44 unchanged sentences
The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination
−Removed: with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study in metastatic
−Removed: breast cancer.
−Removed: The pivotal Phase 3 study of Bria-IMT™ is currently under Fast Track Designation by the U.S.
−Removed: FDA intended to accelerate
−Removed: the review process of novel treatments that address unmet medical needs.
−Removed: Positive completion of the pivotal Phase 3 study, following
−Removed: review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer.
+Added: with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study (ClinicalTrials.gov
+Added: NCT06072612 ) in metastatic breast cancer.
+Added: The pivotal Phase 3 study of Bria-IMT™ is currently
+Added: under Fast Track Designation by the U.S.
+Added: FDA intended to accelerate the review process of novel treatments that address unmet medical
+Added: Positive completion of the pivotal Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™
+Added: plus an immune checkpoint inhibitor in metastatic breast cancer.
+Added: is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
Additionally,
BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier:
−Removed: NCT06471673 ) to evaluate the safety and efficacy
−Removed: of Bria-OTS™, BriaCell’s personalized next generation immunotherapy.
−Removed: The study will investigate Bria-OTS™ alone and
−Removed: in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by BeiGene, Ltd.)
−Removed: for the treatment of metastatic breast cancer.
−Removed: Bria-OTS™/Bria-OTS+™, provides a platform technology to develop personalized
−Removed: off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of
−Removed: the immune system as well as an immune checkpoint inhibitor.
−Removed: is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
−Removed: September 10, 2024, BriaCell announced it had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND)
−Removed: meeting with the FDA for Bria-PROS+™ in prostate cancer.
−Removed: The meeting provides a clear path towards filing an IND and
−Removed: conducting a Phase 1/2 study of Bria-PROS+™
−Removed: September 11, 2024, BriaCell reported positive overall survival (OS) in metastatic breast cancer in its Phase 2 study of the Bria-IMT™
−Removed: regimen in combination with an immune checkpoint inhibitor.
−Removed: Median overall survival of 15.6 months in patients treated with the phase
−Removed: 3 formulation of Bria-IMT™ since 2022 was reported.
−Removed: OS of 15.6 months compared favorably with 5.9-9.8 months reported for similar
−Removed: patients in the literature.
−Removed: Ongoing Phase 3 study investigates Bria-IMT™ in similar metastatic breast cancer population.
−Removed: related discontinuations were reported.
−Removed: September 12, 2024, BriaCell announced closing of $8.5 million offering.
−Removed: The Company announced the closing of its previously announced
−Removed: best-efforts offering priced at-the-market under Nasdaq rules for 821,666 common shares.
−Removed: Each common share was sold at an offering price
−Removed: of $10.35 per share, for gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses.
−Removed: All the shares in the offering were offered by the Company.
−Removed: The Company announced its intention to use the net proceeds from the offering
−Removed: for working capital requirements, general corporate purposes, and the advancement of business objectives.
−Removed: ThinkEquity acted as sole placement
−Removed: agent for the offering.
−Removed: The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement
−Removed: on Form S-3 (File No.
−Removed: 333-276650), including a base prospectus, filed with the U.S.
−Removed: Securities and Exchange Commission (the “SEC”)
−Removed: on January 22, 2024 and declared effective on January 31, 2024.
−Removed: The offering was made by means of a prospectus supplement and prospectus
−Removed: which have been filed with the SEC and available on the SEC’s website at www.sec.gov.
−Removed: September 18, 2024, BriaCell announced an FDA-authorized expanded access policy for metastatic breast cancer patients.
−Removed: FDA authorized
−Removed: the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need of novel treatments.
−Removed: The expanded access policy will
−Removed: provide Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s pivotal Phase 3 clinical trial.
−Removed: October 1, 2024, BriaCell reported 100% Resolution of brain metastasis in breast cancer patient with “eye-bulging” tumor.
−Removed: The dramatic anti-tumor response included complete resolution of right temporal lobe brain metastasis.
−Removed: Heavily pre-treated, this patient
−Removed: had failed 8 prior regimens including antibody-drug conjugate ( ADC) therapy and continues to receive Bria-IMT™ treatment.
