What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-03-16 compared with 2022-12-14 · 335 added, 165 removed, 132 unchanged (79% of the section changed)

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

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

The following

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

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

Certain information contained in

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

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

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

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

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

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

of operations, and is organized as follows:

References to the “Company,” “our,”

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

The following discussion and analysis of the Company’s

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

and the notes thereto contained elsewhere in this report.

Certain information contained in the discussion and analysis set forth below

includes forward-looking statements that involve risks and uncertainties.

This Management’s Discussion

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

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

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

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

This MD&A provides

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

1 - Business Overview.

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2 - Results of Operations.

This section provides an analysis of our results of operations for the first quarter of fiscal 2023

in comparison to the first quarter of fiscal 2022.

This section provides an analysis of our results of operations for the second quarter of fiscal 2023

in comparison to the second quarter of fiscal 2022.

3 - Financial Liquidity and Capital Resources.

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prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S.

Our unaudited Condensed

Consolidated Financial Statements, and the financial information contained herein, are reported in U.S Dollars.

Our unaudited Condensed Consolidated

Financial Statements, and the financial information contained herein, are reported in U.S Dollars.

Note Regarding Forward-Looking Statements

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

amended, and Section 21E of the Exchange Act.

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

about future events.

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

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

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

In some cases, you can identify

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

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

or the negative of such terms or other similar expressions.

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

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

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

Immunotherapies

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

cancer cells.

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

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

We have based

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

These forward-looking statements are

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

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

by such forward-looking statements.

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

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

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

Factors that might cause or

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

BriaCell (the “ Company ”) is an

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

Immunotherapies have come to the forefront in the fight

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

BriaCell owns the U.S.

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

for cancer (U.S.

7,674,456), as well as patents related to PKCδ inhibitors (U.S.

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

7,674,456), as well

as patents related to PKCδ inhibitors (U.S.

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

The Company is currently advancing our targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™

in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™, to identify patients most likely to

benefit from Bria-IMT™.

The Bria-IMT™ regimen was evaluated in four patients in a prior study in 2004-2006 by Dr.

Wiseman, the scientific founder, former member of the board of directors of the Company (the “ Board ”) and principal

scientific advisor.

Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at HLA-DR alleles and had

a grade II tumor.

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

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

at least at one HLA allele and/or if they had grade I or grade II tumors.

A combination study with the immune checkpoint inhibitor pembrolizumab

(KEYTRUDA®) was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September

The Company is currently advancing our targeted

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

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

The Bria-IMT™

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

Charles Wiseman, the scientific founder, former member of

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

Encouraging results were obtained,

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

In 2017-2018 BriaCell evaluated 23 patients

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

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

I or grade II tumors.

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

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

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KEYTRUDA® and subsequently dosing with this combination was discontinued.

The study was modified under an amended protocol which

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

similar to pembrolizumab).

The study was modified under an amended protocol which evaluates

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

pembrolizumab).

The study is ongoing.

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

That means that every two minutes an American woman is diagnosed with breast cancer and more than 43,000 are projected to die

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 2,710 new cases of invasive

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

to the May 2019 “Global Oncology Trends 2021” report by the IQVIA Institute, the global market for cancer drugs (including

immunotherapy drugs) is expected to reach nearly $269 billion by the end of 2025, growing at a compound annual growth rate (“ CAGR ”)

of 10% between 2021 and 2025, of which about 20% is expected to be immuno-oncology drugs.

12.9% percent of women will be diagnosed with breast cancer at some point during their lifetime.

In 2018, there were an estimated 3,676,262

women living with female breast cancer in the United States.

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

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

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

It is estimated that the lifetime risk of men getting breast

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

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

According to the May 2019 “Global Oncology Trends

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

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

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

About 12.9% percent of women will be diagnosed with

breast cancer at some point during their lifetime.

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

the United States.

Approximately 81% of cases present as invasive breast cancer.

