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Item 1. Business

2024-10-29 compared with 2023-10-25 · 665 added, 674 removed, 714 unchanged (65% of the section changed)

1 unchanged sentence

Therapeutics Corp.

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

transform cancer care.

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

system to recognize and destroy cancer cells.

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

with an immune check point inhibitor in a pivotal 1 Phase 3 study in advanced metastatic breast cancer.

BriaCell recently reported

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

BriaCell’s advanced metastatic breast cancer patients vs.

6.7-9.8 months for similar patients reported in the literature 2 .

A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability

and early-stage efficacy.

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

technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic

which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.

is estimated by the National Cancer Institute that in 2023, approximately 297,790 women 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 43,170 are

projected to die in 2023.

(“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-IMT™ targeted

immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal 1 Phase 3 study in metastatic

breast cancer.

Bria-IMT™ 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-IMT™ immune checkpoint inhibitor combination in metastatic breast

BriaCell reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with median overall survival

of 13.4 months in BriaCell’s metastatic breast cancer patients vs.

6.7-9.8 months 2 for similar patients reported in

the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at the 2023 San Antonio Breast Cancer Symposium.

Additionally, BriaCell reported median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in

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

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

early-stage efficacy.

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

provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer.

In September 2024,

the Company announced BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting

with FDA for Bria-PROS+™ for prostate cancer.

is estimated by the National Cancer Institute Cancer Facts and Figures that in 2024, approximately 310,720 women 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

42,250 are projected to die in 2024.

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

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

2,790 new cases of invasive male breast cancer will be diagnosed and approximately 530 men will die from breast cancer in 2024.

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Tripathy D, et al.

About 13% percent

of women will be diagnosed with breast cancer at some point during their lifetime.

In 2022, over 4 million women were living with female

breast cancer in the United States.

13% percent of women will be diagnosed with breast cancer at some point during their lifetime.

In 2024, 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).

Approximately 6% of new

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

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+.

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

2 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.

currently propose that Bria-IMT’s™ 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.

showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy, 175 (45%)

is estimated that over 150,000 women in the US were living with MBC in 2015 2 and this is projected to increase to over 240,000

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’s™ 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.

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.

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

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.

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

Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M.

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and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece:

Results from the EMERGE multicenter

retrospective chart review study.

2019 Jan 18;19(1):88.

Overview of current drugs for breast cancer, demonstrating the pattern of novel therapeutic introductions and significant market

These precedents demonstrate a strong market pull for Bria-IMT™.

best response to the Bria-IMT™ monotherapy regimen to date is in patients who matched Bria-IMT™ at one or more HLA

alleles, with higher response rates for patients with 2+ HLA allele matches.

If one HLA allele match is found to be sufficient, we

will be able to treat ~50-60% of the patient population, while patients with 2+ HLA matches constitutes ~15-35% of

8 We also saw higher clinical benefit rates for patients with grade I/II tumors.

Tumor differentiation in breast

cancer cell lines is often described by their classification as Luminal, Basal A and Basal B subtypes, with Luminal representing

well differentiated tumors, Basal B poorly differentiated tumors, and Basal A an intermediate stage tumor (“moderately”

differentiated).

2 Yao and colleagues in 2005 identified a 9-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D, FGD3,

NCAPH, TNFRSF18, FCGR1A) discriminating poorly (grade 3) from moderately (grade 2) differentiated tumors.

3 To understand

the place of SV-BR-1-GM in this model, we compared its RNA expression profile with those of three other cell lines representing

Luminal (MCF-7), Basal A (MDA-MB-468) and Basal B (MDA-MB-231), using a 10-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D,

FGD3, NCAPH, DLGAP, KIF2C, VAV3) derived from those by Yao and colleagues.

The results, shown in the figure below, demonstrate that

Bria-IMT™ most closely clusters with MDA-MB-468 and as such is considered a grade II “moderately differentiated”

Results from the EMERGE multicenter retrospective chart review study.

2019 Jan 18;19(1):88.

Gragert, Loren, Abeer Madbouly, John Freeman, and Martin Maiers.

“Six-Locus High Resolution HLA Haplotype Frequencies

Derived from Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.

Neve RM, Chin K, Fridlyand J, et al.

A collection of breast cancer cell lines for the study of functionally distinct cancer subtypes.

2006;10(6):515-527.

Doi:10.1016/j.ccr.2006.10.008)

Yao F, Zhang C, Du W, Liu C, Xu Y.

Identification of gene-expression signatures and protein markers for breast cancer grading and

Doi:10.1371/journal.pone.0138213)

on a publication of patients with relapsed breast cancer, we estimate that this will account for ~40% of relapsed metastatic breast

cancer cases (33% grade II and 7% grade I) (Sundquist M, Brudin L, Tejler G.

Improved survival in metastatic breast cancer 1985-2016.

2017 Feb;31:46-50.

10.1016/j.breast.2016.10.005.

Epub 2016 Nov 2).

In patients with relapsed disease, the overall survival

following relapse appears similar for those with grade II and grade III tumors.

recent information comes from combination therapy studies of the Bria-IMT™ regimen with immune checkpoint inhibitors (CPI).

the ongoing study of BRI-ROL-001, in phase I the Bria-IMT™ regimen was dosed in combination with Keytruda ® in 11 patients

and in 12 patients with Zynyz® with one patient starting on the combination with Keytruda® and crossing-over to the combination

with Zynyz® (22 patients total).

In phase II of the study, the Bria-IMT™ regimen is being dosed in combination with Zynyz®

with patients randomized to either receive the Bria-IMT™ regimen first (12 patients) or Zynyz® first (12 patients).

11 patients treated in combination with Keytruda® in phase I, the disease control data is shown below:

patients were treated with Bria-IMT™ + Keytruda®

patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens

chemotherapy), further underscoring BriaCell’s positive patient outcomes

■ Tolerability

excellent with no dose-limiting toxicities

benefit demonstrated:

1 PR and 3 SD in 8 immune responders

the 12 patients treated in combination with Zynyz® in phase I, the disease control data is shown below:

patients were treated with Bria-IMT™ plus Zynyz®

patients were very heavily pre-treated with a median of 5 prior systemic therapy regimens

chemotherapy), further underscoring BriaCell’s positive patient outcomes

■ Tolerability

excellent with no dose-limiting toxicities

70% (7/10) of evaluable patients showed disease control (5/10 evaluable patients including

1 PR and 4 SD) and/or progression-free survival (PFS) benefits compared with their last therapy

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 advanced breast cancer who have failed at least 2 prior regimens.

Several recent publications are noted here:

Annals of Oncology 2018:

Open-label randomized phase 3 trial

Median 4 prior lines of Rx;

~20% HER2 positive, ~20%TNBC;

n= 298 vs 296 (vinflunine vs alkylating

Response Rate (ORR) 6% vs 4%;

Clinical Benefit Rate (CBR) 44% vs 35%;

Progression Free Survival

(PFS) 1.9 vs 2.5 months;

Overall Survival (OS) 9.3.

vs 9.1 months

Breast Cancer Res Treat.

Overall survival analysis

2 prior lines of Rx;

229 Rx w eribulin, 134 gemcitabine, 80 capecitabine;

29% TNBC, 62% HR+/HER2-,

OS eribulin 9.8 months, gemcitabine 7.2 months, capecitabine 9.1 months

■ O’Shaughnessy

Breast Cancer Res Treat.

Phase 3 randomized ASCENT study

4-5 prior lines of Rx;

235 on Sacituzumab, 233 on TPC;

31% non-TNBC initially, 69% TNBC at

w/o initial TNBC:

ORR 31% vs 4% ;

CBR 44% vs 7%;

PFS 4.6 vs 2.3 months;

OS 12.4 vs 6.7 months

w initial TNBC:

ORR 36% vs 5%;

CBR 45% vs 10%;

PFS 5.7 vs 1.6 months;

OS 12.1 vs 6.9 months

Phase 3 ATTAIN Randomized Clinical Trial

■ Patients:~90%

≥4 prior lines of Rx;

92 on Etirinotecan Pegol 86 TPC;

~15% HER2+ ~40% TNBC

4.8% vs 2.7%;

CBR 24.1% vs 9.5%;

PFS 2.8 vs 1.9 months;

OS 7.8 vs 7.5 months

contrast, the Bria-IMT™ regimen with a CPI has shown a median overall survival (OS) of 13.3 months for patients treated before

2022 and 13.5 months for all patients by the Kaplan Meier method, as shown in the Figure below.

