What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-12-14 compared with 2023-06-14 · 113 added, 349 removed, 90 unchanged (84% of the section changed)

16 unchanged sentences

2 - Results of Operations.

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.

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 2023.

3 - Financial Liquidity and Capital Resources.

18 unchanged sentences

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.

BriaCell owns the U.S.

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

for cancer (U.S.

7,674,456, U.S.

11,559,574 B2, Japanese Patent No.

6901505), 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 II clinical trial with Bria-IMT™ in combination with an immune checkpoint inhibitor.

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 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 2018.

BriaCell purchased the KEYTRUDA® for this study as BriaCell does not have an agreement

with Merck & Co., Inc.

for the supply of KEYTRUDA®.

Eleven patients were dosed in the combination therapy trial with Bria-IMT™

and the immune checkpoint inhibitor 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 completed Phase I and Phase II is ongoing.

Bria-IMT™ has obtained Fast

Track designation from the U.S.

Food and Drug Administration, or FDA, and is progressing to a pivotal study in advanced breast cancer

patients following an end of phase II meeting with the FDA with agreement on the primary endpoint.

BriaCell is also developing Bria-OTS™,

an off-the-shelf personalized approach to whole cell cancer immunotherapy.

August 4, 2022, the Company announced that it has secured an exclusive license from University of Maryland, Baltimore County (UMBC) to

develop and commercialize Soluble CD80, or 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 U.S.

Patent Number 8,956,619 B2, U.S.

Patent Number 9,650,429 B2, and U.S.

Patent Number 10,377,810 B2.

In animal models,

sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity.

Importantly, as demonstrated

in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy

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

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.

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

cancer patients who matched our lead candidate, Bria-IMT™, at HLA type/s, and these findings guided the development of further

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

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.

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

I/II clinical trial in advanced metastatic breast cancer of certain genetically defined subgroups.

The partnership between BriaCell and

Caris leverages Caris’ Right-In-Time (RIT) Clinical Trial Network, a group of over 495 oncology sites that are able to quickly

identify and enroll eligible patients in biomarker-directed clinical trials.

This service offers patients and physicians access to the

most cutting-edge precision medicine in development.

Additionally, through Caris’ comprehensive molecular profiling (Whole Exome

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

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.

November 10, 2022, the Company announced positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients.

Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study

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

Researchers also noted that:

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 outcomes.

positive data was presented at the San Antonio Breast Cancer meeting in December 2022.

clinical data reported included tumor shrinkage, disease control, progression free survival,

and potential long term survival benefit in advanced metastatic breast cancer patients treated

with the Bria-IMT™ combination regimen.

quality of life” and “less pain” were reported by many gravely ill advanced

metastatic breast cancer patients treated with the Bria-IMT™ combination regimen.

many patients remained in our study longer than other prior therapies, suggesting excellent

tolerability and clinical effectiveness of the Bria-IMT™ combination regimen.

remained well-tolerated with no dose-limiting toxicities.

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

an additive or synergistic effect of Bria-IMT™ in combination with PD-1 inhibitors, and supporting the strategy of using the Bria-IMT™

combination regimen with retifanlimab for the treatment of advanced breast cancer patients.

of immune system activation by Bria-OTS+™ and Bria-PROS™

poster presentation at the SITC meeting in November 2022 highlighted the development details and activities of BriaCell’s next

generation (enhanced version) off-the-shelf personalized immunotherapies.

has recently developed its novel next generation off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™,

that are designed to produce several immune activating molecules in addition to their original immune activating mechanisms for increased

This represents a significant advancement in BriaCell’s novel off-the-shelf personalized immunotherapy technology.

Bria-OTS+™ for advanced breast cancer, and Bria-PROS™ for advanced prostate cancer, were able to activate naïve T cells,

suggesting their potential capabilities to produce very strong immune responses in patients.

Results show that the very strong immune

responses observed may be due to:

1) direct activation of the components of the immune system such as naïve T cells, and 2) indirect

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

expect both Bria-OTS+™ and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients

with advanced breast cancer and prostate cancer, respectively.

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

The patent was issued

on January 24, 2023 as US Patent No.

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

Additionally, BriaCell was awarded an Australian

patent (Patent No.

