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 January 31, 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
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 March 12, 2025, there were 3,709,440 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 January 31, 2025 (unaudited) and July 31, 2024 (audited)
3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months ended January 31, 2025
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Six Months ended January 31, 2025
5
Unaudited Condensed Consolidated Statement of Cash Flows for the Six Months ended January 31, 2025
7
Notes to Unaudited Condensed Consolidated Financial Statements
8
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item
3.
Quantitative and Qualitative Disclosures Regarding Market Risk
28
Item
4.
Controls and Procedures
29
Part II. Other Information
30
Item
1.
Legal Proceedings
30
Item
1A.
Risk Factors
30
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
30
Item
3.
Defaults Upon Senior Securities
24
Item
4.
Mine Safety Disclosures
30
Item
5.
Other Information
30
Item
6.
Exhibits
30
Signatures
31
2
PART
I-FINANCIAL INFORMATION
Item
1. Financial Statements
BRIACELL
THERAPEUTICS CORP.
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
January 31, 2025
July 31, 2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 5,013,654
$ 862,089
Amounts receivable and prepaid expenses
2,148,919
2,791,765
Total current assets
7,162,573
3,653,854
NON-CURRENT ASSETS:
Equity investment in BC Therapeutics
454,391
418,490
Intangible assets, net
192,160
199,796
Property and equipment, net
342,497
388,175
Long term prepaid expenses
1,211,946
1,211,946
Total non-current assets
2,200,994
2,218,407
Total assets
$ 9,363,567
$ 5,872,261
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$ 5,003,239
$ 7,170,781
Accrued expenses and other payables
227,599
290,376
Total current liabilities
5,230,838
7,461,157
NON-CURRENT LIABILITIES:
Warrant liability
905,838
1,096,036
Total non-current liabilities
905,838
1,096,036
SHAREHOLDERS’ EQUITY (DEFICIT) (1) :
Share Capital of no
par value - Authorized: unlimited at January 31, 2025 and July 31, 2024, Issued and outstanding: 2,946,940
shares January 31, 2025 and 1,218,984
July 31, 2024, respectively (1)
85,451,119
72,166,414
Share-based payment reserve (1)
10,091,325
9,189,261
Warrant Reserve (1)
5,736,454
1,844,296
Accumulated other comprehensive loss (1)
( 138,684 )
( 138,684 )
Non-controlling Interest (1)
( 376,031 )
( 302,522 )
Accumulated deficit (1)
( 97,537,292 )
( 85,443,697 )
Total shareholders’ equity (deficit) (1)
3,226,891
( 2,684,932 )
Total liabilities and shareholders’ equity (deficit)
$ 9,363,567
$ 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 SIX MONTHS ENDED JANUARY 31, 2025
(Unaudited)
2025
2024
2025
2024
Three months ended
January 31,
Six months ended
January 31,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development, and clinical trial expenses
$ 5,684,777
$ 8,257,455
$ 9,350,118
$ 15,114,712
General and administrative expenses
1,484,666
1,571,991
2,972,157
3,217,762
Total operating expenses
7,169,443
9,829,446
12,322,275
18,332,474
Operating loss
( 7,169,443 )
( 9,829,446 )
( 12,322,275 )
( 18,332,474 )
Financial expenses, net
67,358
81,628
79,072
261,450
Change in fair value of the warrant liability
806,841
( 1,567,747 )
190,198
12,714,331
Share of loss on equity investment
( 42,584 )
( 18,345 )
( 114,099 )
( 18,345 )
Net loss for the period
$ ( 6,337,828 )
$ ( 11,333,910 )
$ ( 12,167,104 )
( 5,375,038 )
Net loss attributable to non-controlling interest
( 46,408 )
( 39,307 )
( 73,509 )
( 81,978 )
Net loss and Comprehensive loss for the period attributable to BriaCell
( 6,291,420 )
( 11,294,603 )
( 12,093,595 )
( 5,293,060 )
Net loss per share attributable to BriaCell – basic and diluted
$ ( 2.33 )
$ ( 10.64 )
$ ( 5.44 )
$ ( 5.04 )
Weighted average number of shares used in computing net basic earnings per share
of common stock (1)
2,699,566
1,065,448
2,224,979
1,065,448
Weighted average number of shares used in computing net diluted earnings per share
of common stock (1)
2,699,566
1,065,448
2,224,979
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 SIX MONTHS ENDED JANUARY 31, 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, October 31, 2024
2,412,216
$ 82,040,741
$ 9,456,232
$ 3,930,221
$ ( 138,684 )
$ ( 91,245,872 )
$ ( 329,623 )
$ 3,713,015
Issuance of Options
-
-
635,093
-
-
-
-
