UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended April 30, 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
(I.R.S.
Employer
incorporation
or organization)
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 June 14, 2024, there were 18,284,661 common shares, no par value per share, of the Company issued and outstanding.
BRIACELL
THERAPEUTICS CORP.
Form
10-Q
Table
of Contents
Page
Part I. Financial Information
3
Item
1.
Financial Statements
3
Condensed Consolidated Balance Sheets as of April 30, 2024 (unaudited) and July 31, 2023 (unaudited)
3
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months ended April 30,
2024
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Nine Months ended April 30, 2024
5
Unaudited Condensed Consolidated Statement of Cash Flows for the Nine Months ended April 30, 2024
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item
3.
Quantitative and Qualitative Disclosures Regarding Market Risk
22
Item
4.
Controls and Procedures
23
Part II. Other Information
24
Item
1.
Legal Proceedings
24
Item
1A.
Risk Factors
24
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
24
Item
3.
Defaults Upon Senior Securities
24
Item
4.
Mine Safety Disclosures
24
Item
5.
Other Information
24
Item
6.
Exhibits
24
Signatures
25
2
PART
I-FINANCIAL
INFORMATION
Item
1. Financial Statements
BRIACELL
THERAPEUTICS CORP.
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
April 30, 2024
July 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 935,694
$ 21,251,092
Amounts receivable
15,233
18,873
Prepaid expenses
4,579,065
5,678,542
Total current assets
5,529,992
26,948,507
NON-CURRENT ASSETS:
Investments
2
2
Equity investment in BC Therapeutics
469,658
-
Intangible assets, net
203,614
215,068
Total non-current assets
673,274
215,070
Total assets
$ 6,203,266
$ 27,163,577
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$ 6,422,402
$ 1,123,739
Accrued expenses and other payables
335,357
677,718
Total current liabilities
6,757,759
1,801,457
NON-CURRENT LIABILITIES:
Warrant liability
5,678,505
29,139,301
Total non-current liabilities
5,678,505
29,139,301
SHAREHOLDERS’ DEFICIT:
Share Capital of no par value - Authorized: unlimited at April 30, 2024 and July 31, 2023, Issued and outstanding: 15,981,726 shares April 30, 2024 and July 31, 2023, respectively
69,591,784
69,591,784
Share-based payment reserve
8,811,369
7,421,950
Accumulated other comprehensive loss
( 138,684 )
( 138,684 )
Non-controlling Interest
( 267,935 )
-
Accumulated deficit
( 84,229,532 )
( 80,652,231 )
Total shareholders’ deficit
( 6,232,998 )
( 3,777,181 )
Total liabilities and shareholders’ deficit
$ 6,203,266
$ 27,163,577
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED APRIL 30,
2024
(Unaudited)
Three months ended
Nine months ended
April 30,
April 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 7,657,632
3,860,568
$ 22,772,344
$ 10,169,140
General and administrative expenses
1,572,016
1,816,461
4,789,778
5,397,363
Total operating expenses
9,229,648
5,677,029
27,562,122
15,566,503
Operating loss
( 9,229,648 )
( 5,677,029 )
( 27,562,122 )
( 15,566,503 )
Financial income (expenses), net
10,958,887
781,593
23,934,668
( 2,317,236 )
Share of loss on equity investment
( 36,997 )
-
( 55,342 )
-
Net income (loss) for the period
$ 1,692,242
$ ( 4,895,436 )
$ ( 3,682,796 )
( 17,883,739 )
Net loss attributable to non-controlling interest
( 23,517 )
-
( 105,495 )
-
Net income (loss) for the period attributable to BriaCell
1,715,759
( 4,895,436 )
( 3,577,301 )
( 17,883,739 )
Net income (loss) per share attributable to BriaCell –
basic and diluted
$ 0.11
$ ( 0.32
)
$ ( 0.22
)
$ ( 1.15
)
Weighted average number of shares used in computing net basic earnings per share of common stock
15,981,726
15,518,072
15,981,726
15,518,036
Weighted average number of shares used in computing net diluted earnings per share of common stock
15,981,726
15,518,072
15,981,726
15,518,036
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
