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 October 31, 2024
☐
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 December 16, 2024, 44,204,161 common
shares, no par value per share, of the Company were 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 October 31, 2024 (unaudited) and July 31, 2024 (audited)
3
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended October 31, 2024
4
Unaudited
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) for the three months ended October 31, 2024
5
Unaudited
Condensed Consolidated Statement of Cash Flows for the three months ended October 31, 2024
6
Notes
to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
18
Item
3.
Quantitative
and Qualitative Disclosures Regarding Market Risk
22
Item
4.
Controls
and Procedures
23
Part
II. Other Information
23
Item
1.
Legal
Proceedings
23
Item
1A.
Risk
Factors
23
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
23
Item
3.
Defaults
Upon Senior Securities
23
Item
4.
Mine
Safety Disclosures
23
Item
5.
Other
Information
24
Item
6.
Exhibits
24
Part
III. Signatures
25
2
PART
I-FINANCIAL INFORMATION
Item
1. Financial Statements
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED BALANCE SHEETS
October
31, 2024
July
31, 2024
(Unaudited)
(Audited)
ASSETS
CURRENT ASSETS:
Cash and cash
equivalents
$ 5,792,265
$ 862,089
Amounts receivable and
prepaid expenses
2,426,830
2,791,765
Total
current assets
8,219,095
3,653,854
NON-CURRENT ASSETS:
Equity Investment in BC
Therapeutics
421,975
418,490
Intangible assets, net
195,978
199,796
Property and equipment,
net
365,336
388,175
Long
term prepaid expenses
1,211,946
1,211,946
Total
non-current assets
2,195,235
2,218,407
Total
assets
$ 10,414,330
$ 5,872,261
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES:
Trade payables
$ 4,233,968
$ 7,170,781
Accrued
expenses and other payables
754,668
290,376
Total
current liabilities
4,988,636
7,461,157
NON-CURRENT LIABILITIES:
Warrant
liability
1,712,679
1,096,036
Total
non-current liabilities
1,712,679
1,096,036
SHAREHOLDERS’ EQUITY
(DEFICIT):
Share capital of no par value - Authorized: unlimited at October 31,
2024 and July 31, 2024, Issued and outstanding: 36,183,161 shares October 31, 2024 and 18,284,661 July 31, 2024, respectively
82,040,741
72,166,414
Share-based payment reserved
9,456,232
9,189,261
Warrant reserve
3,930,221
1,844,296
Accumulated other comprehensive loss
( 138,684 )
( 138,684 )
Non-controlling interest
( 329,623 )
( 302,522 )
Accumulated deficit
( 91,245,872 )
( 85,443,697 )
Total
shareholders’ equity (deficit)
3,713,015
( 2,684,932 )
Total
liabilities and shareholders’ equity
$ 10,414,330
$ 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
(Unaudited)
2024
2023
Three months
ended
October
31,
2024
2023
Operating expenses:
Research and
development expenses
$ 3,665,341
6,857,257
General
and administrative expenses
1,487,491
1,645,771
Total operating expenses
5,152,832
8,503,028
Operating loss
( 5,152,832 )
( 8,503,028 )
Financial income, net
11,714
179,822
Change in fair value of
the warrant liability
( 616,643 )
14,282,078
Share
of loss on equity investment
( 71,515 )
-
Net income (loss) for the
period
$ ( 5,829,276 )
$ 5,958,872
Net
loss attributable to non-controlling interest
( 27,101 )
( 42,671 )
Net
income (loss) for the period attributable to BriaCell
( 5,802,175 )
6,001,543
Net
income (loss) per share attributable to BriaCell – basic
$ ( 0.22 )
$ 0.38
Net
income (loss) per share attributable to BriaCell – diluted
( 0.22 )
( 0.50 )
Weighted average number of shares used in computing