Approximately

6% of new breast cancer diagnoses are Stage IV (metastatic breast cancer (“ MBC ”), which has already spread to other

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, 74.6% were found to be HR+/HER2−, 10.8% were

triple-negative (HR−/HER2−), 10.5% were HR+/HER2+, and 4.0% were HR−/HER2+.

Approximately 6% of new breast cancer diagnoses are Stage

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

Twenty to thirty percent of all women

diagnosed with breast cancer will develop MBC.

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

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

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

HR+/HER2+, and 4.0% were HR−/HER2+.

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

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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 failed at least two lines of therapy.

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.

4 We currently propose that the Bria-IMT™

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

Similarly, another study showed that

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

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

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

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

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

covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2.

In animal models, sCD80 was well-tolerated and stopped tumor

growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al.

The novel technology, originally developed by Suzanne

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

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

and USPN 10,377,810 B2.

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

immunity (see Lucas A Horn, et al.

and Samuel T Haile et al.

in collaboration with

in collaboration with Dr.

Ostrand-Rosenberg).

Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn,

Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune

system to recognize and destroy tumor cells.

Additionally, strong anti-tumor

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

Importantly, as demonstrated in the same studies,

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

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

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agreement was coordinated by UMBC’s Office of Technology Development.

September 7, 2022, the Company announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting,

held November 10-12, 2022, in Boston, MA.

regimen combined with Incyte’s retifanlimab

Company’s data showed clinical benefit including extended survival time and tumor reductions in heavily pre-treated advanced breast

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

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

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

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

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

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

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

immunotherapy treatments.

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

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

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

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

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

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

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

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

regimen in combination with Incyte’s retifanlimab produced evidence of disease control,

tumor shrinkage, and potential survival benefit amongst BriaCell’s recent 12 patient

cohort in advanced breast cancer.

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

benefit amongst BriaCell’s recent 12 patient cohort in advanced breast cancer.

regimen remains well tolerated as recently reported in Phase I evaluation.

of patients showed either disease control or progression-free survival (PFS) benefits compared

with their last therapy.

to enrollment, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated

with at least 2 prior therapy regimens, further underscoring BriaCell’s positive patient

information was summarized in BriaCell’s poster session at the Society for Immunotherapy of Cancer (SITC) 37 th Annual

Meeting, held November 10-12, 2022, in Boston, Massachusetts.

The poster session highlights BriaCell’s novel off-the-shelf personalized

cellular therapy approach to immunotherapy treatment.

An off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors.

Abstract Number:

Omni Boston Hotel, 450 Summer Street, Boston, Massachusetts 02210, Poster Hall, Hall C

Date and Time:

November 10, 2022, 9:00 am – 9:00 pm

regimen combined with Incyte’s retifanlimab

percent of evaluable patients participating in the Phase I/IIa clinical study showed either disease control or progression-free survival

(PFS) benefits compared with their last therapy regimen.

Disease control rate (DCR) of 57% (4/7) was observed in evaluable patients,

measured as the percentage of patients who have achieved certain clinical end points (i.e.

complete response, partial response and stable

DCR is used in cancer clinical trials to measure the clinical effectiveness of a treatment.

PFS is the time period during which

a patient’s cancer does not get worse, commonly used as a key survival and efficacy measurement compared to the PFS values of their

previous therapy regimen.

to enrollment in the study, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated or were in the terminal

stage of breast cancer, further underscoring the uniquely positive outcome BriaCell’s treatment has achieved.

The 12 patients had

each failed at least 2 prior systemic therapy regimens (including chemotherapy, biological and “targeted” therapy).

control rates of the study are impressive in our view, suggesting robust clinical efficacy of the combination treatment.

we are very encouraged by the early PFS data in our ongoing study, since it is commonly known in cancer therapy that PFS values typically

drop from one therapy to the next in advanced cancers.

Please note that the PFS data is early data, as patients continue to remain in

The positive PFS trend BriaCell has observed in this patient cohort highlights the effectiveness of BriaCell’s treatment

without harmful side effects.

study, recently awarded U.S.

