What changed in this filing

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Item 1A. Risk Factors

2023-10-25 compared with 2022-10-28 · 746 added, 800 removed, 217 unchanged (88% of the section changed)

11 unchanged sentences

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 $26,838,903

and $13,816,200 in the fiscal years ended 2022 and 2021, 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

are an early stage development company

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.

incurred net losses of $20,302,394 and $26,838,903 in the fiscal years ended 2023 and 2022, 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.

are a pre-revenue clinical stage company

Company is developing novel technologies that may not be efficacious or safe.

11 unchanged sentences

unwanted side effects.

is a lack of supporting clinical data.

clinical effectiveness and safety of any of the Company’s developmental products is not yet supported by extensive clinical data

and the medical community has not yet developed a large body of peer reviewed literature that supports the safety and efficacy of the

Company’s products.

If future studies call into question the safety or efficacy of the Company’s products, the Company’s

business, financial condition, and results of operations could be adversely affected.

have an unproven market for our product candidates

12 unchanged sentences

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

a majority shareholder of BriaPro.

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

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.

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.

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

110 unchanged sentences

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

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 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 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.

We may not succeed in completing the development

of our products, commercializing our products or generating significant revenues

Since commencing our operations,

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

Our 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;

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

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

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

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

healthcare 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;

changes 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;

third-party 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;

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

we may face third-party claims of intellectual property infringement;

we 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;

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

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 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:

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.

If 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.

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 enter clinical

trials, we will face an inherent risk of product liability suits and will face an even greater risk if we obtain approval to commercialize

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.

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;

a decline in the price of our common shares.

We shall seek to obtain the appropriate

insurance once our candidates are ready for clinical trial.

However, our inability to obtain 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.

We currently do not have in place product liability insurance and although we plan to have in place such

insurance as and when the products are ready for commercialization, as well as insurance covering clinical trials, 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.

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;

a decline in the price of our common shares.

We face business disruption and related risks

resulting from the recent outbreak of COVID-19, which could have a material adverse effect on our business plan.

The development of our product

candidates could be disrupted and materially adversely affected by the outbreak of COVID-19.

As a result of measures imposed by the governments

in affected regions, businesses and schools have been suspended due to quarantines intended to contain this outbreak.

We have enrolled,

and will seek to enroll, subject to funding constraints, cancer patients in our clinical trials.

In the event that clinical trial sites

are slowed down or closed to enrollment in our trials, this could have a material adverse impact on our clinical trial plans and timelines.

We may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected by the virus

or are fearful of visiting or traveling to our clinical trial sites because of the outbreak.

We are continuing to assess our business

plans and the impact COVID-19 is having on our clinical trial timelines and our ability to recruit candidates for clinical trials, but

there can be no assurance that this analysis will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences,

including downturns in business sentiment generally or in our sector in particular.

The extent to which COVID-19 and global efforts to

contain its spread will impact our operations will depend on future developments, which are highly uncertain and cannot be predicted at

this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak.

We currently believe that the execution of our clinical trials and research programs are delayed by at least one quarter due to COVID-19.

Global 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, could make it more difficult for us to access financing and could adversely affect our business and

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 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.

We may be adversely

affected by the effects of inflation.

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:

demand for our drugs;

to our reputation;

of clinical trial participants and inability to continue clinical trials;

of investigations by regulators;

to defend the related litigation;

of management’s time and our resources;

monetary awards to trial participants or patients;

recalls, withdrawals or labeling, marketing or promotional restrictions;

of any available insurance and our capital resources;

inability to commercialize any drug candidate;

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.

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:

demand for those products;

to our reputation;

incurred related to product recalls;

our opportunities to enter into future commercial partnerships;

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 rising tensions 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.

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.

Even if such 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.

Failure to remediate

material weaknesses in internal accounting controls could result in material misstatements in our financial statements.

Our management

has identified material weaknesses in our internal control over financial reporting related to lack of segregation of duties within account

processes, and systems, inadequate documentation to evidence the operation of controls, inconsistent procedures and approvals, lack of

periodic user access reviews, lack of assessment of controls of financially significant vendors and insufficient written policies and

procedures for accounting, IT and financial reporting and record keeping.

Our management has concluded that, due to such material weakness,

our disclosure controls and procedures were not effective as of July 31, 2022.

We have implemented remediation efforts including independent

review and approval of transactions and reconciliations in some processes by hiring personnel and segregating duties amongst the team.

Management is implementing processes to document and retain evidence to support reviews and reconciliations.

Such changes may not, however,

be effective in establishing the adequacy of our internal control over financial reporting.

If the material weaknesses are not adequately

remedied, or if we identify further material weaknesses in our internal controls, our failure to establish and maintain effective disclosure

controls and procedures and internal control over financial reporting could result in material misstatements in our financial statements

and a failure to meet our reporting and financial obligations, each of which could have a material adverse effect on our financial condition

and the trading price of our securities.

In addition, investors’ perceptions that our internal control over financial reporting

is inadequate or that we are unable to produce accurate financial statements may materially adversely affect the price of our securities.

Risks Related to Our Intellectual Property

We may not successfully develop, maintain and

protect our proprietary products and technologies

BriaCell’s success depends

to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies.

BriaCell files patent

applications in the United States and other countries as part of its global strategy to protect its intellectual property and maintains

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.

Related to Our Intellectual Property

may not successfully develop, maintain and protect our proprietary products and technologies

success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies.

files patent applications in the United States and other countries as part of its global strategy to protect its intellectual property

and maintains certain U.S.

patents in its intellectual property portfolio.

However, patents provide only limited protection of BriaCell’s

intellectual property.

The assertion of patent protection involves complex legal and factual determinations and is therefore uncertain

and can be expensive.

BriaCell cannot provide assurances that patents will be granted with respect to any of its pending patent applications,

or that the scope of any of its granted patents, or any patents granted in the future, will be sufficiently broad to offer meaningful

protection, or that it will develop and file patent applications on additional proprietary technologies that are patentable, or, if patentable,

that any patents will be granted from such patent applications.

BriaCell’s current or future patents could be successfully challenged,

invalidated or circumvented.

This could result in BriaCell’s patent rights failing to create an effective competitive barrier.

a significant patent or failing to get a patent to issue from a pending patent application that BriaCell considers significant could have

a material adverse effect on BriaCell’s business.

The laws governing the scope of patent coverage in various countries continue

The laws of some foreign countries may not protect BriaCell’s intellectual property rights to the same extent as the

laws of the United States.

However, patents provide only limited protection

of BriaCell’s intellectual property.

The assertion of patent protection involves complex legal and factual determinations and is

therefore uncertain and can be expensive.

BriaCell cannot provide assurances that patents will be granted with respect to any of its

pending patent applications, or that the scope of any of its granted patents, or any patents granted in the future, will be sufficiently

broad to offer meaningful protection, or that it will develop and file patent applications on additional proprietary technologies that

are patentable, or, if patentable, that any patents will be granted from such patent applications.

BriaCell’s current or future

patents could be successfully challenged, invalidated or circumvented.

