What changed in this filing

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Item 1A. Risk Factors

2025-10-16 compared with 2024-10-29 · 348 added, 400 removed, 673 unchanged (53% of the section changed)

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Related to Our Business

have a history of losses, may incur future losses and may not achieve profitability

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

is substantial doubt about our ability to continue as a going concern

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.

This going concern risk may materially limit our ability to raise additional funds through the issuance of new debt

or equity or may adversely affect the terms upon which such capital may be available.

The inability to obtain sufficient financing on

acceptable terms could have a material adverse effect on the Company’s financial condition, results of operations, and business

Company is actively pursuing strategies to mitigate these risks, focusing on transitioning towards revenue generation from its existing

product offerings and expanding its customer base.

However, there can be no assurance that these efforts will prove successful or that

the Company will achieve its intended financial stability.

The failure to successfully address these going concern risks may materially

and adversely affect the Company’s business, financial condition, and results of operations.

Investors should consider the substantial

risks and uncertainties inherent in the Company’s business before investing in the Company’s securities.

are a pre-revenue clinical stage company

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.

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

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.

have an unproven market for our product candidates

Company believes that the anticipated market for its potential products and technologies if successfully developed will continue to exist

These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree

of commercial viability of the potential product.

may not succeed in adapting to and meeting the business needs associated with our anticipated growth

growth in all areas of BriaCell’s business is expected to continue to place a significant strain on its managerial, operational

and technical resources.

The Company expects operating expenses and staffing levels to increase in the future.

To manage such growth,

the Company must expand its operational and technical capabilities and manage its employee base while effectively administering multiple

relationships with various third parties.

There can be no assurance that the Company will be able to manage its expanding operations

Any failure to implement cohesive management and operating systems, to add resources on a cost-effective basis or to properly

manage the Company’s expansion could have a material adverse effect on its business and results of operations.

may not generate revenue as expected

are a majority shareholder of BriaPro.

BriaPro may not generate financial returns or may not yield the desired business outcome.

success of our investment in a company is sometimes dependent on the availability of additional funding on favorable terms or a liquidity

event such as an initial public offering.

We may record impairment charges in relation to our strategic investments which will have a

negative impact on our financial position.

may expose us to additional reputational, financial, legal, compliance or operational risks.

This could impact our return on our investment.

In the event BriaPro fails to generate revenue, this may erode or dilute its value to our shareholders.

studies and initial clinical trials are not necessarily predictive of future results

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.

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

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

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.

are heavily reliant on third-parties to carry out a large portion of our business

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or its suppliers will be able to meet the supply requirements in respect of the product development or commercial sales.

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.

The Company has

limited in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical

The Company has limited

in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical trials.

The Company is significantly reliant on third-party consultants and contractors to provide the requisite advice and management.

There can be no assurance that the clinical trials and product development will not encounter delays which could adversely affect prospects

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.

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manner is likely to negatively affect the Company.

studies and initial clinical trials are not necessarily predictive of future results

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.

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

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.

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

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.

must obtain additional capital to continue our operations

Company anticipates that additional capital will be required to complete its current research and development programs.

It is anticipated

that future research, additional pre-clinical and toxicology studies and manufacturing initiatives, including to prepare for market approval

and successful product market launch, will require additional funds.

Further financing may dilute the current holdings of shareholders

and may thereby result in a loss for the shareholders.

There can be no assurance that the Company will be able to obtain adequate financing,

or financing on terms that are reasonable or acceptable for these or other purposes, or to fulfill the Company’s obligations under

various license agreements.

Failure to obtain such additional financing could result in delay or indefinite postponement of further research

and development of the Company’s technologies with the possible loss of license rights to these technologies.

are highly dependent on our key personnel

the Company is expected to have experienced senior management and personnel, the Company will be substantially dependent upon the services

of a few key personnel, particularly Dr.

Williams, Dr.

Giuseppe Del Priore, Dr.

Miguel Lopez-Lago and other professionals

for the successful operation of its business.

Pivotal Phase 3 of Bria-IMT™ regimen with an immune check point inhibitor, and Phase

1/2 study of Bria-OTS ™, and the Company’s research and product development is planned to be completed by qualified professionals

and is expected to concentrate on treatment of advanced breast cancer and prostate cancer.

The loss of the services of any of these personnel

could have a material adverse effect on the business of the Company.