−Removed: October 2, 2024, BriaCell announced closing of $5 million offering.
−Removed: The Company announced the closing of its previously announced best-efforts
−Removed: 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
−Removed: and associated warrant, priced at-the-market under Nasdaq rules.
−Removed: The warrants had an exercise price of $12.75 per share and are immediately
−Removed: exercisable upon issuance for a period of five years following the date of issuance.
−Removed: Total gross proceeds from the offering, before deducting
−Removed: the placement agent’s fees and other offering expenses, are approximately $5 million.
−Removed: The Company announced its intentions to use
−Removed: the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.
−Removed: ThinkEquity acted as sole placement agent for the offering.
−Removed: The securities were offered and sold pursuant to the Company’s currently
−Removed: effective shelf registration statement on Form S-3 (File No.
−Removed: 333-276650), including a base prospectus, filed with the U.S.
−Removed: and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024.
−Removed: The offering was made
−Removed: 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.
−Removed: You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering.
−Removed: October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main
−Removed: and 17 satellite) are active and enrolling patients.
−Removed: Additional sites are in various stages of start-up.
−Removed: Interim data will be analyzed
−Removed: once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen
−Removed: versus those treated with physician’s choice as the primary endpoint.
−Removed: Positive results of the pivotal Phase 3 study could result
−Removed: in full approval and marketing authorization for Bria-IMT™ in MBC patients.
−Removed: Secondary analyses include comparison of the Bria-IMT™
−Removed: combination regimen vs Bria-IMT™ monotherapy.
−Removed: BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient
−Removed: The Bria-IMT™ combination regimen has received FDA Fast Track designation.
−Removed: October 22, 2024, the Company reported that in the Company’s Phase 2 clinical study, patients treated with the same Bria-IMT™
−Removed: regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e.
−Removed: 55% of patients
−Removed: remain alive at least one year after starting on the study).
−Removed: This rate exceeds the survival data of the current standard of care for
−Removed: similar patients (see Table 1 below).
−Removed: Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.
−Removed: Comparable Analysis of 1 year survival for the BriaCell Phase 2 study
−Removed: Breast Cancer Type
−Removed: Median prior lines of therapy
−Removed: Median OS (months)
−Removed: Percent Survival at 1 year
−Removed: Bria-IMT™ plus CPI
−Removed: Cortes et al.
−Removed: Bardia et al.
−Removed: Patients treated with the Phase 3 formulation
−Removed: Patients treated with the Phase 3 formulation since 2022
−Removed: Annals of Oncology 2018
−Removed: Breast Cancer Res Treat.
−Removed: J Clin Oncol.
−Removed: Abbreviations:
−Removed: hormone receptor-positive
−Removed: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal
−Removed: growth factor receptor 2 (HER2))
−Removed: Human epidermal growth factor receptor 2 positive
−Removed: hormone receptor-positive and human epidermal growth factor receptor 2 negative
−Removed: Treatment of Physicians Choice
−Removed: November, 21, 2024, the Company announced that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier:
−Removed: to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy.
+Added: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS™,
+Added: BriaCell’s personalized next generation immunotherapy, in metastatic breast cancer and other cancers.
The study will investigate
−Removed: Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab® (manufactured and supplied by BeiGene, Ltd.)
−Removed: for the treatment of metastatic breast cancer.
−Removed: Bria-OTS™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study
−Removed: for metastatic breast cancer.
−Removed: November 23, 2024, Marc Lustig resigned from the board of directors of the Company.
−Removed: December 2, 2024, BriaCell received green-light from Data Safety Monitoring Board for its Phase 3 Study in metastatic breast cancer.
−Removed: The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study
−Removed: of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer.
−Removed: December 11, 2024, BriaCell presented unprecedented overall survival data in metastatic breast cancer in Spotlight Poster at 2024 SABCS®.
−Removed: Median overall survival (OS) of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated
−Removed: since 2022), was ~double that of comparable patients in the literature.
−Removed: Final Phase 2 OS calculation was pending as many patients remain
−Removed: alive well over 1 year after starting the study.
−Removed: Median OS of 13.7 months was reported in breast cancer patients with central nervous
−Removed: system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI).
