UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended April 30, 2025
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File No. 001-40101
BRIACELL
THERAPEUTICS CORP.
(Exact
name of registrant as specified in its charter)
British
Columbia, Canada
47-1099599
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
235
15 th Street, Suite 300 ,
West
Vancouver ,
BC , V7T 2X1
(Address
of Principal Executive Offices, including zip code)
604 - 921-1810
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of each exchange on which registered
Common
shares, no par value
BCTX
The
Nasdaq Stock Market LLC
Warrants
to purchase common shares, no par value
BCTXW
The
Nasdaq Stock Market LLC
Warrants to purchase common shares, no par value
BCTXZ
The Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☐
Large accelerated filer
☐Accelerated
filer
☒
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ☒ No ☐
As
of June 16, 2025, there were 6,776,092 common shares, no par value per share, of the Company issued and outstanding.
BRIACELL
THERAPEUTICS CORP.
Form
10-Q
Table
of Contents
Page
Part I. Financial Information
3
Item
1.
Financial Statements
3
Condensed Consolidated Balance Sheets as of April 30, 2025 (unaudited) and July 31, 2024 (audited)
3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months ended April 30, 2025
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Nine Months ended April 30, 2025
5
Unaudited Condensed Consolidated Statement of Cash Flows for the Nine Months ended April 30, 2025
7
Notes to Unaudited Condensed Consolidated Financial Statements
8
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
21
Item
3.
Quantitative and Qualitative Disclosures Regarding Market Risk
30
Item
4.
Controls and Procedures
31
Part II. Other Information
32
Item
1.
Legal Proceedings
32
Item
1A.
Risk Factors
32
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
32
Item
3.
Defaults Upon Senior Securities
32
Item
4.
Mine Safety Disclosures
32
Item
5.
Other Information
32
Item
6.
Exhibits
32
Signatures
33
2
PART
I-FINANCIAL INFORMATION
Item
1. Financial Statements
BRIACELL
THERAPEUTICS CORP.
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
April
30, 2025
July
31, 2024
ASSETS
CURRENT ASSETS:
Cash and cash
equivalents
$ 12,460,253
$ 862,089
Amounts
receivable and prepaid expenses
2,324,945
2,791,765
Total
current assets
14,785,198
3,653,854
NON-CURRENT ASSETS:
Equity investment in BC
Therapeutics
496,653
418,490
Intangible assets, net
188,343
199,796
Property and equipment,
net
319,658
388,175
Long
term prepaid expenses
1,211,946
1,211,946
Total
non-current assets
2,216,600
2,218,407
Total
assets
$ 17,001,798
$ 5,872,261
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES:
Trade payables
$ 3,279,204
$ 7,170,781
Accrued
expenses and other payables
1,051,429
290,376
Total
current liabilities
4,330,633
7,461,157
NON-CURRENT LIABILITIES:
Warrant
liability
730,012
1,096,036
Total
non-current liabilities
730,012
1,096,036
SHAREHOLDERS’
EQUITY (DEFICIT) (1) :
Share Capital of no
par value - Authorized: unlimited
at April 30, 2025 and July 31, 2024, Issued and outstanding: 6,558,092
shares April 30, 2025 and 1,218,984
July 31, 2024, respectively (1)
94,022,525
72,166,414
Share-based payment reserve (1)
10,316,140
9,189,261
Warrant Reserve (1)
11,879,424
1,844,296
Accumulated other comprehensive loss (1)
( 138,684 )
( 138,684 )
Non-controlling Interest (1)
( 474,058 )
( 302,522 )
Accumulated deficit (1)
( 103,664,194 )
( 85,443,697 )
Total
shareholders’ equity (deficit) (1)
11,941,153
( 2,684,932 )
Total
liabilities and shareholders’ equity (deficit)
$ 17,001,798
$ 5,872,261
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED APRIL 30, 2025
(Unaudited)
2025
2024
2025
2024
Three months
ended
Nine months
ended
April
30,
April
30,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development,
and clinical trial expenses
$ 4,810,196
7,657,632
$ 14,160,314
$ 22,772,344
General
and administrative expenses
1,518,059
1,572,016
4,490,216
4,789,778
Total operating expenses
6,328,255
9,229,648
18,650,530
27,562,122
Operating loss
( 6,328,255 )
( 9,229,648 )
( 18,650,530 )
( 27,562,122 )
Financial income (expenses),
net
( 9,762 )
13,215
69,310
274,665
Change in fair value of the warrant liability
175,826
10,945,672
366,024
23,660,003
Share
of loss on equity investment
( 62,738 )
( 36,997 )
( 176,837 )
( 55,342 )
Net income (loss) for the
period
$ ( 6,224,929 )
$ 1,692,242
$ ( 18,392,033 )
( 3,682,796 )
Net loss attributable
to non-controlling interest
( 98,027 )
( 23,517 )
( 171,536 )
( 105,495 )
Net
income (loss) for the period attributable to BriaCell
( 6,126,902 )
1,715,759
( 18,220,497 )
( 3,577,301 )
Net income (loss) per share
attributable to BriaCell – basic and diluted
$ ( 1.64 )
$ 1.61
$ ( 6.70 )
$ ( 3.36 )
Weighted average number
of shares used in computing net basic earnings per share of common stock (1)
3,735,517
1,065,448
2,717,927
1,065,448
Weighted average number
of shares used in computing net diluted earnings per share of common stock (1)
3,735,517
1,065,448
2,717,927
1,065,448
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
FOR
THE THREE AND NINE MONTHS ENDED APRIL 30, 2025
Number
Amount
capital
reserve
loss
deficit
Interest
(deficit)
Share
capital
Additional
paid in
Warrant
Accumulated
other
comprehensive
Accumulated
Non-
Controlling
Total
shareholders’
equity
Number
Amount
capital
reserve
loss
deficit
Interest
(deficit)
Balance, January 31, 2025
2,946,940
$ 85,451,119
$ 10,091,325
$ 5,736,454
$ ( 138,684 )
$ ( 97,537,292 )
$ ( 376,031 )
$ 3,226,891
Issuance of Options
-
-
224,815
-
-
-
-
224,815
Issuance of units
3,611,152
8,571,406
-
6,142,970
-
-
-
14,714,376
Net loss for the period
-
-
-
-
-
( 6,126,902 )
( 98,027 )
( 6,224,929 )
Balance, April 30,
2025
6,558,092
$ 94,022,525
$ 10,316,140
$ 11,879,424
$ ( 138,684 )
$ ( 103,664,194 )
$ ( 474,058 )
$ 11,941,153
Share
capital
Additional
paid in
Warrant
Accumulated
other
comprehensive
Accumulated
Non-
Controlling
Total
shareholders’
equity
Number
Amount
capital
reserve
loss
deficit
Interest
(deficit)
Balance, July 31, 2024
1,218,984
$ 72,166,414
$ 9,189,261
$ 1,844,296
$ ( 138,684 )
$ ( 85,443,697 )
$ ( 302,522 )
$ ( 2,684,932 )
Issuance of Options
-
-
1,126,879
-
-
-
-
1,126,879
Exercise of prefunded warrants
6,666
-
-
-
-
-
-
-
Exercise of broker warrants
64,391
1,239,367
-
( 418,352 )
-
-
-
821,015
Issuance of units
5,268,051
20,616,744
-
10,453,480
-
-
-
31,070,224
Net loss for the period
-
-
-
-
-
( 18,220,497 )
( 171,536 )
( 18,392,033 )
Balance, April 30,
2025
6,558,092
$ 94,022,525
$ 10,316,140
$ 11,879,424
$ ( 138,684 )
$ ( 103,664,194 )
$ ( 474,058 )
$ 11,941,153
5
Number
Amount (1)
capital
loss
deficit
interest
(deficit)
Share
capital (1)
Additional
paid in
Accumulated
other comprehensive
Accumulated
Non-
controlling
Total
shareholders’
equity
Number
Amount
capital
loss
deficit
interest
(deficit)
Balance, January 31, 2024
1,065,455
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Issuance of options
-
-
392,215
-
-
-
392,215
Income (loss) for the
period
-
-
-
-
1,715,759
( 23,517 )
1,692,242
Balance, April 30, 2024
1,065,455
$ 69,591,784
$ 8,811,369
$ ( 138,684 )
$ ( 84,229,532 )
$ ( 267,935 )
$ ( 6,232,998 )
Share
capital (1)
Additional
paid in
Accumulated
other comprehensive
Accumulated
Non-
controlling
Total
shareholders’
equity
Number
Amount
Capital
loss
deficit
interest
(deficit)
Balance, July 31, 2023
1,065,455
$ 69,591,784
$ 7,421,950
$ ( 138,684 )
$ ( 80,652,231 )
-
$ ( 3,777,181 )
Balance
1,065,455
$ 69,591,784
$ 7,421,950
$ ( 138,684 )
$ ( 80,652,231 )
-
$ ( 3,777,181 )
Instruments issued to minority shareholders
at the Arrangement Date
-
-
( 36,767 )
-
-
( 162,440 )
( 199,207 )
Issuance of options
-
-
1,426,186
-
-
-
1,426,186
Loss for the period
-
-
-
-
( 3,577,301 )
( 105,495 )
( 3,682,796 )
Income (loss) for the
period
-
-
-
-
( 3,577,301 )
( 105,495 )
( 3,682,796 )
Balance, April 30, 2024
1,065,455
$ 69,591,784
$ 8,811,369
$ ( 138,684 )
$ ( 84,229,532 )
$ ( 267,935 )
$ ( 6,232,998 )
Balance
1,065,455
$ 69,591,784
$ 8,811,369
$ ( 138,684 )
$ ( 84,229,532 )
$ ( 267,935 )
$ ( 6,232,998 )
(1)
On
January 3, 2025, the Company’s board of directors approved a 1-for-15 reverse stock split , which became effective on January
24, 2025. The Company’s common shares began trading on a post-split basis on January 29, 2025, under the existing ticker symbols
“BCTX” (Nasdaq) and “BCT” (TSX). The reverse stock split did not change the total authorized share capital
of the Company or the par value of its common shares (“Reverse Stock-Split”). Outstanding stock options, warrants, and
other equity-based instruments were adjusted proportionally, with the number of shares issuable reduced and the exercise price per
share increased by a factor of 15. Any fractional shares resulting from the split were rounded down to the nearest whole share.
