NASDAQ: BCTXZ

Market

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

According
to the May 2023 “Global Oncology Trends 2023” report by the IQVIA Institute, the global market for cancer drugs (including
immunotherapy drugs) is expected to reach nearly $375 billion by the end of 2027, growing at a compound annual growth rate (“CAGR”)
of 17% between 2023 and 2027, of which about 20% is expected to be immuno-oncology drugs.

1
“Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy
of a treatment.

2
Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast
Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022

5

About
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). Based on the latest SEER statistics, 68% were found to be HR+/HER2−, 10% were triple-negative (HR−/HER2−),
10% were HR+/HER2+, and 4% were HR−/HER2+.1

It
is estimated that over 150,000 women in the US were living with MBC in 20152 and this is projected to increase to over 240,000
by 2030. For those with metastatic disease at diagnosis, their 5-year survival rate is 30%.1 For patients who develop MBC
after initially having localized disease, if they had a good response to treatment (i.e. a disease-free interval of more than 24 months),
their survival rate is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is less than 24
months, their prognosis is worse.4 We currently propose that Bria-IMT’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.6
One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy,
175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.7 More recent data indicates that
for patients with MBC who have received 2 or more prior lines of therapy, median survival is 5.9-9.8 months.

1
See https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2022-2024-breast-cancer-fact-figures-acs.pdf

2
Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer
in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

3
Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

4
Lobbezoo, D. J. A. et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated
with the most favorable outcome. Breast Cancer Res. Treat. 141, 507-514 (2013).

5
Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast
cancer. Ann Oncol. 2010 Nov; 21(11):2169-74.

6
Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World
Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist.

7
Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes
and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter
retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

6

Figure
A: Overview of current drugs for breast cancer, demonstrating the pattern of novel therapeutic introductions and significant market
uptake. These precedents demonstrate a strong market pull for Bria-IMT™.

■$2-5Bil
Opportunity in Breast Cancer

■Up
to $25Bil Opportunity across broad indications

*
Worldwide sales figure is based on SEC filings

**
Approved for multiple cancer indications.

References
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.

7

Competition

Currently
available therapeutic options for breast cancer offer some hope for patients, but there is much room for improvement. Comparable studies
looking primarily at second line or later treatment are shown in Table “A”, below. Evaluating response rates (partial and
complete responses = ORR), progression free survival (“PFS”) and overall survival (“OS”) from clinical trials
in similar subjects with metastatic or recurrent breast cancer indicate that response rates range from 2.7% up to 59%, depending on the
population studied and the intervention (median 24%). PFS ranges from 8 weeks to 12 months (median 5 months) and OS from 6 months to
31 months (median 13 months).

Table
A: Studies evaluating second-line or later treatment options. Data depict an unpredictable response rate to treatment ranging from
6.9-59%, therefore establishing and confirming the opportunity for Bria-IMT™.

Study
Treatment
& Design
#
of Pts
ORR
PFS/TTP
OS

Licchetta1
Cyclophosphamide and megestrol
acetate
29
31%
7.4
mo
13.4 mo

Harvey2
Docetaxel Monotherapy 60 mg/m2
122
22.1%
12.7
wk
10.6 mo

Docetaxel Monotherapy 75 mg/m2
146
23.3%
15.0
wk
10.3 mo

Docetaxel Monotherapy 100 mg/m2
139
36.0%
16.6
wk
12.3 mo

Rivera3
Docetaxel Monotherapy q3wk
59
35.6%
5.7
mo
18.3 mo

Docetaxel Monotherapy qwk
59
20.3%
5.5
mo
18.6 mo

Gradishar4
ABI-007 (Nab paclitaxel)
229
33%
23.0
wk
65.0 wk

Paclitaxel Monotherapy
225
19%
16.9
wk
55.7 wk

ABI-007 (Nab paclitaxel) 2nd
line
132
27%
20.9
wk
56.4 wk

Paclitaxel Monotherapy 2nd
line
136
13%
16.1
wk
46.7 wk

Perez5
Ixabepilone Monotherapy
126
11.5%
3.1
mo
8.6 mo

Leyland-Jones6
Trastuzumab with paclitaxel
32
59%
12.2
mo

von Minckwitz7
Trastuzumab with capecitabine
78
48.1%
8.2
mo
25.5 mo

Capecitabine Monotherapy
78
27.0%
5.6
mo
20.4 mo

Verma8
Trastuzumab emtansine
495
43.6%
9.6
mo
30.9 mo

lapatinib plus capecitabine
496
30.8%
6.4
mo
25.1 mo

Geyer9
Lapatinib plus capecitabine
163
22%
8.4
mo

Capecitabine Monotherapy
161
14%
4.4
mo

Bartsch10
Capecitabine and trastuzumab
40
20%
8
mo
24 mo

Blackwell11
Lapatinib Monotherapy
148
6.9%
8.1
wk
39.0 wk

Lapatinib with trastuzumab
148
10.3%
12.0
wk
51.6 wk

Cortes12
Vinflunine
298

9.8 mo

alkylating agent
296

7.2 mo

Kazmi13
Eribulin
229

9.1 mo

Gemcitabine
134

9.1 mo

Capecitabine
80

9.3 mo

O’Shaughnessy14
Sacituzumab
235
31%
4.6
mo
12.4 mo

Treatment of Physicians Choice
233
4%
2.3
mo
6.7 mo

Tripathy15
Etirinotecan Pegol
92
4.8%
2.8
mo
7.8 mo

Treatment of Physicians Choice
86
2.7%
1.9
mo
7.5 mo

MBC
treated with second or higher lines of therapy has a very poor prognosis and few effective therapies that consistently induce long-term
remission,15 which indicates the market demand and clinical need for new and improved therapeutic drugs and treatment options
in order to improve these response outcomes and patient survival rates. Thus, Bria-IMT™ has the potential to induce long-term remission,
especially in combination with immunotherapies. Current treatment of MBC is outlined in Figure “B”, below, which illustrates
different therapeutic treatment options and drugs used upon diagnoses from biopsy and identification of breast cancer biomarkers.16

1 Licchetta A, Correale P, Migali C, Remondo C, Francini E, Pascucci A, Magliocca A, Guarnieri A, Savelli V, Piccolomini A, Carli
AF, Francini G. Oral metronomic chemo-hormonal-therapy of metastatic breast cancer with cyclophosphamide and megestrol acetate. J Chemother.
2010 Jun;22(3):201-4.