Food and Drug Administration fast track designation, continues with additional clinical data forthcoming.

of patients showed either disease control or progression-free survival (PFS) benefits compared with their last therapy.

to enrollment, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated with at least 2 prior therapy regimens,

further underscoring BriaCell’s positive patient outcomes.

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

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

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

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

We expect both Bria-OTS+™

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and prostate cancer, respectively.

of Operations for the Three Months Ended October 31, 2022, and 2021

Three months ended

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

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

The patent issued

on January 24, 2023 as US Patent No.

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

Additionally, BriaCell was awarded an Australian

patent (Patent No.

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

immunotherapy technology in Australia.

Intellectual Property:

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

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

novel technology involves the development of several HLA specific whole-cell immunotherapies in advance, and selection of the appropriate

off-the-shelf (i.e.

pre-made) immunotherapies for each patient (i.e.

personalized therapy) based on the patient’s HLA type using

a fast and easy saliva test.

Once issued, the patent will provide intellectual property protection through May 25, 2040, and a patent

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

Additionally, BriaCell was awarded

Australian Patent No.

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

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

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

matter and method of use worldwide.

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

Program Timelines

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

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

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

Clinical Sites

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

Cancer Institute, Urbana, Illinois

Oncology Network, LLC (AON), Baltimore, Maryland

Clinic, Jacksonville, Florida

Newport Beach, California

Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, Miami, Florida

Health System, Morristown and Overlook Hospitals, Morristown and Summit, New Jersey

Clinical Research, Webster, Texas

Crowley Cancer Research center, Dallas, Texas

Medical Group, Santa Rosa, California

Center of Kansas, Wichita, Kansas

of Phase II Meeting with the Food and Drug Administration

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

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

in advanced metastatic breast cancer.

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

in BriaCell’s upcoming pivotal clinical study.

This pivotal registration study will be enrolling advanced metastatic breast cancer

patients for whom no approved treatment options exist.

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

in advanced metastatic breast cancer.

Clinical Data

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

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

advanced metastatic breast cancer.

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

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

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

difficult to treat patient population.

Median PFS of 3.5 months (with one subject ongoing)

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

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

remains well tolerated with no dose limiting toxicities.

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

a life expectancy of merely months or weeks in some cases.

Patients in this cohort had failed a median of 5 other treatments prior to

enrolling in BriaCell’s study.

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

of top-responding patients:

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

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

These subgroups represent large segments of

the advanced breast cancer patient population.

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

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

Corporate Matters

09, 2023 BriaCell announced the results

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

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

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

At the Meeting, the Shareholders

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

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

Williams, Mr.

Jamieson Bondarenko, Mr.

Marc Lustig, Dr.

Rebecca Taub, Mr.

Embro-Pantalony,

Schmieg as directors of the Company;

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

of restricted share units awarded under the Omnibus Plan;

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

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

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

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

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

profile at www.sedar.com .

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

Three months ended January 31,

Operating Expenses:

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Interest income

Change in fair value of warrant liability

Gain on government grant

Foreign exchange gain

Total financial income (expenses), net

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

$ (11,881,762 )

Net loss per share – basic and diluted

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

and Development Costs

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

and (ii) clinical trials and investigational

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

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

Three months ended January 31,

Clinical trials

Pre-clinical projects

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

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.

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

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

pre-clinical program (sCD80).

costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational

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

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

Other costs increased in 2023 as we investigated additional potential pre-clinical projects.

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

Three months ended January 31,

Clinical trial sites and investigational drug costs

Wages and salaries

Laboratory Rent

Professional fees

Insurance product

Share-based compensation

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

three-month period ended January 31, 2022.

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

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

Clinical Trials and investigational drug costs increased

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

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

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

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

in research and development expenses.

and Administrative Expenses

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

the three-month period ended January 31, 2022.

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

income (expenses), net

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

the three-month period ended January 31, 2022.

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

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

period ending January 31, 2022.

for the period

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

three-month period ended January 31, 2022.

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

with the addition of increased operational spending.

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

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

Six months ended January 31,

Operating Expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Operating loss

Interest income

Interest expense

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(10,456,148 )

Gain of government grant

Foreign exchange gain

Total financial income (expenses), net

Total financial expenses, net

(10,441,360 )

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

the period ended October 31, 2022, research costs amounted to $3,255,215 as compared to $875,636 for the period ended October 31, 2021.

The rise in cost is attributed to the continued expansion of the Company’s clinical trials, the increased activity in the lab,

including the hiring of additional lab employees, and the addition of share based compensation (non-cash) expenses.

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

Six months ended January 31,

Clinical trials

Pre-clinical projects

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.

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

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

pre-clinical program (sCD80).

costs include the manufacturing of Bria-IMT™ and Bria-OTS™.

CMC costs increased in 2023 to support the additional patients

in our trials.

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

board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development

Other costs increased in 2023 as we investigated additional potential pre-clinical projects.

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

Six months ended January 31,

Clinical trial sites and Investigational drug costs

Wages and salaries

Laboratory Rent

Professional fees

Insurance product

Share-based compensation

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

ended January 31, 2022.

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

specifically our Bria-IMT™ trial.

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

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

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

Finally, the increase in share based compensation

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

and Administrative Expenses

the period ended October 31, 2022, general and administrative expenses amounted to $2,147,936 as compared to $1,409,173 for the period

ended October 31, 2021.

These increases relate primarily to increased insurance premiums, share based compensation (non-cash), professional

fees, and salaries due the hiring more personnel.

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

the six-month period ended January 31, 2022.

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

income (expenses), net

the period ended October 31, 2022, financial income, net, amounted to $4,296,610 as compared to an expense of $25,248,676 for the period

ended October 31, 2021.

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

a gain of $4,117,790 in the three-month period ending October 31, 2022 and a loss of $25,254,036 in the three-month period ending October

The Company recorded $188,353 in interest income in the three-month period ending October 31, 2022 as compared to $6,305 in

the three-month period ending October 31, 2021.

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

period ended January 31, 2022.

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

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

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

the six-month period ending January 31, 2022.

for the period

Company reported a loss for the period ended October 31, 2022, of $1,106,541, as compared to $27,533,485 for the period ended October

The loss in 2022 is due to a significant decrease in the fair value of the warrant liability offset by increased operational

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

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

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

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

Concern Uncertainty

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

of October 31, 2022, the Company has total assets of $38,450,320 (July 31, 2022 - $42,577,041) and a positive working capital balance

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

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

4 unchanged sentences

and Capital Resources

of October 31, 2022, the Company has working capital of $37,249,747 (July 31, 2022 - $41,405,613) and an accumulated deficit of $61,456,378

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

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

of October 31, 2022, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly

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

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

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

government securities, U.S.

1 unchanged sentence

and investment grade corporate debt securities.

Our investment policy and strategy are focused

on preservation of capital and supporting our liquidity requirements.

Our investment policy and strategy are focused on preservation of capital and supporting

our liquidity requirements.

Historically,

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no assurance that such a plan will be successful

the period ended October 31, 2022, the Company’s overall position of cash and cash equivalents decreased by $18,038,110 from the

period ended October 31, 2021 (including effects of foreign exchange).

This decrease in cash can

be attributed to the following:

Company’s net cash used in operating activities during the period ended October 31, 2022, was $3,542,382 as compared to $1,778,599

for the period ended October 31, 2021.

used in financing activities for the period ended October 31, 2022, was $47,294 as compared to $nil for the period ended October 31,

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

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

This decrease in cash can be attributed to

the following:

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

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

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

period ended January 31, 2022.

Sheet Arrangements

4 unchanged sentences

Accounting Policies Adopted

Company did not adopt any new accounting policies during the period ended October 31, 2022.

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

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis