trial expenses for the three months ended October 31, 2024, were $2,439,667, compared to $3,627,290 during the same period in 2023.
−Removed: decrease in expenses is primarily attributable to the conclusion of patient recruitment and related activities in the Bria-IMT™
−Removed: Phase 1/2a clinical trial in fiscal 2024.
−Removed: This reduction in costs aligns with our transition to the pivotal Phase 3 study of Bria-IMT™,
−Removed: which has become the primary focus of our clinical development efforts.
−Removed: the three-month period ending October 31, 2024, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,185,543, remaining consistent
−Removed: with the prior year’s $2,278,258.
−Removed: This consistency reflects our strategic decision to optimize spending while focusing expenditures
−Removed: on this pivotal trial, underscoring our commitment to prioritizing the Phase 3 study as the cornerstone of our clinical development program.
−Removed: Resources were effectively allocated toward patient recruitment, trial operations, and preparation for key milestones.
−Removed: the three-month period ending October 31, 2024, Bria-IMT™ Phase 1/2a costs amounted to $142,496, a significant decrease compared
−Removed: to $1,214,440 during the same period in 2023.
−Removed: This decrease is attributed to the trial’s conclusion in fiscal 2024, with only minimal
−Removed: remaining expenses related to final data analysis and study close-out activities.
−Removed: the three-month period ending October 31, 2024, indirect research and development expenses allocated to trials amounted to $111,628,
−Removed: compared to $134,592 in the prior year.
−Removed: This reduction is primarily due to streamlined trial operations and a shift in resource allocation
−Removed: toward the pivotal Phase 3 study.
−Removed: remain focused on advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to direct resources accordingly
−Removed: to ensure its timely progression.
+Added: Supplies decreased, from $312,543 in 2024 to $85,264 in 2025, driven
+Added: by lowered spending.
+Added: Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in capital assets to support research
+Added: Professional fees increased to $1,908 in 2025, compared to nil in 2024.
+Added: Notably, share-based compensation expenses decreased
+Added: significantly, from $234,253 in 2024 to $50,839 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
+Added: Clinical trial expenses for the
+Added: period are as follows:
+Added: months ended January 31,
+Added: Pivotal Phase 3 study
+Added: Bria-OTS™ Phase 1/2a
+Added: trial expenses for the three months ended January 31, 2025, were $3,923,559, compared to $4,359,850 during the same period in 2024.
+Added: The slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024,
+Added: resulting in lower associated costs.
+Added: As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly
+Added: directed toward the pivotal Phase 3 study, which remains our primary focus.
+Added: At the same time, we have begun incurring costs related
+Added: to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
+Added: the three-month period ended January 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $3,642,650, an increase from $2,519,420
+Added: This increase reflects our intensified efforts to advance the pivotal Phase 3 study, with a focus on patient recruitment, site
+Added: activation, and trial execution as we push toward key milestones.
+Added: the three-month period ended January 31, 2025, Bria-IMT™ Phase 1/2a costs were $215,301, a significant decline from $1,840,430
+Added: in 2024, as the trial has now concluded.
+Added: The remaining expenses primarily relate to final data analysis and study close-out activities.
+Added: the three-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $65,608, compared to $nil in 2024.
+Added: increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
and Administrative Expenses
−Removed: the three-month period ending October 31, 2024, general and administrative expenses amounted to $1,487,491, showing a decrease from $1,645,771
−Removed: in the same period of 2023.
−Removed: The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional
−Removed: fees and share-based compensation expenses.
−Removed: The Company has reduced general and administrative expenses in order to devote more resources
−Removed: to its clinical program.
+Added: the three-month period ended January 31, 2025, general and administrative expenses amounted to $1,484,666, compared to $1,571,991 for
+Added: the same period in 2024.
+Added: The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
+Added: in overall stable general and administrative expenses quarter over quarter.
income (expenses), net
−Removed: the three-month period ending October 31, 2024, net financial income amounted to $11,714, a significant decrease from the $179,822 recorded
−Removed: in the same period of 2023.
−Removed: Financial income for the three-month period ending October 31, 2024 primarily consists of interest income
−Removed: of $13,050, offset by a foreign exchange loss of $1,336.
−Removed: In comparison, For the three-month period ending October 31, 2023, interest
−Removed: income was $190,815, while foreign exchange losses totaled $10,993.