2
Harvey, V. et al. Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer. J. Clin.
Oncol. 24, 4963-4970 (2006).

3
Rivera, E. et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic
breast cancer. Cancer 112, 1455-1461 (2008).

4
Gradishar WJ. Taxanes for the treatment of metastatic breast cancer. Breast Cancer (Auckl). 2012;6:159-71.

5
Perez, E. A. et al. Efficacy and Safety of Ixabepilone (BMS-247550) in a Phase II Study of Patients With Advanced Breast Cancer
Resistant to an Anthracycline, a Taxane, and Capecitabine. J. Clin. Oncol. 25, 3407-3414 (2007).

6
Leyland-Jones, B. et al. Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination With
Paclitaxel. J. Clin. Oncol. 21, 3965-3971 (2003). Only 41% of patients had prior systemic chemotherapy.

7
von Minckwitz G et el. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive
breast cancer. Eur J Cancer. 2011 Oct;47(15):2273-81. Prior therapy limited to trastuzamab alone or in combination with a taxane.

8
Verma, S. et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 367, 1783-1791 (2012).

9
Geyer, C. E. et al. Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 355, 2733-2743 (2006).

10
Bartsch, R. et al. Capecitabine and Trastuzumab in Heavily Pretreated Metastatic Breast Cancer. J. Clin. Oncol. 25, 3853-3858 (2007).

11
Blackwell, K. L. et al. Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab-Refractory
Metastatic Breast Cancer. J. Clin. Oncol. 28, 1124-1130 (2010).

12 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.
Ann Oncol. 2018 Apr 1;29(4):881-887. Doi: 10.1093/annonc/mdy051. PMID: 29481630.

13 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. Breast Cancer Res Treat. 2020 Nov;184(2):559-565. Doi:
10.1007/s10549-020-05867-0. Epub 2020 Aug 17. Erratum in: Breast Cancer Res Treat. 2021 Jun;187(2):603. PMID: 32808239; PMCID:
PMC7599186.

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
Res Treat. 2022 Sep;195(2):127-139. Doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646.

15 Tripathy
D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Müller V, Tagliaferri M, Hannah AL,
Cortés J. ATTAIN: Phase III study of etirinotecan pegol versus treatment of physician’s choice in patients with
metastatic breast cancer and brain metastases. Future Oncol. 2019 Jul;15(19):2211-2225. Doi: 10.2217/fon-2019-0180. Epub 2019 May
10. PMID: 31074641; PMCID: PMC7466911.

16
NCCN Guidelines Version 2.2019, 07/02/2019 © 2019 National Comprehensive Cancer Network (NCCN®).

8

Figure
B: Current treatment paradigm for metastatic breast cancer including between different treatment strategies and combination therapies
dependent upon biomarker identification and activity within the breast cancer signaling pathway.

Of
patients treated with trastuzumab for MBC, one study showed that 241/331 (72%) progressed within 27 months (32% per year) with median
survival of 13-14 months (CI 10-15 months).1 This indicates the high unmet need in this patient population which should facilitate
regulatory review of novel therapies such as Bria-IMT™.

There are a number of cancer vaccines
in development for breast cancer, including but not limited to TPIV200 (Marker Therapeutics, Inc.), AE-37 (Antigen Express), and Stimuvax
(Merck KgA). While these development candidates are aimed at a number of different targets, and AE-37 has published data in the HER2 breast
cancer patient population, there is no guarantee that any of these compounds will not in the future be indicated for treatment of low-to-intermediate
HER2 breast cancer patients and become directly competitive with Bria-IMT.

While
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.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
trials.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)
at one year.5 Finally, the study of targeted cancer immunotherapies in combination with other therapies is receiving much
attention, particularly combination with checkpoint inhibitors.6

1 Rossi, V.; Nole, F.; Redana, S.; Adamoli, L.; Martinello, R.; Aurilio, G.; Verri, E.; Sapino, A.; Viale, G.; Aglietta, M.; Montemurro,
F., Clinical outcome in women with HER2-positive de novo or recurring stage IV breast cancer receiving trastuzumab-based therapy. Breast
2014, 23 (1), 44-9.

2
Mittendorf, E. A.; Peoples, G. E., Injecting Hope-A Review of Breast Cancer Vaccines. Oncology (Williston Park) 2016, 30 (5), 475-81,
485.

3
Heery, C. R.; Ibrahim, N. K.; Arlen, P. M.; Mohebtash, M.; Murray, J. L.; Koenig, K.; Madan, R. A.; McMahon, S.; Marte, J. L.;
Steinberg, S. M.; Donahue, R. N.; Grenga, I.; Jochems, C.; Farsaci, B.; Folio, L. R.; Schlom, J.; Gulley, J. L., Docetaxel Alone or in
Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol
2015, 1 (8), 1087-95.

4
Huang, C.; Yu, A.; Tseng, L., Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic
breast cancer. J Clin Oncol 2016, 34 (15).

5
Chen, G.; Gupta, R.; Petrik, S.; Laiko, M.; Leatherman, J. M.; Asquith, J. M.; Daphtary, M. M.; Garrett-Mayer, E.; Davidson, N.
E.; Hirt, K.; Berg, M.; Uram, J. N.; Dauses, T.; Fetting, J.; Duus, E. M.; Atay-Rosenthal, S.; Ye, X.; Wolff, A. C.; Stearns, V.; Jaffee,
E. M.; Emens, L. A., A feasibility study of cyclophosphamide, trastuzumab, and an allogeneic GM-CSF-secreting breast tumor vaccine for
HER2+ metastatic breast cancer. Cancer Immunol Res 2014, 2 (10), 949-61.