This could result in BriaCell’s patent rights failing to

create an effective competitive barrier.

Losing a significant patent or failing to get a patent to issue from a pending patent application

that BriaCell considers significant could have a material adverse effect on BriaCell’s business.

The laws governing the scope of

patent coverage in various countries continue to evolve.

The laws of some foreign countries may not protect BriaCell’s intellectual

property rights to the same extent as the laws of the United States.

BriaCell has applied for patent protection only in selected countries.

Therefore, third parties may be able

to replicate BriaCell technologies covered by BriaCell’s patent portfolio in countries in which it does not have patent protection.

BriaCell’s future success

and competitive position depends in part upon its ability to maintain its intellectual property portfolio.

There can be no assurance that

any patents will be issued on any existing or future patent applications.

We are susceptible to intellectual property

suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates

There is a substantial amount

of litigation over patent and other intellectual property rights in the biotechnology industry.

Whether or not a product infringes a patent

involves complex legal and factual considerations, the determination of which is often uncertain.

Our management is presently unaware

of any other parties’ patents and proprietary rights which our products under development would infringe.

Searches typically performed

to identify potentially infringed patents of third parties are often not conclusive and, because patent applications can take many years

to issue, there may be applications now pending, which may later result in issued patents which our current or future products may infringe

or be alleged to infringe.

In addition, our competitors or other parties may assert that our product candidates and the methods employed

may be covered by patents held by them.

If any of our products infringes a valid patent, we could be prevented from manufacturing or selling

such product unless we are able to obtain a license or able to redesign the product in such a manner as to avoid infringement.

may not always be available or may require us to pay substantial royalties.

We also may not be successful in any attempt to redesign our

product to avoid infringement, nor does a later redesign protect BriaCell from prior infringement.

Infringement and other intellectual

property claims, with or without merit, can be expensive and time-consuming to litigate and can divert our management’s attention

from operating our business.

The steps we have taken to protect our intellectual

property may not be adequate, which could have a material adverse effect on our ability to compete in the market

BriaCell’s ability to establish

and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its

In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions.

In addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment of inventions provisions,

as appropriate, in our agreements with our employees, consultants, and service providers, to protect and otherwise seek to control access

to, and distribution of, our proprietary information.

These measures may not be adequate to protect our intellectual 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.

Specifically, with respect to

non-compete agreements, both state law and precedent varies greatly from state to state and we may be unable to enforce these agreements,

in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our former employees gained

while working for us.

If our intellectual property is disclosed or misappropriated, it could harm our ability to protect our rights and

could have a material adverse effect on our business, financial condition and results of operations.

We may need to initiate lawsuits to protect

or enforce our patents and other intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of

our intellectual property rights, which would harm our ability to compete in the market

We rely on patents, confidentiality

and trade secrets to protect a portion of our intellectual property and our competitive position.

Patent law relating to the scope of

claims in the technology fields in which we operate is still evolving and, consequently, patent positions in the biotechnology/pharmaceutical

industry can be uncertain.

In order to protect or enforce our patent rights, we may initiate patent and related litigation against third

parties, such as infringement suits or requests for injunctive relief.

BriaCell’s ability to establish and maintain a competitive

position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights.

In addition, enforcement

of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions.

Any lawsuits that we

initiate could be expensive, take significant time and divert our management’s attention from other business concerns and the outcome

of litigation to enforce our intellectual property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable.

Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing,

or adversely affect its ability to distribute any products that are subject to such litigation.

In addition, we may provoke third parties

to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, including

attorney fees, if any, may not be commercially valuable.

The occurrence of any of these events could have a material adverse effect on

our business, financial condition and results of operations.

We may be subject to damages resulting from claims that we or our

employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers

Therefore, third parties may be able to replicate BriaCell technologies covered by BriaCell’s patent portfolio in countries in

which it does not have patent protection.

future success and competitive position depends in part upon its ability to maintain its intellectual property portfolio.

no assurance that any patents will be issued on any existing or future patent applications.

are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit

us from selling our product candidates

is a substantial amount of litigation over patent and other intellectual property rights in the biotechnology industry.

Whether or not

a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain.

Our management

is presently unaware of any other parties’ patents and proprietary rights which our products under development would infringe.

Searches typically performed to identify potentially infringed patents of third parties are often not conclusive and, because patent

applications can take many years to issue, there may be applications now pending, which may later result in issued patents which our

current or future products may infringe or be alleged to infringe.

In addition, our competitors or other parties may assert that our

product candidates and the methods employed may be covered by patents held by them.

If any of our products infringes a valid patent,

we could be prevented from manufacturing or selling such product unless we are able to obtain a license or able to redesign the product

in such a manner as to avoid infringement.

A license may not always be available or may require us to pay substantial royalties.

may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect BriaCell from prior

infringement.

Infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate

and can divert our management’s attention from operating our business.

steps we have taken to protect our intellectual property may not be adequate, which could have a material adverse effect on our ability

to compete in the market

ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes

to be infringing its rights.

In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures

in those jurisdictions.

In addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment

of inventions provisions, as appropriate, in our agreements with our employees, consultants, and service providers, to protect and otherwise

seek to control access to, and distribution of, our proprietary information.

These measures may not be adequate to protect our intellectual

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

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,

with respect to non-compete agreements, both state law and precedent varies greatly from state to state and we may be unable to enforce

these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our

former employees gained while working for us.

If our intellectual property is disclosed or misappropriated, it could harm our ability

to protect our rights and could have a material adverse effect on our business, financial condition and results of operations.

may need to initiate lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive and,

if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market

rely on patents, confidentiality and trade secrets to protect a portion of our intellectual property and our competitive position.

law relating to the scope of claims in the technology fields in which we operate is still evolving and, consequently, patent positions

in the biotechnology/pharmaceutical industry can be uncertain.

In order to protect or enforce our patent rights, we may initiate patent

and related litigation against third parties, such as infringement suits or requests for injunctive relief.

BriaCell’s ability

to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing

In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those

jurisdictions.

Any lawsuits that we initiate could be expensive, take significant time and divert our management’s attention from

other business concerns and the outcome of litigation to enforce our intellectual property rights in patents, copyrights, trade secrets

or trademarks is highly unpredictable.

Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our

patent applications at risk of not issuing, or adversely affect its ability to distribute any products that are subject to such litigation.

In addition, we may provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the damages

or other remedies awarded, including attorney fees, if any, may not be commercially valuable.

The occurrence of any of these events could

have a material adverse effect on our business, financial condition and results of operations.

may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade

secrets of their former employers

of our employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including

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A loss of key research personnel or their work

product could hamper or prevent our ability to commercialize certain therapeutic candidates, which could severely harm our business, financial

condition and results of operations.

Even if we are successful in defending against these claims, litigation could result in substantial

costs and be a distraction to management.

If the FDA or comparable foreign regulatory

authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products

appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

product could hamper or prevent our ability to commercialize certain therapeutic candidates, which could severely harm our business,

financial condition and results of operations.

