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Item 7. Management’s Discussion and Analysis

2024-10-29 compared with 2023-10-25 · 172 added, 110 removed, 57 unchanged (83% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in

this Annual Report.

This discussion and other parts of this Annual Report contain forward-looking statements based upon current expectations

that involve risks and uncertainties.

Our actual results and the timing of selected events could differ materially from those anticipated

in these forward-looking statements as a result of several factors, including those set forth under “ Risk Factors ”

and elsewhere in this Annual Report.

preparation of financial statements in conformity with these accounting principles requires us to make estimates and assumptions that

affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial statement date and reported

amounts of revenue and expenses during the reporting period.

On an on-going basis, we review our estimates and assumptions.

The estimates

were based on historical experience and other assumptions that we believe to be reasonable under the circumstances.

Actual results are

likely to differ from those estimates or other forward-looking statements under different assumptions or conditions, but we do not believe

such differences will materially affect our financial position or results of operations.

Our actual results may differ materially as

a result of many factors, including those set forth under the headings entitled “ Special Note Regarding Forward-Looking Statements ”

and “ Risk Factors ”.

BriaCell Therapeutics Corp.

(the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies

to transform cancer care.

Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own

immune system to recognize and destroy cancer cells.

The Company is currently advancing its Bria-IMT™ targeted immunotherapy in

combination with an immune check point inhibitor in a pivotal1 Phase 3 study in advanced metastatic breast cancer.

BriaCell recently reported

benchmark-beating patient survival and clinical benefit in advanced metastatic breast with median overall survival of 13.5 months in BriaCell’s

advanced metastatic breast cancer patients vs.

6.7-9.8 months for similar patients reported in the literature2.

A completed Bria-IMT™

Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy.

BriaCell is also developing a personalized off-the-shelf immunotherapy, Bria-OTS™, which provides a platform technology to develop

personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator

of the immune system as well as an immune checkpoint inhibitor.

following discussion and analysis should be read in conjunction with our consolidated financial statements and related notes

included elsewhere in this Annual Report.

This discussion and other parts of this Annual Report contain forward-looking statements

based upon current expectations that involve risks and uncertainties.

Our actual results and the timing of selected events could

differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set

forth under “ Risk Factors ” and elsewhere in this Annual Report.

preparation of our consolidated financial statements in conformity with these accounting principles requires us to make estimates

and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial

statement date and reported amounts of revenue and expenses during the reporting period.

On an on-going basis, we review our

estimates and assumptions.

The estimates were based on historical experience and other assumptions that we believe to be reasonable

under the circumstances.

Actual results are likely to differ from those estimates or other forward-looking statements under

different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results

of operations.

Our actual results may differ materially as a result of many factors, including those set forth under the headings

entitled “ Special Note Regarding Forward-Looking Statements ” and “ Risk Factors ”.

is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care.

Immunotherapies have come

to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells.

The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab)

in a pivotal Phase 3 study in metastatic breast cancer.

Bria-IMT™ is currently under Fast Track Designation by the U.S.

Drug Administration(the “FDA”) intended to accelerate the review process of novel treatments that address unmet medical needs.

Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint

inhibitor combination in metastatic breast cancer.

BriaCell reported benchmark-beating patient survival and clinical benefit in metastatic

breast cancer with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer patients vs.

6.7-9.8 months for

similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at the 2023 San

Antonio Breast Cancer Symposium.

A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured

by Incyte) confirmed tolerability and early-stage efficacy.

BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS™

and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of

cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.

Accounting Policies and Estimates

Critical Estimates and Judgements

preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported

amounts of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period.

preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the

reported amounts of assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses

during the reporting period.

Actual outcomes could differ from these estimates.

The financial statements include estimates which, by their nature, are uncertain.

The impacts of such estimates are pervasive throughout the financial statements, and may require accounting adjustments based on future

Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods

when the revision affects both current and future periods.

