BCTX US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

Form

10-K

(Mark

One)

For

the fiscal year ended July 31, 2025

For

the Transition Period from [●] to [●]

Commission

File Number: 001-40101

BRIACELL

THERAPEUTICS CORP.

(Exact

name of registrant as specified in its charter)

(Address of principal executive offices) (Zip Code)

(604)921-1810

(Registrant’s

telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol Name of each exchange on which registered

Common shares, no par value BCTX The Nasdaq Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained

herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated

by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting

company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”,

and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The

aggregate market value of the voting and non-voting common equity held by non-affiliates based on a closing sale price of $50.20 per

share, which was the last sale price of the common shares as of January 31, 2025, the last business day of the registrant’s most

recently completed second fiscal quarter, was $94,477,705.

As

of October 15, 2025, 1,883,906 shares of the registrant’s common shares, no par value per share, were issued and outstanding.

TABLE

OF CONTENTS

Page

PART I

Item 1 Business 4

Item 1A Risk Factors 30

Item 1B Unresolved Staff Comments 47

Item 1C Cybersecurity 47

Item 2 Properties 47

Item 3 Legal Proceedings 47

Item 4 Mine Safety Disclosures 47

PART II

Item 6 [Reserved] 48

Item 7A Quantitative and Qualitative Disclosures About Market Risk 53

Item 8 Financial Statements and Supplementary Data 53

Item 9A Controls and Procedures 54

Item 9B Other Information 54

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 54

PART III

Item 10 Directors, Executive Officers, and Corporate Governance 55

Item 11 Executive Compensation 64

Item 14 Principal Accountant Fees and Services 68

PART IV

SIGNATURES 73

Forward-Looking

Statements

This

Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of

the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,”

“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”

“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other

comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections

about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually

achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially

from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements

involve substantial known and unknown risks and uncertainties, including the risks in the section titled “Risk Factors”,

that may cause our or our industry’s 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 these forward-looking statements. In

addition, you are directed to factors discussed in the “Business” section and the “Management’s Discussion

and Analysis of Financial Condition and Results of Operations” section, as well as those discussed elsewhere in this Annual

Report on Form 10-K.

All

of our forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ

materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will

prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties

referred to in this Annual Report on Form 10-K or included in our other public disclosures or our other periodic reports or other documents

or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely

affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan

to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections

or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on Form 10-K, even if

such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements

or disclosures by us following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained

in this Annual Report on Form 10-K will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.

This

Annual Report on Form 10-K may include market data and certain industry data and forecasts, which we may obtain from internal company

surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications,

articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained

therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed.

While we believe that such studies, clinical trials and publications are reliable, we have not independently verified market and industry

data from third-party sources.

Risk

Factor Summary

Our

business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what

we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider

the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information

in this Annual Report on Form 10-K. If any of the following risks actually occurs (or if any of those listed elsewhere in this Annual

Report on Form 10-K occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could

be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also

become important factors that adversely affect our business.

● We are developing novel technologies which may not be effective or safe;

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

● We are highly dependent on our key personnel;

● We have an unproven market for our product candidates;

● We are a pre-revenue clinical stage company;

PART

I

ITEM

BUSINESS

BUSINESS

Overview

of the Company

BriaCell

Therapeutics Corp. (“Briacell” or 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-IMTTM targeted

immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal1 Phase 3 study in metastatic

breast cancer (listed on ClinicalTrials.gov as NCT06072612). Bria-IMTTM is currently under Fast Track Designation

by the U.S. Food and 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-IMTTM

immune checkpoint inhibitor combination in metastatic breast cancer. BriaCell has 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 months2 for similar patients reported in the literature in its Phase 2 study of Bria-IMTTM combination study

with retifanlimab. Additionally, BriaCell reported median overall survival of 16.5 months in Phase 2 Bria-IMTTM study patients treated

in combination with immune checkpoint inhibitor in patients treated with the Phase 3 formulation since 2022 (post-COVID). A completed

Bria-IMTTM Phase 1/2 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and

early-stage efficacy (listed on ClinicalTrials.gov as NCT03328026).

