What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-06-14 compared with 2023-03-16 · 247 added, 275 removed, 192 unchanged (73% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

References to the “Company,” “our,”

“us” or “we” refer to BriaCell Therapeutics Corp.

The following discussion and analysis of the Company’s

financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements

and the notes thereto contained elsewhere in this report.

Certain information contained in the discussion and analysis set forth below

includes forward-looking statements that involve risks and uncertainties.

This Management’s Discussion

and Analysis (“MD&A”) should be read together with other information, including our unaudited condensed interim consolidated

financial statements and the related notes to those statements included in Part I, Item 1 of this Quarterly Report (the “Condensed

Consolidated Financial Statements”), our consolidated financial statements appearing in our Annual Report on Form 10-K for the year

ended July 31, 2022 (the “Annual Report”) and Part I, Item 1A, Risk Factors, of the Annual Report.

This MD&A provides

additional information on our business, recent developments, financial condition, cash flows and results of operations, and is organized

to the “Company,” “our,” “us” or “we” refer to BriaCell Therapeutics Corp.

The following

discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited

condensed consolidated financial statements and the notes thereto contained elsewhere in this report.

Certain information contained in

the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.

Management’s Discussion and Analysis (“MD&A”) should be read together with other information, including our unaudited

condensed interim consolidated financial statements and the related notes to those statements included in Part I, Item 1 of this Quarterly

Report (the “Condensed Consolidated Financial Statements”), our consolidated financial statements appearing in our Annual

Report on Form 10-K for the year ended July 31, 2022 (the “Annual Report”), and Part I, Item 1A, Risk Factors, of the Annual

This MD&A provides additional information on our business, recent developments, financial condition, cash flows and results

of operations, and is organized as follows:

1 - Business Overview.

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Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q includes forward-looking

statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act.

We have based

these forward-looking statements on our current expectations and projections about future events.

These forward-looking statements are

subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance

or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied

by such forward-looking statements.

In some cases, you can identify forward-looking statements by terminology such as “may,”

“should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,”

“estimate,” “continue,” or the negative of such terms or other similar expressions.

Factors that might cause or

contribute to such a discrepancy include, but are not limited to, those described in our other SEC filings.

BriaCell (the “ Company ”) is an

immuno-oncology biotechnology company with a strong focus on cancer immunotherapy.

Immunotherapies have come to the forefront in the fight

against cancer since they harness the body’s own immune system to recognize and destroy cancer cells.

Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as

amended, and Section 21E of the Exchange Act.

We have based these forward-looking statements on our current expectations and projections

about future events.

These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us

that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results,

levels of activity, performance or achievements expressed or implied by such forward-looking statements.

In some cases, you can identify

forward-looking statements by terminology such as “may,” “should,” “could,” “would,”

“expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,”

or the negative of such terms or other similar expressions.

Factors that might cause or contribute to such a discrepancy include, but

are not limited to, those described in our other SEC filings.

(the “Company”) is an immuno-oncology biotechnology company with a strong focus on cancer immunotherapy.

Immunotherapies

have come to the forefront in the fight against cancer since they harness the body’s own immune system to recognize and destroy

cancer cells.

BriaCell owns the U.S.

to SV-BR-1-GM (“ Bria-IMT™ ”), a whole-cell targeted immunotherapy for cancer (U.S.

7,674,456), as well

as patents related to PKCδ inhibitors (U.S.

and Japanese patents to SV-BR-1-GM (“Bria-IMT™”), a whole-cell targeted immunotherapy

for cancer (U.S.

7,674,456, U.S.

11,559,574 B2, Japanese Patent No.

6901505), as well as patents related to PKCδ

inhibitors (U.S.

9,364,460 and 9,572,793).

The Company is currently advancing our targeted

immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™ in combination with an immune checkpoint inhibitor

and a companion diagnostic test, BriaDx™, to identify patients most likely to benefit from Bria-IMT™.

The Bria-IMT™

regimen was evaluated in four patients in a prior study in 2004-2006 by Dr.

Charles Wiseman, the scientific founder, former member of

the board of directors of the Company (the “ Board ”) and principal scientific advisor.

Encouraging results were obtained,

especially in a patient who matched Bria-IMT™ at HLA alleles and had a grade II tumor.