Even if we are successful in defending against these claims, litigation could result in

substantial costs and be a distraction to management.

the FDA or comparable foreign regulatory authorities approve generic versions of any of our products that receive marketing approval,

or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the

sales of our products could be adversely affected.

a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication,

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approval of generic versions of reference listed drugs through submission of abbreviated new drug applications in the United States.

support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials.

In support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials.

Rather, the applicant generally

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of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic

may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for the

reference listed drug has expired.

FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for

the reference listed drug has expired.

The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of non-patent

exclusivity for a new drug containing a new chemical entity (“NCE”).

Specifically, in cases where such exclusivity

has been granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years, unless the submission

Specifically, in cases where such exclusivity has been

granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years, unless the submission

is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed

by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug.

we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be

afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period that

is less than five years.

by the generic product, in which case the applicant may submit its application four years following approval of the reference listed

we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should

be afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period

that is less than five years.

If the FDA were to award NCE exclusivity to someone other than us, we believe that we would still be awarded

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our business may be materially harmed.

Competition that our products

may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows

and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

Patent terms may be inadequate to protect our

competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest

United States non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection it affords,

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition

from competitive products, including generics or biosimilars.

Given the amount of time required for the development, testing, and regulatory

review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing

products similar or identical to ours.

Risks Related to Regulations

Changes in legislation and regulations may affect

our revenue and profitability

Existing and proposed changes

in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company evaluates the implications

of new rules and responds to new requirements.

Failure to comply with new rules and regulations could result in enforcement actions or

the assessment of other penalties.

New laws and regulations could make it more difficult to obtain certain types of insurance, including

director’s and officer’s liability insurance, and the Company may be forced to accept reduced policy limits and coverage or

incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage remains available.

The impact of these events could

also make it more difficult for the Company to attract and retain qualified persons to serve on the Board, or as executive officers.

Company may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which

could cause the Company’s general and administrative costs to increase beyond what the Company currently has planned.

Company evaluates and monitors developments with respect to new rules and laws, the Company cannot predict or estimate the amount of the

additional costs the Company may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide

assurances that such additional costs will render the Company compliant with such new rules and laws.

If we or our licensees

are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize

our therapeutic candidates

we have not marketed, distributed or sold an approved product.

Our therapeutic candidates are subject to extensive governmental regulations

relating to development, clinical trials, manufacturing and commercialization of drugs.

We may not obtain marketing approval for any of

our therapeutic candidates in a timely manner or at all.

In connection with the clinical trials for our product candidates and other therapeutic

candidates that we may seek to develop in the future, either on our own or throughout licensing arrangements, we 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.

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

that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability

and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

have a limited lifespan.

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally

20 years from its earliest United States non-provisional filing date.

Various extensions may be available, but the life of a patent,

and the protection it affords, is limited.

Even if patents covering our product candidates are obtained, once the patent life has expired,

we may be open to competition from competitive products, including generics or biosimilars.

Given the amount of time required for the

development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly

after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights

to exclude others from commercializing products similar or identical to ours.

Related to Regulations

in legislation and regulations may affect our revenue and profitability

and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company

evaluates the implications of new rules and responds to new requirements.

Failure to comply with new rules and regulations could result

in enforcement actions or the assessment of other penalties.

New laws and regulations could make it more difficult to obtain certain

types of insurance, including director’s and officer’s liability insurance, and the Company may be forced to accept reduced

policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage

remains available.

impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Board,

or as executive officers.

The Company may be required to hire additional personnel and utilize additional outside legal, accounting and

advisory services, all of which could cause the Company’s general and administrative costs to increase beyond what the Company

currently has planned.

Although the Company evaluates and monitors developments with respect to new rules and laws, the Company cannot

predict or estimate the amount of the additional costs the Company may incur or the timing of such costs with respect to such evaluations

and/or compliance and cannot provide assurances that such additional costs will render the Company compliant with such new rules and

we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable

to commercialize our therapeutic candidates

date, we have not marketed, distributed or sold an approved product.

Our therapeutic candidates are subject to extensive governmental

regulations relating to development, clinical trials, manufacturing and commercialization of drugs.

We may not obtain marketing approval

for any of our therapeutic candidates in a timely manner or at all.

In connection with the clinical trials for our product candidates

and other therapeutic candidates that we may seek to develop in the future, either on our own or throughout licensing arrangements, we

face the risk that:

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

from a particular product candidate.

Any regulatory approval to market a product may be subject to limitations on the indicated uses for

which we may market the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the size

of the market for the product.

We and our licensees, as applicable, also are, and will be, subject to numerous foreign regulatory requirements

that govern the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement.

regulatory approval process includes all of the risks associated with the FDA approval process that we describe above, as well as risks

attributable to the satisfaction of foreign requirements.

Approval by the FDA does not ensure approval by regulatory authorities outside

the United States.

Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional

testing requirements for our therapeutic candidates.

If the third parties on which we rely to conduct

our clinical trials and clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory

clearance or approval for, or commercialize, our product candidates

We do not have the ability to

independently conduct our clinical trials for our product candidates and we must rely on third parties, such as contract research organizations,

medical institutions, clinical investigators and contract laboratories to conduct such trials.

If these third parties do not successfully

carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or

if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory

requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated,

and we may not be able to obtain regulatory clearance for, or successfully commercialize, our product candidates on a timely basis, if

at all, and our business, operating results and prospects may be adversely affected.

Furthermore, our third-party clinical trial investigators

may be delayed in conducting our clinical trials for reasons outside of their control.

Modifications to our

product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances or approvals

or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained

Any regulatory approval to market a product may be subject to limitations on the indicated uses

for which we may market the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the

size of the market for the product.

We and our licensees, as applicable, also are, and will be, subject to numerous foreign regulatory

requirements that govern the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement.

The foreign regulatory approval process includes all of the risks associated with the FDA approval process that we describe above, as

well as risks attributable to the satisfaction of foreign requirements.

Approval by the FDA does not ensure approval by regulatory authorities

outside the United States.

Foreign jurisdictions may have different approval processes than those required by the FDA and may impose

additional testing requirements for our therapeutic candidates.

the third parties on which we rely to conduct our clinical trials and clinical development do not perform as contractually required or

expected, we may not be able to obtain regulatory clearance or approval for, or commercialize, our product candidates

do not have the ability to independently conduct our clinical trials for our product candidates and we must rely on third parties, such

as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials.

these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these

third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere

to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials

may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory clearance for, or successfully commercialize,

our product candidates on a timely basis, if at all, and our business, operating results and prospects may be adversely affected.

our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

Modifications

to our product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances

or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances

Modifications

to our product candidates, after they have been approved for marketing, if at all, or to any other pharmaceutical product that we may

develop in the future, may require new regulatory clearance, or approvals, and, if necessitated by a problem with a marketed product,

may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the

modified product are obtained.

The FDA requires pharmaceutical products manufacturers to initially make and document a determination of

whether or not a modification requires a new approval, supplement or clearance.

may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of

the modified product are obtained.