For patients treated since 2022, the

median OS has not been reached.

Overall Survival of Patients with Metastatic Breast Cancer treated with the Bria-IMT™ regimen with a CPI.

The market for breast cancer drugs is a multibillion-dollar

market with new drugs being approved on an ongoing basis, indicating the shortage of safe and effective treatments for this deadly disease.

Figure A summarizes current drugs on the market utilized in combination therapy along with their reported market sales, which further

supports market potential for Bria-IMT™ to be used for combination therapy for breast cancer patients.

propose the following calculation in order to show the rationale behind the number of patients that we anticipate can be currently treated

by SV-BR-1-GM:

Cancer Incidence

cancer incidence and mortality.

IV mortality rate represents 3L+ patient mortality rate

novo incidence growth rate of 0.53% / year

0.2% Stage III:

Local relapse:

61% Stage III:

118K Stage III:

80K Stage IV:

stage Incidence Rate

US only stage III and IV patients.

Compliance Rate

research based on SOC therapy data

% Market Share

Cannibalization

Price (Yearly)

yearly price growth

annual cost of model PD-(L)1i

Gross to Net discount

See note 5, above.

Momenimovahed Z, Salehiniya H.

Epidemiological characteristics of and risk factors for breast cancer in the world.

Breast Cancer

(Dove Med Press).

2019 Apr 10;11:151-164.

SEER Cancer Statistics Factsheets:

Female Breast Cancer.

National Cancer Institute.

American Cancer Society.

Breast Cancer Facts & Figures 2017-2018.

American Cancer Society, Inc.

11 Liang TJ, Wang BW, Liu SI, Yeh MH, Chen

YC, Chen JS, Mok KT, Chang HT.

Recurrence after skin-sparing mastectomy and immediate transverse rectus abdominis musculocutaneous flap

reconstruction for invasive breast cancer.

World J Surg Oncol.

2013 Aug 14;11(1):194.

10.1186/1477-7819-11-194.

12 Dawood S, Broglio K, Ensor J, Hortobagyi

GN, Giordano SH.

Survival differences among women with de novo stage IV and relapsed breast cancer.

2010 Nov;21(11):2169-2174.

10.1093/annonc/mdq220.

Epub 2010 Apr 28.

13 Zhao H, Lei X, Niu J, Zhang N, Duan

Z, Chavez-MacGregor M, Giordano SH.

Prescription Patterns, Initiation, and 5-Year Adherence to Adjuvant Hormonal Therapy Among Commercially

Insured Patients With Breast Cancer.

JCO Oncol Pract.

2021 Jun;17(6):e794-e808.

10.1200/OP.20.00248.

Epub 2021 Feb 17.

See note 5, above.

Opportunity in Breast Cancer

to $25Bil Opportunity across broad indications

Worldwide sales figure is based on SEC filings

Approved for multiple cancer indications.

for figure A:

1.https://pubmed.ncbi.nlm.nih.gov/31235441/

2.https://pubmed.ncbi.nlm.nih.gov/23810467/

3.https://pubmed.ncbi.nlm.nih.gov/25501126/

4.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8676999/

5.https://pubmed.ncbi.nlm.nih.gov/15699478/

6.https://pubmed.ncbi.nlm.nih.gov/18000498/

7.https://pubmed.ncbi.nlm.nih.gov/20124182/

8.https://www.nejm.org/doi/10.1056/NEJMoa1814213?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

9.https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.1095

10.https://pubmed.ncbi.nlm.nih.gov/20421541/

11.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581697/

12.https://aacrjournals.org/clincancerres/article/26/20/5310/82934/A-Phase-II-Study-of-Abemaciclib-in-Patients-with

13.https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70329-7/abstract

14.https://pubmed.ncbi.nlm.nih.gov/20421541/

15.https://pubmed.ncbi.nlm.nih.gov/21172893/

For further information on our lead candidate Bria-IMT™

clinical development, see “Bria-IMT™” in the “Production /Pipeline” section.

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

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6.9-59%, therefore establishing and confirming the opportunity for Bria-IMT™.

Treatment & Design

Cyclophosphamide and megestrol acetate

Cyclophosphamide and megestrol

Docetaxel Monotherapy 60 mg/m2

5 unchanged sentences

Paclitaxel Monotherapy

ABI-007 (Nab paclitaxel) 2 nd line

Paclitaxel Monotherapy 2 nd line

ABI-007 (Nab paclitaxel) 2 nd

Paclitaxel Monotherapy 2 nd

Ixabepilone Monotherapy

60 unchanged sentences

28, 1124-1130 (2010).

26 Cortes J, Perez-Garcia J, Levy C, Gómez

Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré

X, Beliakouski V, Román García J, Holgado E, Campone M.

Open-label randomised phase III trial of vinflunine versus an alkylating

agent in patients with heavily pretreated metastatic breast cancer.

J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M,

Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M.

randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer.

2018 Apr 1;29(4):881-887.

10.1093/annonc/mdy051.

27 Kazmi S, Chatterjee D, Raju D, Hauser

R, Kaufman PA.

Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin,

gemcitabine, or capecitabine.

S, Chatterjee D, Raju D, Hauser R, Kaufman PA.

Overall survival analysis in patients with metastatic breast cancer and liver or lung

metastases treated with eribulin, gemcitabine, or capecitabine.

Breast Cancer Res Treat.

4 unchanged sentences

2021 Jun;187(2):603.

28 O’Shaughnessy J, Brufsky A, Rugo HS,

Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu

Y, Phan S, Cortés J.

Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized

ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.

Breast Cancer Res Treat.

14 O’Shaughnessy

J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia

A, Henry S, Mayer I, Zhu Y, Phan S, Cortés J.

Analysis of patients without and with an initial triple-negative breast cancer

diagnosis in the Phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer.

Breast Cancer

2022 Sep;195(2):127-139.

1 unchanged sentence

Epub 2022 May 11.

29 Tripathy D, Tolaney SM, Seidman AD, Anders

CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Müller V, Tagliaferri M, Hannah AL, Cortés J.

Phase III study of etirinotecan

pegol versus treatment of physician’s choice in patients with metastatic breast cancer and brain metastases.

D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Müller V, Tagliaferri M, Hannah AL,

Phase III study of etirinotecan pegol versus treatment of physician’s choice in patients with

metastatic breast cancer and brain metastases.

Future Oncol.

2 unchanged sentences

Epub 2019 May

Cancer Network (NCCN®).

Current treatment paradigm for metastatic breast cancer including between different treatment strategies and combination therapies

4 unchanged sentences

regulatory review of novel therapies such as Bria-IMT™.

there are many biotech companies working to create an effective breast cancer 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.

32 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.

33 An immunogen targeting a carbohydrate antigen, globo-H, was associated with improved

PFS, but only in the subset able to mount antibody responses.

34 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.

35 Finally, the study of targeted cancer immunotherapies in combination

with other therapies is receiving much attention, particularly combination with checkpoint inhibitors.

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

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.

there are many biotech companies working to create an effective breast cancer 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

2 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

3 An immunogen targeting a carbohydrate antigen, globo-H, was associated with improved PFS, but only in the subset

able to mount antibody responses.

4 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)

5 Finally, the study of targeted cancer immunotherapies in combination with other therapies is receiving much

attention, particularly combination with checkpoint inhibitors.

Martinello, R.;

5 unchanged sentences

Oncology (Williston Park) 2016, 30 (5), 475-81,

(5), 475-81, 485.

Mohebtash, M.;

32 unchanged sentences

License Application (“BLA”).

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.

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.

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

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

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.

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.

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

About Bria-IMT ™

BriaCell’s lead candidate, is a whole-cell immunotherapy.

Bria-IMT™ 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.