635,093
Exercise of warrants
41,391
796,690
-
( 268,925 )
-
-
-
527,765
Issuance of units
493,333
2,613,688
-
2,075,158
-
-
-
4,688,846
Net loss for the period
-
-
-
-
-
( 6,291,420 )
( 46,408 )
( 6,337,828 )
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
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
-
-
902,064
-
-
-
-
902,064
Exercise of prefunded warrants
6,666
-
-
-
-
-
-
-
Exercise of broker warrants
64,391
1,239,367
-
( 418,352 )
-
821,015
Issuance of units
1,656,899
12,045,338
-
4,310,510
-
-
-
16,355,848
Net loss for the period
-
-
-
-
-
( 12,093,595 )
( 73,509 )
( 12,167,104 )
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
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, October 31, 2023
1,065,455
$ 69,591,784
$ 7,918,999
$ ( 138,684 )
$ ( 74,650,688 )
$ ( 205,111 )
$ 2,516,300
Issuance of options
-
-
500,155
-
-
-
500,155
Loss for the period
-
-
-
-
( 11,294,603 )
( 39,307 )
( 11,333,910 )
Balance, January 31, 2024
1,065,455
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Share capital (1)
Additional
paid in
Accumulated other
comprehensive
Accumulated
Non-
controlling
Total
shareholders’
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
-
-
1,033,971
-
-
-
1,033,971
Loss for the period
-
-
-
-
( 5,293,060 )
( 81,978 )
( 5,375,038 )
Net loss for the period
-
-
-
-
( 5,293,060 )
( 81,978 )
( 5,375,038 )
Balance, January 31, 2024
1,065,455
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Balance
1,065,455
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
(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 SIX MONTHS ENDED JANUARY 31, 2025
(Unaudited)
2025
2024
Six months ended January 31,
2025
2024
Cash flow from operating activities
Net loss for the period
$ ( 12,167,104 )
$ ( 5,375,038 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
53,314
7,637
Share-based compensation
552,064
1,033,971
Share of loss on equity investment
114,099
18,345
Change in fair value of warrants
( 190,198 )
( 12,714,331 )
Changes in assets and liabilities:
Decrease (increase) in amounts receivable
723,172
( 11,272 )
Decrease in prepaid expenses
( 80,326 )
( 88,744 )
(Decrease) increase in trade payable
( 2,167,542 )
2,587,716
Increase (decrease) in accrued expenses and other payables
287,223
( 464,848 )
Total cash flow from operating activities
( 12,875,298 )
( 15,006,564 )
Cash flows from investing activities
Equity Investment in BC Therapeutics
( 150,000 )
-
Total cash flow from investing activities
( 150,000 )
-
Cash flows from financing activities
Proceeds from exercise of warrants
821,015
-
Proceeds from the issuance of shares, net of issuance costs
16,355,848
-
Total cash flow from financing activities
17,176,863
-
Decrease in cash and cash equivalents
4,151,565
( 15,006,564 )
Cash and cash equivalents at beginning of the period
862,089
21,251,092
Cash and cash equivalents at end of the period
$ 5,013,654
$ 6,244,528
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” and “BCTXW”.
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.
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 January 31, 2025 was $ 97,537,292 and
negative cash flows from operating activities during the six-month period ended January 31, 2025 was $ 12,875,298 .
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 5(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 and in February 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 – see note 9a.
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”).
8
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 January 31, 2025, 554,553 Briacell Legacy Warrants are exercisable into
554,553 Briacell Shares and 8,168,295 BriaPro Shares.
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.
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)
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.
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 statements
of operation and comprehensive loss. The Company has a 57.4 % 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.
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)
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. During the six-month period ended January 31, 2025, the Company exercised this option in six monthly tranches,
totaling $ 150,000 for 120,000 shares. As of January 31, 2025, the Company holds 540,000 shares in BC Therapeutics, representing 57.4 %
of the total issued and outstanding shares.