As
a result of the reverse stock split, the number of common shares outstanding as of January 24, 2025, was 2,946,940 .
All
share and per-share amounts presented in these condensed consolidated financial statements and accompanying notes have been retroactively
adjusted to reflect the reverse stock split for all periods presented, in accordance with ASC 260.
The
accompanying notes are an integral part of the condensed consolidated financial statements.
6
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE NINE MONTHS ENDED APRIL 30, 2025
(Unaudited)
2025
2024
Nine
months ended April 30,
2025
2024
Cash flow from operating
activities
Net loss for the period
$ ( 18,392,033 )
$ ( 3,682,796 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization
79,970
11,453
Share-based compensation
776,879
1,426,186
Share of loss on equity
investment
176,837
55,342
Change in fair value of warrants
( 366,024 )
( 23,660,003 )
Changes in assets and liabilities:
Decrease in amounts receivable
733,115
3,640
(Increase) decrease in
prepaid expenses
( 266,295 )
799,477
(Decrease) increase in
trade payable
( 3,891,577 )
5,298,663
Increase
(decrease) in accrued expenses and other payables
1,111,053
( 342,360 )
Total cash flow from operating
activities
( 20,038,075 )
( 20,090,398 )
Cash flows from investing
activities
Equity
Investment in BC Therapeutics
( 255,000 )
( 225,000 )
Total
cash flow from investing activities
( 255,000 )
( 225,000 )
Cash flows from financing
activities
Proceeds from exercise of warrants
821,015
-
Proceeds
from the issuance of units, net of issuance costs
31,070,224
-
Total
cash flow from financing activities
31,891,239
-
Increase (decrease) in cash
and cash equivalents
11,598,164
( 20,315,398 )
Cash and cash equivalents
at beginning of the period
862,089
21,251,092
Cash and cash equivalents
at end of the period
$ 12,460,253
$ 935,694
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
1: GENERAL AND GOING CONCERN
a.
BriaCell
Therapeutics Corp. (“BriaCell” or the “Company”) was incorporated under the Business Corporations Act (British
Columbia) on July 26, 2006 and is listed on the Toronto Stock Exchange (“TSX”) under the symbol “BCT”. The
Company also trades on the Nasdaq Capital Market (“NASDAQ”) under the symbols “BCTX”, “BCTXW”
and “BCTXZ”.
b.
BriaCell
Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company
that is developing novel immunotherapies to transform cancer care. Immunotherapies have come
to the forefront in the fight against cancer as they harness the body’s own immune
system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™
targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab,
manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study in metastatic
breast cancer. The pivotal Phase 3 study of 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 Phase 3 study, following
review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint
inhibitor in metastatic breast cancer.
Additionally,
BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy
of Bria-OTS™, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS™ alone
and in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by BeiGene, Ltd.) for
the treatment of metastatic breast cancer. Bria-OTS™/Bria-OTS+™ (enhanced version) provides a platform technology to
develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble cluster of differentiation 80 (“soluble
CD80” protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.
c.
Basis
of presentation of the financial statements:
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions
to Form 10-Q and Article 8 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain
information or footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed
or omitted pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all
the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows.
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments consisting
of a normal recurring nature which are necessary for a fair presentation of the financial position, operating results, and cash flows
for the periods presented.
The
accompanying unaudited condensed consolidated financial statements should be read in conjunction
with the Company’s Annual Report for the year ended July 31, 2024, filed with the SEC
on October 28, 2024. The interim period results do not necessarily indicate the results that
may be expected for any other interim period or for the full fiscal year.
On
January 3, 2025, the Company’s board of directors approved a 1-for-15 reverse stock split , which became effective on January
24, 2025. The Company’s common shares began trading on a post-split basis on January 29, 2025, under the existing ticker symbols
“BCTX” (Nasdaq) and “BCT” (TSX). The reverse stock split did not change the total authorized share capital
of the Company or the par value of its common shares. Outstanding stock options, warrants, and other equity-based instruments were
adjusted proportionally, with the number of shares issuable reduced and the exercise price per share increased by a factor of 15.
Any fractional shares resulting from the split were rounded down to the nearest whole share.
All
share and per-share amounts presented in these unaudited condensed consolidated financial statements and accompanying notes have
been retroactively adjusted to reflect the reverse stock split for all periods presented, in accordance with ASC 260.
8
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
d.
Going
concern
The
Company continues to devote substantially all of its efforts toward research, development, and clinical 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, 2025 was $ 103,664,194 and negative cash flows from operating activities during
the nine-month period ended April 30, 2025 was $ 20,038,075 . The Company is planning to finance its operations by exploring additional
sources of capital and financing, while managing its existing working capital resources. The Company’s ability to continue
as a going concern is dependent upon its ability to attain future profitable operations and to obtain the necessary financing to
meet its obligations arising from normal business operations when they come due. The uncertainty of the Company’s ability to
raise such financial capital casts substantial doubt on the Company’s ability to continue as a going concern. These unaudited
condensed consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities
that might be necessary should the Company not be able to continue as a going concern. See note 6(b) for details of an $ 8.5 million
gross offering completed in September 2024, a $ 5.0 million gross offering completed in October 2024, a $ 5.55 million gross offering
completed in December 2024, a $ 3.05 million gross offering completed in February 2025, and a $ 13.8 million gross offering in April
2025.
e.
The
Company has two wholly-owned U.S. subsidiaries: (i) BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April
3, 2014, under the laws of the state of Delaware, and (ii) BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”),
which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company also has one Canadian subsidiary:
BriaPro Therapeutics Corp, (“BriaPro”) which was incorporated on May 15, 2023, under the Business Corporations Act (British
Columbia). See also note 1f. (Sapientia and BTC and BriaPro together, the “Subsidiaries”).
f.
On
August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”) pursuant to which certain
pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications
including cancer (the “BriaPro Assets”), were spun-out to BriaPro Therapeutics Corp. (“BriaPro”), resulting
in a 2/3rd owned subsidiary of the Company with the remaining 1/3rd held by BriaCell shareholders (“BriaCell Shareholders”).
Pursuant
to the terms of the Arrangement, BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration
for the issuance by BriaPro to the Company of BriaPro common shares. Under the terms of the Arrangement, for each BriaCell share
held immediately prior to closing, BriaCell Shareholders received one (1) common share of BriaPro (“BriaPro Share”),
and one (1) new common share of BriaCell (retiring their old share) having the same terms and characteristics as the existing BriaCell
common shares. The Company will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting
issuer in Canada.
Immediately
following the closing of the Arrangement, the Company controls 2/3rd of the BriaPro common shares representing approximately 66.6 %
of the issued and outstanding common shares of BriaPro.
As
a result of the Arrangement, there are 47,945,178 BriaPro Shares issued and outstanding. The Company now beneficially owns or controls
approximately 31,963,452 BriaPro Shares, representing 2/3rd of the issued and outstanding BriaPro Shares).