The Company may not be able to attract and retain personnel on acceptable

terms given the intense competition for such personnel among high technology enterprises, including biotechnology and healthcare companies,

universities and non-profit research institutions.

If we lose any of these persons, or are unable to attract and retain qualified personnel,

our business, financial condition and results of operations may be materially and adversely affected.

in the future may acquire businesses, products or technologies that it believes complement or expand its existing business.

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.

the Company experiences a data security breach and confidential information is disclosed, the Company may be subject to penalties and

experience negative publicity

Company and its customers could suffer harm if personal and health information were accessed by third parties due to a system security

The collection of data requires the Company to receive and store a large amount of personally de-identifiable data.

Recently, data

security breaches suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting

legislative proposals addressing data privacy and security.

The Company may become exposed to potential liabilities with respect to the

data that it collects, manages and processes, and may incur legal costs if information security policies and procedures are not effective

or if the Company is required to defend its methods of collection, processing and storage of personal data.

Future investigations, lawsuits

or adverse publicity relating to its methods of handling such information could have a material adverse effect on the Company’s

business, financial condition and results of operations due to the costs and negative market reaction relating to such developments.

may not succeed in completing the development of our products, commercializing our products or generating significant revenues

commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates.

ability to generate revenues and achieve profitability depends on our ability to successfully complete the development of our products,

obtain market approval and generate significant revenues.

The future success of our business cannot be determined at this time, and we

do not anticipate generating revenues from product sales for the foreseeable future.

In addition, we face a number of challenges with

respect to our future commercialization efforts, including, among others, that:

we may not have adequate

financial or other resources to complete the development of our product, including two stages of clinical development that are necessary

in order to commercialize our products;

may not be able to manufacture our products in commercial quantities, at an adequate quality or at an acceptable cost;

may not be able to maintain our CE mark due to regulatory changes;

may never receive FDA or Health Canada approval for our intended development plans;

may not be able to establish adequate sales, marketing and distribution channels;

professionals and patients may not accept our product candidates;

technological

breakthroughs in cancer detection, treatment and prevention may reduce the demand for our product candidates;

in the market for cancer treatment, new alliances between existing market participants and the entrance of new market participants

may interfere with our market penetration efforts;

payors may not agree to reimburse patients for any or all of the purchase price of our products, which may adversely affect patients’

willingness to purchase our product candidates;

as to market demand may result in inefficient pricing of our product candidates;

may face third-party claims of intellectual property infringement;

may fail to obtain or maintain regulatory approvals for our products candidates in our target markets or may face adverse regulatory

or legal actions relating to our product candidates even if regulatory approval is obtained;

are dependent upon the results of ongoing clinical studies relating to our product candidates and the products of our competitors.

We may fail in obtaining positive results.

we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our product candidates

could be limited, which in turn could have a material adverse effect on our business, financial condition and results of operations.

product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates

may be affected

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

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

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;

a decline in the price

of our common shares.

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.

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

damage to our reputation;

costs incurred related

to product recalls;

limiting our opportunities

to enter into future commercial partnerships;

a decline in the price

of our common shares.

economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and

conflicts, such as the conflict between Russia and Ukraine and rising tensions in the Middle East, could make it more difficult for us

to access financing and could adversely affect our business and operations.

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

may be adversely affected by the effects of inflation.

has the potential to adversely affect our business, results of operations, financial position and liquidity by increasing our overall

cost structure, particularly if we are unable to achieve commensurate increases in the prices we charge our customers.

The existence

of inflation in the economy has the potential to result in higher interest rates and capital costs, supply shortages, increased costs

of labor and other similar effects.

As a result of inflation, we may experience increases in the costs of labor, materials, and other

inputs, such as engineering consultants.

Although we may take measures to mitigate the impact of this inflation, if these measures are

not effective our business, results of operations, financial position and liquidity could be materially adversely affected.

measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations

and when the cost inflation is incurred.

material breach in security relating to the Company’s information systems and regulation related to such breaches, cyber-attacks,

or other disruptions could adversely affect the Company, expose us to liability and affect our business and reputation.

security risks have generally increased in recent years, in part because of the proliferation of new technologies and the use of the

Internet, and the increased sophistication and activity of organized crime, hackers, terrorists, activists, cybercriminals and other

external parties, some of which may be linked to terrorist organizations or hostile foreign governments.