6
McArthur, H. L.; Page, D. B., Immunotherapy for the treatment of breast cancer: checkpoint blockade, cancer vaccines, and future
directions in combination immunotherapy. Clin Adv Hematol Oncol 2016, 14 (11), 922-933.

9

There
are several other approaches to developing targeted breast cancer immunotherapies. These include using peptide cocktails, a triple peptide
regimen, recombinant HER2, antigen-pulsed dendritic cells, DNA immunogens, whole cell allogeneic GM-CSF secreting SKBR3 or T47D cells,
an (HLA)-A2/A3-restricted immunogenic peptide derived from the HER2 protein, oxidized mannan-MUC1, and personalized peptide immunogens.

Among
the most promising results in patients with advanced disease have been using whole-cell preparations, particularly if the cells are engineered
to express GM-CSF. We are taking this approach and capitalizing on positive initial results with Bria-IMT™ monotherapy in difficult
to treat patients using a regimen that both limits regulatory T cell activity (using low dose cyclophosphamide pre-treatment) and boosts
the immune response (using post-dose alpha interferon in the inoculation sites). The combination with PD-1 inhibitors is a logical extension
of our findings where 21 of 23 MBC patients had demonstrable PD-L1 expression on the circulating tumor cells (“CTCs”) and/or
circulating cancer-associated macrophage-like cells (“CAMLs”). The overall strategy, once the initial milestones have been
met, to enroll additional patients for product registration, will allow rapid progression of the best therapeutic option to a Biologics
License Application (“BLA”).

Cancer
immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well
as small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both companies with currently
approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint inhibitors,
as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who have successfully
obtained approval for cancer immunotherapy products include Bristol-Myers Squib Company, Merck & Co., Inc., Genentech, Inc. (a subsidiary
of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson/Janssen Pharmaceuticals, Amgen, Novartis, Acerta Pharmaceuticals
(a subsidiary of AstraZeneca), Juno Therapeutics, Inc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead
Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc. Most of these companies, either alone or together with their collaborative partners,
have substantially greater financial resources than does BriaCell.

Companies
developing novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and maintain
market share. For patients with early stage breast cancer, adjuvant therapy is often given to prevent recurrence and increase the chance
of long-term disease-free survival. Adjuvant therapy for breast cancer can include chemotherapy, hormonal therapy, radiation therapy,
or combinations thereof. In addition, the HER2 targeted drug trastuzumab (HERCEPTIN), alone or in combination with pertuzumab (PERJETA),
both manufactured and marketed by Roche/Genentech, may be given to patients with tumors with high expression of HER2 (IHC 3+), as well
as other novel targets such as MUC1, which may be useful in treating breast cancer. In addition, the FDA approved the first ever immunotherapy
regimen for breast cancer to the Roche/Genentech PD-L1 checkpoint inhibitor atezolizumab (TECENTRIQ), combined with Celgene’s nab-paclitaxel
(ABRAXANE) for TNBC that cannot be removed with surgery and is locally advanced or metastatic.

Many
of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources
than we do, and also have greater experience in obtaining FDA and other regulatory approvals of treatments and commercializing those
treatments. Accordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving
widespread market acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize,
thus causing limited market share before we can recover the expenses of developing and commercializing of our cancer immunotherapy product
candidate.

Mergers
and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller
number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development
of cancer immunotherapy product candidates.

These
competitors also compete with us in recruiting and retaining qualified scientific and management personnel, the ability to work with
specific clinical contract organizations due to conflicts of interest, and the conduct of trials in the ability to recruit clinical trial
sites and subjects for our clinical trials.

We
expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price and the
availability of reimbursement from government and other third-party payors. Our commercial opportunity could be reduced or eliminated
if our competitors develop and commercialize products that are viewed as safer, more convenient or less expensive than any products that
we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval
for our current product candidates or any other future product candidate, which could result in our competitors establishing a strong
market position before we are able to enter the market.

10

Products/Pipeline

Bria-IMT™

About Bria-IMT ™

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

Developed
and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed
for the treatment of breast cancer. Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune
cells and clinically applied as a targeted immunotherapy.

In
short, Bria-IMT™ immunotherapy is a genetically engineered human breast cancer cell line derived from a grade II tumor which activates
the immune system to attack and destroy breast cancer tumors.

Mechanism
of Action of Bria-IMT™

The
mechanism of action of Bria-IMT™ is currently under investigation. It is likely that the expression of certain breast cancer antigens
(proteins expressed in breast cancer cells) in Bria-IMT™ generates strong T cell and potentially antibody responses - resulting
in recognition and destruction of cancerous cells.37

Bria-IMT™
is designed to secrete GM-CSF, a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic cells,
the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune system, to
recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMT™ with other immune
system activators including cyclophosphamide (used in low doses to reduce immune suppression), and interferon-α, a cytokine that
further activates the immune system. We believe this approach of simultaneous activation of the immune system via different pathways
will improve the immune system response to attack and destroy cancer cells.

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

Bria-IMT™
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.

The
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.

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

BriaCell’s
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.

In
collaboration with Prevail InfoWorks, Inc. (“InfoWorks”), a Philadelphia, PA based contract research organization, BriaCell
continues to recruit additional sites to speed up the patient recruitment process. BriaCell has signed a Master Service and Technology
Agreement (“MSTA”) agreement with InfoWorks to provide clinical services and technologies for BriaCell’s upcoming pivotal
study in advanced metastatic breast cancer. Services include clinical site coordination, project management, clinical monitoring and
pharmacovigilance (safety management) services, and the use of InfoWork’s integrated real-time data analytics platform, The Single
Interface ®, for clinical support and real-time data analysis.