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

immunotherapy technology in Australia.

11,559,574, titled “Whole-cell cancer vaccines and methods for selection thereof,” was issued 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).

November 24, 2022, 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 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

FDA 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 the FDA’s requirements, BriaCell expects to initiate the Bria-OTS™ study under

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

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 study will enroll 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

February 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, sharing that:

regimen remains well tolerated with no dose limiting toxicities.

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 benefits,

including survival and delayed cancer progression in this very difficult to treat patient

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 (Cortes J, et al.

Annals of Oncology 2018;

O’Shaughnessy J et al.

Breast Cancer

Tripathy D, et al.

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

were also identified subsets of top-responding patients, This included 4 of 5 patients with Grade I/II cancer, and 6 of 8 patients with

hormone receptor positive (HR+) cancer who had either disease control or improved progression free survival compared to their last therapy,

suggesting these may represent potentially better responding subgroup/s of patients.

These subgroups represent large segments of the

advanced breast cancer patient population.

January 24, 2023, Dr.

Williams, BriaCell’s CEO, issued a letter to shareholders, sharing that positive FDA feedback

on our pivotal study from the end of Phase II meeting for lead clinical candidate Bria-IMT™ in combination with a checkpoint inhibitor

could greatly accelerate the path to commercialization.

Successful completion of the pivotal study could be followed by a Biologics License

Application submission and commercialization.

The pivotal study’s primary endpoint is to be linked to survival improvement compared

to treatment of physician’s choice.

March 15, 2023, BriaCell announced that it would present four posters at the American Association for Cancer Research (AACR) 2023 Annual

On April 17, 2023, the data presented at the AACR meeting was announced.

This included positive data demonstrating survival

and clinical benefits in advanced metastatic breast cancer:

of 18 patients remained alive of those recruited since the study reopened in 2021.

than expected patient survival data highlights tolerability and clinical effectiveness of

BriaCell’s combination treatment.

Bria-IMT ™ combination regimen activated the immune system even in anergic patients

with very weak immune systems.

positive clinical data suggests more meaningful survival and clinical benefits in advanced

metastatic breast cancer.

of Operations for the Three Months Ended April 30, 2023, and 2022

months ended April 30,

and development expenses

and administrative expenses

operating expenses

income (expenses), net

in fair value of warrant liability

exchange gain

financial income (expenses), net

and Comprehensive loss for the period

$ (4,895,436 )

$ (10,015,573 )

loss per share – basic and diluted

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:

months ended April 30,

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 additional

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 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:

Three months ended April 30,

Clinical trial sites and investigational drug costs

Wages and salaries

Laboratory Rent

Share-based compensation

the three-month period ended April 30, 2023, research costs totaled $3,860,568, compared to $2,268,805 for the same period in 2022.

increase primarily resulted from the expansion of the Company’s Bria-IMT™ trial and higher clinical trials and investigational

drug costs, which rose from $1,364,090 in 2022 to $2,469,105 in 2023.

Laboratory costs also increased due to the hiring of additional

employees and higher supplies, growing from $580,506 to $947,509 and $131,605 to $155,079, respectively.

Additionally, non-cash share-based

compensation expenses rose from $158,204 in 2022 to $239,435 in 2023, contributing to the overall increase in research and development

and Administrative Expenses

the three-month period ended April 30, 2023, general and administrative expenses totaled $1,816,461, compared to $1,854,455 for the same

period in 2022.

The decrease is primarily attributed to a reduction in non-cash share-based compensation expenses, which declined from

$705,423 in 2022 to $41,754 in 2023.

income (expenses), net

the three-month period ended April 30, 2023, financial income, net, amounted to $781,593, as compared to a loss of $5,892,313 for the

three-month period ended April 30, 2022.

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

which amounted to a gain of $539,427 in the three-month period ended April 30, 2023, and a loss of $5,928,528 in the three-month period

ended April 30, 2022.

for the period

the three-month period ended April 30, 2023, the Company reported a loss of $4,895,436, compared to a loss of $10,015,573 for the same

period in 2022.

The loss in 2023 primarily resulted from increased operational spending, partially offset by a small gain due to the

decrease in fair value of the warrant liability.

In contrast, the significant loss in the prior period was primarily due to a large change

in the value of the Company’s warrant liability.

of Operations for the Nine Months Ended April 30, 2023 and 2022

Nine months ended April 30,

Therapeutics Corp.

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

transform cancer care.

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

system to recognize and destroy cancer cells.

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

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

BriaCell recently reported

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

BriaCell’s advanced metastatic breast cancer patients vs.

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

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

and early-stage efficacy.

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

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

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

August 31, 2023, the Company closed the previously announced 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.

resulting in a 2/3rd owned subsidiary of the Company with the remaining 1/3rd held by BriaCell shareholders (“BriaCell Shareholders”).

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.

Computershare

Investor Services Inc.

(“Computershare”) will forward replacement certificates to each Company shareholder that is entitled

to receive certificates, representing their allotted number of BriaPro common shares and BriaCell common shares in accordance with the

Letters of transmittal have been mailed to registered holders of BriaCell common shares, which must be completed and returned

to Computershare together with the share certificates of BriaCell common shares at the address specified in the letter of transmittal

in order for Company shareholders to receive common shares of BriaPro and new common shares of BriaCell.

A copy of the letter of transmittal

is also available under the Company’s profile on SEDAR at www.sedar.com.

noted above, 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 Corporation now beneficially owns or controls approximately 31,963,452 BriaPro common shares,

representing 2/3rd of the issued and outstanding BriaPro common shares.

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

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

Three months ended October 31,

Operating Expenses:

3 unchanged sentences

Operating loss

(15,566,503 )

(10,054,878 )

Financial income, net

Interest income

Interest expense

Change in fair value of warrant liability

(16,384,676 )

Gain of government grant

Foreign exchange loss

Total financial expenses, net

(16,333,673 )

Loss and Comprehensive loss for the period

$ (17,883,739 )

$ (26,388,551 )

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

Foreign exchange gain

Total financial income, net

Income (loss) for the period

Losses attributable to noncontrolling interest

Income (loss) for the period attributable to BriaCell

Net earnings (loss) per share attributable to BriaCell

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

Weighted average number of shares used in computing net 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

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:

Nine months ended April 30,

Three months ended October 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.

1 unchanged sentence

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™.

projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, Bria-PROS™, and pre-clinical work on our BriaPro Assets.

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).

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

CMC costs increased in 2023 to support the additional patients

in our trials.

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 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

2 unchanged sentences

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

Nine months ended April 30,

Three months ended October 31,

Clinical trial sites and investigational drug costs

3 unchanged sentences

Share-based compensation

the nine-month period ended April 30, 2023, research costs amounted to $10,169,140, compared to $4,852,620 for the nine-month period

ended April 30, 2022.

The increase in research costs is primarily attributed to the continued expansion of the Company’s clinical

trials, specifically the Bria-IMT™ trial.

Clinical trials and investigational drug costs rose from $2,861,870 in 2022 to $5,799,621

in 2023, reflecting a substantial increase.

Laboratory costs also experienced growth during 2023, including the addition of new lab personnel,

resulting in an increase from $1,390,154 in 2022 to $2,946,494 in 2023.

Furthermore, supplies expenses rose from $211,996 in 2022 to

$455,504 in 2023.

Finally, the increase in share-based compensation (non-cash) expenses contributed to the overall rise in research and

development expenses, with expenses increasing from $267,657 in 2022 to $814,782 in 2023.

the three-month period ending October 31, 2023, research costs amounted to $6,857,257, a significant increase from the $3,255,215 incurred

during the same period in 2022.

This upturn was primarily fueled by the expansion of the Company’s Bria-IMT™ trial and heightened

costs associated with clinical trials and investigational drugs, surging from $2,041,939 in 2022 to $5,397,438 in 2023.

Concurrently,

laboratory costs increased due to the recruitment of additional employees, growing from $48,000 to $88,480.

Notably, non-cash share-based

compensation expenses decreased from $350,256 in 2022 to $257,809 in 2023, mitigating some of the overall increase in research and development

and Administrative Expenses

the nine-month period ended April 30, 2023, general and administrative expenses amounted to $5,397,363, compared to $5,202,258 for the

nine-month period ended April 30, 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.

the three-month period ending October 31, 2023, general and administrative expenses amounted to $1,645,771, showing a decrease from $2,147,936

in the same period of 2022.

This reduction is mainly attributed to a decrease in non-cash share-based compensation expenses, which declined

from $761,685 in 2022 to $276,007 in 2023.

income (expenses), net

the nine-month period ended April 30, 2023, financial expense, net, amounted to $2,317,236, in contrast to $16,333,673 for the nine-month

period ended April 30, 2022.

The substantial variance primarily arises from the fluctuation in the value of the Company’s warrant

liability, resulting in a loss of $2,972,285 in the nine-month period ended April 30, 2023, and a loss of $16,384,676 in the nine-month

period ended April 30, 2022.

Additionally, interest income recorded for the nine-month period ended April 30, 2023, amounted to $682,437,

compared to $54,373 for the nine-month period ended April 30, 2022.

for the period

Company recorded a loss of $17,883,739 for the period ended April 30, 2023, compared to a loss of $26,388,551 for the period ended April

The loss in 2023 primarily stems from a substantial increase in the fair value of the warrant, along with higher operational

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.

the three-month period ending October 31, 2023, net financial income amounted to $14,461,900, a significant increase from the

$4,296,610 recorded in the same period of 2022.

This substantial difference is primarily attributed to the change in the value of

the Company’s warrant liability, which is directly affected by the shortened life of the warrants and decrease in share price,

resulting in a gain of $14,282,078 for the three-month period ended October 31, 2023, compared to a gain of $4,117,790 in the

three-month period ended October 31, 2022.

(loss) for the period

the three-month period ended October 31, 2023, the Company reported a profit of $5,958,872 compared to a loss of $1,106,541 for the

same period in 2022.

The profit in 2023 primarily resulted from increased operational spending, offset by a large gain due to the decrease

in fair value of the warrant liability.

In contrast, the loss in the prior period was primarily due to a smaller change in the value

of the Company’s warrant liability.

Concern Uncertainty

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 April 30, 2023, was $78,233,576 and negative cash flows from operating activities during the nine-month period ended April

30, 2023 was $12,825,853.

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 condensed consolidated financial

of April 30, 2023, the Company has total assets of $29,721,868 (July 31, 2022 - $42,577,041) and a positive working capital balance of

$28,119,886 (July 31, 2022 -$41,405,613).

financial statements have been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and

discharge its liabilities in the normal course of business for the foreseeable future.

The continuing operations of the Company are dependent

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

of October 31, 2023, the Company has total assets of $18,619,235 (July 31, 2023 - $27,163,577) and a positive working capital balance

of $17,361,478 (July 31, 2023 -$25,147,050).

Company is planning to finance its research and developmental activities from its existing and future working capital resources and

will 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 condensed

consolidated financial statements.

and Capital Resources

of April 30, 2023, the Company has working capital of $29,119,886 (July 31, 2022 - $41,405,613) and an accumulated deficit of $78,233,576

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

of April 30, 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.

of October 31, 2023, the Company has working capital of $17,361,478 (July 31, 2023 - $25,147,050) and an accumulated deficit of $74,560,688 (July 31, 2023 - $80,652,231).

of October 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.

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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 nine-month period ended April 30, 2023, the Company’s overall position of cash and cash equivalents decreased by $12,871,553

from the nine-month period ended April 30, 2022 (including effects of foreign exchange).

This decrease in cash can be attributed to the

Company’s net cash used in operating activities during the nine-month period ended April 30, 2023, was $12,825,853, as compared

to $9,158,647 for the nine-month period ended April 30, 2022.

used in financing activities for the nine-month period ended April 30, 2023, was $45,700, as compared to $3,582,874 for the nine-month

period ended April 30, 2022.

the period ended October 31, 2023, the Company’s overall position of cash and cash equivalents decreased by $7,605,245 from the

period ended October 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 period ended October 31, 2023, was $7,605,245 as compared to $3,542,382

for the period ended October 31, 2022.

used in financing activities for the period ended October 31, 2023, was nil as compared to $47,294 for the period ended October 31, 2022.

Sheet Arrangements

4 unchanged sentences

Accounting Policies Adopted

Company did not adopt any new accounting policies during the three and nine-month periods ended April 30, 2023.

Company did not adopt any new accounting policies during the period ended October 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