BCTX 10-K & 10-Q changes, risk factors and insider trading
BriaCell Therapeutics Corp. (also BCTXL, BCTXZ) · Nasdaq · Pharmaceutical Preparations · CIK 1610820 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Business related risks”
Removed heading “An inability to obtain raw materials or product supply could have a material adverse effect on the Company’s business, financial condition and results of operations”
Removed heading “BriaCell in the future may acquire businesses, products or technologies that it believes complement or expand its existing business.”
Removed heading “If product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates may be affected”
Removed heading “Our executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted to our shareholders for approval”
Largest changes
“In addition, geopolitical developments and international conflicts—such as instability or war in the Middle East, the ongoing conflict between Russia and Ukraine, or a deterioration in relations between the United States and China—may contribute to global uncertainty, disrupt financial and commodity markets, and adversely affect investor risk appetite. Resulting government actions, including the imposition of sanctions, export controls, tariffs, or other trade restrictions, could disrupt global supply chains and trade flows, further exacerbating inflationary or recessionary pressures. …”see in full comparison
“Our ability to raise capital is subject to the risk of adverse changes in the market value of our stock. Periods of macroeconomic weakness or recession and heightened market volatility caused by adverse geopolitical developments could increase these risks, potentially resulting in adverse impacts on our ability to raise further capital on favorable terms. …”see in full comparison
“If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, we may experience material adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits and inspections), additional reporting requirements and oversight, restrictions on processing sensitive data (including personal data), litigation (including class claims), indemnification obligations, negative publicity, reputational harm, monetary fund diversions, diversion of management attention, interruptions in our …”see in full comparison
“Our ability to access capital markets and raise additional funds depends in large part on investor confidence and market valuations of our securities. The market value and liquidity of our common shares are subject to significant fluctuations based on factors beyond our control, including changes in general economic conditions, interest rate environments, inflationary pressures, investor sentiment toward biotechnology and early-stage issuers, and overall equity market volatility. …”see in full comparison
“If product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates may be affected”see in full comparison
“Under amended Nasdaq Listing Rule 5810(c)(3)(A)(iv) (the “Nasdaq Excessive Reverse Stock Split Rule”), companies are now limited by how many times they can effect reverse stock splits within a certain time period to regain compliance with the minimum bid price requirement. Under the Nasdaq Excessive Reverse Stock Split Rule, if a company’s common shares fail to meet the minimum bid price requirement and the company has effected a reverse stock split within the prior one-year period, it will not be eligible for any compliance period to address a bid price deficiency. …”see in full comparison
Full comparison: every changed paragraph (44)
Pre-clinical tests and Phase 1/2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules.
Regulatory authorities may disagree with our analysis of data or may require the conduct of additional studies or analyses before permitting further development or marketing approval. Favorable results in early trials may not be repeated in later trials. Differences in trial design, patient populations, endpoints, statistical methodologies, or other variables between studies may lead to inconsistent results or render comparisons unreliable. Moreover, early-stage trials are often conducted with small patient cohorts drawn from limited and relatively homogeneous populations; as a result, these findings may not predict outcomes in larger or more diverse patient populations or in the commercial A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting, and also may not predict the ability of our products to achieve their intended goals, or to do so safely.
BriaCell
is a development stage immune-oncology biotechnology corporation that to date has not recorded any revenues from the sale of diagnostic
or therapeutic products. Since incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences
product and pre-clinical development and eventually enters into license agreements for its technology. We incurred net losses of $4,791,466
and $20,302,394 in the fiscal years ended 2024 and 2023, respectively. Management expects to continue to incur substantial operating
losses unless and until such time as product sales generate sufficient revenues to fund continuing operations. BriaCell has neither a
history of earnings nor has it paid any dividends, and it is unlikely to pay dividends or enjoy earnings in the immediate or foreseeable
future.
The
Company has incurred significant losses since its inception, including net losses of $4,791,466 and $20,302,394 in the fiscal years ended
2024 and 2023, respectively, and an accumulated deficit of $85,443,697 and $80,652,231 as of July 31, 2024 and July 31, 2023, respectively.
These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s
continuation as a going concern is dependent upon its ability to generate positive cash flows from operations and to secure additional
sources of equity and/or debt financing. Despite the Company’s intent to fund operations through equity and debt financing arrangements,
there is no assurance that such financing will be available on terms acceptable to the Company, if at all.
The
Company is developing novel technologies that may not be efficacious or safe. The Company expects to spend a significant amount of capital
to fund research and development. As a result, the Company expects that its operating expenses will increase significantly and, consequently,
it will need to generate significant revenues to become profitable. Even if the Company does become profitable, it may not be able to
sustain or increase profitability on a quarterly or annual basis. The Company cannot predict when, if ever, it will be profitable. There
can be no assurances that the intellectual property of BriaCell, or other technologies it may acquire, will meet applicable regulatory
standards, obtain required regulatory approvals, be capable of being produced in commercial quantities at reasonable costs, or be successfully
marketed. The Company will be undertaking additional laboratory studies or trials with respect to the intellectual property of BriaCell,
and there can be no assurance that the results from such studies or trials will result in a commercially viable product or will not identify
unwanted side effects.