In May 2023, Prevail
Partners, LLC (“Prevail Partners”), an investment fund and affiliate of InfoWorks, 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.

11

Phase
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.

BriaCell
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 months1 for similar patients reported
in the literature.

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

■
11
patients were treated with Bria-IMT™ + Keytruda®

■
All
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

■
Tolerability
excellent with no dose-limiting toxicities

■
Clinical
benefit demonstrated: 1 PR and 3 SD in 8 immune responders

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

■
12
patients were treated with Bria-IMT™ plus retifanlimab

■
All
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

■
Tolerability
excellent with no dose-limiting toxicities

■
Efficacy:
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.

The
overall survival of the patients for all patients on this study has been evaluated in an ongoing fashion. Since the study was largely
on hold during COVID (2020 and 2021), patients dosed in 2019 and 2020 have been followed for a longer time. Therefore survival data has
been evaluated for patients dosed before 2022 and since 2022. This should be considered in the context of clinical studies in patients
with advanced breast cancer who have failed at least 2 prior regimens. Several recent publications are noted here:

■
Cortes
J, et al. Annals of Oncology 2018: Open-label randomized Phase 3 trial

■
Patients:
Median 4 prior lines of Rx; ~20% HER2 positive, ~20%TNBC; n= 298 vs 296 (vinflunine vs alkylating agent)

■
Overall
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

■
Kazmi
S, et al. Breast Cancer Res Treat. 2020 Aug 17: Overall survival analysis

■
Patients:
2 prior lines of Rx; 229 Rx w eribulin, 134 gemcitabine, 80 capecitabine; 29% TNBC, 62% HR+/HER2-, 9% HER2+

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

■
O’Shaughnessy
J et al. Breast Cancer Res Treat. 2022: Phase 3 randomized ASCENT study

■
Patients:
4-5 prior lines of Rx; 235 on Sacituzumab, 233 on TPC; 31% non-TNBC initially, 69% TNBC at Dx

■
Patient
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

■
Patients
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

■
Tripathy
D, et al. JAMA Oncol. 2022: Phase 3 ATTAIN Randomized Clinical Trial

■
Patients:~90%
≥4 prior lines of Rx; 92 on Etirinotecan Pegol 86 TPC; ~15% HER2+ ~40% TNBC

■
ORR
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

In
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.

1Cortes J, et al. Annals of
Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy
D, et al. JAMA Oncol. 2022

12

Figure
B. Overall Survival of Patients with Metastatic Breast Cancer treated with the Bria-IMT™ regimen using the Phase 3 formulation
with a CPI.

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

In
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

We
do not own or operate manufacturing facilities for the production of our product candidates, nor do we have plans to develop our own
manufacturing operations in the foreseeable future. We currently depend on third-party contract manufacturers for all of our required
raw materials, active pharmaceutical ingredients, and finished product candidate for our clinical trials. We currently employ internal
resources and third-party consultants to manage our manufacturing contractors.

Bria-IMT™
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.

On
June 11, 2015, the Company entered into an Agreement for Services with The Regents of the University of California, acting for and on
behalf of UC Davis, pursuant to which UC Davis manufactures Bria-IMT™ (previously known as BriaVax) at its GMP facility. The Company
pays UC Davis certain hourly rates depending on the specific services provided by UC Davis in connection with its manufacturing of Bria-IMT™.

13

On
July 5, 2022, BriaCell announced that it had entered into a manufacturing service agreement with Waisman Biomanufacturing at the University
of Wisconsin-Madison (“Waisman”), to manufacture Bria-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
by the FDA.

Pursuant
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.

Bria-OTS™

●Bria-OTS™:
Personalized Off-the-Shelf Immunotherapy

BriaCell
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™)

14

Development
of Additional Immunotherapy Cell Lines

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

●
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. BriaCell
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.

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

●
Enhanced
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.

Early
Phase Programs

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. 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.

The
patents are listed as the following: USPN 8,956,619 B2; USPN 9,650,429 B2; USPN 10,377,810 B2

CD80
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.

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

Marketing
and Sales Strategy

The
product will initially be marketed to oncologists who are well-versed in the use of immunotherapy for cancer. Partnering with other pharmaceutical
companies in order to market combinations with a number of drugs is also an option that we intend to pursue. This study will utilize
a frozen formulation which consists of irradiated SV-BR-1-GM cells in viable freezing media. This formulation will permit stockpiling
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 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.

Other
Commercial Considerations

There
is a high unmet medical need in late-stage breast cancer, providing potential for accelerated approval of Bria-IMT™. The FDA is
interested in facilitating the availability of novel therapies of patients with unmet medical needs, especially those that can target
the population most likely to respond. In addition, the FDA has granted “Fast Track” status to BriaCell’s lead candidate,
Bria-IMT™, for the treatment of metastatic breast cancer. These two facts may help facilitate the accelerated approval of Bria-IMT™.

Production
and Marketing Plan

Bria-IMT™
cells grow in simple tissue culture media and are irradiated prior to inoculation. Bria-IMT™ manufacturing will be performed by
Contract Manufacturing Organizations. We have been working with FUJIFILM Diosynth Biotechnologies (“Fuji”) and the University
of California, Davis Health System (“UC Davis”) GMP facility, who have developed a frozen formulation where the cells are
grown, harvested and irradiated, followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical
sites for inoculation. Each lot of Bria-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. To date, there have been no issues with these tests. Additional
manufacturing facilities have been evaluated and may be enlisted as demand grows.