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

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 the FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast

FDA has agreed that improvement in overall survival in the Bria-IMT™ 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-IMT™

combination therapy arm and 177 patients in the treatment of physician’s choice arm.

To gather additional information on the

Bria-IMT™ 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.

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

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

the path to commercialization.

recently announced partnership with New York Cancer & Blood Specialists (“NYCBS”) as clinical site with more than 30 locations and

35 hospital affiliations throughout Nassau and Suffolk counties, in the Bronx, Manhattan, Queens, Staten Island, and Brooklyn to conduct

its pivotal Phase 3 Study of Bria-IMT™ in Advanced Breast Cancer.

collaboration with Prevail InfoWorks, Inc.

(“InfoWorks”), a Philadelphia, PA based contract research organization,

BriaCell expects 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.

Partners, LLC (“Prevail Partners”), an investment fund and affiliate of InfoWorks, has purchased 463,408 BriaCell common

shares at a price of $8.63 for gross proceeds of $4 million, representing 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.

The transaction closed on May 19, 2023.

Letter of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Phase 2 Clinical Trial of Bria-IMT™ in High-Risk Early-Stage

Triple Negative Breast Cancer

recently announced that it has accepted a letter of intent from Dr.

Massimo Cristofanilli, Director of Breast Medical Oncology and Associate

Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties’ plans

and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s novel

immunotherapy, Bria-IMT™, in combination with a check point inhibitor, in early stage, newly diagnosed, high-risk triple

negative breast cancer patients who have failed to achieve a pathological complete response in the neoadjuvant setting.

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

BriaCell has been conducting a Phase 1/2a

clinical trial of Bria-IMT™, 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.

recently announced benchmark-beating patient survival and clinical benefit in advanced metastatic breast cancer with median overall survival of 13.5 months in BriaCell’s advanced metastatic breast cancer patients vs.

months for similar patients reported in the literature.

has achieved proof of concept based on data from a Phase 1/2a study of Bria-IMT™ in advanced breast cancer patients.

BriaCell has demonstrated disease control and clinical benefit in a high proportion of patients with advanced breast cancer

who have exhausted other therapeutic options.

There is also promising data on overall survival as noted above.

Proof of Concept

has been evaluated in a regimen including pre-dose low-dose cyclophosphamide (to reduce immune suppression), intradermal inoculation

with 20-50 million irradiated Bria-IMT™ cells between two and three days later, with subsequent intradermal inoculation with

interferon-α2 approximately two days later.

This is known as the Bria-IMT™ regimen.

has evaluated the Bria-IMT™ regimen in two Phase I/IIa studies of Bria-IMT™ in advanced breast cancer patients.

Both were single arm studies, so there were no untreated patients for comparison.

were four evaluable patients treated in one study (Study SVMC #01-026) and 23 evaluable patients treated in another study (Study

WRI-GEV-007) with this regimen with cycles every two weeks for the first month and then monthly.

They were heavily pre-treated with

a median of four prior systemic therapy regimens.

data shows an outstanding safety and tolerability profile for Bria-IMT™ in advanced breast cancer patients.

Study SVMC #01-026

the SVMC #01-026 study, treatment was limited to six cycles over five months.

Four post-menopausal white women were enrolled aged

between 58.7 and 73 years.

Three had breast cancer and one had Her2+ ovarian cancer.

All had failed at least one prior systemic therapy.

patients received between four and six cycles of treatment on protocol.

One patient had an additional 13 cycles off protocol.

only adverse events that occurred in more than one patient were itch and rash at the inoculation sites.

No deaths were reported during

There were four serious adverse events (“SAEs”) in 3 patients with one (transient urticaria, grade 3) judged

probably related to treatment.

All SAEs were manageable with community practice therapies.

Bria-IMT™ regimen was able to elicit delayed-type hypersensitivity (“DTH”) responses in all patients.

measure of cell-mediated immunity.

This response involves the interaction of T-cells, monocytes, and macrophages.

This reaction is

caused when CD4+ Th1 helper T cells recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting

These can be macrophages or dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation

of additional CD4+ Th1 cells.

CD4+ T cells secrete other cytokines including IL-2 and interferon gamma, inducing the further release

of other TH1 cytokines, thus mediating the immune response.

This results also in the activation of CD8+ T cells which destroy target

cells on contact, and activated macrophages which produce hydrolytic enzymes.

DTH response involves the interaction of T-cells, monocytes, and macrophages.

This reaction is caused when CD4+ Th1 helper T cells

recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting cells.

These can be macrophages

or dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation of additional CD4+ Th1 cells.

CD4+ T cells secrete other cytokines including IL-2 and interferon gamma, inducing the further release of other Th1 cytokines, thus

mediating the immune response.

This results also in the activation of CD8+ T cells which destroy target cells on contact and activated

macrophages which produce hydrolytic enzymes.

patient (A002) had a partial response with regression of breast lesions, resolution of lung and soft tissue lesions, and improvement

of stability of bone lesions.

She completed therapy and 3 months after her last Bria-IMT™ inoculation, imaging studies

identified regrowth of tumor notably in the breast, lung, and brain.

After consultation with the FDA, the patient was treated

off-protocol which also produced tumor regression, including the resolution of brain metastases.

The HLA-DRB3 and HLA-DRB1 alleles

of patient A002 matched with that of SV-BR-1-GM.

was grade II (moderately differentiated).

One other patient on this study (B001) with a grade II tumor had disease limited to bony

She did not have measurable disease but was felt to progress on study.

time to tumor progression was 144 days (range 64 – 223 days) for the initial round of treatment.

Overall survival was more

than 33 months in all patients except B001 (7 months).

the WRI-GEV-007 study, patients were treated with a median of three cycles of therapy (range 1-8).

Bria-IMT™ regimen was able to elicit both cellular immune responses (as evidenced by DTH responses in 85% of patients evaluated)

and antibody responses (present in 58% of patients evaluated).

most common adverse events seen were local irritation at the inoculation sites.

patients showed evidence of anti-tumor activity of the Bria-IMT™ regimen in spite of their being heavily pre-treated advanced

breast cancer patients.

Specifically, one patient (designated 01-002) had regression or disappearance of 20 lung metastases, and

stable disease in liver metastases (as the liver metastases were the target lesions, she did not qualify as a partial response).

She displayed a robust DTH response, had a grade I tumor and matched Bria-IMT™ at 2 HLA loci.

One patient (05-002) had a reduction

in the size of a breast lesion but progression of a liver lesion and did not meet criteria for a partial response.

She also displayed

a robust DTH response, had a grade II tumor and matched Bria-IMT™ at 2 HLA loci.

One patient (01-005) had a marked reduction

in cutaneous involvement but developed restrictive cardiomyopathy (unrelated to study drug) with subsequent mortality.

grade III (poorly differentiated) tumor and matched Bria-IMT™ at one HLA locus.

She was not on study long enough to be evaluated

for her response.

01-002, 05-002 and 01-005 who showed objective evidence of tumor shrinkage all matched the Bria-IMT™ cell line at least at

one HLA locus and all had evidence of DTH responses to Bria-IMT™ and/or the parent cell line (SV-BR-1 – the breast cancer

cell line from which Bria-IMT™ was derived).

Patients who did not develop a DTH response did not show evidence of tumor shrinkage.

01-002 and 05-002 had grade I/II tumors.

Both of them also had two HLA matches with Bria-IMT™.

Two other patients with grade

II tumors (patient 03-001 and 06-001) had stable disease on the study and were also considered to have received clinical benefit

from the treatment.

(Clinical benefit was defined as some evidence of tumor shrinkage (including a mixed response with shrinkage

of some tumors but progression of others, as for 05-002) with over 90 days on study;

or as stable disease, a partial response or

a complete response as per RECIST criteria).

Neither 03-001 nor 06-001 had HLA matches with Bria-IMT™, suggesting that HLA matching

may not be required for clinical benefit in patients with grade I/II tumors.

Thus, four of the six patients with grade I/II tumors

exhibited clinical benefit.

