13 unchanged sentences
1 - Business Overview.
−Removed: This section provides a general description of our business, which
−Removed: we believe is important in understanding the results of our operations, financial condition,
−Removed: and potential future trends.
+Added: This section provides a general description of our business, which we believe is important in understanding
+Added: the results of our operations, financial condition, and potential future trends.
2 - Results of Operations.
−Removed: This section provides an analysis of our results of operations
−Removed: for the first half and second quarter of fiscal 2024 in comparison to the first half and
−Removed: second quarter of fiscal 2023.
+Added: This section provides an analysis of our results of operations for the first quarter of fiscal 2024
+Added: in comparison to the first quarter of fiscal 2023.
3 - Financial Liquidity and Capital Resources.
−Removed: This section provides an analysis of our
−Removed: cash flows and outstanding debt and commitments.
−Removed: Included in this analysis is a discussion
−Removed: of the amount of financial capacity available to fund our ongoing operations and future commitments.
+Added: This section provides an analysis of our cash flows and outstanding debt and commitments.
+Added: Included in this analysis is a discussion of the amount of financial capacity available to fund our ongoing operations and future
prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S.
15 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.
−Removed: (Retifanlimab)
−Removed: in a pivotal 1 Phase 3 study in advanced metastatic breast cancer.
−Removed: Bria-IMT™ is currently under Fast Track Designation
−Removed: FDA intended to accelerate the review process of novel treatments that address unmet medical needs.
−Removed: Positive completion of
−Removed: the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination
−Removed: in advanced metastatic breast cancer.
−Removed: BriaCell reported benchmark-beating patient survival and clinical benefit in advanced metastatic
−Removed: breast cancer with median overall survival of 13.4 months in BriaCell’s advanced metastatic breast cancer patients vs.
−Removed: months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at
−Removed: the 2023 San Antonio Breast Cancer Symposium.
−Removed: A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody
−Removed: manufactured by Incyte) confirmed tolerability and early-stage efficacy.
−Removed: BriaCell is also developing a personalized off-the-shelf immunotherapy,
−Removed: Bria-OTS™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer,
−Removed: and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.
−Removed: “Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy
−Removed: of a treatment.
−Removed: August 31, 2023, the Company closed the previously announced plan of arrangement spinout transaction (the “Arrangement”)
−Removed: pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors
−Removed: for multiple indications including cancer (the “BriaPro Assets”), were spun-out to BriaPro Therapeutics Corp.
−Removed: resulting in a 2/3rd owned subsidiary of the Company with the remaining 1/3rd held by BriaCell shareholders (“BriaCell Shareholders”).
−Removed: to the terms of the Arrangement, BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration for
−Removed: the issuance by BriaPro to the Company of BriaPro common shares.
−Removed: Under the terms of the Arrangement, for each BriaCell share held immediately
−Removed: prior to closing, BriaCell Shareholders receive one (1) common share of BriaPro, and one (1) new common share of BriaCell (retiring their
−Removed: old share) having the same terms and characteristics as the existing BriaCell common shares.
−Removed: The Company will remain listed on the NASDAQ
−Removed: Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada.
−Removed: noted above, immediately following the closing of the Arrangement, the Company controlled 2/3rd of the BriaPro common shares representing
−Removed: approximately 66.6% of the issued and outstanding common shares of BriaPro As a result of the Arrangement, there were approximately 47,945,178
−Removed: BriaPro common shares issued and outstanding immediately following consummation of the Arrangement.
−Removed: The Corporation now beneficially
−Removed: owns or controls approximately 31,963,452 BriaPro common shares, representing 2/3rd of the issued and outstanding BriaPro common shares.
−Removed: October 3, 2023, BriaCell initiated its pivotal Phase 3 Study of Bria-IMT™ in advanced metastatic breast Cancer.
−Removed: The study will
−Removed: evaluate the efficacy and safety of the Bria-IMT™ combination regimen with an immune check point inhibitor (Retifanlimab) in patients
−Removed: who have failed at least two approved therapies for the disease.
−Removed: Bria-IMT™ is currently under Fast Track Designation by the U.S.
−Removed: FDA intended to accelerate the review process of novel treatments that address unmet medical needs.
−Removed: Positive completion of the pivotal
−Removed: study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced
−Removed: metastatic breast cancer.
−Removed: FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the
−Removed: physician’s choice of treatment arm will be the primary endpoint of the study.