−Removed: The decrease in financial income from 2023 to 2024 reflects lower
−Removed: interest income due to reduced cash and cash equivalents available for investment in interest-bearing funds
−Removed: (loss) for the period
−Removed: the three-month period ended October 31, 2024, the Company reported a loss of $5,829,276 compared to a gain of $5,958,872 for the same
−Removed: period in 2023.
−Removed: The loss in the three-month period ended October 31, 2024, primarily resulted from the significant change in the fair
−Removed: value of the warrant liability, which accounted for a loss of $616,643 in 2024 compared to a gain of $14,282,078 in 2023.
−Removed: This highlights
−Removed: the substantial impact that warrant liability valuation has on the Company’s overall financial performance, despite decreased operational
−Removed: spending during the period, particularly in research and development.
+Added: the three-month period ended January 31, 2025, financial income amounted to $67,358, compared to $81,628 for the three-month period ended
+Added: January 31, 2024.
+Added: Financial income for the 2025 period consisted of $46,832 in interest income and a $20,256 foreign exchange gain.
+Added: comparison, financial income for the 2024 period included $81,595 in interest income and a $33 foreign exchange gain.
+Added: The decrease in
+Added: financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents available
+Added: for investment in interest-bearing funds.
+Added: for the period
+Added: Company reported a loss of $6,291,420 for the three-month period ended January 31, 2025, compared to $11,294,603 for the same period
+Added: The decrease in net loss was primarily driven by a reduction in research, development, and clinical trial expenses, which declined from $8,257,455
+Added: in 2024 to $5,684,777 in 2025, mainly due to lower clinical trial and investigational drug costs following the completion of the Bria-IMT™
+Added: Phase 1/2a trial.
+Added: Additionally, the change in fair value of the warrant liability resulted in a gain of $806,841 in 2025, compared to
+Added: a loss of $1,567,747 in 2024, further contributing to the improved financial results.
+Added: of Operations for the Six Months Ended January 31, 2025 and 2024
+Added: Six months ended
+Added: Operating Expenses:
+Added: Research, development, and clinical trial expenses
+Added: General and administrative expenses
+Added: Total operating expenses
+Added: Operating loss
+Added: (12,322,275 )
+Added: (18,332,474 )
+Added: Financial expenses, net
+Added: Change in fair value of the warrant liability
+Added: Share of loss on equity investments
+Added: Net loss for the period
+Added: $ (12,167,104 )
+Added: Net loss attributable to non-controlling interest
+Added: Net loss for the period attributable to BriaCell
+Added: (12,093,595 )
+Added: Net loss per share attributable to BriaCell – basic and diluted
+Added: Weighted average number of shares used in computing net basic earnings per share of common stock
+Added: Weighted average number of shares used in computing net diluted earnings per share of common stock
+Added: Development, and Clinical Trial Costs
+Added: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;
+Added: 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, development, and clinical trial costs by nature of expenses:
+Added: Six months ended January 31,
+Added: Clinical trial sites and Investigational drug costs
+Added: Wages and salaries
+Added: Laboratory Rent
+Added: Professional fees
+Added: Share-based compensation
+Added: the six-month period ending January 31, 2025, research, development and clinical trial costs amounted to $9,350,118, a significant
+Added: decrease from the $15,114,712 incurred during the same period in 2024.
+Added: This reduction was primarily driven by lower clinical trial
+Added: sites and investigational drug costs, which decreased from $11,598,418 in 2024 to $6,557,243 in 2025.
+Added: The decrease reflects the
+Added: conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
+Added: salaries decreased slightly, from $2,422,404 in 2024 to $2,241,110 in 2025, reflecting resource allocation adjustments.
+Added: rent increased to $228,660 in 2025, up from $196,480 in 2024, due to expanded use of facilities to support ongoing research.
+Added: Supplies decreased, from $401,566 in 2024 to $184,694 in 2025, driven by lowered spending.
+Added: Depreciation expenses of $45,678 were
+Added: recognized in 2025, reflecting investments in capital assets to support research activities.
+Added: Professional fees increased to $9,176
+Added: in 2025, compared to $3,782 in 2024, primarily due to consulting and support for clinical operations.
