Item 2. Management’s Discussion and Analysis
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, 2025 (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 nine months and third quarter
of fiscal 2026 in comparison to the nine months and third quarter of fiscal 2025.
●
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. (“Briacell” or 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) in a pivotal Phase 3 study in metastatic
breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). Bria-IMT™ is currently under Fast Track Designation
by the U.S. Food and Drug Administration (the “FDA”) intended to accelerate the review process of novel treatments that address
unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™
immune checkpoint inhibitor combination in metastatic breast cancer.
BriaCell
has reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with median overall survival of 13.4
months in BriaCell’s metastatic breast cancer patients vs. 6.7-9.8 months for similar patients reported in the literature
in its Phase 2 study of Bria-IMT™ combination study with retifanlimab. Additionally, BriaCell reported median overall survival
of 16.5 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor in patients treated
with the Phase 3 formulation since 2022 (post-COVID). A completed Bria-IMT™ Phase 1/2 combination study with retifanlimab (an anti-PD1
antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy (listed on ClinicalTrials.gov as NCT03328026 ).
BriaCell
Phase 1/2 Study of Bria-OTS™, BriaCell’s personalized off-the-shelf immunotherapy, also known as Bria-BRES™, in metastatic
breast cancer is ongoing (listed on ClinicalTrials.gov as NCT06471673 ). The first patient treated with 4 inoculations of
cells (single agent) demonstrated complete resolution of a lung metastasis.
BriaCell
is currently developing Bria-OTS™ and its advanced form, Bria-OTS+™, as a platform technology for personalized off-the-shelf
immunotherapies for numerous types of cancer. The Company announced BriaCell had received positive feedback from its Pre-Investigational
New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ for prostate cancer.
18
Recent
Developments
During
the period from August 1, 2025 through to the date of this report, we announced a number of corporate, financing and R&D developments.
On August 21, 2025, our board approved a consolidation of the Company’s issued and outstanding common shares on the basis of one
post-consolidation common share for every ten pre-consolidation common shares, primarily to help ensure continued compliance with Nasdaq
Capital Market listing requirements. The consolidation became effective on August 25, 2025, with the post-consolidation common shares
commencing trading on the Toronto Stock Exchange and Nasdaq on that date.
Throughout
this time period, there were several important updates on the ongoing pivotal Phase 3 study of Bria-IMT™ in patients with
advanced metastatic breast cancer, including accelerating enrollment, adding additional clinical sites, and several positive Data
Safety Monitoring Board meetings. Some of these are detailed below.
We
also strengthened our non-dilutive funding and external collaborations. On August 13, 2025, we announced acceptance into Memorial Sloan
Kettering Cancer Center’s (MSK’s) 2025 Therapeutics Accelerator Cohort program for the Bria-OTS+™ platform, which includes
the Bria-BRES+™ product candidate for breast cancer.
On
August 25, 2025, we reported that we had been awarded a US$2.0 million Small Business Innovation Research (SBIR) grant from the U.S.
National Cancer Institute (NCI) to advance Bria-PROS+™ in prostate cancer, providing non-dilutive funding to support manufacturing
and planned clinical evaluation activities for this program
On
October 21, 2025, we further announced a collaboration with MSK’s Therapeutics Accelerator program focused on the Bria-OTS+ platform.
The collaboration includes support for manufacturing, IND development and clinical protocol work for a planned Phase 1 study of Bria-BRES+
in breast cancer, and is intended to help accelerate clinical development of Bria-OTS+ across multiple cancer indications.
Bria-IMT™
On
November 25, 2025, BriaCell highlighted positive Phase 2 & Phase 3 clinical data at SABCS® 2025 with poster presentations at
the San Antonio Breast Cancer Symposium (December 10, 2025) which highlighted positive Phase 2 safety and efficacy signals and
positive biomarker findings in both the Phase 2 and the pivotal Phase 3 studies. On December 9 , 2025, BriaCell announced
that patient enrollment is on track for 1H2026 topline data readout with over 230 patients screened and over 160 patients enrolled
in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC).
