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 first half and second quarter
of fiscal 2026 in comparison to the first half and second 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 1 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 2 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 updated 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) will highlight 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.
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
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. The Transaction
is expected to close by the end of March 2026, subject to certain conditions including (i) approval of the disinterested
shareholders of BriaPro, and (ii) receipt of a third-party valuation confirming that the Transaction is occurring at fair market
value.
Shareholder Approval
In accordance
with Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“ MI
61-101 ”), the resolution approving the Purchase Agreement must be approved by a simple majority of votes cast by shareholders,
present in person or represented by proxy and entitled to vote at the Meeting, excluding the votes cast by any “interested party”
(as defined in MI 61-101). As a 10% shareholder with an interest in the Transaction, BriaCell's shareholdings in BriaPro will be excluded
from voting.
Formal Valuation Requirements
In respect
of the formal valuation requirement of MI 61-101, BriaPro intends to rely on the specified markets exemptions set forth in subsection
5.5(b) of MI 61-101, as none of its securities are listed or quoted on a specified senior exchange.
Though a
formal valuation is not required under applicable securities laws, as a matter of good governance and best corporate practice, BriaPro
intends to obtain a valuation from an independent third-party valuator as a condition to closing, verifying and validating that Transaction
is occurring at fair market value.
On March 5, 2026, the disinterested shareholders of BriaPro approved the Transaction.
Results
of Operations for the Three and Six Months Ended January 31, 2026, and 2025
Three months ended January 31,
2026
2025
(Unaudited)
(Unaudited)
Operating expenses:
Research and development expenses
$
6,053,689
5,684,777
General and administrative expenses
1,477,577
1,484,666
Total operating expenses
7,531,266
7,169,443
Operating loss
(7,531,266
)
(7,169,443
)
Financial income, net
84,589
67,358
Change in fair value of the warrant liability
211,777
806,841
Share of loss on equity investment
(61,993
)
(42,584
)
Net loss for the period
$
(7,296,893
)
$
(6,337,828
)
Net loss attributable to non-controlling interest
(75,073
)
(46,408
)
Net loss for the period attributable to BriaCell
(7,221,820
)
(6,291,420
)
Net loss per share attributable to BriaCell – basic and diluted
$
(2.58
)
$
(23.31
)
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
2,802,337
269,957
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 January 31,
2026
2025
(Unaudited)
(Unaudited)
Clinical trial
sites and investigational drug costs
$ 3,799,523
$ 4,117,576
Wages and salaries
1,881,893
1,292,021
Laboratory Rent
130,500
114,330
Supplies
134,974
85,264
Depreciation
22,839
22,839
Professional fees
4,944
1,908
Share-based
compensation
79,016
50,839
$ 6,053,689
$ 5,684,777
For
the three-month period ended January 31, 2026, total research and development expenses were $6,053,689, compared to $5,684,777 for
the three-month period ended January 31, 2025. Clinical trial sites and investigational drug costs decreased modestly year over
year, primarily reflecting decreased reliance of third-party vendors in our trials as we expand our in-house headcount to advance
our trials, which also explains the increase in wages and salaries as detailed below. The increase in total research and development
expenses was primarily driven by wages and salaries, which rose from $1,292,021 in 2025 to $1,881,893 in 2026, reflecting higher
headcount and additional personnel required to support clinical operations and ongoing development programs. Laboratory rent
increased to $130,500 in 2026, compared to $114,330 in 2025, due to expanded utilization of laboratory space and related facility
charges. Supplies increased from $85,264 in 2025 to $134,974 in 2026, reflecting increased consumable usage driven by greater
clinical and laboratory activity during the current period. Depreciation expense was consistent year over year at $22,839 for both
periods. Professional fees increased from $1,908 in 2025 to $4,944 in 2026, primarily due to higher consulting, regulatory, and
scientific support related to advancing clinical development. Share-based compensation increased from $50,839 in 2025 to $79,016 in
2026, reflecting a higher level of equity-based awards outstanding during the period.
Our
clinical trial expenses are broken down as follows:
Three
months ended January 31,
2026
2025
(Unaudited)
(Unaudited)
Bria-IMT™
Pivotal Phase 3 study
$ 3,874,242
$ 3,642,650
Bria-IMT™ Phase 1/2a
197,203
215,301
Bria-OTS™
Phase 1/2a
936,726
65,608
$ 5,008,171
$ 3,923,559
Clinical
trial expenses for the three months ended January 31, 2026, were $5,008,171, compared to $3,923,559 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 January 31, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $3,874,242, compared to $3,642,650 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 January 31, 2026, Bria-IMT™ Phase 1/2a expenses were $197,203, compared to $215,301 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 January 31, 2026, Bria-OTS™ Phase 1/2a expenses were $936,726, compared to $65,608 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 January 31, 2026, general and administrative expenses were $1,477,577, compared to $1,484,666 for the same
period in 2025. The decrease was primarily driven by lower share-based compensation, professional fees, consulting, shareholder communications,
and travel expenses, partially offset by higher wages and salaries, regulatory, filing and transfer agent fees, insurance, and other
general administrative costs.
Financial
income, net
For the three-month period ended January 31, 2026, the Company recorded
net financial income of $84,589, compared to $67,358 in the same period of 2025. The increase is mainly attributable to higher foreign
exchange losses offset by higher interest income. For the three-month period ended January 31, 2026, financial income was comprised of
$105,638 of interest income, and a $21,049 foreign exchange loss.
