What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-03-18 compared with 2023-12-14 · 192 added, 98 removed, 105 unchanged (73% of the section changed)

16 unchanged sentences

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 2023.

This section provides an analysis of our results of operations for the first half and second quarter

of fiscal 2024 in comparison to the first half and second quarter of fiscal 2023.

3 - Financial Liquidity and Capital Resources.

19 unchanged sentences

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.

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

to transform cancer care.

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

own immune system to recognize and destroy cancer cells.

The Company is currently advancing its Bria-IMT™ targeted

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

advanced metastatic breast cancer.

Bria-IMT™ is currently under Fast Track Designation by the U.S.

FDA intended to accelerate

the review process of novel treatments that address unmet medical needs.

Positive completion of the pivotal study, following review

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

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

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

6.7-9.8 months for similar

patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at the 2023 San

Antonio Breast Cancer Symposium.

A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody

manufactured by Incyte) confirmed tolerability and early-stage efficacy.

BriaCell is also developing a personalized off-the-shelf

immunotherapy, Bria-OTS™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for

numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an

immune checkpoint inhibitor.

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

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

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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,

noted above, immediately following the closing of the Arrangement, the Company controlled 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 were

approximately 47,945,178 BriaPro common shares issued and outstanding immediately following consummation of the Arrangement.

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.

October 3, 2023, BriaCell initiated its pivotal Phase 3 Study of Bria-IMT™ in advanced metastatic breast Cancer.

The study will

evaluate the efficacy and safety of the Bria-IMT™ combination regimen with an immune check point inhibitor (Retifanlimab) in patients

who have failed at least two approved therapies for the disease.

Bria-IMT™ is currently under Fast Track Designation by the U.S.

FDA intended to accelerate the review process of novel treatments that address unmet medical needs.

Positive completion of the pivotal

study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced

metastatic breast cancer.

FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the

physician’s choice of treatment arm will be the primary endpoint of the study.

The study will 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 will be enrolled in this regimen and will be eligible for combination therapy following their initial post

treatment evaluation.

BriaCell expects frequent and responsive FDA communication under its Fast Track status during the pivotal Phase

The successful completion of the pivotal Phase 3 study would allow BriaCell to subsequently submit a Biologics License Application

and accelerate the path to commercialization.

of Operations for the Three Months Ended January 31, 2024 and 2023

Three months ended

Operating Expenses:

3 unchanged sentences

Operating loss

Financial income, net

Interest income

Change in fair value of warrant liability

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

Financial expenses, net

Share of loss on equity investments

Net loss for the period

$ (11,333,910 )

$ (11,881,762 )

Net loss attributable to non-controlling interest

Net loss for the period attributable to BriaCell

(11,294,603 )

(11,881,762 )

Net loss per share attributable to BriaCell – basic and diluted

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 the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical

Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.

a longer than expected overall survival).

Additionally,

our costs increased significantly compared with the same period in 2023 for much higher set up

costs for the pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation

for the upcoming clinical studies of Bria-OTS™.

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

Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional

pre-clinical program (sCD80).

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 2024 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

Share-based compensation

the three-month period ended January 31, 2024, total research costs amounted to $8,257,455 as compared to $3,053,357 for the three-month

period ended January 31, 2023.

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 $1,288,577 in 2023 to $6,200,980

Laboratory costs increase during 2024 as well, including the hiring of additional lab employees which increased from $1,282,441

in 2023 to $1,401,679 in 2024 and increased supplies from $207,061 in 2023 to $312,543 in 2024.

Finally, the increase in share-based

compensation (non-cash) expenses, from $225,091 in 2023 to $234,253 in 2024 also contributed to the increase in research and development

and Administrative Expenses

the three-month period ended January 31, 2024, general and administrative expenses amounted to $1,571,991 as compared to $1,432,966 for

the three-month period ended January 31, 2023.

The increase relates primarily to shareholder communication expenses and in share-based compensation (non-cash) expense, offset by a decrease in insurance expenses and professional fees.

income (expenses), net

the three-month period ended January 31, 2024, financial expense, net, amounted to $1,486,119 as compared to $7,395,439 for the three-month

period ended January 31, 2023.

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

to a loss of $1,567,746 in the three-month period ending January 31, 2024, and a loss of $7,629,502 in the three-month period ending

January 31, 2023.

for the period

Company reported a loss for the three-month period ended January 31, 2024, of $11,294,603, as compared to a loss of $11,881,762 for the

three-month period ended January 31, 2023.