Presentation
Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine Maturing positive Phase 2 data continue to
support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further
evaluating this immunotherapy and the role of biomarkers in predicting patient response.
Presentation
Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer. BriaCell’s
data suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT
regimen in metastatic breast cancer.
Copies
of the posters are available at https://briacell.com/scientific-publications/ .
On
December 10, 2025, BriaCell presented three posters highlighting robust survival and clinical benefit data in Phase 2, plus positive
key biomarker data from the pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI) at the San Antonio Breast
Cancer Symposium (SABCS®) 2025. Data from the Phase 3 study continues to support biomarkers to identify patients who benefit from
treatment with BriaCell’s regimen. Additionally, maturing Phase 2 study data continues to support meaningful clinical benefit of
the Bria-IMT regimen with outstanding long-term survival. Importantly, no toxicity related discontinuations was reported in the Phase
3 study. Summaries of the studies are shown here.
On
December 18, 2025, BriaCell announced that its Phase 3 Bria-IMT™ clinical trial in metastatic breast cancer was prominently and
independently featured in the Nature Medicine Year In Review’s publication, “ Eleven clinical trials that will shape medicine
in 2026”. Nature Medicine asked leading researchers to name their top clinical trial for 2026, from long-awaited vaccines for infectious
diseases to new treatments for advanced cancers and long COVID. BriaCell’s Phase 3 clinical trial in metastatic breast cancer featured
as “clinical trial to watch in 2026”
On
January 27, 2026, BriaCell Highlighted extended >18-47 months survival in Phase 2 metastatic breast cancer patients. 9 of 25 BriaCell
patients treated since 2022 remained alive >18-47 months post enrollment, markedly exceeding benchmarks reported for standard of care
therapies in similar patient populations. No Bria-IMT™ related discontinuations was reported to that date. Bria-IMT regimen continues
under Fast Track Designation from US FDA.
19
New
positive Phase 2 survival data highlighted multiple patients surpassing expected benchmarks for metastatic breast cancer and survival
length over 18 months in 9 cases as of their last assessment.
Table
1: Ongoing Long-Term Survivors
Patient/Subtype
Months Since Study Start
Age
Number of Prior Regimens
Cycles of Bria-IMT
01-009/ER+/PR+/HER2low
47
74
5
14
07-001/ER+/PR+/HER2low
30
55
7
8
15-001/ER+/PR-/HER2-
30
62
3
12
11-018/ER+/PR+/HER2+
(Highlighted below)
27
66
8; including ENHERTU
35
15-005/ER+/PR+/HER2-
(Highlighted below)
27
44
5
6
15-006/ER+/PR-/HER2-
(Highlighted below)
25
64
8; including TRODELVY
4
15-004/ER+/PR+/HER2-
25
50
3
6
11-019/ER+/PR+/HER2low
23
63
9; including TRODELVY
6
07-014/ER+/PR+/HER2low
>18
62
9; including TRODELVY
5
Note
that Trodelvy and Enhertu are antibody-drug conjugates recently approved for late-stage breast cancer.
Table
2: Comparable analysis of 1- and 2-year survival for the BriaCell Phase 2 study using the Phase 3 formulation since 2022 independent
of subsequent treatment
Breast cancer
Median prior
Median OS
% Survival at:
Reference
type
lines of therapy
(months)
1 year
2 years
Bria-IMT ™ plus CPI
All types
61% HR+
33% TNBC
6% HER2+
6
15.6
52%
32%
Cortes et al. 1
All types
57% HR+
18-19% TNBC
18-20% HER2+
4
9.1-9.3
~38-40%
7-14%
Kazmi et al. 2
All types
51-52% HR+
25-29% TNBC
9-24% HER2+
2
7.2-9.8
30-38 %
11.9-14%
Bardia et al. (TPC) 3
TNBC
4
6.9
~23 %
6%
Bardia et al. (Trodelvy) 3
TNBC
4
11.8
50%
21%
Rugo et al (TPC) 4
HR+ HER2-
4
11.2
47%
21%
Rugo et al (Trodelvy) 4
HR+ HER2-
4
14.4
60%
25%
1.