Cybersecurity attacks are becoming

more sophisticated and include malicious software, ransomware, attempts to gain unauthorized access to data and other electronic security

breaches that could lead to disruptions in critical systems, unauthorized release of confidential or otherwise protected information

and corruption of data, substantially damaging the Company’s reputation.

Any person who circumvents the security measures could

steal proprietary or confidential customer information or cause interruptions in the Company’s operations.

are increasingly dependent on our information technology systems and infrastructure for our business.

We, our collaborators and our service

providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, and personal

information in connection with our business operations.

The secure maintenance of this information is critical to our operations and

business strategy.

Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives

and expertise, including organized criminal groups, “hacktivists,” disgruntled current or former employees, nation-state

and nation-state supported actors, and others.

Cyber-attacks are of ever-increasing levels of sophistication, and despite our security

measures, our information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee

error or malfeasance.

have implemented information security measures to protect our systems, proprietary information, and sensitive data against the risk of

inappropriate and unauthorized external use and disclosure and other types of compromise.

However, despite these measures, and due to

the ever-changing information cyber-threat landscape, we cannot guarantee that these measures will be adequate to detect, prevent or

mitigate security breaches and other incidents and we may be subject to data breaches through cyber-attacks, malicious code (such as

viruses and worms), phishing attacks, social engineering schemes, and insider theft or misuse.

Any such breach could compromise our networks

and the information stored there could be accessed, modified, destroyed, publicly disclosed, lost or stolen.

If our systems become compromised,

we may not promptly discover the intrusion.

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.

Related to Our Intellectual Property

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property from unauthorized disclosure, third-party infringement or misappropriation, for the following reasons:

the agreements may be breached,

may not provide the scope of protection we believe they provide or may be determined to be unenforceable;

we may have inadequate

remedies for any breach;

proprietary information

could be disclosed to our competitors;

others may independently

develop substantially equivalent or superior proprietary information and techniques or otherwise gain access to our trade secrets

or disclose such technologies.

agreements may be breached, may not provide the scope of protection we believe they provide or may be determined to be unenforceable;

may have inadequate remedies for any breach;

information could be disclosed to our competitors;

may independently develop substantially equivalent or superior proprietary information and techniques or otherwise gain access to

our trade secrets or disclose such technologies.

Specifically,

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face the risk that:

a product candidate may

not prove safe or efficacious;

the results with respect

to any product candidate may not confirm the positive results from earlier preclinical studies or clinical trials;

the results may not meet

the level of statistical significance required by the FDA, Health Canada or other regulatory authorities;

the results will justify

only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit

the marketability and profitability of the therapeutic candidate.

product candidate may not prove safe or efficacious;

results with respect to any product candidate may not confirm the positive results from earlier preclinical studies or clinical trials;

results may not meet the level of statistical significance required by the FDA, Health Canada or other regulatory authorities;

results will justify only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could

significantly limit the marketability and profitability of the therapeutic candidate.

delay or failure in obtaining the required regulatory approvals will materially and adversely affect our ability to generate future revenues

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not limited to:

delays in securing clinical

investigators or trial sites for the clinical trials;

delays in obtaining institutional

review board and other regulatory approvals to commence a clinical trial;

slower than anticipated

patient recruitment and enrollment;

negative or inconclusive

results from clinical trials;

unforeseen safety issues;

uncertain dosing issues;

an inability to monitor

patients adequately during or after treatment;

problems with investigator

or patient compliance with the trial protocols.

in securing clinical investigators or trial sites for the clinical trials;

in obtaining institutional review board and other regulatory approvals to commence a clinical trial;

than anticipated patient recruitment and enrollment;

or inconclusive results from clinical trials;

safety issues;

dosing issues;

inability to monitor patients adequately during or after treatment;

with investigator or patient compliance with the trial protocols.

number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us,

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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.

pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement and access

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product development and could have an adverse effect on the business.

may not succeed in completing the development of our products, commercializing our products or generating significant revenues

commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates.

ability to generate revenues and achieve profitability depends on our ability to successfully complete the development of our products,

obtain market approval and generate significant revenues.

The future success of our business cannot be determined at this time, and we

do not anticipate generating revenues from product sales for the foreseeable future.