In 2017-2018 BriaCell evaluated 23 patients

with advanced breast cancer with the Bria-IMT™ regimen and obtained confirmation of the ability of the Bria-IMT™ regimen to

induce regression of metastatic breast cancer in patients who match Bria-IMT™ at least at one HLA allele and/or if they had grade

I or grade II tumors.

A combination study with the immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) was initiated on September

BriaCell purchased the KEYTRUDA® for this study as BriaCell does not have an agreement with Merck & Co., Inc.

for the supply

of KEYTRUDA®.

Eleven patients were dosed in the combination therapy trial with Bria-IMT™ and the immune checkpoint inhibitor

KEYTRUDA® and subsequently dosing with this combination was discontinued.

The study was modified under an amended protocol which evaluates

the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs retifanlimab (anti-PD-1 antibody similar to

pembrolizumab).

The study is ongoing.

is estimated by the National Cancer Institute that in 2022, approximately 287,500 women were diagnosed with breast cancer in the United

That means that every two minutes an American woman is diagnosed with breast cancer and more than 43,000 died in 2022.

about 100 times less common than in women, breast cancer also affects men.

It is estimated that the lifetime risk of men getting breast

cancer is about 1 in 1,000, and the American Cancer Society estimates that approximately 2,710 new cases of invasive male breast cancer

will be diagnosed and approximately 530 men will die from breast cancer in 2022.

According to the May 2019 “Global Oncology Trends

2021” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly

$269 billion by the end of 2025, growing at a compound annual growth rate (“ CAGR ”) of 10% between 2021 and 2025, of

which about 20% is expected to be immuno-oncology drugs.

About 12.9% percent of women will be diagnosed with

breast cancer at some point during their lifetime.

In 2018, there were an estimated 3,676,262 women living with female breast cancer in

the United States.

Approximately 81% of cases present as invasive breast cancer.

Approximately 6% of new breast cancer diagnoses are Stage

IV (metastatic breast cancer (“ MBC ”), which has already spread to other organs).

Twenty to thirty percent of all women

diagnosed with breast cancer will develop MBC.

Breast cancer can be subdivided based on receptor status - the hormone receptors for estrogen

(ER) and progesterone (PR), collectively referred to as hormone receptors (HR), and the Her2/neu growth factor co-receptor (HER2).

on the latest SEER statistics, 74.6% were found to be HR+/HER2−, 10.8% were triple-negative (HR−/HER2−), 10.5% were

HR+/HER2+, and 4.0% were HR−/HER2+.

is estimated that over 150,000 women in the US are living with MBC.

For those with metastatic disease at diagnosis, their 5-year survival

For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e.

disease-free interval of more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but

if their disease-free interval is less than 24 months, their prognosis is worse.

4 We currently propose that the Bria-IMT™

indication will be for the treatment of patients with MBC who have failed other approved therapies.

Similarly, another study showed that

the median overall survival among patients with de novo stage IV MBC was 39.2 months, while for patients with relapsed disease it was

Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent

lines of therapy.

One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line

therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.

The Company is currently advancing our targeted immunotherapy program by prioritizing

a Phase II clinical trial with Bria-IMT™ in combination with an immune checkpoint inhibitor.

The Bria-IMT™ regimen was evaluated

in four patients in a prior study in 2004-2006 by Dr.

Charles Wiseman, the scientific founder, former member of the board of directors

of the Company and principal scientific advisor.

Encouraging results were obtained, especially in a patient who matched Bria-IMT™

at HLA-DR alleles and had a grade II tumor.

In 2017-2018 BriaCell evaluated 23 patients with advanced breast cancer with the Bria-IMT™

regimen and obtained confirmation of the ability of the Bria-IMT™ regimen to induce regression of metastatic breast cancer in patients

who match Bria-IMT™ at least at one HLA allele and/or if they had grade I or grade II tumors.

A combination study with the immune

checkpoint inhibitor pembrolizumab (KEYTRUDA®) was initiated and the first patient dosing in the “combination therapy”

clinical trial occurred in September 2018.

BriaCell purchased the KEYTRUDA® for this study as BriaCell does not have an agreement

with Merck & Co., Inc.

for the supply of KEYTRUDA®.

Eleven patients were dosed in the combination therapy trial with Bria-IMT™

and the immune checkpoint inhibitor KEYTRUDA® and subsequently dosing with this combination was discontinued.