Cortes J, et al. Annals of Oncology 2018 (estimated from Kaplan-Meier curve)
2.
Kazmi S, et al. Breast Cancer Res Treat. 2020
3.
Bardia A, et al. J Clin Oncol. 2024 (estimated from Kaplan-Meier curve)
4.
Rugo HS, et al. The Lancet. 2023 (estimated from Kaplan-Meier curve)
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
On
January 28, 2026, BriaCell reported patients’ images showing regression and resolution of metastasized tumors and immune activation
in patients with orbital (eye), temporal lobe (brain), liver, and spinal involvement. Survival details on these and other select patients
in its Phase 2 study, along with comparable populations, were previously reported.
Images
below confirm clinical responses seen in patients with metastatic orbital (eye), temporal (brain), liver, and spine lesions.
20
Example
1: Patient 11-018
A
66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, heavily pretreated with 8 prior lines of therapy, including an antibody-drug
conjugate (Enhertu), remains alive 27 months post-enrollment. At baseline, she presented with metastatic involvement of the right orbit
(behind the eye), right temporal lobe of the brain and multiple skeletal sites. Following treatment, she achieved complete resolution
of the temporal lobe metastasis, substantial improvement in the orbital lesion and stable disease in the bone. She remained on study
for 26 months after initiating treatment and receiving 35 cycles of therapy. Images though 20 months for this patient have been previously
described (link). Shown here are updated images through 2 years with measurements superimposed (through 18 months for the temporal lobe
brain metastases).
Example
1 Images ( Patient 11-018) : Bria-IMT treatment resulted in complete resolution of the right temporal lobe lesion and continued
regression of the right orbital (behind the eye) tumor. Measurements of lesion sizes are shown.
LA
= long axis. SA = short axis.
Example
2: Patient 15-005 :
A
44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, previously treated with 5 prior lines of therapy. At baseline, she presented
with metastases to the spine. She completed 6 cycles of therapy achieving stable disease as her best response and remains in survival
follow-up 27 months after study entry.
Before
BriaCell Treatment Image A : CD8 ImmunoPET image
Pre-treatment
imaging of cervical (neck) lymph nodes with moderate uptake indicating presence of some CD8+ cytotoxic (“killer”) T cells.
After
BriaCell Treatment Image B : CD8 ImmunoPET image
Post
treatment enhancement of cervical (neck) lymph nodes indicating immune system activation and increased presence of CD8+ cytotoxic T cells.
Example
2 Images ( Patient 15-005) : CD8 ImmunoPET images pre (A) and post (B) Bria-IMT treatment
Example
3: Patient 15-006 :
A
64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, heavily pre-treated with 8 prior lines of therapy, including the antibody-drug
conjugate Trodelvy, remains alive 25 months post-enrollment. At baseline, presented with hepatic metastasis.
Before
BriaCell Treatment Image A : A liver metastasis (lower arrow) is “cold,” indicating minimal to no CD8+ cytotoxic T cells
in the tumor while enlarged lymph nodes (upper arrow) show moderate uptake.
After
BriaCell Treatment Image B : Swelling (induration) around the metastasis (lower arrow) demonstrates the liver metastasis has become
“hot”, indicating marked CD8+ cytotoxic T cell infiltration while further lymph node enlargement is consistent with increased
activity (upper arrow) indicating increased CD8+ T cells.
21
Example
3 Images ( Patient 15-006) : Combined MRI and CD8 ImmunoPET images Pre (A) and Post (B) Bria-IMT treatment
The
Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median six prior therapies) who received the Bria-IMT
regimen plus a checkpoint inhibitor. Of these, 37 patients were treated with the same formulation now being evaluated in the pivotal
Phase 3 study (NCT06072612). Significantly, no Bria-IMT related discontinuations have been reported to date.No Bria-IMT™ related
discontinuations reported to date. Bria-IMT regimen continues under Fast Track Designation from US FDA.