The FDA requires pharmaceutical products manufacturers to initially make and document a determination

of whether or not a modification requires a new approval, supplement or clearance.

A manufacturer may determine in conformity with applicable

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The FDA may also on its own initiative determine that a new clearance or approval is required.

If the FDA requires

new clearances or approvals of any pharmaceutical product or medical device for which we or our licensees receive marketing approval,

if any, we or our licensees may be required to recall such product and to stop marketing the product as modified, which could require

us or our licensees to redesign the product and will have a material adverse effect on our business, financial condition and results of

requires new clearances or approvals of any pharmaceutical product or medical device for which we or our licensees receive marketing

approval, if any, we or our licensees may be required to recall such product and to stop marketing the product as modified, which could

require us or our licensees to redesign the product and will have a material adverse effect on our business, financial condition and

results of operations.

In these circumstances, we may be subject to significant enforcement actions.

The results of our clinical trials may not support our product claims

or may result in the discovery of adverse side effects

Even if our clinical trials are

completed as planned, we cannot be certain that their results will support our product claims or that any regulatory authority whose approval

we will require in order to market and sell our products in any territory will agree with our conclusions regarding them.

Success in pre-clinical

studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that clinical trials

will replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product

candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development

Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability

to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience

adverse side effects that are not currently part of the product candidate’s profile.

Clinical trials involve

a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial

limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval.

trials are expensive and complex, can take many years and have uncertain outcomes.

We cannot predict whether we or our licensees will

encounter problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory authorities

to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials.

We estimate that clinical

trials of our most advanced therapeutic candidates will continue for several years, but they may take significantly longer to complete.

Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical

trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited

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.

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.

The pharmaceutical business is subject to increasing government price

controls and other restrictions on pricing, reimbursement and access to drugs, which could adversely affect our future revenues and profitability

To the extent our products are

developed, commercialized, and successfully introduced to market, they may not be considered cost-effective and third-party or government

reimbursement might not be available or sufficient.

Globally, governmental and other third-party payors are becoming increasingly aggressive

in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases,

limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement

from both governments and private payors inside and outside the U.S.

In the U.S., we are subject to

substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit

managers, and implementation of U.S.

results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects

if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any

regulatory authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions

regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful,

and we cannot be sure that clinical trials will replicate the results of prior trials and pre-clinical studies.

The clinical trial process

may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon

a product and may delay development of others.

Any delay or termination of our clinical trials will delay the filing of our regulatory

submissions and, ultimately, our ability to commercialize our product candidates and generate revenues.

It is also possible that patients

enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive

of future trial results

have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval.

Clinical trials are expensive and complex, can take many years and have uncertain outcomes.

We cannot predict whether we or our licensees

will encounter problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory

authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials.

that clinical trials of our most advanced therapeutic candidates will continue for several years, but they may take significantly longer

Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of,

the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but

not limited to:

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,

have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials.

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

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.

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

to drugs, which could adversely affect our future revenues and profitability

the extent our products are developed, commercialized, and successfully introduced to market, they may not be considered cost-effective

and third-party or government reimbursement might not be available or sufficient.

Globally, governmental and other third-party payors

are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing

and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect

pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S.

the U.S., we are subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance

programs and pharmacy benefit managers, and implementation of U.S.

health care reform legislation is increasing these pricing pressures.

The Affordable Care Act instituted

comprehensive health care reform, and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require

all individuals to have health insurance (with limited exceptions), and impose new and/or increased taxes.

The future of the Affordable

Care Act and its constituent parts are uncertain at this time.

In almost all markets, pricing

and choice of prescription pharmaceuticals are subject to governmental control.

Therefore, the price of our products and their reimbursement

in Europe and in other countries is and will be determined by national regulatory authorities.

Reimbursement decisions from one or more

of the European markets may impact reimbursement decisions in other European markets.

A variety of factors are considered in making reimbursement

decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments,

that the product represents good value for money for the health service it provides, and that treatment with the product works at least

as well as currently available treatments.

The continuing efforts of government

and insurance companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health

care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as well

as the availability of capital.

United States federal and state privacy laws,

and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions

HIPPA, and the regulations that

have been issued under it, and similar laws outside the United States, contains substantial restrictions and requirements with respect

to the use and disclosure of individuals’ protected health information.

The HIPAA privacy rules prohibit “covered entities,”

such as healthcare providers and health plans, from using or disclosing an individual’s protected health information, unless the

use or disclosure is authorized by the individual or is specifically required or permitted under the privacy rules.

Under the HIPAA security

rules, covered entities must establish administrative, physical and technical safeguards to protect the confidentiality, integrity and

availability of electronic protected health information maintained or transmitted by them or by others on their behalf.

While we do not

believe that we will be a covered entity under HIPAA, we believe many of our customers will be covered entities subject to HIPAA.

customers may require us to enter into business associate agreements, which will obligate us to safeguard certain health information we

obtain in the course of our relationship with them, restrict the manner in which we use and disclose such information and impose liability

on us for failure to meet our contractual obligations.

In addition, under HITECH, which

was signed into law as part of the U.S.

stimulus package in February 2009, certain of HIPAA’s privacy and security requirements

are now also directly applicable to “business associates” of covered entities and subject them to direct governmental enforcement

for failure to comply with these requirements.

We may be deemed as a “business associate” of some of our customers.

we may be subject as a “business associate” to civil and criminal penalties for failure to comply with applicable privacy

and security rule requirements.

Moreover, HITECH created a new requirement obligating “business associates” to report any

breach of unsecured, individually identifiable health information to their covered entity customers and imposes penalties for failing

In addition to HIPAA, most U.S.

states have enacted patient confidentiality laws that protect against the disclosure of confidential medical information, and many U.S.

states have adopted or are considering adopting further legislation in this area, including privacy safeguards, security standards, and

data security breach notification requirements.

state laws, which may be even more stringent than the HIPAA requirements, are

not supplanted by the federal requirements, and we are therefore required to comply with them to the extent they are applicable to our

These and other possible changes

to HIPAA or other U.S.

federal or state laws or regulations, or comparable laws and regulations in countries where we conduct business,

could affect our business and the costs of compliance could be significant.

Failure by us to comply with any of the standards regarding

patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including civil monetary penalties

and in some circumstances, criminal penalties.

In addition, such failure may damage our reputation and adversely affect our ability to

retain customers and attract new customers.

The protection of personal

data, particularly patient data, is subject to strict laws and regulations in many countries.

The collection and use of personal health

data in the E.U.

is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995

on the protection of individuals with regard to the processing of personal data and on the free movement of such data (the “ Data

Protection Directive ”).

The Data Protection Directive imposes a number of requirements, including an obligation to seek the

consent of individuals to whom the personal data relates, the information that must be provided to the individuals, notification of data

processing obligations to the competent national data protection authorities of individual E.U.

member states and the security and confidentiality

of the personal data.

The Data Protection Directive also imposes strict rules on the transfer of personal data out of the E.U.

Failure to comply with the requirements of the Data Protection Directive and the related national data protection laws of the E.U.