In
addition, pursuant to the Arrangement, each BriaCell warrant in issuance at the time of the Arrangement (“Briacell Legacy Warrant”)
shall, in accordance with its terms, entitle the holder thereof to receive, upon the exercise thereof, one BriaCell Share (and post
Reverse Stock-Split – 15 Briacell Shares) and one BriaPro Share for the original exercise price. Warrants issued by the Company,
subsequent to the Arrangement are not subject to the terms above.
Upon
the exercise of 15 BriaCell Legacy Warrants (post Reverse Stock-Split), BriaCell shall, as agent for BriaPro, collect and pay to
BriaPro an amount for each one (1) BriaPro Share so issued that is equal to the exercise price under the 15 BriaCell Legacy Warrants
multiplied by the fair market value of one (1) BriaPro Share at the Effective Date divided by the total fair market value of one
(1) BriaCell Share and one (1) BriaPro Share at the Effective Date (“BriaPro Warrant Shares”). On a post Reverse Stock-Split
basis, as of April 30, 2025, 554,553 Briacell Legacy Warrants are exercisable into 554,553 Briacell Shares and 8,168,295 BriaPro
Shares.
9
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
In
addition, pursuant to the Arrangement, all Briacell option holders in issuance at the time of the Arrangement (“BriaCell Legacy
Options”) received the same amount of BriaPro options (“BriaPro Option”) and under the BriaPro incentive plan.
There were 2,131,400 (pre Reverse Stock Split) Briacell Legacy Options at the time of the Arrangement. The exercise price of the
BriaCell Legacy Options was apportioned between the BriaCell Legacy Options and the BriaPro options, as follows:
Each
fifteen (15) BriaPro Legacy Options (post Reverse Stock-Split) to acquire one (1) BriaPro share shall have an exercise price equal
to the product obtained by multiplying the original exercise price of the BriaCell Option by the quotient obtained by dividing (A)
the fair market value of a BriaPro Share at the Effective Date by (B) the aggregate fair market value of a BriaCell Share and a BriaPro
Share at the Effective Date.
Pursuant
to the Arrangement, all BriaCell Restricted Shares Units (“RSU”) holders in issuance at the time of the Arrangement received
the same amount of BriaPro RSU’s under the BriaPro incentive plan.
Transition
Services Agreement
On
August 31, 2023, the Company and BriaPro executed a transition services agreement (the “Agreement”), pursuant to which
BriaCell will provide certain research and development and head office services (the “Services”) to BriaPro for a fixed
monthly fee of $ 20,000 .
Briacell
and BriaPro acknowledged the transitional nature of the Services and accordingly, as promptly as practicable, BriaPro agreed to use
commercially reasonable efforts to transition each Service to its own internal organization or to obtain alternate third party providers
to provide the Services.
In
accordance with US GAAP’s Accounting Standards Codification 505 “Equity”, the Arrangement was determined to be
a spinoff of nonmonetary assets which did not constitute a business. However, since the assets were transferred to an entity under
the Company’s control, the assets is being recorded on the Company’s basis (carry value) and not at fair market value.
NOTE
2: SIGNIFICANT ACCOUNTING POLICIES
a.
Use of estimates :
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that
affect the amounts reported in the condensed consolidated financial statements and accompanying notes. The Company’s management
believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made.
These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the condensed consolidated
financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.
10
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
b.
Prepaid expenses
The
Company has prepaid certain expenses in respect of its pivotal phase III trial and estimates the period over which such expenses
will be incurred. As of July 31, 2024, the Company revised its estimate of the time to completion in respect of this trial. Amounts
estimated to be expenses in more than 12 months have been classified to long-term prepaid expenses.
c.
The useful life of property and equipment
Property
and equipment are depreciated over their useful lives. Useful lives are based on management’s estimates of the period that
the assets will be used which are periodically reviewed for continued appropriateness. Changes to estimates can result in significant
variations in the amounts charged to the consolidated statement of operations and comprehensive loss in specific periods.
d.
Investment equity method :
Investments
in entities over which the Company does not have a controlling financial interest but has significant influence are accounted for
using the equity method, with the Company’s share of losses reported in the loss from equity method investments on the unaudited
condensed consolidated statement of operations and comprehensive loss. The Company has a 60.9 % interest in BC Therapeutics. Management
evaluates whether it has control over the investee in accordance with the guidance of ASC 810, which requires judgment to assess
factors such as power over significant activities of the investee, exposure to variable returns, and the ability to affect those
returns. Based on this evaluation, management determines whether control or significant influence is present for accounting purposes.
e.
Recently issued and adopted accounting standards :
As
an “emerging growth company,” the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay
adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to
private companies. The Company has elected to use this extended transition period under the JOBS Act. The adoption dates discussed below
reflects this election. The pronouncements below relate to standards that impact the Company.
1.
In
December 2023, the FASB issued ASU 2023-09 - Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard
modifies the rules on income tax disclosures to require entities to disclose specific categories in the rate reconciliation, the
income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing
operations. ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local
jurisdictions. The ASU is effective for years beginning after December 15, 2024, but early adoption is permitted. This ASU should
be applied on a prospective basis, although retrospective application is permitted. The Company is currently evaluating the impact
of this standard on its financial statements and disclosures.
2.
In
March 2024, the FASB issued ASU 2024-01 - Compensation—Stock Compensation (Topic 718): Scope Application of Profits Interest
and Similar Awards. This standard clarifies whether profits interest and similar awards fall within the scope of stock-based
compensation guidance as defined in ASC Topic 718, introducing examples to demonstrate this. The ASU includes scenarios where profits
interest awards are classified as equity instruments or liability awards and situations where they fall outside ASC Topic 718, being
accounted for under ASC Topic 710. The ASU is effective for years beginning after December 15, 2024, but early adoption is permitted.
This ASU should be applied on a prospective basis, although retrospective application is permitted. No director, officer, employee
or consultant has a profit interests awards and therefore this standard has no effect on the Company’s financial statements
and disclosures.
3
In June 2025, the FASB issued ASU 2025-03 - Business Combinations (Topic
805) and Consolidation (Topic 810): Determining the Accounting Acquirer in a Variable-Interest Entity . This standard clarifies that
when a business combination is effected primarily by exchanging equity interests and the legal acquiree is a variable-interest entity
(“VIE”) that meets the definition of a business, entities must identify the accounting acquirer using the factors in ASC 805-10-55-12
through 55-15, rather than relying solely on the VIE consolidation model. The ASU is effective for years beginning after December 15,
2026, but early adoption is permitted. This ASU should be applied on a prospective basis, although retrospective application is permitted.
The Company is currently evaluating the impact of this standard on its financial statements and disclosures.
4.
In January 2025, the FASB issued ASU 2025-01 - Income Statement —
Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This standard
amends the guidance issued in 2024 to confirm that all public business entities must present the required expense-disaggregation disclosures
in annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027. The
ASU is effective for years beginning after those dates, but early adoption is permitted. This ASU should be applied on a prospective basis,
although retrospective application is permitted. Because the amendment only affects disclosure timing, the Company does not expect this
standard to have a material impact on its financial statements and disclosures.
11
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
3: INVESTMENT IN BC THERAPEUTICS INC.
On
December 21, 2023, the Company and BC Therapeutics, Inc. (“BC Therapeutics” or “the Investee”) entered a
share purchase agreement (“SPA”), pursuant to which the Company initially provided a loan of $ 300,000 to BC Therapeutics,
with no interest to be paid. Subsequently, in accordance with the SPA, this loan was converted into an equity investment in BC Therapeutics
at a rate of $ 1.25 per share, resulting in a 37.5 % ownership interest (“Initial Investment”).
Pursuant
to the SPA (“Initial Investment”), Briacell also received two options to invest an additional $ 225,000 per option at
$ 1.25 per BC Therapeutics share. The first option expired on February 15, 2024 (“First BC Therapeutics Option”) and the
second option expired on June 30, 2024 (“Second BC Therapeutics Options”, together, the “BC Therapeutic Options”).
In accordance with ASC 321 and ASC 815, the BC Therapeutics Options were initially valued at $ 76,350 in accordance with the Black
Scholes Option Price Model, using the following assumptions: Share price: $ 1.25 , Exercise price: $ 1.25 , Dividend yield: 0 %, Risk
free interest rate: 4.902 %, Volatility: 100 %.
BC
Therapeutics has a board of four representatives, with two representatives appointed by BriaCell and two representatives appointed
by the existing shareholders. All significant decisions related to BC Therapeutics require the approval of at least a majority of
the board members.