In addition, we face a number of challenges with

respect to our future commercialization efforts, including, among others, that:

may not have adequate financial or other resources to complete the development of our product, including two stages of clinical development

that are necessary in order to commercialize our products;

may not be able to manufacture our products in commercial quantities, at an adequate quality or at an acceptable cost;

may not be able to maintain our CE mark due to regulatory changes;

may never receive FDA or Health Canada approval for our intended development plans;

may not be able to establish adequate sales, marketing and distribution channels;

professionals and patients may not accept our product candidates;

technological

breakthroughs in cancer detection, treatment and prevention may reduce the demand for our product candidates;

in the market for cancer treatment, new alliances between existing market participants and the entrance of new market participants

may interfere with our market penetration efforts;

payors may not agree to reimburse patients for any or all of the purchase price of our products, which may adversely affect patients’

willingness to purchase our product candidates;

as to market demand may result in inefficient pricing of our product candidates;

may face third-party claims of intellectual property infringement;

may fail to obtain or maintain regulatory approvals for our products candidates in our target markets or may face adverse regulatory

or legal actions relating to our product candidates even if regulatory approval is obtained;

are dependent upon the results of ongoing clinical studies relating to our product candidates and the products of our competitors.

We may fail in obtaining positive results.

we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our product candidates

could be limited, which in turn 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.

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.

This going concern risk may materially

limit our ability to raise additional funds through the issuance of new debt or equity or may adversely affect the terms upon which such

capital may be available.

The inability to obtain sufficient financing on acceptable terms could have a material adverse effect on the

Company’s financial condition, results of operations, and business prospects.

The Company is actively pursuing

strategies to mitigate these risks, focusing on transitioning towards revenue generation from its existing product offerings and expanding

its customer base.

However, there can be no assurance that these efforts will prove successful or that the Company will achieve its intended

financial stability.

The failure to successfully address these going concern risks may materially and adversely affect the Company’s

business, financial condition, and results of operations.

Investors should consider the substantial risks and uncertainties inherent

in the Company’s business before investing in the Company’s securities.

We have an unproven market for our product candidates

The Company believes that the

anticipated market for its potential products and technologies if successfully developed will continue to exist and expand.

These assumptions

may prove to be incorrect for a variety of reasons, including competition from other products and the degree of commercial viability

of the potential product.

We are a pre-revenue clinical stage company

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.

The Company expects operating expenses and staffing levels to increase in the future.

To manage such growth, the Company must expand its

operational and technical capabilities and manage its employee base while effectively administering multiple relationships with various

third parties.

There can be no assurance that the Company will be able to manage its expanding operations effectively.

Any failure to

implement cohesive management and operating systems, to add resources on a cost-effective basis or to properly manage the Company’s

expansion could have a material adverse effect on its business and results of operations.

BriaPro may not generate

revenue as expected

We are a majority shareholder

BriaPro may not generate financial returns or may not yield the desired business outcome.

The success of our investment in

a company is sometimes dependent on the availability of additional funding on favorable terms or a liquidity event such as an initial

public offering.

We may record impairment charges in relation to our strategic investments which will have a negative impact on our financial

This may expose us to additional

reputational, financial, legal, compliance or operational risks.

This could impact our return on our investment.

In the event BriaPro

fails to generate revenue, this may erode or dilute its value to our shareholders.

We are highly dependent on our key personnel

Although the Company is expected

to have experienced senior management and personnel, the Company will be substantially dependent upon the services of a few key personnel,

particularly Dr.

Williams, Dr.

Giuseppe Del Priore, Dr.

Miguel Lopez-Lago and other professionals for the successful operation

of its business.

Pivotal Phase 3 of Bria-IMT™ regimen with an immune check point inhibitor, and Phase 1/2 study of Bria-OTS ™,

and the Company’s research and product development is planned to be completed by qualified professionals and is expected to concentrate

on treatment of advanced breast cancer and prostate cancer.

The loss of the services of any of these personnel could have a material adverse

effect on the business of the Company.

The Company may not be able to attract and retain personnel on acceptable terms given the intense

competition for such personnel among high technology enterprises, including biotechnology and healthcare companies, universities and non-profit

research institutions.

If we lose any of these persons, or are unable to attract and retain qualified personnel, our business, financial

condition and results of operations may be materially and adversely affected.

If the Company experiences a data security breach

and confidential information is disclosed, the Company may be subject to penalties and experience negative publicity

The Company and its customers

could suffer harm if personal and health information were accessed by third parties due to a system security failure.