On February 17, 2026, BriaCell received its fifth
positive recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 study in metastatic breast cancer. Independent DSMB has identified
no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point
inhibitor. This fifth consecutive positive DSMB recommendation supports the favorable safety profile observed to date.
On April 20, 2026, BriaCell presented positive Phase
3 quality of life (QOL) data in heavily pretreated metastatic breast cancer patients with prior failed ADC, CPI, and CDK4/6 inhibitor
treatments at the 2026 American Association for Cancer Research (AACR) annual meeting. The data showed preservation of quality QOL in
patients who had been on multiple prior failed therapy attempts. Additionally, we showed identification of potential prognostic biomarkers
upon further analyses of Phase 2 Bria-IMT™ study data.
On April 27, 2026, BriaCell announced that it has
six clinical data presentations at the American Society of Clinical Oncology (ASCO 2026) meeting.
On May 7, 2026, and May 13, 2026, BriaCell
announced the addition of NYU Langone Health’s Perlmutter Cancer Center and Penn Medicine’s Abramson Cancer Center, respectively, as clinical
sites in the Bria-ABC pivotal breast cancer study. On May 12, 2026, BriaCell announced that enrollment in that the Bria-ABC pivotal
breast cancer study had surpassed 230 patients.
Bria-OTS
and Bria-OTS+
On
November 7, 2025, BriaCell presented robust anti-cancer activity of Bria-OTS+ in breast and prostate cancer models at the Society for
Immunotherapy of Cancer (SITC) 2025. Bria-OTS+ represents a novel, cost-effective, off-the-shelf potent next generation cancer therapy
platform. Next generation Bria-OTS+ platform demonstrated rapid, potent and durable anti-cancer activity by activating both innate and
adaptive immune responses. Increased tumor cell cytotoxicity induced by both Bria-BRES+™ (breast cancer) and Bria-PROS+™
(prostate cancer) was reported. In summary, preclinical data reinforces broad potential of Bria-OTS+ platform across multiple indications.
BriaCell added that lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) are completing GMP manufacturing for
planned clinical trials. As a reminder, $2 million National Cancer Institute (NCI) Small Business Innovative Research (SBIR) award supports
manufacturing and planned clinical evaluation of Bria-PROS+.
On
January 13, 2026, BriaCell reported sustained complete resolution of lung metastasis in Bria-OTS Patient (Figure 1 as shown below). 11-month
sustained complete resolution of lung metastasis was observed in Bria-OTS Phase 1/2a metastatic breast cancer study. No treatment limiting
toxicities reported. The patient maintained stable disease at all other evaluable sites.
Figure
1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the right lung of the metastatic breast cancer (MBC) patient
following 2 months of therapy and confirmed at 4, 6, and 11 months of therapy 1 (axial and coronal views)
22
On April 21, 2026, BriaCell presented positive data
from its preclinical Bria-OTS+ platform at the 2026 AACR meeting showing that Bria-OTS+ platform provided early, potent and durable activation
of innate and adaptive immunity in in-vitro cancer cell line models. Additionally, our data showed immune cells activated by Bria-OTS+
exhibited serial killing activity across multiple rounds of tumor cell challenge.
On May 6, 2026, BriaCell announced that it has received
FDA clearance initiate clinical evaluation of Bria-BRES+™ in advanced metastatic breast cancer. The IND application opens the path
to commence Phase 1/2a clinical study for Bria-BRES+ in metastatic breast cancer. Bria-BRES+ is BriaCell’s next generation personalized
immunotherapy for breast cancer, and features additional immune activating components designed to enhance clinical efficacy. BriaCell
has prepared clinical supplies of Bria-BRES+ and plans to initiate a Phase 1/2a clinical study in metastatic breast cancer in the coming
months.