−Removed: Five BriaCell posters were presented that showcased robust survival and clinical benefit data, plus key biomarker data from the Phase
−Removed: 2 trial of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer (MBC).
−Removed: identify patients who benefit from treatments with the Bria-IMT™ regimen.
−Removed: No toxicity-related discontinuations were reported.
−Removed: 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 493,333 common shares of the Company for aggregate gross proceeds of approximately $5.55 million before
−Removed: deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”).
−Removed: Each common share
−Removed: was sold together with one warrant to purchase one common share at a combined purchase price of $11.25.
−Removed: The warrants have an exercise
−Removed: price of $14.06 per share, and are immediately exercisable for a period of five years from the closing date.
−Removed: In addition, the Company
−Removed: issued 24,666 agent warrants.
−Removed: The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise
−Removed: price of $14.06.
+Added: Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by
+Added: BeiGene, Ltd.) for the treatment of metastatic breast cancer.
+Added: Bria-OTS™/Bria-OTS+™, provides a platform technology to develop
+Added: personalized off-the-shelf immunotherapies for numerous types of cancer.
January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of
5 unchanged sentences
consolidation was January 29, 2025.
−Removed: February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer
−Removed: tumor that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient
−Removed: treated with Bria-OTS™.
−Removed: Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a
−Removed: Phase 1/2a dose escalation study (ClinicalTrials.gov identifier:
+Added: February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor
+Added: that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient treated with
+Added: Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation
+Added: study (ClinicalTrials.gov identifier:
NCT06471673) in metastatic recurrent breast cancer.
−Removed: Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is
−Removed: currently in a pivotal Phase 3 study for metastatic breast cancer.
+Added: Bria-OTS™ represents a personalized,
+Added: next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic
+Added: breast cancer.
February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate
6 unchanged sentences
of $5.00 per share.
−Removed: of Operations for the Three Months Ended January 31, 2025 and 2024
−Removed: Three months ended
+Added: April 10, 2025, the Company announced that its majority owned subsidiary, BriaPro Therapeutics Corp.
+Added: (“ BriaPro ”),
+Added: is developing novel, high affinity antibodies to B7-H3, a key player in cancer progression, using molecular modeling techniques.
+Added: has filed provisional US patent applications for the corresponding technology and plans on filing an international patent application
+Added: under the Patent Cooperation Treaty (PCT).
+Added: both an immune checkpoint molecule that regulates T cell activity and a cell surface molecule expressed on many types of cancer cells,
+Added: B7-H3 is a promising drug target.
+Added: BriaPro plans on developing anti-B7-H3 antibodies for multiple cancer indications and plans to incorporate
+Added: them into its Bria-TILsRx™ platform—a proprietary antibody platform designed to redirect and activate T cells within the
+Added: tumor microenvironment.
+Added: This platform integrates both T cell engagers, which promote T cell-mediated tumor killing, and tumor-targeted
+Added: immune checkpoint modulators, which selectively block inhibitory signals on tumor infiltrating lymphocytes (TILs) to enhance their anti-tumor
+Added: April 16, 2025, the Company announced new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI),
+Added: outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients.
+Added: In BriaCell’s Phase 2 clinical
+Added: study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+
+Added: breast cancer.
+Added: As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of
+Added: care TRODELVY ® (14.4 months).
+Added: The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple
+Added: negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2)
+Added: receptors, was similar to TRODELVY ® but still markedly higher (70%) than those of chemotherapy.Table 1:
+Added: Comparable Analysis
+Added: of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™
+Added: plus CPI versus other drugs in MBC patient subsets
+Added: govitecan-hziy)
+Added: agent chemotherapy
+Added: govitecan-hziy)
+Added: agent chemotherapy
+Added: Patients treated with the Phase 3 formulation
+Added: Number of prior chemotherapy-containing regimens
+Added: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
+Added: Abbreviations:
+Added: hormone receptor-positive
+Added: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth
+Added: factor receptor 2 (HER2))
+Added: April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612)
+Added: has consented over 100 and has enrolled over 75 patients.
+Added: BriaCell anticipates completing patient enrollment in late 2025 or early 2026,
+Added: and may report top line data as early as H1-2026.