One of the remaining patients showed no evidence of an immune response as evaluated by DTH.

of the five grade I/II patients able to develop an immune response, as noted by DTH, exhibited clinical benefit.

preliminary data indicate that the Bria-IMT™ regimen in advanced breast cancer patients is well tolerated, able to elicit an

immune response and able to induce reduction in tumor burden.

phase I/IIa study (BRI-ROL-001) was initiated evaluating the combination of the Bria-IMT™ regimen with KEYTRUDA® (pembrolizumab).

This combination combines the induction of an immune response by Bria-IMT™ (i.e.

“putting the foot on the gas”

of the immune response) with the ability of KEYTRUDA® to block the PD-1 – PD-L1 immune checkpoint (i.e.

the foot off the brakes” of the immune response).

patients with advanced breast cancer (median of four prior systemic therapy regimens) have been treated with this regimen with cycles

every three weeks for a median of three cycles (range 1 – 9 cycles).

patients had evidence of tumor regression, both of whom had robust immune responses (as measured by DTH) to Bria-IMT™.

of them had grade II tumors.

One matched Bria-IMT™ at two HLA types (06-005) while the other did not match Bria-IMT™

at any HLA types (06-001, who “rolled over” from the WRI-GEV-007 study where she had stable disease), suggesting that

the Bria-IMT™ regimen, when given in combination with a PD-1 inhibitor, may be able to induce tumor regression without an HLA

match especially in patients with grade I/II tumors.

One additional patient (06-004) in this study had a grade II tumor and was noted

to have stable disease.

The other seven patients treated had grade III tumors (poorly differentiated).

Thus, all three of the patients

with grade I/II tumors showed evidence of clinical benefit.

the establishment of a collaboration with Incyte Corporation, this study was altered to evaluate the combination of the

Bria-IMT™ regimen with retifanlimab (anti-PD-1 antibody similar to KEYTRUDA®).

The combination with KEYTRUDA® has been discontinued.

A total of 12 patients

were treated in the phase I part of the study in combination with retifanlimab.

One of then switched from the Keytruda®

combination to the retifanlimab combination.

50% of the evaluable patients

showed disease control (stable disease or a partial response) with the safety profile again excellent.

Dosing in this study is

ongoing in the randomized phase II portion, with patients randomized either to receive Bria-IMT™ first for retifanlimab first.

Overall survival data has

been evaluated for all patients as of 2023 September 8.

The median overall survival is 13.5 months, which compares favorably with

literature reports of similar patients where overall survival has been 6.7-9.8 months (see references above).

data confirms the clinical activity of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor and justifies further

evaluation in a pivotal registration study.

Bria-IMT™ 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.

Phase 3 combination study is listed on ClinicalTrials.gov as NCT06072612.

and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed

19 unchanged sentences

will improve the immune system response to attack and destroy cancer cells.

BriaCell’s novel technology platform and our strong research and development capabilities, BriaCell plans to develop Bria-OTS™,

a personalized off-the-shelf immunotherapy for breast cancer, and similar immunotherapy cell lines for other cancer indications.

is under development as an off-the-shelf personalized immunotherapy for advanced breast cancer.

concept for Bria-OTS™ comes from BriaCell’s work with Bria-IMT™, where BriaCell noted that if a patient “matches”

Bria-IMT™ in their HLA type, they were more likely to respond.

molecules are the molecules that start immune responses but are polymorphic – i.e.

they are different in different people,

although some people will share the same HLA molecules (referred to as HLA alleles or HLA types).

is made from cell lines that are genetically engineered to expresses the immune boosters GM-CSF and interferon-α, as well as

specific HLA types (a.k.a.

cell lines are being pre-manufactured to express different HLA types covering >99% of the overall breast cancer patient population.

the BriaDX™, a companion diagnostic test performed on the patient’s saliva, the suitable personalized treatment will

be selected for each patient for administration.

approach allows personalized treatment without the need for personalized manufacturing.

Additionally, it saves time, and skips expensive

and complicated manufacturing procedures associated with other personalized treatments.

cell lines are being engineered and transferred to good manufacturing practice (“ GMP ”) production and clinical evaluation

is planned to commence in 2023 (expected authorization by FDA and expected first patient to be dosed in 2023) with safety and efficacy

data expected to be released during 2023 and 2024.

Bria-OTS™ cell lines have also been engineered to express co-stimulatory molecules and additional cytokines

that can activate naïve T cells (those that have not been pre-activated).

These “Bria-OTS™ 2.0” cells are expected

to be very potent in eliciting an anticancer immune response.

Bria-OTS™ 2.0 cell lines for breast cancer and prostate cancer cells should be entering

GMP manufacturing in 2023 or early 2024.

Similar cell lines for lung cancer and melanoma will follow.

Bria-OTS™ 2.0 cell lines have the potential to transform cancer treatment as with simple intradermal injections

tailored to the individual patient, a potent and broad immune response against their cancer can be elicited, which should result in marked

destruction of the tumors by the patient’s own immune system.

Lacher M.D., Bauer G.

Fury B., Graeve S., Fledderman E.L., Petrie T.D., Coleal-Bergum D.P., Hackett T., Perotti N.H., Kong Y.Y.,

Kwok W.W., Wagner J.P., Wiseman C.L., and Williams W.V.

SV-BR-1-GM, a Clinically Effective GM-CSF- Secreting Breast Cancer Cell Line,

Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes.

Frontiers in Immunology 2018;

Phase 3 Clinical Study of Bria-IMT™ in Combination with an Immune Check Point Inhibitor in Metastatic Breast Cancer

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-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer.

FDA has agreed that improvement in overall survival in the Bria-IMT™ 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-IMT™ combination

therapy arm and 177 patients in the treatment of physician’s choice arm.

To gather additional information on the Bria-IMT™

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.

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.

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

the path to commercialization.

partnership with New York Cancer & Blood Specialists (“NYCBS”) as clinical site with more than 30 locations and 35 hospital

affiliations throughout Nassau and Suffolk counties, in the Bronx, Manhattan, Queens, Staten Island, and Brooklyn to conduct its pivotal

Phase 3 Study of Bria-IMT™ in Advanced Breast Cancer.

Currently the Phase 3 study has 14 locations throughout the USA as

noted in the ClinicalTrials.gov listing https://clinicaltrials.gov/study/NCT06072612 .

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, purchased 463,408 BriaCell common

shares at a price of $8.63 for gross proceeds of $4 million, representing 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.

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

has been conducting a Phase 1/2a clinical trial of Bria-IMT™, in combination with immune checkpoint inhibitors such as pembrolizumab

manufactured by Merck & Co., Inc.) and retifanlimab, an immune checkpoint inhibitor manufactured by Incyte.

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.

announced benchmark-beating patient survival and clinical benefit in advanced metastatic breast cancer with median overall survival of

13.5 months in BriaCell’s advanced metastatic breast cancer patients vs.

6.7-9.8 months 1 for similar patients reported

in the literature.

ongoing study of BRI-ROL-001 combination therapy studies of the Bria-IMT™ regimen with immune checkpoint inhibitors (CPI).

the ongoing study of BRI-ROL-001, in phase I the Bria-IMT™ regimen was dosed in combination with Keytruda ® in 11 patients

and in 12 patients with retifanlimab, with one patient starting on the combination with

Keytruda® and crossing-over to the combination with retifanlimab (22 patients total).

In phase II of the study, the

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

Bria-IMT™ regimen first (16 patients) or retifanlimab first (16 patients).

For the 11 patients treated in combination with

Keytruda® in phase I, the disease control data is shown below:

patients were treated with Bria-IMT™ + Keytruda®

patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens (i.e.

chemotherapy), further underscoring

BriaCell’s positive patient outcomes

excellent with no dose-limiting toxicities

benefit demonstrated:

1 PR and 3 SD in 8 immune responders

the 12 patients treated in combination with retifanlimab in phase I, the disease control data is shown below:

patients were treated with Bria-IMT™ plus retifanlimab

patients were very heavily pre-treated with a median of 5 prior systemic therapy regimens (i.e.

chemotherapy), further underscoring

BriaCell’s positive patient outcomes

excellent with no dose-limiting toxicities

70% (7/10) of evaluable patients showed disease control (5/10 evaluable patients including 1 PR and 4 SD) and/or progression-free

survival (PFS) benefits compared with their last therapy regimen.