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
150,000
Share
of losses
( 114,099 )
Balance
– January 31, 2025
$ 454,391
The
following amounts represent the Company’s 57.4 % share of the assets of BC Therapeutics:
SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As of
January 31, 2025
Current assets: Cash
$ 1,595
Net assets
$ 1,595
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 January 31, 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 January 2025, the Company continues to occupy the space on a month-to-month basis under
the same terms
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
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 January
31, 2025, and July 31, 2024:
SCHEDULE OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair Value Measurements at
January 31, 2025
July 31, 2024
Level 1
Level 2
Total
Level 1
Level 2
Total
Financial Assets:
Cash and cash equivalents
5,013,654
-
5,013,654
862,089
-
862,089
Total assets measured at fair value
$ 5,013,654
$ -
$ 5,013,654
$ 862,809
$ -
$ 862,089
Financial liabilities:
Warrants liability
252,343
653,495
905,838
760,657
335,379
1,096,036
Total liabilities measured at fair value
$ 252,343
$ 653,495
$ 905,838
$ 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).
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 six-month period ended January 31, 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”).
12
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, 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.
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, 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 %.
13
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.
During
the six-month period ended January 31, 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 six-month period ending January 31, 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
( 64,931 )
( 12.75 )
Granted in the October 2024 Offering
341,900
12.75
Granted in the January 2025 Offering
493,333
14.06
Balance, January 31, 2025
1,472,480
$ 42.29
(ii)
As
of January 31, 2025, warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number of
Warrants
Exercise Price
Exercisable At
January 31, 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
1,472,480
1,472,480
(*)
Briacell Legacy Warrants – see note 1(f)
d.
Compensation Warrants
(i)
A
summary of changes in compensation warrants for the six-month period ended January 31, 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
Balance, January 31, 2025
89,280
$ 17.56
14
(ii)
As
of January 31, 2025, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number of
Warrants
Exercise Price
Exercisable At
January 31, 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
(**) -
September 12, 2029
17,095
$ 18.28
17,095
October 2, 2029
24,666
$ 14.06
24,666
December 12, 2029
89,280
48,197
(*)
Briacell Legacy Warrants – see note 1(f)
(**)
Exercisable
from March 11, 2025.
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
$ ( 190,198 )
Balance as of January 31, 2025
$ 905,838
The
key inputs used in the valuation of the non-public warrants as of January 31, 2025 and at July 31, 2024 were as follows:
SCHEDULE OF VALUATION OF NON-PUBLIC WARRANTS
January 31, 2025
July 31, 2024
Share price
$ 5.02
$ 11.25
Exercise price
$ 79.69 - 92.85
$ 79.69 - 92.85
Expected life (years)
0.79 - 1.85
1.57 - 2.35
Volatility
110 - 148 %
77 - 79 %
Dividend yield
0 %
0 %
Risk free rate
2.77 - 4.22 %
4.27 %
15
The
key inputs used in the valuation of the of the BriaPro Warrant Shares as of January 31, 2025 were as follows:
SCHEDULE OF BRIA PRO WARRANTS
August 31, 2023
(Effective Date)
January 31, 2025
Share price
$ 0.0365
$ 0.0365
Exercise price
$ 0.0206 - 0.0308
$ 0.0206 - 0.0308
Expected life (years)
2.21 - 3.27
0.79 - 1.85
Volatility
100 %
110 - 148 %
Dividend yield
0 %
0 %
Risk free rate
4.40 %
2.66 - 2.77 %
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 six-month period ended January 31, 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
4.96
-
Balance as of January 31, 2025
145,429
90.02
2.09
-
Exercisable as of January 31, 2025
141,096
$ 91.01
2.03
$ -
(i) On
January 16, 2025, the Company granted 3,333 options to a consultant with an exercise price
of $ 6.00 . 50% vested immediately, and the remaining 50% will vest three months from the grant
date. The options expire on January 16, 2030. The fair value of the 3,333 stock options issued
was $ 16,241.60 .
As
of January 31, 2025, there are $ 270,747 of total unrecognized costs related to share-based compensation that is expected to be recognized
over the next quarter.
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)
NOTE
7: SHARE-BASED COMPENSATION (Cont.)
c.
The
following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of January
31, 2025.