net basic earnings per share of common stock
26,641,036
15,981,726
Weighted average number
of shares used in computing net diluted earnings per share of common stock
26,641,036
16,674,891
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
(Unaudited)
FOR
THE THREE MONTHS ENDED OCTOBER 31, 2024
Number
Amount
capital
loss
Equity
interest
(deficit)
Share
capital
Additional
paid in
Accumulated
other
comprehensive
Accumulated
Non-
controlling
Total
shareholders’
equity
Number
Amount
capital
loss
Equity
interest
(deficit)
Balance, July 31, 2023
15,981,726
$ 69,591,784 -
$ 7,421,950
$ ( 138,684 )
$ ( 80,652,231 )
-
$ ( 3,777,181 )
Balance
15,981,726
$ 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
-
-
533,816
-
-
-
533,816
Income (loss) for the
period
-
- -
-
-
6,001,543
( 42,671 )
5,958,872
Balance, October 31, 2023
15,981,726
$ 69,591,784 -
$ 7,918,999
$ ( 138,684 )
$ ( 74,650,688 )
( 205,111 )
$ 2,516,300
Balance
15,981,726
$ 69,591,784 -
$ 7,918,999
$ ( 138,684 )
$ ( 74,650,688 )
( 205,111 )
$ 2,516,300
Number
Amount
CAPITAL
Reserve
INCOME
(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, July 31, 2024
18,284,661
$ 72,166,414
$ 9,189,261
$ 1,844,296
$ ( 138,684 )
$ ( 85,443,697 )
$ ( 302,522 )
$ ( 2,684,932 )
Issuance of Options
-
-
266,971
-
-
-
-
266,971
Exercise of prefunded warrants
100,000
-
-
-
-
-
-
-
Exercise of broker warrants
345,000
442,677
-
( 149,426 )
-
-
-
293,251
Issuance of units
17,453,500
9,431,650
-
2,235,351
-
-
-
11,667,001
Net loss for the period
-
-
-
-
-
( 5,802,175 )
( 27,101 )
( 5,829,276 )
Balance, October 31,
2024
36,183,161
$ 82,040,741
$ 9,456,232
$ 3,930,221
$ ( 138,684 )
$ ( 91,245,872 )
$ ( 329,623 )
$ 3,713,015
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
2024
2023
Three
months ended
October 31,
2024
2023
Cash flow from operating
activities
Net income (loss) for the period
$ ( 5,829,276 )
$ 5,958,872
Adjustments to reconcile net loss to net cash
used in operating activities:
Amortization
3,818
3,818
Depreciation
22,839
-
Share-based compensation
266,971
533,816
Equity losses
71,515
-
Change in fair value of
warrants
616,643
( 14,282,078 )
Changes in assets and liabilities:
Decrease (increase) in amounts receivable
736,788
( 2,537 )
(Increase) decrease in prepaid expenses
( 371,853 )
937,816
Decrease in
accounts payable
( 2,936,813 )
( 689,824 )
Increase (decrease)
in accrued expenses and other payables
464,292
( 65,128 )
Total cash flow from operating
activities
( 6,955,076 )
( 7,605,245 )
Cash flows from Investing
activities
Equity investment in BC
Therapeutics
( 75,000 )
-
Total
cash flow from investing activities
( 75,000 )
-
Cash flows from financing
activities
Proceeds from exercise of warrants
293,251
-
Proceeds
from the issuance of shares, net of issuance costs
11,667,001
-
Total
cash flow from financing activities
11,960,252
-
Increase (decrease) in cash and cash
equivalents
4,930,176
( 7,605,245 )
Cash and cash equivalents
at beginning of the period
862,089
21,251,092
Cash and cash equivalents
at end of the period
$ 5,792,265
$ 13,645,847
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
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
is an immuno-oncology biotechnology company. The Company is currently advancing its Bria-IMT targeted immunotherapy program against
end-stage breast cancer to Phase 3 study which has been approved by the FDA. BriaCell is also developing a personalized off-the-shelf
immunotherapy, Bria-OTS™, and a 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.
d.