The financial statements include estimates which, by

their nature, are uncertain.

The impacts of such estimates are pervasive throughout the financial statements, and may require

accounting adjustments based on future occurrences.

Revisions to accounting estimates are recognized in the period in which the

estimate is revised and also in future periods when the revision affects both current and future periods.

critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized

in the consolidated financial statements are:

of the consolidated financial statement on a going concern basis, which contemplates the realization of assets and payments of liabilities

in the ordinary course of business.

Should the Company be unable to continue as a going concern, it may be unable to realize the carrying

value of its assets, including its intangible assets and to meet its liabilities as they become due.

Company uses the Black-Scholes option-pricing model to estimate the fair value of options at the grant date, and the warrant liability

at the grant date and each reporting period date.

The key assumptions used in the model are the expected future volatility in the price

of the Company’s shares and the expected life of the warrants.

Company accounts for income taxes in accordance with Accounting Standard Codification 740, Income Taxes (“FASB ASC 740”),

on a tax jurisdictional basis.

The Company files income tax returns in the United States.

tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the tax bases of

assets and liabilities and the consolidated financial statements reported amounts using enacted tax rates and laws in effect in the year

in which the differences are expected to reverse.

A valuation allowance is provided against deferred tax assets when it is determined

to be more likely than not that the deferred tax asset will not be realized.

for Income Taxes.

Management accounts for income taxes by estimating future tax effects of temporary differences between the tax and

book basis of assets and liabilities considering the provisions of enacted tax laws.

The application of income tax law is inherently

Laws and regulations in this area are voluminous and are often ambiguous.

As such, management is required to make many subjective

assumptions and judgments regarding the Corporation’s income tax exposures, including judgments in determining the amount and timing

of recognition of the resulting deferred tax assets and liabilities, including projections of future taxable income.

Interpretations

of and guidance surrounding income tax laws and regulations change over time.

As such, changes in management’s subjective assumptions

and judgments can materially affect amounts recognized in the Consolidated balance sheet and Consolidated Statements of Operations and

Comprehensive Loss

assets are tested for impairment annually or more frequently if there is an indication of impairment.

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is impaired and impairment loss is recognized.

Company uses the Black-Scholes option-pricing model to estimate fair value of options and the warrant liability at each reporting

The key assumptions used in the model are the expected future volatility in the price of the Company’s shares and the

expected life of the warrants.

Preparation of the consolidated

financial statement on a going concern basis, which contemplates the realization of assets and payments of liabilities in the ordinary

course of business.

Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of

its assets, including its intangible assets and to meet its liabilities as they become due

for taxes are made using the best estimate of the amount expected to be paid based on a qualitative assessment of all relevant factors.

The Company reviews the adequacy of these provisions at the end of the reporting period.

However, it is possible that at some future

date an additional liability could result from audits by taxing authorities.

Where the final outcome of these tax-related matters

is different from the amounts that were initially recorded, such differences will affect the tax provisions in the period in which

such determination is made.

Company has prepaid certain expenses in respect of its pivotal phase III trial and estimates the period over which such expenses will

As of July 31, 2024, the Company revised its estimate of the time to completion in respect of this trial.

Amounts estimated

to be expenses in more than 12 months have been classified to long-term prepaid expenses.

useful life of property and equipment

and equipment are depreciated over their useful lives.

Useful lives are based on management’s estimates of the period that the

assets will be used which are periodically reviewed for continued appropriateness.

Changes to estimates can result in significant variations

in the amounts charged to the consolidated statement of operations and comprehensive loss in specific periods.

equity method

in entities over which the Company does not have a controlling financial interest but has significant influence are accounted for using

the equity method, with the Company’s share of losses reported in the loss from equity method investments on the statements of

operation and comprehensive loss.

The Company has a 51.2% interest in BC Therapeutics.