+Added: April 24, 2025, BriaCell Confirmed 100% Resolution of Lung Metastasis with Bria-OTS (Figure 1).
+Added: Complete resolution of lung metastasis
+Added: confirmed at 4 months follow-up in a hormone receptor positive (HR+) breast cancer patient.
+Added: Treatment well-tolerated and the patient
+Added: remained on study with stable disease elsewhere.
+Added: Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy
+Added: approach in Phase 1/2a metastatic breast cancer study.
+Added: Treatment with Bria-OTS monotherapy resulted in 100% resolution of
+Added: tumor in the lung of the MBC patient following 2 months of therapy and confirmed at 4 months of therapy 1 (axial and coronal
+Added: Note that the other white dots in the lungs are blood vessels.
+Added: shown, the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months.
+Added: images supersede those previously reported.
+Added: April 28, 2025, the Company closed an underwritten public offering for the purchase and sale of 3,066,666 units for aggregate gross proceeds
+Added: of approximately $13.8 million before deducting underwriting discounts, commissions, and other offering expenses (the “April 2025
+Added: Of those units, 2,405,966 were “regular” units, each consisting of one common share and one five-year publicly
+Added: traded warrant at a combined purchase price of $4.50 per unit, and 660,700 were “pre-funded” units, each consisting of one
+Added: pre-funded warrant (at a $0.001 strike) and one five-year publicly traded warrant at a combined purchase price of $4.499 per unit.
+Added: warrants have an exercise price of $5.25 per share, are immediately exercisable, and expire five years from the date of issuance (“April
+Added: 2025 Warrants”).
+Added: The April 2025 Warrants trade on the NASDAQ under the symbol “BCTXZ.”
+Added: connection with the April 2025 Offering, the Company issued 153,333 representative’s warrants.
+Added: The representative’s warrants
+Added: are immediately exercisable at an exercise price of $5.625 per share and expire five years from the date of issuance.
+Added: April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025.
+Added: Positive tolerability profile and potential response
+Added: biomarkers were identified.
+Added: Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in
+Added: Phase 2 study.
+Added: Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits.
+Added: Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were linked
+Added: to longer progression-free survival (PFS) in Phase 3 patients.
+Added: Presence of Circulating Tumor Cells (CTC) after patients’ initial
+Added: Phase 3 treatment supports their role as negative prognostic marker (p = 0.04).
+Added: The Bria-IMT Phase 3 regimen was well-tolerated with
+Added: a preferred tolerability profile.
+Added: May 23, 2025, BriaCell reported that its abstracts showcased positive survival and clinical benefit data at ASCO 2025.
+Added: Phase 2 survival
+Added: and clinical benefit data met or exceeded outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no
+Added: treatment-related discontinuations.
+Added: Successful completion of the pivotal Phase 3 study may support Biologics License Application, Priority
+Added: Review, Full Approval, and Commercialization.
+Added: May 27, 2025, BriaCell announced that the Bria-OTS Phase 1/2 Study cleared safety evaluation, and BriaCell dosed its first patient in
+Added: Bria-OTS combination with an immune checkpoint inhibitor.
+Added: Specifically, Bria-OTS has cleared its safety evaluation in the Phase 1/2 study
+Added: monotherapy dosage setting.
+Added: Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic
+Added: breast cancer.
+Added: The first Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis.
+Added: of Operations for the Three Months Ended April 30, 2025 and 2024
+Added: development, and clinical trial expenses
+Added: and administrative expenses
operating expenses
−Removed: Research, development, and clinical trial expenses
−Removed: General and administrative expenses
−Removed: Total operating expenses
−Removed: Operating loss
−Removed: Financial expenses, net
−Removed: Change in fair value of the warrant liability
−Removed: Share of loss on equity investments
−Removed: Net loss for the period
−Removed: $ (6,337,828 )
−Removed: $ (11,333,910 )
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss for the period attributable to BriaCell
−Removed: (11,294,603 )
−Removed: Net loss per share attributable to BriaCell – basic and diluted
+Added: expenses, net
+Added: in fair value of the warrant liability
+Added: of loss on equity investments
+Added: loss for the period
+Added: loss attributable to non-controlling interest
+Added: loss for the period attributable to BriaCell
+Added: loss per share attributable to BriaCell – basic and diluted
Development, and Clinical Trial Costs
3 unchanged sentences
following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
−Removed: Three months ended January 31,
−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 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
−Removed: period ended January 31, 2024.