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 advanced breast cancer who have failed at least 2 prior regimens.

Several recent publications are noted here:

Annals of Oncology 2018:

Open-label randomized Phase 3 trial

Median 4 prior lines of Rx;

~20% HER2 positive, ~20%TNBC;

n= 298 vs 296 (vinflunine vs alkylating agent)

Response Rate (ORR) 6% vs 4%;

Clinical Benefit Rate (CBR) 44% vs 35%;

Progression Free Survival (PFS) 1.9 vs 2.5 months;

Survival (OS) 9.3.

vs 9.1 months

Breast Cancer Res Treat.

Overall survival analysis

2 prior lines of Rx;

229 Rx w eribulin, 134 gemcitabine, 80 capecitabine;

29% TNBC, 62% HR+/HER2-, 9% HER2+

OS eribulin 9.8 months, gemcitabine 7.2 months, capecitabine 9.1 months

O’Shaughnessy

Breast Cancer Res Treat.

Phase 3 randomized ASCENT study

4-5 prior lines of Rx;

235 on Sacituzumab, 233 on TPC;

31% non-TNBC initially, 69% TNBC at Dx

w/o initial TNBC:

ORR 31% vs 4%;

CBR 44% vs 7%;

PFS 4.6 vs 2.3 months;

OS 12.4 vs 6.7 months

w initial TNBC:

ORR 36% vs 5%;

CBR 45% vs 10%;

PFS 5.7 vs 1.6 months;

OS 12.1 vs 6.9 months

Phase 3 ATTAIN Randomized Clinical Trial

Patients:~90%

≥4 prior lines of Rx;

92 on Etirinotecan Pegol 86 TPC;

~15% HER2+ ~40% TNBC

4.8% vs 2.7%;

CBR 24.1% vs 9.5%;

PFS 2.8 vs 1.9 months;

OS 7.8 vs 7.5 months

contrast, the Bria-IMT™ 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 15.6 months.

1 Cortes J, et al.

Oncology 2018;

Kazmi S, et al.

Breast Cancer Res Treat.

O’Shaughnessy J et al.

Breast Cancer Res Treat.

Overall Survival of Patients with Metastatic Breast Cancer treated with the Bria-IMT™ regimen using the Phase 3 formulation

of Intent from Weill Cornell Medicine Outlining Plans to Initiate a Phase 2 Clinical Trial of Bria-IMT™ in High-Risk Early-Stage

Triple Negative Breast Cancer

August, 2023, BriaCell announced that it has accepted a letter of intent from Dr.

Massimo Cristofanilli, Director of Breast Medical Oncology

and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties’

plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s

novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor, in early stage, newly diagnosed, high-risk triple

negative breast cancer patients who have failed to achieve a pathological complete response in the neoadjuvant setting.

As of the date

of this filing, the investigative study has not yet commenced, as the Company is focusing on its pivotal Phase 3 study.

Manufacturing

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.

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

Fuji, which is located in Thousand Oaks, California.

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-IMT™ (previously known as BriaVax) at its GMP facility.

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

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-Pros™, 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-Pros™ 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-Pros™ in compliance with applicable regulatory requirements

to the Company’s master services agreement with Fuji, dated May 29, 2023, to manufacture Bria-IMT™, 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-IMT™

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-IMT™ in compliance with applicable regulatory requirements by the FDA.

Personalized Off-the-Shelf Immunotherapy

Phase 1/2 Study of Bria-OTS™, also known as Bria-BRES™, in metastatic breast cancer is open .

The Phase 1/2 clinical study

is listed on ClinicalTrials.gov as NCT06471673 .

Bucket trial with additional cancer indications planned

Enhanced version (Bria-OTS+™) scheduled to enter the clinic 1H2025 starting with Bria-Pros™ (prostate cancer)

We believe Bria-IMT™ is most effective in human leukocyte antigens (HLA) – type matched patients

Bria-OTS™ is engineered to express 15 unique HLA types through 4 independent cell lines

Provides matched treatment to greater than 99% of patients

Simple saliva test provides HLA matched personalized off-the-shelf Bria-OTS™ immunotherapy

HLA matched off-the-shelf therapy is faster and less costly than other expensive and complex personalized immunotherapies

BriaCell received a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to further develop Bria-OTS™

Ongoing collaboration with the NCI to investigate the Bria-OTS™ mechanism action

BriaCell has secured numerous US and international patents for Bria-OTS™

Similar immunotherapies are in development for prostate cancer (Bria-Pros™), lung cancer (Bria-Lung™), and melanoma (Bria-Mel™)

of Additional Immunotherapy Cell Lines

on these observations, BriaCell is extending this technology to other types of cancer by developing additional immunotherapy cell

lines currently being genetically engineered include a breast cancer cell line, a prostate cancer cell line, a non-small cell lung

cancer cell line and a melanoma cell line.

The genetic engineering has been completed for the breast cancer cell line and GMP manufacturing completed.

Release testing

is underway with the goal to initiate clinical studies in 2H2023.

The prostate cancer cell line is expected to initiate GMP manufacturing

in late 2023 or early 2024 with the lung cancer and melanoma cell lines to follow.

filings for these immunotherapy cell lines are anticipated starting in 2023.

Based on these

observations, BriaCell is extending this technology to other types of cancer by developing additional immunotherapy cell lines.

currently being genetically engineered include a breast cancer cell line, a prostate cancer cell line, a non-small cell lung cancer

cell line and a melanoma cell line.

genetic engineering has been completed for the breast cancer cell line and GMP manufacturing completed.

is currently evaluating its personalized immunotherapy, Bria-BRES™, as monotherapy and in combination with

PD-1 inhibitor tislelizumab, in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673 ).

The Phase 1/2 study is a bucket trial with initial study in breast cancer with extensions to prostate cancer, lung

cancer and melanoma.

On May 28, 2024, BriaCell announced

a clinical supply agreement with BeiGene for Bria-OTS™ First in Human Study.

Study is to evaluate the effects of Bria-OTS™

in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated metastatic breast cancer.

2024, BriaCell announced positive pre-IND meeting with FDA for Bria-PROS+™ for prostate cancer

version (Bria-OTS+™) is scheduled to enter the clinic 1H2025 starting with Bria-Pros™ (prostate cancer)

BriaCell is currently developing

the proprietary Bria-OTS+™ platform as the company pursues the development of Bria-BRES+™, Bria-LUNG+™ and Bria-MEL+™,

for breast cancer, lung cancer and melanoma, respectively.

IND filings for these immunotherapy cell

lines are anticipated starting in 2025.

Phase Programs

4, 2022, BriaCell 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.

Under the terms of the agreement, BriaCell has the

worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of the patents.

BriaCell will pay royalties to UMBC

upon the commercialization of the product plus patent management costs.

The licensing agreement was coordinated by UMBC’s Office

of Technology Development.

are listed as the following:

August 4, 2022, BriaCell 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.

Under the terms of the agreement, BriaCell has

the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of the patents.

BriaCell will pay royalties to

UMBC upon the commercialization of the product plus patent management costs.

The licensing agreement was coordinated by UMBC’s

Office of Technology Development.

patents are listed as the following:

USPN 8,956,619 B2;

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USPN 10,377,810 B2

an important co-stimulatory molecule present on antigen-presenting cells and key for activating T cells.

CD80 also acts as an immune checkpoint

As noted in the patents, significant data has been generated showing that in animal models sCD80 is capable of enhancing anti-cancer

immune responses and shrinking tumors in model systems.

The sCD80 appears to act both as an immune stimulator and checkpoint inhibitor.

is an important co-stimulatory molecule present on antigen-presenting cells and key for activating T cells.

CD80 also acts as an immune

checkpoint inhibitor.

As noted in the patents, significant data has been generated showing that in animal models sCD80 is capable of

enhancing anti-cancer immune responses and shrinking tumors in model systems.

The sCD80 appears to act both as an immune stimulator and

checkpoint inhibitor.

This makes it an ideal candidate to combine with BriaCells’s cellular immunotherapy platform.