The
Company initially acquired a significant interest in BC Therapeutics on February 1, 2024,
by exercising the First BC Therapeutics Option, increasing its ownership to 51.2 %. On August
7, 2024, following the expiration of the original Second BC Therapeutics Option, the Company
and BC Therapeutics amended the SPA to introduce new options, allowing the exercise in tranches
of at least 20,000 shares at $ 1.25 per share. On March 18, 2025, the SPA was amended a second
time, such that the Second BC Therapeutics Option is increased to 424,000 shares and expires
in June 2026 (a one year extension). During the nine-month period ended April 30, 2025, the
Company exercised this option in totaling $ 255,000 and received 204,000 shares.
As
of April 30, 2025, the Company holds 624,000 of the 1,024,000 issued and outstanding shares in BC Therapeutics, representing a 60.9 %
ownership interest. In addition, 220,000 shares remain available for purchase under the Second
BC Therapeutics Option at an exercise price of $ 1.25 per share; these options expire on June 30, 2026.
In
accordance with ASC 810, the Company continues to account for the investment under the equity method of accounting as the Company
does not exercise control over BC Therapeutics.
Changes
in the Company’s equity investment in BC Therapeutics is summarized as follows:
SCHEDULE OF CHANGES IN INVESTMENT
Balance
– August 1, 2023
$
-
Funding
(including the value of the BC Therapeutics Options)
525,000
Share
of losses
( 106,510
)
Balance
– July 31, 2024
418,490
Funding
255,000
Share
of losses
( 176,837 )
Balance
– April 30, 2025
$
496,653
The
following amounts represent the Company’s 60.9% share of the assets of BC Therapeutics:
SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As
of
April
30, 2025
Current
assets: Cash
$
1,088
Net
assets
$
1,088
12
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
4: CONTINGENT LIABILITIES AND COMMITMENTS
a.
BriaPro
Warrants
Upon
the exercise of 15 BriaCell Legacy Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount based on an agreed
formula (detailed in note 1(f)). As of April 30, 2025, this amount totaled up to $ 241,164 and is eliminated on consolidation.
b.
Lease
The
Company was previously in a 12 -month commitment for office and lab space in Philadelphia, PA, costing approximately $ 38,110 per month.
The lease expired on August 31, 2024 , and as of April 2025, the Company continues to occupy the space on a month-to-month basis under
the same terms
NOTE
5: FAIR VALUE MEASUREMENTS
The
following table presents information about our financial instruments that are measured at fair value on a recurring basis as of April
30, 2025, and July 31, 2024:
SCHEDULE OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair
Value Measurements at
April
30, 2025
July
31, 2024
Level
1
Level
2
Total
Level
1
Level
2
Total
Financial
Assets:
Cash
and cash equivalents
12,460,253
-
12,460,253
862,089
-
862,089
Total
assets measured at fair value
$
12,460,253
$
-
$
12,460,253
$
862,089
$
-
$
862,089
Financial
liabilities:
Warrant
liability
467,617
262,395
730,012
760,657
335,379
1,096,036
Total
liabilities measured at fair value
$
467,617
$
262,395
$
730,012
$
760,657
$
335,379
$
1,096,036
The
Company classifies its cash and cash equivalents and the liability in respect of publicly traded warrants within Level 1 because we use
quoted market prices in active markets.
The
fair value of the warrant liability for non-public warrants is measured using inputs other than quoted prices included in Level 1 that
are observable for the liability either directly or indirectly, and thus are classified as Level 2 financial instruments.
NOTE
6: SHAREHOLDERS’ EQUITY
a.
Authorized share capital
The
authorized share capital consists of an unlimited number of common shares with no par value.
b.
Issued share capital
(i)
Reverse
Stock Split:
1.
On
January 3, 2025, the Company’s board of directors approved a reverse stock split (the
“Reverse Split”) of the Company’s common shares on a 1-for-15 basis, which
became effective on January 24, 2025 (the “Effective Date”). The Company’s
post-split common shares began trading on The Nasdaq Capital Market (“Nasdaq”)
and the Toronto Stock Exchange (“TSX”) at market open on January 29, 2025, under
the existing ticker symbols “BCTX” (Nasdaq) and “BCT” (TSX”)
with a new CUSIP number (107930208).
13
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
As
a result of the Reverse Split, every fifteen (15) pre-split common shares issued and outstanding were automatically combined into
one (1) new common share. No fractional common shares were issued in connection with the Reverse Split. Instead, any fractional common
shares resulting from the Reverse Split were deemed to have been tendered to the Company for cancellation for no consideration.
Following
the Reverse Split, the number of common shares outstanding as of the Effective Date was 2,946,940 .
The
Reverse Split also resulted in a proportional adjustment to the number of common shares issuable upon the exercise of the Company’s
outstanding warrants, stock options, and other convertible securities, as well as an adjustment to the exercise prices and conversion
prices, as applicable.
The Reverse Split was implemented to ensure compliance with Nasdaq’s minimum bid price requirement and did not impact the par value
of the Company’s common shares or the Company’s authorized share capital.
All
share and per share amounts in the accompanying consolidated financial statements and related notes have been retroactively adjusted
to reflect the Reverse Split for all periods presented.
(ii)
The
Company issued the following shares during the nine-month period ended April 30, 2025:
1.
On
September 12, 2024, the Company completed a registered direct offering for the purchase and sale of 821,666 common shares of the
Company at an offering price of $ 10.35 per share, for aggregate gross proceeds of approximately $ 8.5 million before deducting placement
agent fees and other offering expenses (the “September 2024 Offering”).
In connection with the September
2024 Offering, the Company issued 41,083 placement agent warrants with an exercise price of $ 12.94 per share. These placement agent
warrants are exercisable beginning on March 11, 2025, and expire five years from the date of issuance. The fair value of the broker
warrants was determined to be $ 247,800 using the Black-Scholes option pricing model, with the following assumptions: share price -
$ 9.45 ; exercise price - $ 12.94 ; expected life – 5 years; annualized volatility - 109 %; dividend yield - 0 %; risk-free rate –
3.469 %, non-marketability discount – 16.38 %.
The amount was credited to the warrant reserve
at the date of the September 2024 Offering.
2.
On October 2, 2024, the Company
closed a registered direct offering for the purchase and sale of 341,900 common shares of the Company and warrants to purchase up to
an aggregate of 341,900 common shares of the Company for aggregate gross proceeds of $ 5 million before deducting placement agent fees
and other offering expenses (the “October 2024 Offering”). Each common share was sold together with one warrant to purchase
one common share at a combined purchase price of $ 14.63 . The warrants have an exercise price of $ 12.75 per share, and are immediately
exercisable, and expire five years from the date of issuance (“October 2024 Warrants”).
In connection with the October 2024 Offering,
the Company issued 17,095 placement agent warrants. The placement agent warrants are immediately exercisable at an exercise price of
$ 18.28 per share and expire five years from the date of issuance.
The fair value of the 341,900 October 2024
Warrants was determined to be $ 2,211,266 (gross, before deducting share issuance costs) using the Black-Scholes option pricing model,
with the following assumptions: share price - $ 8.10 ; exercise price - $ 12.75 ; expected life – 5 years; annualized volatility
- 121 %; dividend yield - 0 %; risk-free rate – 3.553 %.
The fair value of the 17,095 placement agent
warrants was determined to be $ 204,128 using the Black-Scholes option pricing model, with the following assumptions: share price -
$ 15.15 ; exercise price - $ 18.28 ; expected life – 5 years; annualized volatility - 112 %; dividend yield - 0 %; risk-free rate –
3.561 %.
The amounts were credited to the warrant reserve
at the date of the October 2024 Offering.
14
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
3.
On December 13, 2024, the Company closed a
public offering for the purchase and sale of 493,333 common shares of the Company and warrants to purchase up to an aggregate of 493,333
common shares of the Company for aggregate gross proceeds of approximately $ 5.55 million before deducting underwriting discounts, commissions,
and other offering expenses (the “December 2024 Offering”). Each common share was sold together with one warrant to purchase
one common share at a combined purchase price of $ 11.25 . The warrants have an exercise price of $ 14.06 per share, and are immediately
exercisable, and expire five years from the date of issuance (“December 2024 Warrants”).
In connection with the December 2024 Offering,
the Company issued 24,666 agent warrants. The agent warrants are immediately exercisable at an exercise price of $ 14.06 per share and
expire five years from the date of issuance.
The fair value of the 493,333 December 2024
Warrants was determined to be $ 2,327,089 (gross, before deducting share issuance costs) using the Black-Scholes option pricing model,
with the following assumptions: share price - $ 6.60 ; exercise price - $ 14.06 ; expected life – 5 years; annualized volatility
- 111 %; dividend yield - 0 %; risk-free rate – 4.133 %.
The fair value of the 24,666 agent warrants
was determined to be $ 188,252 using the Black-Scholes option pricing model, with the following assumptions: share price - $ 9.90 ; exercise
price - $ 14.06 ; expected life – 5 years; annualized volatility - 111 %; dividend yield - 0 %; risk-free rate – 4.133 %.