The Affordable Care Act instituted comprehensive health care reform, and includes provisions that, among other things, reduce and/or

limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions), and impose new and/or increased

The future of the Affordable Care Act and its constituent parts are uncertain at this time.

almost all markets, pricing and choice of prescription pharmaceuticals are subject to governmental control.

Therefore, the price of our

products and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities.

Reimbursement

decisions from one or more of the European markets may impact reimbursement decisions in other European markets.

A variety of factors

are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product

is more effective than current treatments, that the product represents good value for money for the health service it provides, and that

treatment with the product works at least as well as currently available treatments.

continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to

contain or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers,

and collaborative partners, as well as the availability of capital.

States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil

and criminal sanctions

and the regulations that have been issued under it, and similar laws outside the United States, contains substantial restrictions and

requirements with respect to the use and disclosure of individuals’ protected health information.

The HIPAA privacy rules prohibit

“covered entities,” such as healthcare providers and health plans, from using or disclosing an individual’s protected

health information, unless the use or disclosure is authorized by the individual or is specifically required or permitted under the privacy

Under the HIPAA security rules, covered entities must establish administrative, physical and technical safeguards to protect the

confidentiality, integrity and availability of electronic protected health information maintained or transmitted by them or by others

on their behalf.

While we do not believe that we will be a covered entity under HIPAA, we believe many of our customers will be covered

entities subject to HIPAA.

Such customers may require us to enter into business associate agreements, which will obligate us to safeguard

certain health information we obtain in the course of our relationship with them, restrict the manner in which we use and disclose such

information and impose liability on us for failure to meet our contractual obligations.

addition, under HITECH, which was signed into law as part of the U.S.

stimulus package in February 2009, certain of HIPAA’s privacy

and security requirements are now also directly applicable to “business associates” of covered entities and subject them

to direct governmental enforcement for failure to comply with these requirements.

We may be deemed as a “business associate”

of some of our customers.

As a result, we may be subject as a “business associate” to civil and criminal penalties for failure

to comply with applicable privacy and security rule requirements.

Moreover, HITECH created a new requirement obligating “business

associates” to report any breach of unsecured, individually identifiable health information to their covered entity customers and

imposes penalties for failing to do so.

addition to HIPAA, most U.S.

states have enacted patient confidentiality laws that protect against the disclosure of confidential medical

information, and many U.S.

states have adopted or are considering adopting further legislation in this area, including privacy safeguards,

security standards, and data security breach notification requirements.

state laws, which may be even more stringent than

the HIPAA requirements, are not supplanted by the federal requirements, and we are therefore required to comply with them to the extent

they are applicable to our operations.

and other possible changes to HIPAA or other U.S.

federal or state laws or regulations, or comparable laws and regulations in countries

where we conduct business, could affect our business and the costs of compliance could be significant.

Failure by us to comply with any

of the standards regarding patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including

civil monetary penalties and in some circumstances, criminal penalties.

In addition, such failure may damage our reputation and adversely

affect our ability to retain customers and attract new customers.

protection of personal data, particularly patient data, is subject to strict laws and regulations in many countries.

The collection and

use of personal health data in the E.U.

is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council

of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data

(the “Data Protection Directive”).

The Data Protection Directive imposes a number of requirements, including an obligation

to seek the consent of individuals to whom the personal data relates, the information that must be provided to the individuals, notification

of data processing obligations to the competent national data protection authorities of individual E.U.

member states and the security

and confidentiality of the personal data.

The Data Protection Directive also imposes strict rules on the transfer of personal data out

Failure to comply with the requirements of the Data Protection Directive and the related national data protection

laws of the E.U.

member states may result in fines and other administrative penalties and harm our business.

We may incur extensive costs in ensuring

compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning of the Data

Protection Directive.

If we fail to comply with the U.S.

federal Anti-Kickback

Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded

healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse

effect on our business and results of operations

A provision of the Social Security

Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer, payment, solicitation or receipt

of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing, purchasing

or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare,

Medicaid or any other federal healthcare program.

Although there are a number of statutory exemptions and regulatory safe harbors to the

federal Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions,

the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor may be subject

The federal Anti-Kickback Statute is very broad in scope and many of its provisions have not been uniformly or definitively

interpreted by existing case law or regulations.

In addition, most of the states have adopted laws similar to the federal Anti-Kickback

Statute, and some of these laws are even broader than the federal Anti-Kickback Statute in that their prohibitions may apply to items

or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the source of payment.

of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion

We may incur extensive costs

in ensuring compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning

of the Data Protection Directive.

we fail to comply with the U.S.

federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal

and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent

third country programs, which would have a material adverse effect on our business and results of operations

provision of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer,

payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring,

ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in

whole or in part, by Medicare, Medicaid or any other federal healthcare program.

Although there are a number of statutory exemptions

and regulatory safe harbors to the federal Anti-Kickback Statute protecting certain common business arrangements and activities from

prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within

an exemption or safe harbor may be subject to scrutiny.

The federal Anti-Kickback Statute is very broad in scope and many of its provisions

have not been uniformly or definitively interpreted by existing case law or regulations.

In addition, most of the states have adopted

laws similar to the federal Anti-Kickback Statute, and some of these laws are even broader than the federal Anti-Kickback Statute in

that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply

regardless of the source of payment.

Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative

penalties, damages, fines and exclusion from participation in federal healthcare programs.

of our future financial relationships with U.S.

healthcare providers, purchasers, formulary managers, and others who provide products

or services to federal healthcare program beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar

We believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws.

cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming

and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse

effect on our business.

In addition, if our arrangements were found to violate the federal Anti-Kickback Statute or similar state laws,

the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial

are other federal and state laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits,

among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment

of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to

pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to

pay money to the federal government.

Moreover, we may be subject to other federal false claim laws, including, among others, federal

criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs.

Moreover, there are analogous

Violations of these laws can result in substantial criminal, civil or administrative penalties, damages, fines and exclusion

from participation in federal healthcare programs.

All of our future financial relationships

healthcare providers, purchasers, formulary managers, and others who provide products or services to federal healthcare program

beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar state laws.

We believe our operations will

be in compliance with the federal Anti-Kickback Statute and similar state laws.

However, we cannot be certain that we will not be subject

to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s

attention from operating our business, which in turn could have a material adverse effect on our business.

In addition, if our arrangements

were found to violate the federal Anti-Kickback Statute or similar state laws, the consequences of such violations would likely have a

material adverse effect on our business, results of operations and financial condition.

There are other federal and state

laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits, among other things, individuals

or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly

making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly

concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.

we may be subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes

that extend to non-government health benefit programs.

Moreover, there are analogous state laws.

Violations of these laws can result in

substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

Moreover, the provisions of the

Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their

intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international

organizations with the intent to obtain or retain business or seek a business advantage.

Recently, there has been a substantial increase

in anti-bribery law enforcement activity by U.S.

regulators, with more aggressive and frequent investigations and enforcement by both

the SEC and the Department of Justice.

the provisions of the Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit

companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties,

or international organizations with the intent to obtain or retain business or seek a business advantage.

