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BriaCell Therapeutics Corp.

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FY2023 Annual Report · BriaCell Therapeutics Corp.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended July 31, 2023

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Transition Period from [●] to [●]

Commission File Number: 001-40101

BRIACELL THERAPEUTICS CORP.
(Exact name of registrant as specified in its charter)

British Columbia
(State or other jurisdiction
of incorporation or organization)

Suite 300 – 235 15th Street
West Vancouver, BC V7T 2X1
(Address of principal executive offices)

47-1099599
(I.R.S. Employer
Identification No.)

V7T 2X1
(Zip Code)

(604) 921-1810
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Common Shares, no par value
 Warrants to purchase common shares, no par value

Trading Symbol
BCTX
BCTXW

Name of each exchange on which registered
The Nasdaq Stock Market LLC
The Nasdaq Stock Market LLC

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

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

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and
will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form
10-K or any amendment to this Form 10-K. ☒

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

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

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the
Exchange Act.

Large accelerated filer ☐  

Accelerated filer ☐  

Non-accelerated filer ☒  

Smaller reporting
company ☒

Emerging growth
company ☒

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

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

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. ☐

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates based on a closing sale price of $7.48 per share, which
was the last sale price of the common shares as of January 31, 2023, the last business day of the registrant’s most recently completed second fiscal quarter,
was $105,163,751.

As of October 25, 2023, 15,981,726 shares of the registrant’s common shares, no par value per share, were issued and outstanding. 

 
 
 
 
 
 
 
 
Business

Item 1
Item 1A Risk Factors
Item 1B Unresolved Staff Comments
Item 2
Item 3
Item 4

Properties
Legal Proceedings
Mine Safety Disclosures

TABLE OF CONTENTS

PART I

PART II

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 5
Item 6
Item 7
Item 7A Quantitative and Qualitative Disclosures About Market Risk
Item 8
Item 9
Item 9A Controls and Procedures
Item 9B Other Information
Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Financial Statements and Supplementary Data
Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

Item 10
Item 11
Item 12
Item 13
Item 14

Directors, Executive Officers, and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationship and Related Transactions, and Director Independence
Principal Accountant Fees and Services

PART III

Item 15
Item 16

Exhibits
Form 10-K Summary

SIGNATURES

PART IV

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Forward-Looking Statements

This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of
the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
These  statements  may  be  identified  by  such  forward-looking  terminology  as  “may,”  “should,”  “expects,”  “intends,”  “plans,”  “anticipates,”  “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based
on  a  series  of  expectations,  assumptions,  estimates  and  projections  about  our  company,  are  not  guarantees  of  future  results  or  performance  and  involve
substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual
results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our
forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks in the section titled “Risk Factors”, that
may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of
activity, performance or achievements expressed or implied by these forward-looking statements. In addition, you are directed to factors discussed in the
“Business” section and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section, as well as those discussed
elsewhere in this Annual Report on Form 10-K.

All  of  our  forward-looking  statements  are  as  of  the  date  of  this  Annual  Report  on  Form  10-K  only.  In  each  case,  actual  results  may  differ
materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct.
An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Annual Report on Form 10-
K or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and
Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as
required  by  law,  we  do  not  undertake  or  plan  to  update  or  revise  any  such  forward-looking  statements  to  reflect  actual  results,  changes  in  plans,
assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on
Form 10-K, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements
or disclosures by us following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained in this Annual
Report on Form 10-K will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.

3

 
 
 
 
 
This Annual Report on Form 10-K may include market data and certain industry data and forecasts, which we may obtain from internal company
surveys,  market  research,  consultant  surveys,  publicly  available  information,  reports  of  governmental  agencies  and  industry  publications,  articles  and
surveys.  Industry  surveys,  publications,  consultant  surveys  and  forecasts  generally  state  that  the  information  contained  therein  has  been  obtained  from
sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies, clinical trials
and publications are reliable, we have not independently verified market and industry data from third-party sources.

Risk Factor Summary

Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what we
believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our
risk factors in the section titled “Risk Factors”,  together  with  the  other  information  in  this  Annual  Report  on  Form  10-K.  If  any  of  the  following  risks
actually  occurs  (or  if  any  of  those  listed  elsewhere  in  this  Annual  Report  on  Form  10-K  occur),  our  business,  reputation,  financial  condition,  results  of
operations, revenue, and future prospects could be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe
are not material, may also become important factors that adversely affect our business.

● We have a history of losses, may incur future losses and may not achieve profitability;
● We are a pre-revenue clinical stage company;
● We are developing novel technologies which may not be effective or safe;
● We have an unproven market for our product candidates;
● We are heavily reliant on third-parties to carry out a large portion of our business;
● Pre-clinical studies and initial clinical trials are not necessarily predictive of future results;
● We must obtain additional capital to continue our operations;
● We are highly dependent on our key personnel;
● We may not succeed in completing the development of our products, commercializing our products or generating significant revenues;
● We may not successfully develop, maintain and protect our proprietary products and technologies;
● Changes in legislation and regulations may affect our revenue and profitability;
● If  we  or  our  licensees  are  unable  to  obtain  U.S.,  Canadian  and/or  foreign  regulatory  approval  for  our  product  candidates,  we  will  be  unable  to

commercialize our therapeutic candidates;

● Short sellers may be manipulative and may drive down the market price of our common shares;
● Our 2/3rd owned subsidiary BriaPro Therapeutics Corp. (“BriaPro”) may not generate revenue as expected;
● Clinical trials involve a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future

trial results;

● Future issuance of our common shares could dilute the interests of existing shareholders; and
● We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to

raise additional equity capital.

4

 
 
 
 
 
 
ITEM 1. BUSINESS

Overview of the Company

PART I

BUSINESS

BriaCell Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to transform
cancer  care.  Immunotherapies  have  come  to  the  forefront  in  the  fight  against  cancer  as  they  harness  the  body’s  own  immune  system  to  recognize  and
destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor in
a  pivotal1  Phase  3  study  in  advanced  metastatic  breast  cancer.  BriaCell  recently  reported  benchmark-beating  patient  survival  and  clinical  benefit  in
advanced  metastatic  breast  with  median  overall  survival  of  13.5  months  in  BriaCell’s  advanced  metastatic  breast  cancer  patients  vs.  6.7-9.8  months  for
similar patients reported in the literature2. A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by
Incyte)  confirmed  tolerability  and  early-stage  efficacy.  BriaCell  is  also  developing  a  personalized  off-the-shelf  immunotherapy,  Bria-OTS™,  which
provides  a  platform  technology  to  develop  personalized  off-the-shelf  immunotherapies  for  numerous  types  of  cancer,  and  a  soluble  CD80  protein
therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor. 

Market

It is estimated by the National Cancer Institute that in 2023, approximately 297,790 women will be diagnosed with breast cancer in the United
States.  That  means  that  every  two  minutes  an  American  woman  is  diagnosed  with  breast  cancer  and  more  than  43,170  are  projected  to  die  in  2023.
Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is
about 1 in 1,000, and the American Cancer Society estimates that approximately 2,800 new cases of invasive male breast cancer will be diagnosed and
approximately 530 men will die from breast cancer in 2023.

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 2022, 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 are living with MBC.2 For those with metastatic disease at diagnosis, their 5-year survival rate
is 30%.1 For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e. a disease-free interval of
more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is less than 24 months,
their  prognosis  is  worse.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

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

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™.

The  best  response  to  the  Bria-IMT™  monotherapy  regimen  to  date  is  in  patients  who  matched  Bria-IMT™  at  one  or  more  HLA  alleles,  with
higher response rates for patients with 2+ HLA allele matches. If one HLA allele match is found to be sufficient, we will be able to treat ~50-60% of the
patient population, while patients with 2+ HLA matches constitutes ~15-35% of cases.8 We also saw higher clinical benefit rates for patients with grade I/II
tumors. Tumor differentiation in breast cancer cell lines is often described by their classification as Luminal, Basal A and Basal B subtypes, with Luminal
representing well differentiated tumors, Basal B poorly differentiated tumors, and Basal A an intermediate stage tumor (“moderately” differentiated).2 Yao
and  colleagues  in  2005  identified  a  9-gene  signature  (AURKB,  CENPI,  DEPDC1,  DEPDC1B,  FAM83D,  FGD3,  NCAPH,  TNFRSF18,  FCGR1A)
discriminating poorly (grade 3) from moderately (grade 2) differentiated tumors.3 To understand the place of SV-BR-1-GM in this model, we compared its
RNA expression profile with those of three other cell lines representing Luminal (MCF-7), Basal A (MDA-MB-468) and Basal B (MDA-MB-231), using a
10-gene  signature  (AURKB,  CENPI,  DEPDC1,  DEPDC1B,  FAM83D,  FGD3,  NCAPH,  DLGAP,  KIF2C,  VAV3)  derived  from  those  by  Yao  and
colleagues.  The  results,  shown  in  the  figure  below,  demonstrate  that  Bria-IMT™  most  closely  clusters  with  MDA-MB-468  and  as  such  is  considered  a
grade II “moderately differentiated” cell line.

Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.
8 Gragert,  Loren,  Abeer  Madbouly,  John  Freeman,  and  Martin  Maiers.  2013.  “Six-Locus  High  Resolution  HLA  Haplotype  Frequencies  Derived  from
Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.
2  Neve  RM,  Chin  K,  Fridlyand  J,  et  al.  A  collection  of  breast  cancer  cell  lines  for  the  study  of  functionally  distinct  cancer  subtypes.  Cancer  Cell.
2006;10(6):515-527. Doi:10.1016/j.ccr.2006.10.008)
3 Yao F, Zhang C, Du W, Liu C, Xu Y. Identification of gene-expression signatures and protein markers for breast cancer grading and staging. PloS One.
2015;10(9). Doi:10.1371/journal.pone.0138213)

7

 
 
 
 
 
 
 
Based on a publication of patients with relapsed breast cancer, we estimate that this will account for ~40% of relapsed metastatic breast cancer
cases (33% grade II and 7% grade I) (Sundquist M, Brudin L, Tejler G. Improved survival in metastatic breast cancer 1985-2016. Breast. 2017 Feb;31:46-
50. Doi: 10.1016/j.breast.2016.10.005. Epub 2016 Nov 2). In patients with relapsed disease, the overall survival following relapse appears similar for those
with grade II and grade III tumors.9

More recent information comes from 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
Zynyz® with one patient starting on the combination with Keytruda® and crossing-over to the combination with Zynyz® (22 patients total). In phase II of
the study, the Bria-IMT™ regimen is being dosed in combination with Zynyz® with patients randomized to either receive the Bria-IMT™ regimen first (12
patients) or Zynyz® first (12 patients). 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 Zynyz® in phase I, the disease control data is shown below:

■ 12 patients were treated with Bria-IMT™ plus Zynyz®
■ 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 with a CPI has shown a median overall survival (OS) of 13.3 months for patients treated before 2022 and
13.5  months  for  all  patients  by  the  Kaplan  Meier  method,  as  shown  in  the  Figure  below.  For  patients  treated  since  2022,  the  median  OS  has  not  been
reached.

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

The market for breast cancer drugs is a multibillion-dollar market with new drugs being approved on an ongoing basis, indicating the shortage of
safe and effective treatments for this deadly disease. Figure A summarizes current drugs on the market utilized in combination therapy along with their
reported market sales, which further supports market potential for Bria-IMT™ to be used for combination therapy for breast cancer patients.

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

SV-BR-1-GM:

Breast Cancer Incidence
Mortality

Incidence Growth Rate
Relapse rate

USA – 2022

128.3/100K
Stage I & II: 0.2% Stage
III: 3%
Stage IV*: 93%

0.53%

Stage I & II: Local relapse:
0.5%
Reg. Relapse: 6.1%
Distant Relapse: 1.4%

Stage split

  Stage I & II: 61% Stage III:

28%
Stage IV: 11%
39%

Advanced stage Incidence Rate  

Therapy Compliance Rate
Stage IV LoT mPFS

Expected Launch Date

Peak % Market Share

Cannibalization
Gross Price (Yearly)

% Gross to Net discount

287K
Stage I & II: 321
Stage III: 2.3K
Stage IV*: 24K

Stage III: Local relapse:
5.4%
Reg. Relapse: 0%
Distant Relapse: 35%
Stage I & II: 118K Stage
III: 80K Stage IV: 29K

  ●    Breast cancer incidence and mortality. Source:

References

SEER10

●    Stage IV mortality rate represents 3L+ patient

mortality rate

●    De novo incidence growth rate of 0.53% / year

  ●    Liang, T.-J.; Wang; et al. (2013)11

  ●    Source: SEER10

●    Dawood.S; Broglio. K; Ensor. J; et al. (2010)12

84%
1L: 9.0 months
2L: 9.7 months
3L: 5.6 months
2026 (BriaIMT)
2029 (BriaOTS)
BriaIMT – 10%
BriaOTS – 20%;
Peak in 5 year
60%
$186k;
0% yearly price growth
-10%

112K

  ●    Includes US only stage III and IV patients.

       Source: SEER10

  ●    Zhao, H.; Lei, X.; Niu, J.; et al. (2021)13.
  ●    Secondary research based on SOC therapy data

  ●    Estimated launch date

  ●    PMR

  ●    Management input
  ●    Current annual cost of model PD-(L)1i

  ●    Internal assumption

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 See note 5, above.
10 Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press).
2019 Apr 10;11:151-164. SEER Cancer Statistics Factsheets: Female Breast Cancer. National Cancer Institute. Bethesda, MD; American Cancer Society.
Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.
11 Liang TJ, Wang BW, Liu SI, Yeh MH, Chen YC, Chen JS, Mok KT, Chang HT. Recurrence after skin-sparing mastectomy and immediate transverse
rectus abdominis musculocutaneous flap reconstruction for invasive breast cancer. World J Surg Oncol. 2013 Aug 14;11(1):194. Doi: 10.1186/1477-7819-
11-194. PMID: 23945398; PMCID: PMC3751148.
12 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):2169-2174. Doi: 10.1093/annonc/mdq220. Epub 2010 Apr 28. PMID: 20427349; PMCID: PMC2962259. .
13 Zhao H, Lei X, Niu J, Zhang N, Duan Z, Chavez-MacGregor M, Giordano SH. Prescription Patterns, Initiation, and 5-Year Adherence to Adjuvant
Hormonal Therapy Among Commercially Insured Patients With Breast Cancer. JCO Oncol Pract. 2021 Jun;17(6):e794-e808. Doi: 10.1200/OP.20.00248.
Epub 2021 Feb 17. PMID: 33596096; PMCID: PMC8257979.
14 See note 5, above.

9

 
 
 
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

Licchetta15
Harvey16

Rivera17

Gradishar18

Perez19
Leyland-Jones20
von Minckwitz21

Verma22

Geyer23

Bartsch24
Blackwell25

Cortes26

Kazmi27

O’Shaughnessy28

Tripathy29

Treatment & Design

# of Pts

ORR

PFS/TTP  

OS

  Cyclophosphamide and megestrol acetate
  Docetaxel Monotherapy 60 mg/m2
  Docetaxel Monotherapy 75 mg/m2
  Docetaxel Monotherapy 100 mg/m2
  Docetaxel Monotherapy q3wk
  Docetaxel Monotherapy qwk
  ABI-007 (Nab paclitaxel)
  Paclitaxel Monotherapy
  ABI-007 (Nab paclitaxel) 2nd line
  Paclitaxel Monotherapy 2nd line

Ixabepilone Monotherapy
  Trastuzumab with paclitaxel
  Trastuzumab with capecitabine
  Capecitabine Monotherapy
  Trastuzumab emtansine

lapatinib plus capecitabine
  Lapatinib plus capecitabine
  Capecitabine Monotherapy
  Capecitabine and trastuzumab
  Lapatinib Monotherapy
  Lapatinib with trastuzumab
  Vinflunine

alkylating agent

  Eribulin
  Gemcitabine
  Capecitabine
  Sacituzumab
  Treatment of Physicians Choice
  Etirinotecan Pegol
  Treatment of Physicians Choice

29   
122   
146   
139   
59   
59   
229   
225   
132   
136   
126   
32   
78   
78   
495   
496   
163   
161   
40   
148   
148   
298   
296   
229   
134   
80   
235   
233   
92   
86   

31% 
22.1% 
23.3% 
36.0% 
35.6% 
20.3% 
33% 
19% 
27% 
13% 
11.5% 
59% 
48.1% 
27.0% 
43.6% 
30.8% 
22% 
14% 
20% 
6.9% 
10.3% 

7.4 mo 
12.7 wk 
15.0 wk 
16.6 wk 
5.7 mo 
5.5 mo 
23.0 wk 
16.9 wk 
20.9 wk 
16.1 wk 
3.1 mo 
12.2 mo 
8.2 mo 
5.6 mo 
9.6 mo 
6.4 mo 
8.4 mo 
4.4 mo 
8 mo 
8.1 wk 
12.0 wk 

31% 
4% 
4.8% 
2.7% 

4.6 mo 
2.3 mo 
2.8 mo 
1.9 mo 

13.4 mo
10.6 mo
10.3 mo
12.3 mo
18.3 mo
18.6 mo
65.0 wk
55.7 wk
56.4 wk
46.7 wk
8.6 mo

25.5 mo
20.4 mo
30.9 mo
25.1 mo

24 mo
39.0 wk
51.6 wk
9.8 mo
7.2 mo
9.1 mo
9.1 mo
9.3 mo
12.4 mo
6.7 mo
7.8 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,29 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.30

15 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.
16 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).
17 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).
18 Gradishar WJ. Taxanes for the treatment of metastatic breast cancer. Breast Cancer (Auckl). 2012;6:159-71.
19 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).
20 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.
21 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.
22 Verma, S. et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 367, 1783–1791 (2012).
23 Geyer, C. E. et al. Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 355, 2733–2743 (2006).
24 Bartsch, R. et al. Capecitabine and Trastuzumab in Heavily Pretreated Metastatic Breast Cancer. J. Clin. Oncol. 25, 3853–3858 (2007).
25 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).

 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
  
 
 
 
  
 
  
 
 
 
 
  
 
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
26Cortes 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.
27Kazmi 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.
28O’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.
29Tripathy 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.
30 NCCN Guidelines Version 2.2019, 07/02/2019 © 2019 National Comprehensive Cancer Network (NCCN®).

10

 
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).31 This indicates the high unmet need in this patient population which should facilitate regulatory review of
novel therapies such as 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.32  The  National
Cancer Institute (“NCI”) randomized trial adding PANVAC (a poxviral-based immunogen) to docetaxel increased the median PFS from 3.9 months to 7.9
months and is to be used as a basis for larger, more sophisticated clinical trials.33 An immunogen targeting a carbohydrate antigen, globo-H, was associated
with  improved  PFS,  but  only  in  the  subset  able  to  mount  antibody  responses.34  A  Johns  Hopkins  breast  cancer  trial  using  a  breast  cancer  cell  line
transfected  with  the  gene  for  GM-CSF  has  not  been  positive  but,  using  the  same  cell  line  with  trastuzumab,  40%  of  patients  enjoyed  clinical  benefit
(CR+PR+stable)  at  one  year.35  Finally,  the  study  of  targeted  cancer  immunotherapies  in  combination  with  other  therapies  is  receiving  much  attention,
particularly combination with checkpoint inhibitors.36

31 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.
32 Mittendorf, E. A.; Peoples, G. E., Injecting Hope—A Review of Breast Cancer Vaccines. Oncology (Williston Park) 2016, 30 (5), 475-81, 485.
33 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.
34 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).
35 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.
36  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.

11

 
 
 
 
 
 
 
 
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”).

Products/Pipeline 

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.

Bria-IMT™ is currently under Fast Track Designation by the U.S. Food and Drug Administration (the “FDA”) intended to accelerate the review
process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by 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 recently announced partnership with New York Cancer & Blood Specialists (“NYCBS”) as clinical site with more than 30 locations and
35 hospital affiliations throughout Nassau and Suffolk counties, in the Bronx, Manhattan, Queens, Staten Island, and Brooklyn to conduct its pivotal Phase
3 Study of Bria-IMT™ in Advanced Breast Cancer.

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

Prevail Partners, LLC (“Prevail Partners”), an investment fund and affiliate of InfoWorks, has purchased 463,408 BriaCell common shares at a
price of $8.63 for gross proceeds of $4 million, representing a 20% premium to the trailing thirty (30) trading day volume-weighted average price of the
common shares of the Company on the Nasdaq Stock Exchange. The transaction closed on May 19, 2023.

12

 
 
 
 
 
 
 
 
 
 
 
 
 
Recent 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

BriaCell  recently  announced  that  it  has  accepted  a  letter  of  intent  from  Dr.  Massimo  Cristofanilli,  Director  of  Breast  Medical  Oncology  and
Associate  Director  of  Precision  Medicine  in  the  Sandra  and  Edward  Meyer  Cancer  Center  at  Weill  Cornell  Medicine,  outlining  the  parties’  plans  and
commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s novel immunotherapy, Bria-IMT™,
in combination with a check point inhibitor, in early stage, newly diagnosed, high-risk triple negative breast cancer patients who have failed to achieve a
pathological complete response in the neoadjuvant setting.

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

survival of 13.5 months in BriaCell’s advanced metastatic breast cancer patients vs. 6.7-9.8 months for similar patients reported in the literature.

BriaCell  has  achieved  proof  of  concept  based  on  data  from  a  Phase  1/2a  study  of  Bria-IMT™  in  advanced  breast  cancer  patients.  In  essence,
BriaCell  has  demonstrated  disease  control  and  clinical  benefit  in  a  high  proportion  of  patients  with  advanced  breast  cancer  who  have  exhausted  other
therapeutic options. There is also promising data on overall survival as noted above.

Positive Proof of Concept

● Bria-IMT™  has  been  evaluated  in  a  regimen  including  pre-dose  low-dose  cyclophosphamide  (to  reduce  immune  suppression),  intradermal
inoculation  with  20-50  million  irradiated  Bria-IMT™  cells  between  two  and  three  days  later,  with  subsequent  intradermal  inoculation  with
interferon-α2 approximately two days later. This is known as the Bria-IMT™ regimen.

● BriaCell has evaluated the Bria-IMT™ regimen in two Phase I/IIa studies of Bria-IMT™ in advanced breast cancer patients. Both were single arm

studies, so there were no untreated patients for comparison.

13

 
 
 
 
 
 
 
 
 
 
 
 
 
 
● There were four evaluable patients treated in one study (Study SVMC #01-026) and 23 evaluable patients treated in another study (Study WRI-
GEV-007) with this regimen with cycles every two weeks for the first month and then monthly. They were heavily pre-treated with a median of
four prior systemic therapy regimens.

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

Study SVMC #01-026

● In  the  SVMC  #01-026  study,  treatment  was  limited  to  six  cycles  over  five  months.  Four  post-menopausal  white  women  were  enrolled  aged

between 58.7 and 73 years. Three had breast cancer and one had Her2+ ovarian cancer. All had failed at least one prior systemic therapy.

● These patients received between four and six cycles of treatment on protocol. One patient had an additional 13 cycles off protocol.

● The only adverse events that occurred in more than one patient were itch and rash at the inoculation sites. No deaths were reported during this
study. There were four serious adverse events (“SAEs”) in 3 patients with one (transient urticaria, grade 3) judged probably related to treatment.
All SAEs were manageable with community practice therapies.

● The Bria-IMT™ regimen was able to elicit delayed-type hypersensitivity (“DTH”) responses in all patients. DTH is a measure of cell-mediated
immunity. This response involves the interaction of T-cells, monocytes, and macrophages. This reaction is caused when CD4+ Th1 helper T cells
recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting cells. These can be macrophages or
dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation of additional CD4+ Th1 cells. CD4+ T cells
secrete  other  cytokines  including  IL-2  and  interferon  gamma,  inducing  the  further  release  of  other  TH1  cytokines,  thus  mediating  the  immune
response.  This  results  also  in  the  activation  of  CD8+  T  cells  which  destroy  target  cells  on  contact,  and  activated  macrophages  which  produce
hydrolytic enzymes.

● The DTH  response  involves  the  interaction  of  T-cells,  monocytes,  and  macrophages.  This  reaction  is  caused  when  CD4+  Th1  helper  T  cells
recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting cells. These can be macrophages or
dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation of additional CD4+ Th1 cells. CD4+ T cells
secrete  other  cytokines  including  IL-2  and  interferon  gamma,  inducing  the  further  release  of  other  Th1  cytokines,  thus  mediating  the  immune
response.  This  results  also  in  the  activation  of  CD8+  T  cells  which  destroy  target  cells  on  contact  and  activated  macrophages  which  produce
hydrolytic enzymes.

14

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
● One patient (A002) had a partial response with regression of breast lesions, resolution of lung and soft tissue lesions, and improvement of stability
of bone lesions. She completed therapy and 3 months after her last Bria-IMT™ inoculation, imaging studies identified regrowth of tumor notably
in  the  breast,  lung,  and  brain.  After  consultation  with  the  FDA,  the  patient  was  treated  off-protocol  which  also  produced  tumor  regression,
including the resolution of brain metastases. The HLA-DRB3 and HLA-DRB1 alleles of patient A002 matched with that of SV-BR-1-GM. Her
tumor  was  grade  II  (moderately  differentiated).  One  other  patient  on  this  study  (B001)  with  a  grade  II  tumor  had  disease  limited  to  bony
metastases. She did not have measurable disease but was felt to progress on study.

● Median time  to  tumor  progression  was  144  days  (range  64  –  223  days)  for  the  initial  round  of  treatment.  Overall  survival  was  more  than  33

months in all patients except B001 (7 months).

Study WRI-GEV-007

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

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

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

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

● Several patients  showed  evidence  of  anti-tumor  activity  of  the  Bria-IMT™  regimen  in  spite  of  their  being  heavily  pre-treated  advanced  breast
cancer patients. Specifically, one patient (designated 01-002) had regression or disappearance of 20 lung metastases, and stable disease in liver
metastases (as the liver metastases were the target lesions, she did not qualify as a partial response). She displayed a robust DTH response, had a
grade I tumor and matched Bria-IMT™ at 2 HLA loci. One patient (05-002) had a reduction in the size of a breast lesion but progression of a liver
lesion and did not meet criteria for a partial response. She also displayed a robust DTH response, had a grade II tumor and matched Bria-IMT™ at
2 HLA loci. One patient (01-005) had a marked reduction in cutaneous involvement but developed restrictive cardiomyopathy (unrelated to study
drug) with subsequent mortality. She had a grade III (poorly differentiated) tumor and matched Bria-IMT™ at one HLA locus. She was not on
study long enough to be evaluated for her response.