BriaCell Phase 1/2 Study of Bria-OTSTM, BriaCell’s personalized off-the-shelf immunotherapy, also known

as Bria-BRESTM, in metastatic breast cancer is ongoing (listed on ClinicalTrials.gov as NCT06471673). The first

patient treated with 4 inoculations of cells (single agent) demonstrated complete resolution of a lung metastasis. BriaCell is currently

developing Bria-OTSTM and its advanced form, Bria-OTS+TM, as a platform technology for personalized off-the-shelf immunotherapies

for numerous types of cancer. In September 2024, the Company announced BriaCell had received positive feedback from its Pre-Investigational

New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+TM for prostate cancer.

Market

It

is estimated by the National Cancer Institute Cancer Facts and Figures that in 2025, approximately 319,750 people (316,950 women and

2,800 men) will be diagnosed with breast cancer in the United States. That means that every two minutes an American woman is

diagnosed with breast cancer and more than 42,170 are projected to die in 2025. Although 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 2,800 new cases of invasive male breast cancer will be diagnosed and

approximately 510 men will die from breast cancer in 2025.

According

to the May 2025 “Global Oncology Trends 2025” report by the IQVIA Institute, the global market for cancer drugs (including

immunotherapy drugs) is expected to reach nearly $441 billion by the end of 2029.

1

“Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy

of a treatment.

2

Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast

Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022

About

13% percent of women will be diagnosed with breast cancer at some point during their lifetime. In 2025, over 4 million women were

living with female breast cancer in the United States. Approximately 83% 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 receptor (HER2). Based on the latest SEER statistics, 68% were found to be

HR+/HER2−, 10% were triple-negative (HR−/HER2−), 10% were HR+/HER2+, and 4% were

HR−/HER2+.1

It

is estimated that over 150,000 women in the US were living with MBC in 20152 and this is projected to increase to over 240,000

by 2030. For those with metastatic disease at diagnosis, their 5-year survival rate is 30%.1 For patients who develop MBC

after initially having localized disease, if they had a good response to treatment (i.e. a 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 Bria-IMT’sTM indication will be for the treatment

of patients with MBC who have no approved alternative therapies available. 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 27.2 months.5 Median

progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent lines of therapy.6

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.7 More recent data indicates that

for patients with MBC who have received 2 or more prior lines of therapy, median survival is 5.9-9.8 months.

1

See https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2022-2024-breast-cancer-fact-figures-acs.pdf

2

Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer

in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

3

Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

4

Lobbezoo, D. J. A. et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated

with the most favorable outcome. Breast Cancer Res. Treat. 141, 507-514 (2013).

5

Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast

cancer. Ann Oncol. 2010 Nov; 21(11):2169-74.

6

Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World

Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist.

7

Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes

and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter

retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

For

further information on our lead candidate Bria-IMTTM clinical development, see “Bria-IMTTM” in the “Production

/Pipeline” section.

Competition

Currently

available therapeutic options for breast cancer offer some hope for patients, but there is much room for improvement. Evaluating

response rates (partial and complete responses = ORR), progression free survival (“PFS”) and overall survival

(“OS”) from recent clinical trials in similar late-stage subjects with metastatic or recurrent breast cancer indicate

that response rates range from 3-5% with PFS from 1.6 to 2.3 months1, and OS from ~7 to 14 months2.

MBC

treated with second or higher lines of therapy has a very poor prognosis and few effective therapies that consistently induce long-term

remission, which indicates the market demand and clinical need for new and improved therapeutic drugs and treatment options in order

to improve these response outcomes and patient survival rates. Thus, Bria-IMTTM has the potential to induce long-term remission,

especially in combination with immunotherapies.

There

are a number of cancer vaccines in development for breast cancer, including but not limited to TPIV200 (Marker Therapeutics, Inc.), AE-37

(Antigen Express), and Stimuvax (Merck KgA). While these development candidates are aimed at a number of different targets, and AE-37

has published data in the HER2 breast cancer patient population, there is no guarantee that any of these compounds will not in the future

be indicated for treatment of low-to-intermediate HER2 breast cancer patients and become directly competitive with Bria-IMT.

1Bardia

A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744; Tripathy D, et al. JAMA Oncol. 2022 Nov 1;8(11):1700-1701; O’Shaughnessy J, et

al. Breast Cancer Res Treat. 2022 Sep;195(2):127-139.

2Rugo,

H. S., et al. The Lancet, 402(10411), 1423–1433; Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744.

While

there are many biotech companies working to create an effective breast cancer therapeutic vaccine, a significant gap remains in the

effectiveness and safety of second or higher lines of therapy. The most studied targeted immunotherapy, Neuvax (Galena), a HER2

peptide vaccine, failed a Phase III trial, but there is encouraging data to support at least three ongoing clinical trials combining

trastuzumab with HER2 epitope immunogens.1 The National Cancer Institute (“NCI”) randomized trial adding

PANVAC (a poxviral-based immunogen) to docetaxel increased the median PFS from 3.9 months to 7.9 months and is to be used as a basis

for larger, more sophisticated clinical trials.2 An immunogen targeting a carbohydrate antigen, globo-H, was associated

with improved PFS, but only in the subset able to mount antibody responses.3 A Johns Hopkins breast cancer trial using a

breast cancer cell line transfected with the gene for GM-CSF has not been positive but, using the same cell line with trastuzumab,

40% of patients enjoyed clinical benefit (CR+PR+stable) at one year.4 Finally, the study of targeted cancer

immunotherapies in combination with other therapies is receiving much attention, particularly combination with checkpoint

inhibitors.5

There

are several other approaches to developing targeted breast cancer immunotherapies. These include using peptide cocktails, a triple peptide

regimen, recombinant HER2, antigen-pulsed dendritic cells, DNA immunogens, whole cell allogeneic GM-CSF secreting SKBR3 or T47D cells,

an (HLA)-A2/A3-restricted immunogenic peptide derived from the HER2 protein, oxidized mannan-MUC1, and personalized peptide immunogens.

Among

the most promising results in patients with advanced disease have been using whole-cell preparations, particularly if the cells are engineered

to express GM-CSF. We are taking this approach and capitalizing on positive initial results with Bria-IMTTM monotherapy in difficult

to treat patients using a regimen that both limits regulatory T cell activity (using low dose cyclophosphamide pre-treatment) and boosts

the immune response (using post-dose alpha interferon in the inoculation sites). The combination with PD-1 inhibitors is a logical extension

of our findings where 21 of 23 MBC patients had demonstrable PD-L1 expression on the circulating tumor cells (“CTCs”) and/or

circulating cancer-associated macrophage-like cells (“CAMLs”). The overall strategy, once the initial milestones have been

met, to enroll additional patients for product registration, will allow rapid progression of the best therapeutic option to a Biologics

License Application (“BLA”).

Cancer

immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well

as small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both companies with currently

approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint inhibitors,

as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who have successfully

obtained approval for cancer immunotherapy products include Bristol-Myers Squib Company, Merck & Co., Inc., Genentech, Inc. (a subsidiary

of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson/Janssen Pharmaceuticals, Amgen, Novartis, Acerta Pharmaceuticals

(a subsidiary of AstraZeneca), Juno Therapeutics, Inc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead

Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc. Most of these companies, either alone or together with their collaborative partners,

have substantially greater financial resources than does BriaCell.

Companies

developing novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and maintain

market share. For patients with early-stage breast cancer, adjuvant therapy is often given to prevent recurrence and increase the chance

of long-term disease-free survival. Adjuvant therapy for breast cancer can include chemotherapy, hormonal therapy, radiation therapy,

or combinations thereof. In addition, the HER2 targeted drug trastuzumab (HERCEPTIN), alone or in combination with pertuzumab (PERJETA),

both manufactured and marketed by Roche/Genentech, may be given to patients with tumors with high expression of HER2 (IHC 3+), as well

as other novel targets such as MUC1, which may be useful in treating breast cancer. In addition, the FDA approved the first ever immunotherapy

regimen for breast cancer to the Roche/Genentech PD-L1 checkpoint inhibitor atezolizumab (TECENTRIQ), combined with Celgene’s nab-paclitaxel

(ABRAXANE) for TNBC that cannot be removed with surgery and is locally advanced or metastatic.

Many

of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources

than we do, and also have greater experience in obtaining FDA and other regulatory approvals of treatments and commercializing those

treatments. Accordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving

widespread market acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize,

thus causing limited market share before we can recover the expenses of developing and commercializing of our cancer immunotherapy product

candidate.

1

Mittendorf, E. A.; Peoples, G. E., Injecting Hope-A Review of Breast Cancer Vaccines. Oncology (Williston Park) 2016, 30 (5), 475-81,

485.

2

Heery, C. R.; Ibrahim, N. K.; Arlen, P. M.; Mohebtash, M.; Murray, J. L.; Koenig, K.; Madan, R. A.; McMahon, S.; Marte, J. L.;

Steinberg, S. M.; Donahue, R. N.; Grenga, I.; Jochems, C.; Farsaci, B.; Folio, L. R.; Schlom, J.; Gulley, J. L., Docetaxel Alone or in

Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol

2015, 1 (8), 1087-95.

3

Huang, C.; Yu, A.; Tseng, L., Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic

breast cancer. J Clin Oncol 2016, 34 (15).

4

Chen, G.; Gupta, R.; Petrik, S.; Laiko, M.; Leatherman, J. M.; Asquith, J. M.; Daphtary, M. M.; Garrett-Mayer, E.; Davidson, N.

E.; Hirt, K.; Berg, M.; Uram, J. N.; Dauses, T.; Fetting, J.; Duus, E. M.; Atay-Rosenthal, S.; Ye, X.; Wolff, A. C.; Stearns, V.; Jaffee,

E. M.; Emens, L. A., A feasibility study of cyclophosphamide, trastuzumab, and an allogeneic GM-CSF-secreting breast tumor vaccine for

HER2+ metastatic breast cancer. Cancer Immunol Res 2014, 2 (10), 949-61.

5

McArthur, H. L.; Page, D. B., Immunotherapy for the treatment of breast cancer: checkpoint blockade, cancer vaccines, and future

directions in combination immunotherapy. Clin Adv Hematol Oncol 2016, 14 (11), 922-933.

Mergers

and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller

number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development

of cancer immunotherapy product candidates.

These

competitors also compete with us in recruiting and retaining qualified scientific and management personnel, the ability to work with

specific clinical contract organizations due to conflicts of interest, and the conduct of trials in the ability to recruit clinical trial

sites and subjects for our clinical trials.

We

expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price and the

availability of reimbursement from government and other third-party payors. Our commercial opportunity could be reduced or eliminated

if our competitors develop and commercialize products that are viewed as safer, more convenient or less expensive than any products that

we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval

for our current product candidates or any other future product candidate, which could result in our competitors establishing a strong

market position before we are able to enter the market.

Products/Pipeline

Bria-IMTTM

About

Bria-IMT TM

Bria-IMTTM,

BriaCell’s lead candidate, is a whole-cell immunotherapy for metastatic breast cancer. Bria-IMTTM in combination with an immune

check point inhibitor is undergoing pivotal Phase 3 clinical testing in patients with advanced MBC patients who have failed prior lines

of therapy. The pivotal Phase 3 combination study is listed on ClinicalTrials.gov as NCT06072612.

Mechanism

of Action of Bria-IMTTM

Bria-IMTTM (SV-BR-1-GM) is

a targeted immunotherapy for the treatment of breast cancer. Bria-IMTTM is a genetically engineered human breast cancer cell line

with features of immune cells and clinically applied as a targeted immunotherapy. Bria-IMTTM immunotherapy is derived from a grade

II (moderately differentiated) tumor which activates the immune system to attack and destroy breast cancer tumors.