15

Marketing
will target oncologists who are well-versed in the use of immunotherapy and especially breast cancer treatment centers. The initial target
will be patients with metastatic or recurrent breast cancer who have failed at least two prior treatment regimens. We plan to develop
the clinical data for Bria-IMT™ and to use this information to reach out to oncologists seeking additional therapeutic options
for their patients. We will include in this effort a physician education campaign targeting the oncologists most likely to treat metastatic
breast cancer. As these physicians become more aware of the data regarding Bria-IMT™ in breast cancer, we will make sure they also
understand how best to use Bria-IMT™ in combination with other therapies that have complementary synergistic mechanisms of action.
This will also come from the clinical studies described above focusing on combination therapy. Partnering with other pharmaceutical companies
in order to market a number of drugs is also an option that we intend to pursue. Our eventual goal is to reach all oncologists who treat
late stage breast cancer, either by direct outreach or by partnering with another company that has an established presence in the oncology
space.

License
Agreements

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. 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.

On
July 24, 2017, the Company entered into a Share Exchange Agreement with its wholly-owned subsidiary, BriaCell Therapeutics Corp., Sapientia,
and all the shareholders of Sapientia. Sapientia, a biotechnology company based in Havertown, PA, is developing novel targeted therapeutics
for multiple indications, including several cancers and fibrotic diseases.

Pursuant
to the terms of the Share Exchange Agreement, BriaCell Therapeutics Corp. agreed to acquire from the Sapientia shareholders all of the
issued and outstanding shares in the capital of Sapientia in consideration to the Sapientia shareholders, pro rata, of an aggregate of
8,333 common shares in the capital of BriaCell (the “Transaction”), which were issued on September 5, 2017.

As
part of the Transaction, BriaCell acquired the license agreement Sapientia entered into with Faller-Williams Technology (“FWT”),
dated March 16, 2017 (the “License Agreement”), pursuant to which BriaCell acquired all rights, including composition of
matter patents (the “PKCδ Patents”), and preclinical study data to a novel therapeutic technology platform, PKCδ
inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.

Pursuant
to the License Agreement, FWT is eligible to receive certain milestone payments, including i) $5,000,000 upon the filing of each New
Drug Application with the FDA with respect to products disclosed and/or described in the PKCδ Patents (the “PKCδ Products”);
ii) $25,000,000 upon final approval of each New Drug Application by the FDA for the marketing of a PKCδ Product; iii) $1,000,000
upon the filing of each Marketing Authorization Application (“MAA”) with the Medicines and Healthcare Products Regulatory
Agency of United Kingdom or the Committee for Medicinal Products for Human Use of the European Commission with respect to a PKCδ
Product; and iv) $5,000,000 upon the final approval of each MAA with the Medicines and Healthcare Products Regulatory Agency of United
Kingdom or the Committee for Medicinal Products for Human Use of the European Commission for the marketing of a PKCδ Product.

FWT
is eligible to receive certain royalty payments under the License Agreement. Following the first commercial sale of a PKCδ Product
in the United States, FWT shall receive i) 5% of worldwide net sales of PKCδ Products encompassed by one or more valid claims of
the PKCδ Patents and/or improvements thereto, and ii) 2.5% of worldwide net sales from PKCδ Products not encompassed within
one or more valid claims of the PKCδ Patents. Additionally, upon BriaCell’s receipt of marketing approval for a PKCδ
Product from the FDA, the Medicines and Healthcare Products Regulatory Agency of United Kingdom, the Committee for Medicinal Products
for Human Use of the European Commission or an equivalent authority, FWT shall receive minimum royalty payments of $250,000 per year.

Unless
terminated earlier pursuant to the provisions therein, the License Agreement shall expire ten years after the last PKCδ Patent
expires.

Intellectual
Property

The
proprietary nature of, and protection for, the Company’s current and/or any future product candidates, processes and know-how are
important to its business, as is its ability to operate without infringing on the proprietary rights of others, and to prevent others
from infringing its proprietary rights. The Company seeks patent protection in the U.S. and internationally for its current and future
product candidates it may develop through other technology. In order to protect its proprietary technologies, the Company relies on combinations
of applications for patent and trade secret protection, as well as confidentiality agreements with employees, consultants, and third
parties.

16

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

Filed
with the United States Patent and Trademark Office (“USPTO”) on June 14, 2004, U.S. Patent No. 7,674,456 B2, includes claims
to the following:

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

2.
Therapeutic
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.

BriaCell
was awarded an Australian patent (Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method
of use for its whole-cell cancer 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. The patent was issued on January 24, 2023 as US Patent No. 11,559,574 B2 with the term extending
to May 25, 2040.

On
July 24, 2017, BriaCell obtained the exclusive license to certain patents related to PKCδ inhibitor technology, including patents
to specific compounds, methods of using the compounds, and methods of assessing patients regarding the compounds. These patents include
U.S. Patent No. 9,364,460, which was issued on June 14, 2016; U.S. Patent No. 9,572,793, which issued on February 21, 2017; U.S. Patent
No. 9,844,534, which was issued December 19, 2017; and EP Patent No. 2897610, which was issued on January 10, 2018.

To
the knowledge of the Company’s management, there are no contested proceedings or third-party claims over any of our patent applications.
Our success depends upon our ability to protect our technologies through intellectual property agreements including patents, trademarks,
know-how, and confidentiality agreements. However, there can be no assurance that the above-mentioned patent applications will be approved
by the appropriate agencies.

All
of the technology for which patents are currently sought is owned by the Company. Our patents are entirely owned or exclusively licensed
by the Company.

Employees

As
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.

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

Research
and Development Activities and Costs

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

For
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)

17

Property,
Plant and Equipment

The
Company does not own any real property. BriaCell’s corporate offices in Canada are located at Suite 300, Bellevue Centre, 235-15th
Street, West Vancouver, BC V7T 2XI, and its corporate and research offices in the United States are located at 2929 Arch Street
3rd Floor, Philadelphia, PA 19104.

We
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.

Government
Regulation

The
FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting
of biologics such as those we are developing. Along with third-party contractors, we will be required to navigate the various preclinical,
clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies
or seek approval or licensure of our current or future product candidates. The process of obtaining regulatory approvals and the subsequent
compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and
financial resources. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the
FDA and in accordance with the provisions of the approved label.