Management evaluates whether it has control over

the investee in accordance with the guidance of ASC 810, which requires judgment to assess factors such as power over significant activities

of the investee, exposure to variable returns, and the ability to affect those returns.

Based on this evaluation, management determines

whether control or significant influence is present for accounting purposes.

New Accounting Policies Adopted

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Chemical, Manufacturing and Control Costs (“CMC Costs”)

clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial.

Clinical trial expenses

increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase 1/2a clinical trial.

Clinical trial

expenses increased in 2024 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.

a longer than expected overall

Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the

pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in

preparation for the upcoming clinical studies of Bria-OTS™.

clinical trial expenses are broken down as follows:

Year ended July 31,

Bria-IMT™ Pivotal Phase 3 study

Bria-IMT™ Phase 1/2a

Indirect research and development expenses allocated to trials

the year ended July 31, 2024 we pivoted from our Bria-IMT™ Phase 1/2a study to the Bria-IMT™ Pivotal Phase 3 Study.

projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.

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pre-clinical program (sCD80).

Towards the end of 2024 the financial year end, we have slowed these programs in order to direct more attention

and resources to our clinical trials.

costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational

CMC costs increased in 2023 to support the additional patients in our trials.

CMC costs decreased in 2024;

this reduction can be attributed to efficiencies gained in the manufacturing process and

a streamlined approach to quality control.

costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory

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rose from $9,611,630 in 2023 to $20,890,266 in 2024.

Laboratory costs also increased due to the hiring of additional employees and higher

supplies, growing from $138,354 to $194,880 and $309,992 to $579,169, respectively.

Additionally, non-cash share-based compensation expenses

rose from $435,563 in 2022 to $1,072,592 in 2023, contributing to the overall increase in research and development expenses.

Wages and salaries increased from $3,878,367 to $4,567,307, reflecting the hiring

of additional employees.

Additionally, non-cash share-based compensation expenses decreased from $1,072,592 in 2023 to $734,986 in 2024,

offsetting some of the overall increase in research and development expenses.

and Administrative Expenses

For the year ended July 31, 2023, general and administrative expenses amounted

to $7,935,626 as compared to $7,267,452 for the year ended July 31, 2022 The increase in general and administrative expenses primarily

stems from higher insurance premiums, professional fees, and salaries, offset by a decrease in share-based compensation expenses.

the year ended July 31, 2024, general and administrative expenses amounted to $6,152,269 as compared to $7,935,626 for the year ended

July 31, 2023.

The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional fees and

share-based compensation expenses.

The Company has reduced general and administrative expenses in order to devote more resources to its

clinical program.

income (expenses), net

For the year ended July 31, 2023, financial income, net amounted to $2,969,870

as compared to financial loss $11,549,962 for the year ended July 31, 2022.

Financial income (expenses) comprises, primarily, changes in

the fair value of the warrant liability and interest earned on our treasury.

For the year ended July 31, 2023, the value of the warrant

liability decreased by $2,119,530.

The decrease was primarily due to the decrease in the share price at period end.

For the year ended

July 31, 2022, there was an increase in the value of the liability of $11,658,372 due to the increased share price at the period end.

Interest income for the year ended July 31, 2023 was $891,213 as compared to $136,731 for the year ended July 31, 2022.

The increase in

2023 is attributable to higher interest rates in North America.

the year ended July 31, 2024, financial income, net amounted to $262,566, compared to $850,340 for the year ended July 31, 2023.

income for 2024 primarily consists of interest income of $288,018, offset by a foreign exchange loss of $25,450.

In comparison, for the

year ended July 31, 2023, interest income was $891,213, while foreign exchange losses totaled $40,873.

The decrease in financial income

from 2023 to 2024 reflects lower interest income due to reduced cash and cash equivalents available for investment in interest-bearing

for the period

The Company reported a loss for the year ended July 31, 2023, of $20,302,394

as compared to $26,838,903 for the year ended July 31, 2022.