−Removed: This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which
−Removed: decreased from $6,200,980 in 2024 to $4,117,576 in 2025.
−Removed: The decrease reflects the conclusion of the Bria-IMT™ Phase 1/2a trial
−Removed: and a focus on optimizing expenditures for the pivotal Phase 3 trial.
−Removed: Wages and salaries decreased slightly, from $1,401,679 in 2024
−Removed: to $1,292,021 in 2025, reflecting resource allocation adjustments.
−Removed: Laboratory rent increased to $114,330 in 2025, up from $108,000 in
−Removed: 2024, due to expanded use of facilities to support ongoing research.
−Removed: Supplies decreased, from $312,543 in 2024 to $85,264 in 2025, driven
−Removed: by lowered spending.
−Removed: Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in capital assets to support research
−Removed: Professional fees increased to $1,908 in 2025, compared to nil in 2024.
−Removed: Notably, share-based compensation expenses decreased
−Removed: significantly, from $234,253 in 2024 to $50,839 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
−Removed: Clinical trial expenses for the
−Removed: period are as follows:
−Removed: months ended January 31,
−Removed: Pivotal Phase 3 study
−Removed: Bria-OTS™ Phase 1/2a
−Removed: 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.
−Removed: The slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024,
−Removed: resulting in lower associated costs.
−Removed: As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly
−Removed: directed toward the pivotal Phase 3 study, which remains our primary focus.
−Removed: At the same time, we have begun incurring costs related
−Removed: to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
−Removed: 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
−Removed: This increase reflects our intensified efforts to advance the pivotal Phase 3 study, with a focus on patient recruitment, site
−Removed: activation, and trial execution as we push toward key milestones.
−Removed: the three-month period ended January 31, 2025, Bria-IMT™ Phase 1/2a costs were $215,301, a significant decline from $1,840,430
−Removed: in 2024, as the trial has now concluded.
+Added: months ended April 30,
+Added: trial sites and investigational drug costs
+Added: the three-month period ended April 30, 2025, total research, development, and clinical trial costs amounted to $4,810,196 as compared
+Added: to $7,657,632 for the three-month period ended April 30, 2024.
+Added: This reduction was primarily driven by lower clinical trial sites and
+Added: investigational drug costs, which decreased from $6,165,072 in 2024 to $3,175,543 in 2025.
+Added: The decrease reflects the conclusion of the
+Added: Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
+Added: Wages and salaries increased considerably,
+Added: from $1,090,902 in 2024 to $1,303,157 in 2025, reflecting the hiring of additional employees.
+Added: Laboratory rent increased to $114,330 in
+Added: 2025, up from $109,500 in 2024, due to expanded use of facilities to support ongoing research.
+Added: Supplies decreased, from $165,264 in 2024
+Added: to $157,184 in 2025, driven by lowered spending.
+Added: Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in
+Added: capital assets to support research activities.
+Added: Professional fees increased to $650 in 2025, compared to $581 in 2024.
+Added: Notably, share-based
+Added: compensation expenses decreased significantly, from $126,313 in 2024 to $36,493 in 2025, contributing to the overall reduction in research,
+Added: development, and clinical trial expenses.
+Added: trial expenses for the period are as follows:
+Added: months ended April 30,
+Added: Bria-IMT™ Pivotal Phase 3
+Added: Bria-IMT™ Phase 1/2a
+Added: Bria-OTS™ Phase
+Added: trial expenses for the three months ended April 30, 2025, were $3,190,751, compared to $4,359,850 during the same period in 2024.
+Added: slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting
+Added: in lower associated costs.
+Added: As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly directed toward
+Added: the pivotal Phase 3 study, which remains our primary focus.
+Added: At the same time, we have begun incurring costs related to the Bria-OTS™
+Added: Phase 1/2a trial, which commenced in August 2024.