Production
of therapeutic products may require raw materials for which the sources and amount of supply are limited, or may be hindered by quality
or scheduling issues in respect of the third party suppliers over which theThe Company has limited control. An inability to obtain adequate
supplies of raw materials could significantly delay the development, regulatory approval and marketing of a product. The Company has
limited in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical trials.
trials. The Company is significantly reliant on third-party consultants and contractors to provide the requisite advice and management. There
There can be no assurance that the clinical trials and product development will not encounter delays which could adversely affect prospects
for the Company’s success.
Pre-clinical
tests and Phase 1/2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand
the side effects of product candidates at various doses and schedules. Success in pre-clinical and early clinical trials does not ensure
that later large-scale efficacy trials will be successful, nor does it predict final results. Favorable results in early trials may not
be repeated in later trials.
A
number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive
results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory
approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed,
repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results
from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting, and also may not predict
the ability of our products to achieve their intended goals, or to do so safely.
An
inability to obtain raw materials or product supply could have a material adverse effect on the Company’s business, financial condition
and results of operations
Raw
materials and supplies are generally available in quantities to meet the needs of the Company’s business. The Company will be dependent
on third-party manufacturers for the pharmaceutical products that it markets An inability to obtain raw materials or product supply could
have a material adverse impact on the Company’s business, financial condition and results of operations.
BriaCell
in the future may acquire businesses, products or technologies that it believes complement or expand its existing business.
Acquisitions
of this type involve a number of risks, including the possibility that the operations of the acquired business will not be profitable
or that the attention of the Company’s management will be diverted from the day-to-day operation of its business. An unsuccessful
acquisition could reduce the Company’s margins or otherwise harm its financial condition.
If
product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates
may be affected
As
our drug candidates are currently in clinical trials, we face an inherent risk of product liability suits and will face an even greater
risk if we obtain approval to commercialize any drugs. For example, we may be sued if our drug candidates cause or are perceived to cause
injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability
claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the drug, negligence,
strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully
defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of
our drug candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or
eventual outcome, liability claims may result in:
We
believe that we currently have appropriate insurance covering clinical trials. However, it may transpire that the amount of such insurance
coverage may not be adequate, we may be unable to maintain such insurance, or we may not be able to obtain additional or replacement
insurance at a reasonable cost, if at all. Any inability to maintain sufficient product liability insurance at an acceptable cost to
protect against potential product liability claims could prevent or inhibit the commercialization of drugs we develop, alone or with
collaborators. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which
we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations
or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if
our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be
available or adequate should any claim arise.
Additionally,
we may be sued if the products that we commercialize, market or sell cause or are perceived to cause injury or are found to be otherwise
unsuitable, and may result in:
Our
ability to raise capital is subject to the risk of adverse changes in the market value of our stock. Periods of macroeconomic weakness
or recession and heightened market volatility caused by adverse geopolitical developments could increase these risks, potentially resulting
in adverse impacts on our ability to raise further capital on favorable terms. The impact of geopolitical tension, such as the war in
the Middle East, a deterioration in the bilateral relationship between the US and China or an escalation in conflict between Russia and
Ukraine, including any resulting sanctions, export controls or other restrictive actions that may be imposed by the US and/or other countries
against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in global trade
patterns, which may in turn impact our ability to source necessary reagents, raw materials and other inputs for our research and development
operations.
Any
security breach or other incident, whether real or perceived, could cause us to suffer reputational damage. Such incidents could result
in costs to respond to, investigate and remedy such incidents, notification obligations to affected individuals, government agencies,
credit reporting agencies and other third parties, legal claims or proceedings, and liability under our contracts with other parties
and federal and state laws that protect the privacy and security of personal information. The Company’s failure to prevent security
breaches, or well-publicized security breaches affecting the Internet in general, could significantly harm the Company’s reputation
and business and financial results.
A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates, we do not know whether any Phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate do not produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations. Further, negative clinical trial results for a product candidate with respect to one indication may impact the potential or perceived potential of other indications. If our product candidates fail to demonstrate satisfactory characteristics in late-stage clinical trials, it could have a material adverse effect on our business, financial condition and results of operations.
Business related risks
The Company has incurred significant losses since its inception, including net losses of $26,311,867 and $4,791,466 in the fiscal years ended 2025 and 2024, respectively, and an accumulated deficit of $111,755,564 and $85,443,697 as of July 31, 2025 and July 31, 2024, respectively. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to generate positive cash flows from operations and to secure additional sources of equity and/or debt financing. Despite the Company’s intent to fund operations through equity and debt financing arrangements, there is no assurance that such financing will be available on terms acceptable to the Company, if at all.