Profit
(loss) for the period
For the three-month period ended January 31, 2026, the Company reported
a net loss of $7,296,893, compared to $6,337,828 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 Six Months Ended January 31, 2026 and 2025
Six months ended January 31,
2026
2025
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development, and clinical trial expenses
$
12,737,332
$
9,350,118
General and administrative expenses
3,116,877
2,972,157
Total operating expenses
15,854,209
12,322,275
Operating loss
(15,854,209
)
(12,322,275
)
Financial income, net
243,235
79,072
Change in fair value of the warrant liability
142,576
190,198
Share of loss on equity investments
(106,823
)
(114,099
)
Net loss for the period
$
(15,575,221
)
(12,167,104
)
Net loss attributable to non-controlling interest
(155,836
)
(73,509
)
Net loss for the period attributable to BriaCell
(15,419,385
)
(12,093,595
)
Net loss per share attributable to BriaCell – basic and diluted
$
(6.58
)
$
(54.35
)
Weighted average number of shares used in computing net basic earnings per share of common stock
2,343,122
222,498
Weighted average number of shares used in computing net diluted earnings per share of common stock
2,343,122
222,498
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,
2026
2025
(Unaudited)
(Unaudited)
Clinical trial
sites and Investigational drug costs
$ 8,662,722
$ 6,557,243
Wages and salaries
3,185,595
2,241,110
Laboratory Rent
255,110
228,660
Supplies
411,631
184,694
Depreciation
45,678
45,678
Professional fees
14,149
9,176
Share-based
compensation
162,447
83,557
$ 12,737,332
$ 9,350,118
For
the six-month period ended January 31, 2026, research, development, and clinical trial expenses were $12,737,332, compared to $9,350,118
for the same period in 2025. The increase was primarily driven by higher clinical trial site and investigational drug costs, which rose
from $6,557,243 in 2025 to $8,662,722 in 2026 as the Company advanced its clinical programs. Wages and salaries increased from $2,241,110
in 2025 to $3,185,595 in 2026, reflecting increased headcount and personnel supporting clinical and development activities. Laboratory
rent increased to $255,110 in 2026 from $228,660 in 2025 due to expanded use of facilities. Supplies increased to $411,631 in 2026 from
$184,694 in 2025, reflecting higher clinical and laboratory activity. Depreciation expense remained consistent year over year at $45,678.
Professional fees increased to $14,149 in 2026 from $9,176 in 2025 due to increased consulting and support for clinical operations. Share-based
compensation increased to $162,447 in 2026 from $83,557 in 2025, reflecting a higher level of equity-based awards outstanding during
the period.
Clinical
trial expenses for the period are as follows:
Six
months ended January 31,
2026
2025
(Unaudited)
(Unaudited)
Bria-IMT™
Pivotal Phase 3 study
$ 7,667,192
$ 6,089,111
Bria-IMT™ Phase 1/2a
360,407
399,343
Bria-OTS™
Phase 1/2a
1,924,764
143,195
$ 9,952,363
$ 6,631,649
Clinical
trial expenses for the six months ended January 31, 2026, were $9,952,363, compared to $6,631,649 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 six-month period ended January 31, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $7,667,192, compared to $6,089,111 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 six-month period ended
January 31, 2026, Bria-IMT™ Phase 1/2a expenses were $360,407, compared to $399,343 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 six-month
period ended January 31, 2026, Bria-OTS™ Phase 1/2a expenses were $1,924,764, compared to $143,195 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 six-month period ended January 31, 2026, general and administrative expenses amounted to $3,116,877, compared
to $2,972,157 for the same period in 2025. The increase was primarily driven by higher wages and salaries, regulatory and filing fees,
insurance, and other administrative costs, partially offset by lower consulting, professional fees, and travel expenses.
Financial
income, net
For the six-month period ended January 31, 2026, financial income amounted
to $243,235, compared to $79,072 for the six-month period ended January 31, 2025. Financial income for the 2026 period consisted of $243,607
in interest income and a $372 foreign exchange loss. In comparison, financial income for the 2025 period included $59,882 in interest
income and a $19,190 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 $15,575,221 for the six-month period
ended January 31, 2026, compared to $12,167,104 for the same period in 2025. The increase in loss was primarily driven by higher research,
development and clinical trial expenses, which rose to $12,737,332 in 2026 from $9,350,118 in 2025 as the Company advanced its clinical
programs. This was partially offset by higher financial income in the current period, including increased interest income and a lower
foreign exchange loss.
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, 2026, the company had a positive working capital
balance of $28,993,334 (July 31, 2025 positive balance of $15,948,588).
As of January 31, 2026, the Company has total assets of $33,594,454
(July 31, 2025 - $ 21,649,706), a positive working capital of $28,993,334 (July 31, 2025 – positive balance of $15,948,588) and
an accumulated deficit of $127,174,949 (July 31, 2025 - negative balance of $ 111,755,564).
As
of January 31, 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.
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 2025, 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.
27
During the period ended January 31, 2026, the Company’s overall
position of cash and cash equivalents increased by $19,409,820 from the period ended July 31, 2025 (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, 2026, was $15,672,094 as compared to $12,875,298 for the period ended January 31, 2025.
Cash
gained in financing activities for the period ended January 31, 2026, was 27,874,441 as compared to 17,176,863 for the period ended January
31, 2025.
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, 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.