The collection of

data requires the Company to receive and store a large amount of personally de-identifiable data.

Recently, data security breaches suffered

by well-known companies and institutions have attracted a substantial amount of media attention, prompting legislative proposals addressing

data privacy and security.

The Company may become exposed to potential liabilities with respect to the data that it collects, manages

and processes, and may incur legal costs if information security policies and procedures are not effective or if the Company is required

to defend its methods of collection, processing and storage of personal data.

Future investigations, lawsuits or adverse publicity relating

to its methods of handling such information could have a material adverse effect on the Company’s business, financial condition

and results of operations due to the costs and negative market reaction relating to such developments.

A material breach in

security relating to the Company’s information systems and regulation related to such breaches, cyber-attacks, or other disruptions

could adversely affect the Company, expose us to liability and affect our business and reputation.

security risks have generally increased in recent years, in part because of the proliferation of new technologies and the use of the Internet,

and the increased sophistication and activity of organized crime, hackers, terrorists, activists, cybercriminals and other external parties,

some of which may be linked to terrorist organizations or hostile foreign governments.

Cybersecurity attacks are becoming more sophisticated

and include malicious software, ransomware, attempts to gain unauthorized access to data and other electronic security breaches that could

lead to disruptions in critical systems, unauthorized release of confidential or otherwise protected information and corruption of data,

substantially damaging the Company’s reputation.

Any person who circumvents the security measures could steal proprietary or confidential

customer information or cause interruptions in the Company’s operations.

increasingly dependent on our information technology systems and infrastructure for our business.

We, our collaborators and our service

providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, and personal

information in connection with our business operations.

The secure maintenance of this information is critical to our operations and business

Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and

expertise, including organized criminal groups, “hacktivists,” disgruntled current or former employees, nation-state and nation-state

supported actors, and others.

Cyber-attacks are of ever-increasing levels of sophistication, and despite our security measures, our information

technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance.

implemented information security measures to protect our systems, proprietary information, and sensitive data against the risk of inappropriate

and unauthorized external use and disclosure and other types of compromise.

However, despite these measures, and due to the ever-changing

information cyber-threat landscape, we cannot guarantee that these measures will be adequate to detect, prevent or mitigate security breaches

and other incidents and we may be subject to data breaches through cyber-attacks, malicious code (such as viruses and worms), phishing

attacks, social engineering schemes, and insider theft or misuse.

Any such breach could compromise our networks and the information stored

there could be accessed, modified, destroyed, publicly disclosed, lost or stolen.

If our systems become compromised, we may not promptly

discover the intrusion.

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.

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.

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.

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.

Company’s international operations expose it and its representatives, agents and distributors to risks inherent to operating in

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risks include:

country specific taxation policies;

imposition of additional foreign governmental controls

or regulations;

export license requirements;

changes in tariffs and other trade restrictions;

complexity of collecting receivables in a foreign jurisdiction.

specific taxation policies;

of additional foreign governmental controls or regulations;

license requirements;

in tariffs and other trade restrictions;

of collecting receivables in a foreign jurisdiction.

applicable agreements relating to business in foreign jurisdictions are governed by foreign laws and are subject to dispute resolution

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Related to Our Securities

we are not able to comply with the applicable continued listing requirements or standards of the TSX Exchange or Nasdaq, TSX Exchange

or Nasdaq could delist our common shares

order to maintain the listing of our common shares on the TSX Exchange and the Nasdaq Capital Market, we must satisfy minimum financial

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

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,

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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.

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.

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.

addition, on August 22, 2024, the Company received a letter from the Nasdaq Listing Qualifications Department notifying the Company that,

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Bid Price Requirement”).

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.

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.

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.

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

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

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).

Nasdaq determines to delist our securities from trading on its exchange and we are unable to obtain listing on another national securities

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number of broker-dealers willing to execute trades in shares of our common shares.

have a history of losses, may incur future losses and may not achieve profitability

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.

must obtain additional capital to continue our operations

Company anticipates that additional capital will be required to complete its current research and development programs.

It is anticipated

that future research, additional pre-clinical and toxicology studies and manufacturing initiatives, including to prepare for market approval

and successful product market launch, will require additional funds.

Further financing may dilute the current holdings of shareholders

and may thereby result in a loss for the shareholders.