Anticipated growth in all areas of BriaCell’s business, including research and development, clinical operations, regulatory compliance, manufacturing, and corporate functions, is expected to continue to place significant strain on the Company’s managerial, operational, financial and technical resources. The Company expects operating expenses and staffing levels to increase in the future as it advances its clinical programs, scales its operations, and undertakes the activities necessary to support potential commercialization of its product candidates. Managing this growth will require the Company to attract, retain, train, and motivate additional qualified personnel and to continue developing and improving its operational, financial and management information systems.
The Company’s ability to manage growth effectively will depend on the adequacy of its operational and financial controls, its ability to establish and maintain robust governance and compliance frameworks, and its success in integrating new employees and contractors into a cohesive organization. As the Company’s business becomes more complex, management will need to ensure that decision-making processes remain efficient, communication across departments remains effective, and that the Company maintains a strong and transparent corporate culture aligned with its strategic objectives.
In addition, BriaCell’s growth will require it to manage multiple, interdependent relationships with third-party contract research organizations, contract manufacturers, clinical investigators, regulatory authorities, academic collaborators, and suppliers. Each of these relationships introduces potential risks related to quality control, regulatory compliance, intellectual property management, and operational coordination. The inability to manage these external partnerships effectively could result in delays in clinical development, increased costs, regulatory non-compliance, or loss of key collaborators.
There can be no assurance that the Company will be able to manage its expanding operations effectively or maintain the level of oversight necessary to ensure quality, compliance and cost control. Any failure to implement cohesive management and operating systems, to allocate resources efficiently, to maintain adequate internal controls, or to properly manage expansion could result in operational inefficiencies, financial losses, reputational harm, and a material adverse effect on the Company’s business, financial condition and results of operations
If we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, we may experience material adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits and inspections), additional reporting requirements and oversight, restrictions on processing sensitive data (including personal data), litigation (including class claims), indemnification obligations, negative publicity, reputational harm, monetary fund diversions, diversion of management attention, interruptions in our operations (including availability of data), financial loss and other similar harms. Security incidents and attendant material consequences may prevent or cause customers to stop using our services, deter new customers from using our services and negatively impact on our ability to grow and operate our business.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our data privacy and security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all or that such coverage will pay future claims.
If
we are not able to comply with the applicable continued listing requirements or standards of the TSX Exchange or Nasdaq, the TSX
Exchange Exchange
or Nasdaq could delist our common shares
In
order to maintain the listing of our common shares on the TSXToronto Stock Exchange (TSX) and the Nasdaq Capital Market, we must satisfy minimum financial
and other continued listing requirements and standards, including those regarding director independence and independent committee requirements,
minimum stockholders’ equity, minimum share price, and certain corporate governance requirements. There can be no assurances that
we will be able to comply with such applicable listing standards.
On
July 3, 2024, the Company received a letter from the Listing Qualifications Department of Nasdaq indicating that, based upon the Company’s
Market Value of Listed Securities (“MVLS”) for the 33 consecutive business days from May 15, 2024, to July 2, 2024, the Company
did not meet the minimum MVLS of $35,000,000 required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(2). The
letter also indicated that the Company will be provided with the Compliance Period of 180 calendar days, or until December 30, 2024,
in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(C). If we regain compliance with the MVLS, Nasdaq will provide
written confirmation to us and close the matter.
On December 18, 2024, we received a letter from the Listing Qualifications Department of Nasdaq notifying the Company that based on our shareholders’ equity, we comply with the Rules and the matter is now closed.
In
the event that we do not regain compliance prior to the end of the compliance period, we will receive written notification that our securities
are subject to delisting, at which point we may appeal the delisting determination.
The Company regained compliance with the Minimum Bid Price Requirement on February 12, 2025.
Under amended Nasdaq Listing Rule 5810(c)(3)(A)(iv) (the “Nasdaq Excessive Reverse Stock Split Rule”), companies are now limited by how many times they can effect reverse stock splits within a certain time period to regain compliance with the minimum bid price requirement. Under the Nasdaq Excessive Reverse Stock Split Rule, if a company’s common shares fail to meet the minimum bid price requirement and the company has effected a reverse stock split within the prior one-year period, it will not be eligible for any compliance period to address a bid price deficiency. Accordingly, if our common shares fall out of compliance with the minimum bid requirement within a one-year period following our August 2025 share consolidation, we will be issued a delisting determination rather than being granted a compliance period. Under these circumstances, we could appeal the delisting determination to a Hearings Panel, during which time any suspension or delisting action will be stayed. This amendment builds upon a 2020 rule change, which established an automatic delisting threshold for companies that have conducted one or more reverse stock splits within a two-year period with a cumulative ratio of 250 shares or more to one. Companies that meet this threshold are also ineligible for a compliance period and are subject to delisting (subject to a stay pursuant to the appeal processes).
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until February 18, 2025, to regain
compliance with the Minimum Bid Price Requirement.