Current timelines project that the sCD80 may be ready to enter the clinic in early 2025.

sCD80 project is temporarily on hold as the Company focused on its pivotal Phase 3 study.

and Sales Strategy

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of immunotherapy so that it can be sent on demand to clinical sites.

The 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

The 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.

Our future commercial strategy

may include the use of strategic partners, distributors, a contract sale force, or the establishment of our own commercial and specialty

sales force, as well as similar strategies for regions and territories outside the United States.

We plan to further evaluate these alternatives

as we approach approval for the use of our product candidates for one or more indications.

Commercial Considerations

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Contract Manufacturing Organizations.

We have been working with KBI Biopharma, Inc.

(“KBI”) 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.

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-IMT™ 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.

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.

manufacturing facilities have been evaluated and may be enlisted as demand grows.

will target oncologists who are well-versed in the use of immunotherapy and especially breast cancer treatment centers.

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

On August 4, 2022, BriaCell 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.

Under the terms of the

agreement, BriaCell has the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of the patents.

will pay royalties to UMBC upon the commercialization of the product plus patent management costs.

The licensing agreement was coordinated

by UMBC’s Office of Technology Development.

August 4, 2022, BriaCell 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.

Under the terms of the agreement, BriaCell has

the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of the patents.

BriaCell will pay royalties to

UMBC upon the commercialization of the product plus patent management costs.

The licensing agreement was coordinated by UMBC’s

Office of Technology Development.

July 24, 2017, the Company entered into a Share Exchange Agreement with its wholly-owned subsidiary, BriaCell Therapeutics Corp., Sapientia,

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of applications for patent and trade secret protection, as well as confidentiality agreements with employees, consultants, and third

Company has filed and own or have licensed all rights in the following pending patent applications and issued patents:

Company has filed and owns or have licensed all rights in the following pending patent applications and issued patents:

with the United States Patent and Trademark Office (“USPTO”) on June 14, 2004, U.S.

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to the following:

comprising SV-BR-1 cells

comprising SV-BR-1 and SV-BR-1-GM cells

methods of using said compositions

On February 27, 2017, BriaCell™ filed an international patent application

under the Patent Cooperation Treaty (PCT) to further expand its intellectual property portfolio underlying the Company’s current

and anticipated pipeline of whole-cell cancer immunotherapeutics including Bria-IMT™ and Bria-OTS™.

The PCT application (PCT/US2017/019757)

claims priority to two provisional patent applications filed by the Company with the USPTO in 2016.

It, in essence, provides the framework

for additional whole-cell cancer immunotherapeutics beyond Bria-IMT™ and strategies for patient-specific selection of the most likely

effective whole-cell immunotherapeutic (BriaDx™).

The PCT application entered the National Phase in the second half of 2018 and

was granted in Japan on June 21, 2021.

was recently awarded an Australian patent (Patent No.

February 27, 2017, BriaCell™ filed an international patent application under the Patent Cooperation Treaty (PCT) to further expand

its intellectual property portfolio underlying the Company’s current and anticipated pipeline of whole-cell cancer immunotherapeutics

including Bria-IMT™ and Bria-OTS™.

The PCT application (PCT/US2017/019757) claims priority to two provisional patent applications

filed by the Company with the USPTO in 2016.

It, in essence, provides the framework for additional whole-cell cancer immunotherapeutics

beyond Bria-IMT™ and strategies for patient-specific selection of the most likely effective whole-cell immunotherapeutic (BriaDx™).

The PCT application entered the National Phase in the second half of 2018 and was granted in Japan on June 21, 2021.

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 immunotherapy technology in Australia.).

BriaCell has also received an Issue Notification from the USPTO for the composition of matter and method of use of

its personalized off-the-shelf cell-based immunotherapy for cancer.

has also received an Issue Notification from the USPTO for the composition of matter and method of use of its personalized off-the-shelf

cell-based immunotherapy for cancer.

The patent was issued on January 24, 2023 as US Patent No.

B2 with the term extending to May 25, 2040.

11,559,574 B2 with the term extending

to May 25, 2040.

July 24, 2017, BriaCell obtained the exclusive license to certain patents related to PKCδ inhibitor technology, including patents

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by the Company.

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.

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.

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 NPS.

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

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

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.

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.

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.

of the date of this filing, we had eleven full-time employees and one part-time employee, located in various US states including:

CA, PA, SC, HI, and NJ.

of the date of this filing, we had seventeen full-time employees and one part-time employee, located in various US states including:

NY, FL, PA, SC, NV and NJ.

We also have international employees located in Canada and Israel.

the year ended July 31, 2023, the average number of employees has been sixteen, of whom four were executive management (July 31, 2022 – eight).

the year ended July 31, 2024, the average number of employees was seventeen, of whom four were executive management.

and Development Activities and Costs

information regarding our clinical studies, please see above under the caption “ Description of the Business – Clinical

information regarding our clinical studies, please see above under the caption “ Description of the Business - Clinical Trials.

the years ended July 31, 2024 and 2023, we incurred $26,442,821 and $14,264,048, respectively, of net research and development expenses

(excluding share based compensation allocated to research and development employees)

Manufacturing

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.

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

KBI, which is located in The Woodlands, Texas.

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-IMT™ (previously known as BriaVax) at its GMP facility.

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

to the Company’s master services agreement with KBI, dated March 17, 2017, KBI has conducted developmental studies to derive and

optimize a cryopreserved formulation of Bria-IMT™ (previously known as BriaVax) as a research working cell bank of final drug product

doses suitable for cold chain shipment (the “KBI Services”).

The Company pays for the cost of materials, consumables, and

third party services, plus an additional 5% fee to compensate KBI for the cost of purchasing, material handling, inventory and administration

and management of third party services necessary for KBI to perform the KBI Services.

The master services agreement with KBI terminates

on May 4, 2027.

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-Pros™, 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-Pros™ 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-Pros™ in compliance with applicable regulatory requirements

and Marketing

future commercial strategy may include the use of strategic partners, distributors, a contract sale force, or the establishment of our

own commercial and specialty sales force, as well as similar strategies for regions and territories outside the United States.

to further evaluate these alternatives as we approach approval for the use of our product candidates for one or more indications.

Plant and Equipment

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3 rd Floor, Philadelphia, PA 19104.

consider our current office space sufficient to meet our anticipated needs for the foreseeable future and suitable for the conduct of

our business.

consider our current office and laboratory space sufficient to meet our anticipated needs for the foreseeable future and suitable for

the conduct of our business.

During the year ended July 31, 2024, we purchased certain laboratory equipment in the gross amount of $456,801.

FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among

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process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following:

of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices

(“GLP”) regulations;

of preclinical laboratory tests and animal studies 1 performed in accordance with the FDA’s current Good Laboratory

Practices (“GLP”) regulations;

to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials may

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to begin a clinical trial.

Note that the FDA has waived the requirement for animal studies as Bria-IMT™, Bria-BRES™ and Bria-PROS+™ are

human cellular vaccines and data from animal studies would be uninterpretable.

trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in

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the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

In some cases, FDA will grant preliminary marketing authorization for drugs treating areas of high unmet medical need based on Phase

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3

clinical trials.

In some cases, the FDA will grant preliminary marketing authorization for drugs treating areas of high unmet

medical need based on Phase 2 clinical trials.

If granted, they will also require confirmatory Phase 3 evaluation post-marketing.

BriaCell is evaluating Bria-IMT

in patients with breast cancer who have failed at least two prior lines of therapy.

In this population there is no approved therapy.

BriaCell is evaluating Bria-IMT in patients with breast cancer who have failed at least two prior lines of therapy.

population there is no approved therapy.

Therefore, the development plan for Bria-IMT is an area of high unmet medical need.

It is anticipated that BriaCell will not need

to complete Phase 3 clinical trials prior to submitting the marketing application for Bria-IMT in patients with advanced breast cancer

who have failed at least two prior lines of therapy.

In this case, a confirmatory Phase 3 evaluation post-marketing will be required.

It is anticipated that this would consist of a randomized, controlled clinical trial of Bria-IMT in combination with immune checkpoint

inhibitors compared with best available therapy.