−Removed: The study will enroll 177 patients in the Bria-IMT™
−Removed: combination therapy arm and 177 patients in the treatment of physician’s choice arm.
−Removed: To gather additional information on the Bria-IMT™
−Removed: regimen alone, 50 patients will be enrolled in this regimen and will be eligible for combination therapy following their initial post
−Removed: treatment evaluation.
−Removed: BriaCell expects frequent and responsive FDA communication under its Fast Track status during the pivotal Phase
−Removed: The successful completion of the pivotal Phase 3 study would allow BriaCell to subsequently submit a Biologics License Application
−Removed: and accelerate the path to commercialization.
−Removed: May 17, 2024, the Company closed a registered direct offering with healthcare-focused institutional investors and a certain existing
−Removed: investor and a director of the Company for the purchase and sale of 2,402,935 common shares of the Company (or pre-funded warrants in
−Removed: lieu thereof) and warrants to purchase up to an aggregate of 2,402,935 common shares of the Company for aggregate gross proceeds of approximately
−Removed: $5.0 million before deducting placement agent fees and other offering expenses (the “Offering”).
−Removed: Each common share (or pre-funded
−Removed: warrant in lieu thereof) was sold together with one warrant to purchase one common share at a combined purchase price of $2.00 to the
−Removed: institutional investors and $2.215 to the existing investor and director of the Company.
−Removed: The warrants have an exercise price of $2.11
−Removed: per share, will become exercisable six months from the date of issuance and expire five years from the initial exercise date.
−Removed: of Operations for the Three Months Ended April 30, 2024 and 2023
−Removed: Three months ended April 30,
+Added: BriaCell 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 Phase 3 study in metastatic breast cancer.
+Added: Bria-IMT™ is currently under Fast Track
+Added: Designation by the U.S.
+Added: Food and Drug Administration(the “FDA”) intended to accelerate the review process of novel treatments
+Added: that address unmet medical needs.
+Added: Positive completion of the pivotal study, following review by FDA, could lead to full approval of the
+Added: Bria-IMT™ immune checkpoint inhibitor combination in metastatic breast cancer.
+Added: BriaCell reported benchmark-beating patient survival
+Added: and clinical benefit in metastatic breast cancer with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer
+Added: 6.7-9.8 months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study
+Added: with retifanlimab at the 2023 San Antonio Breast Cancer Symposium.
+Added: A completed Bria-IMT™ Phase 1 combination study with retifanlimab
+Added: (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy.
+Added: BriaCell is also developing personalized
+Added: off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf
+Added: immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system
+Added: as well as an immune checkpoint inhibitor.
+Added: October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main
+Added: and 17 satellite) are active and enrolling patients.
+Added: Additional sites are in various stages of start-up.
+Added: Interim data will be analyzed
+Added: once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen
+Added: versus those treated with physician’s choice as the primary endpoint.
+Added: Positive results of the pivotal Phase 3 study could result
+Added: in full approval and marketing authorization for Bria-IMT™ in MBC patients.
+Added: Secondary analyses include comparison of the Bria-IMT™
+Added: combination regimen vs Bria-IMT™ monotherapy.
+Added: BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient
+Added: The Bria-IMT™ combination regimen has received FDA Fast Track designation.
+Added: October 22, 2024, the Company reported that in the Company’s Phase 2 clinical study, patients treated with the same Bria-IMT™
+Added: regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e.
+Added: 55% of patients
+Added: remain alive at least one year after starting on the study).
+Added: This rate exceeds the survival data of the current standard of care for
+Added: similar patients (see Table 1).
+Added: Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.
+Added: November, 21, 2024, the Company announced that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier:
+Added: to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy.
+Added: The study will investigate
+Added: Bria-OTS™ alone and 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™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study
+Added: for metastatic breast cancer.
+Added: November 23, 2024, Marc Lustig resigned from the board of directors of the Company.
+Added: December 13, 2024, the Company closed a public offering for the purchase and sale of 7,400,000 common shares of the Company and warrants
+Added: to purchase up to an aggregate of 7,400,000 common shares of the Company for aggregate gross proceeds of approximately $5.55 million
+Added: before deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”).
+Added: share was sold together with one warrant to purchase one common share at a combined purchase price of $0.75.
+Added: The warrants have an exercise
+Added: price of $0.9375 per share, and are immediately exercisable for a period of five years from the closing date.
+Added: In addition, the Company
+Added: issued 370,000 agent warrants.
+Added: The agent warrants are immediately exercisable for a period of five years from the closing date at an
+Added: exercise price of $0.9375.
+Added: of Operations for the Three Months Ended October 31, 2024, and 2023
Operating expenses:
−Removed: Research and development expenses
−Removed: General and administrative expenses
−Removed: Total operating expenses
−Removed: Operating loss
−Removed: Financial expenses, net
−Removed: Share of loss on equity investments
−Removed: Net loss for the period
−Removed: $ (4,895,436 )
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss for the period attributable to BriaCell
−Removed: Net loss per share attributable to BriaCell – basic and diluted
−Removed: and Development 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 and development costs by project:
−Removed: Three months ended April 30,
−Removed: Clinical trials
−Removed: Pre-clinical projects
−Removed: Chemical, Manufacturing and Control Costs (“CMC Costs”)
−Removed: clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial.
−Removed: trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.
−Removed: a longer than expected overall survival).
−Removed: Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the pivotal Phase
−Removed: 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation for
−Removed: the upcoming clinical studies of Bria-OTS™.
−Removed: projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
−Removed: Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional
−Removed: pre-clinical program (sCD80).
−Removed: costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
−Removed: board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
−Removed: following is a breakdown of our research and development costs by nature of expenses:
−Removed: Three months ended April 30,
−Removed: Clinical trial sites and investigational drug costs
−Removed: Wages and salaries
−Removed: Laboratory Rent
−Removed: Professional fees
−Removed: Share-based compensation
−Removed: the three-month period ended April 30, 2024, total research costs amounted to $7,657,632 as compared to $3,860,568 for the three-month
−Removed: period ended April 30, 2023.
−Removed: The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical
−Removed: trials, specifically our Bria-IMT™ trial.
−Removed: Clinical trials and investigational drug costs increased from $2,469,105 in 2023 to $6,165,072
−Removed: Laboratory costs increase during 2024 as well, including the hiring of additional lab employees which increased from $947,509
−Removed: in 2023 to $1,090,902 in 2024 and increased supplies from $155,079 in 2023 to $165,264 in 2024.
+Added: development expenses
and administrative expenses
−Removed: the three-month period ended April 30, 2024, general and administrative expenses amounted to $1,572,016 as compared to $1,816,461 for
−Removed: the three-month period ended April 30, 2023.
−Removed: The decrease relates primarily to a lowering of shareholder communication expense, insurance
−Removed: expenses, and professional fees.
−Removed: income (expenses), net
−Removed: the three-month period ended April 30, 2024, financial expense, net, amounted to $10,958,887 as compared to $781,593 for the three-month
−Removed: period ended April 30, 2023.
−Removed: The large difference is due to the change in value of the Company’s warrant liability which amounted
−Removed: to a gain of $10,945,672 in the three-month period ending April 30, 2024, and a gain of $539,427 in the three-month period ending April
−Removed: (profit) for the period
−Removed: Company reported a profit for the three-month period ended April 30, 2024, of $1,692,242, as compared to a loss of $4,895,436 for the
−Removed: three-month period ended April 30, 2023.
−Removed: The profit in 2024 is due to a significant decrease in fair value of the warrant liability.
−Removed: of Operations for the Nine Months Ended April 30, 2024 and 2023
−Removed: Nine months ended April 30,
−Removed: Operating Expenses:
−Removed: Research and development expenses
−Removed: General and administrative expenses
Total operating expenses
Operating loss
−Removed: (27,562,122 )
−Removed: (15,566,503 )
−Removed: Financial expenses, net
−Removed: Share of loss on equity investments
−Removed: Net loss for the period
−Removed: $ (3,682,796 )
−Removed: (17,883,739 )
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss for the period attributable to BriaCell
+Added: Financial income, net
+Added: Change in fair value of
+Added: the warrant liability
+Added: of loss on equity investment
+Added: Net income (loss) for the
$ (5,829,276 )
−Removed: Net loss per share attributable to BriaCell – basic and diluted
−Removed: Weighted average number of shares used in computing net basic earnings per share
−Removed: of common stock
−Removed: Weighted average number of shares used in computing net diluted earnings per share of common stock
+Added: loss attributable to non-controlling interest
+Added: income (loss) for the period attributable to BriaCell
+Added: income (loss) per share attributable to BriaCell – basic
+Added: income (loss) per share attributable to BriaCell – diluted
+Added: Weighted average number of shares used in computing
+Added: net basic earnings per share of common stock
+Added: Weighted average number
+Added: of shares used in computing net diluted earnings per share of common stock
and Development Costs
−Removed: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;
−Removed: and (ii) Clinical trials and investigational
+Added: costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and (ii) clinical trials and investigational
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 project:
−Removed: Nine months ended April 30,
−Removed: Clinical trials
−Removed: Pre-clinical projects
−Removed: clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial.