Bria-IMTTM

is designed to secrete GM-CSF, a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic

cells, the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune

system, to recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMTTM with

other immune system activators including cyclophosphamide (used in low doses to reduce immune suppression), and low-dose local

interferon-α, a cytokine that further activates the immune system. This is termed the Bria-IMTTM regimen. We believe this

approach of simultaneous activation of the immune system via different pathways will improve the immune system response to attack

and destroy cancer cells.

Phase

1/2 Clinical Trial of the Bria-IMTTM regimen in Advanced Metastatic Breast Cancer

BriaCell

conducted Phase 1/2a clinical trials (SVMC #01-026 and WRI-GEV-007) of the Bria-IMTTM regimen in patients with advanced breast cancer.

In the 2 studies a total of 27 patients were treated. They had failed on the average (median) 5 prior lines of therapy. The treatment

was generally well tolerated with local irritation at the inoculation sites the main adverse event judged at least possibly related to

study medication. In total, 18 patients were evaluable (had measurable disease and both baseline and on treatment imaging studies). The

efficacy data is shown here.

● Tolerability was excellent with no dose-limiting toxicities.

In

this study it was also noted that in 21 of 23 patients with circulating tumor cells or cancer-associated macrophage-like cells expressed

PD-L1, and immune checkpoint that blocks the activity of activated T cells to kill tumor cells. This led to the design of a combination

study where the Bria-IMTTM regimen is given in combination with an immune checkpoint inhibitor (CPI).

Phase

1/2 Clinical Trial of Bria-IMTTM in Combination with Immune Check Point Inhibitors in Advanced Metastatic Breast Cancer

BriaCell

has been conducting a Phase 1/2a clinical trial (BRI-ROL-001) of Bria-IMTTM, in combination with immune checkpoint inhibitors such

as pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) and retifanlimab, an immune checkpoint inhibitor manufactured

by Incyte. The combination study is listed in ClinicalTrials.gov as NCT03328026 under FDA-approved BB-IND 10312 under protocol

BRI-ROL-001 at ten clinical sites throughout the United States. The study is now closed to enrollment.

In

the Phase 1 part of the study, the Bria-IMTTM regimen was dosed in combination with Keytruda ® in 11 patients and in 11 patients

with retifanlimab, with one patient starting on the combination with Keytruda® and crossing-over to the combination with retifanlimab.

In the Phase 2 part of the study an additional 32 patients were dosed (54 patients total). In Phase 2 part of the study, the Bria-IMTTM

regimen is being dosed in combination with retifanlimab with patients randomized to either receive the Bria-IMTTM regimen first

(16 patients) or retifanlimab first (16 patients).

BriaCell

also evaluated 2 formulations of Bria-IMT, one treated with interferon gamma and one untreated.

The design of the study is shown here.

The

patients had advanced breast cancer as shown here.

N (%)

Age, Median (Range) 61 (38-81) years

Race/Ethnicity

● Asian 3 (6%)

● Other 3 (6%)

ECOG

Tumor Grade

● Unknown 3 (5%)

Prior systemic therapy, Median (Range) 6 (2-13)

Previous therapies

● Antibody Drug Conjugate 23 (44%)

● Checkpoint Inhibitror 11 (20%)

Metastatic or Recurrent Target Lesion sites

● Brain 4 (7%)

Metastatic Breast Cancer Subtype

● HER2low/HR+ 4 (7%)

Treatment

with the combination regimen was generally well tolerated as shown here.

There was no statistically significant

difference in Progression Free Survival (PFS) based on order of administration (CPI in cycle 1 or delayed to cycle 2). There was a significant

effect of PFS of formulation as shown here.

Data presented at ASCO 2024

see Calfa et al. Journal of Clinical Oncology 42, 6_suppl

https://doi.org/10.1200/JCO.2024.42.16_suppl.1022

The

overall survival of the patients for all patients on this study has been evaluated in an ongoing fashion. Since the study was largely

on hold during COVID (2020 and 2021), patients dosed in 2019 and 2020 have been followed for a longer time. Therefore survival data has

been evaluated for patients dosed before 2022 and since 2022. This should be considered in the context of clinical studies in patients

with metastatic breast cancer who have failed at least 2 prior regimens1.