However, this design is subject to negotiation with the FDA.

anticipated that BriaCell will not need to complete Phase 3 clinical trials prior to submitting the marketing application for

Bria-IMT in patients with advanced breast cancer who have failed at least two prior lines of therapy.

In this case, a confirmatory

Phase 3 evaluation post-marketing will be required.

It is anticipated that this would consist of a randomized, controlled clinical

trial of Bria-IMT in combination with immune checkpoint inhibitors compared with best available therapy.

However, this design is

subject to negotiation with the FDA.

3 -The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically

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trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Plan of Arrangement

of Arrangement

August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”).

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and SpinCo is an unlisted reporting issuer in Canada.

As part of the Arrangement, the Company obtained a third-party independent

valuation for BriaPro which amounted to $1.75 million.

Based on the number of issued shares of BriaPro, this amounts to $0.0365 per BriaPro

As part of the Arrangement, the Company obtained a third-party independent valuation

for BriaPro which amounted to $1.75 million.

Based on the number of issued shares of BriaPro, this amounts to $0.0365 per BriaPro share.

is a pre-clinical stage immunotherapy company developing binding agents and proteins with the intention to boost the ability of the body’s

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Bria-TILsRx™:

Multi-Specific

Binding Reagents – Immunotherapy for Cancer:

Multi-Specific Binding Reagents - Immunotherapy for Cancer:

being developed in collaboration with ImmunoPrecise Antibodies.

Small Molecule Program:

Molecule Program:

Protein Kinase C delta (PKCδ) Inhibitors being developed with Receptor AI.

power of AI in drug candidate selection has been hailed by experts and investments in AI-driven drug discovery companies have

tripled over the past four years, reaching $24.6 billion in 2022.

2 Using AI technology to identify the next blockbuster

therapies can help eliminate some of the guesswork that typically requires hundreds of lab experiments—often spread over many

years—to identify promising molecules.

power of AI in drug candidate selection has been hailed by experts and investments in AI-driven drug discovery companies have tripled

over the past four years, reaching $24.6 billion in 2022.

2 Using AI technology to identify the next blockbuster therapies

can help eliminate some of the guesswork that typically requires hundreds of lab experiments-often spread over many years-to identify

promising molecules.

of coming up with tens of thousands of compounds to figure out, computers suggest testing ten compounds in a lab, then getting feedback

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the second half of 2025.

On May 9, 2023, the Company entered into a

Master Service and Technology Agreement (the “MST Agreement”) with Prevail InfoWorks, Inc.

(“InfoWorks”) pursuant

to which InfoWorks will provide clinical services and technologies for the Company’s upcoming pivotal study in advanced metastatic

January 4, 2024, BriaCell disclosed images confirming robust anti-tumor

activity in patient with “Eye-Bulging” metastatic breast cancer.

Significant reduction of metastatic breast cancer tumor behind-the-eye

was reported after only 3 cycles.

Powerful anti-tumor response associated with reduction in proptosis (eye-bulging) and reduced ocular

Heavily pre-treated patient had failed 7 prior regimens including antibody-drug conjugate therapy and remains on BriaCell treatment.

MRI images showed the tumor in the right orbit behind the eye with the eye not being visible pre-treatment.

After treatment with the Bria-IMT™

regimen, the eye becomes visible as it has regained its normal position.

Reduction in tumor size was also seen.

Images of this patient

are shown further below.

On February 6, 2024, BriaCell

announced initiation of Good Manufacturing Practice (GMP) of its lead candidate for treating prostate cancer, Bria-Pros+™, part

of the Bria-OTS+ platform of cellular immunotherapies.

GMP manufacturing of Bria-Pros+ will provide clinical supplies for planned clinical

As presented at the Society for the Immunotherapy of Cancer (SITC) meeting 2023, the pre-clinical proof-of-concept data demonstrated

both feasibility and efficacy of BriaCell’s platform of cellular cancer vaccines overall, with specific emphasis on Bria-Pros+.

BriaCell genetically engineers cancer cell lines to produce cytokines and co-stimulatory factors that significantly increase immune stimulation

compared to the unmodified (parent) cancer cell lines.

These cell lines also express patient-specific Human leukocyte antigens (HLA) alleles

and potentially provide personalized off the shelf treatment.

7, 2024, BriaCell announced strong clinical data in breast cancer patients, and reported another notable responder case.

Disease control

rate of 61% was observed in evaluable Phase 2 patients treated with the same formulation in BriaCell’s pivotal Phase 3 study.

control rate of 50% in evaluable patients treated with the Phase 3 formulation who failed prior antibody-drug conjugate (ADC) therapy.

Notable responder had failed 4 prior therapies including ADC therapy with metastatic liver tumor “no longer observed” following

BriaCell treatment.

March 7, 2024, BriaCell announced that it had received and executed a letter of intent with Paula Pohlmann, MD, MSc, PhD, Associate Professor,

Department of Investigational Cancer Therapeutics and Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD

Anderson Cancer Center, Houston, TX to advance the clinical development of Bria-OTS+ and Bria-PROS+, BriaCell’s personalized off-the-shelf

cellular cancer vaccines in advanced breast cancer and prostate cancer, respectively.

April 9, 2024, BriaCell presented positive clinical data demonstrating unmatched progression-free-survival (PFS) and clinical efficacy

in antibody-drug conjugate (ADC) resistant and central nervous system (CNS) metastatic breast cancer at two posters at the 2024 American

Association for Cancer Research (AACR) Annual Meeting.

Progression fee survival of 4.2 months reported in Phase 2 ADC resistant patients

who received Bria-IMT™ pivotal Phase 3 formulation was twice that of controls in similar studies 1 .

Progression-free-survival

results were reinforced by larger number of prior treatments in Bria-IMT™ population than in comparable studies.

PFS compared favorably to patients’ most recent treatment PFS in 48% of patients.

Additionally, Clinical benefit rate of 56% was

reported in evaluable patients.

Finally, 71% intracranial objective response rate (iORR) was reported in heavily pretreated patients.

Findings supported clinical efficacy of Bria-IMT™ and highlighted its significant potential in managing CNS metastatic disease

in advanced breast cancer.

Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE):

3 open-label randomized study.

Lancet (2011) 377:

April 10, 2024, BriaCell reported preclinical data showing strong anti-cancer activity of its next generation, personalized, off-the-shelf,

cell-based breast and prostate cancer clinical candidates, Bria-OTS+™ and Bria-PROS+™, in a poster session during the 2024

AACR Annual Meeting.

Preclinical data showed that BriaCell’s Bria-OTS+™ and Bria-PROS+™ effectively induced an anti-cancer

immune response via multiple mechanisms including naïve helper and killer T cells, dendritic cells, and natural killer (NK) cells.

BriaCell hypothesizes that the novel mechanisms of action may lead to strong anti-cancer activity in breast and prostate cancer patients.

April 24, 2024, BriaCell announced an oral presentation on the clinical data of the randomized Phase 2 study evaluating Bria-IMT™

in patients with metastatic breast cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31

– June 4 at McCormick Place, Chicago, IL.

Principal Investigator and Professor of Oncology, Mayo Clinic, Saranya Chumsri, MD, provided

the presentation.

of the poster presentations and abstracts are posted on https://briacell.com/scientific- publications/.

On May 24, 2024, BriaCell announced

doubling of progression-free-survival (PFS) and reported clinical benefit data at the 2024 American Society of Clinical Oncology (ASCO).

83% intracranial objective response rate (iORR) with Bria-IMT™ was reported in heavily pretreated advanced breast cancer patients

with CNS metastases.

Median progression free survival (PFS) of 4.1 months in ADC resistant patients - doubled the PFS of patients in similar

studies 1,2, 3 .

Clinical benefit rate of 55% in

evaluable patients includes HR+, HER2+ and TNBC disease - much higher than comparable studies 1,2, 3 .

May 28, 2024, BriaCell announced a clinical supply agreement with BeiGene, Ltd.