● Patients 01-002, 05-002 and 01-005 who showed objective evidence of tumor shrinkage all matched the Bria-IMT™ cell line at least at one HLA
locus and all had evidence of DTH responses to Bria-IMT™ and/or the parent cell line (SV-BR-1 – the breast cancer cell line from which Bria-
IMT™ was derived). Patients who did not develop a DTH response did not show evidence of tumor shrinkage.

● Patients 01-002 and 05-002 had grade I/II tumors. Both of them also had two HLA matches with Bria-IMT™. Two other patients with grade II
tumors (patient 03-001 and 06-001) had stable disease on the study and were also considered to have received clinical benefit from the treatment.
(Clinical benefit was defined as some evidence of tumor shrinkage (including a mixed response with shrinkage of some tumors but progression of
others, as for 05-002) with over 90 days on study; or as stable disease, a partial response or a complete response as per RECIST criteria). Neither
03-001 nor 06-001 had HLA matches with Bria-IMT™, suggesting that HLA matching may not be required for clinical benefit in patients with
grade I/II tumors. Thus, four of the six patients with grade I/II tumors exhibited clinical benefit. One of the remaining patients showed no evidence
of an immune response as evaluated by DTH. Thus, four of the five grade I/II patients able to develop an immune response, as noted by DTH,
exhibited clinical benefit.

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

response and able to induce reduction in tumor burden.

15

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study BRI-ROL-001

● Another  phase  I/IIa  study  (BRI-ROL-001)  was  initiated  evaluating  the  combination  of  the  Bria-IMT™  regimen  with  KEYTRUDA®
(pembrolizumab). This  combination  combines  the  induction  of  an  immune  response  by  Bria-IMT™  (i.e.  “putting  the  foot  on  the  gas”  of  the
immune response) with the ability of KEYTRUDA® to block the PD-1 – PD-L1 immune checkpoint (i.e. to “take the foot off the brakes” of the
immune response).

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

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

● Two patients had evidence of tumor regression, both of whom had robust immune responses (as measured by DTH) to Bria-IMT™. Both of them
had grade II tumors. One matched Bria-IMT™ at two HLA types (06-005) while the other did not match Bria-IMT™ at any HLA types (06-001,
who  “rolled  over”  from  the  WRI-GEV-007  study  where  she  had  stable  disease),  suggesting  that  the  Bria-IMT™  regimen,  when  given  in
combination with a PD-1 inhibitor, may be able to induce tumor regression without an HLA match especially in patients with grade I/II tumors.
One additional patient (06-004) in this study had a grade II tumor and was noted to have stable disease. The other seven patients treated had grade
III tumors (poorly differentiated). Thus, all three of the patients with grade I/II tumors showed evidence of clinical benefit.

● Following the  establishment  of  a  collaboration  with  Incyte  Corporation,  this  study  was  altered  to  evaluate  the  combination  of  the  Bria-IMT™

regimen with retifanlimab (anti-PD-1 antibody similar to KEYTRUDA®). The combination with KEYTRUDA® has been discontinued.

● A total of 12 patients were treated in the phase I part of the study in combination with retifanlimab.  One of then switched from the Keytruda®

combination to the retifanlimab combination.  

● 50% of the evaluable patients showed disease control (stable disease or a partial response) with the safety profile again excellent.

● Dosing in this study is ongoing in the randomized phase II portion, with patients randomized either to receive Bria-IMT™ first for retifanlimab

first.

● Overall survival data has been evaluated for all patients as of 2023 September 8. The median overall survival is 13.5 months, which compares

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

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

evaluation in a pivotal registration study.

About Bria-IMT™

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.

16

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bria-OTS™

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

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

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

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

HLA type, they were more likely to respond.

● HLA molecules  are  the  molecules  that  start  immune  responses  but  are  polymorphic  –  i.e.  they  are  different  in  different  people,  although some

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

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

specific HLA types (a.k.a. alleles).

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

● Using the BriaDX™, a companion diagnostic test performed on the patient’s saliva, the suitable personalized treatment will be selected for each

patient for administration.

● This approach allows personalized treatment without the need for personalized manufacturing. Additionally, it saves time, and skips expensive and

complicated manufacturing procedures associated with other personalized treatments.

● Bria-OTS™ cell lines are being engineered and transferred to good manufacturing practice (“GMP”) production and clinical evaluation is planned
to commence in 2023 (expected authorization by FDA and expected first patient to be dosed in 2023) with safety and efficacy data expected to be
released during 2023 and 2024.

● Bria-OTS™  cell  lines  have  also  been  engineered  to  express  co-stimulatory  molecules  and  additional  cytokines  that  can  activate  naïve  T  cells

(those that have not been pre-activated). These “Bria-OTS™ 2.0” cells are expected to be very potent in eliciting an anticancer immune response.

● Bria-OTS™ 2.0 cell lines for breast cancer and prostate cancer cells should be entering GMP manufacturing in 2023 or early 2024. Similar cell

lines for lung cancer and melanoma will follow.

● Bria-OTS™ 2.0 cell lines have the potential to transform cancer treatment as with simple intradermal injections tailored to the individual patient, a
potent and broad immune response against their cancer can be elicited, which should result in marked destruction of the tumors by the patient’s
own immune system.

37 Lacher M.D., Bauer G. Fury B., Graeve S., Fledderman E.L., Petrie T.D., Coleal-Bergum D.P., Hackett T., Perotti N.H., Kong Y.Y., Kwok W.W., Wagner
J.P., Wiseman C.L., and Williams W.V. SV-BR-1-GM, a Clinically Effective GM-CSF- Secreting Breast Cancer Cell Line, Expresses an Immune Signature
and Directly Activates CD4+ T Lymphocytes. Frontiers in Immunology 2018; 9: Article 776.

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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. Release testing is underway with
the goal to initiate clinical studies in 2H2023. The prostate cancer cell line is expected to initiate GMP manufacturing in late 2023 or early 2024
with the lung cancer and melanoma cell lines to follow.

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

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.

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

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.

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 KBI Biopharma, Inc. (“KBI”) and the University of California, Davis Health System
(“UC Davis”) GMP facility, who have developed a frozen formulation where the cells are grown, harvested and irradiated, followed by cryopreservation in
a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation. 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.

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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.

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The Company has filed and own 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.

2.

Compositions comprising SV-BR-1 cells

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 recently 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.

Competition

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.

20

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 NPS.

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.

Employees

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

SC, HI, and NJ. We also have international employees located in Canada and Israel.

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

eight).

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, 2023 and 2022, we incurred $14,264,048 and $7,585,926, respectively, of net research and development expenses

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

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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

KBI, which is located in The Woodlands, Texas.

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™.

Pursuant to the Company’s master services agreement with KBI, dated March 17, 2017, KBI has conducted developmental studies to derive and
optimize a cryopreserved formulation of Bria-IMT™ (previously known as BriaVax) as a research working cell bank of final drug product doses suitable
for cold chain shipment (the “KBI Services”). The Company pays for the cost of materials, consumables, and third party services, plus an additional 5% fee
to compensate KBI for the cost of purchasing, material handling, inventory and administration and management of third party services necessary for KBI to
perform the KBI Services. The master services agreement with KBI terminates on May 4, 2027.

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.

Sales and Marketing

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.

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

business.

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.

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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 studies 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.

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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.

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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, 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.

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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.

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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.

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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.

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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.

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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.

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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 May 9, 2023, the Company entered into a Master Service and Technology Agreement (the “MST Agreement”) with Prevail InfoWorks, Inc.
(“InfoWorks”)  pursuant  to  which  InfoWorks  will  provide  clinical  services  and  technologies  for  the  Company’s  upcoming  pivotal  study  in  advanced
metastatic breast cancer. The Company has agreed to pay InfoWorks $5,379,945 upon signing of the MST Agreement and pay InfoWorks additional fees
upon the achievement of certain milestones.  

On May 12, 2023, the Company entered into a stock purchase agreement (the “Prevail Partners Purchase Agreement”) with Prevail Partners, LLC,
an investment fund and affiliate of InfoWorks, pursuant to which the Company agreed to issue 463,408 common shares for an aggregate purchase price of
$4,000,000. The funds received were used to pay amounts owed to InfoWorks under the MST Agreement.

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ITEM 1A. RISK FACTORS 

An investment in our securities involves a high degree of risk. An investor should carefully consider the risks described below as well as other information
contained  in  this  Annual  Report  on  Form  10-K  and  our  other  reports  filed  with  the  U.S.  Securities  and  Exchange  Commission  (“SEC”).  The  risks  and
uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe are
immaterial may also impair our business operations. If any of the following risks actually occur, our business, financial condition or results of operations
could be materially adversely affected, the value of our securities could decline, and investors in our company may lose all or part of their investment.

Risks Related to Our Business

We have a history of losses, may incur future losses and may not achieve profitability

BriaCell  is  a  development  stage  immune-oncology  biotechnology  corporation  that  to  date  has  not  recorded  any  revenues  from  the  sale  of
diagnostic or therapeutic products.  Since incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences product
and pre-clinical development and eventually enters into license agreements for its technology. We incurred net losses of $20,302,394 and $26,838,903 in
the  fiscal  years  ended  2023  and  2022,  respectively.  Management  expects  to  continue  to  incur  substantial  operating  losses  unless  and  until  such  time  as
product sales generate sufficient revenues to fund continuing operations. BriaCell has neither a history of earnings nor has it paid any dividends, and it is
unlikely to pay dividends or enjoy earnings in the immediate or foreseeable future.

We are a pre-revenue clinical stage company

The Company is developing novel technologies that may not be efficacious or safe. The Company expects to spend a significant amount of capital
to fund research and development. As a result, the Company expects that its operating expenses will increase significantly and, consequently, it will need to
generate significant revenues to become profitable. Even if the Company does become profitable, it may not be able to sustain or increase profitability on a
quarterly  or  annual  basis.  The  Company  cannot  predict  when,  if  ever,  it  will  be  profitable.  There  can  be  no  assurances  that  the  intellectual  property  of
BriaCell,  or  other  technologies  it  may  acquire,  will  meet  applicable  regulatory  standards,  obtain  required  regulatory  approvals,  be  capable  of  being
produced in commercial quantities at reasonable costs, or be successfully marketed. The Company will be undertaking additional laboratory studies or trials
with respect to the intellectual property of BriaCell, and there can be no assurance that the results from such studies or trials will result in a commercially
viable product or will not identify unwanted side effects.

We have an unproven market for our product candidates

The Company believes that the anticipated market for its potential products and technologies if successfully developed will continue to exist and
expand. These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree of commercial
viability of the potential product.

We may not succeed in adapting to and meeting the business needs associated with our anticipated growth

Anticipated  growth  in  all  areas  of  BriaCell’s  business  is  expected  to  continue  to  place  a  significant  strain  on  its  managerial,  operational  and
technical resources. The Company expects operating expenses and staffing levels to increase in the future. To manage such growth, the Company must
expand its operational and technical capabilities and manage its employee base while effectively administering multiple relationships with various third
parties.  There  can  be  no  assurance  that  the  Company  will  be  able  to  manage  its  expanding  operations  effectively.  Any  failure  to  implement  cohesive
management  and  operating  systems,  to  add  resources  on  a  cost-effective  basis  or  to  properly  manage  the  Company’s  expansion  could  have  a  material
adverse effect on its business and results of operations.

BriaPro may not generate revenue as expected

We are a majority shareholder of BriaPro. BriaPro may not generate financial returns or may not yield the desired business outcome. The success
of our investment in a company is sometimes dependent on the availability of additional funding on favorable terms or a liquidity event such as an initial
public offering. We may record impairment charges in relation to our strategic investments which will have a negative impact on our financial position. 

This may expose us to additional reputational, financial, legal, compliance or operational risks. This could impact our return on our investment. In

the event BriaPro fails to generate revenue, this may erode or dilute its value to our shareholders.

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We are heavily reliant on third-parties to carry out a large portion of our business

The  Company  does  not  expect  to  have  any  in-house  manufacturing,  pharmaceutical  development  or  marketing  capability.  To  be  successful,  a
product must be manufactured and packaged in commercial quantities in compliance with regulatory requirements and in reasonable time frames and at
accepted costs. The Company intends to contract with third parties to develop its products. No assurance can be given that the Company or its suppliers
will be able to meet the supply requirements in respect of the product development or commercial sales.

Production  of  therapeutic  products  may  require  raw  materials  for  which  the  sources  and  amount  of  supply  are  limited,  or  may  be  hindered  by
quality or scheduling issues in respect of the third party suppliers over which the Company has limited control. An inability to obtain adequate supplies of
raw materials could significantly delay the development, regulatory approval and marketing of a product. The Company has limited in-house personnel to
internally manage all aspects of product development, including the management of multi-center clinical trials. The Company is significantly reliant on
third-party  consultants  and  contractors  to  provide  the  requisite  advice  and  management.  There  can  be  no  assurance  that  the  clinical  trials  and  product
development will not encounter delays which could adversely affect prospects for the Company’s success.

To  be  successful,  an  approved  product  must  also  be  successfully  marketed.  The  market  for  the  Company’s  product  being  developed  by  the
Company may be large and will require substantial sales and marketing capability. At the present time, the Company does not have any internal capability
to  market  pharmaceutical  products.  The  Company  intends  to  enter  into  one  or  more  strategic  partnerships  or  collaborative  arrangements  with
pharmaceutical  companies  or  other  companies  with  marketing  and  distribution  expertise  to  address  this  need.  If  necessary,  the  Company  will  establish
arrangements  with  various  partners  for  geographical  areas.  There  can  be  no  assurance  that  the  Company  can  market,  or  can  enter  into  a  satisfactory
arrangement with a third party to market a product in a manner that would assure its acceptance in the marketplace. However, if a satisfactory arrangement
with a third party to market and/or distribute a product is obtained; the Company will be dependent on the corporate collaborator(s) who may not devote
sufficient time, resources and attention to the Company’s programs, which may hinder efforts to market the products.

Should  the  Company  not  establish  marketing  and  distribution  strategic  partnerships  and  collaborative  arrangements  on  acceptable  terms,  and
undertake some or all of those functions, the Company will require significant additional human and financial resources and expertise to undertake these
activities, the availability of which is not guaranteed. The Company will rely on third parties for the timely supply of raw materials, equipment, contract
manufacturing, and formulation or packaging services. Although the Company intends to manage these third-party relationships to ensure continuity and
quality, some events beyond the Company’s control could result in complete or partial failure of these goods and services. Any such failure could have a
material adverse effect on the financial conditions and result of operation of the Company.

Due  to  the  complexity  of  the  process  of  developing  pharmaceutical  products,  the  Company’s  business  may  depend  on  arrangements  with
pharmaceutical and biotechnology companies, corporate and academic collaborators, licensors, licensees and others for the research, development, clinical
testing,  technology  rights,  manufacturing,  marketing  and  commercialization  of  its  products.  Such  agreements  could  obligate  the  Company  to  diligently
bring potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the costs of filing and
prosecuting patent applications. There can be no assurance that the Company will be able to establish or maintain collaborations that are important to its
business on favorable terms, or at all.

A  number  of  risks  arise  from  the  Company’s  potential  dependence  on  collaborative  agreements  with  third  parties.  Product  development  and
commercialization efforts could be adversely affected if any collaborative partner terminates or suspends its agreement with the Company, causes delays,
fails to on a timely basis develop or manufacture in adequate quantities a substance needed in order to conduct clinical trials, fails to adequately perform
clinical  trials,  determines  not  to  develop,  manufacture  or  commercialize  a  product  to  which  it  has  rights,  or  otherwise  fails  to  meet  its  contractual
obligations. The Company’s collaborative partners could pursue other technologies or develop alternative products that could compete with the products
the Company is developing.

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The Company has signed Non-Disclosure Agreements (“NDA”) with many different third parties. As is customary in the industry. There is no
guarantee  that,  despite  the  terms  of  the  NDA  which  bind  third  parties,  the  Company  will  ultimately  be  able  to  prevent  from  such  third  parties  from
breaching their obligations under the NDA. Use of the Company’s confidential information in an unauthorized manner is likely to negatively affect the
Company.

Pre-clinical studies and initial clinical trials are not necessarily predictive of future results

Pre-clinical  tests  and  Phase  I/II  clinical  trials  are  primarily  designed  to  test  safety,  to  study  pharmacokinetics  and  pharmacodynamics  and  to
understand the side effects of product candidates at various doses and schedules. Success in pre-clinical and early clinical trials does not ensure that later
large-scale efficacy trials will be successful, nor does it predict final results. Favorable results in early trials may not be repeated in later trials.

A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in
earlier  trials.  Clinical  results  are  frequently  susceptible  to  varying  interpretations  that  may  delay,  limit  or  prevent  regulatory  approvals.  Negative  or
inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated. Any pre-clinical data
and  the  clinical  results  obtained  for  BriaCell’s  technology  may  not  predict  results  from  studies  in  larger  numbers  of  subjects  drawn  from  more  diverse
populations or in the commercial setting, and also may not predict the ability of our products to achieve their intended goals, or to do so safely.

An inability to obtain raw materials or product supply could have a material adverse effect on the Company’s business, financial condition and results
of operations

Raw materials and supplies are generally available in quantities to meet the needs of the Company’s business. The Company will be dependent on
third-party  manufacturers  for  the  pharmaceutical  products  that  it  markets  An  inability  to  obtain  raw  materials  or  product  supply  could  have  a  material
adverse impact on the Company’s business, financial condition and results of operations.

We must obtain additional capital to continue our operations

The Company anticipates that additional capital will be required to complete its current research and development programs. It is anticipated that
future  research,  additional  pre-clinical  and  toxicology  studies  and  manufacturing  initiatives,  including  to  prepare  for  market  approval  and  successful
product market launch, will require additional funds. Further financing may dilute the current holdings of shareholders and may thereby result in a loss for
the  shareholders.  There  can  be  no  assurance  that  the  Company  will  be  able  to  obtain  adequate  financing,  or  financing  on  terms  that  are  reasonable  or
acceptable for these or other purposes, or to fulfill the Company’s obligations under various license agreements. Failure to obtain such additional financing
could result in delay or indefinite postponement of further research and development of the Company’s technologies with the possible loss of license rights
to these technologies.

We are highly dependent on our key personnel

Although the Company is expected to have experienced senior management and personnel, the Company will be substantially dependent upon the
services of a few key personnel, particularly Dr. William V. Williams, Dr. Giuseppe Del Priore, Dr. Miguel Lopez-Lago and other professionals for the
successful  operation  of  its  business.  Phase  I  of  the  Company’s  research  and  development  is  planned  to  be  completed  by  qualified  professionals  and  is
expected to concentrate on treatment of advanced breast cancer. The loss of the services of any of these personnel could have a material adverse effect on
the business of the Company. The Company may not be able to attract and retain personnel on acceptable terms given the intense competition for such
personnel among high technology enterprises, including biotechnology and healthcare companies, universities and non-profit research institutions. If we
lose  any  of  these  persons,  or  are  unable  to  attract  and  retain  qualified  personnel,  our  business,  financial  condition  and  results  of  operations  may  be
materially and adversely affected.

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BriaCell in the future may acquire businesses, products or technologies that it believes complement or expand its existing business.

Acquisitions of this type involve a number of risks, including the possibility that the operations of the acquired business will not be profitable or
that the attention of the Company’s management will be diverted from the day-to-day operation of its business. An unsuccessful acquisition could reduce
the Company’s margins or otherwise harm its financial condition.

If the Company experiences a data security breach and confidential information is disclosed, the Company may be subject to penalties and experience
negative publicity

The  Company  and  its  customers  could  suffer  harm  if  personal  and  health  information  were  accessed  by  third  parties  due  to  a  system  security
failure. The collection of data requires the Company to receive and store a large amount of personally identifiable data. Recently, data security breaches
suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting legislative proposals addressing data
privacy and security. The Company may become exposed to potential liabilities with respect to the data that it collects, manages and processes, and may
incur  legal  costs  if  information  security  policies  and  procedures  are  not  effective  or  if  the  Company  is  required  to  defend  its  methods  of  collection,
processing and storage of personal data. Future investigations, lawsuits or adverse publicity relating to its methods of handling such information could have
a material adverse effect on the Company’s business, financial condition and results of operations due to the costs and negative market reaction relating to
such developments.

We may not succeed in completing the development of our products, commercializing our products or generating significant revenues

Since commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates. Our
ability  to  generate  revenues  and  achieve  profitability  depends  on  our  ability  to  successfully  complete  the  development  of  our  products,  obtain  market
approval  and  generate  significant  revenues.  The  future  success  of  our  business  cannot  be  determined  at  this  time,  and  we  do  not  anticipate  generating
revenues from product sales for the foreseeable future. In addition, we face a number of challenges with respect to our future commercialization efforts,
including, among others, that:

● we  may  not  have  adequate  financial  or  other  resources  to  complete  the  development  of  our  product,  including  two  stages  of  clinical

development that are necessary in order to commercialize our products;

● we may not be able to manufacture our products in commercial quantities, at an adequate quality or at an acceptable cost;

● we may not be able to maintain our CE mark due to regulatory changes;

● we may never receive FDA or Health Canada approval for our intended development plans;

● we may not be able to establish adequate sales, marketing and distribution channels;

● healthcare professionals and patients may not accept our product candidates;

● technological breakthroughs in cancer detection, treatment and prevention may reduce the demand for our product candidates;

● changes in the market for cancer treatment, new alliances between existing market participants and the entrance of new market participants

may interfere with our market penetration efforts;

● third-party  payors  may  not  agree  to  reimburse  patients  for  any  or  all  of  the  purchase  price  of  our  products,  which  may  adversely  affect

patients’ willingness to purchase our product candidates;

● uncertainty as to market demand may result in inefficient pricing of our product candidates;

● we may face third-party claims of intellectual property infringement;

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● we may fail to obtain or maintain regulatory approvals for our products candidates in our target markets or may face adverse regulatory or

legal actions relating to our product candidates even if regulatory approval is obtained; and

● we are dependent upon the results of ongoing clinical studies relating to our product candidates and the products of our competitors. We may

fail in obtaining positive results.

If we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our product candidates could be

limited, which in turn could have a material adverse effect on our business, financial condition and results of operations.

If  product  liability  lawsuits  are  brought  against  us,  we  may  incur  substantial  liabilities  and  the  commercialization  of  our  drug  candidates  may  be
affected

As our drug candidates are currently in clinical trials, we face an inherent risk of product liability suits and will face an even greater risk if we
obtain approval to commercialize any drugs. For example, we may be sued if our drug candidates cause or are perceived to cause injury or are found to be
otherwise  unsuitable  during  clinical  testing,  manufacturing,  marketing  or  sale.  Any  such  product  liability  claims  may  include  allegations  of  defects  in
manufacturing, defects in design, a failure to warn of dangers inherent in the drug, negligence, strict liability or a breach of warranties. Claims could also be
asserted  under  state  consumer  protection  acts.  If  we  cannot  successfully  defend  ourselves  against  product  liability  claims,  we  may  incur  substantial
liabilities or be required to limit commercialization of our drug candidates. Even successful defense would require significant financial and management
resources. Regardless of the merits or eventual outcome, liability claims may result in:

● decreased demand for our drugs;

● injury to our reputation;

● withdrawal of clinical trial participants and inability to continue clinical trials;

● initiation of investigations by regulators;

● costs to defend the related litigation;

● diversion of management’s time and our resources;

● substantial monetary awards to trial participants or patients;

● product recalls, withdrawals or labeling, marketing or promotional restrictions;

● loss of revenue;

● exhaustion of any available insurance and our capital resources;

● the inability to commercialize any drug candidate; and

● a decline in the price of our common shares.

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We  believe  that  we  currently  have  appropriate  insurance  covering  clinical  trials.  However,  it  may  transpire  that  the  amount  of  such  insurance
coverage may not be adequate, we may be unable to maintain such insurance, or we may not be able to obtain additional or replacement insurance at a
reasonable cost, if at all. Any inability to maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability
claims  could  prevent  or  inhibit  the  commercialization  of  drugs  we  develop,  alone  or  with  collaborators.  Our  insurance  policies  may  also  have  various
exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or
negotiated  in  a  settlement  that  exceed  our  coverage  limitations  or  that  are  not  covered  by  our  insurance,  and  we  may  not  have,  or  be  able  to  obtain,
sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such
indemnification may not be available or adequate should any claim arise.

Additionally,  we  may  be  sued  if  the  products  that  we  commercialize,  market  or  sell  cause  or  are  perceived  to  cause  injury  or  are  found  to  be

otherwise unsuitable, and may result in:

● decreased demand for those products;

● damage to our reputation;

● costs incurred related to product recalls;

● limiting our opportunities to enter into future commercial partnerships; and

● a decline in the price of our common shares.

Global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts,
such as the conflict between Russia and Ukraine and rising tensions in the Middle East, could make it more difficult for us to access financing and
could adversely affect our business and operations.

Our  ability  to  raise  capital  is  subject  to  the  risk  of  adverse  changes  in  the  market  value  of  our  stock.  Periods  of  macroeconomic  weakness  or
recession and heightened market volatility caused by adverse geopolitical developments could increase these risks, potentially resulting in adverse impacts
on our ability to raise further capital on favorable terms. The impact of geopolitical tension, such as rising tensions in the Middle East, a deterioration in the
bilateral relationship between the US and China or an escalation in conflict between Russia and Ukraine, including any resulting sanctions, export controls
or other restrictive actions that may be imposed by the US and/or other countries against governmental or other entities in, for example, Russia, also could
lead to disruption, instability and volatility in global trade patterns, which may in turn impact our ability to source necessary reagents, raw materials and
other inputs for our research and development operations.

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We may be adversely affected by the effects of inflation.

Inflation  has  the  potential  to  adversely  affect  our  business,  results  of  operations,  financial  position  and  liquidity  by  increasing  our  overall  cost
structure, particularly if we are unable to achieve commensurate increases in the prices we charge our customers. The existence of inflation in the economy
has  the  potential  to  result  in  higher  interest  rates  and  capital  costs,  supply  shortages,  increased  costs  of  labor  and  other  similar  effects.  As  a  result  of
inflation, we may experience increases in the costs of labor, materials, and other inputs, such as engineering consultants. Although we may take measures
to  mitigate  the  impact  of  this  inflation,  if  these  measures  are  not  effective  our  business,  results  of  operations,  financial  position  and  liquidity  could  be
materially adversely affected. Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact
our results of operations and when the cost inflation is incurred.