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

●
completion
of preclinical laboratory tests and animal studies1 performed in accordance with the FDA’s current Good Laboratory
Practices (“GLP”) regulations;

●
submission
to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials may
begin and must be updated annually or when significant changes are made;

●
approval
by an independent Institutional Review Board (“IRB”) or ethics committee at each clinical site before the trial is begun;

●
performance
of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product
candidate for its intended purpose;

●
preparation
of and submission to the FDA of a Biologics License Application (“BLA”), after completion of all pivotal clinical trials;

●
satisfactory
completion of an FDA Advisory Committee review, if applicable;

●
a
determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

●
satisfactory
completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced
to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s
continued safety, purity and potency, and of selected clinical investigations to assess compliance with current Good Clinical Practices
(“GCP”); and

●
FDA
review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States,
which must be updated annually when significant changes are made.

The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
our current or future product candidates will be granted on a timely basis, if at all. Prior to beginning the first clinical trial with
a product candidate, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational
new drug to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies.
The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic
characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support
the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes
effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about
the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any
outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization
to begin a clinical trial.

1
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.

18

Clinical
trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
accordance with GCP, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,
the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing
IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments.
Furthermore, an IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and
its informed consent form before the clinical trial begins at that site and must monitor the clinical trial until completed. Regulatory
authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects
are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include
oversight by a Data & Safety Monitoring Board (“DSMB”) organized by the clinical trial sponsor, which provides authorization
for whether or not a clinical trial may move forward at designated check points based on access to certain data from the clinical trial,
and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects, or based on other grounds, such
as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical trial results
to public registries.

For
purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

●
Phase
1-The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.
These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product
in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

●
Phase
2-The investigational product is administered to a limited patient population with a specified disease or condition to evaluate
the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
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. 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.

●
Phase
3-The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically
significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical
trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to
provide an adequate basis for product approval.

●
Phase
4-In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved
to gain more information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA.

Phase
1, Phase 2 and Phase 3 testing may not be completed successfully within a specified period, if at all, and there can be no assurance
that the data collected will support FDA approval or licensure of the product. Concurrent with clinical trials, companies may complete
additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize
a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must
be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing
the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate
packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo
unacceptable deterioration over its shelf life.

19

BLA
Submission and Review by the FDA

Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development,
nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or
more indications. The BLA must include all relevant data available from pertinent preclinical and clinical studies, including negative
or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing,
controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety
and effectiveness of a use of the product, or from a number of alternative sources, including studies initiated by investigators. The
submission of a BLA requires payment of a substantial user fee to FDA, and the sponsor of an approved BLA is also subject to annual product
and establishment user fees. These fees are typically increased annually. A waiver of user fees may be obtained under certain limited
circumstances.

Once
a BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing,
or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts
the application for filing. The review process is often significantly extended by FDA requests for additional information or clarification.
The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and whether the facility in which
it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.
The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA
will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it
determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent
production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or
more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing
facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information.
Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy
the regulatory criteria for approval.

The
testing and approval process requires substantial time, effort and financial resources, and each may take several years to complete.
The FDA may not grant approval on a timely basis, or at all, and we may encounter difficulties or unanticipated costs in our efforts
to secure necessary governmental approvals, which could delay or preclude us from marketing our products. After the FDA evaluates a BLA
and conducts inspections of manufacturing facilities where the investigational product and/or drug substance will be produced, the FDA
may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific
prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete
and the application is not ready for approval. A Complete Response Letter may request additional information or clarification. The FDA
may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information
and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If
regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be
marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy plan to mitigate risks, which could
include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient
registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling
or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with
pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. The FDA
may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness
after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. In addition,
new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change,
which could delay or prevent regulatory approval of our products under development.

20

A
sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs
and biological products that meet certain criteria. Specifically, new drugs and biological products are eligible for Fast Track designation
if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for
the condition. For a product candidate with Fast Track designation, the FDA may consider sections of the BLA for review on a rolling
basis before the complete application is submitted if relevant criteria are met. A Fast Track designated product candidate may also qualify
for priority review, under which the FDA sets the target date for FDA action on the BLA at six months after the FDA accepts the application
for filing. Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety
or effectiveness of the treatment, diagnosis, or prevention of a serious condition. If criteria are not met for priority review, the
application is subject to the standard FDA review period of 10 months after FDA accepts the application for filing. Priority review designation
does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

Under
the Accelerated Approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to
predict clinical benefit, or a clinical endpoint that can be measured earlier than irreversible morbidity or mortality and that is reasonably
likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity,
or prevalence of the condition and the availability or lack of alternative treatments. Post-marketing studies or completion of ongoing
studies after marketing approval are generally required to verify the biologic’s clinical benefit in relationship to the surrogate
endpoint or ultimate outcome in relationship to the clinical benefit.

In
addition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended,
alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary
clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough
therapy, it may take actions appropriate to expedite the development and review of the application. Breakthrough designation also allows
the sponsor to file sections of the BLA for review on a rolling basis.

Fast
Track, Priority Review and Breakthrough Therapy designations do not change the standards for approval but may expedite the development
or approval process.

Other
Healthcare Laws and Compliance Requirements

Our
sales, promotion, medical education and other activities following product approval will be subject to regulation by numerous regulatory
and law enforcement authorities in the United States in addition to the FDA, including potentially the Federal Trade Commission, the
Department of Justice, the Centers for Medicare and Medicaid Services, other divisions of the Department of Health and Human Services,
and state and local governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute,
the Foreign Corrupt Practices Act, the False Claims Act (“FCA”), the Veterans Health Care Act, physician payment transparency
laws, privacy laws, security laws, and additional state laws similar to the foregoing.

The
federal Anti-Kickback Statute prohibits, among other things, the offer, receipt, or payment of remuneration in exchange for or to induce
the referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal
health care programs. Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free
or reduced price items and services. The government has enforced the Anti-Kickback Statute to reach large settlements with healthcare
companies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not
need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the government
may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false
or fraudulent claim for purposes of the FCA. Many states have similar laws that apply to their state health care programs as well as
private payors.

21

The
FCA imposes liability on persons who, among other things, present or cause to be presented false or fraudulent claims for payment by
a federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent,
that are for services not provided as claimed, or for services that are not medically necessary. Actions under the FCA may be brought
by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result
in significant monetary penalties and treble damages. For example, the federal government is using the FCA, and the accompanying threat
of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country,
in connection with the promotion of products for unapproved uses and other sales and marketing practices. The government has obtained
multi-million and multibillion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal
statutes. In addition, companies have been forced to implement extensive corrective action plans, and have often become subject to consent
decrees or corporate integrity agreements, restricting the manner in which they conduct their business. The federal Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”) also created federal criminal statutes that prohibit, among other things,
knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly
and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement
in connection with the delivery of or payment for healthcare benefits, items or services. Given the significant size of actual and potential
settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’
and manufacturers’ compliance with applicable fraud and abuse laws.

In
addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare
providers. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively,
the “Affordable Care Act”), among other things, imposed new reporting requirements on drug manufacturers for payments or
other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians
and their immediate family members. Failure to submit required information may result in civil monetary penalties. Certain states
also mandate implementation of commercial compliance programs, impose restrictions on drug manufacturer marketing practices and/or require
the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

We
may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business.
HIPAA, as amended by the Health Information Technology and Clinical Health Act (“HITECH”) and their respective implementing
regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information.
Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,”
defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information
in connection with providing a service for or on behalf of a covered entity. HITECH also increases the civil and criminal penalties that
may be imposed against covered entities, business associates and possibly other persons, and gives state attorneys general new authority
to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and
costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in
certain circumstances, many of which differ from each other in significant ways and may not have the same effect.

If
our operations are found to be in violation of any of such laws or any other governmental regulations that apply to it, we may be subject
to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations,
exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability
to operate our business and our financial results. Also, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws
generally prohibit companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining
or retaining business. We cannot assure you that our internal control policies and procedures will protect us from reckless or negligent
acts committed by our employees, future distributors, partners, collaborators or agents. Violations of these laws, or allegations of
such violations, could result in fines, penalties or prosecution and have a negative impact on our business, results of operations and
reputation.

Coverage
and Reimbursement

Sales
of pharmaceutical products depend significantly on the availability of third-party coverage and reimbursement. Third-party payors include
government health administrative authorities, managed care providers, private health insurers and other organizations. Although we currently
believe that third-party payors will provide coverage and reimbursement for our product candidates, if approved, these third-party payors
are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant
uncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive clinical studies
to demonstrate the comparative cost-effectiveness of our product candidates. Seeking coverage and reimbursement from third-party payors
can be time consuming and expensive. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an
adequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our products on a
competitive and profitable basis.

22

Foreign
Regulation

In
addition to regulations in the United States, we are and will be subject, either directly or through our distribution partners, to a
variety of regulations in other jurisdictions governing, among other things, clinical trials and commercial sales and distribution of
our products, if approved.

Whether
or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries
prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United
States have processes that require the submission of a clinical trial application much like an IND prior to the commencement of human
clinical trials. In Europe, for example, a clinical trial application (“CTA”) must be submitted to the competent national
health authority and to independent ethics committees in each country in which a company plans to conduct clinical trials. Once the CTA
is approved in accordance with a country’s requirements, clinical trials may proceed in that country.

The
requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to
country, even though there is already some degree of legal harmonization in the European Union (the “E.U.”) member states
resulting from the national implementation of underlying E.U. legislation. In all cases, the clinical trials are conducted in accordance
with GCP and other applicable regulatory requirements.

To
obtain regulatory approval of a new drug or medicinal product in the E.U., a sponsor must obtain approval of a marketing authorization
application. The way in which a medicinal product can be approved in the E.U. depends on the nature of the medicinal product.

The
centralized procedure results in a single marketing authorization granted by the European Commission that is valid across the E.U., as
well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived from biotechnology
processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as
HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) officially
designated as “orphan drugs” and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered
medicines. The centralized procedure may at the request of the applicant also be used for human drugs which do not fall within the above
mentioned categories if the human drug (a) contains a new active substance which was not authorized in the European Community; or (b)
the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the
granting of authorization in the centralized procedure is in the interests of patients or animal health at the European Community level.

Under
the centralized procedure in the E.U., the maximum timeframe for the evaluation of a marketing authorization application by the EMA is
210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions
asked by the Committee for Medicinal Products for Human Use (“CHMP”)), with adoption of the actual marketing authorization
by the European Commission thereafter. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product
is expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria:
(i) the seriousness of the disease to be treated, (ii) the absence of an appropriate alternative therapeutic approach, and (iii) anticipation
of exceptional high therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed
within 150 days and the opinion issued thereafter.

The
Mutual Recognition Procedure (“MRP”) for the approval of human drugs is an alternative approach to facilitate individual
national marketing authorizations within the E.U. The MRP may be applied for all human drugs for which the centralized procedure is not
obligatory. The MRP is applicable to the majority of conventional medicinal products, and is based on the principle of recognition of
an already existing national marketing authorization by one or more member states.

23

The
characteristic of the MRP is that the procedure builds on an already existing marketing authorization in a member state of the E.U. that
is used as reference in order to obtain marketing authorizations in other E.U. member states. In the MRP, a marketing authorization for
a drug already exists in one or more member states of the E.U. and subsequently marketing authorization applications are made in other
E.U. member states by referring to the initial marketing authorization. The member state in which the marketing authorization was first
granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied for
act as concerned member states.