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding
as of
January
31, 2025
Weighted
average remaining contractual term (years)
Options
exercisable
as of
January
31, 2025
Weighted
average
remaining
contractual
term
(years)
Expiry
Date
$ 6.00
3,333
4.96
1,667
4.96
January
16, 2030
$ 90.45
29,335
3.39
26,668
3.39
June
20, 2028
$ 107.40
1,400
3.08
1,400
3.08
February
27, 2028
$ 86.73
12,008
2.51
12,008
2.51
August
02, 2027
$ 70.65
2,066
2.31
2,066
2.31
May
20, 2027
$ 112.65
10,000
2.04
10,000
2.04
February
16, 2027
$ 127.05
34,980
1.95
34,980
1.95
January
13, 2027
$ 102.67
840
1.75
840
1.75
November
01, 2026
$ 86.14
6,667
1.59
6,667
1.59
September
01, 2026
$ 63.30
4,000
1.22
4,000
1.22
April
19, 2026
$ 63.30
40,800
1.16
40,800
1.16
March
29, 2026
145,429
141,096
d.
As
result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of January 31, 2025:
17
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
Price
Options
outstanding as of January 31, 2025
Options
exercisable as
of January 31, 2025
Expiry Date
$ 0.0933
440,000
385,000
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
2,076,400
e.
Restricted
Share Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of January 31, 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, January 31, 2025
62,946
$ 315,989
(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, with 50% vesting immediately and the remaining 50% vesting three months
from the grant date.
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)
NOTE
7: SHARE-BASED COMPENSATION (Cont.)
f.
The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and six-month
period ended January 31, 2025 and 2024 is comprised as follows:
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES
Three months ended
January 31,
Six months ended
January 31,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Research, development, and clinical trial expenses
$ 234,254
265,902
$ 468,507
541,909
General and administrative expenses
50,839
234,253
83,557
492,062
Total share-based compensation
$ 285,093
500,155
$ 552,064
1,033,971
NOTE
8: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET
2025
2024
2025
2024
Three months ended
January 31,
Six months ended
January 31,
2025
2024
2025
2024
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Interest income
$ 46,832
81,595
$ 59,882
272,410
Foreign exchange gain (loss)
20,526
33
19,190
( 10,960 )
Financial income (expenses), net
$ 67,358
$ 81,628
$ 79,072
$ 261,450
NOTE
9: SUBSEQUENT EVENT
The
Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements
through March 12, 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
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 .
19
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 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+™, provides a platform technology to develop personalized
off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of
the immune system as well as an immune checkpoint inhibitor.
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.
20
Recent
Developments
On
September 10, 2024, BriaCell announced it had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND)
meeting with the FDA for Bria-PROS+™ in prostate cancer. The meeting provides a clear path towards filing an IND and
conducting a Phase 1/2 study of Bria-PROS+™
On
September 11, 2024, BriaCell reported positive overall survival (OS) in metastatic breast cancer in its Phase 2 study of the Bria-IMT™
regimen in combination with an immune checkpoint inhibitor. Median overall survival of 15.6 months in patients treated with the phase
3 formulation of Bria-IMT™ since 2022 was reported. OS of 15.6 months compared favorably with 5.9-9.8 months reported for similar
patients in the literature. Ongoing Phase 3 study investigates Bria-IMT™ in similar metastatic breast cancer population. No drug
related discontinuations were reported.
On
September 12, 2024, BriaCell announced closing of $8.5 million offering. The Company announced the closing of its previously announced
best-efforts offering priced at-the-market under Nasdaq rules for 821,666 common shares. Each common share was sold at an offering price
of $10.35 per share, for gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses.
All the shares in the offering were offered by the Company. The Company announced its intention to use the net proceeds from the offering
for working capital requirements, general corporate purposes, and the advancement of business objectives. ThinkEquity acted as sole placement
agent for the offering. The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement
on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”)
on January 22, 2024 and declared effective on January 31, 2024. The offering was made by means of a prospectus supplement and prospectus
which have been filed with the SEC and available on the SEC’s website at www.sec.gov.
On
September 18, 2024, BriaCell announced an FDA-authorized expanded access policy for metastatic breast cancer patients. FDA authorized
the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need of novel treatments. The expanded access policy will
provide Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s pivotal Phase 3 clinical trial.
On
October 1, 2024, BriaCell reported 100% Resolution of brain metastasis in breast cancer patient with “eye-bulging” tumor.
The dramatic anti-tumor response included complete resolution of right temporal lobe brain metastasis. Heavily pre-treated, this patient
had failed 8 prior regimens including antibody-drug conjugate ( ADC) therapy and continues to receive Bria-IMT™ treatment.