FOR
THE THREE AND NINE MONTHS ENDED APRIL 30, 2024
Share capital
Additional
paid in
Accumulated
other comprehensive
Accumulated
Non-
controlling
Total
shareholders’
equity
Number
Amount
capital
loss
deficit
interest
(deficit)
Balance, January 31, 2024
15,981,726
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Issuance of options
-
-
392,215
-
-
-
392,215
Income (loss) for the period
-
-
-
-
1,715,759
( 23,517 )
1,692,242
Balance, April 30, 2024
15,981,726
$ 69,591,784
$ 8,811,369
$ ( 138,684 )
$ ( 84,229,532
)
$ ( 267,935 )
$ ( 6,232,998 )
Share capital
Additional
paid in
Accumulated other comprehensive
Accumulated
Non-
controlling
Total shareholders’
equity
Number
Amount
Capital
loss
deficit
interest
(deficit)
Balance, July 31, 2023
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
-
-
1,426,186
-
-
-
1,426,186
Loss for the period
-
-
-
-
( 3,577,301
)
( 105,495 )
( 3,682,796 )
Balance, April 30, 2024
15,981,726
$ 69,591,784
$ 8,811,369
$ ( 138,684 )
$ ( 84,229,532
)
$ ( 267,935 )
$ ( 6,232,998 )
Share capital
Additional
paid in
Accumulated other comprehensive
Accumulated
Total
shareholders’
Equity
Number
Amount
capital
loss
deficit
(deficit)
Balance, January 31, 2023
15,518,018
$ 65,589,293
$ 6,606,945
$ ( 138,684 )
$ ( 73,338,140 )
$ ( 1,280,586 )
Exercise of public offering warrants
300
2,491
-
-
-
2,491
Issuance of options
-
-
281,189
-
-
281,189
Net loss for the period
-
-
-
-
( 4,895,436 )
( 4,895,436 )
Balance, April 30, 2023
15,518,318
$ 65,591,784
$ 6,888,134
$ ( 138,684 )
$ ( 78,233,576 )
$ ( 5,892,342 )
Share capital
Additional
paid in
Accumulated other comprehensive
Accumulated
Total
shareholders’ equity
Number
Amount
capital
loss
deficit
(deficit)
Balance, July 31, 2022
15,518,018
$ 65,589,293
$ 5,228,160
$ ( 138,684 )
$ ( 60,349,837 )
$ 10,328,932
Balance
15,518,018
$ 65,589,293
$ 5,228,160
$ ( 138,684 )
$ ( 60,349,837 )
$ 10,328,932
Exercise of public offering warrants
300
2,491
-
-
-
2,491
Issuance of options
-
-
1,659,974
-
-
1,659,974
Net loss for the period
-
-
( 17,883,739 )
( 17,883,739 )
Income (loss) for the period
-
-
( 17,883,739 )
( 17,883,739 )
Balance, April 30, 2023
15,518,318
$ 65,591,784
$ 6,888,134
$ ( 138,684 )
$ ( 78,233,576 )
$ ( 5,892,342 )
Balance
15,518,318
$ 65,591,784
$ 6,888,134
$ ( 138,684 )
$ ( 78,233,576 )
$ ( 5,892,342 )
The
accompanying notes are an integral part of the condensed consolidated financial statements.
5
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE NINE MONTHS ENDED APRIL 30, 2024
(Unaudited)
Nine months ended April 30,
2024
2023
Cash flow from operating activities
Net loss for the period
$ ( 3,682,796 )
$ ( 17,883,739 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
11,453
11,453
Share-based compensation
1,426,186
1,659,974
Share of loss on equity investment
55,342
-
Change in fair value of warrants
( 23,660,003 )
2,972,285
Changes in assets and liabilities:
Increase in amounts receivable
3,640
9,207
Decrease (increase) in prepaid expenses
799,477
( 37,040 )
Increase in trade payable
5,298,663
531,972
Decrease in accrued expenses and other payables
( 342,360 )
( 89,965 )
Total cash flow from operating activities
( 20,090,398 )
( 12,825,853 )
Cash flows from investing activities
Equity Investment in BC Therapeutics ( * )
( 225,000 )
-
Total cash flow from investing activities
( 225,000 )
-
Cash flows from financing activities
Share and warrant buyback program
-
( 47,294 )
Proceeds from exercise of warrants
-
1,594
Total cash flow from financing activities
-
( 45,700 )
Decrease in cash and cash equivalents
( 20,315,398 )
( 12,871,553 )
Cash and cash equivalents at beginning of the period
21,251,092
41,041,652
Cash and cash equivalents at end of the period
$ 935,694
$ 28,170,099
(*)
In
Addition, $ 125,000 was loaned to BC Therapeutics during the year ended July 31, 2023 and an additional $ 175,000 was loaned to BC
Therapeutics between August 1, 2023 and December 20, 2023. The total amount ($ 300,000 ) was converted into an investment.