−Removed: trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.
−Removed: longer than expected overall survival).
−Removed: Additionally, our costs increased significantly compared with those in the same period in 2023 for much higher set up costs for the pivotal
−Removed: Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation
−Removed: for the upcoming clinical studies of Bria-OTS™.
−Removed: projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
−Removed: Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional
−Removed: pre-clinical program (sCD80).
−Removed: Costs include the manufacturing of Bria-IMT™ and Bria-OTS™.
−Removed: CMC Costs increased in 2024 to support the pivotal Phase 3 study,
−Removed: and the upcoming clinical studies of Bria-OTS™.
−Removed: costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
−Removed: board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
−Removed: Other costs increased in 2024 as we investigated additional potential pre-clinical projects.
following is a breakdown of our research and development costs by nature of expenses:
−Removed: Nine months ended April 30,
−Removed: Clinical trial sites and Investigational drug costs
+Added: months ended October 31,
+Added: Clinical trial sites and investigational
Wages and salaries
2 unchanged sentences
Share-based compensation
−Removed: the nine-month period ending April 30, 2024, research costs amounted to $22,772,344, a significant increase from the $10,169,140 incurred
+Added: the three-month period ending October 31, 2024, research costs amounted to $3,665,341, a significant decrease from the $6,857,257 incurred
during the same period in 2023.
−Removed: This upturn was primarily fueled by the expansion of the Company’s Phase 2 trial, and initiation
−Removed: of the Phase 3 trial of the Bria-IMT™ regimen, and heightened costs associated with clinical trials and investigational drugs,
−Removed: surging from $5,799,621 in 2023 to $17,763,490 in 2024.
−Removed: Concurrently, laboratory costs increased due to the recruitment of additional
−Removed: employees, growing from $145,440 to $305,980.
−Removed: Notably, non-cash share-based compensation expenses decreased from $814,782 in 2023 to
−Removed: $618,375 in 2024, mitigating some of the overall increase in research and development expenses.
+Added: This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which
+Added: decreased from $5,397,438 in 2023 to $2,439,667 in 2024.
+Added: The decrease reflects the conclusion of the Bria-IMT™ Phase 1/2a trial
+Added: and a focus on optimizing expenditures for the pivotal Phase 3 trial.
+Added: Wages and salaries decreased slightly, from $1,020,725 in 2023
+Added: to $949,089 in 2024, reflecting resource allocation adjustments.
+Added: Laboratory rent increased to $114,330 in 2024, up from $88,480 in 2023,
+Added: due to expanded use of facilities to support ongoing research.
+Added: Supplies also increased, from $89,023 in 2023 to $99,430 in 2024, driven
+Added: by higher operational needs.
+Added: Depreciation expenses of $22,839 were recognized in 2024, reflecting investments in capital assets to support
+Added: research activities.
+Added: Professional fees increased to $7,268 in 2024, compared to $3,782 in 2023, primarily due to consulting and support
+Added: for clinical operations.
+Added: Notably, share-based compensation expenses decreased significantly, from $257,809 in 2023 to $32,718 in 2024,
+Added: contributing to the overall reduction in research and development expenses.
+Added: clinical trial expenses are broken down as follows:
+Added: months ended October 31,
+Added: Bria-IMT™ Pivotal Phase 3
+Added: Bria-IMT™ Phase 1/2a
+Added: Indirect research and
+Added: development expenses allocated to trials
+Added: 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.
+Added: decrease in expenses is primarily attributable to the conclusion of patient recruitment and related activities in the Bria-IMT™
+Added: Phase 1/2a clinical trial in fiscal 2024.
+Added: This reduction in costs aligns with our transition to the pivotal Phase 3 study of Bria-IMT™,
+Added: which has become the primary focus of our clinical development efforts.
+Added: the three-month period ending October 31, 2024, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,185,543, remaining consistent
+Added: with the prior year’s $2,278,258.