On May 14, 2026, BriaCell announced that it has completed
manufacturing clinical supplies of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy candidate for
prostate cancer. On May 15 th , 2026, BriaCell announced that it is making progress in developing Bria-OVA+, its next generation,
personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer.
BriaPro
On
February 18, 2026, the Company and BriaPro Therapeutics Corp. (“ BriaPro ”), a announced that we have entered into a
definitive purchase agreement (the “ Purchase Agreement ”) pursuant to which BriaPro has agreed to purchase BriaCell’s
exclusive license to develop and commercialize Soluble CD80 (“ sCD80 ”) as a biologic agent for the treatment of cancer
and other associated assets (the “ Transaction ”).
Background
BriaCell
originally secured the exclusive license from the University of Maryland, Baltimore County (“ UMBC ”) on August 2, 2022.
The novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s
scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and
is covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped
tumor growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al. and Samuel T Haile et al. in collaboration
with Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A
Horn, et al.). Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting
the immune system to recognize and destroy tumor cells.
The
Transaction
Under
the terms of the Purchase Agreement, BriaPro gains the worldwide rights to develop and commercialize sCD80 as a therapeutic agent for
the treatment of cancer, while UMBC holds all rights, title and interest in the inventions and the patent, except for certain rights
retained by the United States Government. BriaPro will pay 2% royalties to UMBC upon the commercialization of the product plus other
development costs.
As
part of the Transaction, BriaCell will make available to BriaPro up to $3 million to fund research and development efforts (the “ Credit
Facility ”). Each drawdown under the Credit Facility will be subject to BriaCell’s approval regarding the use of funds.
As
consideration for the transfer of the exclusive license and the Credit Facility, BriaPro will issue to BriaCell 23,972,589 Common Shares
at an aggregate value of approximately C$1.18M, increasing BriaCell’s interest in BriaPro to approximately 78% post-transaction.
On March 5, 2026, the disinterested shareholders of BriaPro approved the Transaction and the Transaction closed on March 31, 2026.
Results
of Operations for the Three and Nine Months Ended April 30, 2026, and 2025
Three months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Operating expenses:
Research and development expenses
$ 5,966,673
4,810,196
General and administrative expenses
1,654,121
1,518,059
Total operating expenses
7,620,794
6,328,255
Operating loss
(7,620,794 )
(6,328,255 )
Financial income (expense), net
186,970
(9,762 )
Change in fair value of the warrant liability
123,242
175,826
Unrealized gain on investment
137,830
-
Share of loss on equity investment
(64,303 )
(62,738 )
Net loss for the period
$ (7,237,055 )
$ (6,224,929 )
Net loss attributable to non-controlling interest
(72,548 )
(98,027 )
Net loss for the period attributable to BriaCell
(7,164,507 )
(6,126,902 )
Net loss per share attributable to BriaCell – basic and diluted
$ (0.99 )
$ (16.42 )
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
7,250,487
373,067
23
Research
and Development 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 and development costs by nature of expenses:
Three months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Clinical trial sites and investigational drug costs
$ 3,980,115
$ 3,175,543
Wages and salaries
1,492,067
1,303,157
Laboratory Rent
130,500
114,330
Supplies
157,096
157,184
Depreciation
29,193
22,839
Professional fees
1,703
650
Share-based compensation
175,999
36,493
$ 5,966,673
$ 4,810,196
For
the three-month period ended April 30, 2026, total research and development expenses were $5, 966,673 ,
compared to $4,810,196 for the three-month period ended April 30, 2025. The increase was primarily driven by higher clinical trial
sites and investigational drug costs, which increased to $3, 980,115 in
2026 from $3,175,543 in 2025, reflecting expanded clinical development activities. Wages and salaries also increased to $1, 492,067
from $1,303,157, due to higher personnel costs supporting ongoing research programs. Laboratory rent increased to $130,500 from
$114,330, while depreciation expense increased to $29,193 from $22,839. Share-based compensation increased significantly to $175,999
in 2026 from $36,493 in 2025, reflecting a higher level of equity-based awards granted during the period.