The study was modified

under an amended protocol which evaluates the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs retifanlimab

(anti-PD-1 antibody similar to pembrolizumab).

The study completed Phase I and Phase II is ongoing.

Bria-IMT™ has obtained Fast

Track designation from the U.S.

Food and Drug Administration, or FDA, and is progressing to a pivotal study in advanced breast cancer

patients following an end of phase II meeting with the FDA with agreement on the primary endpoint.

BriaCell is also developing Bria-OTS™,

an off-the-shelf personalized approach to whole cell cancer immunotherapy.

August 4, 2022, the Company announced that it has secured an exclusive license from University of Maryland, Baltimore County (UMBC) to

develop and commercialize Soluble CD80 (sCD80) as a biologic agent for the treatment of cancer.

The novel technology, originally developed by Suzanne

Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s scientific advisory board, is titled “Soluble

CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and covered under USPN 8,956,619 B2, USPN 9,650,429 B2,

and USPN 10,377,810 B2.

In animal models, sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor

immunity (see Lucas A Horn, et al.

and Samuel T Haile et al.

in collaboration with Dr.

Ostrand-Rosenberg).

Additionally, strong anti-tumor

activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn, et al.).

Importantly, as demonstrated in the same studies,

sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.

develop and commercialize Soluble CD80, or sCD80, as a biologic agent for the treatment of cancer.

novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s

scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and

covered under U.S.

Patent Number 8,956,619 B2, U.S.

Patent Number 9,650,429 B2, and U.S.

Patent Number 10,377,810 B2.

In animal models,

sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity.

Importantly, as demonstrated

in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy

the terms of the agreement, BriaCell gains the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of

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optimized off-the-shelf personalized immunotherapies for advanced breast cancer and other cancers.

September 14, 2022, the Company signed an agreement with Caris Life Sciences® (Caris), a leading molecular

science and technology company actively developing and delivering innovative solutions to revolutionize healthcare.

goal is to develop immunotherapies that are personalized for each patient, and Caris’ extensive library of clinical data, cutting-edge

biomarker technology, and expertise will be invaluable in achieving our objectives,” The Company expects Caris’ unique platform

to help us identify patients who do not respond to existing treatments and are more likely to benefit from the Company’s immunotherapy

September 14, 2022, the Company signed an agreement with Caris Life Sciences® (“Caris”), a leading molecular science

and technology company actively developing and delivering innovative solutions to revolutionize healthcare.

the terms of the agreement, Caris will help BriaCell with efficient patient identification, accelerating enrollment for its current Phase

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and Whole Transcriptome Sequencing), Caris will perform tumor profiling for the patients enrolled in the clinical trial.

October 12, 2022, the Company added Mayo Clinic, Jacksonville, Florida as a clinical site in the Phase I/II study of

BriaCell’s lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab, in advanced breast cancer.

October 12, 2022, the Company added Mayo Clinic, Jacksonville, Florida as a clinical site in the Phase I/II study of BriaCell’s

lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab, in advanced breast cancer.

November 10, 2022, the Company announced positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients.

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of Bria-IMT™ in combination with Incyte’s retifanlimab.

Researchers also noted that:

regimen in combination with Incyte’s retifanlimab produced evidence of disease control, tumor shrinkage, and potential survival

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further underscoring BriaCell’s positive patient outcomes.

positive data was presented at the San Antonio Breast Cancer meeting in December 2022.

clinical data reported included tumor shrinkage, disease control, progression free survival,

and potential long term survival benefit in advanced metastatic breast cancer patients treated

with the Bria-IMT™ combination regimen.

quality of life” and “less pain” were reported by many gravely ill advanced

metastatic breast cancer patients treated with the Bria-IMT™ combination regimen.

many patients remained in our study longer than other prior therapies, suggesting excellent

tolerability and clinical effectiveness of the Bria-IMT™ combination regimen.

remained well-tolerated with no dose-limiting toxicities.

summary, these findings show evidence of clinical and survival benefits in heavily pre-treated advanced breast cancer patients, suggesting

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of immune system activation by Bria-OTS+™ and Bria-PROS™

poster presentation highlights the development details and activities of BriaCell’s next generation (enhanced version) off-the-shelf

personalized immunotherapies.

poster presentation at the SITC meeting in November 2022 highlighted the development details and activities of BriaCell’s next

generation (enhanced version) off-the-shelf personalized immunotherapies.

has recently developed its novel next generation off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™,

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activation of the immune system components via production of immune activating molecules.

is impressed with the data showing very strong immune responses for both Bria-OTS+™ and Bria-PROS™.

We expect both Bria-OTS+™

and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients with advanced breast cancer

and prostate cancer, respectively.

expect both Bria-OTS+™ and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients

with advanced breast cancer and prostate cancer, respectively.

January 10, 2023, the Company announced that it received an Issue Notification from the United States Patent and Trademark Office for

the composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer.

The patent issued

the composition of matter and method of use of our personalized off-the-shelf cell-based immunotherapy for cancer.

The patent was issued

on January 24, 2023 as US Patent No.

11,559,574 with the term extending to May 25, 2040.

11,559,574, with a term extending to May 25, 2040.

Additionally, BriaCell was awarded an Australian

patent (Patent No.

2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer

2017224232, valid until February 27, 2037) covering composition of matter and method of use for its whole-cell cancer

immunotherapy technology in Australia.

Intellectual Property:

11,559,574, titled “Whole-cell cancer vaccines and methods for selection thereof,” will issue on January 24, 2023,

11,559,574, titled “Whole-cell cancer vaccines and methods for selection thereof,” was issued on January 24, 2023,

and covers the composition of matter and method of use of BriaCell’s personalized off-the-shelf whole-cell immunotherapies.

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term extension under Hatch-Waxman potentially applies (which would extend such protection for an additional five years).

Additionally, BriaCell was awarded

Australian Patent No.

2017224232, titled “Whole-cell cancer vaccines and methods for selection thereof,” for claims covering

composition of matter and method of use for BriaCell’s whole-cell immunotherapy for cancer in Australia.

currently holds multiple issued patents and pending patent applications to cover its whole-cell immunotherapy’s composition of

matter and method of use worldwide.

November 24, 2022, BriaCell was awarded Australian Patent No.

2017224232, titled “Whole-cell cancer vaccines and methods for selection

thereof,” for claims covering composition of matter and method of use for BriaCell’s whole-cell immunotherapy for cancer

in Australia.

currently holds multiple patents and pending patent applications to cover its whole-cell immunotherapy’s composition of matter

and method of use worldwide.

For a summary of BriaCell’s issued patents, please visit https://briacell.com/patents /.

Program Timelines

has provided guidance regarding the development of cells and final cell-bank testing for BriaCell’s Bria-OTS™ clinical-grade

Once completed in accordance with FDA’s requirements, BriaCell expects to initiate the Bria-OTS™ study under

an Investigational New Drug Application (IND) in the first half of 2023.

Clinical Sites

FDA has provided guidance regarding the development of cells and final cell-bank testing for BriaCell’s Bria-OTS™ clinical-grade

Once completed in accordance with the FDA’s requirements, BriaCell expects to initiate the Bria-OTS™ study under

an Investigational New Drug Application (IND) in the second half of 2023.

following clinical sites are actively enrolling patients for BriaCell’s ongoing Phase II combination study:

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of Phase II Meeting with the Food and Drug Administration

January 18, 2023 BriaCell received agreement and positive feedback from its End of Phase II meeting with the FDA regarding

BriaCell’s lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation),

in advanced metastatic breast cancer.

January 18, 2023, BriaCell received agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell’s

lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic

breast cancer.

and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled

in BriaCell’s upcoming pivotal clinical study.

This pivotal registration study will be enrolling advanced metastatic breast cancer

patients for whom no approved treatment options exist.

This study will enroll advanced metastatic breast cancer patients for whom no approved

treatment options exist.

study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization

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Clinical Data

23, 2023 BriaCell reported updated survival data from its previously disclosed group of 12 patients (11 patients enrolled in 2021/2022)

in the ongoing Phase II clinical trial evaluating Bria-IMT™ in combination with Incyte’s retifanlimab for the treatment of

advanced metastatic breast cancer.

February 23, 2023, BriaCell reported updated survival data from its previously disclosed group of 12 patients (11 patients enrolled in

2021/2022) in the ongoing Phase II clinical trial evaluating Bria-IMT™ in combination with Incyte’s retifanlimab for the

treatment of advanced metastatic breast cancer, sharing that:

regimen remains well tolerated with no dose limiting toxicities.

of 11 (82%) patients remain alive from 2021/2022 dosing, suggesting strong survival benefits.

of 11 (64%) patients showed either disease control or progression-free survival (“PFS”) benefits compared with their

most recent prior therapy regimen suggesting clinical benefit, including survival and delayed cancer progression in this very

difficult to treat patient population.