Going concern
The Company
continues to devote substantially all of its efforts toward research and development activities. In the course of such activities,
the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s
accumulated deficit as of October 31, 2024 was $ 91,245,872
and negative cash flows from operating activities during the three-month period ended October 31, 2024 was $ 6,955,076 .
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 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 and $ 5.0
million gross offering that was completed in September 2024 and October 2024, respectively.
e.
The
Company has two wholly-owned U.S. subsidiaries: (i) BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April
3, 2014, under the laws of the state of Delaware, and (ii) BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”),
which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company also has one Canadian subsidiary:
BriaPro Therapeutics Corp, (“BriaPro”) which was incorporated on May 15, 2023, under the Business Corporations Act (British
Columbia). See also note 1f. (Sapientia and BTC and BriaPro together, the “Subsidiaries”).
f.
On August 31, 2023, the Company closed a plan of arrangement spinout transaction
(the “Arrangement”) pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase
C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”), were spun-out to BriaPro
Therapeutics Corp. (“BriaPro”), resulting in a 2/3rd owned subsidiary of the Company with the remaining 1/3rd held by BriaCell
shareholders (“BriaCell Shareholders”).
Pursuant to the terms of the Arrangement,
BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration for the issuance by BriaPro to the Company
of BriaPro common shares. Under the terms of the Arrangement, for each BriaCell share held immediately prior to closing, BriaCell Shareholders
receive one (1) common share of BriaPro, and one (1) new common share of BriaCell (retiring their old share) having the same terms and
characteristics as the existing BriaCell common shares. The Company will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange,
and BriaPro is an unlisted reporting issuer in Canada.
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 common shares issued and outstanding. The Company now beneficially owns or controls approximately 31,963,452 BriaPro
common shares, representing 2/3rd of the issued and outstanding BriaPro common shares.
Pursuant to the Arrangement, each BriaCell
warrant in issuance at the time of the Arrangement shall, in accordance with its terms, entitle the holder thereof to receive, upon the
exercise thereof, one BriaCell Share 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 BriaCell Warrants,
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 BriaCell Warrant 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”).
Pursuant to the Arrangement, all Briacell
option holders received the same amount of BriaPro options (“BriaPro Option”) and under the BriaPro incentive plan. The exercise
price of the BriaCell options was apportioned between the BriaCell options and the BriaPro options, as follows:
Each one (1) BriaPro Option to acquire one
(1) 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 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.
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
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 54.6 % 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 reflect 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. The Company is currently
evaluating the impact of this standard on its financial statements and disclosures.
8
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
3: INVESTMENT IN BC THERAPEUTICS INC.
On December 21, 2021, 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 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 quarter
ended October 31, 2024, the Company exercised this option in three tranches, totaling $ 75,000
for 60,000
shares. As of October 31, 2024, the Company holds 480,000
shares in BC Therapeutics, representing 54.6 %
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
75,000
Share of losses
( 71,515 )
Balance – October
31, 2024
$ 421,975
The
following amounts represent the Company’s 54.6 % share of the assets of BC Therapeutics:
SCHEDULE
OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As
of
October
31, 2024
Current
assets: Cash
$ 2,805
Net assets
$ 2,805
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
4: CONTINGENT LIABILITIES AND COMMITMENTS
a.
BriaPro
Warrants
Upon
the exercise of BriaCell 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 October 31, 2024, 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 October 2024, the Company continues to occupy the space on a month-to-month basis
under the same terms.