The
MRP is based on the principle of the mutual recognition by E.U. member states of their respective national marketing authorizations.
Based on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member
states. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment
is completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling
and package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary
of product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement
of the agreement.

Should
any E.U. member state refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious
risk to public health, the issue will be referred to a coordination group. Within a timeframe of 60 days, member states shall, within
the coordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee
for arbitration. The opinion of this EMA Committee is then forwarded to the Commission, for the start of the decision-making process.
As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee
on Human Medicinal Products or Veterinary Medicinal Products, as appropriate.

For
other countries outside of the E.U., such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct
of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials
are conducted in accordance with GCP and the other applicable regulatory requirements.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical
trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Plan
of Arrangement

On
August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”). Pursuant to the Arrangement,
certain pipeline assets of the Company were spun-out to BriaPro Therapeutics Corp. (“BriaPro” or “SpinCo”), including
Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”),
resulting in a two-third (2/3) owned subsidiary of the Company with the remaining one-third (1/3) held by the Company’s shareholders.
BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration for the issuance by BriaPro to the Company
of BriaPro’s common shares. Under the terms of the Arrangement, for each common share of the Company held immediately prior to
closing, the shareholders of the Company received one common share of BriaPro, and one new common share of the Company (retiring their
old share) having the same terms and characteristics as the existing common shares of the Company. The Company’s common shares
and public warrants remained listed on the Nasdaq Capital Market and the common shares remained listed on the Toronto Stock Exchange,
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 share.

BriaPro
is a pre-clinical stage immunotherapy company developing binding agents and proteins with the intention to boost the ability of the body’s
own cancer-fighting cells to destroy cancerous tumors. Using artificial intelligence (“AI”) with ImmunoPrecise Antibodies
and Receptor AI, BriaPro will identify drug candidates.

The
lead drug discovery candidates for BriaPro includes:

●
Bria-TILsRx™:
Multi-Specific Binding Reagents - Immunotherapy for Cancer: being developed in collaboration with ImmunoPrecise Antibodies.

●
Small
Molecule Program: Protein Kinase C delta (PKCδ) Inhibitors being developed with Receptor AI.

24

The
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.

Instead
of coming up with tens of thousands of compounds to figure out, computers suggest testing ten compounds in a lab, then getting feedback
from the lab results. The machines learn from those results to make a better prediction to provide the next hundred candidates for testing
and ultimately filter to one molecule.

Over
the course of the next year, BriaPro expects to screen several different multi specific binding reagents for activity in vitro as well
as in mouse models of cancer. BriaPro also expects to select at least one candidate to advance into IND enabling studies. Human clinical
studies are expected to be initiated in the first half of 2025. In parallel, BriaPro will continue to optimize the structure of its proprietary
protein kinase C delta inhibitors and advance to the candidates election stage. Human clinical studies are expected to be initiated in
the second half of 2025.

Recent
Developments

On
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
pain. 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
trial use. 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.

On February
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. Disease
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.

On
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.

On
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 studies1. Progression-free-survival
results were reinforced by larger number of prior treatments in Bria-IMT™ population than in comparable studies. Bria-IMT™
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.

1 Cortes
J et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase
3 open-label randomized study. Lancet (2011) 377: 914–23.

25

On
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.

On
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.

Copies
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.

On
May 28, 2024, BriaCell announced a clinical supply agreement with BeiGene, Ltd. (NASDAQ: 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.

On
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. Therapy
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.

Oral
Presentation Summary

Abstract
Number for Publication: 1022

Title:
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: 6/3/2024; 11:30 AM-1:00 PM CDT

This
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.

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

Table
1. Prior Therapies in the Bria-IMT™ Phase 2 Study

Previous
Therapies

Number
of Patients (%)

Antibody-Drug
Conjugates (ADC)

23
(44%)

Immune
Checkpoint Inhibitor (CPI)

11
(20%)

Cyclin-Dependent
Kinase (CDK) 4/6 Inhibitors

34
(63%)

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. Nearly 2/3
of the patients had failed therapy with a CDK 4/6 inhibitor. On average they had failed six prior therapy attempts.

26

In
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
study. The data are shown in Figure 1.

Figure
1. Effect of treatment sequence and formulation on PFS

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

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

The
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.

27

Table
2. Comparative PFS, ORR and CBR in Similar Patients

Study

Prior
Lines of

Therapy

(median, range)

PFS

(months)

ORR

(%)

CBR

(%)

BriaCell’s
Phase 2 study patients who received pivotal Phase 3 study formulation

6
(2-13)

3.9

9.5*

55*

BriaCell’s
ADC Resistant Phase 2 patients who received pivotal Phase 3 study formulation

6
(3-13)

4.1

12**

53**

Bardia,
A. et. al. 1

4
(2-14)

1.7

4

8

Tripathy
D. et. al. 2

≥4
in 91%

1.9

3

10

O’Shaughnessy
J. et. al. non-TNBC 3

5
(2-14)

2.3

4

7

O’Shaughnessy
J. et. al. TNBC 3

4
(2-10)

1.6

5

10

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

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

References: 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

1. Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744.

2. Tripathy D, et al. JAMA Oncol. 2022 Nov 1;8(11):1700-1701. jamaoncol.2022.4346. PMID: 36136348. This paper describes patients with
brain metastases.

3. O’Shaughnessy J, et al. Breast Cancer Res Treat. 2022 Sep;195(2):127-139.

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

On
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.

On
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.

On
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.

On
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. In addition,
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.

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

28

On
October 1, 2024, BriaCell reported 100% resolution of brain metastasis in breast cancer patient with “Eye-Bulging” tumor. Dramatic
anti-tumor response included complete resolution of right temporal lobe brain metastasis in patient with “Eye-Bulging” metastatic
breast cancer. Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continued
to receive BriaCell treatment.

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

As
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.

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

On
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.

29