+Added: the three-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,708,394, a decrease from $3,764,521
+Added: This decrease reflects the planned phasing of expenditures within the pivotal study;
+Added: the prior-year quarter included higher
+Added: up-front activities, whereas current spending is concentrated on ongoing patient recruitment, treatment, and data-management costs as
+Added: we push toward key milestones.
+Added: the three-month period ended April 30, 2025, Bria-IMT™ Phase 1/2a costs were $300,013, a significant decline from $898,528 in 2024,
+Added: as the trial has now concluded.
The remaining expenses primarily relate to final data analysis and study close-out activities.
−Removed: the three-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $65,608, compared to $nil in 2024.
−Removed: increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
+Added: the three-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $182,344, compared to $nil in 2024.
+Added: is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
and Administrative Expenses
−Removed: the three-month period ended January 31, 2025, general and administrative expenses amounted to $1,484,666, compared to $1,571,991 for
−Removed: the same period in 2024.
+Added: the three-month period ended April 30, 2025, general and administrative expenses amounted to $1,518,059, compared to $1,572,016 for the
+Added: same period in 2024.
The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
1 unchanged sentence
income (expenses), net
−Removed: the three-month period ended January 31, 2025, financial income amounted to $67,358, compared to $81,628 for the three-month period ended
−Removed: January 31, 2024.
−Removed: Financial income for the 2025 period consisted of $46,832 in interest income and a $20,256 foreign exchange gain.
−Removed: comparison, financial income for the 2024 period included $81,595 in interest income and a $33 foreign exchange gain.
−Removed: The decrease in
−Removed: financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents available
−Removed: for investment in interest-bearing funds.
+Added: the three-month period ended April 30, 2025, financial expense amounted to $9,762, compared to income of $13,215 for the three-month
+Added: period ended April 30, 2024.
+Added: Financial expense for the 2025 period consisted of $26,632 in interest income offset by $585 foreign exchange
+Added: loss and interest expense of $36,979 .
+Added: In comparison, financial income for the 2024 period included $15,606 in interest income and a
+Added: $2,391 foreign exchange loss.
+Added: The decrease in financial income to a loss from 2024 to 2025 was primarily due to higher interest expense
+Added: in 2025 compared to nil in 2024.
for the period
−Removed: 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
−Removed: The decrease in net loss was primarily driven by a reduction in research, development, and clinical trial expenses, which declined from $8,257,455
−Removed: 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™
−Removed: Phase 1/2a trial.
−Removed: Additionally, the change in fair value of the warrant liability resulted in a gain of $806,841 in 2025, compared to
−Removed: a loss of $1,567,747 in 2024, further contributing to the improved financial results.
−Removed: of Operations for the Six Months Ended January 31, 2025 and 2024
−Removed: Six months ended
+Added: Company reported a loss of $6,224,929 for the three-month period ended April 30, 2025, compared to income of $1,692,242 for the same
+Added: period in 2024.
+Added: The swing to a net loss was primarily driven by a significantly smaller non-cash gain from the change in fair value of
+Added: the warrant liability, which declined from $10,945,672 in 2024 to $175,826 in 2025.
+Added: Additionally, research, development, and clinical
+Added: trial expenses decreased from $7,657,632 in 2024 to $4,810,196 in 2025, mainly due to lower clinical-trial and investigational-drug costs
+Added: following the completion of the Bria-IMT™ Phase 1/2a trial, partially offsetting the impact of the reduced warrant-liability gain.
+Added: of Operations for the Nine Months Ended April 30, 2025 and 2024
+Added: development, and clinical trial expenses
+Added: and administrative expenses
operating expenses
−Removed: Research, development, and clinical trial expenses
−Removed: General and administrative expenses
−Removed: Total operating expenses
−Removed: Operating loss
−Removed: (12,322,275 )
−Removed: (18,332,474 )
−Removed: Financial expenses, net
−Removed: Change in fair value of the warrant liability
−Removed: Share of loss on equity investments
−Removed: Net loss for the period
−Removed: $ (12,167,104 )
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss for the period attributable to BriaCell
−Removed: (12,093,595 )
−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 of common stock
−Removed: Weighted average number of shares used in computing net diluted earnings per share of common stock
+Added: expenses, net
+Added: in fair value of the warrant liability
+Added: of loss on equity investments
+Added: loss for the period
+Added: loss attributable to non-controlling interest
+Added: loss for the period attributable to BriaCell
+Added: loss per share attributable to BriaCell – basic and diluted
Development, and Clinical Trial Costs
3 unchanged sentences
following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
−Removed: Six months ended January 31,
−Removed: Clinical trial sites and Investigational drug costs
−Removed: Wages and salaries
−Removed: Laboratory Rent
−Removed: Professional fees
−Removed: Share-based compensation
−Removed: the six-month period ending January 31, 2025, research, development and clinical trial costs amounted to $9,350,118, a significant
−Removed: decrease from the $15,114,712 incurred during the same period in 2024.
−Removed: This reduction was primarily driven by lower clinical trial
−Removed: sites and investigational drug costs, which decreased from $11,598,418 in 2024 to $6,557,243 in 2025.
−Removed: The decrease reflects the
−Removed: conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
−Removed: salaries decreased slightly, from $2,422,404 in 2024 to $2,241,110 in 2025, reflecting resource allocation adjustments.
−Removed: rent increased to $228,660 in 2025, up from $196,480 in 2024, due to expanded use of facilities to support ongoing research.
−Removed: Supplies decreased, from $401,566 in 2024 to $184,694 in 2025, driven by lowered spending.
−Removed: Depreciation expenses of $45,678 were
−Removed: recognized in 2025, reflecting investments in capital assets to support research activities.
−Removed: Professional fees increased to $9,176
−Removed: in 2025, compared to $3,782 in 2024, primarily due to consulting and support for clinical operations.
−Removed: Notably, share-based
−Removed: compensation expenses decreased significantly, from $492,062 in 2024 to $83,557 in 2025, contributing to the overall reduction in
−Removed: research, development, and clinical trial expenses.
−Removed: Clinical trial expenses for the
−Removed: period are as follows:
−Removed: months ended January 31,
+Added: months ended April 30,
+Added: trial sites and Investigational drug costs
+Added: the nine-month period ending April 30, 2025, research, development and clinical trial costs amounted to $14,160,314, a significant decrease
+Added: from the $22,772,344 incurred during the same period in 2024.
+Added: This reduction was primarily driven by lower clinical trial sites and investigational
+Added: drug costs, which decreased from $17,763,490 in 2024 to $9,732,786 in 2025.
+Added: The decrease reflects the conclusion of the Bria-IMT™
+Added: Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial.
+Added: Wages and salaries increased slightly, from $3,513,306
+Added: in 2024 to $3,544,267 in 2025, reflecting the hiring of additional employees.
+Added: Laboratory rent increased to $342,990 in 2025, up from
+Added: $305,980 in 2024, due to expanded use of facilities to support ongoing research.
+Added: Supplies decreased, from $566,830 in 2024 to $341,878
+Added: in 2025, driven by lowered spending.
+Added: Depreciation expenses of $68,517 were recognized in 2025, reflecting investments in capital assets
+Added: to support research activities.
+Added: Professional fees increased to $9,826 in 2025, compared to $4,363 in 2024, primarily due to consulting
+Added: and support for clinical operations.
+Added: Notably, share-based compensation expenses decreased significantly, from $618,375 in 2024 to $120,050
+Added: in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
+Added: trial expenses for the period are as follows:
+Added: months ended April 30,
Pivotal Phase 3 study
−Removed: Bria-OTS™ Phase 1/2a
−Removed: Clinical trial expenses for the six-month period ended January 31, 2025, were $6,631,649, compared to $7,987,140
−Removed: during the same period in 2024.
−Removed: This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the continued prioritization
−Removed: of the pivotal Phase 3 study, which remains our primary focus.
−Removed: While resources have been increasingly directed toward Phase 3, we have
−Removed: also begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
−Removed: 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.
−Removed: The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, activating
−Removed: additional sites, and streamlining trial execution to support the study’s advancement.
+Added: trial expenses for the nine-month period ended April 30, 2025, were $9,822,400, compared to $12,650,189 during the same period in 2024.