The

Bria-IMTTM regimen, using the Phase 3 formulation, with a CPI has shown a median overall survival (OS) of 13.4 months for all patients

by the Kaplan Meier method, as shown in the Figure below. For patients treated since 2022, the median OS was estimated at 16.5 months.

Figure

B. Overall Survival of Patients with Metastatic Breast Cancer treated with the Bria-IMTTM regimen using the Phase 3 formulation

with a CPI.

Update of data presented at the 2024 San Antonio

Breast Cancer Symposium

ClinicalTrials.gov ID NCT03328026

1 Cortes J, et al. Annals of Oncology 2018;

Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA

Oncol. 2022

In

its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperformed ADC drugs in hormone receptor positive (HR+) metastatic

breast cancer (MBC) patients. In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing

pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25

patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY® (14.4 months) and those treated with

chemotherapy (11.3 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer

(TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was also

better than TRODELVY® and markedly higher than those of chemotherapy.

Table

1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s

Bria-IMTTM plus CPI versus other drugs in MBC patient subsets.

Bria-IMTTM plus CPI* HR+ 6 17.3

TRODELVY®1 (sacituzumab govitecan-hziy) HR+ 4 14.4

Single agent chemotherapy HR+ 4 11.3

Bria-IMTTM plus CPI* TNBC 6 13.9

TRODELVY®1 (sacituzumab govitecan-hziy) TNBC 3** 11.8

Single agent chemotherapy TNBC 3** 6.9

*

Patients treated with the Phase 3 formulation

**

Number of prior chemotherapy-containing regimens

HR+:

hormone receptor-positive

TNBC:

Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth

factor receptor 2 (HER2))

BriaCell

has also analyzed the data from the Phase 1/2 study in patients who have failed prior ADC therapy. The results are shown here in comparison

to studies of comparable patients in the literature.

During

the course of this study, BriaCell has had several remarkable responders. The data for 2 of them is shown here.

Patient

06-005 had failed 13 prior regimens. She had baseline breast cancer metastases behind the left eye (orbit), in the outside lining of

the brain (dura mater) and the adrenal gland. Following 6 months of treatment the orbital tumor completely resolved and the others improved.

She was judged an overall partial responder.

Imaging

for Patient 06-005

Patient

11-018 had failed 8 prior regimens including the ADC Enhertu®. She had a right orbital tumor causing extensive proptosis (eye bulging)

& brain (temporal lobe) metastasis. There was a complete resolution of the temporal lobe metastasis and a marked reduction in the

orbital lesion with resolution of proptosis and improvement in eye pain. She has been on the study for >21 months.

Imaging

for Patient 11-018

Overall

BriaCell has treated 7 patients with intracranial (inside the skull) metastatic disease who had measurable disease. The intracranial

overall response rate (iORR) is 71%, which compares very favorably with the data for comparable patients in the literature. Some of this

data is shown here.

Intracranial

responses for patients treated with Bria-IMTTM

Note

that the iORR in comparable patients typically <20%. (see Niwinska A, Pogoda K, Jagiello-Gruszfeld A, Duchnowska R. Intracranial Response

Rate in Patients with Breast Cancer Brain Metastases after Systemic Therapy. Cancers (Basel). 2022 Feb 15;14(4):965 and Tripathy D, Tolaney

SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Diéras V, Müller V, Du Y, Currie SL, Hoch U, Tagliaferri M, Hannah

AL, Cortés J; ATTAIN Investigators. Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases:

Final Results From the Phase III ATTAIN Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1047-1052.)

Phase

3 Clinical Trial of Bria-IMTTM in Combination with Immune Check Point Inhibitors in Advanced Metastatic Breast Cancer compared with

Treatment of Physician’s Choice (Bria-ABC)

BriaCell

has been conducting a Phase 3 clinical trial (Bria-ABC) of Bria-IMTTM, in combination with immune checkpoint inhibitor retifanlimab,

an immune checkpoint inhibitor manufactured by Incyte. The combination study is listed in ClinicalTrials.gov as NCT06072612 under

FDA-approved BB-IND 10312. The primary endpoint is overall survival.