The loss in 2024 is due to a significant increase in operational spending.

The loss in the

prior period is primarily due to the large increase in fair value of the warrant liability.

of Operations for the Six Months Ended January 31, 2024 and 2023

Six months ended

Operating Expenses:

Research and development expenses

General and administrative expenses

Total operating expenses

Operating loss

(18,332,474 )

Financial expenses, net

Share of loss on equity investments

Net loss for the period

$ (5,375,038 )

(12,988,303 )

Net loss attributable to non-controlling interest

Net loss for the period attributable to BriaCell

(12,988,303 )

Net loss per share attributable to BriaCell – basic and diluted

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

1 unchanged sentence

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:

Three months ended October 31,

Six 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+™, Bria-PROS™, and pre-clinical work on our BriaPro Assets.

clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial.

trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e.

longer than expected overall survival).

Additionally, our costs increased significantly compared with those in the same period in 2023 for much higher set up costs for the pivotal

Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation

for the upcoming clinical studies of Bria-OTS™.

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

CMC Costs increased in 2024 to support the pivotal Phase 3 study,

and the upcoming clinical studies of Bria-OTS™.

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:

Three months ended October 31,

Six months ended January 31,

Clinical trial sites and Investigational drug costs

3 unchanged sentences

Share-based compensation

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

the six-month period ending January 31, 2024, research costs amounted to $15,114,712, a significant increase from the $6,308,572

incurred during the same period in 2023.

This upturn was primarily fuelled by the expansion of the Company’s Phase 2 trial,

and initiation of the Phase 3 trial of the Bria-IMT™ regimen, and heightened costs associated with clinical trials and

investigational drugs, surging from $3,330,516 in 2023 to $11,598,418 in 2024.

Concurrently, laboratory costs increased due to the

recruitment of additional employees, growing from $96,000 to $196,480.

Notably, non-cash share-based compensation expenses decreased

from $575,347 in 2023 to $492,062 in 2024, mitigating some of the overall increase in research and development expenses.

and Administrative 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.

the six-month period ended January 31, 2024, general and administrative expenses amounted to $3,217,762 as compared to $3,580,902 for

the six-month period ended January 31, 2023.

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

which declined from $803,438 in 2023 to $541,909 in 2024 and insurance expenses which declined from $847,241 in 2023 to $583,997 in 2024.

income (expenses), net

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

the six-month period ending January 31, 2024, net financial income amounted to $12,975,781, a significant increase from the loss of $3,098,829

recorded in the same period of 2023.

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.

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 $12,714,331 for the six-month period ended January 31, 2024, compared to a loss of $3,511,712 in the six-month period ended January

for the period

Company reported a loss for the period ended January 31, 2024, of $5,375,038, as compared to $12,988,303 for the period ended January

The reduced loss in 2024 was primarily due to a significant increase in operational spending, offset by a large gain resulting

from the decrease in the fair value of the warrant liability.

In contrast, the larger loss in the prior period was primarily due to higher

operational spending and an increase in the value of the Company’s warrant liability.

Concern Uncertainty

3 unchanged sentences

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 January 31, 2024, the Company has total assets of $12,231,047 (July 31, 2023 - $27,163,577) and a positive working capital balance

of $7,817,634 (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.

The Company had negative cash flows from operating activities during the

six-month period ended January 31, 2024 of $15,006,564.

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 uncertainty of the Company’s ability to raise such financial

capital casts significant doubt on the Company’s ability to continue as a going concern.

and Capital Resources

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.

of January 31, 2024, the Company has working capital of $7,817,634 (July 31, 2023 - $25,147,050) and an accumulated deficit of $85,945,291

(July 31, 2023 - $80,652,231).

of January 31, 2024, 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,

12 unchanged sentences

no assurance that such a plan will be successful.

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.

the six-month period ended January 31, 2024, the Company’s overall position of cash and cash equivalents decreased by $15,006,563

from the six-month period ended January 31, 2023 (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, 2024, was $15,006,564, as compared

to $7,494,122 for the six-month period ended January 31, 2023.

used in financing activities for the six-month period ended January 31, 2024, was nil, as compared to $47,294 for the six-month period

ended January 31, 2023.

Sheet Arrangements

4 unchanged sentences

Accounting Policies Adopted

Company did not adopt any new accounting policies during the period ended October 31, 2023.

Company did not adopt any new accounting policies during the six-month period ended January 31, 2024.

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