+Added: Notably, share-based
+Added: compensation expenses decreased significantly, from $492,062 in 2024 to $83,557 in 2025, contributing to the overall reduction in
+Added: research, development, and clinical trial expenses.
+Added: Clinical trial expenses for the
+Added: period are as follows:
+Added: months ended January 31,
+Added: Pivotal Phase 3 study
+Added: Bria-OTS™ Phase 1/2a
+Added: Clinical trial expenses for the six-month period ended January 31, 2025, were $6,631,649, compared to $7,987,140
+Added: during the same period in 2024.
+Added: This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the continued prioritization
+Added: of the pivotal Phase 3 study, which remains our primary focus.
+Added: While resources have been increasingly directed toward Phase 3, we have
+Added: also begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
+Added: the six-month period ended January 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $6,089,111, up from $4,887,207 in 2024.
+Added: The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, activating
+Added: additional sites, and streamlining trial execution to support the study’s advancement.
+Added: Phase 1/2a costs declined to $399,343, a sharp reduction from $3,099,933 in 2024, reflecting the trial’s conclusion.
+Added: costs are tied to final reporting, regulatory submissions, and study close-out activities.
+Added: For the six-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $143,195, compared
+Added: to $nil in 2024.
+Added: The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
+Added: remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources
+Added: strategically to ensure its successful execution.
+Added: and Administrative Expenses
+Added: the six-month period ended January 31, 2025, general and administrative expenses amounted to $2,972,157, compared to $3,217,762 for the
+Added: same period in 2024.
+Added: The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
+Added: in overall stable general and administrative expenses period over period.
+Added: income (expenses), net
+Added: the six-month period ended January 31, 2025, financial income amounted to $79,072, compared to $261,450 for the six-month period ended
+Added: January 31, 2024.
+Added: Financial income for the 2025 period consisted of $59,882 in interest income and a $19,190 foreign exchange gain.
+Added: comparison, financial income for the 2024 period included $272,410 in interest income, offset by a $10,960 foreign exchange loss.
+Added: decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents
+Added: available for investment in interest-bearing funds.
+Added: for the period
+Added: Company reported a loss of $12,167,104 for the six-month period ended January 31, 2025, compared to $5,375,038 in 2024.
+Added: was primarily due to a smaller gain on the fair value of warrant liability, which was $190,198 in 2025 compared to $12,714,331 in 2024.
+Added: This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $15,114,712 in 2024 to $9,350,118 in
+Added: 2025, mainly due to lower clinical trial and investigational drug costs following the completion of the Bria-IMT™ Phase 1/2a trial.
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 October 31, 2024, and a positive working capital balance of $3,230,459 (July 31, 2024 negative balance of $3,807,303).
−Removed: of October 31, 2024, the Company has total assets of $10,414,330 (July 31, 2024 - $5,872,261), a positive working capital of $3,230,459
+Added: of January 31, 2025, and a positive working capital balance of $1,931,735 (July 31, 2024 negative balance of $3,807,303).
+Added: of January 31, 2025, the Company has total assets of $9,363,567 (July 31, 2024 - $5,872,261), a positive working capital of $1,931,735
(July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $97,537,292 (July 31, 2024 - $85,443,697).
−Removed: of October 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
+Added: of January 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 October 31, 2024, the Company’s overall position of cash and cash equivalents increased by $4,930,176 from the
+Added: the period ended January 31, 2025, the Company’s overall position of cash and cash equivalents increased by $4,151,565 from the
period ended July 31, 2024 (including effects of foreign exchange).
1 unchanged sentence
attributed to the following:
−Removed: Company’s net cash used in operating activities during the period ended October 31, 2024, was $6,955,076 as compared to $7,605,245
−Removed: for the period ended October 31, 2023.
−Removed: gained in financing activities for the period ended October 31, 2024, was 11,960,252 as compared to nil for the period ended October
+Added: Company’s net cash used in operating activities during the period ended January 31, 2025, was $12,875,298 as compared to $15,006,564
+Added: for the period ended January 31, 2024.
+Added: gained in financing activities for the period ended January 31, 2025, was 17,176,863 as compared to nil for the period ended January
Sheet Arrangements
4 unchanged sentences
Accounting Policies Adopted
−Removed: Company did not adopt any new accounting policies during the period ended October 31, 2024.
+Added: Company did not adopt any new accounting policies during the period ended January 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.