Bria-IMTTM is currently under

Fast Track Designation by 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 the FDA, could lead to full approval of the Bria-IMTTM immune checkpoint inhibitor

combination in advanced metastatic breast cancer.

The FDA has agreed that improvement

in overall survival in the Bria-IMTTM combination arm as compared to the physician’s choice of treatment arm will be the primary

endpoint of the study. The study is expected to enroll 177 patients in the Bria-IMTTM combination therapy arm and 177 patients in

the treatment of physician’s choice arm. To gather additional information on the Bria-IMTTM regimen alone, 50 patients are

expected to be enrolled in this regimen and will be eligible for combination therapy following their initial post treatment evaluation.

These patients will not be included in the primary analysis. The study will have an interim evaluation for efficacy which could result

in early completion of the study. We expect frequent and responsive FDA communication under our Fast Track status during our pivotal Phase

3 study. The overall design of the study is shown here.

The

first interim analysis will be at 144 events (mortalities). If the hazard ratio (HR) is ≤ 0.6, BriaCell will submit a Biologics Licensing

Application (BLA). If the HR is > 0.6, the study will continue to completion with HR target of 0.7. Either of these could result in

full approval of the Bria-IMTTM CPI combination regimen in advanced metastatic breast cancer.

The

successful completion of the pivotal study would allow BriaCell to subsequently submit a Biologics License Application and accelerate

the path to commercialization. The Phase 3 study has multiple locations throughout the USA as noted in the ClinicalTrials.gov listing

https://clinicaltrials.gov/study/NCT06072612.

On

December 2, 2024, March 20, 2025, and June 24, 2025, BriaCell announced that the Data Safety Monitoring Board (DSMB), an independent

group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted

early, had completed its first, second, and third reviews of safety events in patients enrolled in BriaCell’s pivotal randomized

Phase 3 study of Bria-IMTTM plus an immune checkpoint inhibitor (CPI) combination regimen (ClinicalTrials.gov NCT06072612)

in metastatic breast cancer. The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s

pivotal Phase 3 study of Bria-IMTTM plus a CPI in MBC.

On

April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612)

has consented over 100 and has enrolled over 75 patients. BriaCell anticipates reporting top line data as early as H1-2026.

On

April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025. Positive tolerability profile and potential response

biomarkers were identified. Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in

the Phase 2 study. Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival

benefits. Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were

linked to longer progression-free survival (PFS) in Phase 3 patients. Presence of Circulating Tumor Cells (CTC) after patients’

initial Phase 3 treatment supports their role as negative prognostic marker (p = 0.04). The Bria-IMT Phase 3 regimen was well-tolerated

with a preferred tolerability profile.

Collaboration with Prevail InfoWorks, Inc.

In

collaboration with Prevail InfoWorks, Inc. (“InfoWorks”), a Philadelphia, PA based contract research organization, BriaCell

continues to recruit additional sites to speed up the patient recruitment process. BriaCell has signed a Master Service and Technology

Agreement (“MSTA”) agreement with InfoWorks to provide clinical services and technologies for BriaCell’s upcoming pivotal

study in advanced metastatic breast cancer. Services include clinical site coordination, project management, clinical monitoring and

pharmacovigilance (safety management) services, and the use of InfoWork’s integrated real-time data analytics platform, The Single

Interface ®, for clinical support and real-time data analysis.

In

May 2023, Prevail Partners, LLC (“Prevail Partners”), an investment fund and affiliate of InfoWorks invested $4 million

in the company at a 20% premium to the trailing thirty (30) trading day volume-weighted average price of the common shares of the

Company on the Nasdaq Stock Exchange.

Manufacturing

We

do not own or operate manufacturing facilities for the production of our product candidates, nor do we have plans to develop our own

manufacturing operations in the foreseeable future. We currently depend on third-party contract manufacturers for all of our required

raw materials, active pharmaceutical ingredients, and finished product candidate for our clinical trials. We currently employ internal

resources and third-party consultants to manage our manufacturing contractors.

