BriaCell Therapeutics Corp. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. References to the “Company,” “our,” “us” or “we” refer to BriaCell Therapeutics Corp. The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Introduction This Management’s Discussion and Analysis (“MD&A”) should be read together with other information, including our unaudited condensed interim consolidated financial statements and the related notes to those statements included in Part I, Item 1 of this Quarterly Report (the “Condensed Consolidated Financial Statements”), our consolidated financial statements appearing in our Annual Report on Form 10-K for the year ended July 31, 2024 (the “Annual Report”) and Part I, Item 1A, Risk Factors, of the Annual Report. This MD&A provides additional information on our business, recent developments, financial condition, cash flows and results of operations, and is organized as follows: ● Part 1 - Business Overview. This section provides a general description of our business, which we believe is important in understanding the results of our operations, financial condition, and potential future trends. ● Part 2 - Results of Operations. This section provides an analysis of our results of operations for the first half and second quarter of fiscal 2025 in comparison to the first half and second quarter of fiscal 2024. ● Part 3 - Financial Liquidity and Capital Resources. This section provides an analysis of our cash flows and outstanding debt and commitments. Included in this analysis is a discussion of the amount of financial capacity available to fund our ongoing operations and future commitments. We prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S. GAAP. Our unaudited Condensed Consolidated Financial Statements, and the financial information contained herein, are reported in U.S Dollars. Cautionary Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other SEC filings. Overview BriaCell Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study in metastatic breast cancer. The pivotal Phase 3 study of Bria-IMT™ is currently under Fast Track Designation by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer. Additionally, BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by BeiGene, Ltd.) for the treatment of metastatic breast cancer. Bria-OTS™/Bria-OTS+™, provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor. 1 ”Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment. 20 Recent Developments On September 10, 2024, BriaCell announced it had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA for Bria-PROS+™ in prostate cancer. The meeting provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™ On September 11, 2024, BriaCell reported positive overall survival (OS) in metastatic breast cancer in its Phase 2 study of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor. Median overall survival of 15.6 months in patients treated with the phase 3 formulation of Bria-IMT™ since 2022 was reported. OS of 15.6 months compared favorably with 5.9-9.8 months reported for similar patients in the literature. Ongoing Phase 3 study investigates Bria-IMT™ in similar metastatic breast cancer population. No drug related discontinuations were reported. On September 12, 2024, BriaCell announced closing of $8.5 million offering. The Company announced the closing of its previously announced best-efforts offering priced at-the-market under Nasdaq rules for 821,666 common shares. Each common share was sold at an offering price of $10.35 per share, for gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses. All the shares in the offering were offered by the Company. The Company announced its intention to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives. ThinkEquity acted as sole placement agent for the offering. The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024. The offering was made 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. On September 18, 2024, BriaCell announced an FDA-authorized expanded access policy for metastatic breast cancer patients. FDA authorized the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need of novel treatments. The expanded access policy will provide Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s pivotal Phase 3 clinical trial. On October 1, 2024, BriaCell reported 100% Resolution of brain metastasis in breast cancer patient with “eye-bulging” tumor. The dramatic anti-tumor response included complete resolution of right temporal lobe brain metastasis. Heavily pre-treated, this patient had failed 8 prior regimens including antibody-drug conjugate ( ADC) therapy and continues to receive Bria-IMT™ treatment. 21 On October 2, 2024, BriaCell announced closing of $5 million offering. The Company announced the closing of its previously announced best-efforts 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 and associated warrant, priced at-the-market under Nasdaq rules. The warrants had an exercise price of $12.75 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are approximately $5 million. The Company announced its intentions to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives. ThinkEquity acted as sole placement agent for the offering. The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024. The offering was made 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. You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering. On October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main and 17 satellite) are active and enrolling patients. Additional sites are in various stages of start-up. Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™ in MBC patients. Secondary analyses include comparison of the Bria-IMT™ combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. The Bria-IMT™ combination regimen has received FDA Fast Track designation. On October 22, 2024, the Company reported that in the Company’s Phase 2 clinical study, patients treated with the same Bria-IMT™ regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for similar patients (see Table 1 below). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well. Table 1: Comparable Analysis of 1 year survival for the BriaCell Phase 2 study Reference Breast Cancer Type Median prior lines of therapy Median OS (months) Percent Survival at 1 year Bria-IMT™ plus CPI All types 61% HR+ 33% TNBC 6% HER2+ 6 13.4* 15.6** 55 % Cortes et al. 1 All types 57% HR+ 18-19% TNBC 18-20% HER2+ 4 9.1-9.3 ~38-40 % Kazmi et al. 2 All types 51-52% HR+ 25-29% TNBC 9-24% HER2+ 2 7.2-9.8 30-38 % Bardia et al. (TPC arm) 3 TNBC 2-3 6.9 ~23 % Rugo et al (TPC arm) 4 HR+ HER2- 2 11.2 47 % * Patients treated with the Phase 3 formulation ** Patients treated with the Phase 3 formulation since 2022 1. Cortes J, et al. Annals of Oncology 2018 2. Kazmi S, et al. Breast Cancer Res Treat. 2020 3. Bardia A, et al. J Clin Oncol. 2024 4. Rugo HS, et al. The Lancet. 2023 Abbreviations: HR+: hormone receptor-positive TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)) HER2+: Human epidermal growth factor receptor 2 positive HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative TPC: Treatment of Physicians Choice 22 On November, 21, 2024, the Company announced that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab® (manufactured and supplied by BeiGene, Ltd.) for the treatment of metastatic breast cancer. Bria-OTS™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study for metastatic breast cancer. On November 23, 2024, Marc Lustig resigned from the board of directors of the Company. On December 2, 2024, BriaCell received green-light from Data Safety Monitoring Board for its Phase 3 Study in metastatic breast cancer. The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer. On December 11, 2024, BriaCell presented unprecedented overall survival data in metastatic breast cancer in Spotlight Poster at 2024 SABCS®. Median overall survival (OS) of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022), was ~double that of comparable patients in the literature. Final Phase 2 OS calculation was pending as many patients remain alive well over 1 year after starting the study. Median OS of 13.7 months was reported in breast cancer patients with central nervous system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI). Five BriaCell posters were presented that showcased robust survival and clinical benefit data, plus key biomarker data from the Phase 2 trial of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer (MBC). Biomarkers identify patients who benefit from treatments with the Bria-IMT™ regimen. No toxicity-related discontinuations were reported. On December 13, 2024, the Company closed a public offering for the purchase and sale of 493,333 common shares of the Company and warrants to purchase up to an aggregate of 493,333 common shares of the Company for aggregate gross proceeds of approximately $5.55 million before deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”). Each common share was sold together with one warrant to purchase one common share at a combined purchase price of $11.25. The warrants have an exercise price of $14.06 per share, and are immediately exercisable for a period of five years from the closing date. In addition, the Company issued 24,666 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price of $14.06. On January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of the Company’s issued and outstanding common shares (the “Common Shares”) on the basis of one (1) post-Consolidation Common Share for every fifteen (15) pre-Consolidation Common Shares. The Consolidation is being implemented to ensure that the Company continues to comply with the listing requirements of The Nasdaq Capital Market (the “Nasdaq”). The effective date of the consolidation was January 29, 2025. On February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer. On February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate gross proceeds of approximately $3.05 million before deducting placement agent fees and other offering expenses (the “February 2025 Offering”). Each common share was sold at a public offering price of $4.00 per share. In addition, the Company issued 38,125 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price of $5.00 per share. 23 Results of Operations for the Three Months Ended January 31, 2025 and 2024 Three months ended January 31, 2025 2024 (Unaudited) (Unaudited) Operating Expenses: Research, development, and clinical trial expenses $ 5,684,777 $ 8,257,455 General and administrative expenses 1,484,666 1,571,991 Total operating expenses 7,169,443 9,829,446 Operating loss (7,169,443 ) (9,829,446 ) Financial expenses, net 67,358 81,628 Change in fair value of the warrant liability 806,841 (1,567,747 ) Share of loss on equity investments (42,584 ) (18,345 ) Net loss for the period $ (6,337,828 ) $ (11,333,910 ) Net loss attributable to non-controlling interest (46,408 ) (39,307 ) Net loss for the period attributable to BriaCell (6,291,420 ) (11,294,603 ) Net loss per share attributable to BriaCell – basic and diluted $ (2.33 ) $ (10.64 ) Research, Development, and Clinical Trial Costs Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development; and (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials. The following is a breakdown of our research, development, and clinical trial costs by nature of expenses: Three months ended January 31, 2025 2024 Clinical trial sites and investigational drug costs $ 4,117,576 $ 6,200,980 Wages and salaries 1,292,021 1,401,679 Laboratory Rent 114,330 108,000 Supplies 85,264 312,543 Depreciation 22,839 - Professional fees 1,908 - Share-based compensation 50,839 234,253 $ 5,684,777 $ 8,257,455 24 For 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 period ended January 31, 2024. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which decreased from $6,200,980 in 2024 to $4,117,576 in 2025. The decrease reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries decreased slightly, from $1,401,679 in 2024 to $1,292,021 in 2025, reflecting resource allocation adjustments. Laboratory rent increased to $114,330 in 2025, up from $108,000 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $312,543 in 2024 to $85,264 in 2025, driven by lowered spending. Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in capital assets to support research activities. Professional fees increased to $1,908 in 2025, compared to nil in 2024. Notably, share-based compensation expenses decreased significantly, from $234,253 in 2024 to $50,839 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses. Clinical trial expenses for the period are as follows: Three months ended January 31, 2025 2024 Bria-IMT™ Pivotal Phase 3 study $ 3,642,650 $ 2,519,420 Bria-IMT™ Phase 1/2a 215,301 1,840,430 Bria-OTS™ Phase 1/2a 65,608 - $ 3,923,559 $ 4,359,850 Clinical 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. The slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting in lower associated costs. As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly directed toward the pivotal Phase 3 study, which remains our primary focus. At the same time, we have begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024. For 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 in 2024. This increase reflects our intensified efforts to advance the pivotal Phase 3 study, with a focus on patient recruitment, site activation, and trial execution as we push toward key milestones. For the three-month period ended January 31, 2025, Bria-IMT™ Phase 1/2a costs were $215,301, a significant decline from $1,840,430 in 2024, as the trial has now concluded. The remaining expenses primarily relate to final data analysis and study close-out activities. For the three-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $65,608, compared to $nil in 2024. The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024. General and Administrative Expenses For the three-month period ended January 31, 2025, general and administrative expenses amounted to $1,484,666, compared to $1,571,991 for the same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting in overall stable general and administrative expenses quarter over quarter. Financial income (expenses), net For the three-month period ended January 31, 2025, financial income amounted to $67,358, compared to $81,628 for the three-month period ended January 31, 2024. Financial income for the 2025 period consisted of $46,832 in interest income and a $20,256 foreign exchange gain. In comparison, financial income for the 2024 period included $81,595 in interest income and a $33 foreign exchange gain. The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents available for investment in interest-bearing funds. Loss for the period The 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 in 2024. The decrease in net loss was primarily driven by a reduction in research, development, and clinical trial expenses, which declined from $8,257,455 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™ Phase 1/2a trial. Additionally, the change in fair value of the warrant liability resulted in a gain of $806,841 in 2025, compared to a loss of $1,567,747 in 2024, further contributing to the improved financial results. Results of Operations for the Six Months Ended January 31, 2025 and 2024 Six months ended January 31, 2025 2024 (Unaudited) (Unaudited) Operating Expenses: Research, development, and clinical trial expenses $ 9,350,118 $ 15,114,712 General and administrative expenses 2,972,157 3,217,762 Total operating expenses 12,322,275 18,332,474 Operating loss (12,322,275 ) (18,332,474 ) Financial expenses, net 79,072 261,450 Change in fair value of the warrant liability 190,198 12,714,331 Share of loss on equity investments (114,099 ) (18,345 ) Net loss for the period $ (12,167,104 ) (5,375,038 ) Net loss attributable to non-controlling interest (73,509 ) (81,978 ) Net loss for the period attributable to BriaCell (12,093,595 ) (5,293,060 ) Net loss per share attributable to BriaCell – basic and diluted $ (5.44 ) $ (5.04 ) Weighted average number of shares used in computing net basic earnings per share of common stock 2,224,979 1,065,448 Weighted average number of shares used in computing net diluted earnings per share of common stock 2,224,979 1,065,448 25 Research, Development, and Clinical Trial Costs Research 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. The following is a breakdown of our research, development, and clinical trial costs by nature of expenses: Six months ended January 31, 2025 2024 Clinical trial sites and Investigational drug costs $ 6,557,243 $ 11,598,418 Wages and salaries 2,241,110 2,422,404 Laboratory Rent 228,660 196,480 Supplies 184,694 401,566 Depreciation 45,678 - Professional fees 9,176 3,782 Share-based compensation 83,557 492,062 $ 9,350,118 $ 15,114,712 For the six-month period ending January 31, 2025, research, development and clinical trial costs amounted to $9,350,118, a significant decrease from the $15,114,712 incurred during the same period in 2024. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which decreased from $11,598,418 in 2024 to $6,557,243 in 2025. The decrease reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries decreased slightly, from $2,422,404 in 2024 to $2,241,110 in 2025, reflecting resource allocation adjustments. Laboratory rent increased to $228,660 in 2025, up from $196,480 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $401,566 in 2024 to $184,694 in 2025, driven by lowered spending. Depreciation expenses of $45,678 were recognized in 2025, reflecting investments in capital assets to support research activities. Professional fees increased to $9,176 in 2025, compared to $3,782 in 2024, primarily due to consulting and support for clinical operations. Notably, share-based compensation expenses decreased significantly, from $492,062 in 2024 to $83,557 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses. Clinical trial expenses for the period are as follows: Six months ended January 31, 2025 2024 Bria-IMT™ Pivotal Phase 3 study $ 6,089,111 $ 4,887,207 Bria-IMT™ Phase 1/2a 399,343 3,099,933 Bria-OTS™ Phase 1/2a 143,195 - $ 6,631,649 $ 7,987,140 Clinical trial expenses for the six-month period ended January 31, 2025, were $6,631,649, compared to $7,987,140 during the same period in 2024. This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the continued prioritization of the pivotal Phase 3 study, which remains our primary focus. While resources have been increasingly directed toward Phase 3, we have also begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024. For 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. The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, activating additional sites, and streamlining trial execution to support the study’s advancement. Bria-IMT™ Phase 1/2a costs declined to $399,343, a sharp reduction from $3,099,933 in 2024, reflecting the trial’s conclusion. Remaining costs are tied to final reporting, regulatory submissions, and study close-out activities. For the six-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $143,195, compared to $nil in 2024. The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024. We remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources strategically to ensure its successful execution. General and Administrative Expenses For the six-month period ended January 31, 2025, general and administrative expenses amounted to $2,972,157, compared to $3,217,762 for the same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting in overall stable general and administrative expenses period over period. Financial income (expenses), net For the six-month period ended January 31, 2025, financial income amounted to $79,072, compared to $261,450 for the six-month period ended January 31, 2024. Financial income for the 2025 period consisted of $59,882 in interest income and a $19,190 foreign exchange gain. In comparison, financial income for the 2024 period included $272,410 in interest income, offset by a $10,960 foreign exchange loss. The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents available for investment in interest-bearing funds. 26 Loss for the period The Company reported a loss of $12,167,104 for the six-month period ended January 31, 2025, compared to $5,375,038 in 2024. The increase 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. 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 2025, mainly due to lower clinical trial and investigational drug costs following the completion of the Bria-IMT™ Phase 1/2a trial. Liquidity, Capital Resources and Going Concern Uncertainty The financial statements have been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to continue to raise adequate financing and to commence profitable operations in the future. As of January 31, 2025, and a positive working capital balance of $1,931,735 (July 31, 2024 negative balance of $3,807,303). As 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). As 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. government securities, U.S. government agency securities, and investment grade corporate debt securities . Our investment policy and strategy are focused 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. The Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives. Management believes that it can be successful in obtaining additional capital; however, there can be no assurance that the Company will be able to do so. There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a going concern. To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. To this end, for several months during calendar year 2024, certain directors and officers agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these fees were paid in full. Further, certain officers have indicated their willingness to receive a portion of their compensation in equity of the Company, subject to applicable Nasdaq rules. In addition, we continue to reduce expenditure on certain non-core activities whilst maintaining our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer. During 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). This increase in cash can be attributed to the following: The 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 for the period ended January 31, 2024. Cash gained in financing activities for the period ended January 31, 2025, was 17,176,863 as compared to nil for the period ended January 31, 2024. 27 Off-Balance Sheet Arrangements None. Tabular Disclosure of Contractual Obligations None. Critical Accounting Policies and Estimates There have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section in our Annual Report. New Accounting Policies Adopted The Company did not adopt any new accounting policies during the period ended January 31, 2025.