+Added: This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the planned phasing of expenditures within the pivotal
+Added: Phase 3 study, which remains our primary focus.
+Added: While resources have been increasingly directed toward Phase 3, we have also begun incurring
+Added: costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
+Added: the nine-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $8,797,505, up from $8,651,728 in 2024.
+Added: The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, treatment,
+Added: site activation, and data-management activities to support the study’s advancement.
Phase 1/2a costs declined to $699,356, a sharp reduction from $3,998,461 in 2024, reflecting the trial’s conclusion.
+Added: The remaining
costs are tied to final reporting, regulatory submissions, and study close-out activities.
−Removed: For the six-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $143,195, compared
−Removed: to $nil in 2024.
−Removed: The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
+Added: the nine-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $325,539, compared to $nil in 2024.
+Added: is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources
1 unchanged sentence
and Administrative Expenses
−Removed: 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: the nine-month period ended April 30, 2025, general and administrative expenses amounted to $4,490,216, compared to $4,789,778 for the
same period in 2024.
2 unchanged sentences
income (expenses), net
−Removed: the six-month period ended January 31, 2025, financial income amounted to $79,072, compared to $261,450 for the six-month period ended
−Removed: January 31, 2024.
−Removed: Financial income for the 2025 period consisted of $59,882 in interest income and a $19,190 foreign exchange gain.
−Removed: comparison, financial income for the 2024 period included $272,410 in interest income, offset by a $10,960 foreign exchange loss.
−Removed: decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents
−Removed: available for investment in interest-bearing funds.
+Added: the nine-month period ended April 30, 2025, financial income amounted to $69,310, compared to $274,665 for the nine-month period ended
+Added: April 30, 2024.
+Added: Financial income for the 2025 period consisted of $86,514 in interest income and a $19,775 foreign exchange gain offset
+Added: by interest expense of $36,979.
+Added: In comparison, financial income for the 2024 period included $288,016 in interest income, offset by a
+Added: $13,351 foreign exchange loss.
+Added: The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting
+Added: reduced cash and cash equivalents available for investment in interest-bearing funds.
for the period
−Removed: Company reported a loss of $12,167,104 for the six-month period ended January 31, 2025, compared to $5,375,038 in 2024.
−Removed: 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.
−Removed: 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
−Removed: 2025, mainly due to lower clinical trial and investigational drug costs following the completion of the Bria-IMT™ Phase 1/2a trial.
+Added: Company reported a loss of $18,392,033 for the nine-month period ended April 30, 2025, compared to $3,682,796 in 2024.
+Added: The increase was
+Added: primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $366,024 in 2025 compared to $23,660,003
+Added: This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $22,772,344
+Added: in 2024 to $14,160,314 in 2025, mainly due to lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™
+Added: 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 January 31, 2025, and a positive working capital balance of $1,931,735 (July 31, 2024 negative balance of $3,807,303).
−Removed: 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
+Added: of April 30, 2025, and a positive working capital balance of $10,454,565 (July 31, 2024 negative balance of $3,807,303).
+Added: of April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261), a positive working capital of $10,454,565
(July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $103,664,194 (July 31, 2024 - $85,443,697).
−Removed: of January 31, 2025, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
+Added: of April 30, 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 January 31, 2025, the Company’s overall position of cash and cash equivalents increased by $4,151,565 from the
+Added: the period ended April 30, 2025, the Company’s overall position of cash and cash equivalents increased by $11,598,164 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 January 31, 2025, was $12,875,298 as compared to $15,006,564
−Removed: for the period ended January 31, 2024.
−Removed: gained in financing activities for the period ended January 31, 2025, was 17,176,863 as compared to nil for the period ended January
+Added: Company’s net cash used in operating activities during the period ended April 30, 2025, was $20,038,075 as compared to $20,090,398
+Added: for the period ended April 30, 2024.
+Added: gained in financing activities for the period ended April 30, 2025, was 31,891,239 as compared to nil for the period ended April 30,
Sheet Arrangements
4 unchanged sentences
Accounting Policies Adopted
−Removed: Company did not adopt any new accounting policies during the period ended January 31, 2025.
+Added: Company did not adopt any new accounting policies during the period ended April 30, 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.