What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-06-14 compared with 2024-03-18 · 125 added, 114 removed, 183 unchanged (57% of the section changed)

13 unchanged sentences

1 - Business Overview.

This section provides a general description of our business, which we believe is important in understanding

the results of our operations, financial condition, and potential future trends.

This section provides a general description of our business, which

we believe is important in understanding the results of our operations, financial condition,

and potential future trends.

2 - Results of Operations.

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.

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.

This section provides an analysis of our cash flows and outstanding debt and commitments.

Included in this analysis is a discussion of the amount of financial capacity available to fund our ongoing operations and future

This section provides an analysis of our

cash flows and outstanding debt and commitments.

Included in this analysis is a discussion

of the amount of financial capacity available to fund our ongoing operations and future commitments.

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

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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 (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.

(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

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.

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.

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.

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.

“Pivotal” 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.

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.

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.

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and accelerate the path to commercialization.

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

Three months ended

May 17, 2024, the Company closed a registered direct offering with healthcare-focused institutional investors and a certain existing

investor and a director of the Company for the purchase and sale of 2,402,935 common shares of the Company (or pre-funded warrants in

lieu thereof) and warrants to purchase up to an aggregate of 2,402,935 common shares of the Company for aggregate gross proceeds of approximately

$5.0 million before deducting placement agent fees and other offering expenses (the “Offering”).

Each common share (or pre-funded

warrant in lieu thereof) was sold together with one warrant to purchase one common share at a combined purchase price of $2.00 to the

institutional investors and $2.215 to the existing investor and director of the Company.

The warrants have an exercise price of $2.11

per share, will become exercisable six months from the date of issuance and expire five years from the initial exercise date.

of Operations for the Three Months Ended April 30, 2024 and 2023

Three months ended April 30,

Operating Expenses:

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$ (4,895,436 )

$ (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

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

Three months ended January 31,

Three months ended April 30,

Clinical trials

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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.

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.

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™.

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™.

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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,

Three months ended April 30,

Clinical trial sites and investigational drug costs

3 unchanged sentences

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 three-month period ended April 30, 2024, total research costs amounted to $7,657,632 as compared to $3,860,568 for the three-month

period ended April 30, 2023.

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

3 unchanged sentences

in 2023 to $1,090,902 in 2024 and increased supplies from $155,079 in 2023 to $165,264 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.

the three-month period ended April 30, 2024, general and administrative expenses amounted to $1,572,016 as compared to $1,816,461 for

the three-month period ended April 30, 2023.

The decrease relates primarily to a lowering of shareholder communication expense, 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 three-month period ended April 30, 2024, financial expense, net, amounted to $10,958,887 as compared to $781,593 for the three-month

period ended April 30, 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

to a gain of $10,945,672 in the three-month period ending April 30, 2024, and a gain of $539,427 in the three-month period ending April

(profit) for the period

Company reported a profit for the three-month period ended April 30, 2024, of $1,692,242, as compared to a loss of $4,895,436 for the

three-month period ended April 30, 2023.

The profit in 2024 is due to a significant decrease in fair value of the warrant liability.

of Operations for the Nine Months Ended April 30, 2024 and 2023

Nine months ended April 30,

Operating Expenses:

4 unchanged sentences

(27,562,122 )

(15,566,503 )

Financial expenses, net

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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

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

4 unchanged sentences

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

Six months ended January 31,

Nine months ended April 30,

Clinical trials

16 unchanged sentences

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

Six months ended January 31,

Nine months ended April 30,

Clinical trial sites and Investigational drug costs

3 unchanged sentences

Share-based compensation

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.

the nine-month period ending April 30, 2024, research costs amounted to $22,772,344, a significant increase from the $10,169,140 incurred

during the same period in 2023.

This upturn was primarily fueled 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 $5,799,621 in 2023 to $17,763,490 in 2024.

Concurrently, laboratory costs increased due to the recruitment of additional

employees, growing from $145,440 to $305,980.

Notably, non-cash share-based compensation expenses decreased from $814,782 in 2023 to

$618,375 in 2024, mitigating some of the overall increase in research and development expenses.

and Administrative Expenses

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.

the nine-month period ended April 30, 2024, general and administrative expenses amounted to $4,789,778 as compared to $5,397,363 for

the nine-month period ended April 30, 2023.

This reduction is mainly attributed to a decrease in professional fees, which declined from

$1,230,220 in 2023 to $970,569 in 2024 and insurance expenses which declined from $1,241,716 in 2023 to $859,287 in 2024.

income (expenses), net

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

the nine-month period ending April 30, 2024, net financial income amounted to $23,934,668, a significant increase from the loss of $2,317,236

recorded in the same period of 2023.

1 unchanged sentence

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

of $23,660,003 for the nine-month period ended April 30, 2024, compared to a loss of $2,972,285 in the nine-month period ended April

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

Company reported a loss for the period ended April 30, 2024, of $3,682,796 as compared to $17,883,739 for the period ended April 30,

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

7 unchanged sentences

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

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).

The Company had negative cash flows from operating activities during the

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

of April 30, 2024, the Company has total assets of $6,203,266 (July 31, 2023 - $27,163,577) and a negative working capital balance of

$1,227,767 (July 31, 2023 - positive $25,147,050).

The Company had negative cash flows from operating activities during the nine-month

period ended April 30, 2024 of $20,090,398.

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

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and Capital Resources

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.

of April 30, 2024, the Company has a negative working capital of $1,227,767 (July 31, 2023 – positive $25,147,050) and an accumulated

deficit of $84,229,532 (July 31, 2023 - $80,652,231).

of April 30, 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.

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the Company has financed its operation through private and public placement of equity securities, as well as debt financing.

The Company’s

ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control.

The Company intends

to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives.

Management believes

that it can be successful in obtaining additional capital;

however, there can be no assurance that the Company will be able to do so.

There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a

going concern.

To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement

a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations.

no assurance that such a plan will be successful.

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.

Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its

The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business

plan objectives.

Management believes that it can be successful in obtaining additional capital;

however, there can be no assurance

that the Company will be able to do so.

There is no assurance that any funds raised will be sufficient to enable the Company to

attain profitable operations or continue as a going concern.

To the extent that the Company is unsuccessful, the Company may need to

curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is

raised to support further operations.

There can be no assurance that such a plan will be successful.

To this end, as of March

1, 2024, certain directors and officers have agreed to defer payment of their directors’ fees/compensation until further

In addition, we are reducing expenditure on certain non-core activities whilst maintaining our focus on our Phase 3

Bria-IMT™ pivotal study in advanced metastatic breast cancer.

the nine-month period ended April 30, 2024, the Company’s overall position of cash and cash equivalents decreased by $20,315,398,

as compared to $12,871,553 for the nine-month period ended April 30, 2023.

This decrease in cash can be attributed to the following:

Company’s net cash used in operating activities during the nine-month period ended April 30, 2024, was $20,090,398, as compared

to $12,825,853 for the nine-month period ended April 30, 2023.

used in investing activities for the nine-month period ended April 30, 2024, was $225,000 compared to nil for the nine-month period ended

April 30, 2023.

used in financing activities for the nine-month period ended April 30, 2024, was nil, as compared to $45,700 for the nine-month period

ended April 30, 2023.

Sheet Arrangements

4 unchanged sentences

Accounting Policies Adopted

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

Company did not adopt any new accounting policies during the nine-month period ended April 30, 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