Risks Related to Our Intellectual Property

We may not successfully develop, maintain and protect our proprietary products and technologies

BriaCell’s success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. BriaCell
files patent applications in the United States and other countries as part of its global strategy to protect its intellectual property and maintains certain U.S.
and  Non-U.S.  patents  in  its  intellectual  property  portfolio.  However,  patents  provide  only  limited  protection  of  BriaCell’s  intellectual  property.  The
assertion of patent protection involves complex legal and factual determinations and is therefore uncertain and can be expensive. BriaCell cannot provide
assurances that patents will be granted with respect to any of its pending patent applications, or that the scope of any of its granted patents, or any patents
granted in the future, will be sufficiently broad to offer meaningful protection, or that it will develop and file patent applications on additional proprietary
technologies that are patentable, or, if patentable, that any patents will be granted from such patent applications. BriaCell’s current or future patents could
be  successfully  challenged,  invalidated  or  circumvented.  This  could  result  in  BriaCell’s  patent  rights  failing  to  create  an  effective  competitive  barrier.
Losing a significant patent or failing to get a patent to issue from a pending patent application that BriaCell considers significant could have a material
adverse effect on BriaCell’s business. The laws governing the scope of patent coverage in various countries continue to evolve. The laws of some foreign
countries  may  not  protect  BriaCell’s  intellectual  property  rights  to  the  same  extent  as  the  laws  of  the  United  States.  BriaCell  has  applied  for  patent
protection  only  in  selected  countries.  Therefore,  third  parties  may  be  able  to  replicate  BriaCell  technologies  covered  by  BriaCell’s  patent  portfolio  in
countries in which it does not have patent protection.

BriaCell’s future success and competitive position depends in part upon its ability to maintain its intellectual property portfolio. There can be no

assurance that any patents will be issued on any existing or future patent applications.

We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our
product candidates

There is a substantial amount of litigation over patent and other intellectual property rights in the biotechnology industry. Whether or not a product
infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. Our management is presently unaware
of  any  other  parties’  patents  and  proprietary  rights  which  our  products  under  development  would  infringe.  Searches  typically  performed  to  identify
potentially  infringed  patents  of  third  parties  are  often  not  conclusive  and,  because  patent  applications  can  take  many  years  to  issue,  there  may  be
applications now pending, which may later result in issued patents which our current or future products may infringe or be alleged to infringe. In addition,
our competitors or other parties may assert that our product candidates and the methods employed may be covered by patents held by them. If any of our
products  infringes  a  valid  patent,  we  could  be  prevented  from  manufacturing  or  selling  such  product  unless  we  are  able  to  obtain  a  license  or  able  to
redesign the product in such a manner as to avoid infringement. A license may not always be available or may require us to pay substantial royalties. We
also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect BriaCell from prior infringement.
Infringement  and  other  intellectual  property  claims,  with  or  without  merit,  can  be  expensive  and  time-consuming  to  litigate  and  can  divert  our
management’s attention from operating our business.

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The steps we have taken to protect our intellectual property may not be adequate, which could have a material adverse effect on our ability to compete
in the market

BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to
be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. In
addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment of inventions provisions, as appropriate, in
our  agreements  with  our  employees,  consultants,  and  service  providers,  to  protect  and  otherwise  seek  to  control  access  to,  and  distribution  of,  our
proprietary information. These measures may not be adequate to protect our intellectual property from unauthorized disclosure, third-party infringement or
misappropriation, for the following reasons:

● the agreements may be breached, may not provide the scope of protection we believe they provide or may be determined to be unenforceable;

● we may have inadequate remedies for any breach;

● proprietary information could be disclosed to our competitors; or

● others may independently develop substantially equivalent or superior proprietary information and techniques or otherwise gain access to our

trade secrets or disclose such technologies.

Specifically,  with  respect  to  non-compete  agreements,  both  state  law  and  precedent  varies  greatly  from  state  to  state  and  we  may  be  unable  to
enforce these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our former employees
gained while working for us. If our intellectual property is disclosed or misappropriated, it could harm our ability to protect our rights and could have a
material adverse effect on our business, financial condition and results of operations.

We may need to initiate lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive and, if we lose, could
cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market

We  rely  on  patents,  confidentiality  and  trade  secrets  to  protect  a  portion  of  our  intellectual  property  and  our  competitive  position.  Patent  law
relating  to  the  scope  of  claims  in  the  technology  fields  in  which  we  operate  is  still  evolving  and,  consequently,  patent  positions  in  the
biotechnology/pharmaceutical industry can be uncertain. In order to protect or enforce our patent rights, we may initiate patent and related litigation against
third parties, such as infringement suits or requests for injunctive relief. BriaCell’s ability to establish and maintain a competitive position may be achieved
in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions
will  depend  on  the  legal  procedures  in  those  jurisdictions.  Any  lawsuits  that  we  initiate  could  be  expensive,  take  significant  time  and  divert  our
management’s attention from other business concerns and the outcome of litigation to enforce our intellectual property rights in patents, copyrights, trade
secrets or trademarks is highly unpredictable. Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications
at risk of not issuing, or adversely affect its ability to distribute any products that are subject to such litigation. In addition, we may provoke third parties to
assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, including attorney fees, if any,
may not be commercially valuable. The occurrence of any of these events could have a material adverse effect on our business, financial condition and
results of operations.

We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of
their former employers

Many of our employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including
our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or any employee or
contractor have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of his or her former employers. Litigation may
be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual
property  rights  or  personnel.  A  loss  of  key  research  personnel  or  their  work  product  could  hamper  or  prevent  our  ability  to  commercialize  certain
therapeutic  candidates,  which  could  severely  harm  our  business,  financial  condition  and  results  of  operations.  Even  if  we  are  successful  in  defending
against these claims, litigation could result in substantial costs and be a distraction to management.

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If  the  FDA  or  comparable  foreign  regulatory  authorities  approve  generic  versions  of  any  of  our  products  that  receive  marketing  approval,  or  such
authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products
could be adversely affected.

Once a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved
Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek approval of generic versions of
reference listed drugs through submission of abbreviated new drug applications in the United States. In support of an abbreviated new drug applications, a
generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage
form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the
reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring
to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Thus, following the
introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for the
reference listed drug has expired. The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of non-patent exclusivity for a
new drug containing a new chemical entity (“NCE”). Specifically, in cases where such exclusivity has been granted, abbreviated new drug applications
may not be submitted to the FDA until the expiration of five years, unless the submission is accompanied by a Paragraph IV certification that a patent
covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application
four years following approval of the reference listed drug.

While we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be
afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period that is less than five
years.  If  the  FDA  were  to  award  NCE  exclusivity  to  someone  other  than  us,  we  believe  that  we  would  still  be  awarded  three  year  “Other”  exclusivity
protection  from  generic  competition,  which  is  awarded  when  an  application  or  supplement  contains  reports  of  new  clinical  investigations  (not
bioavailability  studies)  conducted  or  sponsored  by  an  applicant  and  essential  for  approval.  Manufacturers  may  seek  to  launch  these  generic  products
following the expiration of the applicable marketing exclusivity period, even if we still have patent protection for our product. If we do not maintain patent
protection and data exclusivity for our product candidates, our business may be materially harmed.

Competition  that  our  products  may  face  from  generic  versions  of  our  products  could  materially  and  adversely  impact  our  future  revenue,

profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years
from  its  earliest  United  States  non-provisional  filing  date.  Various  extensions  may  be  available,  but  the  life  of  a  patent,  and  the  protection  it  affords,  is
limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive
products,  including  generics  or  biosimilars.  Given  the  amount  of  time  required  for  the  development,  testing,  and  regulatory  review  of  new  product
candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed
patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

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Risks Related to Regulations

Changes in legislation and regulations may affect our revenue and profitability

Existing and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the
Company  evaluates  the  implications  of  new  rules  and  responds  to  new  requirements.  Failure  to  comply  with  new  rules  and  regulations  could  result  in
enforcement  actions  or  the  assessment  of  other  penalties.  New  laws  and  regulations  could  make  it  more  difficult  to  obtain  certain  types  of  insurance,
including director’s and officer’s liability insurance, and the Company may be forced to accept reduced policy limits and coverage or incur substantially
higher costs to obtain the same or similar coverage, to the extent that such coverage remains available.

The impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Board, or as
executive officers. The Company may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of
which could cause the Company’s general and administrative costs to increase beyond what the Company currently has planned. Although the Company
evaluates and monitors developments with respect to new rules and laws, the Company cannot predict or estimate the amount of the additional costs the
Company may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide assurances that such additional
costs will render the Company compliant with such new rules and laws.

If  we  or  our  licensees  are  unable  to  obtain  U.S.,  Canadian  and/or  foreign  regulatory  approval  for  our  product  candidates,  we  will  be  unable  to
commercialize our therapeutic candidates

To  date,  we  have  not  marketed,  distributed  or  sold  an  approved  product.  Our  therapeutic  candidates  are  subject  to  extensive  governmental
regulations relating to development, clinical trials, manufacturing and commercialization of drugs. We may not obtain marketing approval for any of our
therapeutic candidates in a timely manner or at all. In connection with the clinical trials for our product candidates and other therapeutic candidates that we
may seek to develop in the future, either on our own or throughout licensing arrangements, we face the risk that:

● a product candidate may not prove safe or efficacious;

● the results with respect to any product candidate may not confirm the positive results from earlier preclinical studies or clinical trials;

● the results may not meet the level of statistical significance required by the FDA, Health Canada or other regulatory authorities; and

● the results  will  justify  only  limited  and/or  restrictive  uses,  including  the  inclusion  of  warnings  and  contraindications,  which  could  significantly

limit the marketability and profitability of the therapeutic candidate.

Any delay or failure in obtaining the required regulatory approvals will materially and adversely affect our ability to generate future revenues from
a particular product candidate. Any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market
the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the size of the market for the product. We and
our  licensees,  as  applicable,  also  are,  and  will  be,  subject  to  numerous  foreign  regulatory  requirements  that  govern  the  conduct  of  clinical  trials,
manufacturing  and  marketing  authorization,  pricing  and  third-party  reimbursement.  The  foreign  regulatory  approval  process  includes  all  of  the  risks
associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign requirements. Approval by the
FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval processes than those
required by the FDA and may impose additional testing requirements for our therapeutic candidates.

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If the third parties on which we rely to conduct our clinical trials and clinical development do not perform as contractually required or expected, we
may not be able to obtain regulatory clearance or approval for, or commercialize, our product candidates

We  do  not  have  the  ability  to  independently  conduct  our  clinical  trials  for  our  product  candidates  and  we  must  rely  on  third  parties,  such  as
contract  research  organizations,  medical  institutions,  clinical  investigators  and  contract  laboratories  to  conduct  such  trials.  If  these  third  parties  do  not
successfully  carry  out  their  contractual  duties  or  regulatory  obligations  or  meet  expected  deadlines,  if  these  third  parties  need  to  be  replaced,  or  if  the
quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other
reasons,  our  pre-clinical  development  activities  or  clinical  trials  may  be  extended,  delayed,  suspended  or  terminated,  and  we  may  not  be  able  to  obtain
regulatory clearance for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results and prospects
may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of
their control.

Modifications to our product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances
or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained

Modifications to our product candidates, after they have been approved for marketing, if at all, or to any other pharmaceutical product that we may
develop in the future, may require new regulatory clearance, or approvals, and, if necessitated by a problem with a marketed product, may result in the
recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained. The
FDA  requires  pharmaceutical  products  manufacturers  to  initially  make  and  document  a  determination  of  whether  or  not  a  modification  requires  a  new
approval, supplement or clearance. A manufacturer may determine in conformity with applicable regulations and guidelines that a modification may be
implemented without pre-clearance by the FDA; however, the FDA can review a manufacturer’s decision and may disagree. The FDA may also on its own
initiative determine that a new clearance or approval is required. If the FDA requires new clearances or approvals of any pharmaceutical product or medical
device for which we or our licensees receive marketing approval, if any, we or our licensees may be required to recall such product and to stop marketing
the product as modified, which could require us or our licensees to redesign the product and will have a material adverse effect on our business, financial
condition and results of operations. In these circumstances, we may be subject to significant enforcement actions.

The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any regulatory
authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions regarding them. Success
in  pre-clinical  studies  and  early  clinical  trials  does  not  ensure  that  later  clinical  trials  will  be  successful,  and  we  cannot  be  sure  that  clinical  trials  will
replicate  the  results  of  prior  trials  and  pre-clinical  studies.  The  clinical  trial  process  may  fail  to  demonstrate  that  our  product  candidates  are  safe  and
effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our
clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize our product candidates and generate revenues.
It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

Clinical  trials  involve  a  lengthy  and  expensive  process  with  an  uncertain  outcome,  and  results  of  earlier  studies  and  trials  may  not  be  predictive  of
future trial results

We  have  limited  experience  in  conducting  and  managing  the  clinical  trials  necessary  to  obtain  regulatory  approvals,  including  FDA  approval.
Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we or our licensees will encounter
problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory authorities to delay or suspend clinical
trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials of our most advanced therapeutic candidates
will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing and we may experience
numerous  unforeseen  events  during,  or  as  a  result  of,  the  clinical  trial  process  that  could  delay  or  prevent  commercialization  of  our  current  or  future
therapeutic candidates, including but not limited to:

● delays in securing clinical investigators or trial sites for the clinical trials;

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● delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;

● slower than anticipated patient recruitment and enrollment;

● negative or inconclusive results from clinical trials;

● unforeseen safety issues;

● uncertain dosing issues;

● an inability to monitor patients adequately during or after treatment; and

● problems with investigator or patient compliance with the trial protocols.

A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have
suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier
clinical trials for our therapeutic candidates, we do not know whether any phase 3 or other clinical trials we or our licensees may conduct will demonstrate
adequate efficacy and safety to result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate
do  not  produce  favorable  results,  our  ability  to  obtain  regulatory  approval  for  the  therapeutic  candidate  may  be  adversely  impacted,  which  will  have  a
material adverse effect on our business, financial condition and results of operations.

The pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement and access to drugs,
which could adversely affect our future revenues and profitability

To the extent our products are developed, commercialized, and successfully introduced to market, they may not be considered cost-effective and
third-party  or  government  reimbursement  might  not  be  available  or  sufficient.  Globally,  governmental  and  other  third-party  payors  are  becoming
increasingly  aggressive  in  attempting  to  contain  health  care  costs  by  strictly  controlling,  directly  or  indirectly,  pricing  and  reimbursement  and,  in  some
cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both
governments and private payors inside and outside the U.S. to continue.

In the U.S., we are subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs
and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these pricing pressures. The Affordable Care Act
instituted  comprehensive  health  care  reform,  and  includes  provisions  that,  among  other  things,  reduce  and/or  limit  Medicare  reimbursement,  require  all
individuals  to  have  health  insurance  (with  limited  exceptions),  and  impose  new  and/or  increased  taxes.  The  future  of  the  Affordable  Care  Act  and  its
constituent parts are uncertain at this time.

In almost all markets, pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of our products
and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities. Reimbursement decisions from one
or  more  of  the  European  markets  may  impact  reimbursement  decisions  in  other  European  markets.  A  variety  of  factors  are  considered  in  making
reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments,
that the product represents good value for money for the health service it provides, and that treatment with the product works at least as well as currently
available treatments.

The continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to contain
or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as
well as the availability of capital.

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United  States  federal  and  state  privacy  laws,  and  equivalent  laws  of  other  nations,  may  increase  our  costs  of  operation  and  expose  us  to  civil  and
criminal sanctions

HIPPA,  and  the  regulations  that  have  been  issued  under  it,  and  similar  laws  outside  the  United  States,  contains  substantial  restrictions  and
requirements with respect to the use and disclosure of individuals’ protected health information. The HIPAA privacy rules prohibit “covered entities,” such
as healthcare providers and health plans, from using or disclosing an individual’s protected health information, unless the use or disclosure is authorized by
the  individual  or  is  specifically  required  or  permitted  under  the  privacy  rules.  Under  the  HIPAA  security  rules,  covered  entities  must  establish
administrative,  physical  and  technical  safeguards  to  protect  the  confidentiality,  integrity  and  availability  of  electronic  protected  health  information
maintained or transmitted by them or by others on their behalf. While we do not believe that we will be a covered entity under HIPAA, we believe many of
our customers will be covered entities subject to HIPAA. Such customers may require us to enter into business associate agreements, which will obligate us
to  safeguard  certain  health  information  we  obtain  in  the  course  of  our  relationship  with  them,  restrict  the  manner  in  which  we  use  and  disclose  such
information and impose liability on us for failure to meet our contractual obligations.

In addition, under HITECH, which was signed into law as part of the U.S. stimulus package in February 2009, certain of HIPAA’s privacy and
security requirements are now also directly applicable to “business associates” of covered entities and subject them to direct governmental enforcement for
failure to comply with these requirements. We may be deemed as a “business associate” of some of our customers. As a result, we may be subject as a
“business  associate”  to  civil  and  criminal  penalties  for  failure  to  comply  with  applicable  privacy  and  security  rule  requirements.  Moreover,  HITECH
created a new requirement obligating “business associates” to report any breach of unsecured, individually identifiable health information to their covered
entity customers and imposes penalties for failing to do so.

In  addition  to  HIPAA,  most  U.S.  states  have  enacted  patient  confidentiality  laws  that  protect  against  the  disclosure  of  confidential  medical
information,  and  many  U.S.  states  have  adopted  or  are  considering  adopting  further  legislation  in  this  area,  including  privacy  safeguards,  security
standards, and data security breach notification requirements. These U.S. state laws, which may be even more stringent than the HIPAA requirements, are
not supplanted by the federal requirements, and we are therefore required to comply with them to the extent they are applicable to our operations.

These and other possible changes to HIPAA or other U.S. federal or state laws or regulations, or comparable laws and regulations in countries
where we conduct business, could affect our business and the costs of compliance could be significant. Failure by us to comply with any of the standards
regarding patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including civil monetary penalties and in
some circumstances, criminal penalties. In addition, such failure may damage our reputation and adversely affect our ability to retain customers and attract
new customers.

The  protection  of  personal  data,  particularly  patient  data,  is  subject  to  strict  laws  and  regulations  in  many  countries.  The  collection  and  use  of
personal health data in the E.U. is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on
the protection of individuals with regard to the processing of personal data and on the free movement of such data (the “Data Protection Directive”). The
Data Protection Directive imposes a number of requirements, including an obligation to seek the consent of individuals to whom the personal data relates,
the information that must be provided to the individuals, notification of data processing obligations to the competent national data protection authorities of
individual  E.U.  member  states  and  the  security  and  confidentiality  of  the  personal  data.  The  Data  Protection  Directive  also  imposes  strict  rules  on  the
transfer of personal data out of the E.U. to the U.S.. Failure to comply with the requirements of the Data Protection Directive and the related national data
protection laws of the E.U. member states may result in fines and other administrative penalties and harm our business. We may incur extensive costs in
ensuring compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning of the Data Protection
Directive.

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If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil
penalties  and  exclusion  from  federally  funded  healthcare  programs  including  the  Medicare  and  Medicaid  programs  and  equivalent  third  country
programs, which would have a material adverse effect on our business and results of operations

A  provision  of  the  Social  Security  Act,  commonly  referred  to  as  the  federal  Anti-Kickback  Statute,  prohibits  the  knowing  and  willful  offer,
payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing,
purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare, Medicaid
or any other federal healthcare program. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback
Statute  protecting  certain  common  business  arrangements  and  activities  from  prosecution  or  regulatory  sanctions,  the  exemptions  and  safe  harbors  are
drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor may be subject to scrutiny. The federal Anti-Kickback Statute is
very broad in scope and many of its provisions have not been uniformly or definitively interpreted by existing case law or regulations. In addition, most of
the states have adopted laws similar to the federal Anti-Kickback Statute, and some of these laws are even broader than the federal Anti-Kickback Statute
in that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the
source of payment. Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and
exclusion from participation in federal healthcare programs.

All  of  our  future  financial  relationships  with  U.S.  healthcare  providers,  purchasers,  formulary  managers,  and  others  who  provide  products  or
services to federal healthcare program beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar state laws. We believe
our  operations  will  be  in  compliance  with  the  federal  Anti-Kickback  Statute  and  similar  state  laws.  However,  we  cannot  be  certain  that  we  will  not  be
subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s
attention from operating our business, which in turn could have a material adverse effect on our business. In addition, if our arrangements were found to
violate  the  federal  Anti-Kickback  Statute  or  similar  state  laws,  the  consequences  of  such  violations  would  likely  have  a  material  adverse  effect  on  our
business, results of operations and financial condition.

There are other federal and state laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits, among
other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or
knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly
concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. Moreover, we may be
subject  to  other  federal  false  claim  laws,  including,  among  others,  federal  criminal  healthcare  fraud  and  false  statement  statutes  that  extend  to  non-
government  health  benefit  programs.  Moreover,  there  are  analogous  state  laws.  Violations  of  these  laws  can  result  in  substantial  criminal,  civil  or
administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

Moreover, the provisions of the Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit
companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international
organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law
enforcement activity by U.S. regulators, with more aggressive and frequent investigations and enforcement by both the SEC and the Department of Justice.
A determination that our operations or activities violated U.S. or foreign laws or regulations could result in imposition of substantial fines, interruption of
business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or equitable sanctions. In
addition, lawsuits brought by private litigants may also follow as a consequence.

44

 
 
 
 
 
 
 
In both domestic and foreign markets, the development, formulation, manufacturing, packaging, labeling, handling, distribution, import, export,
licensing,  sale  and  storage  of  pharmaceuticals  and  medical  devices  are  affected  by  a  body  of  laws,  governmental  regulations,  administrative
determinations, including those by Health Canada and the FDA, court decisions and similar constraints.

Such laws, regulations and other constraints can exist at the federal, provincial or local levels in Canada and at all levels of government in foreign
jurisdictions.  There  can  be  no  assurance  that  the  Company  and  the  Company’s  partners  are  in  compliance  with  all  of  these  laws,  regulations  and  other
constraints. The Company and its partners may be required to incur significant costs to comply with such laws and regulations in the future, and such laws
and  regulations  may  have  an  adverse  effect  on  the  business.  The  failure  of  the  Company  or  its  partners  to  comply  with  current  or  future  regulatory
requirements  could  lead  to  the  imposition  of  significant  penalties  or  claims  and  may  have  a  material  adverse  effect  on  the  business.  In  addition,  the
adoption of new laws, regulations or other constraints or changes in the interpretations of such requirements might result in significant compliance costs or
lead the Company and its partners to discontinue product development and could have an adverse effect on the business.

The  Company’s  international  operations  expose  it  and  its  representatives,  agents  and  distributors  to  risks  inherent  to  operating  in  foreign
jurisdictions that could materially adversely affect its operations and financial position.

These risks include:

● country specific taxation policies;

● imposition of additional foreign governmental controls or regulations;

● export license requirements;

● changes in tariffs and other trade restrictions; and

● complexity of collecting receivables in a foreign jurisdiction.

Moreover, applicable agreements relating to business in foreign jurisdictions are governed by foreign laws and are subject to dispute resolution in
the courts of, or through arbitration proceedings in, the country or region in which the parties are located or another jurisdiction agreed upon by the parties.
The Company cannot accurately predict whether such jurisdictions will provide an effective and efficient means of resolving disputes that may arise in the
future. Even if it obtains a satisfactory decision through arbitration or a court proceeding, the Company could have difficulty in enforcing any award or
judgment on a timely basis or at all.

Risks Related to Our Securities

If we are not able to comply with the applicable continued listing requirements or standards of the TSX Exchange or Nasdaq, TSX Exchange or
Nasdaq could delist our common shares

In order to maintain the listing of our common shares on the TSX Exchange and the Nasdaq Capital Market, we must satisfy minimum financial
and  other  continued  listing  requirements  and  standards,  including  those  regarding  director  independence  and  independent  committee  requirements,
minimum stockholders’ equity, minimum share price, and certain corporate governance requirements. There can be no assurances that we will be able to
comply with such applicable listing standards.

Future issuance of our common shares could dilute the interests of existing shareholders

We  may  issue  additional  common  shares  in  the  future.  The  issuance  of  a  substantial  number  of  common  shares  could  have  the  effect  of
substantially diluting the interests of our shareholders. In addition, the sale of a substantial amount of common shares in the public market, in the initial
issuance, in a situation in which we acquire a company and the acquired company receives common shares as consideration and the acquired company
subsequently sells its common shares, or by investors who acquired such common shares in a private placement, could have an adverse effect on the market
price of our common shares.

Short sellers may be manipulative and may drive down the market price of our common shares

Short selling is the practice of selling securities that the seller does not own, but rather has borrowed or intends to borrow from a third party with
the intention of buying identical securities at a later date to return to the lender. A short seller hopes to profit from a decline in the value of the securities
between  the  sale  of  the  borrowed  securities  and  the  purchase  of  the  replacement  shares,  as  the  short  seller  expects  to  pay  less  in  that  purchase  than  it
received  in  the  sale.  It  is  therefore  in  the  short  seller’s  interest  for  the  price  of  the  stock  to  decline,  and  some  short  sellers  publish,  or  arrange  for  the
publication of, opinions or characterizations regarding the relevant issuer, often involving misrepresentations of the issuer’s business prospects and similar
matters calculated to create negative market momentum, which may permit them to obtain profits for themselves as a result of selling the stock short.

As a public entity, we may be the subject of concerted efforts by short sellers to spread negative information in order to gain a market advantage.
In addition, the publication of misinformation may also result in lawsuits, the uncertainty and expense of which could adversely impact our reputation,
business, financial condition, and operating results. There are no assurances that we will not face short sellers’ efforts or similar tactics in the future, and
the market price of our common shares may decline as a result of their actions.