21
On
October 2, 2024, BriaCell announced closing of $5 million offering. The Company announced the closing of its previously announced best-efforts
offering of 341,900 common shares and warrants to purchase up to 341,900 common shares at a combined offering price of $14.63 per share
and associated warrant, priced at-the-market under Nasdaq rules. The warrants had an exercise price of $12.75 per share and are immediately
exercisable upon issuance for a period of five years following the date of issuance. Total gross proceeds from the offering, before deducting
the placement agent’s fees and other offering expenses, are approximately $5 million. The Company announced its intentions to use
the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.
ThinkEquity acted as sole placement agent for the offering. The securities were offered and sold pursuant to the Company’s currently
effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities
and Exchange Commission (the “SEC”) on January 22, 2024 and declared effective on January 31, 2024. The offering was made
by means of a prospectus supplement and prospectus which have been filed with the SEC and available on the SEC’s website at www.sec.gov.
You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering.
On
October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main
and 17 satellite) are active and enrolling patients. Additional sites are in various stages of start-up. Interim data will be analyzed
once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen
versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result
in full approval and marketing authorization for Bria-IMT™ in MBC patients. Secondary analyses include comparison of the Bria-IMT™
combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient
population. The Bria-IMT™ combination regimen has received FDA Fast Track designation.
On
October 22, 2024, the Company reported that in the Company’s Phase 2 clinical study, patients treated with the same Bria-IMT™
regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients
remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for
similar patients (see Table 1 below). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.
Table
1: Comparable Analysis of 1 year survival for the BriaCell Phase 2 study
Reference
Breast Cancer Type
Median prior lines of therapy
Median OS (months)
Percent Survival at 1 year
Bria-IMT™ plus CPI
All types
61% HR+
33% TNBC
6% HER2+
6
13.4*
15.6**
55 %
Cortes et al. 1
All types
57% HR+
18-19% TNBC
18-20% HER2+
4
9.1-9.3
~38-40 %
Kazmi et al. 2
All types
51-52% HR+
25-29% TNBC
9-24% HER2+
2
7.2-9.8
30-38 %
Bardia et al.
(TPC arm) 3
TNBC
2-3
6.9
~23
%
Rugo et al
(TPC arm) 4
HR+ HER2-
2
11.2
47 %
*
Patients treated with the Phase 3 formulation
**
Patients treated with the Phase 3 formulation since 2022
1. Cortes
J, et al. Annals of Oncology 2018
2. Kazmi
S, et al. Breast Cancer Res Treat. 2020
3. Bardia
A, et al. J Clin Oncol. 2024
4. Rugo
HS, et al. The Lancet. 2023
Abbreviations:
HR+:
hormone receptor-positive
TNBC:
Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal
growth factor receptor 2 (HER2))
HER2+:
Human epidermal growth factor receptor 2 positive
HR+
HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC:
Treatment of Physicians Choice
22
On
November, 21, 2024, the Company announced that the first patient was dosed in its 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™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study
for metastatic breast cancer.
On
November 23, 2024, Marc Lustig resigned from the board of directors of the Company.
On
December 2, 2024, BriaCell received green-light from Data Safety Monitoring Board for its Phase 3 Study in metastatic breast cancer.
The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study
of Bria-IMT™ plus an immune check point inhibitor in metastatic breast cancer.
On
December 11, 2024, BriaCell presented unprecedented overall survival data in metastatic breast cancer in Spotlight Poster at 2024 SABCS®.
Median overall survival (OS) of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated
since 2022), was ~double that of comparable patients in the literature. Final Phase 2 OS calculation was pending as many patients remain
alive well over 1 year after starting the study. Median OS of 13.7 months was reported in breast cancer patients with central nervous
system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI).
Five BriaCell posters were presented that showcased robust survival and clinical benefit data, plus key biomarker data from the Phase
2 trial of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer (MBC). Biomarkers
identify patients who benefit from treatments with the Bria-IMT™ regimen. No toxicity-related discontinuations were reported.
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 for a period of five years from the closing date. In addition, the Company
issued 24,666 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise
price of $14.06.
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.