Our
clinical trial expenses are broken down as follows:
Three months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Bria-IMT™ Pivotal Phase 3 study
$ 3,149,348
$ 2,708,394
Bria-IMT™ Phase 1/2a
159,579
300,013
Bria-OTS™ Phase 1/2a
1,040,724
182,344
$ 4,349,651
$ 3,190,751
Clinical
trial expenses for the three months ended April 30, 2026, were $4,349,651, compared to $3,190,751 during the same period in 2025. The
increase reflects continued investment in the Bria-IMT™ pivotal Phase 3 program and ongoing advancement of the Bria-OTS™
Phase 1/2a program as it progresses through early clinical development. Together, these programs account for the majority of the year-over-year
increase in clinical trial expenses.
For
the three-month period ended April 30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $3,149,348, compared to $2,708,394 in 2025.
The increase reflects the study’s continued progression through an advanced, cost-intensive stage, including expanded patient enrollment,
increased clinical site activity, CRO services, central laboratory work, and clinical supply management. The level of spending is consistent
with maintaining study momentum as the program advances toward planned interim analyses.
For
the three-month period ended April 30, 2026, Bria-IMT™ Phase 1/2a expenses were $159,579, compared to $300,013 in 2025. The decrease
reflects the continued wind-down of the program following completion of primary activities in fiscal 2024, with current-period costs
primarily related to residual close-out procedures, data management, and limited follow-up activities. Expenses are expected to remain
modest as final wrap-up items are completed.
For
the three-month period ended April 30, 2026, Bria-OTS™ Phase 1/2a expenses were $1,040,724, compared to $182,344 in 2025. The substantial
increase reflects continued advancement of the OTS program in early clinical development. Current-period costs include expanded development
and manufacturing activities, GMP production of Bria-BRES+ and Bria-PROS+, regulatory and analytical support, and operational activities
necessary to support ongoing evaluation of the next-generation Bria-OTS+ platform. The increased investment aligns with the program’s
progression and the expansion of OTS across multiple solid tumor indications.
24
General
and Administrative Expenses
For
the three-month period ended April 30, 2026, general and administrative expenses were $1,654,121, compared to $1,518,059 for the three-month
period ended April 30, 2025. The increase was primarily attributable to higher shareholder communications expense, which increased from
$146,616 in 2025 to $307,058 in 2026, higher share-based compensation of $256,208 in 2026 compared to $188,322 in 2025, increased consulting
expenses from $44,222 in 2025 to $98,621 in 2026, and higher wages and salaries, which increased from $325,926 in 2025 to $359,873 in
2026. These increases were partially offset by lower professional fees, insurance expense, regulatory, filing and transfer agent fees,
and travel expenses.
Financial
income, net
For
the three-month period ended April 30, 2026, the Company recorded net financial income of $186,970, compared to net financial expense
of $9,762 in the same period of 2025. The increase is mainly attributable to higher interest income and lower interest expense. For the
three-month period ended April 30, 2026, financial income was comprised of $219,220 of interest income, $29,631 of interest expense and
$2,619 foreign exchange loss.
Profit
(loss) for the period
For
the three-month period ended April 30, 2026, the Company reported a net loss of $7,237,055, compared to $6,224,929 for the same period
in 2025. The higher loss primarily reflects higher operating expenses, including increased research and development spending as the Company
continued to advance its pivotal Phase 3 trial, including higher clinical-site activity, investigational product costs, and supporting
operational infrastructure.