45

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
We have a significant number of restricted share units, options and warrants outstanding, and while these options and warrants are outstanding, it may
be more difficult to raise additional equity capital

As of October 25, 2023, we had outstanding restricted share units, options and warrants to purchase 10,314,012 common shares, respectively. The
holders of these restricted share units, options and warrants are given the opportunity to profit from a rise in the market price of our common shares. We
may find it more difficult to raise additional equity capital while these options and warrants are outstanding. At any time during which these warrants are
likely to be exercised, we may be unable to obtain additional equity capital on more favorable terms from other sources. Additionally, the exercise of these
options and warrants will cause the increase of our outstanding Common shares, which could have the effect of substantially diluting the interests of our
current shareholders.

Sales of a substantial number of our common shares in the public market by our existing shareholders could cause our share price to fall

Sales of a substantial number of our common shares in the public market, or the perception that these sales might occur, could depress the market
price of our common shares and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect
that sales may have on the prevailing market price of our common shares. As of October 25, 2023, we have 10,314,012 shares issuable upon exercise of
restricted share units, options and warrants. Sales of shares by these shareholders could have a material adverse effect on the trading price of our common
shares. We intend to register the offering, issuance, and sale of all common shares that we may issue under our equity compensation plans. Once we register
these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

We are an Emerging Growth Company, which may reduce the amount of information available to investors

The Jumpstart Our Business Start-ups Act (the “JOBS Act”), and our status as a foreign private issuer will allow us to postpone the date by which
we must comply with some of the laws and regulations intended to protect investors and to reduce the amount of information we provide in our reports
filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our Common shares.

For as long as we remain an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions from

various requirements that are applicable to public companies that are not emerging growth companies including:

● the provisions of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the

effectiveness of our internal control over financial reporting;

● any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement

to the auditor’s report on the financial statements.

We  intend  to  take  advantage  of  these  exemptions  until  we  are  no  longer  an  “emerging  growth  company.”  We  will  remain  an  emerging  growth
company until the earlier of (1) the last day of the fiscal year of the fifth anniversary of our initial public offering in the United States, (b) in which we have
total annual gross revenue of at least US$1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our
Common shares that is held by non-affiliates exceeds US$700 million as of the prior June 30; and (2) the date on which we have issued more than US$1.0
billion in non-convertible debt during the prior three-year period.

We  cannot  predict  if  investors  will  find  our  common  shares  or  listed  warrants  (“Warrants”)  less  attractive  because  we  may  rely  on  these
exemptions. If some investors find our common shares or Warrants less attractive as a result, there may be a less active trading market for our common
shares or Warrants, and our common share or Warrant price may be more volatile and may decline.

We have never paid cash dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future. Consequently, any
gains from an investment in our common shares will likely depend on whether the price of our Common shares increases, which may not occur

We have not paid cash dividends on any capital stock to date and we currently intend to retain our future earnings, if any, to fund the development
and growth of our business. Consequently, in the foreseeable future, you will likely only experience a gain from your investment in our common shares if
the price of our common shares increases beyond the price in which you originally acquired the common shares.

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In the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be volatile

In the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be highly volatile.
Some of the factors that may materially affect the market price of our common shares or Warrants are beyond our control, such as changes in financial
estimates by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our common shares or Warrants. These
factors may materially adversely affect the market price of our common shares or Warrants, regardless of our performance. In addition, the public stock
markets  have  experienced  extreme  price  and  trading  volume  volatility.  This  volatility  has  significantly  affected  the  market  prices  of  securities  of  many
companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may adversely affect
the market price of our Common shares.

Our  executive  officers,  directors  and  principal  shareholders  will  maintain  the  ability  to  exert  significant  control  over  matters  submitted  to  our
shareholders for approval

Our executive officers, directors and principal shareholders who owned more than 5% of our outstanding common shares will, in the aggregate,
beneficially own shares representing approximately 21.16% of our share capital. As a result, if these shareholders were to act together, they would be able
to control all matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they act together,
would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of voting
power could delay or prevent an acquisition of our company on terms that other shareholders may desire or result in management of our company that our
public shareholders disagree with.

If we are or become classified as a passive foreign investment company, our U.S. shareholders may suffer adverse tax consequences as a result

Generally, for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to
assets  that  produce  passive  income  or  are  held  for  the  production  of  passive  income,  including  cash,  we  would  be  characterized  as  a  passive  foreign
investment company (“PFIC”) for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest gains from
commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income (including amounts
derived by reason of the temporary investment of funds raised in offerings of our shares) and rents and royalties other than rents and royalties which are
received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a PFIC, our U.S. shareholders may
suffer adverse tax consequences, including having gains realized on the sale of our common shares treated as ordinary income, rather than capital gains, the
loss of the preferential rate applicable to dividends received on our common shares by individuals who are U.S. holders, and having interest charges apply
to distributions by us and gains from the sales of our shares.

Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets. Asset value is
based on which the fair market value of each asset, including goodwill and going concern value (which may be determined by reference to the market value
of our common shares, which may be volatile). Our status will also depend, in part, on when and how we utilize the cash proceeds from any securities
offerings our business. Based upon the value of our assets, including any goodwill, and the nature and composition of our income and assets, we believe
that we will be classified as a PFIC for the taxable year ending July 31, 2023, and possibly for succeeding years. However, even if we are classified as a
PFIC for the year ending July 31, 2023, under an exception to the PFIC classification rules, we may be able to avoid such classification altogether if we can
meet certain conditions set forth in the exception. (See the discussion of PFIC status under “Taxation, U.S. Federal Income Taxation”, below. Because the
determination of whether we are a PFIC for any taxable year is a factual determination made annually after the end of each taxable year, there can be no
assurance as to our status as a PFIC in any taxable year.

47

 
 
 
 
 
 
 
 
 
The tax consequences that would apply if we are classified as a PFIC would also be different from those described above if a U.S. shareholder
were able to make a valid qualified electing fund (“QEF”) election. If we are classified as a PFIC, then we expect to provide U.S. shareholders with the
information necessary for a U.S. shareholder to make a QEF election but there is no assurance that we will do so. See the discussion of PFIC status under
“Taxation, U.S. Federal Income Taxation”, below.

If estimates of revenue, expenses, or capital or liquidity requirements change or are inaccurate, or if cash generated from operations is insufficient
to satisfy liquidity requirements, the Company may arrange additional financings

BriaCell expects that its current cash and cash equivalent reserves will be sufficient to meet its anticipated needs for working capital and capital
expenditures for the near future. In the future, the Company may also arrange financings to give it the financial flexibility to pursue attractive acquisition or
investment opportunities that may arise. The Company may pursue additional financing through various means, including equity investments, issuances of
debt,  joint  venture  projects,  licensing  arrangements  or  through  other  means.  The  Company  cannot  be  certain  that  it  will  be  able  to  obtain  additional
financing on commercially reasonable terms or at all. The Company’s ability to obtain additional financing may be impaired by such factors as the status of
capital markets, both generally and specifically in the pharmaceutical and medical device industries, and by the fact that it is a new enterprise without a
proven  operating  history.  If  the  amount  of  capital  raised  from  additional  financing  activities,  together  with  revenues  from  operations  (if  any),  is  not
sufficient  to  satisfy  the  Company’s  capital  needs,  it  may  not  be  able  to  develop  or  advance  its  products,  execute  its  business  and  growth  plans,  take
advantage of future opportunities, or respond to competitive pressures or unanticipated customer or partner requirements. If any of these events occur, the
Company’s business, financial condition, and results of operations could be adversely affected. Any future equity financings undertaken are likely to be
dilutive to existing shareholders. Finally, the terms of securities issued in future capital transactions may include preferences that are more favourable to
new investors.

If  securities  or  industry  analysts  do  not  publish  or  cease  publishing  research  or  reports  about  us,  our  business  or  our  market,  or  if  they  adversely
change their recommendations or publish negative reports regarding our business or our shares, our share price and trading volume could decline

The trading market for our securities will be influenced by the research and reports that industry or securities analysts may publish about us, our
business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or
provide  favorable  coverage.  If  any  of  the  analysts  who  may  cover  us  adversely  change  their  recommendation  regarding  our  shares,  or  provide  more
favorable relative recommendations about our competitors, the market value of our securities would likely decline. If any analyst who may cover us were to
cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the
price of our common shares and Warrants and our trading volume to decline.

Certain Canadian legislation contains provisions that may have the effect of delaying or preventing a change in control

Canadian legislation could discourage potential acquisition proposals, delay or prevent a change in control and limit the price that certain investors
may be willing to pay for our subordinate voting shares. For instance, a non-Canadian must file an application for review with the Minister responsible for
the Investment Canada Act and obtain approval of the Minister prior to acquiring control of a “Canadian business” within the meaning of the Investment
Canada Act, where prescribed financial thresholds are exceeded. Furthermore, limitations on the ability to acquire and hold our subordinate voting shares
and multiple voting shares may be imposed by the Competition Act (Canada). This legislation permits the Commissioner of Competition to review any
acquisition or establishment, directly or indirectly, including through the acquisition of shares, of control over or of a significant interest in us. Otherwise,
there  are  no  limitations  either  under  the  laws  of  Canada  or  British  Columbia,  or  in  our  articles  on  the  rights  of  non-Canadians  to  hold  or  vote  our
subordinate  voting  shares  and  multiple  voting  shares.  Any  of  these  provisions  may  discourage  a  potential  acquirer  from  proposing  or  completing  a
transaction that may have otherwise presented a premium to our shareholders.

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Because we are a corporation incorporated in British Columbia and some of our directors and officers are resident in Canada or other countries, it
may be difficult for investors in the United States to enforce civil liabilities against us based solely upon the federal securities laws of the United States.
Similarly, it may be difficult for Canadian investors to enforce civil liabilities against our directors and officers residing outside of Canada

We  are  a  corporation  incorporated  under  the  laws  of  British  Columbia  with  our  principal  place  of  business  in  West  Vancouver.  Some  of  our
directors and officers and the auditors or other experts named herein are residents of Canada and all or a substantial portion of our assets and those of such
persons are located outside the United States. Consequently, it may be difficult for U.S. investors to effect service of process within the United States upon
us or our directors or officers or such auditors who are not residents of the United States, or to realize in the United States upon judgments of courts of the
United States predicated upon civil liabilities under the Securities Act. Investors should not assume that Canadian courts: (1) would enforce judgments of
U.S. courts obtained in actions against us or such persons predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or
blue sky laws of any state within the United States, or (2) would enforce, in original actions, liabilities against us or such persons predicated upon the U.S.
federal securities laws or any such state securities or blue sky laws.

Similarly,  some  of  our  directors  and  officers  are  residents  of  countries  other  than  Canada  and  all  or  a  substantial  portion  of  the  assets  of  such
persons are located outside Canada. As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against these non-Canadian
residents. In addition, it may not be possible for Canadian investors to collect from these non-Canadian residents judgments obtained in courts in Canada
predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada. It may also be difficult for Canadian
investors to succeed in a lawsuit in the United States, based solely on violations of Canadian securities laws.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 2. PROPERTIES

As  of  September  2023,  the  Company  commenced  a  month-to-month  lease  arrangement  for  office  and  lab  space  in  Philadelphia,  Pennsylvania,  in  the
amount of approximately $36,000 per month.

ITEM 3. LEGAL PROCEEDINGS

We may be involved from time to time in ordinary litigation, negotiation, and settlement matters that will not have a material effect on our operations or
finances.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

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PART II

ITEM  5.  MARKET  FOR  REGISTRANT’S  COMMON  EQUITY,  RELATED  STOCKHOLDER  MATTERS  AND  ISSUER  PURCHASES  OF
EQUITY SECURITIES

Market information

Our  common  shares  and  Warrants  to  purchase  common  shares  trade  on  The  Nasdaq  Capital  Market  under  the  symbols  “BCTX”  and  “BCTXW”,
respectively, since February 24, 2021 and on the Toronto Stock Exchange (“TSX”) under the symbol “BCT” since December 31, 2021, and prior to that, on
the TSX Venture Exchange from December 3, 2014.

Number of Shareholders

As of October 25, 2023, we have approximately 48 shareholders of record of our common shares.

Dividend Policy

Historically, we have not paid any cash dividends to the holders of shares of our common shares and we do not expect to pay any such dividends in the
foreseeable future as we expect to retain our future earnings for use in the operation and expansion of our business.

Issuer Purchases of Equity Securities

None.

ITEM 6.

Not applicable.

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in this
Annual  Report.  This  discussion  and  other  parts  of  this  Annual  Report  contain  forward-looking  statements  based  upon  current  expectations  that  involve
risks  and  uncertainties.  Our  actual  results  and  the  timing  of  selected  events  could  differ  materially  from  those  anticipated  in  these  forward-looking
statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report.

The preparation of financial statements in conformity with these accounting principles requires us to make estimates and assumptions that affect
the  reported  amounts  of  assets  and  liabilities,  disclosure  of  contingent  liabilities  at  the  financial  statement  date  and  reported  amounts  of  revenue  and
expenses during the reporting period. On an on-going basis, we review our estimates and assumptions. The estimates were based on historical experience
and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates or other forward-
looking statements under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results
of  operations.  Our  actual  results  may  differ  materially  as  a  result  of  many  factors,  including  those  set  forth  under  the  headings  entitled  “Special  Note
Regarding Forward-Looking Statements” and “Risk Factors”.

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Overview

BriaCell Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to transform
cancer  care.  Immunotherapies  have  come  to  the  forefront  in  the  fight  against  cancer  as  they  harness  the  body’s  own  immune  system  to  recognize  and
destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor in
a  pivotal1  Phase  3  study  in  advanced  metastatic  breast  cancer.  BriaCell  recently  reported  benchmark-beating  patient  survival  and  clinical  benefit  in
advanced  metastatic  breast  with  median  overall  survival  of  13.5  months  in  BriaCell’s  advanced  metastatic  breast  cancer  patients  vs.  6.7-9.8  months  for
similar patients reported in the literature2. A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by
Incyte)  confirmed  tolerability  and  early-stage  efficacy.  BriaCell  is  also  developing  a  personalized  off-the-shelf  immunotherapy,  Bria-OTS™,  which
provides  a  platform  technology  to  develop  personalized  off-the-shelf  immunotherapies  for  numerous  types  of  cancer,  and  a  soluble  CD80  protein
therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.

Critical Accounting Policies and Estimates

1. Critical Estimates and Judgements

The  preparation  of  these  consolidated  financial  statements  requires  management  to  make  estimates  and  assumptions  that  affect  the  reported
amounts  of  assets  and  liabilities  at  the  date  of  the  financial  statements  and  reported  amounts  of  expenses  during  the  reporting  period. Actual  outcomes
could  differ  from  these  estimates.  The  financial  statements  include  estimates  which,  by  their  nature,  are  uncertain.  The  impacts  of  such  estimates  are
pervasive throughout the financial statements, and may require accounting adjustments based on future occurrences. Revisions to accounting estimates are
recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future periods.

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

the consolidated financial statements are:

● Intangible assets are tested for impairment annually or more frequently if there is an indication of impairment. The carrying value of intangibles
with  definite  lives  is  reviewed  each  reporting  period  to  determine  whether  there  is  any  indication  of  impairment.  If  there  are  indications  of
impairment the impairment analysis is completed and if the carrying amount of an asset exceeds its recoverable amount, the asset is impaired and
impairment loss is recognized.

● The Company uses the Black-Scholes option-pricing model to estimate fair value of options and the warrant liability at each reporting date. The
key assumptions used in the model are the expected future volatility in the price of the Company’s shares and the expected life of the warrants.

● Preparation  of  the  consolidated  financial  statement  on  a  going  concern  basis,  which  contemplates  the  realization  of  assets  and  payments  of
liabilities  in  the  ordinary  course  of  business.  Should  the  Company  be  unable  to  continue  as  a  going  concern,  it  may  be  unable  to  realize  the
carrying value of its assets, including its intangible assets and to meet its liabilities as they become due

● Provisions for taxes are made using the best estimate of the amount expected to be paid based on a qualitative assessment of all relevant factors.
The  Company  reviews  the  adequacy  of  these  provisions  at  the  end  of  the  reporting  period.  However,  it  is  possible  that  at  some  future  date an
additional  liability  could  result  from  audits  by  taxing  authorities.  Where  the  final  outcome  of  these  tax-related  matters  is  different  from  the
amounts that were initially recorded, such differences will affect the tax provisions in the period in which such determination is made.

2. New Accounting Policies Adopted

No new accounting policies were adopted during the year ended July 31, 2023.

Results of Operations

Comparison of the year ended July 31, 2023, compared to the year ended July 31, 2022

Research Costs

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

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

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

Clinical trials
Pre-clinical projects
Chemical, Manufacturing and Control Costs (“CMC Costs”)
Other

51

Year ended July 31,

2023

2022

$

$

7,843,760    $
3,787,673   
1,801,287   
1,903,918   
15,336,638    $

3,540,955 
2,076,127 
1,346,810 
1,057,597 
8,021,489 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Our  clinical  trial  expenses  include  our  immunotherapy  program,  Bria-IMT™,  a  46-subject  Phase  I/IIa  clinical  trial.  Clinical  trial  expenses  increased  in
2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

Pre-clinical  projects  include  expenses  incurred  in  our  off-the-shelf  personalized  immunotherapies,  including  Bria-OTS+™,  and  Bria-PROS™.  Our  pre-
clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional pre-clinical program
(sCD80).

CMC costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational product.
CMC costs increased in 2023 to support the additional patients in our trials.

Other costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory board expenses,
contracts with vendors for pre-clinical work, and administration costs associated with all our research and development expenditure. Other costs increased
in 2023 as we investigated additional potential pre-clinical projects.

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

Clinical trial sites and investigational drug costs
Wages and salaries
Laboratory Rent
Supplies
Share-based compensation

Year ended July 31,

2023

2022

$

$

9,611,630    $
3,878,367   
194,880   
579,169   
1,072,592   
15,336,638    $

4,912,530 
2,225,050 
138,354 
309,992 
435,563 
8,021,489 

For the year ended July 31, 2023, research costs totaled $15,336,638, compared to $8,021,489 for the same period in 2022. The increase primarily
resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational drug costs, which rose from $4,912,530 in
2022  to  $9,611,630  in  2023.  Laboratory  costs  also  increased  due  to  the  hiring  of  additional  employees  and  higher  supplies,  growing  from  $138,354  to
$194,880 and $309,992 to $579,169, respectively. Additionally, non-cash share-based compensation expenses rose from $435,563 in 2022 to $1,072,592 in
2023, contributing to the overall increase in research and development expenses.

General and Administrative Expenses

For the year ended July 31, 2023, general and administrative expenses amounted to $7,935,626 as compared to $7,267,452 for the year ended July
31, 2022 The increase in general and administrative expenses primarily stems from higher insurance premiums, professional fees, and salaries, offset by a
decrease in share-based compensation expenses.

Financial income (expenses), net

For the year ended July 31, 2023, financial income, net amounted to $2,969,870 as compared to financial loss $11,549,962 for the year ended July
31, 2022. Financial income (expenses) comprises, primarily, changes in the fair value of the warrant liability and interest earned on our treasury. For the
year ended July 31, 2023, the value of the warrant liability decreased by $2,119,530. The decrease was primarily due to the decrease in the share price at
period end. For the year ended July 31, 2022, there was an increase in the value of the liability of $11,658,372 due to the increased share price at the period
end. Interest income for the year ended July 31, 2023 was $891,213 as compared to $136,731 for the year ended July 31, 2022. The increase in 2023 is
attributable to higher interest rates in North America.

Loss for the period

The Company reported a loss for the year ended July 31, 2023, of $20,302,394 as compared to $26,838,903 for the year ended July 31, 2022. The
loss in 2023 primarily stems from a substantial increase in operational spending, offset by a gain in from a decrease in the fair value of the warrant liability.
Conversely, the higher loss in the prior period can be attributed to a larger increase in the fair value of the warrant liability. These factors account for the
variance  in  the  reported  losses  between  the  two  periods,  highlighting  the  impact  of  changes  in  warrant  valuation  and  operational  spending  on  the
Company’s financial performance.

52

 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Liquidity and Capital Resources

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

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

As of July 31, 2023, the Company’s capital resources consist primarily of cash and cash equivalents, comprised mostly of cash on deposit with
banks, investments in money market funds, investments in U.S. government securities, U.S. government agency securities, and investment grade corporate
debt securities. Our investment policy and strategy are focused on preservation of capital and supporting our liquidity requirements.

Historically,  the  Company  has  financed  its  operation  through  private  and  public  placement  of  equity  securities,  as  well  as  debt  financing.  The
Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends to
raise  additional  capital,  either  through  debt  or  equity  financings  in  order  to  achieve  its  business  plan  objectives.  Management  believes  that  it  can  be
successful in obtaining additional capital; however, there can be no assurance that the Company will be able to do so. There is no assurance that any funds
raised  will  be  sufficient  to  enable  the  Company  to  attain  profitable  operations  or  continue  as  a  going  concern.  To  the  extent  that  the  Company  is
unsuccessful,  the  Company  may  need  to  curtail  or  cease  its  operations  and  implement  a  plan  to  extend  payables  or  reduce  overhead  until  sufficient
additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.

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

July 31, 2022 (including effects of foreign exchange). This decrease in cash can be attributed to the following:

The Company’s net cash used in operating activities during the year ended July 31, 2023, was $23,744,860 as compared to $12,484,376 for the

year ended July 31, 2022.

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

31, 2022.

Off-balance Sheet Arrangements

None.

Tabular Disclosure of Contractual Obligations

None.

53

 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the
information required under this Item 7A.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The report of independent registered public accounting firm with PCAOB ID: 1930 and financial information required by this Item is attached hereto at the
end of this report beginning on page F-1 and is hereby incorporated by reference.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure
that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized
and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and
procedures  designed  to  ensure  that  information  required  to  be  disclosed  by  a  company  in  the  reports  that  it  files  or  submits  under  the  Exchange  Act  is
accumulated  and  communicated  to  our  management,  including  our  principal  executive  and  principal  financial  officers,  as  appropriate  to  allow  timely
decisions regarding required disclosure.

Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of
our  disclosure  controls  and  procedures  (as  defined  in  Rules  13a-15(e)  and  15d-15(e)  under  the  Securities  Exchange  Act  of  1934  under  the  Securities
Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Annual Report on Form 10-K. Our management
recognizes  that  any  controls  and  procedures,  no  matter  how  well  designed  and  operated,  can  provide  only  reasonable  assurance  of  achieving  their
objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on
such  evaluation,  our  principal  executive  officer  and  principal  accounting  and  financial  officer  have  concluded  that  as  of  July  31,  2023,  our  disclosure
controls and procedures were effective at the reasonable assurance level.

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act
Rule  13a-15(f).  Internal  control  over  financial  reporting  is  a  process  designed  under  the  supervision  and  with  the  participation  of  our  management,
including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the U.S. All internal control
systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable
assurance with respect to financial statement preparation and presentation.

As of July 31, 2023, under the supervision and with the participation of our management, including our principal executive officer and principal financial
officer,  we  conducted  an  evaluation  of  the  effectiveness  of  our  internal  control  over  financial  reporting  based  on  the  framework  in  Internal  Control-
Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. All control deficiencies that contributed
to the material weakness as at Jul 31, 2022 were found to be effectively remediated. Management implemented the following remedial measures to address
the material weakness which we tested and found to be operating effectively:

● Periodic user access reviews of key applications
● Adequate segregation of incompatible duties.
● Approvals supporting transactions documented and evidence retained.
● Monthly and quarterly checklists to keep track of the review performed for every key control and to ensure the control was performed consistently.
● Adequate documentation to evidence key review procedures including appropriate documentation of the review.
● Mitigating controls to compensate for the lack of SOC 1 reports of service organizations to cover the entire fiscal year.

Based on this assessment, our management concluded that, as of July 31, 2023, our internal control over financial reporting was effective at the reasonable
assurance level.

Changes in Internal Control Over Financial Reporting

There  has  been  no  material  changes  in  our  internal  control  over  financial  reporting  during  the  quarter  ended  July  31,  2023.  No  change  in  our  internal
control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended July 31, 2023 that
has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting, except for our remediation efforts described
above.

ITEM 9B. OTHER INFORMATION

None.

ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

54

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Executive Officers, Directors and Key Employees

PART III

The  following  table  sets  forth  the  name,  age  and  position  of  each  of  our  executive  officers,  key  employees  and  directors  as  of  October  25,  2023.  All
directors hold office until the next annual meeting of shareholders and the election and qualification of their successors. Officers serve at the discretion of
the board.

Name
William V. Williams, MD, FRCP
Gadi Levin, CA, MBA
Giuseppe Del Priore, MD, MPH
Miguel A. Lopez-Lago, PhD
Jamieson Bondarenko, CFA, CMT
Vaughn C. Embro-Pantalony, MBA, FCPA, FCMA, CDIR,
ACC
Marc Lustig, MSC, MBA
Martin E. Schmieg
Rebecca Taub, MD
Jane A. Gross, PhD

Age
68
50
61
54
39

66
51
61
71
66

Biographies

Position

  President, Chief Executive Officer, and Director
  Chief Financial Officer and Corporate Secretary
  Chief Medical Officer
  Chief Scientific Officer
  Chairman of the Board of Directors

  Director
  Director
  Director
  Director
  Director

William V. Williams, MD, President, Chief Executive Officer and Director, is a seasoned biopharmaceutical executive with over 35 years of industry and
academic  expertise,  including  significant  clinical  management  in  multinational  pharmaceutical  companies.  Dr.  Williams  has  served  as  President,  Chief
Executive  Officer  and  Director  of  the  Company  since  November  1,  2016.  Dr.  Williams  served  as  Vice  President  of  Exploratory  Development  at  Incyte
Corporation  from  March  2005  through  November  2016.  There  he  facilitated  entry  of  over  20  compounds  into  the  clinic,  including  ruxolitinib  (Jakafi),
baricitinib  (Olumiant),  and  epacadostat.  Dr.  Williams  held  several  positions  at  GlaxoSmithKline  Pharmaceuticals,  including  Head  of  Experimental
Medicine and Vice President of Clinical Pharmacology from December 2000 through March 2002; Director and Head of Clinical Pharmacology, Oncology,
Musculoskeletal  and  Inflammation  from  March  2002  through  December  2004  and  Director  and  Head  of  Clinical  Pharmacology,  Musculoskeletal,
Inflammation,  Gastrointestinal  and  Urology  from  December  2004  through  March  2005.  He  has  also  served  as  Assistant  Professor  of  Medicine  and  the
Director of Rheumatology Research at the University of Pennsylvania from July 1991 through January 1998. Dr. Williams earned his BSc in Chemistry and
Biotechnology from Massachusetts Institute of Technology and Medical Doctorate from Tufts University School of Medicine. We believe that Dr. Williams
is qualified to serve as a member of our Board because of his experience as our President and Chief Executive Officer, as well as his depth of academic and
industry experience.

Gadi Levin, CA, MBA, Chief Financial Officer and Secretary, was appointed Chief Financial Officer and Secretary of the Company on February 1, 2016.
Mr. Levin has also served as Chief Financial Officer and Director of Vaxil Bio Ltd since March 1, 2016, and as the Finance Director of Eco (Atlantic) Oil
&  Gas  Ltd.  since  December  1,  2016.  Mr.  Levin  has  over  15  years  of  experience  working  with  public  U.S.,  Canadian  and  multi-jurisdictional  public
companies. Previously, Mr. Levin served as Chief Financial Officer of DarioHeath Corp from November 2013 through January 2015. Mr. Levin also served
as the Vice President of Finance and Chief Financial Officer for two Israeli investment firms specializing in private equity, hedge funds and real estate. Mr.
Levin began his CPA career at the accounting firm Arthur Andersen, where he worked for nine years, specializing in U.S. listed companies involved in
initial public offerings. Mr. Levin has a Bachelor of Commerce degree in Accounting and Information Systems from the University of Cape Town, South
Africa, and a post graduate diploma in Accounting from the University of South Africa. He received his Chartered Accountant designation in South Africa
and has an MBA from Bar Ilan University in Israel.

55

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Giuseppe  Del  Priore,  MD,  MPH,  Chief  Medical  Officer,  was  appointed  Chief  Medical  Officer  on  February  16,  2022.  Dr.  Del  Priore  is  a  seasoned
healthcare executive with over 25 years of experience in research, drug development, and clinical trial management. Dr. Del Priore’s prior work experience
includes  serving  as  a  biotechnology  company  Chief  Medical  Officer,  a  National  Director  at  the  Cancer  Treatment  Centers  of  America,  and  faculty  at
Indiana University School of Medicine, Weill Cornell Medicine, and New York University School of Medicine. Dr. Del Priore completed his MPH degree
in Biostatistics and Epidemiology at the University of Illinois Chicago School of Public Health, his medical degree with Distinction at The State University
of New York, and his BA, magna cum laude, in Philosophy, at The City University of New York, with additional training at Memorial Sloan Kettering
Cancer Center, The University of Chicago, Northwestern University, and the University of Rochester. He has authored numerous publications, was named
on several patents, and was listed as the “Best Doctors” by the U.S. News & World Report. He regularly appears in various media outlets as a Key Opinion
Leader in oncology. We believe that Dr. Del Priore is qualified to serve as Chief Medical Officer because of his medical and clinical trial experience.

Miguel A. Lopez-Lago, PhD, Chief Scientific Officer, was appointed Chief Scientific Officer on May 26, 2022, a promotion from his prior title of Senior
Director, Research and Development. Since 2000, Dr. Lopez-Lago has been working as a cancer scientist at Memorial Sloan Kettering Cancer Center, New
York.  Specifically,  he  has  investigated  various  aspects  of  tumor  biology,  including  the  development  of  targeted  therapies  for  mesothelioma  and  the
characterization of the biological mechanisms underlying cancer metastasis. More recently, Dr. Lopez-Lago has been interested in the study of the tumor
immune-microenvironment  and  in  the  development  of  immunotherapies  for  thoracic  cancers  using  chimeric  antigen  receptor  T  cell  technologies.  Since
2013, Dr. Lopez-Lago has been working as Senior Research Scientist at MSKCC. Dr. Lopez-Lago received his Bachelor of Science in Bio-Sciences and his
doctorate in Molecular Biology from Santiago of Compostela University, Spain. We believe that Dr. Lopez-Lago is qualified to serve as Chief Scientific
Officer because of his scientific training, especially in immunology and cellular therapies.

Jamieson Bondarenko, CFA, CMT, Chairman of the Board, was appointed as a Director of the Company on February 12, 2019 and elected as Chairman
on April 24, 2019. Mr. Bondarenko provides strategic capital markets & corporate development advice to early-stage life sciences companies through his
merchant capital company, JGRNT Capital Corp., a company he founded in November 2016. From December 2016 through October 2017, he served as
Principal and Managing Director of the Equity Capital Markets group of Eight Capital. He also held several positions in the Capital Markets division of
Dundee  Securities  Ltd.,  including  Managing  Director  from  July  2016  through  December  2016,  Director  from  October  2015  through  July  2016,  Vice
President  from  December  2012  through  October  2015  and  Associate  from  February  2010  through  December  2012.  We  believe  that  Mr.  Bondarenko  is
qualified to serve as a member of our Board because of his industry-specific and capital markets experience.

Vaughn C. Embro-Pantalony, MBA, FCPA, FCMA, CDIR, ACC, Director, has been a Director of the Company since his appointment on March 18,
2019. In February 2018, he joined the Board of Directors of Soricimed Biopharma Inc., a private clinical-stage biopharma company developing targeted
cancer therapies, and in August 2018 he was appointed Chairman of the Board of Soricimed, where he continues to serve in this capacity. He is also a
Director of Microbix Biosystems Inc., a public company and leading manufacturer of viral and bacterial antigens and reagents for the global diagnostis
industry. He originally joined the Microbix Board in February 2007, and he also served as its President and Chief Executive Officer from November 2012
to July 2017. He is President of Stratpath Management Inc., consulting on strategy and governance to the life sciences sector. He has held other executive
positions in life sciences with responsibility for finance, business development, strategic planning and information technology, including Vice President,
Finance,  and  Chief  Financial  Officer  of  Novopharm  Limited  from  May  2003  through  April  2006;  Vice  President,  Information  Technology,  and  Chief
Information Officer of Bayer Inc. from July 1999 through April 2003; Vice President, Finance and Administration of Bayer Healthcare from October 1996
through June 1999; and Director, Finance and Administration and Chief Financial Officer of Zeneca Pharma Inc. from March 1995 through August 1996.
He received his bachelor’s degree from Wilfrid Laurier University and his master of business administration degree from University of Windsor. He is a
Fellow Chartered Professional Accountant and a Chartered Director (C. Dir.) and is Audit Committee Certified (A.C.C.) through the Directors College,
McMaster  University.  We  believe  that  Mr.  Embro-Pantalony  is  qualified  to  serve  as  a  member  of  our  Board  due  to  his  extensive  experience  as  a
pharmaceutical and life sciences executive.

56

 
 
 
 
 
 
Marc Lustig, Director, was appointed to the Company’s Board on September 1, 2021. Mr. Lustig is a highly regarded investor, entrepreneur, and corporate
finance veteran with a deep understanding of the life sciences industry, including biotechnology and pharmaceuticals, as well as the legal cannabis industry.
He holds MSc and MBA degrees from McGill University. His professional experience includes working at Merck & Co., and his capital markets career
includes roles in biotechnology equity research and corporate finance. Mr. Lustig was the founder and CEO of Origin House, which was sold to Cresco
Labs Inc. (CSE: CL; OTCQX: CRLBF) in 2020, where he currently serves as a director and as Head of Capital Markets. In addition to being a director of a
number  of  public  companies,  he  founded  the  Lustig  Family  Medical  Cannabis  Research  &  Care  Fund  of  the  Cedars  Cancer  Foundation  that  provides
cannabis to palliative cancer patients. We believe that Mr. Lustig is qualified to serve as a member of our Board because of his industry-specific and capital
markets experience.

Martin Schmieg, Director, rejoined the Company’s Board on November 24, 2020. Having served as a member of BriaCell’s Board from 2016 to March
2019,  Mr.  Schmieg  is  a  “C”  level  executive  with  30  years  of  business  experience  and  a  diversified  background  in  the  global  biotech,  med-tech  and
pharmaceutical  industries.  He  currently  serves  as  Co-Founder,  Chief  Operating  and  Financial  Officer  of  Clear  Intradermal  Technologies,  Inc.  (formerly,
ClearIt  LLC),  a  private  company  based  in  Texas.  As  a  hands-on  leader,  Mr.  Schmieg’s  early  career  focused  on  accounting  and  financial  management
responsibilities,  serving  as  Chief  Financial  Officer  to  privately  held  Cytometrics,  Inc.  and  Advanced  Bionics  Corporation,  and  publicly  traded  Sirna
Therapeutics, Inc. and Isolagen, Inc. We believe that Mr. Schmieg is qualified to serve as a member of our Board because of his long-term familiarity with
the Company and his perspective and experience in relevant industries.

Rebecca Taub, MD, Director, has been a Director of the Company since her appointment on March 18, 2019. Dr. Taub currently serves as the President of
Research  and  Development  for  Madrigal  Pharmaceuticals,  a  clinical-stage  biopharmaceutical  company.  She  previously  served  as  Vice  President  of
Research and Development from July 2016 through her recent promotion to President of Research and Development on June 27, 2019. She has also served
as Madrigal’s Chief Medical Officer since July 2016. Dr. Taub served as the CEO and a Director of Madrigal from September 2011 through Madrigal’s
merger with Synta Pharmaceuticals Corp. in July 2016. Prior to joining Madrigal, Dr. Taub served as Senior Vice President, Research and Development of
VIA Pharmaceuticals from 2008 to 2011 and as Vice President, Research, Metabolic Diseases at Hoffmann-LaRoche from 2004 to 2008. In those positions,
Dr. Taub oversaw clinical development and drug discovery programs in cardiovascular and metabolic diseases, including the conduct of a series of Phase I
and  II  proof  of  conduct  clinical  trials.  Dr.  Taub  led  drug  discovery  programs,  including  target  identification,  lead  optimization  and  advancement  of
preclinical  candidates  into  clinical  development.  From  2000  through  2003,  Dr.  Taub  worked  at  Bristol-Myers  Squibb  Co.  and  DuPont  Pharmaceutical
Company, in a variety of positions, including Executive Director of CNS and metabolic diseases research. Before becoming a pharmaceutical executive,
Dr. Taub was a tenured Professor of Genetics and Medicine at the University of Pennsylvania, and remains an adjunct professor. Dr. Taub is the author of
more  than  120  research  articles.  Before  joining  the  faculty  of  the  University  of  Pennsylvania,  Dr.  Taub  served  as  an  Assistant  Professor  at  the  Joslin
Diabetes  Center  of  Harvard  Medical  School,  Harvard  University  and  an  associate  investigator  with  the  Howard  Hughes  Medical  Institute.  Dr.  Taub
received her M.D. from Yale University School of Medicine and her B.A. from Yale College. We believe that Dr. Taub is qualified to serve as a member of
our Board due to her extensive experience as a pharmaceutical executive heading up major development programs in non-alcoholic steatohepatitis.

Jane Gross, Director, was appointed to the Company’s Board in November 2021. Dr. Gross is a highly experienced biotech executive with over 30 years in
leading research and development teams from discovery through preclinical evaluation and clinical development of therapeutics for the treatment of cancer
and  autoimmune  and  inflammatory  diseases.  Dr.  Gross  currently  serves  as  an  Independent  Director  for  aTyr  Pharmaceuticals  (Nasdaq:  LIFE),  a
biotechnology  company  developing  novel  therapeutics  for  respiratory  diseases  and  multiple  cancer  indications.  Dr.  Gross’s  experience  includes  roles  as
Chief Scientific Officer and SVP, Research and Non-Clinical Development at Aptevo Therapeutics (Nasdaq: APVO), during which she led the discovery of
novel  antibody-based,  bispecific  protein  therapeutics  as  immunotherapies  to  treat  diseases  like  cancer.  Previously,  Dr.  Gross  served  as  VP,  Applied
Research and Non-Clinical Development at Emergent BioSolutions (NYSE: EBS), during which she successfully introduced a drug to patients from the
design  stage  into  the  clinic  stage.  Formerly,  as  VP,  Immunology  Research  at  ZymoGenetics,  Dr.  Gross  discovered  and  developed  30+  new  product
candidates,  completed  partnerships  and  out-licensing  of  assets,  and  helped  position  ZymoGenetics  for  a  successful  acquisition  by  Bristol  Myers  Squibb
(NYSE: BMY) in 2010. Dr. Gross earned her Ph.D. in Immunology from the University of California, Berkeley and her Post-Doctoral Fellowship from the
University  of  Washington  in  Immunology.  We  believe  that  Dr.  Gross  is  qualified  to  serve  as  a  member  of  our  Board  due  to  her  extensive  industry
experience and academic background.

57

 
 
 
 
 
 
Family Relationships and Other Arrangements

There are no family relationships among our directors and executive officers. There are no arrangements or understandings between or among our

executive officers and directors pursuant to which any director or executive officer was or is to be selected as a director or executive officer.

Composition of our Board

Under our amended articles of incorporation, our Board consists of a minimum of three directors and up to that number which was last set by
ordinary resolution of the shareholders. Our Board is currently comprised of seven directors, and under the Business Corporations Act (British Columbia)
(“BCBCA”), as a reporting issuer, we must have no fewer than three directors. Under the BCBCA, a director may be removed with or without cause by a
resolution  passed  by  at  least  two-thirds  of  the  votes  cast  by  shareholders  present  in  person  or  by  proxy  at  a  meeting  and  who  are  entitled  to  vote.  The
directors are appointed at the annual general meeting of shareholders and the term of office for each of the directors will expire at the time of our next
annual shareholders meeting. Our amended articles of incorporation provide that, between annual general meetings of our shareholders, the directors may
appoint one or more additional directors, but the number of additional directors may not at any time exceed one-third of the number of directors who held
office  at  the  expiration  of  the  last  meeting  of  our  shareholders.  Under  the  BCBCA,  there  is  no  minimum  number  of  directors  required  to  be  resident
Canadians as defined in the BCBCA.

Director Term Limits and Other Mechanisms of Board Renewal

Our  Board  has  not  adopted  director  term  limits  or  other  automatic  mechanisms  of  Board  renewal.  Rather  than  adopting  formal  term  limits,
mandatory age-related retirement policies and other mechanisms of Board renewal, the nominating and corporate governance committee of our Board will
develop  a  skills  and  competencies  matrix  for  our  Board  as  a  whole  and  for  individual  directors.  The  nominating  and  corporate  governance  committee
conducts a process for the assessment of our board of directors, each committee and each director regarding his or her effectiveness and contribution, and
reports evaluation results to our Board on a regular basis.

Director Independence

Under the Nasdaq Rules, independent directors must comprise a majority of a listed company’s board of directors. For purposes of the Nasdaq
Rules, an independent director means a person other than an executive officer or employee of the company who, in the opinion of the board of directors,
has no relationship with the company that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. Under
NI 58-101, a director is considered to be independent if he or she is independent within the meaning of Section 1.4 of National Instrument 52-110—Audit
Committees. Section 1.4 of NI 52-110 generally provides that a director is independent if he or she has no direct or indirect relationship with the issuer
which could, in the view of the issuer’s board of directors, be reasonably expected to interfere with the exercise of the director’s independent judgment.

Our Board has undertaken a review of the independence of each director. Based on information provided by each director concerning his or her
background, employment and affiliations, our Board has determined that Dr. Gross, Dr. Taub, Mr. Embro-Pantalony, Mr. Schmieg, and Mr. Bondarenko,
representing five of the seven members of our Board, are “independent” as that term is defined under the Nasdaq Rules. In making this determination, our
Board considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our Board
deemed relevant in determining their independence, including the beneficial ownership of our shares by each non-employee director. Dr. Williams is not
independent by virtue of being the Company’s Chief Executive Officer. Mr. Lustig is not independent by virtue of being a significant securityholder of the
Company.

Certain members of our Board are also members of the boards of other public companies. Our Board has not adopted a director interlock policy,

but is kept informed of other public directorships held by its members.

58

 
 
 
 
 
 
 
 
 
 
 
 
Mandate of the Board of Directors

Our  Board  is  responsible  for  supervising  the  management  of  our  business  and  affairs,  including  providing  guidance  and  strategic  oversight  to

management. Our Board’s mandate includes, among other things, the following matters:

● succession planning, including appointing, training and monitoring senior management;

● developing the corporate goals and objectives that management is responsible for meeting and reviewing the performance of our senior officers

against such corporate goals and objectives;

● taking steps to satisfy itself as to the integrity of our executive officers and that our executive officers create a culture of integrity throughout the

organization;

● reviewing  and  approving  our  code  of  conduct  and  reviewing  and  monitoring  compliance  with  the  code  of  conduct  and  our  enterprise  risk

management processes;

● reviewing and approving management’s strategic and business plans and our financial objectives, plans and actions, including significant capital

allocations and expenditures; and

● reviewing and approving material transactions not in the ordinary course of business.

Meetings of Independent Directors

Our Board holds regularly-scheduled quarterly meetings as well as ad hoc meetings from time to time. The independent members of our Board

also meet, as required, without the non-independent directors and members of management after each regularly scheduled board meeting.

A director who has a material interest in a matter before our Board or any committee on which he or she serves is required to disclose such interest
as soon as the director becomes aware of it. In situations where a director has a material interest in a matter to be considered by our Board or any committee
on which he or she serves, such director may be required to absent himself or herself from the meeting while discussions and voting with respect to the
matter are taking place. Directors are also required to comply with the relevant provisions of the BCBCA regarding conflicts of interest.

Position Descriptions

Our  Board  has  adopted  written  terms  of  reference  for  the  chairman  which  set  out  his  or  her  key  responsibilities,  including  duties  relating  to
determining the frequency, dates and locations of meetings and setting Board meeting agendas, chairing Board and shareholder meetings and carrying out
any other or special assignments or any functions as may be requested by our Board or management, as appropriate.

Our  Board  has  also  adopted  written  terms  of  reference  for  each  of  the  committee  chairs  which  set  out  each  of  the  committee  chair’s  key
responsibilities, including duties relating to determining the frequency, dates and locations of meetings and setting committee meeting agendas, chairing
committee meetings, reporting to our Board and carrying out any other special assignments or any functions as may be requested by our Board.

In addition, our Board, in conjunction with our Chief Executive Officer, will develop and implement a written position description for the role of

our Chief Executive Officer.

Orientation and Continuing Education

We  have  implemented  an  orientation  program  for  new  directors  under  which  a  new  director  meets  separately  with  the  chairman  of  our  Board,

members of the senior executive team and the secretary.

The  nominating  and  corporate  governance  committee  will  be  responsible  for  coordinating  orientation  and  continuing  director  development
programs  relating  to  the  committee’s  mandate.  The  chairman  of  our  Board  will  be  responsible  for  overseeing  director  continuing  education  designed  to
maintain or enhance the skills and abilities of our directors and to ensure that their knowledge and understanding of our business remains current.

59

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Code of Conduct

Our board of directors has adopted a Code of Ethics that applies to all of our directors, officers and employees. We have made the Code of Ethics
available  on  our  website  https://briacell.com/corporate/corporate-governance/.  We  intend  to  disclose  future  amendments  to,  or  waivers  of,  our  Code  of
Ethics, as and to the extent required by SEC regulations, at the same location on our website identified above or in public filings.

Monitoring Compliance with the Code of Conduct

Our nominating and corporate governance committee will be responsible for reviewing and evaluating the code of conduct at least annually and
will recommend any necessary or appropriate changes to our Board for consideration. The nominating and corporate governance committee will assist our
Board  with  the  monitoring  of  compliance  with  the  code  of  conduct,  and  will  be  responsible  for  considering  any  waivers  therefrom  (other  than  waivers
applicable to members of the nominating and corporate governance committee, which shall be considered by the audit committee, or waivers applicable to
our directors or executive officers, which shall be subject to review by our Board as a whole).

Requirement for Directors and Officers to Disclose Interest in a Contract or Transaction

In  accordance  with  the  BCBCA,  each  director  and  officer  must  disclose  the  nature  and  extent  of  any  interest  that  he  or  she  has  in  a  material
contract  or  material  transaction  whether  made  or  proposed  with  us,  if  the  director  or  officer  is  a  party  to  the  contract  or  transaction,  is  a  director  or  an
officer or an individual acting in a similar capacity of a party to the contract or transaction, or has a material interest in a party to the contract or transaction.
Subject to certain limited exceptions under the BCBCA, no director may vote on a resolution to approve a material contract or material transaction which is
subject to such disclosure requirement.

As of the date hereof, except as otherwise disclosed in this Annual Report on Form 10-K, to the knowledge of the Board or the management of the
Company, there are no material interests, whether direct or indirect, of any informed person of the Company, any proposed director of the Company, or any
associate or affiliate of any informed person or proposed director, in any transaction since the commencement of the Company’s most recently completed
financial year or in any proposed transaction which has materially affected or would materially affect the Company of any of its subsidiaries.

Benefits upon Termination of Employment

The service contracts with our directors do not provide for any benefits upon termination of employment, other than a “tail” directors and officers

insurance policy.

Complaint Reporting

In order to foster a climate of openness and honesty in which any concern or complaint pertaining to a suspected violation of the law, our code of
conduct or any of our policies, or any unethical or questionable act or behavior, our code of conduct will require that our employees promptly report the
violation  or  suspected  violation.  In  order  to  ensure  that  violations  or  suspected  violations  can  be  reported  without  fear  of  retaliation,  harassment  or  an
adverse  employment  consequence,  we  will  adopt  a  whistleblowing  policy  which  will  contain  procedures  that  are  aimed  to  facilitate  confidential,
anonymous submissions of complaints by our directors, officers, employees and others.

Committees of the Board

We currently have an audit committee, a compensation committee and a nominating and corporate governance committee, with each committee

having a written charter.

60

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Audit Committee

Our Audit  Committee  is  currently  comprised  of  Vaughn  C.  Embro-Pantalony,  Martin  Schmieg  and  Jane  A.  Gross,  and  chaired  by  Mr.  Embro-
Pantalony. Our Board has determined that each of Mr. Schmieg and Mr. Embro-Pantalony is financially literate and meets the independence requirements
for directors, including the heightened independence standards for members of the audit committee under Rule 10A-3 under the Exchange Act and NI 52-
110.  Our  Board  has  determined  that  Mr.  Embro-Pantalony  is  “financially  sophisticated”  within  the  meaning  of  the  Nasdaq  Rules,  “financially  literate”
within the meaning of NI 52-110, and a “financial expert” as defined by Rule 10A-3 under the Exchange Act.

We  have  adopted  an  Audit  Committee  Charter  setting  forth  the  purpose,  composition,  authority  and  responsibility  of  the  audit  committee. The
primary function of the audit committee is to assist the Board in fulfilling its financial oversight responsibilities by reviewing the financial reports and other
financial  information  provided  by  the  company  to  regulatory  authorities  and  the  Company’s  shareholders,  the  Company’s  systems  of  internal  controls
regarding finance and accounting and the Company auditing, accounting and financial reporting processes. Consistent with this function, the Committee
will encourage continuous improvement of, and should foster adherence to, Company’s policies, procedures and practices at all levels. The Committee’s
primary duties and responsibilities are to:

● Serve as  an  independent  and  objective  party  to  monitor  the  Company’s  financial  reporting  and  internal  control  system  and  review  Company’s

financial statements;

● Review and appraise the performance of the Company’s external auditors; and
● Provide an open avenue of communication among the Company’s auditors, financial and senior management and the Board.

During the year ended July 31, 2023, the Audit Committee held 5 meetings in person or through conference calls. As part of its job to foster open

communication, the Audit Committee meets at least annually with the external auditors.

To fulfill its responsibilities and duties, the Audit Committee:

● Reviews and updates the Audit Committee’s charter annually;
● Reviews  the  Company’s  financial  statements,  Management  Discussion  &  Analysis  and  any  annual  and  interim  earnings,  press
releases before the Company publicly discloses this information and any reports or other financial information (including quarterly
financial statements), which are submitted to any governmental body, or to the public, including any certification, report, opinion, or
review rendered by the external auditors;

● Reviews annually, the performance of the external auditors who shall be ultimately accountable to the Board and the Committee as

representatives of the shareholders of the Company;

● Obtains annually, a formal written statement of external auditors setting forth all relationships between the external auditors and the

Company, consistent with Independence Standards Board Standard I;

● Reviews  and  discusses  with  the  external  auditors  any  disclosed  relationships  or  services  that  may  impact  the  objectivity  and

independence of the external auditors;

● Takes, or recommends that the full Board takes, appropriate action to oversee the independence of the external auditors;
● Recommends  to  the  Board  the  selection  and,  where  applicable,  the  replacement  of  the  external  auditors  nominated  annually  for

shareholder approval;

● Reviews  and  approves  the  Company’s  hiring  policies  regarding  partners,  employees  and  former  partners  and  employees  of  the

present and former external auditors of the Company;

● Reviews and pre-approves all audit and audit-related services and the fees and other compensation related thereto;
● In consultation with the external auditors, reviews with management the integrity of the Company’s financial reporting process, both

internal and external;

61

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
● Considers the external auditors’ judgments about the quality and appropriateness of the Company’s accounting principles as applied

in its financial reporting;

● Considers and approves, if appropriate, changes to the Company’s auditing and accounting principles and practices as suggested by

the external auditors and management;

● Reviews significant  judgments  made  by  management  in  the  preparation  of  the  financial  statements  and  the  view  of  the  external

auditors as to appropriateness of such judgments;

● Following completion of the annual audit, reviews separately with management and the external auditors any significant difficulties

encountered during the course of the audit, including any restrictions on the scope of work or access to required information;

● Reviews  any  significant  disagreement  among  management  and  the  external  auditors  in  connection  with  the  preparation  of  the

financial statements;

● Reviews  with  the  external  auditors  and  management  the  extent  to  which  changes  and  improvements  in  financial  or  accounting

practices have been implemented;

● Reviews any complaints or concerns about any questionable accounting, internal accounting controls or auditing matters;
● Reviews certification process; and
● Reviews any related-party transactions.