There can be no assurance that the Company will be able to obtain adequate financing,

or financing on terms that are reasonable or acceptable for these or other purposes, or to fulfill the Company’s obligations under

various license agreements.

Failure to obtain such additional financing could result in delay or indefinite postponement of further research

and development of the Company’s technologies with the possible loss of license rights to these technologies.

issuance of our common shares could dilute the interests of existing shareholders

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have 1,938,873 shares issuable upon exercise of restricted share units, options and warrants.

Sales of shares by these shareholders

could have a material adverse effect on the trading price of our common shares.

We intend to register the offering, issuance, and sale

of all common shares that we may issue under our equity compensation plans.

Once we register these shares, they can be freely sold in

the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

Sales of shares by these shareholders could

have a material adverse effect on the trading price of our common shares.

We intend to register the offering, issuance, and sale of all

common shares that we may issue under our equity compensation plans.

Once we register these shares, they can be freely sold in the public

market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

are an Emerging Growth Company, which may reduce the amount of information available to investors

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from various requirements that are applicable to public companies that are not emerging growth companies including:

the provisions of the Sarbanes-Oxley

Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal

control over financial reporting;

any rules that may be adopted

by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report

on the financial statements.

provisions of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report

on the effectiveness of our internal control over financial reporting;

rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement

to the auditor’s report on the financial statements.

intend to take advantage of these exemptions until we are no longer an “emerging growth company.” We will remain an emerging

growth company until the earlier of (1) the last day of the fiscal year of the fifth anniversary of our initial public offering in the

United States, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be

a large accelerated filer, which means the market value of our Common shares that is held by non-affiliates exceeds $700 million

as of the prior June 30;

and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior

three-year period.

cannot predict if investors will find our common shares or listed warrants (“Warrants”) less attractive because we may rely

United States, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large

accelerated filer, which means the market value of our Common shares that is held by non-affiliates exceeds $700 million as of the prior

and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

cannot predict if investors will find our common shares or listed Warrants less attractive because we may rely

on these exemptions.

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These broad market fluctuations may adversely affect the market price of our Common shares.

executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted

to our shareholders for approval

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.

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.

we are or become classified as a passive foreign investment company, our U.S.

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in the exception.

Because the determination

of whether we are a PFIC for any taxable year is a factual determination made annually after the end of each taxable year, there can

be no assurance as to our status as a PFIC in any taxable year.

Because the determination of whether we are a PFIC for any taxable year is a factual determination made annually after

the end of each taxable year, there can be no assurance as to our status as a PFIC in any taxable year.

tax consequences that would apply if we are classified as a PFIC would also be different from those described above if a U.S.

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are a corporation incorporated under the laws of British Columbia with our registered office in West Vancouver.

directors and officers and the auditors or other experts named herein are residents of Canada and all or a substantial portion of our

assets and those of such persons are located outside the United States.

Some of our directors

and officers and the auditors or other experts named herein are residents of Canada and all or a substantial portion of our assets and

those of such persons are located outside the United States.

Consequently, it may be difficult for U.S.

investors to effect

service of process within the United States upon us or our directors or officers or such auditors who are not residents of the United

States, or to realize in the United States upon judgments of courts of the United States predicated upon civil liabilities under the

Securities Act.

investors to effect service of

process within the United States upon us or our directors or officers or such auditors who are not residents of the United States, or

to realize in the United States upon judgments of courts of the United States predicated upon civil liabilities under the Securities

Investors should not assume that Canadian courts:

(1) would enforce judgments of U.S.

courts obtained in actions against

us or such persons predicated upon the civil liability provisions of the U.S.

federal securities laws or the securities or blue sky laws

of any state within the United States, or (2) would enforce, in original actions, liabilities against us or such persons predicated upon

courts obtained in actions against us or such

persons predicated upon the civil liability provisions of the U.S.

federal securities laws or the securities or blue sky laws of any

state within the United States, or (2) would enforce, in original actions, liabilities against us or such persons predicated upon the

federal securities laws or any such state securities or blue sky laws.

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on violations of Canadian securities laws.

economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and

conflicts, such as the conflict between Russia and Ukraine and rising tensions in the Middle East, could make it more difficult for us

to access financing and could adversely affect our business and operations.

ability to access capital markets and raise additional funds depends in large part on investor confidence and market valuations of our

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,

A decline in the market price of our securities could also impair our ability to raise capital without substantial dilution

to existing shareholders.

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.

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.