Results
of Operations for the Nine Months Ended April 30, 2026 and 2025
Nine months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development, and clinical trial expenses
$ 18,704,005
$ 14,160,314
General and administrative expenses
4,770,998
4,490,216
Total operating expenses
23,475,003
18,650,530
Operating loss
(23,475,003 )
(18,650,530 )
Financial income, net
430,205
69,310
Change in fair value of the warrant liability
265,818
366,024
Unrealized gain on investment
137,830
-
Share of loss on equity investments
(171,126 )
(176,837 )
Net loss for the period
$ (22,812,276 )
(18,392,033 )
Net loss attributable to non-controlling interest
(228,384 )
(171,536 )
Net loss for the period attributable to BriaCell
(22,583,892 )
(18,220,497 )
Net loss per share attributable to BriaCell – basic and diluted
$ (5.73 )
$ (67.08 )
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
3,942,959
271,639
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:
Nine months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Clinical trial sites and Investigational drug costs
$ 12,642,837
$ 9,732,786
Wages and salaries
4,677,662
3,544,267
Laboratory Rent
385,610
342,990
Supplies
568,727
341,878
Depreciation
74,871
68,517
Professional fees
15,852
9,826
Share-based compensation
338,446
120,050
$ 18,704,005
$ 14,160,314
For
the nine-month period ended April 30, 2026, research, development, and clinical trial expenses were $18,704,005, compared to $14,160,314
for the same period in 2025. The increase was primarily driven by higher clinical trial sites and investigational drug costs, which increased
from $9,732,786 in 2025 to $12,642,837 in 2026, reflecting the advancement of the Company’s clinical development programs. Wages
and salaries increased from $3,544,267 in 2025 to $4,677,662 in 2026, due to increased headcount and personnel supporting clinical and
development activities. Laboratory rent increased from $342,990 in 2025 to $385,610 in 2026, while supplies increased from $341,878 in
2025 to $568,727 in 2026, reflecting higher clinical and laboratory activity. Share-based compensation increased from $120,050 in 2025
to $338,446 in 2026, reflecting a higher level of equity-based awards outstanding during the period.
Clinical
trial expenses for the period are as follows:
Nine months ended April 30,
2026
2025
(Unaudited)
(Unaudited)
Bria-IMT™ Pivotal Phase 3 study
$ 10,816,541
$ 8,797,505
Bria-IMT™ Phase 1/2a
519,986
699,356
Bria-OTS™ Phase 1/2a
2,965,488
325,539
$ 14,302,014
$ 9,822,400
Clinical
trial expenses for the nine months ended April 30, 2026, were $14,302,014, compared to $9,822,400 during the same period in 2025. The
increase reflects sustained investment in the Bria-IMT™ pivotal Phase 3 program and significant advancement of the Bria-OTS™
Phase 1/2a program as it progresses through early clinical development. These programs continue to be the primary drivers of the year-over-year
increase in clinical trial expenses.
For
the nine-month period ended April 30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $10,816,541, compared to $8,797,505 in 2025.
The increase reflects continued patient enrollment, expansion of clinical sites, increased clinical site activity, CRO services, central
laboratory testing, and clinical supply management associated with the ongoing progression of the Phase 3 study. Spending levels during
the period are consistent with maintaining operational momentum as the trial advances toward planned interim analyses.
For
the nine-month period ended April 30, 2026, Bria-IMT™ Phase 1/2a expenses were $519,986, compared to $699,356 in 2025. The decrease
reflects the continued wind-down of the program following completion of primary activities in fiscal 2024. Current-period costs primarily
relate to residual close-out procedures, data management, and limited follow-up activities. Expenses are expected to decline further
as final wrap-up activities conclude.
For
the nine-month period ended April 30, 2026, Bria-OTS™ Phase 1/2a expenses were $2,965,488, compared to $325,539 in 2025. The substantial
increase reflects continued advancement of the OTS program into early clinical development. Costs incurred during the period include
expanded development and manufacturing activities, GMP production of Bria-BRES+ and Bria-PROS+, regulatory and analytical support, and
operational activities necessary to support ongoing evaluation of the next-generation Bria-OTS+ platform. The increased investment aligns
with the program’s progression and expansion across multiple solid tumor indications.