Principal Accountant’s Fees

External Audit Service Fees

The following table sets forth the aggregate fees paid to the Company’s external auditors, Chartered Professional Accountants, by the Company

during the financial years ended July 31, 2023 and 2022:

Audit Fees
Audit-Related Fees
Tax Fees
All Other Fees
Total:

Compensation Committee

Year ended 
July 31, 2023

Year ended 
July 31, 2022

  $

153,000    $
113,000   
81,400   

  $

347,400    $

232,884 
- 
11,900 
17,134 
261,918

Our  compensation  committee  is  comprised  of  Mr.  Embro-Pantalony  and  Mr.  Schmieg  and  is  chaired  by  Mr.  Schmieg.  The  Compensation
Committee is appointed by the Board to assist in promoting a culture of integrity throughout the Company, to assist the Board in setting director and senior
executive  compensation,  and  to  develop  and  submit  to  the  Board  recommendations  with  respect  to  other  employee  benefits  as  the  Compensation
Committee sees fit. In the performance of its duties, the Compensation Committee is guided by the following principles:

● offering competitive compensation to attract, retain and motivate highly qualified executives in order for the Company to meet its goals; and

● acting in the interests of the Company and the shareholders by being fiscally responsible.

The Board relies on the knowledge and experience of the members of the Compensation Committee to set appropriate levels of compensation for
senior  officers.  Neither  the  Company  nor  the  Compensation  Committee  currently  has,  or  has  had  at  any  time  since  incorporation,  any  contractual
arrangement  with  any  executive  compensation  consultant  who  has  a  role  in  determining  or  recommending  the  amount  or  form  of  senior  officer
compensation.

62

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
When determining compensation payable, the Compensation Committee considers both external and internal data. External data includes general
market conditions and well as information regarding compensation paid to directors, CEOs and CFOs of companies of similar size and at a similar stage of
development in the industry. Internal data includes annual reviews of the performance of the directors, CEO and CFO in light of the Company’s corporate
objectives and considers other factors that may have impacted the Company’s success in achieving its objectives. During the year ended July 31, 2023, the
Compensation Committee held four meetings in person or through conference calls.

Nominating and Corporate Governance Committee

The Nominating and Corporate Governance Committee is appointed by the Board to assist in fulfilling its corporate governance responsibilities
under applicable laws. The Nominating and Corporate Governance Committee is responsible for, among other things, developing the Company’s approach
to  governance  issues  and  establishing  sound  corporate  governance  practices  that  are  in  the  interests  of  shareholders  and  that  contribute  to  effective  and
efficient decision-making.

Our  Nominating  and  Corporate  Governance  Committee  is  currently  comprised  of  Mr.  Marc  Lustig  and  Dr.  Taub  and  is  chaired  by  Mr.  Lustig.

During the year ended July 31, 2023, the Nominating and Corporate Governance Committee held one meeting in person.

Exculpation, Insurance and Indemnification of Directors and Officers

Under  the  BCBCA,  a  company  may  indemnify:  (i)  a  current  or  former  director  or  officer  of  that  company;  (ii)  a  current  or  former  director  or
officer of another corporation if, at the time such individual held such office, the corporation was an affiliate of the company, or if such individual held such
office  at  the  company’s  request;  or  (iii)  an  individual  who,  at  the  request  of  the  company,  held,  or  holds,  an  equivalent  position  in  another  entity  (an
“indemnifiable person”) against all costs, charges and expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by
him  or  her  in  respect  of  any  civil,  criminal,  administrative  or  other  legal  proceeding  or  investigative  action  (whether  current,  threatened,  pending  or
completed) in which he or she is involved because of that person’s position as an indemnifiable person, unless: (i) the individual did not act honestly and in
good faith with a view to the best interests of such company or the other entity, as the case may be; or (ii) in the case of a proceeding other than a civil
proceeding,  the  individual  did  not  have  reasonable  grounds  for  believing  that  the  individual’s  conduct  was  lawful.  A  company  cannot  indemnify  an
indemnifiable person if it is prohibited from doing so under its articles or by applicable law. A company may pay, as they are incurred in advance of the
final disposition of an eligible proceeding, the expenses actually and reasonably incurred by an indemnifiable person in respect of that proceeding only if
the indemnifiable person has provided an undertaking that, if it is ultimately determined that the payment of expenses was prohibited, the indemnifiable
person will repay any amounts advanced. Subject to the aforementioned prohibitions on indemnification, a company must, after the final disposition of an
eligible  proceeding,  pay  the  expenses  actually  and  reasonably  incurred  by  an  indemnifiable  person  in  respect  of  such  eligible  proceeding  if  such
indemnifiable person has not been reimbursed for such expenses, and was wholly successful, on the merits or otherwise, in the outcome of such eligible
proceeding or was substantially successful on the merits in the outcome of such eligible proceeding. On application from an indemnifiable person, a court
may make any order the court considers appropriate in respect of an eligible proceeding, including the indemnification of penalties imposed or expenses
incurred in any such proceedings and the enforcement of an indemnification agreement. As permitted by the BCBCA, under Article 21.1, we are required
to indemnify our directors and former directors (and such individual’s respective heirs and legal representatives) and we will indemnify any such person to
the extent permitted by the BCBCA.

The  BCBCA  provides  certain  protections  under  Part  5  –  Management, Division 5 - Indemnification  of  Directors  and  Officers  and  Payment  of
Expenses, to our current and former directors and officers, as well as other eligible parties defined in Section 159 of the BCBCA (the “Eligible Parties”,
each an “Eligible Party”). The Company will indemnify the Eligible Parties, to the fullest extent permitted by law and subject to certain limitations listed in
Section 163 of the BCBCA, against any proceeding in which an Eligible Party or any of the heirs and personal or other legal representatives of the Eligible
Party, by reason of the Eligible Party being or having been a director or officer of, or holding or having held a position equivalent to that of a director or
officer of, the Company or an associated corporation (a) is or may be joined as a party, or (b) is or may be liable for or in respect of a judgment, penalty or
fine in, or expenses related tom, the proceeding.

63

 
 
 
 
 
 
 
 
 
We maintain insurance policies relating to certain liabilities that our directors and officers may incur in such capacity.

ITEM 11. EXECUTIVE COMPENSATION

Summary Compensation Table

The following table presents the compensation awarded to, earned by or paid to each of our named executive officers for the years ended July 31, 2023 and
July 31, 2022.

Name and Principal Position
William V. Williams, MD, FRCP
President and Chief Executive Officer
Gadi Levin, CA, MBA
Chief Financial Officer and Corporate Secretary
Giuseppe Del Priore, MD, MPH(2)
Chief Medical Officer
Miguel A. Lopez-Lago, PhD(3)
Chief Scientific Officer

  Year    
2022    
2023    
2022    
2023    
2022    
2023    
2022    
2023    

Salary
($)
  560,992   
  736,555   
  202,091   
  285,715   
  199,665   
  466,927   
  211,616   
  282,247   

Bonus
($)
  150,000   
  48,750   
  45,000   
  18,750   
-   
  25,578   
  35,000   
  16,650   

Stock
Awards
($)(1)

   -   

-   

-   

-   

Option
Awards
($)
  100,152   
  430,209   
9,240   
  86,970   
  215,881   
  456,396   
  22,456   
  69,547   

All Other
Compensation
($)

      -   
-   
-   
-   
-   
-   
-   
-   

Total
($)
811,144 
  1,215,514 
256,331 
391,435 
415,546 
948,901 
269,072 
368,444 

(1) This  column  represents  the  grant  date  fair  value  of  the  award  in  accordance  with  stock-based  compensation  rules  under  Accounting  Standards
Codification Topic 718. For a more detailed discussion of the valuation model and assumptions used to calculate the fair value of each option award,
refer to Note 2 of the financial statements included in this annual report.

(2) Giuseppe Del Priore was appointed as the Chief Medical Officer on February 16, 2022

(3) Miguel A. Lopez-Lago was appointed as the Chief Scientific Officer on May 26, 2022

Outstanding Equity Awards at Fiscal Year-End

The following table provides information regarding option awards held by each of our named executive officers that were outstanding as of July 31, 2023.

Option Awards

Stock Awards

Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable

Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable

Option
Exercise Price
($)

Option
Expiration Date  

Number of
shares or units
of
stock that
have not vested
(#)

Market value
of
shares or units
of
stock that
have not vested
($)

200,000 
22,300 
50,900 
5,000 
19,200(1) 

75,000 
12,500 
10,150 

112,500 
5,000 

13,125 
5,000 

-   
-   
50,900   
35,000   
-   

-   
7,500   
10,150   

37,500   
5,000   

1,875   
5,000   

4.24   
8.47   
6.14   
6.03   
0.00   

4.24   
4.71   
6.14   

7.51   
6.14   

8.47   
6.14   

03/29/26 
01/13/27 
08/02/27 
06/20/28 
08/02/27 

03/29/26 
05/20/27 
08/02/27 

02/16/27 
08/02/27 

01/13/27 
08/02/27 

       -   
-   
-   
-   
-   

-   
-   
-   

-   
-   

-   
-   

    - 
- 
- 
- 
- 

- 
- 
- 

- 
- 

- 
- 

Name

William V.
Williams, MD,
FRCP

Gadi Levin, CA,
MBA

Giuseppe Del
Priore, MD, MPH  

Miguel A. Lopez-
Lago, PhD

(1) Restricted Share Units

64

 
 
 
 
 
 
   
   
   
   
   
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-Employee Director Compensation

The following table presents the total compensation for each person who served as a non-employee member of our Board and received compensation for
such  service  during  the  fiscal  year  ended  July  31,  2023.  Other  than  as  set  forth  in  the  table  and  described  more  fully  below,  we  did  not  pay  any
compensation, make any equity awards or non-equity awards to, or pay any other compensation to any of the non-employee members of our Board in 2023.

Fees
Earned or
Paid in
Cash
($)
187,984   

89,414   
65,625   
73,125   
57,501   
43,749   

Stock
Awards
($)

    -   

-   
-   
-   
-   
-   

Option
Awards
($)
489,092   

All Other
Compensation
($)

       -   

97,818   
97,818   
97,818   
37,936   
97,818   

-   
-   
-   
-   
-   

Total
($)
677,076 

187,232 
163,443 
170,943 
95,437 
141,567 

Name
Jamieson Bondarenko, CFA, CMT
Vaughn C. Embro-Pantalony, MBA, FCPA, FCMA, CDIR,
ACC
Marc Lustig, MSC, MBA
Martin E. Schmieg
Rebecca Taub, MD
Jane A. Gross, PhD

Employment Agreements

Dr. Williams V. Williams

On  August  31,  2021,  we  entered  into  a  compensation  package  with  Dr.  Williams,  our  Chief  Executive  Officer  (the  “2021  Compensation  Package”).
Pursuant to the 2021 Compensation Package, Mr. Williams receives $550,000 annually and may earn an equity incentive bonus compensation, which may
include a direct stock award of up to $125,000 based upon a performance review as of December 31, 2021 (the “Performance Review”). In addition, the
2021  Compensation  Package  provides  for  an  option  award  to  purchase  up  to  $250,000  in  common  shares  of  the  Company,  in  connection  with  the
Performance Review, which vests over a four year period and provides for an aggregate cash, stock and option award of up to $950,000.

On June 21, 2022, we entered into a compensation package with Dr. Williams (the “2022 Compensation Package”). Pursuant to the 2022 Compensation
Package,  Mr.  Williams  receives  $650,000  annually  and  an  annual  bonus  of  $150,000.  In  addition,  the  2022  Compensation  Package  provides  for  a
performance stock option award of $250,000 and a total cash, bonus and option award of up to $1,050,000. On May 1, 2023, Dr. Williams’ annual salary
was increased to $675,000 per annum.

Giuseppe Del Priore

On February 14, 2022, we entered into an employment agreement with Dr. Giuseppe Del Priore, our Chief Medical Officer (the “Del Priore Employment
Agreement”).  The  Del  Priore  Employment  Agreement  provides  for  a  full-time  position,  $350,000  annual  salary  and  standard  employee  benefit  plan
participation.  In  addition,  Mr.  Del  Priore  was  granted  an  option  to  purchase  150,000  of  the  Company’s  common  shares.  The  Del  Priore  Employment
Agreement provides that Mr. Del Priore is eligible for an annual bonus in either cash or options to purchase common shares of the Company based on the
successful  completion  of  certain  corporate  milestones  selected  by  our  Chief  Executive  Officer  and  reviewed  in  the  sole  discretion  of  our  Board  or  a
compensation committee. On May 1, 2023, Dr. Giuseppe Del Priore’s annual salary was increased to $460,000 per annum.

Gadi Levin

On  March  2,  2022,  we  entered  into  an  executive  employment  agreement  with  Gadi  Levin,  our  Chief  Financial  Officer  (the  “Levin  Employment
Agreement”),  effective  January  1,  2022.  The  Levin  Employment  Agreement  provides  for  a  part-time  position  (80%),  $350,000  annual  salary  (“Base
Salary”) and standard employee benefit plan participation. Our Board approved a annual discretionary bonus of (i) up to 30% of Mr. Levin’s yearly salary;
and (ii) $100,000 in stock options, which vest over a four year period per calendar year. In addition, Mr. Levin was granted 20,000 options in accordance
with the terms of the Company’s stock option plan. During August 2022, Mr. Levin’s Base Salary was increased to $250,000, retroactively to January 1,
2022. On May 1, 2023, Mr. Leving’s Base Salary was increased to $350,000 per annum.

65

 
 
 
 
 
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Miguel Lopez-Lago

On  May  26,  2022,  we  entered  into  an  employment  agreement  with  Miguel  Lopez-Lago,  our  Chief  Scientific  Officer  (the  “Lopez-Lago  Employment
Agreement”).  The  Lopez-Lago  Employment  Agreement  provides  for  $210,000  annually  for  Mr.  Lopez-Lago’s  duties  as  our  Chief  Scientist  Officer.  On
May 1, 2023, Mr. Lopez-Lago’s annual salary was increased to $325,000 per annum.

Equity Compensation Plan Information

The  following  table  summarizes  the  total  number  of  outstanding  awards  and  shares  available  for  other  future  issuances  of  options  under  all  of  our

equity compensation plans as of July 31, 2023. All of the outstanding awards listed below were granted under our stock option plan.

Plan Category
Equity compensation plans approved by shareholders
Equity compensation plans not approved by shareholders

Number of Shares to
be Issued Upon
Exercise of
Outstanding
Options,

Warrants and Rights    
10,299,702   
-   

Weighted-Average
Exercise Price of
Outstanding
Options,
Warrants and Rights    
            5.84   
$
-   

Number of Shares
Remaining Available
for Future Issuance
Under the Equity
Compensation Plan
(Excluding Shares in
First Column)

265,859 
- 

ITEM  12.  SECURITY  OWNERSHIP  OF  CERTAIN  BENEFICIAL  OWNERS  AND  MANAGEMENT  AND  RELATED  STOCKHOLDER
MATTERS

The following table sets forth certain information regarding the beneficial ownership of our common shares as of October 25, 2023 by:

● each of our named executive officers;

● each of our directors;

● all of our current directors and executive officers as a group; and

● each shareholder known by us to own beneficially more than 5% of our common shares.

Beneficial  ownership  is  determined  in  accordance  with  the  rules  of  the  SEC  and  includes  voting  or  investment  power  with  respect  to  the  securities.
Common shares that may be acquired by an individual or group within 60 days of October 25, 2023, pursuant to the exercise of options or warrants, vesting
of  common  shares  or  conversion  of  preferred  stock  or  convertible  debt,  are  deemed  to  be  outstanding  for  the  purpose  of  computing  the  percentage
ownership of such individual or group, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person
shown in the table. Percentage of ownership is based on 15,981,726 common shares issued and outstanding as of October 25, 2023.

66

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Except as indicated in footnotes to this table, we believe that the shareholders named in this table have sole voting and investment power with respect to all
common  shares  shown  to  be  beneficially  owned  by  them,  based  on  information  provided  to  us  by  such  shareholders.  Unless  otherwise  indicated,  the
address for each director and executive officer listed is: c/o BriaCell Therapeutics Corp., Suite 300 – 235 15th Street, West Vancouver, BC V7T 2X1.

Name of Beneficial Owner
Directors and Named Executive Officers
Jamieson Bondarenko, CFA, CMT(1)
William V. Williams, MD, FRCP(2)
Gadi Levin, CA, MBA(3)
Giuseppe Del Priore, MD, MPH(4)
Miguel A. Lopez-Lago, PhD(5)
Vaughn C. Embro-Pantalony, MBA, FCPA, FCMA, CDIR, ACC(6)
Marc Lustig, MSC, MBA
Martin E. Schmieg(7)
Rebecca Taub, MD(8)
Jane A. Gross, PhD(9)
All current named executive officers and directors as a group (10 persons)

5% or Greater Shareholders
Marc Lustig, MSC, MBA

* Represents beneficial ownership of less than 1%.

Notes :

Number of
Shares
Beneficially
Owned

Percentage
of Common
Shares
Beneficially
Owned

644,856   
476,838   
100,460   
117,500   
18,125   
89,524   
1,765,000   
80,575   
25,000   
65,000   
3,382,878   

4.03%
2.98%
* 
* 
* 
* 

11.04%

* 
* 
* 

21.16%

1,765,000   

11.04%

(1)

(2)

(3)

(4)

(5)

Includes 150,000 BriaCell Options with an exercise price of $4.24, expiring on March 29, 2026, 250,000 BriaCell Options with an exercise price
of $8.47, expiring on January 13, 2027, 25,000 BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028 and 100,000 BriaCell
Warrants to purchase common shares with an exercise price of $5.3125, expiring on February 26, 2026.
Includes 150,000 options with an exercise price of $4.35, expiring on March 29, 2026, 187,500 options with an exercise price of $8.47, expiring
on January 13, 2027, 100,000 warrants to purchase common shares with an exercise price of $5.3125, expiring on February 26, 2026 and 19,200
restricted share units.
Includes 200,000 BriaCell Options with an exercise price of $4.24, expiring on March 29, 2026, 22,300 BriaCell Options with an exercise price
of $8.47, expiring on January 13, 2027, 50,900 BriaCell Options with an exercise price of C$8.38, expiring on August 2, 2027, 5,000 BriaCell
Options with an exercise price of $6.03, expiring on June 20, 2028 and 29,802 BriaCell Warrants to purchase common shares with an exercise
price of $5.3125, expiring on February 26, 2026.
Includes 75,000 BriaCell Options with an exercise price of US$4.24, expiring on March 29, 2026, 12,500 BriaCell Options with an exercise price
of US$4.71, expiring on May 20, 2027 and 12,687 BriaCell Options with an exercise price of C$8.38, expiring on August 2, 2027.
Includes  112,500  BriaCell  Options  with  an  exercise  price  of  US$7.51,  expiring  on  February  16,  2027  and  10,000  BriaCell  Options  with  an
exercise price of C$8.38, expiring on August 2, 2027.

(6) 11,250 BriaCell Options with an exercise price of $8.47, expiring on January 13, 2027 and 10,000 BriaCell Options with an exercise price of

(7)

C$8.38, expiring on August 2, 2027.
Includes 25,000 BriaCell Options with an exercise price of US$4.24, expiring on March 29, 2026, 50,000 BriaCell Options with an exercise price
of $8.47, expiring on January 13, 2027 and 5,000 BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028.

(8) Securities held by L5 Capital Inc. includes 100,000 BriaCell Options with an exercise price of US$5.74, expiring on September 1, 2026 and 5,000

(9)

BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028.
Includes 25,000 BriaCell Options with an exercise price of US$4.24, expiring on March 29, 2026 and 37,500 BriaCell Options with an exercise
price of $8.47, expiring on January 13, 2027 and 5,000 BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028.

(10) Includes 5,000 BriaCell Options with an exercise price of US$4.24, expiring on March 29, 2026 and 5,000 BriaCell Options with an exercise

price of $8.47, expiring on January 13, 2027 and 5,000 BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028.

(11) Includes 5,000 BriaCell Options with an exercise price of US$7.74, expiring on November 1, 2026 and 50,000 BriaCell Options with an exercise

price of $8.47, expiring on January 13, 2027 and 5,000 BriaCell Options with an exercise price of $6.03, expiring on June 20, 2028.

Section 16(A) Beneficial Ownership Reporting Compliance

Section 16(a) of the Exchange Act requires our officers and directors, and persons who own more than 10% of a registered class of our equity securities, to
file reports of ownership and changes in ownership with the SEC. Officers, directors and greater than 10% shareholders are required by SEC regulations to
furnish us with copies of all Section 16(a) forms they file.

Based on a review of the copies of such forms received, we believe that during the fiscal year ending July 31, 2023, all filing requirements applicable to our
officers, directors and greater than 10% beneficial owners were complied with.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

There  have  been  no  transactions  since  August  1,  2022  to  which  we  have  been  a  party,  including  transactions  in  which  the  amount  involved  in  the
transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for the last two completed fiscal years, and in which any of
our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate family of
any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control
and other arrangements, which are described elsewhere in this Annual Report on Form 10-K. We are not a party to a current related party transaction, and

 
 
 
 
   
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
no transaction is currently proposed, in which the amount of the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-
end for the last two completed fiscal years and in which a related person had or will have a direct or indirect material interest.

67

 
Director Independence

Our board of directors undertook a review of the independence of our directors and considered whether any director has a relationship with us that could
compromise that director’s ability to exercise independent judgment in carrying out that director’s responsibilities. Our board of directors has affirmatively
determined that Dr. Gross, Dr. Taub. Mr. Bondarenko, Mr. Empro-Pantalony, Mr. Lustig, and Mr. Schmieg are each an “independent director,” as defined
under the Nasdaq rules.

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

Audit Fees

The aggregate fees billed to us by MNP LLP, our independent registered public accounting firm, for the indicated services for each of the last two fiscal
years were as follows:

Audit fees (1)
Audit-related fees (2)
Tax fees
All other fees

2023

2022

153,000    $
113,000    $
81,400    $
-    $

232,884 
- 
11,900 
17,134 

$
$
$
$

(1) Audit fees consist of fees for professional services performed by MNP LLP for the audit and review of our quarterly financial statements.
(2) Audit related fees consist of fees for preparation and filing of the carve-out financial statements related to the proxy statement filed.

Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors

Consistent  with  SEC  policies  and  guidelines  regarding  audit  independence,  the  Audit  Committee  is  responsible  for  the  pre-approval  of  all  audit  and
permissible  non-audit  services  provided  by  our  independent  registered  public  accounting  firm  on  a  case-by-case  basis.  Our  Audit  Committee  has
established a policy regarding approval of all audit and permissible non-audit services provided by our principal accountants. Our Audit Committee pre-
approves these services by category and service. Our Audit Committee has pre-approved all of the services provided by our independent registered public
accounting firm.

68

 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
PART IV

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

Exhibit
Number

(b) Exhibits

  (a)(1) Financial Statements

Description of Exhibit

The financial statements required by this item are submitted in a separate section beginning on page F-1 of this Annual Report on Form 10-
K.

Exhibit
3.1

  Description
  Articles of BriaCell Therapeutics Corp, dated July 26, 2006

3.2

3.3

3.4

3.5

3.6

3.7

4.1

10.1

10.2

10.3

10.4

10.5

10.6

10.7

10.8

10.9

  Articles of BriaCell Therapeutics Corp, dated October 22, 2019

  Notice of Articles, dated November 25, 2014

  Notice of Articles, dated August 22, 2019

  Alteration to Articles of BriaCell Therapeutics Corp., dated February 13, 2023

  Notice of Articles filed August 31, 2023

  Notice of Articles filed August 31, 2023

  Description of Securities Registered Under Section 12 of the Exchange Act

  Stock Option Plan, dated November 25, 2014

  Service Agreement with UC Davis, dated June 11, 2015

  Clinical Study Agreement with Cancer Insight, LLC, dated May 2, 2016

  Amendment #1 to Service Agreement with UC Davis, dated June 12, 2016

  Licensing Agreement between Faller & Williams Technology LLC and Sapientia Pharmaceuticals, Inc., dated March 16, 2017

  Master Services Agreement with KBI Biopharma, Inc., dated March 17, 2017

  Clinical Study Agreement with Cancer Insight, LLC, dated September 29, 2017

  Amendment #2 to Service Agreement with UC Davis, dated August 27, 2018

  First Supplement to Clinical Study Agreement with Cancer Insight, LLC, dated October 18, 2018

10.10

  Amendment #1 to Services Agreement with Colorado State University, dated April 2, 2019

10.11

10.12

10.13

  Stem Cell Program Services Agreement with UC Davis, May 3, 2019

  HLA Typing Services Agreement with Histogenetics, dated October 3, 2019

  Procurement Agreement with Catalent Pharma Solutions, LLC, dated June 13, 2019

69

 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
10.14

10.15

10.16

10.17

10.18

10.19

10.20

10.21

  Clinical Supply Services Agreement with Catalent Pharma Solutions, LLC, dated June 13, 2019

  Quality Agreement with Catalent Pharma Solutions, LLC, dated June 25, 2019

  Master Services Agreement, dated February 27, 2020

  Cooperative Research and Development Agreement, dated October 28, 2020

  Form of Securities Purchase Agreement (June 2021)

  Form of Placement Agency Agreement (June 2021)

  Form of Registration Rights Agreement (June 2021)

  Form of Underwriting Agreement dated February 22, 2021

10.22+

  Compensation Agreement with Dr. William V. Williams, dated August 31, 2021

10.23

  Compensation Agreement with Dr. William V. Williams, dated June 21, 2022

10.24+

  Employment Agreement with Giuseppe Del Priore, dated February 14, 2022

10.25+

  Employment Agreement with Gadi Levin, dated March 2, 2022

10.26+

  Employment Agreement with Miguel Lopez-Lago, dated May 26, 2022

10.27

10.28

10.29

10.30

10.31

21.1

31.1

31.2

32.1

  Exclusive License Agreement

  Omnibus Equity Incentive Plan (incorporated by reference from Schedule I to the Proxy Statement for BriaCell Therapeutics Corp. 2023

Annual and Special Meeting of Shareholders, filed with the SEC on January 17, 2023).

  Master Service and Technology Agreement dated May 9, 2023

  Stock Purchase Agreement dated May 12, 2023

  Arrangement Agreement dated May 24, 2023

  List of Subsidiaries

  Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

  Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

  Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley

Act of 2002**

32.2

  Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley

Act of 2002**

101.INS
101.SCH
101.CAL
101.LAB
101.PRE
101.DEF
104

  Inline XBRL Instance Document
  Inline XBRL Taxonomy Extension Schema
  Inline XBRL Taxonomy Extension Calculation Linkbase
  Inline XBRL Taxonomy Extension Labels Linkbase
  Inline XBRL Taxonomy Extension Presentation Linkbase
  Inline XBRL Taxonomy Extension Definition Linkbase
  Cover Page Interactive Data File (embedded within the Inline XBRL document)

Indicates a management contract or compensatory plan or arrangement.
+
*
Filed herewith
** Furnished herewith

ITEM 16. FORM 10-K SUMMARY

None.