NOTE
5: FAIR VALUE MEASUREMENTS
The
following table presents information about our financial instruments that are measured at fair value on a recurring basis as of October
31, 2024 and July 31, 2024:
SCHEDULE
OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair
Value Measurements at
October
31, 2024
July
31, 2024
Level
1
Level
2
Total
Level
1
Level
2
Total
Financial Assets:
Cash and cash
equivalents
5,792,265
-
5,792,265
862,089
-
862,089
Total assets measured
at fair value
$ 5,792,265
$ -
$ 5,792,265
$ 862,809
$ -
$ 862,089
Financial liabilities:
Warrants liability
1,207,621
505,058
1,712,679
760,657
335,379
1,096,036
Total liabilities measured
at fair value
$ 1,207,621
$ 505,058
$ 1,712,679
$ 760,657
$ 335,379
$ 1,096,036
We
classify our 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.
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
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)
The
Company issued the following shares during the three-month period ended October 31, 2024:
1.
On
September 12, 2024, the Company completed a registered direct offering for the purchase and sale of 12,325,000 common shares of the
Company at an offering price of $ 0.69 per share, for aggregate gross proceeds of approximately $ 8.5 million before deducting placement
agent fees and other offering expenses (the “September 2024 Offering”).
In
connection with the September 2024 Offering, the Company issued 616,250
placement agent warrants with an exercise price of $ 0.8625
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 - $ 0.63 ;
exercise price - $ 0.8625 ;
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 5,128,500 common shares of the Company
and warrants to purchase up to an aggregate of 5,128,500 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 $ 0.975 . The warrants have an exercise price of $ 0.85 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 256,425 placement agent warrants. The placement agent warrants are immediately
exercisable at an exercise price of $ 1.21875 per share and expire five years from the date of issuance.
The
fair value of the 5,128,500 October 2024 Warrants was determined to be $ 2,211,266 using the Black-Scholes option pricing model, with
the following assumptions: share price - $ 0.54 ; exercise price - $ 0.85 ; expected life – 5 years; annualized volatility - 121 %;
dividend yield - 0 %; risk-free rate – 3.553 %.
The
fair value of the 256,425 placement agent warrants was determined to be $ 204,128 using the Black-Scholes option pricing model, with the
following assumptions: share price - $ 1.01 ; exercise price - $ 1.22 ; 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.
During
October 2024, 345,000 October 2024 Warrants with an exercise price of $ 0.85 were exercised for gross proceeds of $ 293,250 . The Company
issued 345,000 common shares in respect of the exercise of these warrants.
11
c.
Share Purchase Warrants
A
summary of changes in share purchase warrants for the three-month period ending October 31, 2024 is presented below:
SUMMARY
OF CHANGES IN WARRANTS
Number
of options outstanding
Weighted
average exercise price (*)
Balance,
July 31, 2024
10,524,585
$ 4.92
Exercised
( 345,000 )
( 0.85 )
Granted
in the October 2024 Offering
5,128,500
0.85
Balance,
October 31, 2024
15,308,085
$ 3.65
(ii)
As
of October 31, 2024, warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number
of
Warrants
Exercise
Price(*)
Exercisable
At
October
31, 2024
Expiry
Date
51,698
$ 3.89
51,698
November 16, 2025
3,896,809
$ 5.31
3,896,809
February 26, 2026 – April 26, 2026
4,173,143
$ 6.19
4,173,143
December 7, 2026
2,402,935
$ 2.11
(*) -
November 17, 2029
4,783,500
$ 0.85
4,783,500
October 2, 2029
15,308,085
12,898,150
(*) Exercisable from
November 17, 2024.
d.
Compensation Warrants
(i)
A
summary of changes in compensation warrants for the three-month period ended October 31,
2024 is presented below:
SUMMARY
OF CHANGES IN WARRANTS
Number
of warrants
outstanding
Weighted
average
exercise
price (*)
Balance,
July 31, 2024
96,652
3.92
Granted in the September
2024 Offering
616,250
0.86
Granted
in the October 2024 Offering
256,425
1.22
Balance,
October 31, 2024
969,327
$ 1.26
(ii)
As
of October 31, 2024, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number
of
Warrants
Exercise
Price
Exercisable
At
October
31, 2024
Expiry
Date
4,890
$ 3.89
4,890
November 16, 2025
17,074
$ 5.31
17,074
February 26, 2026
24,688
$ 6.19
24,688
June 7, 2026
50,000
$ 2.32
(*) -
May 17, 2029
616,250
$ 0.86
(**) -
March 13, 2030
256,425
$ 1.22
256,425
October 2, 2029
969,327
303,077
(*) Exercisable from
November 17, 2024.