23
Results
of Operations for the Three Months Ended January 31, 2025 and 2024
Three months ended
January 31,
2025
2024
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development, and clinical trial expenses
$ 5,684,777
$ 8,257,455
General and administrative expenses
1,484,666
1,571,991
Total operating expenses
7,169,443
9,829,446
Operating loss
(7,169,443 )
(9,829,446 )
Financial expenses, net
67,358
81,628
Change in fair value of the warrant liability
806,841
(1,567,747 )
Share of loss on equity investments
(42,584 )
(18,345 )
Net loss for the period
$ (6,337,828 )
$ (11,333,910 )
Net loss attributable to non-controlling interest
(46,408 )
(39,307 )
Net loss for the period attributable to BriaCell
(6,291,420 )
(11,294,603 )
Net loss per share attributable to BriaCell – basic and diluted
$ (2.33 )
$ (10.64 )
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 January 31,
2025
2024
Clinical trial sites and investigational drug costs
$ 4,117,576
$ 6,200,980
Wages and salaries
1,292,021
1,401,679
Laboratory Rent
114,330
108,000
Supplies
85,264
312,543
Depreciation
22,839
-
Professional fees
1,908
-
Share-based compensation
50,839
234,253
$ 5,684,777
$ 8,257,455
24
For
the three-month period ended January 31, 2025, total research, development, and clinical trial costs amounted to $5,684,777 as compared to $8,257,455 for the three-month
period ended January 31, 2024. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which
decreased from $6,200,980 in 2024 to $4,117,576 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 decreased slightly, from $1,401,679 in 2024
to $1,292,021 in 2025, reflecting resource allocation adjustments. Laboratory rent increased to $114,330 in 2025, up from $108,000 in
2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $312,543 in 2024 to $85,264 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 $1,908 in 2025, compared to nil in 2024. Notably, share-based compensation expenses decreased
significantly, from $234,253 in 2024 to $50,839 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
Clinical trial expenses for the
period are as follows:
Three
months ended January 31,
2025
2024
Bria-IMT™
Pivotal Phase 3 study
$
3,642,650
$
2,519,420
Bria-IMT™
Phase 1/2a
215,301
1,840,430
Bria-OTS™ Phase 1/2a
65,608
-
$
3,923,559
$
4,359,850
Clinical
trial expenses for the three months ended January 31, 2025, were $3,923,559, 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 January 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $3,642,650, an increase from $2,519,420
in 2024. This increase reflects our intensified efforts to advance the pivotal Phase 3 study, with a focus on patient recruitment, site
activation, and trial execution as we push toward key milestones.
For
the three-month period ended January 31, 2025, Bria-IMT™ Phase 1/2a costs were $215,301, a significant decline from $1,840,430
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 January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $65,608, 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 January 31, 2025, general and administrative expenses amounted to $1,484,666, compared to $1,571,991 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 January 31, 2025, financial income amounted to $67,358, compared to $81,628 for the three-month period ended
January 31, 2024. Financial income for the 2025 period consisted of $46,832 in interest income and a $20,256 foreign exchange gain. In
comparison, financial income for the 2024 period included $81,595 in interest income and a $33 foreign exchange gain. 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 $6,291,420 for the three-month period ended January 31, 2025, compared to $11,294,603 for the same period
in 2024. The decrease in net loss was primarily driven by a reduction in research, development, and clinical trial expenses, which declined from $8,257,455
in 2024 to $5,684,777 in 2025, mainly due to lower clinical trial and investigational drug costs following the completion of the Bria-IMT™
Phase 1/2a trial. Additionally, the change in fair value of the warrant liability resulted in a gain of $806,841 in 2025, compared to
a loss of $1,567,747 in 2024, further contributing to the improved financial results.
Results
of Operations for the Six Months Ended January 31, 2025 and 2024
Six months ended
January 31,
2025
2024
(Unaudited)
(Unaudited)
Operating Expenses:
Research, development, and clinical trial expenses
$ 9,350,118
$ 15,114,712
General and administrative expenses
2,972,157
3,217,762
Total operating expenses
12,322,275
18,332,474
Operating loss
(12,322,275 )
(18,332,474 )
Financial expenses, net
79,072
261,450
Change in fair value of the warrant liability
190,198
12,714,331
Share of loss on equity investments
(114,099 )
(18,345 )
Net loss for the period
$ (12,167,104 )
(5,375,038 )
Net loss attributable to non-controlling interest
(73,509 )
(81,978 )
Net loss for the period attributable to BriaCell
(12,093,595 )
(5,293,060 )
Net loss per share attributable to BriaCell – basic and diluted
$ (5.44 )
$ (5.04 )
Weighted average number of shares used in computing net basic earnings per share of common stock
2,224,979
1,065,448
Weighted average number of shares used in computing net diluted earnings per share of common stock
2,224,979
1,065,448
25
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:
Six months ended January 31,
2025
2024
Clinical trial sites and Investigational drug costs
$ 6,557,243
$ 11,598,418
Wages and salaries
2,241,110
2,422,404
Laboratory Rent
228,660
196,480
Supplies
184,694
401,566
Depreciation
45,678
-
Professional fees
9,176
3,782
Share-based compensation
83,557
492,062
$ 9,350,118
$ 15,114,712
For
the six-month period ending January 31, 2025, research, development and clinical trial costs amounted to $9,350,118, a significant
decrease from the $15,114,712 incurred during the same period in 2024. This reduction was primarily driven by lower clinical trial
sites and investigational drug costs, which decreased from $11,598,418 in 2024 to $6,557,243 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 decreased slightly, from $2,422,404 in 2024 to $2,241,110 in 2025, reflecting resource allocation adjustments. Laboratory
rent increased to $228,660 in 2025, up from $196,480 in 2024, due to expanded use of facilities to support ongoing research.