General
and Administrative Expenses
For
the nine-month period ended April 30, 2026, general and administrative expenses amounted to $4,770,998, compared to $4,490,216 for the
same period in 2025. The increase was primarily driven by higher shareholder communications expenses, which increased from $425,804 in
2025 to $860,951 in 2026, as well as higher wages and salaries, which increased from $951,371 in 2025 to $1,228,753 in 2026. These increases
were partially offset by lower professional fees, which decreased from $875,632 in 2025 to $667,463 in 2026, and lower travel expenses,
which decreased from $265,617 in 2025 to $106,439 in 2026.
Financial
income, net
For
the nine-month period ended April 30, 2026, financial income amounted to $430,205, compared to $69,310 for the nine-month period ended
April 30, 2025. Financial income for the 2026 period consisted of $462,827 in interest income, an interest expense of $29,631 and a $2,991
foreign exchange loss. In comparison, financial income for the 2025 period included $86,514 in interest income, an interest expense of
$36,979 and a $19,775 foreign exchange gain. The increase in financial income from 2025 to 2026 was primarily due to higher interest
income, reflecting increased cash and cash equivalents available for investment in interest-bearing funds.
26
Loss
for the period
The
Company reported a loss of $22,812,276 for the nine-month period ended April 30, 2026, compared to $18,392,033 for the same period in
2025. The increase in loss was primarily driven by higher research, development and clinical trial expenses, which rose to $18,704,005
in 2026 from $14,160,314 in 2025 as the Company advanced its clinical programs.
Liquidity,
Capital Resources and Going Concern Uncertainty
As
of April 30, 2026, the company had a positive working capital balance of $21,802,678 (July 31, 2025 positive balance of $15,948,588).
As
of April 30, 2026, the Company has total assets of $27,071,310 (July 31, 2025 - $ 21,649,706), working capital of $21,802,678
(July 31, 2025 – positive balance of $15,948,588) and an accumulated deficit of $134,339,456 (July 31, 2025 - $111,755,564).
As
of April 30, 2026, 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.
The Company continues to devote substantially all of its efforts toward research and development activities. In the
course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The
Company’s accumulated deficit as of April 30, 2026 was $134,339,456 and negative cash flows from operating activities during the
nine-month period ended April 30, 2026 was $22,692,452. The Company is planning to finance its operations by exploring additional sources
of capital and financing, while managing its existing working capital resources. During the year ended July 31, 2025, the Company raised
$50.9 million in gross proceeds from equity financings and, in January 2026, completed a public offering generating approximately $30
million in gross proceeds. However, the Company’s ability to continue as a going concern is dependent upon its ability to attain
future profitable operations and to continue to obtain the necessary financing to meet its obligations arising from normal business operations
when they come due. The uncertainty of the Company’s ability to raise such financial capital casts substantial doubt on the Company’s
ability to continue as a going concern. These condensed consolidated financial statements do not include any adjustments to the amounts
and classification of assets and liabilities that might be necessary should the Company not be able to continue as a going concern.
27
During
the period ended April 30, 2026, the Company’s overall position of cash and cash equivalents decreased by $3,613,587 from the
period ended July 31, 2025 (including effects of foreign exchange). This decrease in cash can
be attributed to the following:
The
Company’s net cash used in operating activities during the nine-month period ended April 30, 2026, was $22,692,452 as compared
to $20,038,075 for the nine-month period ended April 30, 2025.
Net cash used in investing activities
during the nine-month period ended April 30, 2026, was $8,795,576 as compared to $225,000 for the nine-month period ended April 30, 2025.
During 2026, this was primarily from the net purchase of short-term investments.
Cash
gained in financing activities for the nine-month period ended April 30, 2026, was 27,874,441 as compared to 31,891,239 for the
nine-month period ended April 30, 2025. During both periods, this was primarily from the proceeds of the issuance of shares in various financings.
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 April 30, 2026.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.