Median PFS of 3.5 months (with one subject ongoing)

compares favorably with other recent studies of patients with advanced disease including other approved agents in earlier lines of therapy

(Tripathy “ATTAIN” 2022, Perez 2015 “BEACON”, Cortes 2018, O’Shaughnessy 2022 “ASCENT”).

remains well tolerated with no dose limiting toxicities.

of 11 (64%) patients showed either disease control or progression-free survival (“PFS”)

benefits compared with their most recent prior therapy regimen, suggesting clinical benefits,

including survival and delayed cancer progression in this very difficult to treat patient

median PFS of 3.5 months (with one subject ongoing) compares favorably with other recent studies of patients with advanced disease including

other approved agents in earlier lines of therapy (Cortes J, et al.

Annals of Oncology 2018;

O’Shaughnessy J et al.

Breast Cancer

Tripathy D, et al.

clinical data from BriaCell’s combination regimen highlights survival benefits in a cohort (3 rd line or later) with

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Other reportable benefits such as less pain and better quality of life were also observed in these

of top-responding patients:

4 of 5 patients with Grade I/II cancer, and 6 of 8 hormone receptor positive (HR+) patients had either disease

control or improved PFS suggesting potentially better responding subgroup/s of patients.

These subgroups represent large segments of

the advanced breast cancer patient population.

9 additional patients have been screened/enrolled in the study, incremental to the 12 patients announced in December 2022.

patients continuing to enroll and remain on the treatment, more data including overall survival data will be disclosed at regular intervals.

Corporate Matters

09, 2023 BriaCell announced the results

of its annual general and special meeting of shareholders of the Company (the “Shareholders”) for the year ended July 31,

2022 held on February 9, 2023 (the “Meeting”).

A total of 6,663,370 common shares of the Company (the “Common Shares”) were voted, representing 42.94% of the Company’s issued and outstanding Common Shares.

At the Meeting, the Shareholders

overwhelmingly voted in favor of all proposed resolutions that consisted of the following:

of MNP LLP as auditors of the Company for the ensuing year and authorizing the directors to fix their remuneration;

Williams, Mr.

Jamieson Bondarenko, Mr.

Marc Lustig, Dr.

Rebecca Taub, Mr.

Embro-Pantalony,

Schmieg as directors of the Company;

of the Company’s new omnibus equity incentive plan (the “Omnibus Plan”);

of restricted share units awarded under the Omnibus Plan;

and adoption of an amendment to the Articles of the Company to require the presence, in person or by proxy, of two or more shareholders

representing at least 33 1/3% of the outstanding shares entitled to be voted in order to constitute a quorum at any meeting of shareholders,

and to remove the quorum exception for succeeding meetings of shareholders.

received Shareholder approval, the Company’s Omnibus Plan remains subject to final approval from the Toronto Stock Exchange.

formal report on voting results with respect to all matters voted upon during the Meeting will be filed on the Company’s SEDAR

profile at www.sedar.com .

of Operations for the Three Months Ended January 31, 2023 and 2022

Three months ended January 31,

were also identified subsets of top-responding patients, This included 4 of 5 patients with Grade I/II cancer, and 6 of 8 patients with

hormone receptor positive (HR+) cancer who had either disease control or improved progression free survival compared to their last therapy,

suggesting these may represent potentially better responding subgroup/s of patients.

These subgroups represent large segments of the

advanced breast cancer patient population.

January 24, 2023, Dr.

Williams, BriaCell’s CEO, issued a letter to shareholders, sharing that positive FDA feedback

on our pivotal study from the end of Phase II meeting for lead clinical candidate Bria-IMT™ in combination with a checkpoint inhibitor

could greatly accelerate the path to commercialization.

Successful completion of the pivotal study could be followed by a Biologics License

Application submission and commercialization.

The pivotal study’s primary endpoint is to be linked to survival improvement compared

to treatment of physician’s choice.

March 15, 2023, BriaCell announced that it would present four posters at the American Association for Cancer Research (AACR) 2023 Annual

On April 17, 2023, the data presented at the AACR meeting was announced.

This included positive data demonstrating survival

and clinical benefits in advanced metastatic breast cancer:

of 18 patients remained alive of those recruited since the study reopened in 2021.

than expected patient survival data highlights tolerability and clinical effectiveness of

BriaCell’s combination treatment.

Bria-IMT ™ combination regimen activated the immune system even in anergic patients

with very weak immune systems.

positive clinical data suggests more meaningful survival and clinical benefits in advanced

metastatic breast cancer.

of Operations for the Three Months Ended April 30, 2023, and 2022

months ended April 30,

and development expenses

and administrative expenses

operating expenses

Research and development expenses

General and administrative expenses

Total operating expenses

Operating loss

income (expenses), net

in fair value of warrant liability

exchange gain

financial income (expenses), net

Interest income

Change in fair value of warrant liability

Gain on government grant

Foreign exchange gain

Total financial income (expenses), net

Prodit (loss) and Comprehensive profit (loss) for the period

and Comprehensive loss for the period

$ (4,895,436 )

Net loss per share – basic and diluted

Weighted average number of shares used in computing net basic and diluted earnings per share of common stock

$ (10,015,573 )

loss per share – basic and diluted

average number of shares used in computing net basic and diluted earnings per share of common stock

and Development Costs

costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;

and (ii) clinical trials and investigational

costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and (ii) clinical trials and investigational

drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.

following is a breakdown of our research and development costs by project:

Three months ended January 31,

months ended April 30,

Clinical trials

Pre-clinical projects

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

Chemical, Manufacturing and

Control Costs (“CMC Costs”)

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

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

Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an addition

Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional

pre-clinical program (sCD80).

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 addition patients in our trials.

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

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

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following is a breakdown of our research and development costs by nature of expenses:

Three months ended January 31,

Three months ended April 30,

Clinical trial sites and investigational drug costs

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Laboratory Rent

Professional fees

Insurance product

Share-based compensation

the three-month period ended January 31, 2023, total research costs amounted to $3,053,357, as compared to $1,708,179 for the

three-month period ended January 31, 2022.

The rise in these costs is primarily attributed to the continued expansion of the

Company’s clinical trials, specifically our Bria-IMT™ trial.

Clinical Trials and investigational drug costs increased

from $1,022,705 in 2022 to $1,288,577 in 2023.

Laboratory costs increase during 2023 as well, including the hiring of additional lab

employees which increased from $524,108 in 2022 to $1,282,441 in 2023 and increased supplies from $20,762 in 2022 to $207,061

Finally, the increase in share based compensation (non-cash) expenses, from $109,453 in 2022 to $225,091 in 2023 also contributed to the increase

in research and development expenses.

the three-month period ended April 30, 2023, research costs totaled $3,860,568, compared to $2,268,805 for the same period in 2022.

increase primarily resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational

drug costs, which rose from $1,364,090 in 2022 to $2,469,105 in 2023.

Laboratory costs also increased due to the hiring of additional

employees and higher supplies, growing from $580,506 to $947,509 and $131,605 to $155,079, respectively.

Additionally, non-cash share-based

compensation expenses rose from $158,204 in 2022 to $239,435 in 2023, contributing to the overall increase in research and development

and Administrative Expenses

the three-month period ended January 31, 2023, general and administrative expenses amounted to $1,432,966 as compared to $1,938,630 for

the three-month period ended January 31, 2022.

The decrease relates primarily to decrease in share based compensation (non-cash) expense.

the three-month period ended April 30, 2023, general and administrative expenses totaled $1,816,461, compared to $1,854,455 for the same

period in 2022.

The decrease is primarily attributed to a reduction in non-cash share-based compensation expenses, which declined from

$705,423 in 2022 to $41,754 in 2023.

income (expenses), net

the three-month period ended January 31, 2023, financial expense, net, amounted to $7,395,439, as compared to income of $14,807,316 for

the three-month period ended January 31, 2022.

the three-month period ended April 30, 2023, financial income, net, amounted to $781,593, as compared to a loss of $5,892,313 for the

three-month period ended April 30, 2022.