(**) Exercisable from
March 11, 2025.
12
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
6: SHAREHOLDERS’ EQUITY (Cont.)
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
$ 616,643
Balance as of October
31, 2024
$ 1,712,679
The
key inputs used in the valuation of the non-public warrants as of October 31, 2024 and at July 31, 2024 were as follows:
SCHEDULE
OF VALUATION OF NON-PUBLIC WARRANTS
October
31, 2024
July
31, 2024
Share price
$ 0.81
$ 0.75
Exercise price
$ 5.31 - 6.19
$
5.31 - 6.19
Expected life (years)
1.32 - 2.10
1.57 - 2.35
Volatility
93 - 106
%
77 - 79 %
Dividend yield
0 %
0 %
Risk free rate
4.19 - 4.29 %
4.27 %
The
key inputs used in the valuation of the of the BriaPro Warrant Shares as of October 31, 2024 were as follows:
SCHEDULE
OF BRIA PRO WARRANTS
August
31, 2023
(Effective Date)
October
31, 2024
Share price
$ 0.0365
$ 0.0365
Exercise price
$ 0.0206 - 0.0308
$ 0.0206 - 0.0308
Expected life (years)
2.21 - 3.27
1.05 - 2.10
Volatility
100 %
93 - 106
%
Dividend yield
0 %
0 %
Risk free rate
4.40 %
3.07 %
13
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 three-month period ended October 31, 2024 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
2,131,400
$ 6.16
2.52
$ -
Balance as of October 31, 2024
2,131,400
6.15
2.27
-
Exercisable as of October 31, 2024
2,018,775
$ 6.16
2.20
$ -
As
of October 31, 2024, there are $ 519,598 of total unrecognized costs related to share-based compensation that is expected to be recognized
over a period of up to 6 months.
14
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
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 October
31, 2024.
SCHEDULE
OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding
as of
October
31, 2024
Weighted
average
remaining
contractual
term
(years)
Options
exercisable
as of
October
31, 2024
Weighted
average
remaining
contractual
term
(years)
Expiry
Date
$ 6.03
440,000
3.64
330,000
3.64
June 20, 2028
$ 7.16
21,000
3.33
18,375
3.33
February 27, 2028
$ 6.04
180,100
2.76
180,100
2.76
August 02, 2027
$ 4.71
31,000
2.56
31,000
2.56
May 20, 2027
$ 7.51
150,000
2.29
150,000
2.29
February 16, 2027
$ 8.47
524,700
2.20
524,700
2.20
January 13, 2027
$ 7.15
12,600
2.00
12,600
2.00
November 01, 2026
$ 5.74
100,000
1.84
100,000
1.84
September 01, 2026
$ 4.24
60,000
1.47
60,000
1.47
April 19, 2026
$ 4.24
612,000
1.41
612,000
1.41
March 29, 2026
2,131,400
2,018,775
15
d.
As
result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of October 31, 2024:
SUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
Price
Options
outstanding
as of October 31, 2024
Options
exercisable
as
of October 31, 2024
Expiry
Date
$ 0.0933
440,000
330,000
June 20, 2028
$ 0.1108
21,000
18,375
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
2,018,775
e.
Restricted
Share Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of October 31, 2024:
SCHEDULE
OF RESTRICTED STOCK UNITS GRANTED
Number
of
RSU’s
outstanding
Aggregate
intrinsic
value
Balance,
July 31, 2024
19,200
$ 14,400
Balance,
October 31, 2024
19,200
$ 15,552
f.