If
the Company does not regain compliance with the Minimum Bid Price Requirement by February 18, 2025, the Company may be afforded a second
180 calendar day period to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for
market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market (which
the Company currently does not meet) with the exception of the Minimum Bid Price Requirement and will need to provide written
notice of its intention to cure the deficiency during such additional compliance period, by effecting a reverse split of its common shares,
if necessary. If it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not
eligible for the additional compliance period, and the Company does not regain compliance by February 18, 2025, Nasdaq will provide written
notification to the Company that its common shares are subject to delisting. At that time, the Company may appeal the delisting determination
to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.
Financial risk
BriaCell is a development stage immune-oncology biotechnology corporation that to date has not recorded any revenues from the sale of diagnostic or therapeutic products. Since incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences product and pre-clinical development and eventually enters into license agreements for its technology. We incurred net losses of $26,311,867 and $4,791,466 in the fiscal years ended 2025 and 2024, respectively. Management expects to continue to incur substantial operating losses unless and until such time as product sales generate sufficient revenues to fund continuing operations. BriaCell has neither a history of earnings nor has it paid any dividends, and it is unlikely to pay dividends or enjoy earnings in the immediate or foreseeable future.
We
cannot predict if investors will find our common shares or listed warrants (“Warrants”) less attractive because we may rely
on these exemptions. If some investors find our common shares or Warrants less attractive as a result, there may be a less active trading
market for our common shares or Warrants, and our common share or Warrant price may be more volatile and may decline.
Our
executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted
to our shareholders for approval
Our
executive officers, directors and principal shareholders who owned more than 5% of our outstanding common shares will, in the aggregate,
beneficially own shares representing approximately 21.16% of our share capital. As a result, if these shareholders were to act together,
they would be able to control all matters submitted to our shareholders for approval, as well as our management and affairs. For example,
these persons, if they act together, would control the election of directors and approval of any merger, consolidation or sale of all
or substantially all of our assets. This concentration of voting power could delay or prevent an acquisition of our company on terms
that other shareholders may desire or result in management of our company that our public shareholders disagree with.
Our ability to access capital markets and raise additional funds depends in large part on investor confidence and market valuations of our securities. The market value and liquidity of our common shares are subject to significant fluctuations based on factors beyond our control, including changes in general economic conditions, interest rate environments, inflationary pressures, investor sentiment toward biotechnology and early-stage issuers, and overall equity market volatility. Periods of macroeconomic weakness or recession, rising interest rates, tightening credit markets, or risk-off investor behavior may limit the availability of equity or debt financing on acceptable terms, or at all. A decline in the market price of our securities could also impair our ability to raise capital without substantial dilution to existing shareholders.
In addition, geopolitical developments and international conflicts—such as instability or war in the Middle East, the ongoing conflict between Russia and Ukraine, or a deterioration in relations between the United States and China—may contribute to global uncertainty, disrupt financial and commodity markets, and adversely affect investor risk appetite. Resulting government actions, including the imposition of sanctions, export controls, tariffs, or other trade restrictions, could disrupt global supply chains and trade flows, further exacerbating inflationary or recessionary pressures. Such events may impair our ability to source key raw materials, reagents, or specialized components required for our research and development programs and clinical manufacturing activities, potentially leading to increased costs, delays in development timelines, or operational interruptions.
Continued market instability or geopolitical tension could also constrain venture capital and institutional investment into the life sciences sector more broadly, reduce valuations for comparable companies, and limit opportunities for strategic partnerships or follow-on financings. If we are unable to obtain additional capital when needed, or only on unfavorable terms, we may be forced to delay, scale back, or discontinue one or more of our product development programs, which could materially and adversely affect our business, financial condition, and prospects.
Management's Discussion & Analysis (MD&A)
Largest changes
“For the year ended July 31, 2025, total research, development, and clinical trial costs amounted to $21,270,678 as compared to $27,177,807 for the year ended July 31, 2024. The decrease was primarily driven by lower clinical trial sites and investigational drug costs, which declined from $20,885,903 in 2024 to $14,765,112 in 2025. The reduction reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. …”see in full comparison
“For the year ended July 31, 2024, research costs totaled $27,177,807, compared to $15,336,638 for the same period in 2023. The increase primarily resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational drug costs, which rose from $9,611,630 in 2023 to $20,890,266 in 2024. Wages and salaries increased from $3,878,367 to $4,567,307, reflecting the hiring of additional employees. …”see in full comparison
“The Company reported a net loss of $26,311,867 for the year ended July 31, 2025, compared to $4,791,466 in 2024. The increase in net loss was primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $758,364 in 2025 compared to $28,242,472 in 2024. This variance outweighed the reduction in research, development, and clinical trial expenses, which decreased from $27,177,807 in 2024 to $21,270,678 in 2025, mainly reflecting lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™ Phase 1/2a trial.”see in full comparison
“Other costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development expenditure. Other costs increased in 2024 as we investigated additional potential pre-clinical projects.”see in full comparison
“CMC costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational product. CMC costs decreased in 2024; this reduction can be attributed to efficiencies gained in the manufacturing process and a streamlined approach to quality control.”see in full comparison
“The Company reported a loss for the year ended July 31, 2024, of $4,791,466, compared to $20,302,394 for the year ended July 31, 2023. The loss in 2024 primarily stems from increased operational spending, particularly in research and development. However, the decrease in the fair value of the warrant liability substantially offset the increase in research and development expenses, leading to a significantly lower reported loss for the year. …”see in full comparison
Full comparison: every changed paragraph (28)
The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Actual outcomes could differ from these estimates. The consolidated financial statements include estimates which, by their nature, are uncertain. The impacts of such estimates are pervasive throughout the consolidated financial statements, and may require accounting adjustments based on future occurrences. Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future periods.