The large difference is due to the change in value of the Company’s warrant liability

which amounted to a loss of $7,629,502 in the three-month period ending January 31, 2023, and a gain of $14,797,888 in the three-month

period ending January 31, 2022.

which amounted to a gain of $539,427 in the three-month period ended April 30, 2023, and a loss of $5,928,528 in the three-month period

ended April 30, 2022.

for the period

Company reported a loss for the three-month period ended January 31, 2023, of $11,881,762, as compared to a gain of $11,160,507 for the

three-month period ended January 31, 2022.

The loss in 2023 is due to a significant increase in the fair value of the warrant liability

with the addition of increased operational spending.

The gain in the prior period is due to the large decrease in fair value of the warrant

of Operations for the Six Months Ended January 31, 2023 and 2022

Six months ended January 31,

the three-month period ended April 30, 2023, the Company reported a loss of $4,895,436, compared to a loss of $10,015,573 for the same

period in 2022.

The loss in 2023 primarily resulted from increased operational spending, partially offset by a small gain due to the

decrease in fair value of the warrant liability.

In contrast, the significant loss in the prior period was primarily due to a large change

in the value of the Company’s warrant liability.

of Operations for the Nine Months Ended April 30, 2023 and 2022

Nine months ended April 30,

Operating Expenses:

3 unchanged sentences

Operating loss

(15,566,503 )

(10,054,878 )

Interest income

3 unchanged sentences

Gain of government grant

Foreign exchange gain

Foreign exchange loss

Total financial expenses, net

10 unchanged sentences

following is a breakdown of our research and development costs by project:

Six months ended January 31,

Nine months ended April 30,

Clinical trials

4 unchanged sentences

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

Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an addition

Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional

pre-clinical program (sCD80).

6 unchanged sentences

following is a breakdown of our research and development costs by nature of expenses:

Six months ended January 31,

Nine months ended April 30,

Clinical trial sites and Investigational drug costs

2 unchanged sentences

Professional fees

Insurance product

Share-based compensation

the six-month period ended January 31, 2023, research costs amounted to $6,308,572, as compared to $2,583,815 for the six-month period

ended January 31, 2022.

The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical trials,

specifically our Bria-IMT™ trial.

Clinical Trials and investigational drug costs increased from $1,497,780 in 2022 to $3,330,516

Laboratory costs increase during 2023 as well, including the hiring of additional lab employees which increased from $809,648

in 2022 to $1,998,985 in 2023 and increased supplies from $80,391 in 2022 to $300,425 in 2023.

Finally, the increase in share based compensation

(non-cash) expenses, from $109,453 in 2022 to $575,347 in 2023 also contributed to the increase in research and development expenses.

the nine-month period ended April 30, 2023, research costs amounted to $10,169,140, compared to $4,852,620 for the nine-month period

ended April 30, 2022.

The increase in research costs is primarily attributed to the continued expansion of the Company’s clinical

trials, specifically the Bria-IMT™ trial.

Clinical trials and investigational drug costs rose from $2,861,870 in 2022 to $5,799,621

in 2023, reflecting a substantial increase.

Laboratory costs also experienced growth during 2023, including the addition of new lab personnel,

resulting in an increase from $1,390,154 in 2022 to $2,946,494 in 2023.

Furthermore, supplies expenses rose from $211,996 in 2022 to

$455,504 in 2023.

Finally, the increase in share-based compensation (non-cash) expenses contributed to the overall rise in research and

development expenses, with expenses increasing from $267,657 in 2022 to $814,782 in 2023.

and Administrative Expenses

the six-month period ended January 31, 2023, general and administrative expenses amounted to $3,580,902 as compared to $3,347,803 for

the six-month period ended January 31, 2022.

These increases relate primarily to increased insurance premiums, professional fees, and

the nine-month period ended April 30, 2023, general and administrative expenses amounted to $5,397,363, compared to $5,202,258 for the

nine-month period ended April 30, 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.

income (expenses), net

the six-month period ended January 31, 2023, financial expense, net, amounted to $3,098,829, as compared to $10,441,360 for the six-month

period ended January 31, 2022.

The large difference is due to the change in value of the Company’s warrant liability which amounted

to a loss of $3,511,712 in the six-month period ending January 31, 2023, and a loss of $10,456,148 in the six-month period ending January

The Company recorded $428,948 in interest income in the six-month period ending January 31, 2023, as compared to $18,386 in

the six-month period ending January 31, 2022.

the nine-month period ended April 30, 2023, financial expense, net, amounted to $2,317,236, in contrast to $16,333,673 for the nine-month

period ended April 30, 2022.