The
total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three-month
period ended October 31, 2024 and 2023 is comprised as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSES
2024
2023
Three
months ended
October
31,
2024
2023
Research and development expenses
$ 32,718
257,809
General and administrative
expenses
234,253
276,007
Total share-based compensation
$ 266,971
533,816
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
8: BASIC AND DILUTED NET LOSS PER SHARE
Basic
net income (loss) per ordinary share is computed by dividing net income (loss) for each reporting period by the weighted-average number
of ordinary shares outstanding during each year. Diluted net income (loss) per ordinary share is computed by dividing net income (loss)
for each reporting period by the weighted average number of ordinary shares outstanding during the period, plus dilutive potential ordinary
shares considered outstanding during the period, in accordance with ASC No. 260-10 “Earnings Per Share”. The company reported
a loss for the three-month period ending October 31, 2023, leading to the exclusion of potentially dilutive ordinary shares. Conversely,
a gain was recorded for the three-month period ending October 31, 2024, resulting in the inclusion of all potentially dilutive ordinary
shares.
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
2024
2023
Three
months ended
October
31,
2024
2023
(Unaudited)
(Unaudited)
Basic EPS
Numerator:
Net income
(loss)
$ ( 5,802,175 )
$ 6,001,543
Denominator:
Shares used in computation
of basic earnings per share
26,641,036
15,981,726
Basic EPS
$ ( 0.22 )
$ 0.38
Diluted EPS
Numerator:
Net income (loss) attributable
to common stock, basic
$ ( 5,802,175 )
$ 6,001,543
Adjustment:
Change in fair value of warrant liability
-
( 14,282,078 )
Net (loss) attributable to common stock, diluted
$ ( 5,802,175 )
$ ( 8,280,535 )
Denominator:
Shares used in computing
net EPS of common stock, basic
26,641,036
15,981,726
Stock Options
-
211,434
Warrants
-
481,731
Shares used in computation of diluted earnings
per share
26,641,036
16,674,891
Diluted EPS
$ ( 0.22 )
$ ( 0.50 )
NOTE
9: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE
OF FINANCIAL INCOME (EXPENSES), NET
2024
2023
Three
months ended
October
31,
2024
2023
Interest income
$ 13,050
$ 190,815
Foreign exchange loss
( 1,336 )
( 10,993 )
Financial income, net
$ 11,714
$ 179,822
NOTE
10: SUBSEQUENT EVENTS
a. Between December 3, 2024 and December 10, 2024, a 620,900 October 2024
Warrants were exercised into 620,900 common shares of the Company, generating gross proceeds of $ 527,765 .
b.
On December 13, 2024, the Company closed a public offering for the purchase
and sale of 7,400,000 common shares of the Company and warrants to purchase up to an aggregate of 7,400,000 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 $ 0.75 . The warrants have an exercise price of $ 0.9375 per share, and are immediately exercisable for a period of five years from the closing date. In addition, the Company issued 370,000 agent warrants. The agent warrants are immediately exercisable for
a period of five years from the closing date at an exercise price of $ 0.9375 .
17
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 quarter of fiscal 2024
in comparison to the first quarter of fiscal 2023.
●
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 is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care.
Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize
and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune
check point inhibitor (Retifanlimab) in a pivotal Phase 3 study in metastatic breast cancer. Bria-IMT™ is currently under Fast Track
Designation by the U.S. Food and Drug Administration(the “FDA”) intended to accelerate the review process of novel treatments
that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the
Bria-IMT™ immune checkpoint inhibitor combination in metastatic breast cancer. BriaCell reported benchmark-beating patient survival
and clinical benefit in metastatic breast cancer with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer
patients vs. 6.7-9.8 months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study
with retifanlimab at the 2023 San Antonio Breast Cancer Symposium. A completed Bria-IMT™ Phase 1 combination study with retifanlimab
(an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy. BriaCell is also developing personalized
off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf
immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system
as well as an immune checkpoint inhibitor.