Preparation
of the consolidated financial statement on a going concern basis, which contemplates that the realizationCompany ofwill assetsbe able to meet its commitments, continue operations and paymentsrealize ofits assets
and discharge its liabilities
in the ordinarynormal course of business.business for at least twelve months from the date of approval of these Financial
Statements from the Board of Directors. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying
value of its assets, including its intangible assets and to meet its liabilities as they become due.
Investments
in entities over which the Company does not have a controlling financial interest but has significant influence are accounted for
using using
the equity method, with the Company’s share of losses reported in the loss from equity method investments on the
statements of
operation and comprehensive loss. The Company has a 51.2%63.1% interest in BC Therapeutics. Management evaluates whether it
has control over
the investee in accordance with the guidance of ASC 810, which requires judgment to assess factors such as power
over significant activities
of the investee, exposure to variable returns, and the ability to affect those returns. Based on this
evaluation, management determines
whether control orconcludes significant influence is present for accounting purposes.
Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development; and (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
The
following is a breakdown of our research and development costs by project:
Our
clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase 1/2a clinical trial. Clinical trial
expenses increased in 2024 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.
Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e. a longer than expected overall
survival). Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the
pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in
preparation for the upcoming clinical studies of Bria-OTS™.
Our
clinical trial expenses are broken down as follows:
During
the year ended July 31, 2024 we pivoted from our Bria-IMT™ Phase 1/2a study to the Bria-IMT™ Pivotal Phase 3 Study.
Pre-clinical
projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional
pre-clinical program (sCD80). Towards the end of 2024 the financial year end, we have slowed these programs in order to direct more attention
and resources to our clinical trials.
CMC
costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational
product. CMC costs decreased in 2024; this reduction can be attributed to efficiencies gained in the manufacturing process and
a streamlined approach to quality control.
Other
costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
expenditure. Other costs increased in 2024 as we investigated additional potential pre-clinical projects.
For the year ended July 31, 2025, total research, development, and clinical trial costs amounted to $21,270,678 as compared to $27,177,807 for the year ended July 31, 2024. The decrease was primarily driven by lower clinical trial sites and investigational drug costs, which declined from $20,885,903 in 2024 to $14,765,112 in 2025. The reduction reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries increased from $4,567,307 in 2024 to $5,356,806 in 2025, reflecting the hiring of additional employees to support ongoing research and clinical activities. Laboratory rent rose to $457,320 in 2025, compared to $420,310 in 2024, due to expanded use of facilities. Supplies decreased, from $496,312 in 2024 to $470,208 in 2025, reflecting reduced consumable needs. Depreciation expenses increased to $91,356 in 2025, compared to $68,626 in 2024. The increase reflects a full year of depreciation on equipment purchased in 2024 as no new equipment was purchased in 2025. Professional fees increased from $4,363 in 2024 to $9,826 in 2025. Share-based compensation expenses decreased significantly from $734,986 in 2024 to $120,050 in 2025, further contributing to the overall reduction in research, development, and clinical trial expenses.
Clinical trial expenses for the period are as follows:
Clinical trial expenses for the year ended July 31, 2025, were $14,953,296, compared to $15,833,879 during the year ended July 31, 2024. The decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting in significantly lower associated costs in 2025. As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources were increasingly directed toward the pivotal Phase 3 study, which remains our primary focus. In addition, we began incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
For the year ended July 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $13,511,235, compared to $11,594,463 in 2024. The increase reflects the progression of the pivotal study, with higher expenditures on patient recruitment, treatment, and data-management activities as the trial advanced through key operational milestones.
For the year ended July 31, 2025, Bria-IMT™ Phase 1/2a costs were $1,013,828, down from $4,239,415 in 2024, reflecting the conclusion of the study. The remaining expenses primarily relate to final data analysis and study close-out activities.
For the year ended July 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $428,233, compared to $nil in 2024, due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
For
the year ended July 31, 2024, research costs totaled $27,177,807, compared to $15,336,638 for the same period in 2023. The increase primarily
resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational drug costs, which
rose from $9,611,630 in 2023 to $20,890,266 in 2024. Wages and salaries increased from $3,878,367 to $4,567,307, reflecting the hiring
of additional employees. Additionally, non-cash share-based compensation expenses decreased from $1,072,592 in 2023 to $734,986 in 2024,
offsetting some of the overall increase in research and development expenses.