The loss in 2023 primarily stems from a substantial increase in operational

spending, offset by a gain in from a decrease in the fair value of the warrant liability.

Conversely, the higher loss in the prior period

can be attributed to a larger increase in the fair value of the warrant liability.

These factors account for the variance in the reported

losses between the two periods, highlighting the impact of changes in warrant valuation and operational spending on the Company’s

financial performance.

Company reported a loss for the year ended July 31, 2024, of $4,791,466, compared to $20,302,394 for the year ended July 31, 2023.

loss in 2024 primarily stems from increased operational spending, particularly in research and development.

However, the decrease in

the fair value of the warrant liability substantially offset the increase in research and development expenses, leading to a significantly

lower reported loss for the year.

In contrast, the larger loss in 2023 is attributed to lower operational costs but a smaller decrease

in the warrant liability, which did not offset expenses to the same extent as in 2024.

This highlights the significant role the warrant

liability valuation plays in influencing the Company’s overall financial performance.

and Capital Resources

of July 31, 2023, the Company has a working capital of 25,147,050 (July 31, 2022 – $41,405,613) and an accumulated deficit of $80,652,231 (July

31, 2022 - $60,349,837).

of July 31, 2023, the Company’s capital resources consist primarily of cash and cash equivalents, comprised mostly of cash on

deposit with banks, investments in money market funds, investments in U.S.

of July 31, 2024, the Company has a negative working capital of ($3,807,303) (July 31, 2023- $25,147,050) and an accumulated deficit of

$85,443,697 (July 31, 2023 - $80,652,231).

of July 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprised mostly of cash on deposit

with banks, investments in money market funds, investments in U.S.

government securities, U.S.

government agency securities,

and investment grade corporate debt securities.

Our investment policy and strategy are focused on preservation of capital and supporting

our liquidity requirements.

government agency securities, and investment

grade corporate debt securities.

Our investment policy and strategy are focused on preservation of capital and supporting our liquidity

requirements.

Historically,

the Company has financed its operation through private and public placement of equity securities, as well as debt financing.

Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its

The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business

plan objectives.

Management believes that it can be successful in obtaining additional capital;

The Company’s

ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control.

The Company intends

to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives.

Management believes

that it can be successful in obtaining additional capital;

however, there can be no assurance that the Company will be able to do so.

There is no assurance that any funds raised will be sufficient to enable the

Company to attain profitable operations or continue as a going concern.

To the extent that the Company is unsuccessful, the Company

may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional

capital is raised to support further operations.

There can be no assurance that such a plan will be successful.

the year ended July 31, 2023, the Company’s overall position of cash and cash equivalents decreased by $19,790,560 from the year ended

July 31, 2022 (including effects of foreign exchange).

There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a

going concern.

To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement

a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations.

no assurance that such a plan will be successful.

To this end, for several months during calendar year 2024, certain directors

and officers agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these

fees were paid in full.

Further, certain officers have indicated their willingness to receive a portion of their compensation

in shares of the Company, subject to applicable Nasdaq rules.

In addition, we continue to reduce expenditure on certain non-core

activities whilst maintaining our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.

the year ended July 31, 2024, the Company’s overall position of cash and cash equivalents decreased by $20,389,003 from the year

ended July 31, 2023 (including effects of foreign exchange).

This decrease in cash can be attributed to the following:

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for the year ended July 31, 2023.

gained in financing activities for the year ended July 31, 2023, was $3,954,300, as compared to a loss of $3,742,657 for the year

ended July 31, 2022.

Although the operating loss was higher during the period ended July 31, 2024, this was offset by an

increase in accounts payable, such that the cash flows from operating activities during both periods were similar.

generated from financing activities for the year ended July 31, 2024, was $4,418,926, as compared to $3,954,300 for the year ended July

In both periods, this relates to proceeds for the issuance of shares.

Sheet Arrangements

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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 7. Management’s Discussion and Analysis