+Added: This consistency reflects our strategic decision to optimize spending while focusing expenditures
+Added: on this pivotal trial, underscoring our commitment to prioritizing the Phase 3 study as the cornerstone of our clinical development program.
+Added: Resources were effectively allocated toward patient recruitment, trial operations, and preparation for key milestones.
+Added: the three-month period ending October 31, 2024, Bria-IMT™ Phase 1/2a costs amounted to $142,496, a significant decrease compared
+Added: to $1,214,440 during the same period in 2023.
+Added: This decrease is attributed to the trial’s conclusion in fiscal 2024, with only minimal
+Added: remaining expenses related to final data analysis and study close-out activities.
+Added: the three-month period ending October 31, 2024, indirect research and development expenses allocated to trials amounted to $111,628,
+Added: compared to $134,592 in the prior year.
+Added: This reduction is primarily due to streamlined trial operations and a shift in resource allocation
+Added: toward the pivotal Phase 3 study.
+Added: remain focused on advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to direct resources accordingly
+Added: to ensure its timely progression.
and Administrative Expenses
−Removed: the nine-month period ended April 30, 2024, general and administrative expenses amounted to $4,789,778 as compared to $5,397,363 for
−Removed: the nine-month period ended April 30, 2023.
−Removed: This reduction is mainly attributed to a decrease in professional fees, which declined from
−Removed: $1,230,220 in 2023 to $970,569 in 2024 and insurance expenses which declined from $1,241,716 in 2023 to $859,287 in 2024.
+Added: the three-month period ending October 31, 2024, general and administrative expenses amounted to $1,487,491, showing a decrease from $1,645,771
+Added: in the same period of 2023.
+Added: The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional
+Added: fees and share-based compensation expenses.
+Added: The Company has reduced general and administrative expenses in order to devote more resources
+Added: to its clinical program.
income (expenses), net
−Removed: the nine-month period ending April 30, 2024, net financial income amounted to $23,934,668, a significant increase from the loss of $2,317,236
−Removed: recorded in the same period of 2023.
−Removed: This substantial difference is primarily attributed to the change in the value of the Company’s
−Removed: warrant liability, which is directly affected by the shortened life of the warrants and decrease in share price, resulting in a gain
−Removed: of $23,660,003 for the nine-month period ended April 30, 2024, compared to a loss of $2,972,285 in the nine-month period ended April
−Removed: for the period
−Removed: Company reported a loss for the period ended April 30, 2024, of $3,682,796 as compared to $17,883,739 for the period ended April 30,
−Removed: The reduced loss in 2024 was primarily due to a significant increase in operational spending, offset by a large gain resulting
−Removed: from the decrease in the fair value of the warrant liability.
−Removed: In contrast, the larger loss in the prior period was primarily due to higher
−Removed: operational spending and an increase in the value of the Company’s warrant liability.
−Removed: Concern Uncertainty
+Added: the three-month period ending October 31, 2024, net financial income amounted to $11,714, a significant decrease from the $179,822 recorded
+Added: in the same period of 2023.
+Added: Financial income for the three-month period ending October 31, 2024 primarily consists of interest income
+Added: of $13,050, offset by a foreign exchange loss of $1,336.
+Added: In comparison, For the three-month period ending October 31, 2023, interest
+Added: income was $190,815, while foreign exchange losses totaled $10,993.
+Added: The decrease in financial income from 2023 to 2024 reflects lower
+Added: interest income due to reduced cash and cash equivalents available for investment in interest-bearing funds
+Added: (loss) for the period
+Added: 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
+Added: period in 2023.
+Added: The loss in the three-month period ended October 31, 2024, primarily resulted from the significant change in the fair
+Added: 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.
+Added: This highlights
+Added: the substantial impact that warrant liability valuation has on the Company’s overall financial performance, despite decreased operational
+Added: spending during the period, particularly in research and development.
+Added: Capital Resources and Going Concern Uncertainty
financial statements have been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and
2 unchanged sentences
upon its ability to continue to raise adequate financing and to commence profitable operations in the future.
−Removed: of April 30, 2024, the Company has total assets of $6,203,266 (July 31, 2023 - $27,163,577) and a negative working capital balance of
−Removed: $1,227,767 (July 31, 2023 - positive $25,147,050).
−Removed: The Company had negative cash flows from operating activities during the nine-month
−Removed: period ended April 30, 2024 of $20,090,398.
−Removed: Company is planning to finance its research and developmental activities from its existing and future working capital resources and will
−Removed: continue to evaluate additional sources of capital and financing.
−Removed: The uncertainty of the Company’s ability to raise such financial
−Removed: capital casts significant doubt on the Company’s ability to continue as a going concern.
−Removed: and Capital Resources
−Removed: of April 30, 2024, the Company has a negative working capital of $1,227,767 (July 31, 2023 – positive $25,147,050) and an accumulated
−Removed: deficit of $84,229,532 (July 31, 2023 - $80,652,231).
−Removed: of April 30, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash on
−Removed: deposit with banks, investments in money market funds, investments in U.S.
+Added: of October 31, 2024, and a positive working capital balance of $3,230,459 (July 31, 2024 negative balance of $3,807,303).
+Added: 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: (July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $91,245,872 (July 31, 2024 - $85,443,697).
+Added: of October 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
+Added: of cash on deposit with banks, investments in money market funds, investments in U.S.
government securities, U.S.
1 unchanged sentence
and investment grade corporate debt securities .
−Removed: Our investment policy and strategy are focused on preservation of capital and supporting
−Removed: our liquidity requirements.
+Added: Our investment policy and strategy are focused
+Added: on preservation of capital and supporting our liquidity requirements.
Historically,
the Company has financed its operation through private and public placement of equity securities, as well as debt financing.
−Removed: Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its
−Removed: The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business
−Removed: plan objectives.
−Removed: Management believes that it can be successful in obtaining additional capital;
−Removed: however, there can be no assurance
−Removed: that the Company will be able to do so.
−Removed: There is no assurance that any funds raised will be sufficient to enable the Company to
−Removed: attain profitable operations or continue as a going concern.
−Removed: To the extent that the Company is unsuccessful, the Company may need to
−Removed: curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is
−Removed: raised to support further operations.
−Removed: There can be no assurance that such a plan will be successful.
−Removed: To this end, as of March
−Removed: 1, 2024, certain directors and officers have agreed to defer payment of their directors’ fees/compensation until further
−Removed: In addition, we are reducing expenditure on certain non-core activities whilst maintaining our focus on our Phase 3
−Removed: Bria-IMT™ pivotal study in advanced metastatic breast cancer.
−Removed: the nine-month period ended April 30, 2024, the Company’s overall position of cash and cash equivalents decreased by $20,315,398,
−Removed: as compared to $12,871,553 for the nine-month period ended April 30, 2023.
−Removed: This decrease in cash can be attributed to the following:
−Removed: Company’s net cash used in operating activities during the nine-month period ended April 30, 2024, was $20,090,398, as compared
−Removed: to $12,825,853 for the nine-month period ended April 30, 2023.
−Removed: used in investing activities for the nine-month period ended April 30, 2024, was $225,000 compared to nil for the nine-month period ended
−Removed: April 30, 2023.
−Removed: used in financing activities for the nine-month period ended April 30, 2024, was nil, as compared to $45,700 for the nine-month period
−Removed: ended April 30, 2023.
+Added: The Company’s
+Added: ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control.
+Added: The Company intends
+Added: to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives.
+Added: Management believes
+Added: that it can be successful in obtaining additional capital;
+Added: however, there can be no assurance that the Company will be able to do so.
+Added: There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a
+Added: going concern.
+Added: To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement
+Added: a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations.
+Added: no assurance that such a plan will be successful.
+Added: To this end, for several months during calendar year 2024, certain directors and officers
+Added: agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these fees were paid
+Added: Further, certain officers have indicated their willingness to receive a portion of their compensation in equity of the Company,
+Added: subject to applicable Nasdaq rules.
+Added: In addition, we continue to reduce expenditure on certain non-core activities whilst maintaining
+Added: our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.
+Added: the period ended October 31, 2024, the Company’s overall position of cash and cash equivalents increased by $4,930,176 from the
+Added: period ended July 31, 2024 (including effects of foreign exchange).
+Added: This increase in cash can be
+Added: attributed to the following:
+Added: 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
+Added: for the period ended October 31, 2023.
+Added: gained in financing activities for the period ended October 31, 2024, was 11,960,252 as compared to nil for the period ended October
Sheet Arrangements
4 unchanged sentences
Accounting Policies Adopted
−Removed: Company did not adopt any new accounting policies during the nine-month period ended April 30, 2024.
+Added: Company did not adopt any new accounting policies during the period ended October 31, 2024.
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.