The amounts were credited to the warrant reserve
at the date of the December 2024 Offering.
4.
On February 5, 2025, the Company closed a
public offering for the purchase and sale of 762,500 common shares of the Company at an offering price of $ 4.00 per share, for aggregate
gross proceeds of approximately $ 3.05 million before deducting placement agent fees and other offering expenses (the “February
2025 Offering”).
In connection with the February 2025 Offering,
the Company issued 38,125 placement agent warrants with an exercise price of $ 5.00 per share. These placement agent warrants are immediately
exercisable and expire five years from the date of issuance. The fair value of the broker warrants was determined to be $ 156,130 using
the Black-Scholes option-pricing model, with the following assumptions: share price – $ 5.04 ; exercise price – $ 5.00 ; expected
life – 5 years; annualized volatility – 112 %; dividend yield – 0 %; risk-free rate – 4.37 %.
The amount
was credited to the warrant reserve at the date of the February 2025 Offering.
5.
On April 28, 2025, the Company closed an underwritten public
offering for the purchase and sale of 3,066,666 units for aggregate gross proceeds of approximately $ 13.8 million before deducting underwriting
discounts, commissions, and other offering expenses (the “April 2025 Offering”). Of those units, 2,405,966 were “regular”
units, each consisting of one common share and one five-year publicly traded warrant at a combined purchase price of $ 4.50 per unit,
and 660,700 were “pre-funded” units, each consisting of one pre-funded warrant (at a $ 0.001 strike) and one five-year publicly
traded warrant at a combined purchase price of $ 4.499 per unit. All warrants have an exercise price of $ 5.25 per share, are immediately
exercisable, and expire five years from the date of issuance (“April 2025 Warrants”). The April 2025 Warrants trade on the
NASDAQ under the symbol “BCTXZ.”
In
connection with the April 2025 Offering, the Company issued 153,333 representative’s warrants. The representative’s warrants
are immediately exercisable at an exercise price of $ 5.625 per share and expire five years from the date of issuance.
The
fair value of the 3,066,666 April 2025 Warrants was determined to be $ 5,666,620 (gross, before deducting share issuance costs) using
the Black-Scholes option pricing model, with the following assumptions: share price - $ 2.65 ; exercise price - $ 5.25 ; expected life –
5 years; annualized volatility - 105 %; dividend yield - 0 %; risk-free rate – 3.885 %.
15
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
The
fair value of the 153,333 representative’s warrants was determined to be $ 602,824 using the Black-Scholes option pricing model,
with the following assumptions: share price - $ 5.00 ; exercise price - $ 5.625 ; expected life – 5 years; annualized volatility -
105 %; dividend yield - 0 %; risk-free rate – 3.885 %.
The amounts were credited to the warrant reserve at the date of the April
2025 Offering.
As of April 30, 2025, 218,000 pre-funded warrants remained un-exercised and outstanding.
6.
During the nine-month period ended April 30, 2025, a total
of 64,391 October 2024 Warrants with an exercise price of $ 12.75 were exercised, generating gross proceeds of $ 821,015 . The Company issued
64,391 common shares in respect of these warrant exercises.
c.
Share Purchase Warrants
A
summary of changes in share purchase warrants for the nine-month period ending April 30, 2025 is presented below:
SUMMARY OF CHANGES IN WARRANTS
Number of
options
outstanding
Weighted
average
exercise
price
Balance,
July 31, 2024
701,638
$
73.82
Exercised
( 64,391
)
( 12.75
)
Granted
in the October 2024 Offering
341,900
12.75
Granted
in the December 2024 Offering
493,333
14.06
Granted
in the April 2025 Offering
3,066,666
5.25
Balance,
April 30, 2025
4,539,146
$
17.27
(ii)
As
of April 30, 2025, warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number
of
Warrants
Exercise
Price
Exercisable
At
April
30, 2025
Expiry
Date
(*) 3,448
$
56.10
3,448
November
16, 2025
(*) 259,793
$
79.69
259,793
February
26, 2026 – April 26, 2026
(*) 278,209
$
92.85
278,209
December
7, 2026
160,195
$
31.65
160,195
November
17, 2029
277,502
$
12.75
277,502
October
2, 2029
493,333
$
14.06
493,333
December
12, 2029
3,066,666
$
5.25
3,066,666
April
24, 2030
4,539,146
4,539,146
(*)
Briacell Legacy Warrants – see note 1(f)
16
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
d.
Compensation Warrants
(i)
A
summary of changes in compensation warrants for the nine-month period ending April 30, 2025 is presented below:
SUMMARY OF CHANGES IN WARRANTS
Number
of warrants
outstanding
Weighted
average
exercise
price
Balance,
July 31, 2024
6,436
58.61
Granted
in the September 2024 Offering
41,083
12.94
Granted
in the October 2024 Offering
17,095
18.28
Granted
in the December 2024 Offering
24,666
14.06
Granted
in the February 2025 Offering
38,125
5.00
Granted
in the April 2025 Offering
153,333
5.63
Balance,
April 30, 2025
280,738
$
9.34
(ii)
As
of April 30, 2025, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number
of
Warrants
Exercise
Price
Exercisable
At
April
30, 2025
Expiry
Date
(*) 326
$
56.10
326
November
16, 2025
(*) 1,133
$
79.69
1,133
February
26, 2026
(*) 1,644
$
92.85
1,644
June
7, 2026
3,333
$
34.80
3,333
May
17, 2029
41,083
$
12.94
41,083
September
12, 2029
17,095
$
18.28
17,095
October
2, 2029
24,666
$
14.06
24,666
December
12, 2029
38,125
$
5.00
38,125
February
2, 2030
153,333
$
5.63
153,333
April
24, 2030
280,738
280,738
(*)
Briacell
Legacy Warrants – see note 1(f)
e.
Warrant liability continuity
The
following table presents the summary of the changes in the fair value of the warrants:
SCHEDULE OF CHANGE IN FAIR VALUE OF WARRANTS
Warrants
liability
Balance
as of August 1, 2024
$
1,096,036
Change
in fair value during the period
$
( 366,024 )
Balance
as of April 30, 2025
$
730,012
17
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
The
key inputs used in the valuation of the non-public warrants as of April 30, 2025 and at July 31, 2024 were as follows:
SCHEDULE OF VALUATION OF NON-PUBLIC WARRANTS
April
30, 2025
July
31, 2024
Share
price
$
4.46
$
11.25
Exercise
price
$
79.69 - 92.85
$
79.69 - 92.85
Expected
life (years)
0.55 - 1.60
1.57 - 2.35
Volatility
127 - 152
%
77 - 79
%
Dividend
yield
0
%
0
%
Risk
free rate
2.60 - 3.87
%
4.27
%
The
key inputs used in the valuation of the of the BriaPro Warrant Shares as of April 30, 2025 were as follows:
SCHEDULE OF BRIA PRO WARRANTS
August
31, 2023
(Effective Date)
April
30, 2025
Share
price
$
0.0365
$
0.0365
Exercise
price
$
0.0206 - 0.0308
$
0.0206 - 0.0308
Expected
life (years)
2.21 - 3.27
0.55 - 1.60
Volatility
100
%
127 - 152
%
Dividend
yield
0
%
0
%
Risk
free rate
4.40
%
2.47 - 2.60
%
NOTE
7: SHARE-BASED COMPENSATION
a.
On
August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan),
which will permit the Company to grant incentive stock options, preferred share units, restricted
share units (“RSU’s”), and deferred share units (collectively, the “Awards”)
for the benefit of any employee, officer, director, or consultant of the Company or any subsidiary
of the Company. The maximum number of shares available for issuance under the Omnibus Plan
shall not exceed 15 % of the issued and outstanding Shares, from time to time, less the number
of Shares reserved for issuance under all other security-based compensation arrangements
of the Company, including the existing Stock Option Plan. On February 9, 2023, the Omnibus
Plan was approved by the shareholders.
b.
The
following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan
for nine-month period ended April 30, 2025 and related information:
SUMMARY OF NUMBER OF OPTIONS GRANTED
Number
of options
Weighted
average
exercise
price
Weighted
average
remaining
contractual
term
(in
years)
Aggregate
intrinsic
value
Balance
as of July 31, 2024
142,096
$
91.99
2.52
$
-
Granted
(i)
3,333
6.00
4.70
-
Forfeited
( 12,667
)
97.81
Balance
as of April 30, 2025
132,762
89.70
1.71
-
Exercisable
as of April 30, 2025
132,762
$
89.70
1.71
$
-
(i)
On
January 16, 2025, the Company granted 3,333 stock options to a consultant at an exercise price of $ 6.00 per share. All options vested
in full on April 16, 2025. The options expire on January 16, 2030. The grant-date fair value of the award was $ 16,242 .
18
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
As
of April 30, 2025, there are no unrecognized costs related to share-based compensation.
c.
The
following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of April
30, 2025.
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding
as of
April 30, 2025
Weighted
average
remaining
contractual term
(years)
Options
exercisable
as
of
April
30, 2025
Weighted
average
remaining
contractual
term
(years)
Expiry
Date
$
6.00
3,333
4.70
3,333
4.70
January
16, 2030
$
90.45
26,668
3.14
26,668
3.14
June
20, 2028
$
107.40
1,400
2.83
1,400
2.83
February
27, 2028
$
86.73
12,008
2.26
12,008
2.26
August
02, 2027
$
70.65
2,066
2.06
2,066
2.06
May
20, 2027
$
112.65
10,000
1.79
10,000
1.79
February
16, 2027
$
127.05
31,647
1.70
31,647
1.70
January
13, 2027
$
102.67
840
1.50
840
1.50
November
01, 2026
$
63.30
4,000
0.97
4,000
0.97
April
19, 2026
$
63.30
40,800
0.91
40,800
0.91
March
29, 2026
132,762
132,762
d.
As
result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of April 30, 2025:
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
Price
Options
outstanding
as
of
April 30,
2025
Options
exercisable
as
of
April 30,
2025
Expiry
Date
$
0.0933
440,000
440,000
June
20, 2028
$
0.1108
21,000
21,000
February
27, 2028
$
0.0984
180,100
180,100
August
02, 2027
$
0.0729
31,000
31,000
May
20, 2027
$
0.1162
150,000
150,000
February
16, 2027
$
0.1310
524,700
524,700
January
13, 2027
$
0.1165
12,600
12,600
November
01, 2026
$
0.0888
100,000
100,000
September
01, 2026
$
0.0656
60,000
60,000
April
19, 2026
$
0.0656
612,000
612,000
March
29, 2026
2,131,400
2,131,400
19
BRIACELL
THERAPEUTICS CORP.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
e.
Restricted
Share Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of April 30, 2025:
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED
Number
of
RSU’s
outstanding
Aggregate
intrinsic
value
Balance,
July 31, 2024
1,280
$
14,400
Granted (i)
61,666
370,000
Balance,
April 30, 2025
62,946
$
280,739
(i)
On
January 16, 2025, the Company granted 58,333 RSU’s to the Chief Executive Officer (“CEO”) as compensation for deferred
salary, with immediate vesting. The fair value of these RSUs was $ 350,000 , offsetting previously accrued compensation owed to the
CEO.
Additionally,
on the same date, the Company granted 3,333 RSUs to a consultant, which fully vested on April 16, 2025.
f.
The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine-month
period ended April 30, 2025 and 2024 is comprised as follows:
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES
Three
months ended
April 30,
Nine
months ended
April 30,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Research,
development, and clinical trial expenses
$
36,493
126,313
$
120,050
618,375
General
and administrative expenses
188,322
265,902
656,829
807,811
Total
share-based compensation
$
224,815
392,215
$
776,879
1,426,186
NOTE
8: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET
2025
2024
2025
2024
Three
months ended
April
30,
Nine
months ended
April 30,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Interest
income
$
26,632
15,606
$
86,514
288,016
Interest
Expense
( 36,979
)
-
( 36,979 )
-
Foreign
exchange gain (loss)
585
( 2,391
)
19,775
( 13,351
)
Financial
income (expenses), net
$
( 9,762
)
$
13,215
$
69,310
$
274,665
NOTE
9: SUBSEQUENT EVENT
The Company evaluated the possibility of subsequent
events existing in the Company’s unaudited condensed consolidated financial statements through June 16, 2025, the date that the
condensed consolidated financial statements were available for issuance. The Company is not aware of any subsequent events which would
require recognition or disclosure in the consolidated financial statements, except as follows:
a.
On May 8, 2025, subsequent to quarter-end, the remaining 218,000 pre-funded warrants were exercised on a cashless basis, resulting in the issuance of 218,000 common shares.
20
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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.
Introduction
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, 2024 (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 as follows:
●
Part
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.
●
Part
2 - Results of Operations. This section provides an analysis of our results of operations for the first half and second quarter
of fiscal 2025 in comparison to the first half and second quarter of fiscal 2024.
●
Part
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
commitments.
We
prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S. GAAP. Our unaudited Condensed Consolidated
Financial Statements, and the financial information contained herein, are reported in U.S Dollars.
Cautionary
Note Regarding Forward-Looking Statements
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.
Overview
BriaCell
Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to
transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune
system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination
with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal 1 Phase 3 study (ClinicalTrials.gov
identifier: NCT06072612 ) in metastatic breast cancer. The pivotal Phase 3 study of 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 Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™
plus an immune checkpoint inhibitor in metastatic breast cancer.
1 ”Pivotal”
is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
21
Additionally,
BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS™,
BriaCell’s personalized next generation immunotherapy, in metastatic breast cancer and other cancers. The study will investigate
Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab ® (manufactured and supplied by
BeiGene, Ltd.) for the treatment of metastatic breast cancer. Bria-OTS™/Bria-OTS+™, provides a platform technology to develop
personalized off-the-shelf immunotherapies for numerous types of cancer.
Recent
Developments
On
January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of
the Company’s issued and outstanding common shares (the “Common Shares”) on the basis of one (1) post-Consolidation
Common Share for every fifteen (15) pre-Consolidation Common Shares. The Consolidation is being implemented to ensure that the Company
continues to comply with the listing requirements of The Nasdaq Capital Market (the “Nasdaq”). The effective date of the
consolidation was January 29, 2025.
On
February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor
that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient treated with
Bria-OTS™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation
study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized,
next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic
breast cancer.
On
February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate
gross proceeds of approximately $3.05 million before deducting placement agent fees and other offering expenses (the “February
2025 Offering”). Each common share was sold at a public offering price of $4.00 per share. In addition, the Company issued 38,125
agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price
of $5.00 per share.
On
April 10, 2025, the Company announced that its majority owned subsidiary, BriaPro Therapeutics Corp. (“ BriaPro ”),
is developing novel, high affinity antibodies to B7-H3, a key player in cancer progression, using molecular modeling techniques. BriaPro
has filed provisional US patent applications for the corresponding technology and plans on filing an international patent application
under the Patent Cooperation Treaty (PCT).
As
both an immune checkpoint molecule that regulates T cell activity and a cell surface molecule expressed on many types of cancer cells,
B7-H3 is a promising drug target. BriaPro plans on developing anti-B7-H3 antibodies for multiple cancer indications and plans to incorporate
them into its Bria-TILsRx™ platform—a proprietary antibody platform designed to redirect and activate T cells within the
tumor microenvironment. This platform integrates both T cell engagers, which promote T cell-mediated tumor killing, and tumor-targeted
immune checkpoint modulators, which selectively block inhibitory signals on tumor infiltrating lymphocytes (TILs) to enhance their anti-tumor
activity.
On
April 16, 2025, the Company announced new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI),
outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients. In BriaCell’s Phase 2 clinical
study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+
breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of
care TRODELVY ® (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple
negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2)
receptors, was similar to TRODELVY ® but still markedly higher (70%) than those of chemotherapy.Table 1: Comparable Analysis
of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™
plus CPI versus other drugs in MBC patient subsets
22
Reference
Breast
Cancer Type
Median
# of prior
lines
of therapy
Median
OS
(months)
Bria-IMT™
plus CPI*
HR+
6
17.3
TRODELVY® 1
HR+
4
14.4
(sacituzumab
govitecan-hziy)
Single
agent chemotherapy
4
11.3
Bria-IMT™
plus CPI*
TNBC
6
11.4
TRODELVY® 1
(sacituzumab
govitecan-hziy)
TNBC
3 **
11.8
Single
agent chemotherapy
3 **
6.9
*
Patients treated with the Phase 3 formulation
**
Number of prior chemotherapy-containing regimens
1. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
Abbreviations:
HR+:
hormone receptor-positive
TNBC:
Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth
factor receptor 2 (HER2))
On
April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612)
has consented over 100 and has enrolled over 75 patients. BriaCell anticipates completing patient enrollment in late 2025 or early 2026,
and may report top line data as early as H1-2026.
On
April 24, 2025, BriaCell Confirmed 100% Resolution of Lung Metastasis with Bria-OTS (Figure 1). Complete resolution of lung metastasis
confirmed at 4 months follow-up in a hormone receptor positive (HR+) breast cancer patient. Treatment well-tolerated and the patient
remained on study with stable disease elsewhere. Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy
approach in Phase 1/2a metastatic breast cancer study. Figure 1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of
tumor in the lung of the MBC patient following 2 months of therapy and confirmed at 4 months of therapy 1 (axial and coronal
views)
1
Note that the other white dots in the lungs are blood vessels.