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” and 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, 2023, filed with the SEC on October 25, 2023. 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. 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 April 30, 2024 was $ 84,229,532 and negative cash flows from operating activities
during the nine-month period ended April 30, 2024 was $ 20,090,398 . The Company is planning
to finance its operations from its existing and future working capital resources and to continue
to evaluate additional sources of capital and financing. 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 significant 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 9 for details of a $ 5.0 million offering that
was completed on May 17, 2024.
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 (Cont.)
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).
As of July 31, 2023, BriaPro was a wholly-owned subsidiary and one U.S subsidiary, as of
February 1, 2024, BC Therapeutics Inc, which was incorporated in September 12, 2022, under
the laws of the state of Delaware (see note 3)
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 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.
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.
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
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 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 consolidated financial statements,
and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.
b.
Equity method investments :
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 loss from equity method investments on the statements of loss
and comprehensive loss. Equity method investments are recorded at cost, plus the Company’s share of undistributed earnings or losses,
and impairment, if any, within interest in equity investees on the statements of financial position.
c.
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.
The Company is currently evaluating the impact of this standard on its financial statements and disclosures.
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 (Cont.)
2. In
July 2023, the FASB issued 2023-03 — Presentation of Financial Statements (Topic 205),
Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities
from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation
(Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120,
SEC Staff Announcement at the March 24, 2022, EITF Meeting, and Staff Accounting Bulletin
Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X: Income
or Loss Applicable to Common Stock (SEC Update). The adoption of this standard did not result
in amended disclosures in the Company’s Condensed Consolidated Financial Statements,
nor did this standard have a material impact the Company’s results of operations.
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 invested $ 300,000
at $ 1.25
per BC Therapeutics share for a 37.5 %
interest in the Investee. 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 expires on February 15, 2024 (“First BC Therapeutics Option”) and the second
option expires 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.
On February 1, 2024, the Company exercised the First BC Therapeutics Option
and currently holds 51.2% of BC Therapeutics. The value of the BC Therapeutics Options was updated to consider the effect of the exercise
of the First BC Therapeutics Option. Consequently, the fair value of the First BC Therapeutics Option, $35,964, has been reclassified
to the investment.
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:
Consulting
( 49,064 )
Legal and Professional Services
( 5,576 )
Dues & Subscriptions
( 621 )
Office Expenses
( 76 )
Bank Charges
( 5 )
Balance – April 30, 2024
$ 469,658
The
following amounts represent the Company’s 51.2 % share of the assets of BC Therapeutics:
SCHEDULE
OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As of
April 30, 2024
Current assets: Cash
$ 83,978
Net assets
$ 83,978
NOTE
4: CONTINGENT LIABILITIES AND COMMITMENTS
a. BriaPro
Warrants
As
detailed in note 1(f), upon the exercise of BriaCell Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount
of up to $ 241,164 .
b. Lease
The
Company is currently in a 12 -month commitment (ending August 31, 2024 ) for office and lab space in Philadelphia, PA, costing the company
approximately $ 36,000 per month.
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
5: FAIR VALUE MEASUREMENTS
The
following table presents information about our financial instruments that are measured at fair value on a recurring basis as of April
30, 2024, and July 31, 2023:
SCHEDULE
OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair Value Measurements at
April 30, 2024
July 31, 2023
Level 1
Level 2
Total
Level 1
Level 2
Total
Financial Assets:
Cash and cash equivalents
935,694
-
935,694
21,251,092
-
21,251,092
Total assets measured at fair value
$ 935,694
$ -
$ 935,694
$ 21,251,092
$ -
$ 21,251,092
Financial liabilities:
Warrants liability
3,546,096
2,132,409
5,678,505
9,742,023
19,397,278
29,139,301
Total liabilities measured at fair value
$ 3,546,096
$ 2,132,409
$ 5,678,505
$ 9,742,023
$ 19,397,278
$ 29,139,301
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
No
shares were issued during the nine-month period ended April 30, 2024.
c.