70

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed

on its behalf by the undersigned, thereunto duly authorized.

SIGNATURES

October 25, 2023

BRIACELL THERAPEUTICS CORP.

/s/ William V. Williams
Chief Executive Officer (Principal Executive Officer and Principal
Accounting and Financial Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the

Registrant and in the capacities and on the dates indicated.

SIGNATURE

TITLE

DATE

/s/ William V. Williams
William V. Williams

/s/ Gadi Levin
Gadi Levin

/s/ Jamieson Bondarenko
Jamieson Bondarenko

/s/ Vaughn C. Embro-Pantalony
Vaughn C. Embro-Pantalony

/s/ Marc Lustig
Marc Lustig

/s/ Martin E. Schmieg
Martin E. Schmieg

/s/ Rebecca Taub
Rebecca Taub

/s/ Jane A. Gross
Jane A. Gross

  Chief Executive Officer, President and Director

  October 25, 2023

(Principal Executive Officer)

Chief Financial Officer and Corporate Secretary (Principal
Accounting and Financial Officer)

  October 25, 2023

  Chairman of the Board of Directors

  October 25, 2023

  Director

  Director

  Director

  Director

  Director

71

  October 25, 2023

  October 25, 2023

  October 25, 2023

  October 25, 2023

  October 25, 2023

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated Financial Statements

For the Years Ended July 31, 2023 and 2022
Expressed in United States Dollars

F-1

 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of BriaCell Therapeutics Corp.

Opinion on the Consolidated Financial Statements

We  have  audited  the  accompanying  consolidated  balance  sheets  of  BriaCell  Therapeutics  Corp.  (the  Company)  as  of  July  31,  2023  and  2022,  and  the
related consolidated statements of operations and comprehensive loss, changes in shareholders’ equity, and cash flows for each of the years in the two-year
period ended July 31, 2023, and the related notes (collectively referred to as the consolidated financial statements).

In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of July
31, 2023 and 2022, and the results of its consolidated operations and its consolidated cash flows for each of the years in the two-year period ended July 31,
2023, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United  States)  (PCAOB)  and  are  required  to  be  independent  with  respect  to  the  Company  in  accordance  with  the  U.S.  federal  securities  laws  and  the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance  about  whether  the  consolidated  financial  statements  are  free  of  material  misstatement,  whether  due  to  error  or  fraud.  The  Company  is  not
required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain
an  understanding  of  internal  control  over  financial  reporting,  but  not  for  the  purpose  of  expressing  an  opinion  on  the  effectiveness  of  the  Company’s
internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis
for our opinion.

Chartered Professional Accountants
Licensed Public Accountants

We have served as the Company’s auditor since 2015.

Mississauga, Canada

October 25, 2023

F-2

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Consolidated Balance Sheets
As at July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data)

ASSETS

CURRENT ASSETS:

Cash and cash equivalents
Amounts receivable
Prepaid expenses

Total current assets

NON-CURRENT ASSETS:

Investments
Intangible assets, net
Total non-current assets

Total assets

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables
Accrued expenses and other payables
Total current liabilities

NON-CURRENT LIABILITIES:

Warrant liability
Total non-current liabilities

CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Share Capital of no par value – Authorized: unlimited at July 31, 2023 and 2022; Issued and
outstanding: 15,981,726 and 15,518,018 shares at July 31, 2023 and 2022, respectively
Share-based payment reserved
Warrant reserve
Accumulated other comprehensive loss
Accumulated deficit
Total shareholders’ equity (deficit)

$

$

$

$

July 31,

2023

2022

  $

21,251,092 
18,873 
5,678,542 
26,948,507 

2 
215,068 
215,070 

41,041,652 
24,103 
1,280,945 
42,346,700 

2 
230,339 
230,341 

27,163,577 

  $

42,577,041 

  $

1,123,739 
677,718 
1,801,457 

463,280 
477,807 
941,087 

29,139,301 
29,139,301 

  $

31,307,022 
31,307,022 

69,591,784 
7,421,950 
- 
(138,684)
(80,652,231)
(3,777,181)

65,589,293 
5,228,160 
- 
(138,684)
(60,349,837)
10,328,932 

Total liabilities and shareholders’ equity (deficit)

$

27,163,577 

  $

42,577,041 

These consolidated financial statements were approved and authorized for issue on behalf of the Board of Directors on October 25, 2023 by:

On behalf of the Board:

“Jamieson Bondarenko”
Director

“William Williams”
Director

The accompanying notes are an integral part of these consolidated financial statements.

F-3

 
 
 
 
 
 
 
 
 
 
 
 
 
  
   
  
 
 
 
  
   
  
 
 
  
   
  
 
 
 
   
 
 
   
 
 
   
 
 
 
  
   
  
 
 
  
   
  
 
 
   
 
 
   
 
 
   
 
 
 
  
   
  
 
 
 
 
  
   
  
 
 
  
   
  
 
 
 
  
   
  
 
 
  
   
  
 
 
 
   
 
 
   
 
 
 
  
   
  
 
 
  
   
  
 
 
   
 
 
 
 
  
   
  
 
 
 
   
 
 
 
  
   
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
  
   
  
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Consolidated Statements of Operations and Comprehensive Loss
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data)

Research and development expenses
General and administrative expenses

Total operating loss

Financial income (expenses), net

Loss and comprehensive loss
Net loss per share attributable to ordinary shareholders, basic and diluted

Weighted average number of shares used in computing net loss per share attributable to
ordinary shareholders, basic and diluted

Year ended
July 31,

2023

2022

15,336,638 
7,935,626 

  $

8,021,489 
7,267,452 

(23,272,264)

(15,288,941)

2,969,870 

(11,549,962)

(20,302,394)
(1.30)

  $
  $

15,619,676 

(26,838,903)
(1.73)

15,494,091 

$

$
$

The accompanying notes are an integral part of these consolidated financial statements.

F-4

 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
   
 
 
 
  
   
  
 
 
   
 
 
 
  
   
  
 
 
   
 
 
 
  
   
  
 
 
 
 
   
 
 
BriaCell Therapeutics Corp
Consolidated Statements of Changes in Shareholders’ Equity
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars , except share and per share data)

Share capital

  Number     Amount

ADDITIONAL

  PAID IN    
CAPITAL    

ACCUMULATED
OTHER

COMPREHENSIVE    ACCUMULATED   

INCOME (LOSS)    

DEFICIT

TOTAL
SHAREHOLDERS’
EQUITY
(DEFICIT)

Balance, July 31, 2021
Exercise of Broker Warrants
Exercise of Private Placement
Warrants
Exercise of Public Offering
Warrants
Shares Issuance Costs
Issuance of Options
Shares Repurchased and
canceled
Expiration of options
Loss for the year
Balance, July 31, 2022
Issuance of Options
Exercise of warrants
Issuance of shares
Loss for the year
Balance, July 31, 2023

  15,269,583    $ 54,774,172    $

2,178,130    $

(138,684)   $

(29,141,897)   $

219,453   

  2,730,754   

997,200   

  12,162,001   

63,454   
-   
-   

683,905   
(57,116)  
-   

  (1,031,672)  
-   
-   
  15,518,018   
-   
300   
463,408   
-   

  (4,704,423)  
-   
-   
  65,589,293   
-   
2,491   
  4,000,000   
-   

-   

-   

-   
-   
3,074,584   

-   
(24,554)  
-   
5,228,160   
2,193,790   
-   
-   
-   

-   

-   

-   
-   
-   

-   
-   
-   
(138,684)  
-   
-   
-   
-   

  15,981,726    $ 69,591,784    $

7,421,950    $

(138,684)   $

-   

-   

-   
-   
-   

(4,393,591)  
24,554   
(26,838,903)  
(60,349,837)  
-   
-   
-   
(20,302,394)  
(80,652,231)  

$

27,671,721
2,730,754

12,162,001

683,905
(57,116)
3,074,584

(9,098,014)
-
(26,838,903)
10,328,932
2,193,790
2,491
4,000,000
(20,302,394)
(3,777,181)

The accompanying notes are an integral part of these consolidated financial statements.

F-5

 
 
 
 
 
   
 
   
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Consolidated Statements of Cash Flows
For the Years Ended July 31, 2023 and 2021
(Expressed in US Dollars, except share and per share data)

Cash flow from operating activities:
Loss
Adjustments to reconcile loss to net cash used in operating activities:

Amortization
Share-based compensation
Interest expense
Gain from government grant
Change in fair value of warrants

Changes in assets and liabilities:

Decrease (increase) in amounts receivable
Increase in prepaid expenses
Increase in accounts payable
Increase in accrued expenses and other payables

Net cash used in operating activities

Cash flow from financing activities:
Proceeds from exercise of warrants
Share and warrant buyback program
Repayment government grant
Proceeds from issuance of shares
Share issuance costs

Net cash provided by (used in) financing activities

Decrease in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year

Year ended
July 31,

2023

2022

$

(20,302,394)   $

(26,838,903)

15,271   
2,193,790   
-   
-   
(2,119,530)  

5,230   
(4,397,597)  
660,459   
199,911   
(23,744,860)  

1,594   
(47,294)  
-   
4,000,000   
-   
3,954,300   

(19,790,560)  
41,041,652   
21,251,092    $

$

15,272 
3,074,584 
979 
(3,388)
11,658,372 

(11,530)
(764,054)
249,164 
135,128 
(12,484,376)

6,509,768 
(10,171,732)
(23,577)
- 
(57,116)
(3,742,657)

(16,227,033)
57,268,685 
41,041,652 

The accompanying notes are an integral part of these consolidated financial statements.

F-6

 
 
 
 
 
 
 
 
   
 
 
 
    
 
  
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 1: GENERAL

a. BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) was incorporated under the Business Corporations Act (British Columbia) on July 26,
2006 and is listed on the Toronto Stock Exchange (“TSX”) under the symbol “BCT” and the Company also trades on the Nasdaq Capital Market
(“NASDAQ”) under the symbols “BCTX” and “BCTXW”.

b. BriaCell Therapeutics Corporation. (the “Company”), is an immuno-oncology biotechnology company. The Company is currently advancing its
Bria-IMT targeted immunotherapy program against end-stage breast cancer to Phase 3 study which has been approved by the FDA and is expected
to start  before  end  of  2023.  BriaCell  is  also  developing  a  personalized  off-the-shelf  immunotherapy,  Bria-OTS™,  and  a  soluble  CD80  protein
therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.

c. The Company continues to devote substantially all of its efforts toward research and development activities. In the course of such activities, the
Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of
July 31, 2023 was $80,652,231(July 31, 2022 - $60,349,837)  and  negative  cash  flows  from  operating  activities  during  the year ended July 31,
2023 was $23,744,860  (July  31,  2022  -  $12,484,376).  The  Company  is  planning  to  finance  its  operations  from  its  existing  and  future  working
capital resources and to continue to evaluate additional sources of capital and financing. The Company believes that its existing capital resources
will be adequate to satisfy its expected liquidity requirements for at least twelve months from the issuance of the consolidated financial statements.

d. The Company has two wholly-owned U.S. subsidiaries: (i) BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April 3, 2014, under
the laws of the state of Delaware. (ii) BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”), which was incorporated
in  September  20,  2012,  under  the  laws  of  the  state  of  Delaware.  The  Company  also  has  one  Canadian  subsidiary:  BriaPro  Therapeutics  Corp,
(“BriaPro”) which was incorporated on May 15, 2023, was incorporated under the Business Corporations Act (British Columbia). As of July 31,
2023, BriaPro was a wholly-owned. See also note 15a. (Sapientia and BTC and BriaPro together, the “Subsidiaries”)

The Company has one operating segment and reporting unit.

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

  a. Basis of presentation of the financial statements:

The  Company’s  consolidated  financial  statements  have  been  prepared  in  accordance  with  the  United  States  generally  accepted  accounting
principles (U.S. GAAP) as set forth in the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (ASC).

F-7

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

  b. Use of estimates, assumptions and judgements:

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that
affect  the  amounts  reported  in  the  consolidated  financial  statements  and  accompanying  notes.  The  Company’s  management  believes  that  the
estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments
and  assumptions  can  affect  the  reported  amounts  of  assets  and  liabilities  at  the  dates  of  the  consolidated  financial  statements,  and  the  reported
amount of expenses during the reporting periods. Actual results could differ from those estimates.

Going Concern

Preparation  of  the  consolidated  financial  statement  on  a  going  concern  basis,  which  contemplates  the  realization  of  assets  and  payments  of
liabilities  in  the  ordinary  course  of  business.  Should  the  Company  be  unable  to  continue  as  a  going  concern,  it  may  be  unable  to  realize  the
carrying value of its assets, including its intangible assets and to meet its liabilities as they become due.

Warrants and options

The Company uses the Black-Scholes option-pricing model to estimate the fair value of options at the grant date, and the warrant liability at the
grant date and each reporting period date. The key assumptions used in the model are the expected future volatility in the price of the Company’s
shares and the expected life of the warrants.

Income Taxes

Provisions for taxes are made using the best estimate of the amount expected to be paid based on a qualitative assessment of all relevant factors.
The  Company  reviews  the  adequacy  of  these  provisions  at  the  end  of  the  reporting  period.  However,  it  is  possible  that  at  some  future  date  an
additional  liability  could  result  from  audits  by  taxing  authorities.  Where  the  final  outcome  of  these  tax-related  matters  is  different  from  the
amounts that were initially recorded, such differences will affect the tax provisions in the period in which such determination is made.

Intangible assets

Intangible assets are tested for impairment annually or more frequently if there is an indication of impairment. The carrying value of intangibles
with  definite  lives  is  reviewed  each  reporting  period  to  determine  whether  there  is  any  indication  of  impairment.  If  there  are  indications  of
impairment the impairment analysis is completed and if the carrying amount of an asset exceeds its recoverable amount, the asset is impaired and
impairment loss is recognized.

  c. Principal of consolidation:

The consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have
been eliminated upon consolidation.

  d. Consolidated financial statements in U.S dollars:

The  functional  currency  is  the  currency  that  best  reflects  the  economic  environment  in  which  the  Company  and  its  subsidiary  operates  and
conducts  their  transactions.  The  Company’s  management  believes  that  the  functional  currency  of  the  Company  and  its  subsidiaries  is  the  U.S.
dollar.

Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars at each reporting period end
in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are
reflected in the statements of operations as financing income or expenses as appropriate.

F-8

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

  e. Cash and cash equivalents:

Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the
date  acquired,  and  investments  with  maturities  of  longer  than  three  months  where  the  investment  can  be  liquidated  before  the  maturity  date
without a significant penalty.

  f. Property and equipment, net:

Property and equipment with individual values of over $2,500 are stated at cost, net of accumulated depreciation. Depreciation is calculated using
the straight-line method over the estimated useful lives of the assets at the following annual rates:

Computers and peripheral equipment

  g. Intangible assets, net:

%
20-33

Separately acquired intangible assets are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a
business combination are measured at fair value at the acquisition date. Expenditures relating to internally generated intangible assets, excluding
capitalized development costs, are recognized in profit or loss when incurred.

Intangible assets with finite useful lives are amortized over their useful lives and whenever there is an indication that the asset may be impaired.
The evaluation is performed at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and
liabilities. Recoverability of these group of assets is measured by a comparison of the carrying amounts to the future undiscounted cash flows the
group  of  assets  is  expected  to  generate.  If  such  review  indicates  that  the  carrying  amount  of  intangible  assets  is  not  recoverable,  the  carrying
amount of such assets is reduced to fair value.

The amortization period and the amortization method for an intangible asset are reviewed at least at each year end.

Intangible  assets  with  indefinite  useful  lives  are  not  systematically  amortized  and  are  tested  for  impairment  annually,  or  whenever  there  is  an
indication that the intangible asset may be impaired. The useful life of these assets is reviewed annually to determine whether their indefinite life
assessment continues to be supportable. If the events and circumstances do not continue to support the assessment, the change in the useful life
assessment from indefinite to finite life is accounted for prospectively as a change in accounting estimate and on that date the asset is tested for
impairment. Commencing from that date, the asset is amortized systematically over its useful life.

The details of intangible assets are as follows:

Useful life
Amortization method
In-house development or purchase

  Patents
  20 years
  Straight-line
  Purchase

For the years ended July 31, 2023 and 2022, no indicators of impairment have been identified.

F-9

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

  h. Research and Development expenses:

Research and development expenses are recognized in the consolidated statements of operations and comprehensive loss when incurred. Research
and development expenses consist of intellectual property, development and production expenditures.

  i. Fair value of financial instruments:

The  accounting  guidance  for  fair  value  provides  a  framework  for  measuring  fair  value,  clarifies  the  definition  of  fair  value,  and  expands
disclosures  regarding  fair  value  measurements.  Fair  value  is  defined  as  the  price  that  would  be  received  to  sell  an  asset  or  paid  to  transfer  a
liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-
tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

Level 1 — Quoted  prices  (unadjusted)  in  active  markets  that  are  accessible  at  the  measurement  date  for  assets  or  liabilities.  The  fair  value

hierarchy gives the highest priority to Level 1 inputs.

Level 2 — Observable inputs that are based on inputs not quoted on active markets but corroborated by market data.

Level 3 — Unobservable inputs are used when little or no market data are available.

The carrying amounts of cash and cash equivalents, trade payable and accrued expenses and other payables approximate their fair value due to the
short-term maturity of such instruments.

The carrying amount of warrant liabilities is recorded at the fair value at each reporting period. 

F-10

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

  j. Leases:

The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of
that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right
to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use
of  the  asset.  An  ROU  asset  represents  the  right  to  use  an  underlying  asset  for  the  lease  term  and  lease  liabilities  represent  the  Company’s
obligation  to  make  lease  payments  arising  from  the  lease  agreement.  An  ROU  asset  is  measured  based  on  the  discounted  present  value  of  the
remaining  lease  payments,  plus  any  initial  direct  costs  incurred  and  prepaid  lease  payments,  excluding  lease  incentives.  The  lease  liability  is
measured  at  lease  commencement  date  based  on  the  discounted  present  value  of  the  remaining  lease  payments.  The  implicit  rate  within  the
operating  leases  is  generally  not  determinable,  therefore  the  Company  uses  the  Incremental  Borrowing  Rate  (“IBR”)  based  on  the  information
available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest
rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. An option to
extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company
will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option.

The  Company  elected  the  practical  expedient  for  lease  agreements  with  a  term  of  twelve  months  or  less  and  does  not  recognize  right-of-use
(“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and
non-lease components for its leases.

  k. Share-based compensation:

The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation – Stock Compensation”, which requires
companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is
recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the
only condition to vesting is continued service.

The Company has selected the Black-Scholes option-pricing model as the most appropriate fair value method for its option awards. The Company
recognizes forfeitures of equity-based awards as they occur. Restricted share units use the share price on the grant date to determine the fair value
of the restricted share unit award.

F-11

 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

  l. Income Taxes:

The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby
deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and
liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company
provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed.

ASC  740  offers  a  two-step  approach  for  recognizing  and  measuring  a  liability  for  uncertain  tax  positions.  The  first  step  is  to  evaluate  the  tax
position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not
that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation
processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement.
As of July 31, 2023, and 2022 no liability for unrecognized tax benefits was recorded as a result of ASC 740.

  m. Basic and diluted net loss per Share:

The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted-average number of
shares  of  ordinary  shares  outstanding  for  the  period,  without  consideration  of  potentially  dilutive  securities.  The  diluted  net  loss  per  share  is
calculated  by  giving  effect  to  all  potentially  dilutive  securities  outstanding  for  the  period  using  the  treasury  share  method  or  the  if-converted
method based on the nature of such securities. Diluted net loss per share is the same as basic net loss per share in periods when the effects of
potentially dilutive ordinary shares are anti-dilutive.

  n. Recently issued and adopted accounting standards:

As  an  “emerging  growth  company,”  the  Jumpstart  Our  Business  Startups  Act  (“JOBS  Act”)  allows  the  Company  to  delay  adoption  of  new  or
revised  accounting  pronouncements  applicable  to  public  companies  until  such  pronouncements  are  made  applicable  to  private  companies.  The
Company has elected to use this extended transition period under the JOBS Act. The adoption dates discussed below reflects this election.

1.

2.

In June  2016,  the  FASB  issued  ASU  No.  2016-13  (Topic  326),  Financial  Instruments—Credit  Losses:  Measurement  of  Credit  Losses  on
Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial
asset measured at amortized cost to be presented at the net amount expected to be collected. The guidance will be effective for the Company
for fiscal years beginning after December 15, 2022. Early adoption is permitted. Effective August 1, 2021, the Company early adopted ASU
2016-13. Adoption of the new standard did not have a material impact on the financial statements.

In August  2020,  the  FASB  issued  ASU  2020-06,  Debt  –  Debt  with  Conversion  and  Other  Options  (Subtopic  470-20)  and  Derivatives  and
Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an  Entity’s  Own
Equity (“ASU 2020-06”). The final guidance issued by the FASB for convertible instruments eliminates two of the three models in ASC 470-
20  that  require  separate  accounting  for  embedded  conversion  features.  Separate  accounting  is  still  required  in  certain  cases.  Additionally,
among other changes, the guidance eliminates some of the conditions for equity classification in ASC 815-40-25 for contracts in an entity’s
own equity. The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share
calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified
share-based  payment  awards.  ASU  2020-06  is  effective  for  the  company  for  fiscal  years  beginning  after  December  15,  2023,  and  interim
periods within those fiscal years. Early adoption is permitted for fiscal years beginning after December 15, 2020. Effective August 1, 2021,
the Company early adopted ASU 2020-06. Adoption of the new standard did not have a material impact on the financial statements.

F-12

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 3: PREPAID EXPENSES

Prepaid expenses as of July 31, 2023 includes an amount of $4,701,679 in respect of a Master Service and Technology Agreement (the “MST Agreement”)
signed  with  Prevail  InfoWorks,  Inc.  (“InfoWorks”)  pursuant  to  which  InfoWorks  will  provide  clinical  services  and  technologies  for  the  Company’s
upcoming  pivotal  study  in  advanced  metastatic  breast  cancer.  The  Company  paid  InfoWorks  an  upfront  fee  of  $5,379,945  upon  signing  of  the  MST
Agreement. These fees will be amortized over the period of the clinical trial.

NOTE 4: INTANGIBLE ASSETS. NET

Acquired intangible assets with finite lives consisted of the following as of July 31, 2023 and 2022:

Patents
Gross intangible assets
Less – accumulated amortization
Intangible assets, net

July 31,

2023

2022

  $

  $

305,130    $
305,130   
(90,062)  
215,068    $

305,130 
305,130 
(74,791)
230,339 

The attributable intellectual property relates to Sapientia’s various patents, which the Company is amortizing over 20 years, consistent with its accounting
policy.

Amortization expenses for the years ended July 31, 2023 and 2022, were $15,271 and $15,271, respectively.

The estimated future amortization expense of intangible assets as of July 31, 2023 is as follows:

2024
2025
2026
2027
2028 and thereafter

See also note 14a regarding the transfer of the intangible asset.

NOTE 5: ACCRUED EXPENSES AND OTHER PAYABLES

Clinical activities
Professional services

  $

  $

15,271 
15,271 
15,271 
15,271 
153,984 
215,068 

July 31,

2023

2022

$

$

20,000   
657,718   
677,718    $

69,720 
408,087 
477,807 

F-13

 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
    
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
    
  
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 6: CONTINGENT LIABILITIES AND COMMITMENTS

Legal proceedings:

On May 24, 2023, the Company reached a settlement agreement with an investor who made certain claims against the Company and was seeking
monetary and injunctive relief, and against which the Company had filed counterclaims. Pursuant to the settlement agreement, the Company paid
$230,000 for the full and final settlement of all of the investor’s claims, in full and final settlement of any and all existing claims that the Company
and investor had or may have had against each other. This amount has been included in general and administrative expenses in the consolidated
statements of operations and comprehensive loss.

b. Lease

The Company is currently on a month-to-month lease arrangement for office and lab space in Philadelphia, PA, in the amount of approximately
$16,500  per  month.  Commencing  September  1,  2023  a  new  lease  will  commence,  replacing  the  current  month-to-month  agreement  with  a  12-
month commitment (ending August 31, 2024) of approximately $36,000 per month.

NOTE 7: FAIR VALUE MEASUREMENTS

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of July 31, 2023 and 2022:

Level 1

July 31, 2023
Level 2

Total

Level 1

July 31, 2022
Level 2

Total

Fair Value Measurements at

Financial Assets:

Cash and cash equivalents

$ 21,251,092   

-   

  21,251,092   

  41,041,652   

-   

  41,041,652 

Total assets measured at fair value

$ 21,251,092   

-   

  21,251,092   

  41,041,652   

-   

  41,041,652 

Financial liabilities:
Warrants liability
Total liabilities measured at fair value

9,742,023   
9,742,023   

  19,397,278   
  19,397,278   

$

  29,139,301   
  31,307,022 
  29,139,301    $ 11,151,608    $ 20,155,414    $ 31,307,022 

  11,151,608   

  20,155,414   

We  classify  our  cash  equivalents  and  the  liability  in  respect  of  publicly  traded  warrants  within  Level  1  because  we  use  quoted  market  prices  in  active
markets.

The fair value of the warrant liability for non-public warrants is measured using inputs other than quoted prices included in Level 1 that are observable for
the liability either directly or indirectly, and thus are classified as Level 2 financial instruments.

F-14

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
   
   
   
   
   
 
 
 
    
 
    
 
    
 
    
 
    
 
  
 
 
 
 
 
 
    
 
    
 
    
 
    
 
    
 
  
 
 
 
 
 
 
    
 
    
 
    
 
    
 
    
 
  
 
 
    
 
    
 
    
 
    
 
    
 
  
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 8: SHAREHOLDERS’ EQUITY

a. Authorized share capital

The authorized share capital consists of an unlimited number of common shares with no par value (“Share”).

b. Issued share capital

(i) The Company issued the following shares during the year ended July 31, 2022:

1. During the year, 554,991 compensation warrants with a weighted average exercise price of $5.68 per warrant were exercised into 219,453

Shares by way of a cashless exercise.