The substantial variance primarily arises from the fluctuation in the value of the Company’s warrant

liability, resulting in a loss of $2,972,285 in the nine-month period ended April 30, 2023, and a loss of $16,384,676 in the nine-month

period ended April 30, 2022.

Additionally, interest income recorded for the nine-month period ended April 30, 2023, amounted to $682,437,

compared to $54,373 for the nine-month period ended April 30, 2022.

for the period

Company reported a loss for the period ended January 31, 2023, of $12,988,303, as compared to $16,372,978 for the period ended January

The loss in 2023 is due to a significant increase in the fair value of the warrant with the addition of increased operational

The higher loss in the prior period is due to the larger increase in fair value of the warrant liability.

Company recorded a loss of $17,883,739 for the period ended April 30, 2023, compared to a loss of $26,388,551 for the period ended April

The loss in 2023 primarily stems from a substantial increase in the fair value of the warrant, along with higher operational

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.

Concern Uncertainty

financial statements have been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and

discharge its liabilities in the normal course of business for the foreseeable future.

The continuing operations of the Company are dependent

upon its ability to continue to raise adequate financing and to commence profitable operations in the future.

of January 31, 2023, the Company has total assets of $34,161,267 (July 31, 2022 - $42,577,041) and a positive working capital balance

of $33,268,148 (July 31, 2022 -$41,405,613).

Company is planning to finance its research and developmental activities from its existing and future working capital resources and will

continue to evaluate additional sources of capital and financing.

The Company believes that its existing capital resources will be adequate

to satisfy its expected liquidity requirements for at least twelve months from the issuance of the consolidated financial statements.

Company continues to devote substantially all of its efforts toward research and development activities.

In the course of such activities,

the Company has sustained operating losses and expects such losses to continue in the foreseeable future.

The Company’s accumulated

deficit as of April 30, 2023, was $78,233,576 and negative cash flows from operating activities during the nine-month period ended April

30, 2023 was $12,825,853.

The Company is planning to finance its operations from its existing and future working capital resources and

to continue to evaluate additional sources of capital and financing.

The Company believes that its existing capital resources will be

adequate to satisfy its expected liquidity requirements for at least twelve months from the issuance of the condensed consolidated financial

of April 30, 2023, the Company has total assets of $29,721,868 (July 31, 2022 - $42,577,041) and a positive working capital balance of

$28,119,886 (July 31, 2022 -$41,405,613).

and Capital Resources

of January 31, 2023, the Company has working capital of $33,268,148 (July 31, 2022 - $41,405,613) and an accumulated deficit of $73,338,140

of April 30, 2023, the Company has working capital of $29,119,886 (July 31, 2022 - $41,405,613) and an accumulated deficit of $78,233,576

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

of January 31, 2023, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash

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

of April 30, 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.

government securities, U.S.

17 unchanged sentences

no assurance that such a plan will be successful

the six-month period ended January 31, 2023, the Company’s overall position of cash and cash equivalents decreased by $14,481,449

from the six-month period ended January 31, 2022 (including effects of foreign exchange).

This decrease in cash can be attributed to

the following:

Company’s net cash used in operating activities during the six-month period ended January 31, 2023, was $7,494,122, as compared

to $4,334,808 for the six-month period ended January 31, 2022.

used in financing activities for the six-month period ended January 31, 2023, was $47,294, as compared to $4,952,192 for the six-month

period ended January 31, 2022.

the nine-month period ended April 30, 2023, the Company’s overall position of cash and cash equivalents decreased by $12,871,553

from the nine-month period ended April 30, 2022 (including effects of foreign exchange).

This decrease in cash can be attributed to the

Company’s net cash used in operating activities during the nine-month period ended April 30, 2023, was $12,825,853, as compared

to $9,158,647 for the nine-month period ended April 30, 2022.

used in financing activities for the nine-month period ended April 30, 2023, was $45,700, as compared to $3,582,874 for the nine-month

period ended April 30, 2022.

Sheet Arrangements

4 unchanged sentences

Accounting Policies Adopted

Company did not adopt any new accounting policies during the six-month period ended January 31, 2023.

Company did not adopt any new accounting policies during the three and nine-month periods ended April 30, 2023.

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-Q

Item 2. Management’s Discussion and Analysis