For the year ended July 31, 2025, general and administrative expenses were $5,934,125, compared to $6,152,269 for
the year ended July 31, 2024,2024. generalExpenses remained relatively consistent year over year, with lower consulting, professional fees, and administrativeshare-based
compensation expenseslargely amountedoffset toby $6,152,269higher as compared to $7,935,626 for the year ended
July 31, 2023. The decrease in generalwages and administrativesalaries, expenses primarily stems from lower insurance premiums, professional fees and
share-based compensation expenses. The Company has reduced generaltravel, and other administrative expenses in order to devote more resources to its
clinical program.costs.
Financial
income (expenses),income, net
For the year ended July 31, 2025, finance income, net, was $114,511, compared to $262,566 for the year ended July 31, 2024. The decrease was primarily due to lower interest income, which declined to $176,431 in 2025 from $288,018 in 2024, reflecting reduced average cash balances available for investment. The decrease was further impacted by the recognition of $36,979 in interest expense in 2025 compared to nil in the prior year. Foreign exchange losses were relatively consistent year over year, amounting to $24,941 in 2025 versus $25,452 in 2024.
For
the year ended July 31, 2024, financial income, net amounted to $262,566, compared to $850,340 for the year ended July 31, 2023. Financial
income for 2024 primarily consists of interest income of $288,018, offset by a foreign exchange loss of $25,450. In comparison, for the
year ended July 31, 2023, interest income was $891,213, while foreign exchange losses totaled $40,873. The decrease in financial income
from 2023 to 2024 reflects lower interest income due to reduced cash and cash equivalents available for investment in interest-bearing
funds.
The Company reported a net loss of $26,311,867 for the year ended July 31, 2025, compared to $4,791,466 in 2024. The increase in net loss was primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $758,364 in 2025 compared to $28,242,472 in 2024. This variance outweighed the reduction in research, development, and clinical trial expenses, which decreased from $27,177,807 in 2024 to $21,270,678 in 2025, mainly reflecting lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™ Phase 1/2a trial.
The
Company reported a loss for the year ended July 31, 2024, of $4,791,466, compared to $20,302,394 for the year ended July 31, 2023. The
loss in 2024 primarily stems from increased operational spending, particularly in research and development. However, the decrease in
the fair value of the warrant liability substantially offset the increase in research and development expenses, leading to a significantly
lower reported loss for the year. In contrast, the larger loss in 2023 is attributed to lower operational costs but a smaller decrease
in the warrant liability, which did not offset expenses to the same extent as in 2024. This highlights the significant role the warrant
liability valuation plays in influencing the Company’s overall financial performance.
As
of July 31, 2024,2025, the Company has a negativepositive working capital of ($3,807,303)$15,948,588 (July 31, 2023-2024 $25,147,050– negative $3,807,303) and an
accumulated deficit of
$85,443,697 $111,755,564 (July 31, 20232024 - $80,652,231$85,443,697).
During
the year ended July 31, 2024,2025, the Company’s overall position of cash and cash equivalents decreasedincreased by $20,389,003$10,493,808 from the year
ended July 31, 20232024 (including effects of foreign exchange). This decreaseincrease in cash can be attributed to the following:
The
Company’s net cash used in operating activities during the year ended July 31, 2024,2025, was $24,126,128$28,170,520 as compared to $23,744,860$24,126,128
for the year ended July 31, 2023. Although the operating loss was higher during the period ended July 31, 2024, this was offset by an
increase in accounts payable, such that the cash flows from operating activities during both periods were similar.2024.
Cash used in investing activities for the year ended July 31, 2025, was $7,646,000, as compared to $681,801 for the year ended July 31, 2024. The amount in 2025 relates primarily to the purchase of short-term investments ($7,316,000) and an equity investment in BC Therapeutics ($330,000), and in the prior year, to the purchase of property, plant and equipment ($456,801) and an equity investment in BC Therapeutics ($225,000).
What changed in the latest 10-Q
Risk Factors
As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors previously disclosed in our Annual Report for the year ended July 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Removed heading “Shareholder Approval”
Removed heading “Formal Valuation Requirements”
Largest changes
“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. …”see in full comparison
For the three-month period endedsee in full comparisonJanuaryApril31,30, 2026, total research and development expenses were$6,053,689,$5,966,673, compared to$5,684,777$4,810,196 for the three-month period endedJanuaryApril31,30, 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 increasein total research and development expenseswas primarily driven bywageshigher clinical trial sites andsalaries,investigational drug costs, whichrose 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 rentincreased to$130,500$3,980,115 in 20262026,fromcompared to $114,330$3,175,543 in 2025,duereflecting expanded clinical development activities. Wages and salaries also increased toexpanded utilization of laboratory space and related facility charges. Supplies increased$1,492,067 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$1,303,157, due to higherconsulting,personnelregulatory,costsand scientificsupportingsupportongoingrelatedresearch programs. Laboratory rent increased toadvancing$130,500clinicalfrom $114,330,development.while depreciation expense increased to $29,193 from $22,839. Share-based compensation increased significantly to $175,999 in 2026 from$50,839$36,493 in2025 to $79,016 in 2026,2025, reflecting a higher level of equity-based awardsoutstandinggranted during the period.