18
Recent
Developments
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). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.
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 13, 2024, the Company closed a public offering for the purchase and sale of 7,400,000 common shares of the Company and warrants
to purchase up to an aggregate of 7,400,000 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 $0.75. The warrants have an exercise
price of $0.9375 per share, and are immediately exercisable for a period of five years from the closing date. In addition, the Company
issued 370,000 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an
exercise price of $0.9375.
Results
of Operations for the Three Months Ended October 31, 2024, and 2023
Three months
ended
October
31,
2024
2023
Operating expenses:
Research and
development expenses
$ 3,665,341
6,857,257
General
and administrative expenses
1,487,491
1,645,771
Total operating expenses
5,152,832
8,503,028
Operating loss
(5,152,832 )
(8,503,028 )
Financial income, net
11,714
179,822
Change in fair value of
the warrant liability
(616,643 )
14,282,078
Share
of loss on equity investment
(71,515 )
-
Net income (loss) for the
period
$ (5,829,276 )
$ 5,958,872
Net
loss attributable to non-controlling interest
(27,101 )
(42,671 )
Net
income (loss) for the period attributable to BriaCell
(5,802,175 )
6,001,543
Net
income (loss) per share attributable to BriaCell – basic
$ (0.22 )
$ 0.38
Net
income (loss) per share attributable to BriaCell – diluted
(0.22 )
(0.50 )
Weighted average number of shares used in computing
net basic earnings per share of common stock
26,641,036
15,619,676
Weighted average number
of shares used in computing net diluted earnings per share of common stock
26,641,036
16,674,891
Research
and Development 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.
19
The
following is a breakdown of our research and development costs by nature of expenses:
Three
months ended October 31,
2024
2023
Clinical trial sites and investigational
drug costs
$ 2,439,667
$ 5,397,438
Wages and salaries
949,089
1,020,725
Laboratory Rent
114,330
88,480
Supplies
99,430
89,023
Depreciation
22,839
-
Professional fees
7,268
3,782
Share-based compensation
32,718
257,809
$ 3,665,341
$ 6,857,257
For
the three-month period ending October 31, 2024, research costs amounted to $3,665,341, a significant decrease from the $6,857,257 incurred
during the same period in 2023. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which
decreased from $5,397,438 in 2023 to $2,439,667 in 2024. 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 $1,020,725 in 2023
to $949,089 in 2024, reflecting resource allocation adjustments. Laboratory rent increased to $114,330 in 2024, up from $88,480 in 2023,
due to expanded use of facilities to support ongoing research. Supplies also increased, from $89,023 in 2023 to $99,430 in 2024, driven
by higher operational needs. Depreciation expenses of $22,839 were recognized in 2024, reflecting investments in capital assets to support
research activities. Professional fees increased to $7,268 in 2024, compared to $3,782 in 2023, primarily due to consulting and support
for clinical operations. Notably, share-based compensation expenses decreased significantly, from $257,809 in 2023 to $32,718 in 2024,
contributing to the overall reduction in research and development expenses.
Our
clinical trial expenses are broken down as follows:
Three
months ended October 31,
2024
2023
Bria-IMT™ Pivotal Phase 3
study
$ 2,185,543
$ 2,278,258
Bria-IMT™ Phase 1/2a
142,496
1,214,440
Indirect research and
development expenses allocated to trials
111,628
134,592
$ 2,439,667
$ 3,627,290
Clinical
trial expenses for the three months ended October 31, 2024, were $2,439,667, compared to $3,627,290 during the same period in 2023. The
decrease in expenses is primarily attributable to the conclusion of patient recruitment and related activities in the Bria-IMT™
Phase 1/2a clinical trial in fiscal 2024. This reduction in costs aligns with our transition to the pivotal Phase 3 study of Bria-IMT™,
which has become the primary focus of our clinical development efforts.
For
the three-month period ending October 31, 2024, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,185,543, remaining consistent
with the prior year’s $2,278,258. This consistency reflects our strategic decision to optimize spending while focusing expenditures
on this pivotal trial, underscoring our commitment to prioritizing the Phase 3 study as the cornerstone of our clinical development program.
Resources were effectively allocated toward patient recruitment, trial operations, and preparation for key milestones.
For
the three-month period ending October 31, 2024, Bria-IMT™ Phase 1/2a costs amounted to $142,496, a significant decrease compared
to $1,214,440 during the same period in 2023. This decrease is attributed to the trial’s conclusion in fiscal 2024, with only minimal
remaining expenses related to final data analysis and study close-out activities.
For
the three-month period ending October 31, 2024, indirect research and development expenses allocated to trials amounted to $111,628,
compared to $134,592 in the prior year. This reduction is primarily due to streamlined trial operations and a shift in resource allocation
toward the pivotal Phase 3 study.
We
remain focused on advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to direct resources accordingly
to ensure its timely progression.
General
and Administrative Expenses
For
the three-month period ending October 31, 2024, general and administrative expenses amounted to $1,487,491, showing a decrease from $1,645,771
in the same period of 2023. The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional
fees and share-based compensation expenses. The Company has reduced general and administrative expenses in order to devote more resources
to its clinical program.
Financial
income (expenses), net
For
the three-month period ending October 31, 2024, net financial income amounted to $11,714, a significant decrease from the $179,822 recorded
in the same period of 2023. Financial income for the three-month period ending October 31, 2024 primarily consists of interest income
of $13,050, offset by a foreign exchange loss of $1,336. In comparison, For the three-month period ending October 31, 2023, interest
income was $190,815, while foreign exchange losses totaled $10,993. The decrease in financial income from 2023 to 2024 reflects lower
interest income due to reduced cash and cash equivalents available for investment in interest-bearing funds
Profit
(loss) for the period
For
the three-month period ended October 31, 2024, the Company reported a loss of $5,829,276 compared to a gain of $5,958,872 for the same
period in 2023. The loss in the three-month period ended October 31, 2024, primarily resulted from the significant change in the fair
value of the warrant liability, which accounted for a loss of $616,643 in 2024 compared to a gain of $14,282,078 in 2023. This highlights
the substantial impact that warrant liability valuation has on the Company’s overall financial performance, despite decreased operational
spending during the period, particularly in research and development.
20
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 October 31, 2024, and a positive working capital balance of $3,230,459 (July 31, 2024 negative balance of $3,807,303).
As
of October 31, 2024, the Company has total assets of $10,414,330 (July 31, 2024 - $5,872,261), a positive working capital of $3,230,459
(July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $91,245,872 (July 31, 2024 - $85,443,697).
As
of October 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly
of cash on deposit with banks, investments in money market funds, investments in U.S. government securities, U.S. 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 October 31, 2024, the Company’s overall position of cash and cash equivalents increased by $4,930,176 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 October 31, 2024, was $6,955,076 as compared to $7,605,245
for the period ended October 31, 2023.
Cash
gained in financing activities for the period ended October 31, 2024, was 11,960,252 as compared to nil for the period ended October
31, 2023.
21
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 October 31, 2024.
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 October 31, 2024, the Company has total assets of $10,414,330 (July 31, 2024 - $5,872,261) and a positive working capital
balance of $3,230,459 (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.
22
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 October 31, 2024, 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.
Evaluation
of 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 October 31, 2024, 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 October 31, 2024, that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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 three months ended October 31, 2024.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
Applicable.
23
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.
24
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.
December
16, 2024
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
December
16, 2024
By:
/s/
Gadi Levin
Name:
Gadi
Levin
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer )
25
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.