Bria-IMTTM

is currently manufactured under current Good Manufacturing Practices (“cGMP”) pursuant to agreements with UC Davis and with

FujiFilm Diosynth Biotechnology (“Fuji”), which is located in Thousand Oaks, California.

On

June 11, 2015, the Company entered into an Agreement for Services with The Regents of the University of California, acting for and on

behalf of UC Davis, pursuant to which UC Davis manufactures Bria-IMTTM (previously known as BriaVax) at its GMP facility. The Company

pays UC Davis certain hourly rates depending on the specific services provided by UC Davis in connection with its manufacturing of Bria-IMTTM.

On

July 5, 2022, BriaCell announced that it had entered into a manufacturing service agreement with Waisman Biomanufacturing at the University

of Wisconsin-Madison (“Waisman”), to manufacture Bria-ProsTM, BriaCell’s off-the-shelf personalized immunotherapy

for prostate cancer, for anticipated use in clinical studies. Waisman is a leading contract manufacturing organization with experience

in the manufacturing of cellular therapies for clinical trials. Under the terms of the agreement, Waisman will be responsible for GMP

manufacturing of Bria-ProsTM for anticipated use in clinical studies. Waisman’s expert team will be working closely with BriaCell’s

scientific and product development teams to ensure timely production of Bria-ProsTM in compliance with applicable regulatory requirements

by the FDA.

Pursuant to the Company’s

master services agreement with Fuji, dated May 29, 2023, to manufacture Bria-IMTTM, for anticipated use in clinical studies including

the Phase 3 study. Fuji is a leading contract manufacturing organization with experience in the manufacturing of cellular therapies for

clinical trials. Under the terms of the agreement, Fuji will be responsible for GMP manufacturing of Bria-IMTTM for anticipated

use in clinical studies. Fuji’s expert team will be working closely with BriaCell’s scientific and product development teams

to ensure timely production of Bria-IMTTM in compliance with applicable regulatory requirements by the FDA.

Production and Marketing Plan

Bria-IMTTM cells grow in

simple tissue culture media and are irradiated prior to inoculation. Bria-IMTTM manufacturing will be performed by Contract Manufacturing

Organizations. We have been working with FUJIFILM Diosynth Biotechnologies (“Fuji”) and the University of California, Davis

Health System (“UC Davis”) GMP facility, who have developed a frozen formulation where the cells are grown, harvested and

irradiated, followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation.

Each lot of Bria-IMTTM is tested for potency (i.e. GM-CSF production), identity (i.e. HER2+ and ER/PR-) and adventitious agents to

rule out contamination with infectious agents. To date, there have been no issues with these tests. Additional manufacturing facilities

have been evaluated and may be enlisted as demand grows.

Marketing will target oncologists

who are well-versed in the use of immunotherapy and especially breast cancer treatment centers. The initial target will be patients with

metastatic or recurrent breast cancer who have failed at least two prior treatment regimens. We plan to develop the clinical data for

Bria-IMTTM and to use this information to reach out to oncologists seeking additional therapeutic options for their patients. We

will include in this effort a physician education campaign targeting the oncologists most likely to treat metastatic breast cancer. As

these physicians become more aware of the data regarding Bria-IMTTM in breast cancer, we will make sure they also understand how

best to use Bria-IMTTM in combination with other therapies that have complementary synergistic mechanisms of action. This will also

come from the clinical studies described above focusing on combination therapy. Partnering with other pharmaceutical companies in order

to market a number of drugs is also an option that we intend to pursue. Our eventual goal is to reach all oncologists who treat late stage

breast cancer, either by direct outreach or by partnering with another company that has an established presence in the oncology space.

Bria-OTSTM

Bria-OTSTM: Personalized Off-the-Shelf Immunotherapy

BriaCell

Phase 1/2 Study of Bria-OTSTM, also known as Bria-BRESTM, in metastatic breast cancer is open. The Phase 1/2 clinical study

is listed on ClinicalTrials.gov as NCT06471673.