“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. …”see in full comparison
“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.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (48)
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.SU.S. Dollars.
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 pivotal1pivotal 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 months2months 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).
Throughout
this time period, there
were several important updatedupdates 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.
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) willwhich highlighthighlighted positive Phase 2 safety and efficacy signals and
positive positive
biomarker findings in both the Phase 2 and the pivotal Phase 3 studies.Onstudies. 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).
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.
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 therapy1 (axial and coronal views) 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 15th, 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.
As
consideration 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 ofOn March 5, 2026, subject to certain conditions including (i) approval of the disinterested
shareholders of BriaPro,BriaPro and (ii) receipt of a third-party valuation confirming thatapproved the Transaction isand occurringthe atTransaction fairclosed market
value.on March 31, 2026.
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 SixNine Months Ended JanuaryApril 31,30, 2026, and 2025
For
the three-month period ended JanuaryApril 31,30, 2026, total research and development expenses were $6,053,689, $5,966,673,
compared to $5,684,777$4,810,196 for
the three-month period ended JanuaryApril 31,30, 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 wageshigher clinical trial
sites and salaries,investigational drug costs, 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$3,980,115 in
2026 2026,from compared to $114,330$3,175,543 in 2025, duereflecting expanded clinical development activities. Wages and salaries also increased to expanded utilization of laboratory space and related facility
charges. Supplies increased $1,492,067
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$1,303,157, due to higher consulting,personnel regulatory,costs and
scientificsupporting supportongoing relatedresearch programs. Laboratory rent increased to advancing$130,500 clinicalfrom
$114,330, development.while depreciation expense increased to $29,193 from $22,839. Share-based compensation increased significantly to $175,999
in 2026 from $50,839$36,493 in 2025 to $79,016 in
2026,2025, reflecting a higher level of equity-based awards outstandinggranted during the period.
Clinical
trial expenses for the three months ended JanuaryApril 31,30, 2026, were $5,008,171,$4,349,651, compared to $3,923,559$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 JanuaryApril 31,30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $3,874,242,$3,149,348, compared to $3,642,650$2,708,394 in 2025.
The increase
reflects the study’s continued progression through an advanced, cost-intensive stage, including expanded patient enrollment,
increased increased
clinical site activity, CRO services, central laboratory work, and clinical supply management. The level of spending is consistent
with with
maintaining study momentum as the program advances toward planned interim analyses.
For
the three-month period ended JanuaryApril 31,30, 2026, Bria-IMT™ Phase 1/2a expenses were $197,203,$159,579, compared to $215,301$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 JanuaryApril 31,30, 2026, Bria-OTS™ Phase 1/2a expenses were $936,726,$1,040,724, compared to $65,608$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.
For
the three-month period ended JanuaryApril 31,30, 2026, general and administrative expenses were $1,477,577,$1,654,121, compared to $1,484,666$1,518,059 for the samethree-month
period inended April 30, 2025. The decreaseincrease was primarily drivenattributable byto lowerhigher shareholder communications expense, which increased from
$146,616 in 2025 to $307,058 in 2026, higher share-based compensation,compensation professionalof fees,$256,208 consulting,in shareholder2026 communications,compared to $188,322 in 2025, increased consulting
expenses from $44,222 in 2025 to $98,621 in 2026, and travel expenses, partially offset by 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, insurance,
and other
generaltravel administrative costs.expenses.
For
the three-month period ended JanuaryApril 31,30, 2026, the Company recorded
net financial income of $84,589,$186,970, compared to $67,358net financial expense
of $9,762 in the same period of 2025. The increase is mainly attributable to higher foreign
exchangeinterest lossesincome offsetand by higherlower interest income.expense. For the
three-month period ended JanuaryApril 31,30, 2026, financial income was comprised of
$105,638 $219,220 of interest income, $29,631 of interest expense and a $21,049
$2,619 foreign exchange loss.
For
the three-month period ended JanuaryApril 31,30, 2026, the Company reported
a net loss of $7,296,893,$7,237,055, compared to $6,337,828$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 SixNine Months Ended JanuaryApril 31,30, 2026 and 2025
For
the six-monthnine-month period ended JanuaryApril 31,30, 2026, research, development, and clinical trial expenses were $12,737,332,$18,704,005, compared to $9,350,118$14,160,314
for the same period in 2025. The increase was primarily driven by higher clinical trial sitesites and investigational drug costs, which roseincreased
from $6,557,243$9,732,786 in 2025 to $8,662,722$12,642,837 in 20262026, asreflecting the Companyadvancement advancedof itsthe Company’s clinical development programs. Wages
and salaries increased from $2,241,110
$3,544,267 in 2025 to $3,185,595$4,677,662 in 2026, reflectingdue to increased headcount and personnel supporting clinical and
development activities. Laboratory
rent increased to $255,110 in 2026 from $228,660$342,990 in 2025 dueto $385,610 in 2026, while supplies increased from $341,878 in
2025 to expanded use of facilities. Supplies increased to $411,631$568,727 in 2026 from
$184,694 in 2025,2026, reflecting higher clinical and laboratory activity. DepreciationShare-based expense remained consistent year over year at $45,678.
Professional feescompensation increased to $14,149 in 2026 from $9,176$120,050 in 2025 due
to increased consulting and support for clinical operations. Share-based
compensation increased to $162,447$338,446 in 2026 from $83,557 in 2025,2026, reflecting a higher level of equity-based awards outstanding during
the period.
Clinical
trial expenses for the sixnine months ended JanuaryApril 31,30, 2026, were $9,952,363,$14,302,014, compared to $6,631,649$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 six-monthnine-month period ended JanuaryApril 31,30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $7,667,192,$10,816,541, compared to $6,089,111$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 six-monthnine-month period ended
January 31,April 30, 2026, Bria-IMT™ Phase 1/2a expenses were $360,407,$519,986, compared to $399,343$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 six-month
nine-month period ended JanuaryApril 31,30, 2026, Bria-OTS™ Phase 1/2a expenses were $1,924,764,$2,965,488, compared to $143,195$325,539 in 2025. The substantial
increase increase
reflects continued advancement of the OTS program into early clinical development. Costs incurred during the period include
expanded expanded
development and manufacturing activities, GMP production of Bria-BRES+ and Bria-PROS+, regulatory and analytical support, and
operational 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.
For
the six-monthnine-month period ended JanuaryApril 31,30, 2026, general and administrative expenses amounted to $3,116,877,$4,770,998, compared
to $2,972,157$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, regulatorywhich andincreased filingfrom fees,$951,371 in 2025 to $1,228,753 in 2026. These increases
insurance, and other administrative costs,were partially offset by lower consulting, professional fees, which decreased from $875,632 in 2025 to $667,463 in 2026, and lower travel expenses.expenses,
which decreased from $265,617 in 2025 to $106,439 in 2026.
For
the six-monthnine-month period ended JanuaryApril 31,30, 2026, financial income amounted
to $243,235,$430,205, compared to $79,072$69,310 for the six-monthnine-month period ended
April January 31,30, 2025. Financial income for the 2026 period consisted of $243,607
$462,827 in interest incomeincome, an interest expense of $29,631 and a $372 $2,991
foreign exchange loss. In comparison, financial income for the 2025 period included $59,882$86,514 in interest income, an interest expense of
income$36,979 and a $19,190$19,775 foreign exchange gain. The increase in financial income from 2025 to 2026 was primarily due to higher interest
income, income,
reflecting increased cash and cash equivalents available for investment in interest-bearing funds.
The
Company reported a loss of $15,575,221$22,812,276 for the six-monthnine-month period
ended JanuaryApril 31,30, 2026, compared to $12,167,104$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 $12,737,332 $18,704,005
in 2026 from $9,350,118$14,160,314 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.
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 JanuaryApril 31,30, 2026, the company had a positive working capital
balance of $28,993,334$21,802,678 (July 31, 2025 positive balance of $15,948,588).
As
of JanuaryApril 31,30, 2026, the Company has total assets of $33,594,454
$27,071,310 (July 31, 2025 - $ 21,649,706), a positive working capital of $28,993,334 $21,802,678
(July 31, 2025 – positive balance of $15,948,588) and
an accumulated deficit of $127,174,949$134,339,456 (July 31, 2025 - negative balance of $ 111,755,564$111,755,564).
As
of JanuaryApril 31,30, 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.
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.
During
the period ended JanuaryApril 31,30, 2026, the Company’s overall
position of cash and cash equivalents increaseddecreased by $19,409,820$3,613,587 from the
period ended July 31, 2025 (including effects of foreign exchange).
This increasedecrease in cash can
be attributed to the following:
The
Company’s net cash used in operating activities during the
nine-month period ended JanuaryApril 31,30, 2026, was $15,672,094$22,692,452 as compared
to $12,875,298$20,038,075 for the nine-month period ended JanuaryApril 31,30, 2025.
Cash
gainedNet cash used in financinginvesting activities for
during the nine-month period ended JanuaryApril 31,30, 2026, was 27,874,441$8,795,576 as compared to 17,176,863$225,000 for the nine-month period ended January
31,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.
The
Company did not adopt any new accounting policies during the period ended JanuaryApril 31,30, 2026.
BCTX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding BCTX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 895,864 | $716.8K | 0.0% | Reduced 15% |