Supplies decreased, from $401,566 in 2024 to $184,694 in 2025, driven by lowered spending. Depreciation expenses of $45,678 were
recognized in 2025, reflecting investments in capital assets to support research activities. Professional fees increased to $9,176
in 2025, compared to $3,782 in 2024, primarily due to consulting and support for clinical operations. Notably, share-based
compensation expenses decreased significantly, from $492,062 in 2024 to $83,557 in 2025, contributing to the overall reduction in
research, development, and clinical trial expenses.
Clinical trial expenses for the
period are as follows:
Six
months ended January 31,
2025
2024
Bria-IMT™
Pivotal Phase 3 study
$
6,089,111
$
4,887,207
Bria-IMT™
Phase 1/2a
399,343
3,099,933
Bria-OTS™ Phase 1/2a
143,195
-
$
6,631,649
$
7,987,140
Clinical trial expenses for the six-month period ended January 31, 2025, were $6,631,649, compared to $7,987,140
during the same period in 2024. This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the continued prioritization
of 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 six-month period ended January 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $6,089,111, up from $4,887,207 in 2024.
The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, activating
additional sites, and streamlining trial execution to support the study’s advancement.
Bria-IMT™
Phase 1/2a costs declined to $399,343, a sharp reduction from $3,099,933 in 2024, reflecting the trial’s conclusion. Remaining
costs are tied to final reporting, regulatory submissions, and study close-out activities.
For the six-month period ended January 31, 2025, Bria-OTS™ Phase 1/2a costs totaled $143,195, 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 six-month period ended January 31, 2025, general and administrative expenses amounted to $2,972,157, compared to $3,217,762 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 six-month period ended January 31, 2025, financial income amounted to $79,072, compared to $261,450 for the six-month period ended
January 31, 2024. Financial income for the 2025 period consisted of $59,882 in interest income and a $19,190 foreign exchange gain. In
comparison, financial income for the 2024 period included $272,410 in interest income, offset by a $10,960 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.
26
Loss
for the period
The
Company reported a loss of $12,167,104 for the six-month period ended January 31, 2025, compared to $5,375,038 in 2024. The increase
was primarily due to a smaller gain on the fair value of warrant liability, which was $190,198 in 2025 compared to $12,714,331 in 2024.
This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $15,114,712 in 2024 to $9,350,118 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.
As
of January 31, 2025, and a positive working capital balance of $1,931,735 (July 31, 2024 negative balance of $3,807,303).
As
of January 31, 2025, the Company has total assets of $9,363,567 (July 31, 2024 - $5,872,261), a positive working capital of $1,931,735
(July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $97,537,292 (July 31, 2024 - $85,443,697).
As
of January 31, 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 January 31, 2025, the Company’s overall position of cash and cash equivalents increased by $4,151,565 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 January 31, 2025, was $12,875,298 as compared to $15,006,564
for the period ended January 31, 2024.
Cash
gained in financing activities for the period ended January 31, 2025, was 17,176,863 as compared to nil for the period ended January
31, 2024.
27
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 January 31, 2025.
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 January 31, 2025, the Company has total assets of $9,363,567 (July 31, 2024 - $5,872,261) and a positive working capital balance
of $1,931,735 (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.
28
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 January 31, 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.
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 January 31, 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 January 31, 2025, that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
29
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 January 31, 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.
30
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.
March
12, 2025
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
March
12, 2025
By:
/s/
Gadi Levin
Name:
Gadi
Levin
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
31
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.