Share Purchase Warrants
SUMMARY OF CHANGES IN WARRANTS
(i) There
were no changes in share purchase warrants for the nine-month period ended April 30, 2024
as presented below:
Number of
Weighted
warrants
average exercise
outstanding
price
Balance, July 31, 2023 and April 30, 2024
8,121,650
$ 5.75
SCHEDULE
OF WARRANTS OUTSTANDING
(ii) As
of April 30, 2024, warrants outstanding were as follows:
Number of
Exercisable At
Warrants
Exercise Price(*)
April 30, 2024
Expiry Date
51,698
$ 3.91
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
8,121,650
8,121,650
(*) See note 4(a).
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
6: SHAREHOLDERS’ EQUITY (Cont.)
d.
Compensation Warrants
(i) There
were no changes to compensation warrants for the nine-month period ended April 30, 2024.
(ii) As
of April 30, 2024, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number of
Exercisable At
Warrants
Exercise Price(*)
April 30, 2024
Expiry Date
4,890
$ 3.91
4,890
November 16, 2025
17,074
$ 5.31
17,074
February 26, 2026
24,688
$ 6.19
24,688
June 7, 2026
46,652
46,652
(*)
See note 4(a).
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, 2023
$ 29,139,301
Fair value of BriaPro Warrant Shares at Effective Date
$ 199,207
Change in fair value during the period
$ ( 23,660,003 )
Balance as of April 30, 2024
$ 5,678,505
12
The
key inputs used in the valuation of the non-public warrants as of April 30, 2024 and at July 31, 2023 were as follows:
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.)
SCHEDULE
OF VALUATION OF WARRANTS
April
30, 2024
July
31, 2023
Share price
$ 2.17
$ 6.69
Exercise price
$ 5.31 - 6.19
$ 5.31 - 6.19
Expected life (years)
1.55 - 2.60
2.58 - 3.35
Volatility
69 - 74 %
100 %
Dividend yield
0 %
0 %
Risk free rate
4.34 - 5.05 %
4.51 %
The
key inputs used in the valuation of the of the BriaPro Warrant Shares as of April 30, 2024 were as follows:
SCHEDULE
OF VALUATION OF WARRANTS
August 31,
April 30,
2023
2024
(Effective Date)
Share price
$ 0.0365
$ 0.0365
Exercise price
$ 0.0206 - 0.0308
$ 0.0206 - 0.0308
Expected life (years)
1.55 - 2.60
2.21 - 3.27
Volatility
69 - 74 %
100 %
Dividend yield
0 %
0 %
Risk free rate
4.23 - 4.34 %
4.40 %
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, RSU,
and deferred share units (collectively, the “Awards”) for the benefit of any
employee, officer, director, or consultant of the Company or any subsidiary of the Company.
The maximum number of shares available for issuance under the Omnibus Plan shall not exceed
15 % of the issued and outstanding Shares, from time to time, less the number of Shares reserved
for issuance under all other security-based compensation arrangements of the Company, including
the existing Stock Option Plan. On February 9, 2023, the Omnibus Plan was approved by the
shareholders.
b. The
following table summarizes the number of options granted to directors, officers, employees,
and consultants under the option plan for nine-month period ended April 30, 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, 2023
2,131,400
$ 6.19
3.55
$ 1,065,700
Balance as of April 30, 2024
2,131,400
6.16
2.80
-
Exercisable as of April 30, 2024
1,881,013
$ 6.17
2.64
$ -
As
of April 30, 2024 there are $ 1,164,462 of total unrecognized costs related to share-based compensation that is expected to be recognized
over a period of up to 1 year.
13
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
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 April 30, 2024.
SUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding as
of
April 30,
2024
Options
exercisable as
of
April 30,
2024
Weighted
average
remaining
contractual
term (years)
Expiry Date
$ 6.03
440,000
220,000
4.14
June 20, 2028
$ 7.16
21,000
13,125
3.83
February 27, 2028
$ 6.10
180,100
157,588
3.26
August 02, 2027
$ 4.71
31,000
31,000
3.06
May 20, 2027
$ 7.51
150,000
150,000
2.79
February 16, 2027
$ 8.47
524,700
524,700
2.70
January 13, 2027
$ 7.22
12,600
12,600
2.50
November 01, 2026
$ 5.74
100,000
100,000
2.34
September 01, 2026
$ 4.24
60,000
60,000
1.97
April 19, 2026
$ 4.24
612,000
612,000
1.91
March 29, 2026
2,131,400
1,881,013
d. As
result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of
April 30, 2024:
SUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
Options outstanding as of
Options
exercisable as of
Price
April 30, 2024
April 30, 2024
Expiry Date
$ 0.0933
440,000
220,000
June 20, 2028
$ 0.1108
21,000
13,125
February 27, 2028
$ 0.0984
180,100
157,588
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
1,881,013
e. Restricted
Share Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of April 30, 2024:
SUMMARY
OF RESTRICTED STOCK UNITS GRANTED
Number of
RSU’s
Aggregate
outstanding
intrinsic value
Balance, July 31, 2023
19,200
$ 128,448
Balance, April 30, 2024
19,200
$ 41,664
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.)
f.
The total share-based compensation expense related to all of
the Company’s equity-based awards, recognized for the three and nine-month period ended
April
30, 2024 and 2023 is comprised as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSES
2024
2023
2024
2023
Three months ended April 30,
Nine months ended April 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Research and development expenses
$ 126,313
239,435
$ 618,375
814,782
General and administrative expenses
265,902
41,754
807,811
845,192
Total share-based compensation
$ 392,215
281,189
$ 1,426,186
1,659,974
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 and nine month period ending April 30, 2023 and for the nine months ended April 30, 2024, leading to the exclusion
of potentially dilutive ordinary shares. Conversely, for the three-month period ended April 30, 2024, the Company reported a gain. However, due to the specific
characteristics and terms of the outstanding warrants and options, they were not considered dilutive for this period and, therefore, no
adjustment was made to include them in the calculation of diluted net income per ordinary share.
SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE
Three months ended
April 30,
Nine months ended
April 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Basic EPS
Numerator:
Net income (loss)
$ 1,715,759
$ ( 4,895,436 )
$ ( 3,577,301 )
$ ( 17,883,739 )
Denominator:
Shares used in computation of basic earnings per share
15,981,726
15,518,072
15,981,726
15,518,036
Basic EPS
$ 0.11
$ ( 0.32 )
$ ( 0.22 )
$ ( 1.15 )
Diluted EPS
Numerator:
Net income (loss) attributable to common stock, basic
$ 1,715,759
$ ( 4,895,436 )
$ ( 3,577,301 )
$ ( 17,883,739 )
Net (loss) attributable to common stock, diluted
-
-
-
-
Denominator:
Shares used in computing net EPS of common stock, basic
15,981,726
15,518,072
15,981,726
15,518,036
Stock Options
-
-
-
-
Warrants
-
-
-
-
Shares used in computation of diluted earnings per share
15,981,726
15,518,072
15,981,726
15,518,036
Diluted EPS
$ 0.11
$ ( 0.32 )
$ ( 0.22 )
$ ( 1.15 )
NOTE
9: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE
OF FINANCIAL INCOME (EXPENSES), NET
2024
2023
2024
2023
Three months ended April 30,
Nine months ended April 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Interest income
$ 15,606
253,489
$ 288,016
682,437
Change in fair value of warrant liability
10,945,672
539,427
23,660,003
( 2,972,285 )
Foreign exchange gain (loss)
( 2,391 )
( 11,323 )
( 13,351 )
( 27,388 )
Financial income (expenses), net
$ 10,958,887
$ 781,593
$ 23,934,668
$ ( 2,317,236 )
NOTE
10: SUBSEQUENT EVENT
The
Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements
through June 14, 2024, 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:
On
May 17, 2024, the Company closed a registered direct offering with healthcare-focused institutional investors and a certain existing
investor and a director of the Company for the purchase and sale of 2,402,935 common shares of the Company (or pre-funded warrants in
lieu thereof) and warrants to purchase up to an aggregate of 2,402,935 common shares of the Company for aggregate gross proceeds of approximately
$ 5.0 million before deducting placement agent fees and other offering expenses (the “Offering”). Each common share (or pre-funded
warrant in lieu thereof) was sold together with one warrant to purchase one common share at a combined purchase price of $ 2.00 to the
institutional investors and $ 2.215 to the existing investor and director of the Company. The warrants have an exercise price of $ 2.11
per share, will become exercisable six months from the date of issuance and expire five years from the initial exercise date.
15
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, 2023 (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 2024 in comparison to the first half and
second 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
Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to
transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune
system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination
with an immune check point inhibitor.
(Retifanlimab)
in a pivotal 1 Phase 3 study in advanced metastatic breast cancer. Bria-IMT™ is currently under Fast Track Designation
by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of
the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination
in advanced metastatic breast cancer. BriaCell reported benchmark-beating patient survival and clinical benefit in advanced metastatic
breast cancer with median overall survival of 13.4 months in BriaCell’s advanced metastatic breast cancer patients vs. 6.7-9.8
months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at
the 2023 San Antonio Breast Cancer Symposium. A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody
manufactured by Incyte) confirmed tolerability and early-stage efficacy. BriaCell is also developing a personalized off-the-shelf immunotherapy,
Bria-OTS™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer,
and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.
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.
16
Recent
Developments
On
August 31, 2023, the Company closed the previously announced 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.
As
noted above, immediately following the closing of the Arrangement, the Company controlled 2/3rd of the BriaPro common shares representing
approximately 66.6% of the issued and outstanding common shares of BriaPro As a result of the Arrangement, there were approximately 47,945,178
BriaPro common shares issued and outstanding immediately following consummation of the Arrangement. The Corporation now beneficially
owns or controls approximately 31,963,452 BriaPro common shares, representing 2/3rd of the issued and outstanding BriaPro common shares.
On
October 3, 2023, BriaCell initiated its pivotal Phase 3 Study of Bria-IMT™ in advanced metastatic breast Cancer. The study will
evaluate the efficacy and safety of the Bria-IMT™ combination regimen with an immune check point inhibitor (Retifanlimab) in patients
who have failed at least two approved therapies for the disease. Bria-IMT™ is currently under Fast Track Designation by the U.S.
FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal
study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced
metastatic breast cancer. FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the
physician’s choice of treatment arm will be the primary endpoint of the study. The study will enroll 177 patients in the Bria-IMT™
combination therapy arm and 177 patients in the treatment of physician’s choice arm. To gather additional information on the Bria-IMT™
regimen alone, 50 patients will be enrolled in this regimen and will be eligible for combination therapy following their initial post
treatment evaluation. BriaCell expects frequent and responsive FDA communication under its Fast Track status during the pivotal Phase
3 study. The successful completion of the pivotal Phase 3 study would allow BriaCell to subsequently submit a Biologics License Application
and accelerate the path to commercialization.
On
May 17, 2024, the Company closed a registered direct offering with healthcare-focused institutional investors and a certain existing
investor and a director of the Company for the purchase and sale of 2,402,935 common shares of the Company (or pre-funded warrants in
lieu thereof) and warrants to purchase up to an aggregate of 2,402,935 common shares of the Company for aggregate gross proceeds of approximately
$5.0 million before deducting placement agent fees and other offering expenses (the “Offering”). Each common share (or pre-funded
warrant in lieu thereof) was sold together with one warrant to purchase one common share at a combined purchase price of $2.00 to the
institutional investors and $2.215 to the existing investor and director of the Company. The warrants have an exercise price of $2.11
per share, will become exercisable six months from the date of issuance and expire five years from the initial exercise date.
17
Results
of Operations for the Three Months Ended April 30, 2024 and 2023
Three months ended April 30,
2024
2023
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 7,657,632
$ 3,860,568
General and administrative expenses
1,572,016
1,816,461
Total operating expenses
9,229,648
5,677,029
Operating loss
(9,229,648 )
(5,677,029 )
Financial expenses, net
10,958,887
781,593
Share of loss on equity investments
(36,997 )
-
Net loss for the period
$ 1,692,242
$ (4,895,436 )
Net loss attributable to non-controlling interest
(23,517 )
-
Net loss for the period attributable to BriaCell
1,715,759
(4,895,436 )
Net loss per share attributable to BriaCell – basic and diluted
$ 0.11
$ (0.32 )
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.
The
following is a breakdown of our research and development costs by project:
Three months ended April 30,
2024
2023
Clinical trials
$ 4,663,049
$ 1,617,172
Pre-clinical projects
2,109,316
908,800
Chemical, Manufacturing and Control Costs (“CMC Costs”)
458,172
671,590
Other
427,095
667,006
$ 7,657,632
$ 3,860,568
Our
clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial. Clinical
trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e. a longer than expected overall survival).
Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the pivotal Phase
3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation for
the upcoming clinical studies of Bria-OTS™.
Pre-clinical
projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional
pre-clinical program (sCD80).
Other
costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
expenditure.
The
following is a breakdown of our research and development costs by nature of expenses:
Three months ended April 30,
2024
2023
Clinical trial sites and investigational drug costs
$ 6,165,072
$ 2,469,105
Wages and salaries
1,090,902
947,509
Laboratory Rent
109,500
49,440
Supplies
165,264
155,079
Professional fees
581
-
Share-based compensation
126,313
239,435
$ 7,657,632
$ 3,860,568
18
For
the three-month period ended April 30, 2024, total research costs amounted to $7,657,632 as compared to $3,860,568 for the three-month
period ended April 30, 2023. The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical
trials, specifically our Bria-IMT™ trial. Clinical trials and investigational drug costs increased from $2,469,105 in 2023 to $6,165,072
in 2024. Laboratory costs increase during 2024 as well, including the hiring of additional lab employees which increased from $947,509
in 2023 to $1,090,902 in 2024 and increased supplies from $155,079 in 2023 to $165,264 in 2024.
General
and Administrative Expenses
For
the three-month period ended April 30, 2024, general and administrative expenses amounted to $1,572,016 as compared to $1,816,461 for
the three-month period ended April 30, 2023. The decrease relates primarily to a lowering of shareholder communication expense, insurance
expenses, and professional fees.
Financial
income (expenses), net
For
the three-month period ended April 30, 2024, financial expense, net, amounted to $10,958,887 as compared to $781,593 for the three-month
period ended April 30, 2023. The large difference is due to the change in value of the Company’s warrant liability which amounted
to a gain of $10,945,672 in the three-month period ending April 30, 2024, and a gain of $539,427 in the three-month period ending April
30, 2023.
Loss
(profit) for the period
The
Company reported a profit for the three-month period ended April 30, 2024, of $1,692,242, as compared to a loss of $4,895,436 for the
three-month period ended April 30, 2023. The profit in 2024 is due to a significant decrease in fair value of the warrant liability.
Results
of Operations for the Nine Months Ended April 30, 2024 and 2023
Nine months ended April 30,
2024
2023
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 22,772,344
$ 10,169,140
General and administrative expenses
4,789,778
5,397,363
Total operating expenses
27,562,122
15,566,503
Operating loss
(27,562,122 )
(15,566,503 )
Financial expenses, net
23,934,668
(2,317,236 )
Share of loss on equity investments
(55,342 )
-
Net loss for the period
$ (3,682,796 )
(17,883,739 )
Net loss attributable to non-controlling interest
(105,495 )
-
Net loss for the period attributable to BriaCell
(3,577,301 )
(17,883,739 )
Net loss per share attributable to BriaCell – basic and diluted
$ (0.22 )
$ (1.15 )
Weighted average number of shares used in computing net basic earnings per share
of common stock
15,981,726
15,518,036
Weighted average number of shares used in computing net diluted earnings per share of common stock
15,981,726
15,518,036
19
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.
The
following is a breakdown of our research and development costs by project:
Nine months ended April 30,
2024
2023
Clinical trials
$ 12,650,189
$ 4,656,919
Pre-clinical projects
7,171,285
2,513,141
CMC Costs
1,425,481
1,416,198
Other
1,525,389
1,582,882
$ 22,772,344
$ 10,169,140
Our
clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial. Clinical
trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e. longer than expected overall survival).
Additionally, our costs increased significantly compared with those in the same period in 2023 for much higher set up costs for the pivotal
Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation
for the upcoming clinical studies of Bria-OTS™.
Pre-clinical
projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™.
Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additional
pre-clinical program (sCD80).
CMC
Costs include the manufacturing of Bria-IMT™ and Bria-OTS™. CMC Costs increased in 2024 to support the pivotal Phase 3 study,
and the upcoming clinical studies of Bria-OTS™.
Other
costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory
board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development
expenditure. Other costs increased in 2024 as we investigated additional potential pre-clinical projects.
The
following is a breakdown of our research and development costs by nature of expenses:
Nine months ended April 30,
2024
2023
Clinical trial sites and Investigational drug costs
$ 17,763,490
$ 5,799,621
Wages and salaries
3,513,306
2,946,494
Laboratory Rent
305,980
145,440
Supplies
566,830
455,504
Professional fees
4,363
7,299
Share-based compensation
618,375
814,782
$ 22,772,344
$ 10,169,140
For
the nine-month period ending April 30, 2024, research costs amounted to $22,772,344, a significant increase from the $10,169,140 incurred
during the same period in 2023. This upturn was primarily fueled by the expansion of the Company’s Phase 2 trial, and initiation
of the Phase 3 trial of the Bria-IMT™ regimen, and heightened costs associated with clinical trials and investigational drugs,
surging from $5,799,621 in 2023 to $17,763,490 in 2024. Concurrently, laboratory costs increased due to the recruitment of additional
employees, growing from $145,440 to $305,980. Notably, non-cash share-based compensation expenses decreased from $814,782 in 2023 to
$618,375 in 2024, mitigating some of the overall increase in research and development expenses.
General
and Administrative Expenses
For
the nine-month period ended April 30, 2024, general and administrative expenses amounted to $4,789,778 as compared to $5,397,363 for
the nine-month period ended April 30, 2023. This reduction is mainly attributed to a decrease in professional fees, which declined from
$1,230,220 in 2023 to $970,569 in 2024 and insurance expenses which declined from $1,241,716 in 2023 to $859,287 in 2024.
Financial
income (expenses), net
For
the nine-month period ending April 30, 2024, net financial income amounted to $23,934,668, a significant increase from the loss of $2,317,236
recorded in the same period of 2023. This substantial difference is primarily attributed to the change in the value of the Company’s
warrant liability, which is directly affected by the shortened life of the warrants and decrease in share price, resulting in a gain
of $23,660,003 for the nine-month period ended April 30, 2024, compared to a loss of $2,972,285 in the nine-month period ended April
30, 2023.
20
Loss
for the period
The
Company reported a loss for the period ended April 30, 2024, of $3,682,796 as compared to $17,883,739 for the period ended April 30,
2023. The reduced loss in 2024 was primarily due to a significant increase in operational spending, offset by a large gain resulting
from the decrease in the fair value of the warrant liability. In contrast, the larger loss in the prior period was primarily due to higher
operational spending and an increase in the value of the Company’s warrant liability.
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 April 30, 2024, the Company has total assets of $6,203,266 (July 31, 2023 - $27,163,577) and a negative working capital balance of
$1,227,767 (July 31, 2023 - positive $25,147,050). The Company had negative cash flows from operating activities during the nine-month
period ended April 30, 2024 of $20,090,398.
The
Company is planning to finance its research and developmental activities from its existing and future working capital resources and will
continue to evaluate additional sources of capital and financing. The uncertainty of the Company’s ability to raise such financial
capital casts significant doubt on the Company’s ability to continue as a going concern.
Liquidity
and Capital Resources
As
of April 30, 2024, the Company has a negative working capital of $1,227,767 (July 31, 2023 – positive $25,147,050) and an accumulated
deficit of $84,229,532 (July 31, 2023 - $80,652,231).
As
of April 30, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash on
deposit with banks, investments in money market funds, investments in U.S. government securities, U.S. 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, as of March
1, 2024, certain directors and officers have agreed to defer payment of their directors’ fees/compensation until further
notice. In addition, we are reducing expenditure on certain non-core activities whilst maintaining our focus on our Phase 3
Bria-IMT™ pivotal study in advanced metastatic breast cancer.
During
the nine-month period ended April 30, 2024, the Company’s overall position of cash and cash equivalents decreased by $20,315,398,
as compared to $12,871,553 for the nine-month period ended April 30, 2023. This decrease in cash can be attributed to the following:
The
Company’s net cash used in operating activities during the nine-month period ended April 30, 2024, was $20,090,398, as compared
to $12,825,853 for the nine-month period ended April 30, 2023.
Cash
used in investing activities for the nine-month period ended April 30, 2024, was $225,000 compared to nil for the nine-month period ended
April 30, 2023.
Cash
used in financing activities for the nine-month period ended April 30, 2024, was nil, as compared to $45,700 for the nine-month period
ended April 30, 2023.
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 nine-month period ended April 30, 2024.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
The
Company’s financial instruments consist of cash and cash equivalents, investments, 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 objective of the Board is to set policies that seek to reduce risk as far as possible without
unduly affecting the Company’s competitiveness and flexibility.
The
type of risk exposure and the way in which such exposure is managed is as follows:
Credit
Risk
The
Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration
with respect to financial instruments is remote.
Liquidity
Risk
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. As of April 30, 2024, the Company has total assets of $6,203,266 (July 31, 2023 - $27,163,577) and a negative working capital balance
of $1,227,767 (July 31, 2023 – positive $25,147,050).
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. The Company
does not believe it is exposed to material interest rate risk as it has no interest-bearing debt.
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 trade payable and cash. As of April 30, 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, 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 April 30, 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 April 30, 2024, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
23
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, 2023.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
There
were no unregistered sales of equity securities during the three months ended April 30, 2024
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.
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.
June
14, 2024
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
June
14, 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.