BCTXL

Risks Related to Our Business Pre-clinical studies and initial clinical trials are not necessarily predictive of future results 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.
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.
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 There is substantial doubt about our ability to continue as a going concern 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.
We are a pre-revenue clinical stage company 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 We may not succeed in adapting to and meeting the business needs associated with our anticipated growth Anticipated growth in all areas of BriaCell’s business is expected to continue to place a significant strain on its managerial, operational and technical resources.
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.
Risks Related to Our Securities If we are not able to comply with the applicable continued listing requirements or standards of the TSX Exchange or Nasdaq, the TSX Exchange or Nasdaq could delist our common shares In order to maintain the listing of our common shares on the Toronto 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.
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.
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).
Financial risk We have a history of losses, may incur future losses and may not achieve profitability 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.
We incurred net losses of $26,311,867 and $4,791,466 in the fiscal years ended 2025 and 2024, respectively.
We have a significant number of restricted share units, options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital As of October 15, 2025, we had outstanding restricted share units, options and warrants to purchase 1,938,873 common shares, respectively.
As of October 15, 2025, we have 1,938,873 shares issuable upon exercise of restricted share units, options and warrants.
We cannot predict if investors will find our common shares or listed Warrants less attractive because we may rely on these exemptions.
Based upon the value of our assets, including any goodwill, and the nature and composition of our income and assets, we believe that we will be classified as a PFIC for the taxable year ending July 31, 2025, and possibly for succeeding years.
However, even if we are classified as a PFIC for the year ending July 31, 2025, under an exception to the PFIC classification rules, we may be able to avoid such classification altogether if we can meet certain conditions set forth in the exception.
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.

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Gone since FY2024

Risks Related to Our Business We have a history of losses, may incur future losses and may not achieve profitability 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.
We incurred net losses of $4,791,466 and $20,302,394 in the fiscal years ended 2024 and 2023, respectively.
There is substantial doubt about our ability to continue as a going concern 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.
We are a pre-revenue clinical stage company 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.
We may not succeed in adapting to and meeting the business needs associated with our anticipated growth Anticipated growth in all areas of BriaCell’s business is expected to continue to place a significant strain on its managerial, operational and technical resources.
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 the 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.
Pre-clinical studies and initial clinical trials are not necessarily predictive of future results 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.
A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in earlier trials.
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: ● decreased demand for our drugs; ● injury to our reputation; ● withdrawal of clinical trial participants and inability to continue clinical trials; ● initiation of investigations by regulators; ● costs to defend the related litigation; ● diversion of management’s time and our resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize any drug candidate; and ● a decline in the price of our common shares.
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: ● decreased demand for those products; ● damage to our reputation; ● costs incurred related to product recalls; ● limiting our opportunities to enter into future commercial partnerships; and ● a decline in the price of our common shares.
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.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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