23
As
shown, the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months. The updated
images supersede those previously reported.
On
April 28, 2025, the Company closed an underwritten public offering for the purchase and sale of 3,066,666 units for aggregate gross proceeds
of approximately $13.8 million before deducting underwriting discounts, commissions, and other offering expenses (the “April 2025
Offering”). Of those units, 2,405,966 were “regular” units, each consisting of one common share and one five-year publicly
traded warrant at a combined purchase price of $4.50 per unit, and 660,700 were “pre-funded” units, each consisting of one
pre-funded warrant (at a $0.001 strike) and one five-year publicly traded warrant at a combined purchase price of $4.499 per unit. All
warrants have an exercise price of $5.25 per share, are immediately exercisable, and expire five years from the date of issuance (“April
2025 Warrants”). The April 2025 Warrants trade on the NASDAQ under the symbol “BCTXZ.”
In
connection with the April 2025 Offering, the Company issued 153,333 representative’s warrants. The representative’s warrants
are immediately exercisable at an exercise price of $5.625 per share and expire five years from the date of issuance.
On
April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025. Positive tolerability profile and potential response
biomarkers were identified. Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in
Phase 2 study. Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits.
Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were linked
to longer progression-free survival (PFS) in Phase 3 patients. Presence of Circulating Tumor Cells (CTC) after patients’ initial
Phase 3 treatment supports their role as negative prognostic marker (p = 0.04). The Bria-IMT Phase 3 regimen was well-tolerated with
a preferred tolerability profile.
On
May 23, 2025, BriaCell reported that its abstracts showcased positive survival and clinical benefit data at ASCO 2025. Phase 2 survival
and clinical benefit data met or exceeded outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no
treatment-related discontinuations. Successful completion of the pivotal Phase 3 study may support Biologics License Application, Priority
Review, Full Approval, and Commercialization.
On
May 27, 2025, BriaCell announced that the Bria-OTS Phase 1/2 Study cleared safety evaluation, and BriaCell dosed its first patient in
Bria-OTS combination with an immune checkpoint inhibitor. Specifically, Bria-OTS has cleared its safety evaluation in the Phase 1/2 study
monotherapy dosage setting. Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic
breast cancer. The first Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis.
24
Results
of Operations for the Three Months Ended April 30, 2025 and 2024
Three
months ended
April 30,
2025
2024
(Unaudited)
(Unaudited)
Operating
Expenses:
Research,
development, and clinical trial expenses
$
4,810,196
$
7,657,632
General
and administrative expenses
1,518,059
1,572,016
Total
operating expenses
6,328,255
9,229,648
Operating
loss
(6,328,255)
(9,229,648
)
Financial
expenses, net
(9,762)
13,215
Change
in fair value of the warrant liability
175,826
10,945,672
Share
of loss on equity investments
(62,738)
(36,997
)
Net
loss for the period
$
(6,224,929)
$
1,692,242
Net
loss attributable to non-controlling interest
(98,027)
(23,517
)
Net
loss for the period attributable to BriaCell
(6,126,902)
1,715,759
Net
loss per share attributable to BriaCell – basic and diluted
$
(1.64)
$
1.61
Research,
Development, and Clinical Trial Costs
Research
costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development; and (ii)
clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our
clinical trials.
The
following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
Three
months ended April 30,
2025
2024
Clinical
trial sites and investigational drug costs
$
3,175,543
$
6,165,072
Wages
and salaries
1,303,157
1,090,902
Laboratory
Rent
114,330
109,500
Supplies
157,184
165,264
Depreciation
22,839
-
Professional
fees
650
581
Share-based
compensation
36,493
126,313
$
4,810,196
$
7,657,632
For
the three-month period ended April 30, 2025, total research, development, and clinical trial costs amounted to $4,810,196 as compared
to $7,657,632 for the three-month period ended April 30, 2024. This reduction was primarily driven by lower clinical trial sites and
investigational drug costs, which decreased from $6,165,072 in 2024 to $3,175,543 in 2025. The decrease reflects the conclusion of the
Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries increased considerably,
from $1,090,902 in 2024 to $1,303,157 in 2025, reflecting the hiring of additional employees. Laboratory rent increased to $114,330 in
2025, up from $109,500 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $165,264 in 2024
to $157,184 in 2025, driven by lowered spending. Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in
capital assets to support research activities. Professional fees increased to $650 in 2025, compared to $581 in 2024. Notably, share-based
compensation expenses decreased significantly, from $126,313 in 2024 to $36,493 in 2025, contributing to the overall reduction in research,
development, and clinical trial expenses.
25
Clinical
trial expenses for the period are as follows:
Three
months ended April 30,
2025
2024
Bria-IMT™ Pivotal Phase 3
study
$ 2,708,394
$ 3,764,521
Bria-IMT™ Phase 1/2a
300,013
898,528
Bria-OTS™ Phase
1/2a
182,344
-
$ 3,190,751
$ 4,359,850
Clinical
trial expenses for the three months ended April 30, 2025, were $3,190,751, compared to $4,359,850 during the same period in 2024. The
slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting
in lower associated costs. As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly directed toward
the pivotal Phase 3 study, which remains our primary focus. At the same time, we have begun incurring costs related to the Bria-OTS™
Phase 1/2a trial, which commenced in August 2024.
For
the three-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,708,394, a decrease from $3,764,521
in 2024. This decrease reflects the planned phasing of expenditures within the pivotal study; the prior-year quarter included higher
up-front activities, whereas current spending is concentrated on ongoing patient recruitment, treatment, and data-management costs as
we push toward key milestones.
For
the three-month period ended April 30, 2025, Bria-IMT™ Phase 1/2a costs were $300,013, a significant decline from $898,528 in 2024,
as the trial has now concluded. The remaining expenses primarily relate to final data analysis and study close-out activities.
For
the three-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $182,344, compared to $nil in 2024. The increase
is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
General
and Administrative Expenses
For
the three-month period ended April 30, 2025, general and administrative expenses amounted to $1,518,059, compared to $1,572,016 for the
same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
in overall stable general and administrative expenses quarter over quarter.
Financial
income (expenses), net
For
the three-month period ended April 30, 2025, financial expense amounted to $9,762, compared to income of $13,215 for the three-month
period ended April 30, 2024. Financial expense for the 2025 period consisted of $26,632 in interest income offset by $585 foreign exchange
loss and interest expense of $36,979 . In comparison, financial income for the 2024 period included $15,606 in interest income and a
$2,391 foreign exchange loss. The decrease in financial income to a loss from 2024 to 2025 was primarily due to higher interest expense
in 2025 compared to nil in 2024.
Loss
for the period
The
Company reported a loss of $6,224,929 for the three-month period ended April 30, 2025, compared to income of $1,692,242 for the same
period in 2024. The swing to a net loss was primarily driven by a significantly smaller non-cash gain from the change in fair value of
the warrant liability, which declined from $10,945,672 in 2024 to $175,826 in 2025. Additionally, research, development, and clinical
trial expenses decreased from $7,657,632 in 2024 to $4,810,196 in 2025, mainly due to lower clinical-trial and investigational-drug costs
following the completion of the Bria-IMT™ Phase 1/2a trial, partially offsetting the impact of the reduced warrant-liability gain.