BGNE) (“BeiGene”) to evaluate the

safety and efficacy of Bria-OTS™, BriaCell’s next generation immunotherapy, in combination with BeiGene’s anti-PD-1

antibody, tislelizumab, for the treatment of advanced heavily pretreated metastatic breast cancer.

May 30, 2024, BriaCell announced the initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™,

BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab,

in metastatic breast cancer.

On June 3, 2024, BriaCell presented clinical efficacy data at the 2024

ASCO annual meeting.

BriaCell doubled progression-free-survival (PFS) and clinical benefit rate vs historical results in the literature.

Bria-IMT™ PFS compared favorably to PFS of most recent treatment in 48% of Antibody-Drug Conjugate (ADC) resistant patients.

was well-tolerated with no Bria-IMT™ related discontinuations.

Clinical data highlighted significant potential of Bria-IMT™

in advanced metastatic breast cancer.

Superiority of selected Phase 3 regimen and formulation was confirmed.

Oral presentation by Mayo

Clinic Professor and Principal Investigator, Saranya Chumsri, MD, was performed.

Presentation Summary

Number for Publication:

Outcomes of advanced/metastatic breast cancer (aMBC) treated with Bria-IMT™, an allogeneic whole cell

immunotherapy.

Session Type and Title:

Rapid Oral Abstract – Breast Cancer—Metastatic

Session Date and Time:

11:30 AM-1:00 PM CDT

presentation details the results of BriaCell’s randomized Phase 2 study of Bria-IMT™ in combination with retifanlimab, an

immune checkpoint inhibitor (CPI).

The goal of randomization was to compare whether administration of the CPI early, in the first cycle

of therapy, or later, late in the second cycle of therapy, offered any advantage.

Two different formulations of Bria-IMT™ were

also evaluated;

one treated with interferon gamma and one untreated.

patients entering the study were very heavily pretreated and had failed multiple prior therapies as shown in the Table 1 below.

Prior Therapies in the Bria-IMT™ Phase 2 Study

of Patients (%)

Antibody-Drug

Conjugates (ADC)

Checkpoint Inhibitor (CPI)

Cyclin-Dependent

Kinase (CDK) 4/6 Inhibitors

A total of 54 patients were included in the Phase 1/2 study.

Nearly half of these had been treated previously with an antibody drug conjugate

and had progressed in their disease following this treatment.

Another 20% had failed a prior immune checkpoint inhibitor.

of the patients had failed therapy with a CDK 4/6 inhibitor.

On average they had failed six prior therapy attempts.

the Phase 2 portion of the study, there were 32 patients with 16 treated with CPI early and 16 treated with CPI late.

There was no statistically

significant difference in progression-free survival (PFS) two groups.

However, a slight advantage in the CPI early group has led this

to be the selected regimen for the Phase 3 study.

In the entire Phase 1/2 experience, with 54 patients, the formulation not incubated

with interferon gamma showed a statistically significant improvement in PFS.

Therefore, this formulation was selected for the Phase 3

The data are shown in Figure 1.

Effect of treatment sequence and formulation on PFS

benefit was seen in 55% of evaluable patients across all subtypes of breast cancer as shown in Figure 2 below.

Objective Response Rate (ORR) and Clinical Benefit Rate (CBR) in the Bria-IMT™ Phase 1/2 Study

progression free survival rate and the clinical benefit rate as well as the objective response rate were markedly higher than those of

similar patients treated with the treatment of their physician’s choice in other studies.

Notably, “Treatment of Physician’s

Choice” (TPC) will be the comparator in the Phase 3 study of Bria-IMT™.

This is noted in Table 2 below.

Comparative PFS, ORR and CBR in Similar Patients

(median, range)

Phase 2 study patients who received pivotal Phase 3 study formulation

ADC Resistant Phase 2 patients who received pivotal Phase 3 study formulation

O’Shaughnessy

is for evaluable patients, n=42 with 12 not evaluable.

** Data is for evaluable patients, n = 17 with 6 not evaluable.

Data is shown for the intent to treat population for the control group treated with treatment of physician’s choice,

which is the comparator in the BriaCell Phase 3 study

Bardia A, et al.

J Clin Oncol.

2024 May 20;42(15):1738-1744.

Tripathy D, et al.

2022 Nov 1;8(11):1700-1701.

jamaoncol.2022.4346.

This paper describes patients with

brain metastases.

O’Shaughnessy J, et al.

Breast Cancer Res Treat.

2022 Sep;195(2):127-139.

additional detailed information of the clinical data on the oral presentation, please visit https://briacell.com/scientific-publications/.

July 18, 2024, BriaCell reported significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell’s Bria-IMT™

regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer.

The patient remains alive and she continues to

receive BriaCell’s treatment regimen.

September 10, 2024, BriaCell announced that it received positive feedback from its Pre-Investigational New Drug Application (“Pre-IND”)

meeting with the FDA for Bria-PROS+™ in prostate cancer.

As a result of the Pre-IND meeting, the FDA waived the animal toxicology

and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+™.

Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing

and testing requirements.

September 11, 2024, BriaCell reported positive updated overall survival data in its Phase 2 clinical study of Bria-IMT™ in combination

with a CPI in late stage metastatic breast cancer.

Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated

in combination with immune checkpoint inhibitor was reported.

Overall survival of 15.6 months compares favorably with 6.7-9.3 months

reported for similar patients in the literature.

The Company’s ongoing Phase 3 study is investigating Bria-IMT™ in

similar metastatic breast cancer population.

No drug related discontinuations have been reported to date.

September 12, 2024, the Company closed a registered direct offering for the purchase and sale of 12,325,000 common shares of the Company

for aggregate gross proceeds of approximately $8.5 million before deducting placement agent fees and other offering expenses.

the Company issued 616,250 placement agent warrants.

The placement agent warrants have a term of five years commencing September 11,

2024, are exercisable commencing March 11, 2025, and have an exercise price of $0.8625 per common share.

September 18, 2024, BriaCell announced FDA-Authorized expanded access policy for metastatic breast cancer patients.

authorized the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need for novel treatments.

Expanded access policy

is expected to provide potential lifesaving Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s

pivotal Phase 3 clinical trial.

October 1, 2024, BriaCell reported 100% resolution of brain metastasis in breast cancer patient with “Eye-Bulging” tumor.

anti-tumor response included complete resolution of right temporal lobe brain metastasis in patient with “Eye-Bulging” metastatic

breast cancer.

The Company has agreed to pay InfoWorks $5,379,945 upon signing of the MST Agreement and pay InfoWorks additional fees

upon the achievement of certain milestones.

On May 12, 2023, the Company entered into a stock purchase agreement (the “Prevail Partners Purchase Agreement”)

with Prevail Partners, LLC, an investment fund and affiliate of InfoWorks, pursuant to which the Company agreed to issue 463,408 common

shares for an aggregate purchase price of $4,000,000.

The funds received were used to pay amounts owed to InfoWorks under the MST Agreement.

Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continued

to receive BriaCell treatment.

Bria-IMT™ regimen resulted in 100% resolution of tumor in the right temporal lobe region of the brain

shown in Figure 1, the right temporal lobe lesion is no longer detectable on the images taken at 8 months and 11 months on the Bria-IMT™

combination regimen.

The orbital lesion has continued to shrink markedly (Figure 2).

In addition, her tumor markers (blood tests that

correlate with the amount of tumor in the body) remain markedly decreased from her pre-treatment levels.

Bria-IMT™ regimen resulted in near complete resolution of breast cancer tumor in the right orbit (behind the eye)

October 2, 2024, the Company closed a registered direct offering for the purchase and sale of 5,128,500 common shares of the Company and warrants to purchase up to an aggregate

of 5,128,000 common shares of the Company for aggregate gross proceeds of approximately $5.0 million before deducting placement agent

fees and other offering expenses (the “October 2024 Offering”).

Each common share was sold together with one warrant to purchase

one common share at a combined purchase price of $0.975.

The warrants have an exercise price of $0.85 per share, and are immediately

exercisable for a period of five years from grant date.

In addition, the Company issued 256,425 placement agent warrants.

The placement

agent warrants are immediately exercisable for a period of five years from grant date at an exercise price of $1.21875.

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

What changed 10-K

Item 1. Business