2. During the year, 63,454 warrants with an exercise price of $5.31 were exercised for gross proceeds of $337,099 and 997,200 warrants with an
exercise  price  of  $6.19  were  exercised  for  gross  proceeds  of  $6,172,669.  In  total,  the  Company  issued  1,060,654  shares  in  respect  of  the
exercise of these warrants.

(ii) The Company issued the following shares during the year ended July 31, 2023:

1. On April 14, 2023, 300 warrants with an exercise price of $5.31 were exercised for gross proceeds of $1,594. The Company issued 300 shares

in respect of the exercise of these warrants.

2. On May 12, 2023, the Company issued 463,408 Shares to Prevail Partners, LLC at a price per share of $8.63, resulting in aggregate gross

proceeds of $4,000,000.

c. Share buyback program

On September 9, 2021 the Company approved a repurchase program whereby the Company may purchase through the facilities of the TSX or NASDAQ
(i)  up  to  1,341,515  common  shares  (the  “Common  Shares”)  and  (ii)  up  to  411,962  publicly  traded  BCTXW  warrants  (the  “Listed  Warrants”)  in  total,
representing 10% of the 13,415,154 Common Shares and 10% of the 4,119,622 Listed Warrants comprising the “public float” as of September 8, 2021,
over the next 12 months (the “Buyback”). Independent Trading Group (ITG) Inc. will act as the Company’s advisor and dealer manager in respect of the
Buyback. The Company received final regulatory approval on September 22, 2021. On September 27, 2022, the Company completed the share buyback
program, repurchasing a total of 1,031,672 shares with a value of $9,098,014 (net of commissions), none of which were repurchased during the year ended
July  31,  2023,  and  259,059  publicly  traded  warrants  for  $1,121,011  (net  of  commissions)  with  a  fair  value  of  $1,130,808,  of  which  15,736  were
repurchased and cancelled during the year ended July 31, 2023. All of the warrants and shares repurchased have been cancelled.

d. Share Purchase Warrants

A summary of changes in share purchase warrants for the years ending July 31, 2023 and 2022 is presented below:

Balance, July 31, 2021
Expired
Exercised
Repurchased and cancelled
Balance, July 31, 2022
Exercised
Repurchased and cancelled
Balance, July 31, 2023

Number of warrants
outstanding

Weighted average
exercise price

9,464,152    $
(22,489)  
(1,060,654)  
(243,323)  
8,137,686    $
(300)  
(15,736)  
8,121,650    $

5.85 
(28.08)
(6.14)
(5.31)
5.76 
(5.31)
(5.31)
5.76 

F-15

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 8: SHAREHOLDERS’ EQUITY (Cont.)

As of July 31, 2023, warrants outstanding were as follows:

Number of
Warrants
outstanding as of
July 31, 2023

  Exercise Price  
4.11   
5.31   
6.19   

51,698    $
3,896,809    $
4,173,143    $
8,121,650   

Number of
Warrants
Exercisable as of
July 31, 2023

51,698   
3,896,809   
4,173,143   
8,121,650   

Expiry Date
November 16, 2025
February 26, 2026 – April 26, 2026
December 7, 2026

e) Compensation Warrants

A summary of changes in compensation warrants for the years ended July 31, 2023 and 2022 is presented below:

Balance, July 31, 2021
Exercised

Balance, July 31, 2022 and 2023 (*)

(*) There was no movement in compensation warrants during the year ended July 31, 2023.

As of July 31, 2023, compensation warrants outstanding were as follows:

Number of
Warrants
as of

July 31, 2023    

4,890    $
17,074    $
24,688    $
46,652   

Exercise Price    
4.11   
5.31   
6.19   

Exercisable
As of

July 31, 2023    
4,890   
17,074   
24,688   
46,652   

f) Warrant liability continuity

Number of
warrants
outstanding

Weighted average
exercise price

601,643   
(554,991)  

46,652    $

5.68 
(5.68)

5.66 

Expiry Date
November 16, 2025
February 26, 2026
June 7, 2026

(i) The following table presents the summary of the changes in the fair value of the warrants recorded as a liability on the Balance Sheet (*):

Balance as of July 31, 2021

Warrant buyback program
Exercise of warrants
Change in fair value
Balance as of July 31, 2022

Exercise of warrants
Warrant buyback program
Change in fair value (*)

Balance as of July 31, 2023

Warrants liability

29,789,260 

(1,073,718)
(9,066,892)
11,658,372 
31,307,022 

(897)
(47,294)
(2,119,530)

29,139,301 

$

$

$

(*) Certain warrants were issued prior to August 1, 2022 in respect of public offerings and private placements that contain terms that require the warrants
to be recorded as a liability at fair value under US GAAP. As a result, these warrants are valued at the end of each reporting period. For the year ended
July 31, 2023, the Company recorded a gain on the revaluation of the total warrant liability of $2,119,530 in the consolidated statements of operations
and comprehensive loss.

(ii) The key inputs used in the valuation of the of the Public Offering Broker Warrants as of July 31, 2023 and at July 31, 2022 were as follows:

  February 26,

  April 12, 2021  

July 31, 2023  

July 31, 2022  

 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
  
 
 
   
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Share price
Exercise price
Expected life (years)
Volatility
Dividend yield
Risk free rate

2021
(Issuance date)

(Issuance date)

  $
  $

  $
  $

3.40 
5.31 
5.00 
100% 
0% 
0.88% 

F-16

  $

3.92 
5.31 
5.00 
100% 
0% 
0.97% 

  $

6.69 
$5.31-6.19 
2.58-3.35 

6.50 
$5.31-6.19 
3.58-4.35 

100% 
0% 
4.51% 

100%
0%
2.68%

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
   
 
 
 
   
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 9: SHARE-BASED COMPENSATION

On August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan), which will permit the Company to grant incentive stock
options,  preferred  share  units,  restricted  share  units  (“RSU’s”),  and  deferred  share  units  (collectively,  the  “Awards”)  for  the  benefit  of  any  employee,
officer,  director,  or  consultant  of  the  Company  or  any  subsidiary  of  the  Company.  The  maximum  number  of  shares  available  for  issuance  under  the
Omnibus Plan shall not exceed 15% of the issued and outstanding Shares, from time to time, less the number of Shares reserved for issuance under all other
security-based  compensation  arrangements  of  the  Company,  including  the  existing  Stock  Option  Plan.  On  February  9,  2023,  the  Omnibus  Plan  was
approved by the shareholders.

a. The following table summarizes the number of options granted under the Stock Option Plan for the year ended July 31, 2023 and related information:

Balance as of July 31, 2021
Granted (i)
Forfeited
Expired
Balance as of July 31, 2022
Granted (ii)
Balance as of July 31, 2023

Exercisable as of July 31, 2023

Number of
options

Weighted average
exercise price

$

$

674,666   
818,300   
(999)  
(1,667)  
1,490,300   
641,100   
2,131,400   

1,585,655   

$

4.38   
7.81   
30.04   
46.80   
6.20   
6.16   
6.19   

6.18   

Weighted average
remaining
contractual
term
(in years)

Aggregate
intrinsic value

2.91    $
3.44   

4.09    $
4.63   
3.55   

573,466 

447,090 

1,065,700 

3.19    $

808,684 

(i)

The vesting periods of the 818,300 options granted to directors and employees during the year ended July 31, 2022 are as follows:

1.
2.
3.

110,000 of the options granted vested immediately.
482,300 of the options granted vest quarterly over the year from grant date.
226,000 of the options granted vest quarterly over the two years from grant date.

(ii)

(iii)

The 641,100 options granted to directors and employees during the year ended July 31, 2023 vest quarterly over the two years from grant
date.

The weighted-average grant date per-share fair value of stock options granted during 2023 and 2022 was $4.72 and $5.76, respectively.
As  of  July  31,  2023,  there  are  $2,590,646  of  total  unrecognized  costs  related  to  share-based  compensation  that  is  expected  to  be
recognized over a period of up to 1.75 years.

b. The following table lists the inputs to the Black-Scholes option-pricing model used for the fair value measurement of equity-settled share options for the
above Options Plans for the years 2023 and 2022:

Dividend yield
Expected volatility of the share prices
Risk-free interest rate
Expected term (in years)

F-17

Year ended July 31,

2023

2022

0% 
100% 
3.99-4.23% 

5 

0%
100%
0.8%-2.83%

5 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
   
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
    
 
  
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
    
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 9: SHARE-BASED COMPENSATION (Cont.)

c. The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of July 31, 2023

Exercise
price

Options
outstanding as of
July 31, 2023  

Weighted
average
remaining
contractual
term (years)

Options
exercisable as of
July 31, 2023  

Weighted
average
remaining
contractual
term (years)

Expiry Date

$
$
$
$
$
$
$
$
$
$

6.03   
7.16   
6.36   
4.71   
7.51   
8.47   
7.53   
5.74   
4.24   
4.24   

d. Restricted Share Units

440,000   
21,000   
180,100   
31,000   
150,000   
524,700   
12,600   
100,000   
60,000   
612,000   
2,131,400   

4.89   
4.58   
4.01   
3.81   
3.54   
3.45   
3.25   
3.09   
2.72   
2.66   

55,000   
5,250   
90,050   
19,375   
112,500   
519,400   
12,080   
100,000   
60,000   
612,000   
1,585,655   

June 20, 2028

4.89   
4.58    February 27, 2028
4.01    August 02, 2027
3.81    May 20, 2027
3.54    February 16, 2027
3.45   
January 13, 2027
3.25    November 01, 2026
3.09    September 01, 2026
2.72    April 19, 2026
2.66    March 29, 2026

The following table summarizes the number of RSU’s granted to directors under the Omnibus Plan for year ended July 31, 2023:

Balance, July 31, 2021 and 2022
Granted (i)
Balance, July 31, 2023

Number of
RSU’s
outstanding

Aggregate
intrinsic value

-    $

19,200   
19,200    $

- 
123,072 
128,448 

(i) On August 2, 2022, the Company issued 19,200 RSU’s to the CEO. The RSU’s vested immediately and have an aggregate intrinsic value of

$123,072.

d. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the years ended July 31, 2023 and 2022
is comprised as follows:

Research and development expenses
General and administrative expenses
Total share-based compensation

Year ended July 31,

2023

2022

$

$

1,072,592    $
1,121,198   
2,193,790    $

435,563 
2,639,021 
3,074,584 

F-18

 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
   
 
   
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
    
 
 
    
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 10: TAXES ON INCOME

a. Components of income taxes excluding cumulative effects of changes in accounting principles, other comprehensive income, and equity in net
results of affiliated companies accounted for after-tax for the years ended July 31 were as follows:

b. The Company recorded loss before taxes on income as follows:

Domestic
Foreign

Year ended July 31,

2023

2022

$

$

(2,469,999)   $
(17,832,395)  
(20,302,394)   $

(16,555,241)
(10,283,662)
(26,838,903)

c. The reconciliation of the combined Canadian federal and provincial statutory income tax rate of 27% (2022 - 27%) to the effective tax rate is as
follows:

Net loss before recovery of income taxes
Expected income tax (recovery) expense
Tax rate changes and effect of taxes of subsidiaries at foreign rates
Share-based compensation and other non-deductible expenses
Foreign exchange loss
Share issuance cost booked directly to equity
Valuation allowance
Income tax (recovery)

Year ended July 31,

2023

2022

$

$

(20,302,394)   $
(5,481,650)  
1,068,270   
622,220   
-   
-  
3,791,160   

-    $

(26,838,903)
(7,246,504)
1,591,220 
828,930 
7,810 
(15,420)
4,833,964 
- 

d. The Company had no  income  tax  expense  for  the  years  ended  July  31,  2023,  and  2022,  due  to  its  history  of  operating  losses  and  valuation
allowances.

e. Significant components of the Company’s deferred tax assets are as follows:

Deferred Tax Assets:

Property, plant and equipment
Marketable Securities
Warrant liability
Share issuance costs
Operating tax losses carried forward
Operating tax losses carried forward- USA
Research and Development

Total deferred tax assets
Valuation allowance
Net deferred tax assets

Deferred Tax Liability:
Intellectual Property
Convertible Debentures

Total net deferred tax liabilities
Valuation allowance
Net deferred tax assets (liabilities)

July 31,

2023

2022

730   
11,760   
3,776,710   
734,300   
3,842,320   
4,913,950   
2,685,825   
15,965,594   
(15,920,430)  

45,160    $

(45,160)   $

(45,160)  
-   
-    $

730 
11,760 
4,330,580 
1,105,220 
2,714,150 
4,015,960 
- 
12,178,400 
(12,130,030)
48,370 

(48,370)
-)
(48,370)
- 
- 

$

$

$

$

f. The  Company  has  net  deferred  tax  assets  relating  primarily  to  net  operating  loss  (“NOL”)  carryforwards  and  resource  properties.  Subject  to
certain limitations, the Company may use these deferred tax assets to offset taxable income in future periods. Due to the Company’s history of
losses and uncertainty regarding future earnings, a full valuation allowance has been recorded against the Company’s deferred tax assets, as it is
more likely than not that such assets will not be realized. The net change in the total valuation allowance for the year ended July 31, 2023, was
$2,790,400.

F-19

 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
    
 
 
 
 
 
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 10: TAXES ON INCOME (Cont.)

At July 31, 2023, the Company had US federal NOL carryforwards of approximately $23,340,000. The federal net operating losses have expiry periods
ranging between 2033 and indefinitely. The Company also has Canadian net operating loss carryovers of approximately $14,231,000 as of July 31, 2023.
The Canadian net operating losses have expiry periods ranging between 2035 and 2043.

Utilization of the NOL carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by the
Internal Revenue Code (“IRC”) Sections 382 and 383, and similar state provisions. The Company has not completed an IRC 382/383 analysis regarding the
limitation of NOL and credit carryforwards. If a change in ownership were to have occurred, the annual limitation may result in the expiration of NOL
carryforwards and credits before utilization. If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding
reduction in the valuation allowance.

The  Company  has  adopted  the  provisions  of  ASC  740-10,  which  clarifies  the  accounting  for  uncertain  tax  positions.  ASC  740-10  requires  that  the
Company recognize the impact of a tax position in its financial statements if the position is more likely than not to be sustained upon examination based on
the  technical  merits  of  the  position.  For  the  year  ended  July  31,  2023,  the  Company  had  no  material  unrecognized  tax  benefits,  and  based  on  the
information currently available, no significant changes in unrecognized tax benefits are expected in the next 12 months.

The Company’s policy is to recognize interest and penalties related to uncertain tax positions as income tax expense. The Company has no accruals for
interest or penalties on its accompanying consolidated balance sheets as of July 31, 2023, and 2022, and has not recognized interest or penalties in the
consolidated statements of operations for the years ended July 31, 2023, and 2022.

NOTE 11: RELATED PARTY TRANSACTIONS AND BALANCES

Parties are considered to be related if one party has the ability, directly or indirectly, to control the other party or exercise significant influence over the
other party in making operating and financial decisions. This would include the Company’s senior management, who are considered to be key management
personnel by the Company. Parties are also related if they are subject to common control or significant influence. Related parties may be individuals or
corporate entities. A transaction is considered to be a related party transaction when there is a transfer of resources or obligations between related parties.

a. The following related party salaries and directors’ fees are included in the consolidated statements of operations and comprehensive loss:

Directors (*)
Officers (**)

(*) Excluding the CEO who is a director

(**) Includes the CEO who is also a director

Year ended
July 31,

2023

2022

  $

  $

517,398    $

1,881,171   
2,398,569    $

476,117 
1,404,363 
1,880,480 

b. The following related party balances are included in the consolidated balance sheets:

Directors (*)
Officers (**)

July 31,

2023

2022

  $

  $

7,500    $
33,253   
40,753    $

20,519 
55,039 
75,558 

F-20

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
BriaCell Therapeutics Corp
Notes to the Consolidated Financial Statements
For the Years Ended July 31, 2023 and 2022
(Expressed in US Dollars, except share and per share data and unless otherwise indicated)

NOTE 12: FINANCIAL EXPENSE, NET

Interest income
Interest expense
Change in fair value of warrant liability
Gain on government grant
Foreign exchange loss
Financial income (expenses), net

Year ended July 31,

2023

2022

891,213    $

-   
2,119,530   
-   
(40,873)  
2,969,870    $

136,731 
(979)
(11,658,372)
3,388 
(30,730)
(11,549,962)

$

$

NOTE 13: BASIC AND DILUTED NET LOSS PER SHARE

Basic net loss per ordinary share is computed by dividing net loss for each reporting period by the weighted-average number of ordinary shares
outstanding during each period. Diluted net loss per ordinary share is computed by dividing net loss for each reporting period by the weighted
average number of ordinary shares outstanding during the period, plus dilutive potential ordinary shares considered outstanding during the period,
in accordance with ASC No. 260-10 “Earnings Per Share”. The Company experienced a loss in the year ended July 31, 2023 and 2022; hence all
potentially dilutive ordinary shares were excluded due to their anti-dilutive effect.

Year ended July 31,

2023

2022

Numerator:

Net loss available to shareholders of ordinary shares

(20,302,394)  

(26,838,903)

Denominator:

Shares used in computing net loss per ordinary shares, basic and diluted

15,619,676   

15,494,091 

NOTE 14: LONG-LIVED ASSETS BY GEOGRAPHIC LOCATION

United States
Total long-lived assets*

July 31,

2023

2022

  $
  $

215,068    $
215,068    $

230,339 
230,339 

(*) Long-lived assets are comprised of property and equipment, net, investments and intangible assets, net.

NOTE 15: SUBSEQUENT EVENTS

a. On August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”) pursuant to which certain pipeline
assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the
“BriaPro Assets”), were spun-out to BriaPro Therapeutics Corp. (“BriaPro”), resulting in a 2/3rd owned subsidiary of the Company with the
remaining 1/3rd held by BriaCell shareholders (“BriaCell Shareholders”).

Pursuant to the terms of the Arrangement, 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  common  shares.  Under  the  terms  of  the  Arrangement,  for  each  BriaCell  share  held
immediately prior to closing, BriaCell Shareholders receive one (1) common share of BriaPro, and one (1) new common share of BriaCell
(retiring their old share) having the same terms and characteristics as the existing BriaCell common shares. The Company will remain listed
on the NASDAQ Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada.

Immediately  following  the  closing  of  the  Arrangement,  the  Company  controls  2/3rd  of  the  BriaPro  common  shares  representing
approximately 66.6% of the issued and outstanding common shares of BriaPro.

As  a  result  of  the  Arrangement,  there  are  approximately  47,945,178  BriaPro  common  shares  issued  and  outstanding.  The  Company  now
beneficially owns or controls approximately 31,963,452  BriaPro  common  shares,  representing  2/3rd  of  the  issued  and  outstanding  BriaPro
common shares.

Pursuant to the Arrangement, each BriaCell warrant shall, in accordance with its terms, entitle the holder thereof to receive, upon the exercise
thereof, one BriaCell Share and one BriaPro Share for the original exercise price.

Upon the exercise of BriaCell Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount for each one (1) BriaPro
Share so issued that is equal to the exercise price under the BriaCell Warrant multiplied by the fair market value of one (1) BriaPro Share at
the Effective Date divided by the total fair market value of one (1) BriaCell Share and one (1) BriaPro Share at the Effective Date.

 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
    
 
  
 
 
 
    
 
  
 
 
 
 
 
 
    
 
  
 
 
    
 
  
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
Transition Services Agreement

On August 31, 2023, the Company and BriaPro executed a transition services agreement (the “Agreement”), pursuant to which BriaCell will
provide certain research and development and head office services (the “Services”) to BriaPro for a fixed monthly fee of $20,000.

Briacell and BriaPro acknowledged the transitional nature of the Services and accordingly, as promptly as practicable, BriaPro agreed to use
commercially  reasonable  efforts  to  transition  each  Service  to  its  own  internal  organization  or  to  obtain  alternate  third  party  providers  to
provide the Services.

F-21

 
 
 
 
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE
SECURITIES EXCHANGE ACT OF 1934

Exhibit 4.1

As  of  August  31,  2023,  BriaCell  Therapeutics  Corp.  (“we,”  “our,”  “us”  or  the  “Company”)  had  the  following  classes  of  securities  registered  under
Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”): (i) our common shares and (ii) our public warrants, with each whole
warrant exercisable for one common share for $5.3125 per share (the “Public Warrants”). 

Description of Common Shares

As of August 31, 2023, our authorized share capital, as described in our Notice of Articles, consisted of an unlimited number of common shares, without
par value, of which approximately 15,981,726 common shares were issued and outstanding. All of our outstanding common shares are validly issued, fully
paid and non-assessable.

Our common shares are the only securities with respect to which a voting right may be exercised at a meeting of the shareholders of the Company.

Dividends. Our shareholders are entitled to receive dividends, as may be declared from time to time and in the sole discretion of the Board. Dividends shall
be paid according to the number of Common Shares owned. Dividends may take the form of specific assets or of fully paid shares or of bonds, debentures
or other securities of the Company, or in any one or more of those ways. Shareholders are not entitled to notice of any dividend. We have never paid cash
dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future.

Voting Rights. Each common share is entitled to one vote at a meeting of shareholders of the Company.

Listing. Our common shares are traded on the Nasdaq Capital Market under the symbol “BCTX” and on the Toronto Stock Exchange under the symbol
“BCT”.

Description of Public Warrants

Securities Issuable Upon Exercise of the Public Warrants. Each Public Warrant is exercisable into one common share. As of August 31, 2023, 8,121,650
Public Warrants were issued and outstanding.

Exercisability.  The  Public  Warrants  are  exercisable  immediately,  have  an  exercise  price  of  $5.3125  per  share,  and  expire  five  years  from  the  date  of
issuance. The exercise price and number of common shares issuable upon exercise is subject to appropriate adjustment in the event of stock dividends,
stock splits, reorganizations or similar events affecting our common shares and the exercise price. 

Cashless Exercise. If at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available for
the issuance of the underlying shares to the holder, in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in
payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of common
shares determined according to a formula set forth in the Public Warrants.

Fractional Shares. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of the Public Warrants. As to any fraction of
a share which the holder would otherwise be entitled to purchase upon such exercise, we shall, at our election, either pay a cash adjustment in respect of
such fraction (in an amount equal to such fraction multiplied by the exercise price) or round the number of shares to be received by the holder up to the
next whole number.

Listing. Our Public Warrants are traded on the Nasdaq Capital Market under the symbol “BCTXW”.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit 31.1

I, William V. Williams, certify that:

1.

I have reviewed this Annual Report on Form 10-K of BriaCell Therapeutics Corp.;

CERTIFICATIONS

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements  made,  in  light  of  the  circumstances  under  which  such  statements  were  made,  not  misleading  with  respect  to  the  period  covered  by  this
report;

3. Based on  my  knowledge,  the  financial  statements,  and  other  financial  information  included  in  this  report,  fairly  present  in  all  material  respects  the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The  registrant’s  other  certifying  officer  and  I  are  responsible  for  establishing  and  maintaining  disclosure  controls  and  procedures  (as  defined  in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:

(a) Designed such  disclosure  controls  and  procedures,  or  caused  such  disclosure  controls  and  procedures  to  be  designed  under  our  supervision,  to
ensure  that  material  information  relating  to  the  registrant,  including  its  consolidated  subsidiaries,  is  made  known  to  us  by  others  within  those
entities, particularly during the period in which this report is being prepared;

(b) Designed  such  internal  control  over  financial  reporting,  or  caused  such  internal  control  over  financial  reporting  to  be  designed  under  our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;

(c) Evaluated  the  effectiveness  of  the  registrant’s  disclosure  controls  and  procedures  and  presented  in  this  report  our  conclusions  about  the

effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in  this  report  any  change  in  the  registrant’s  internal  control  over  financial  reporting  that  occurred  during  the  registrant’s  most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably

likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control

over financial reporting.

October 25, 2023

/s/ William V. Williams
William V. Williams
President and Chief Executive Officer
(Principal Executive Officer)

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exhibit 31.2

I, Gadi Levin, certify that:

1.

I have reviewed this Annual Report on Form 10-K of BriaCell Therapeutics Corp.;

CERTIFICATIONS

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements  made,  in  light  of  the  circumstances  under  which  such  statements  were  made,  not  misleading  with  respect  to  the  period  covered  by  this
report;

3. Based  on  my  knowledge,  the  financial  statements,  and  other  financial  information  included  in  this  report,  fairly  present  in  all  material  respects  the

financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The  registrant’s  other  certifying  officer  and  I  are  responsible  for  establishing  and  maintaining  disclosure  controls  and  procedures  (as  defined  in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:

(a) Designed  such  disclosure  controls  and  procedures,  or  caused  such  disclosure  controls  and  procedures  to  be  designed  under  our  supervision,  to
ensure  that  material  information  relating  to  the  registrant,  including  its  consolidated  subsidiaries,  is  made  known  to  us  by  others  within  those
entities, particularly during the period in which this report is being prepared;

(b) Designed  such  internal  control  over  financial  reporting,  or  caused  such  internal  control  over  financial  reporting  to  be  designed  under  our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;

(c) Evaluated  the  effectiveness  of  the  registrant’s  disclosure  controls  and  procedures  and  presented  in  this  report  our  conclusions  about  the

effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed  in  this  report  any  change  in  the  registrant’s  internal  control  over  financial  reporting  that  occurred  during  the  registrant’s  most  recent

fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the

registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably

likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control

over financial reporting.

October 25, 2023

/s/ Gadi Levin
Gadi Levin
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32.1

I,  William  V.  Williams,  President  and  Chief  Executive  Officer  of  BriaCell  Therapeutics  Corp.  (the  “Company”),  hereby  certify,  pursuant  to  18  U.S.C.
§1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

1. The Annual Report on Form 10-K of the Company for the year ended July 31, 2023 (the “Report”) fully complies with the requirements of Section

13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

October 25, 2023

/s/ William V. Williams
William V. Williams
President and Chief Executive Officer
(Principal Executive Officer)

 
 
 
 
 
 
 
 
 
 
 
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 32.2

I, Gadi Levin, Chief Financial Officer of BriaCell Therapeutics Corp. (the “Company”), hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to
§906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

1. The Annual Report on Form 10-K of the Company for the year ended July 31, 2023 (the “Report”) fully complies with the requirements of Section

13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

October 25, 2023

/s/ Gadi Levin
Gadi Levin
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)