26
Results
of Operations for the Nine Months Ended April 30, 2025 and 2024
Nine
months ended
April 30,
2025
2024
(Unaudited)
(Unaudited)
Operating
Expenses:
Research,
development, and clinical trial expenses
$
14,160,314
$
22,772,344
General
and administrative expenses
4,490,216
4,789,778
Total
operating expenses
18,650,530
27,562,122
Operating
loss
(18,650,530)
(27,562,122
)
Financial
expenses, net
69,310
274,665
Change
in fair value of the warrant liability
366,024
23,660,003
Share
of loss on equity investments
(176,837)
(55,342
)
Net
loss for the period
$
(18,392,033)
(3,682,796
)
Net
loss attributable to non-controlling interest
(171,536)
(105,495
)
Net
loss for the period attributable to BriaCell
(18,220,497)
(3,577,301
)
Net
loss per share attributable to BriaCell – basic and diluted
$
(6.70)
$
(3.36
)
Research,
Development, and Clinical Trial Costs
Research
costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory; and (ii) Clinical trials and investigational
drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
The
following is a breakdown of our research, development, and clinical trial costs by nature of expenses:
Nine
months ended April 30,
2025
2024
Clinical
trial sites and Investigational drug costs
$
9,732,786
$
17,763,490
Wages
and salaries
3,544,267
3,513,306
Laboratory
Rent
342,990
305,980
Supplies
341,878
566,830
Depreciation
68,517
-
Professional
fees
9,826
4,363
Share-based
compensation
120,050
618,375
$
14,160,314
$
22,772,344
For
the nine-month period ending April 30, 2025, research, development and clinical trial costs amounted to $14,160,314, a significant decrease
from the $22,772,344 incurred during the same period in 2024. This reduction was primarily driven by lower clinical trial sites and investigational
drug costs, which decreased from $17,763,490 in 2024 to $9,732,786 in 2025. The decrease reflects the conclusion of the Bria-IMT™
Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries increased slightly, from $3,513,306
in 2024 to $3,544,267 in 2025, reflecting the hiring of additional employees. Laboratory rent increased to $342,990 in 2025, up from
$305,980 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $566,830 in 2024 to $341,878
in 2025, driven by lowered spending. Depreciation expenses of $68,517 were recognized in 2025, reflecting investments in capital assets
to support research activities. Professional fees increased to $9,826 in 2025, compared to $4,363 in 2024, primarily due to consulting
and support for clinical operations. Notably, share-based compensation expenses decreased significantly, from $618,375 in 2024 to $120,050
in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
27
Clinical
trial expenses for the period are as follows:
Nine
months ended April 30,
2025
2024
Bria-IMT™
Pivotal Phase 3 study
$
8,797,505
$
8,651,728
Bria-IMT™
Phase 1/2a
699,356
3,998,461
Bria-OTS™
Phase 1/2a
325,539
-
$
9,822,400
$
12,650,189
Clinical
trial expenses for the nine-month period ended April 30, 2025, were $9,822,400, compared to $12,650,189 during the same period in 2024.
This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the planned phasing of expenditures within the pivotal
Phase 3 study, which remains our primary focus. While resources have been increasingly directed toward Phase 3, we have also begun incurring
costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
For
the nine-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $8,797,505, up from $8,651,728 in 2024.
The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, treatment,
site activation, and data-management activities to support the study’s advancement.
Bria-IMT™
Phase 1/2a costs declined to $699,356, a sharp reduction from $3,998,461 in 2024, reflecting the trial’s conclusion. The remaining
costs are tied to final reporting, regulatory submissions, and study close-out activities.
For
the nine-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $325,539, compared to $nil in 2024. The increase
is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
We
remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources
strategically to ensure its successful execution.
General
and Administrative Expenses
For
the nine-month period ended April 30, 2025, general and administrative expenses amounted to $4,490,216, compared to $4,789,778 for the
same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting
in overall stable general and administrative expenses period over period.
Financial
income (expenses), net
For
the nine-month period ended April 30, 2025, financial income amounted to $69,310, compared to $274,665 for the nine-month period ended
April 30, 2024. Financial income for the 2025 period consisted of $86,514 in interest income and a $19,775 foreign exchange gain offset
by interest expense of $36,979. In comparison, financial income for the 2024 period included $288,016 in interest income, offset by a
$13,351 foreign exchange loss. The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting
reduced cash and cash equivalents available for investment in interest-bearing funds.
Loss
for the period
The
Company reported a loss of $18,392,033 for the nine-month period ended April 30, 2025, compared to $3,682,796 in 2024. The increase was
primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $366,024 in 2025 compared to $23,660,003
in 2024. This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $22,772,344
in 2024 to $14,160,314 in 2025, mainly due to lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™
Phase 1/2a trial.
Liquidity,
Capital Resources and Going Concern Uncertainty
The
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.
28
As
of April 30, 2025, and a positive working capital balance of $10,454,565 (July 31, 2024 negative balance of $3,807,303).
As
of April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261), a positive working capital of $10,454,565
(July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $103,664,194 (July 31, 2024 - $85,443,697).
As
of April 30, 2025, 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. government agency securities,
and investment grade corporate debt securities . Our investment policy and strategy are focused
on preservation of capital and supporting our liquidity requirements.
Historically,
the Company has financed its operation through private and public placement of equity securities, as well as debt financing. The Company’s
ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends
to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives. Management believes
that it can be successful in obtaining additional capital; however, there can be no assurance that the Company will be able to do so.
There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a
going concern. To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement
a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations. There can be
no assurance that such a plan will be successful. To this end, for several months during calendar year 2024, certain directors and officers
agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these fees were paid
in full. Further, certain officers have indicated their willingness to receive a portion of their compensation in equity of the Company,
subject to applicable Nasdaq rules. In addition, we continue to reduce expenditure on certain non-core activities whilst maintaining
our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.
During
the period ended April 30, 2025, the Company’s overall position of cash and cash equivalents increased by $11,598,164 from the
period ended July 31, 2024 (including effects of foreign exchange). This increase in cash can be
attributed to the following:
The
Company’s net cash used in operating activities during the period ended April 30, 2025, was $20,038,075 as compared to $20,090,398
for the period ended April 30, 2024.
Cash
gained in financing activities for the period ended April 30, 2025, was 31,891,239 as compared to nil for the period ended April 30,
2024.
Off-Balance
Sheet Arrangements
None.
Tabular
Disclosure of Contractual Obligations
None.
Critical
Accounting Policies and Estimates
There
have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section
in our Annual Report.
New
Accounting Policies Adopted
The
Company did not adopt any new accounting policies during the period ended April 30, 2025.
29
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
The
Company’s financial instruments consist of cash and cash equivalents, investments, warrant liability, short term loans, trade payable,
and accrued expenses and other payables. Unless otherwise noted, it is management’s opinion that the Company is not exposed to
significant interest or credit risks arising from these financial instruments. The fair value of these financial instruments approximates
their carrying values, unless otherwise noted.
Management
understands that the Company is exposed to financial risk arising from fluctuations in foreign exchange rates and the degree of volatility
of these rates as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs relating to being a public company
in Canada), and the Company’s functional and presentation currency is the US dollar. The Company does not use derivative instruments
to reduce its exposure to foreign currency risk.
The
Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors
the risk management process. The overall objectives of the Board are to set policies that seek to reduce risk as far as possible without
unduly affecting the Company’s competitiveness and flexibility.
The
type of risk exposure and the way in which such exposure is managed is as follows:
Credit
Risk
The
Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration
with respect to financial instruments is remote.
Liquidity
Risk
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. As of April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261) and a positive working capital balance
of $10,454,565 (July 31, 2024 - negative working capital balance of $3,807,303).
Market
Risk
Interest
rate risk
Interest
Rate risk is the risk that the fair value of a financial instrument will fluctuate because of changes in market interest rates. Loans
payable include both fixed and variable interest rates; however, the Company does not believe it is exposed to material interest rate
risk.
Price
risk
As
the Company has no revenues, price risk is remote.
Exchange
risk
The
Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs
relating to being a public company in Canada) and, therefore, the Company is exposed to foreign currency risk at the end of the reporting
period through its Canadian denominated accounts payable and cash. As of April 30, 2025, a 5% depreciation or appreciation of the Canadian
dollar against the US dollar would not have a material effect on the in total loss and comprehensive loss.
Fair
Values
The
carrying values of cash and cash equivalents, trade payable, warrant liability, short term loans, and accrued expenses and other payables
approximate their fair values due to their short terms to maturity.
30
Cash
and cash equivalents are valued using quoted market prices in active markets. The fair value of the warrant liability is determined based
on the nature of the warrant. For publicly traded warrants we use the quoted market price and for all other warrants we use the Black-Scholes
pricing model.
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934 under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly
Report on Form 10-Q. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal accounting
and financial officer have concluded that as of April 30, 2025, our disclosure controls and procedures were effective at the reasonable
assurance level.
Changes
in Internal Control over Financial Reporting
There
have not been material changes in our internal control over financial reporting during the quarter ended April 30, 2025, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
31
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
None.
Item
1A. Risk Factors.
As
of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors previously disclosed in
our Annual Report for the year ended July 31, 2024.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
There
were no unregistered sales of equity securities during the quarter ended April 30, 2025
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
Applicable.
Item
5. Other Information.
None.
Item
6. Exhibits
The
following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.
EXHIBIT
INDEX
Exhibit
Description
31.1
Certification of Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2
Certification of Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
32.2
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101.INS
Inline
XBRL Instance Document*
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document*
101.SCH
Inline
XBRL Taxonomy Extension Schema Document*
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB
Inline
XBRL Taxonomy Extension Labels Linkbase Document*
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document*
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
herewith.
32
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
BRIACELL
THERAPEUTICS CORP.
June
16, 2025
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
June
16, 2025
By:
/s/
Gadi Levin
Name:
Gadi
Levin
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
33
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.