Recently, there has been a

substantial increase in anti-bribery law enforcement activity by U.S.

regulators, with more aggressive and frequent investigations and

enforcement by both the SEC and the Department of Justice.

A determination that our operations or activities violated U.S.

or foreign laws or regulations

could result in imposition of substantial fines, interruption of business, loss of supplier, vendor or other third-party relationships,

termination of necessary licenses and permits, and other legal or equitable sanctions.

In addition, lawsuits brought by private litigants

may also follow as a consequence.

In both domestic and foreign markets, the development,

formulation, manufacturing, packaging, labeling, handling, distribution, import, export, licensing, sale and storage of pharmaceuticals

and medical devices are affected by a body of laws, governmental regulations, administrative determinations, including those by Health

Canada and the FDA, court decisions and similar constraints.

Such laws, regulations and other

constraints can exist at the federal, provincial or local levels in Canada and at all levels of government in foreign jurisdictions.

can be no assurance that the Company and the Company’s partners are in compliance with all of these laws, regulations and other

The Company and its partners may be required to incur significant costs to comply with such laws and regulations in the future,

and such laws and regulations may have an adverse effect on the business.

The failure of the Company or its partners to comply with current

or future regulatory requirements could lead to the imposition of significant penalties or claims and may have a material adverse effect

on the business.

In addition, the adoption of new laws, regulations or other constraints or changes in the interpretations of such requirements

might result in significant compliance costs or lead the Company and its partners to discontinue product development and could have an

adverse effect on the business.

The Company’s international operations expose

it and its representatives, agents and distributors to risks inherent to operating in foreign jurisdictions that could materially adversely

affect its operations and financial position.

These 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.

Moreover, applicable agreements relating to business

in foreign jurisdictions are governed by foreign laws and are subject to dispute resolution in the courts of, or through arbitration proceedings

in, the country or region in which the parties are located or another jurisdiction agreed upon by the parties.

The Company cannot accurately

predict whether such jurisdictions will provide an effective and efficient means of resolving disputes that may arise in the future.

if it obtains a satisfactory decision through arbitration or a court proceeding, the Company could have difficulty in enforcing any award

or judgment on a timely basis or at all.

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, TSX Exchange or Nasdaq could delist our common shares

In order to maintain the listing of our common shares

on the TSX Exchange 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

Future issuance of our common shares could dilute the interests of

existing shareholders

We may issue additional common

shares in the future.

The issuance of a substantial number of common shares could have the effect of substantially diluting the interests

of our shareholders.

In addition, the sale of a substantial amount of common shares in the public market, in the initial issuance, in

a situation in which we acquire a company and the acquired company receives common shares as consideration and the acquired company subsequently

sells its common shares, or by investors who acquired such common shares in a private placement, could have an adverse effect on the market

laws or regulations could result in imposition of substantial fines, interruption of business, loss of supplier, vendor or other third-party

relationships, termination of necessary licenses and permits, and other legal or equitable sanctions.

In addition, lawsuits brought by

private litigants may also follow as a consequence.

both domestic and foreign markets, the development, formulation, manufacturing, packaging, labeling, handling, distribution, import,

export, licensing, sale and storage of pharmaceuticals and medical devices are affected by a body of laws, governmental regulations,

administrative determinations, including those by Health Canada and the FDA, court decisions and similar constraints.

laws, regulations and other constraints can exist at the federal, provincial or local levels in Canada and at all levels of government

in foreign jurisdictions.

There can be no assurance that the Company and the Company’s partners are in compliance with all of these

laws, regulations and other constraints.

The Company and its partners may be required to incur significant costs to comply with such

laws and regulations in the future, and such laws and regulations may have an adverse effect on the business.

The failure of the Company

or its partners to comply with current or future regulatory requirements could lead to the imposition of significant penalties or claims

and may have a material adverse effect on the business.

In addition, the adoption of new laws, regulations or other constraints or changes

in the interpretations of such requirements might result in significant compliance costs or lead the Company and its partners to discontinue

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

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

foreign jurisdictions that could materially adversely affect its operations and financial position.

risks include:

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

in the courts of, or through arbitration proceedings in, the country or region in which the parties are located or another jurisdiction

agreed upon by the parties.

The Company cannot accurately predict whether such jurisdictions will provide an effective and efficient

means of resolving disputes that may arise in the future.

Even if it obtains a satisfactory decision through arbitration or a court proceeding,

the Company could have difficulty in enforcing any award or judgment on a timely basis or at all.

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

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.

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

may issue additional common shares in the future.

The issuance of a substantial number of common shares could have the effect of substantially

diluting the interests of our shareholders.

In addition, the sale of a substantial amount of common shares in the public market, in the

initial issuance, in a situation in which we acquire a company and the acquired company receives common shares as consideration and the

acquired company subsequently sells its common shares, or by investors who acquired such common shares in a private placement, could

have an adverse effect on the market price of our common shares.

Short sellers may be manipulative and may

drive down the market price of our common shares

selling is the practice of selling securities that the seller does not own, but rather has borrowed or intends to borrow from a third

party with the intention of buying identical securities at a later date to return to the lender.

A short seller hopes to

profit from a decline in the value of the securities between the sale of the borrowed securities and the purchase of the replacement shares,

as the short seller expects to pay less in that purchase than it received in the sale.

It is therefore in the short seller’s

interest for the price of the stock to decline, and some short sellers publish, or arrange for the publication of, opinions or characterizations

regarding the relevant issuer, often involving misrepresentations of the issuer’s business prospects and similar matters calculated

to create negative market momentum, which may permit them to obtain profits for themselves as a result of selling the stock short.

As a public entity, we may be the subject

of concerted efforts by short sellers to spread negative information in order to gain a market advantage.

In addition, the publication

of misinformation may also result in lawsuits, the uncertainty and expense of which could adversely impact our reputation, business, financial

condition, and operating results.

There are no assurances that we will not face short sellers’ efforts or similar tactics in the

future, and the market price of our common shares may decline as a result of their actions.

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

of October 25, 2023, we had outstanding restricted share units, options and warrants to purchase 10,314,012 common shares,

respectively.

The holders of these restricted share units, options and warrants are given the opportunity to profit from a rise in

the market price of our common shares.

We may find it more difficult to raise additional equity capital while these options and

warrants are outstanding.

At any time during which these warrants are likely to be exercised, we may be unable to obtain additional

equity capital on more favorable terms from other sources.

Additionally, the exercise of these options and warrants will cause the

increase of our outstanding Common shares, which could have the effect of substantially diluting the interests of our current

shareholders.

of a substantial number of our common shares in the public market by our existing shareholders could cause our share price to fall

of a substantial number of our common shares in the public market, or the perception that these sales might occur, could depress the

market price of our common shares and could impair our ability to raise capital through the sale of additional equity securities.

are unable to predict the effect that sales may have on the prevailing market price of our common shares.

As of October 25, 2023, we

have 10,314,012 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.

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

Jumpstart Our Business Start-ups Act (the “JOBS Act”), and our status as a foreign private issuer will allow us to postpone

the date by which we must comply with some of the laws and regulations intended to protect investors and to reduce the amount of information

we provide in our reports filed with the SEC, which could undermine investor confidence in our company and adversely affect the market

price of our Common shares.

We have a significant number of 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 27, 2022

we had outstanding options and warrants to purchase 9,674,638 common shares, respectively.

The holders of these options and warrants

are given the opportunity to profit from a rise in the market price of our common shares.

We may find it more difficult to raise

additional equity capital while these options and warrants are outstanding.

At any time during which these warrants are likely to be

exercised, we may be unable to obtain additional equity capital on more favorable terms from other sources.

Additionally, the

exercise of these options and warrants will cause the increase of our outstanding Common shares, which could have the effect of

substantially diluting the interests of our current shareholders.

Sales of a substantial number of our common

shares in the public market by our existing shareholders could cause our share price to fall

Sales of a substantial number

of our common shares in the public market, or the perception that these sales might occur, could depress the market price of our common

shares and could impair our ability to raise capital through the sale of additional equity securities.

We are unable to predict the effect

that sales may have on the prevailing market price of our common shares.

As of October 27, 2022 we have 8,184,338 shares issuable upon

exercise of outstanding 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

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.

We are an Emerging Growth Company, which may

reduce the amount of information available to investors

The Jumpstart Our Business Start-ups

Act (the “ JOBS Act ”), and our status as a foreign private issuer will allow us to postpone the date by which we must

comply with some of the laws and regulations intended to protect investors and to reduce the amount of information we provide in our reports

filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our Common shares.

For as long as we remain an “emerging

growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions 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.

We 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 US$1.07 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 US$700 million as of the prior June 30;

and (2) the date on which we have

issued more than US$1.0 billion in non-convertible debt during the prior three-year period.

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.

We have never paid cash dividends on our capital

stock and we do not anticipate paying any dividends in the foreseeable future.

Consequently, any gains from an investment in our common

shares will likely depend on whether the price of our Common shares increases, which may not occur

We have not paid cash dividends

on any capital stock to date and we currently intend to retain our future earnings, if any, to fund the development and growth of our

Consequently, in the foreseeable future, you will likely only experience a gain from your investment in our Common shares if

the price of our Common shares increases beyond the price in which you originally acquired the Common shares.

In the event a market develops for our common

shares or Warrants, the market price of our common shares or Warrants may be volatile

In the event a market develops

for our common shares or Warrants, the market price of our common shares or Warrants may be highly volatile.

Some of the factors that

may materially affect the market price of our common shares or Warrants are beyond our control, such as changes in financial estimates

by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our common shares or Warrants.

These factors may materially adversely affect the market price of our common shares or Warrants, regardless of our performance.

the public stock markets have experienced extreme price and trading volume volatility.

This volatility has significantly affected the

market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specific companies.

as long as we remain an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions

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

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 US$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 US$700 million as of the

prior June 30;

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

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.

have never paid cash dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future.

Consequently,

any gains from an investment in our common shares will likely depend on whether the price of our Common shares increases, which may not

have not paid cash dividends on any capital stock to date and we currently intend to retain our future earnings, if any, to fund the

development and growth of our business.

Consequently, in the foreseeable future, you will likely only experience a gain from your investment

in our common shares if the price of our common shares increases beyond the price in which you originally acquired the common shares.

the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be volatile

the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be highly volatile.

Some of the factors that may materially affect the market price of our common shares or Warrants are beyond our control, such as changes

in financial estimates by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our

common shares or Warrants.

These factors may materially adversely affect the market price of our common shares or Warrants, regardless

of our performance.

In addition, the public stock markets have experienced extreme price and trading volume volatility.

This volatility

has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating performance

of the specific companies.

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

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 19.14% 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.

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.

If we are or become classified as a passive

foreign investment company, our U.S.

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.

shareholders may suffer adverse tax consequences as a result

Generally, for any taxable year,

if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce

passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment

company (“ PFIC ”) for U.S.

for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable

to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as

a passive foreign investment company (“PFIC”) for U.S.

federal income tax purposes.

For purposes of these tests, passive income includes dividends,

interest gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce

passive income (including amounts derived by reason of the temporary investment of funds raised in offerings of our shares) and rents

and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade

For purposes of these tests, passive

income includes dividends, interest gains from commodities and securities transactions, the excess of gains over losses from the disposition

of assets which produce passive income (including amounts derived by reason of the temporary investment of funds raised in offerings

of our shares) and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the

active conduct of a trade or business.

If we are characterized as a PFIC, our U.S.

shareholders may suffer adverse tax consequences, including having gains realized

on the sale of our common shares treated as ordinary income, rather than capital gains, the loss of the preferential rate applicable to

dividends received on our common shares by individuals who are U.S.

holders, and having interest charges apply to distributions by us

and gains from the sales of our shares.

Our status as a PFIC will depend

on the nature and composition of our income and the nature, composition and value of our assets.

Asset value is based on which the fair

market value of each asset, including goodwill and going concern value (which may be determined by reference to the market value of our

common shares, which may be volatile).

Our status will also depend, in part, on when and how we utilize the cash proceeds from any securities

offerings our business.

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, 2022 and possibly for succeeding years.

even if we are classified as a PFIC for the year ending July 31, 2022, 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.

(See the discussion of PFIC

status under “Taxation, U.S.

shareholders may suffer adverse tax consequences,

including having gains realized on the sale of our common shares treated as ordinary income, rather than capital gains, the loss of the

preferential rate applicable to dividends received on our common shares by individuals who are U.S.

holders, and having interest charges

apply to distributions by us and gains from the sales of our shares.

status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets.

is based on which the fair market value of each asset, including goodwill and going concern value (which may be determined by reference

to the market value of our common shares, which may be volatile).

Our status will also depend, in part, on when and how we utilize the

cash proceeds from any securities offerings our business.

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, 2023,

and possibly for succeeding years.

However, even if we are classified as a PFIC for the year ending July 31, 2023, 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.

(See the discussion of PFIC status under “Taxation, U.S.

Federal Income Taxation”, below.

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.

The tax consequences that would

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

shareholder were able to make a valid

qualified electing fund (“ QEF ”) election.

If we are classified as a PFIC, then we expect to provide U.S.

with the information necessary for a U.S.

shareholder to make a QEF election but there is no assurance that we will do so.

See the discussion

of PFIC status under “ Taxation , U.S.

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.

were able to make a valid qualified electing fund (“QEF”) election.

If we are classified as a PFIC, then we expect to provide

shareholders with the information necessary for a U.S.

shareholder to make a QEF election but there is no assurance that we will

See the discussion of PFIC status under “Taxation, U.S.

Federal Income Taxation”, below.

If estimates of revenue, expenses, or capital or

liquidity requirements change or are inaccurate, or if cash generated from operations is insufficient to satisfy liquidity requirements,

the Company may arrange additional financings

BriaCell expects that its current

cash and cash equivalent reserves will be sufficient to meet its anticipated needs for working capital and capital expenditures for the

In the future, the Company may also arrange financings to give it the financial flexibility to pursue attractive acquisition

or investment opportunities that may arise.

The Company may pursue additional financing through various means, including equity investments,

issuances of debt, joint venture projects, licensing arrangements or through other means.

The Company cannot be certain that it will be

able to obtain additional financing on commercially reasonable terms or at all.

The Company’s ability to obtain additional financing

may be impaired by such factors as the status of capital markets, both generally and specifically in the pharmaceutical and medical device

industries, and by the fact that it is a new enterprise without a proven operating history.

If the amount of capital raised from additional

financing activities, together with revenues from operations (if any), is not sufficient to satisfy the Company’s capital needs,

it may not be able to develop or advance its products, execute its business and growth plans, take advantage of future opportunities,

or respond to competitive pressures or unanticipated customer or partner requirements.

If any of these events occur, the Company’s

business, financial condition, and results of operations could be adversely affected.

Any future equity financings undertaken are likely

to be dilutive to existing shareholders.

Finally, the terms of securities issued in future capital transactions may include preferences

that are more favourable to new investors.

If securities or industry analysts do not publish

or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish

negative reports regarding our business or our shares, our share price and trading volume could decline

The trading market for our securities

will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or

our competitors.

We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide

favorable coverage.

If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more

favorable relative recommendations about our competitors, the market value of our securities would likely decline.

If any analyst who

may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial

markets, which in turn could cause the price of our common shares and Warrants and our trading volume to decline.

Certain Canadian legislation

contains provisions that may have the effect of delaying or preventing a change in control

estimates of revenue, expenses, or capital or liquidity requirements change or are inaccurate, or if cash generated from operations is

insufficient to satisfy liquidity requirements, the Company may arrange additional financings

expects that its current cash and cash equivalent reserves will be sufficient to meet its anticipated needs for working capital and capital

expenditures for the near future.

In the future, the Company may also arrange financings to give it the financial flexibility to pursue

attractive acquisition or investment opportunities that may arise.

The Company may pursue additional financing through various means,

including equity investments, issuances of debt, joint venture projects, licensing arrangements or through other means.

The Company cannot

be certain that it will be able to obtain additional financing on commercially reasonable terms or at all.

The Company’s ability

to obtain additional financing may be impaired by such factors as the status of capital markets, both generally and specifically in the

pharmaceutical and medical device industries, and by the fact that it is a new enterprise without a proven operating history.

amount of capital raised from additional financing activities, together with revenues from operations (if any), is not sufficient to

satisfy the Company’s capital needs, it may not be able to develop or advance its products, execute its business and growth plans,

take advantage of future opportunities, or respond to competitive pressures or unanticipated customer or partner requirements.

of these events occur, the Company’s business, financial condition, and results of operations could be adversely affected.

future equity financings undertaken are likely to be dilutive to existing shareholders.

Finally, the terms of securities issued in future

capital transactions may include preferences that are more favourable to new investors.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they

adversely change their recommendations or publish negative reports regarding our business or our shares, our share price and trading

volume could decline

trading market for our securities will be influenced by the research and reports that industry or securities analysts may publish about

us, our business, our market or our competitors.

We do not have any control over these analysts and we cannot provide any assurance that

analysts will cover us or provide favorable coverage.

If any of the analysts who may cover us adversely change their recommendation regarding

our shares, or provide more favorable relative recommendations about our competitors, the market value of our securities would likely

If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose

visibility in the financial markets, which in turn could cause the price of our common shares and Warrants and our trading volume to

Canadian legislation contains provisions that may have the effect of delaying or preventing a change in control

legislation could discourage potential acquisition proposals, delay or prevent a change in control and limit the price that certain investors

3 unchanged sentences

within the meaning of the Investment Canada Act, where prescribed financial thresholds are exceeded.

Furthermore, limitations on the ability

to acquire and hold our subordinate voting shares and multiple voting shares may be imposed by the Competition Act (Canada).

This legislation

permits the Commissioner of Competition to review any acquisition or establishment, directly or indirectly, including through the acquisition

of shares, of control over or of a significant interest in us.

Otherwise, there are no limitations either under the laws of Canada or

British Columbia, or in our articles on the rights of non-Canadians to hold or vote our subordinate voting shares and multiple voting

Any of these provisions may discourage a potential acquirer from proposing or completing a transaction that may have otherwise

presented a premium to our shareholders.

Because we are a corporation

incorporated in British Columbia and some of our directors and officers are resident in Canada or other countries, it may be difficult

for investors in the United States to enforce civil liabilities against us based solely upon the federal securities laws of the United

Similarly, it may be difficult for Canadian investors to enforce civil liabilities against our directors and officers residing

outside of Canada

a corporation incorporated under the laws of British Columbia with our principal place of business in West Vancouver.

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.

Furthermore, limitations on the

ability to acquire and hold our subordinate voting shares and multiple voting shares may be imposed by the Competition Act (Canada).

This legislation permits the Commissioner of Competition to review any acquisition or establishment, directly or indirectly, including

through the acquisition of shares, of control over or of a significant interest in us.

Otherwise, there are no limitations either under

the laws of Canada or British Columbia, or in our articles on the rights of non-Canadians to hold or vote our subordinate voting shares

and multiple voting shares.

Any of these provisions may discourage a potential acquirer from proposing or completing a transaction that

may have otherwise presented a premium to our shareholders.

we are a corporation incorporated in British Columbia and some of our directors and officers are resident in Canada or other countries,

it may be difficult for investors in the United States to enforce civil liabilities against us based solely upon the federal securities

laws of the United States.

Similarly, it may be difficult for Canadian investors to enforce civil liabilities against our directors and

officers residing outside of Canada

are a corporation incorporated under the laws of British Columbia with our principal place of business 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.

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 Act.

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 the U.S.

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

Similarly, some of our directors

and officers are residents of countries other than Canada and all or a substantial portion of the assets of such persons are located outside

As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against these non-Canadian residents.

In addition, it may not be possible for Canadian investors to collect from these non-Canadian residents judgments obtained in courts in

Canada predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada.

may also be difficult for Canadian investors to succeed in a lawsuit in the United States, based solely on violations of Canadian securities

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

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

some of our directors and officers are residents of countries other than Canada and all or a substantial portion of the assets of such

persons are located outside Canada.

As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against

these non-Canadian residents.

In addition, it may not be possible for Canadian investors to collect from these non-Canadian residents

judgments obtained in courts in Canada predicated on the civil liability provisions of securities legislation of certain of the provinces

and territories of Canada.

It may also be difficult for Canadian investors to succeed in a lawsuit in the United States, based solely

on violations of Canadian securities laws.

UNRESOLVED STAFF COMMENTS

of September 2023, the Company commenced a month-to-month lease arrangement for office and lab space in Philadelphia, Pennsylvania, in the

amount of approximately $36,000 per month.

LEGAL PROCEEDINGS

may be involved from time to time in ordinary litigation, negotiation, and settlement matters that will not have a material effect on

our operations or finances.

MINE SAFETY DISCLOSURES

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors