UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended January 31, 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 March 18, 2024, there were 15,981,726 common shares, no par value per share, of the Company issued and outstanding.
BRIACELL
THERAPEUTICS CORP.
Form
10-Q
Table
of Contents
Page
Part I. Financial Information
3
Item
1.
Financial Statements
3
Condensed Consolidated Balance Sheets as of January 31, 2024 (unaudited) and July 31, 2023 (unaudited)
3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months ended January 31, 2024
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Six Months ended January 31, 2024
5
Unaudited Condensed Consolidated Statement of Cash Flows for the Six Months ended January 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
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
January 31, 2024
July 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 6,244,528
$ 21,251,092
Amounts receivable
30,145
18,873
Prepaid expenses
5,467,286
5,678,542
Total current assets
11,741,959
26,948,507
NON-CURRENT ASSETS:
Investments
2
2
Equity investment in BC Therapeutics
281,655
-
Intangible assets, net
207,431
215,068
Total non-current assets
489,088
215,070
Total assets
$ 12,231,047
$ 27,163,577
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$ 3,711,455
$ 1,123,739
Accrued expenses and other payables
212,870
677,718
Total current liabilities
3,924,325
1,801,457
NON-CURRENT LIABILITIES:
Warrant liability
16,624,177
29,139,301
Total non-current liabilities
16,624,177
29,139,301
SHAREHOLDERS’ DEFICIT:
Share Capital of no par value - Authorized: unlimited at January 31, 2024 and July 31, 2023, Issued and outstanding: 15,981,726 shares January 31, 2024 and July 31, 2023, respectively
69,591,784
69,591,784
Share-based payment reserve
8,419,154
7,421,950
Accumulated other comprehensive loss
( 138,684 )
( 138,684 )
Non-controlling Interest
( 244,418 )
-
Accumulated deficit
( 85,945,291 )
( 80,652,231 )
Total shareholders’ deficit
( 8,317,455 )
( 3,777,181 )
Total liabilities and shareholders’ deficit
$ 12,231,047
$ 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 SIX MONTHS ENDED JANUARY 31, 2024
(Unaudited)
2024
2023
2024
2023
Three months ended
January 31,
Six months ended
January 31,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 8,257,455
$ 3,053,357
$ 15,114,712
$ 6,308,572
General and administrative expenses
1,571,991
1,432,966
3,217,762
3,580,902
Total operating expenses
9,829,446
4,486,323
18,332,474
9,889,474
Operating loss
( 9,829,446 )
( 4,486,323 )
( 18,332,474 )
( 9,889,474 )
Financial expenses, net
( 1,486,119 )
( 7,395,439 )
12,975,781
( 3,098,829 )
Share of loss on equity investment
( 18,345 )
-
( 18,345 )
-
Net loss for the period
$ ( 11,333,910 )
$ ( 11,881,762 )
$ ( 5,375,038 )
( 12,988,303 )
Net loss attributable to non-controlling interest
( 39,307 )
-
( 81,978 )
-
Net loss and Comprehensive loss for the period attributable
to BriaCell
( 11,294,603 )
( 11,881,762 )
( 5,293,060 )
( 12,988,303 )
Net loss per share attributable to BriaCell – basic and diluted
$ ( 0.71 )
$ ( 0.77 )
$ ( 0.33 )
$ ( 0.84 )
Weighted average number of shares used in computing net basic earnings per share of common stock
15,981,726
15,518,018
15,981,726
15,518,018
Weighted average number of shares used in computing net diluted earnings per share of common stock
15,981,726
15,518,018
15,981,726
15,518,018
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
FOR
THE THREE AND SIX MONTHS ENDED JANUARY 31, 2024
Number
Amount
capital
loss
deficit
interest
(deficit)
Share capital
Additional
paid in
Accumulated other
comprehensive
Accumulated
Non-
controlling
Total
shareholders’
equity
Number
Amount
capital
loss
deficit
interest
(deficit)
Balance, October 31, 2023
15,981,726
$ 69,591,784
$ 7,918,999
$ ( 138,684 )
$ ( 74,650,688 )
$ ( 205,111 )
$ 2,516,300
Issuance of options
-
-
500,155
-
-
-
500,155
Loss for the period
-
-
-
-
( 11,294,603 )
( 39,307 )
( 11,333,910 )
Balance, January 31, 2024
15,981,726
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Share capital
Additional
paid in
Accumulated other
comprehensive
Accumulated
Non-
controlling
Total
shareholders’
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
-
-
1,033,971
-
-
-
1,033,971
Loss for the period
-
-
-
-
( 5,293,060 )
( 81,978 )
( 5,375,038 )
Balance, January 31, 2024
15,981,726
$ 69,591,784
$ 8,419,154
$ ( 138,684 )
$ ( 85,945,291 )
$ ( 244,418 )
$ ( 8,317,455 )
Number
Amount
capital
loss
deficit
(deficit)
Share capital
Additional paid in
Accumulated other comprehensive
Accumulated
Total
shareholders’
equity
Number
Amount
capital
loss
deficit
(deficit)
Balance, October 31, 2022
15,518,018
$ 65,589,293
$ 6,340,101
$ ( 138,684 )
$ ( 61,456,378 )
$ 10,334,332
Issuance of options
-
-
266,844
-
-
266,844
Loss for the period
-
-
-
-
( 11,881,762 )
( 11,881,762 )
Balance, January 31, 2023
15,518,018
$ 65,589,293
$ 6,606,945
$ ( 138,684 )
$ ( 73,338,140 )
$ ( 1,280,586 )
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
Issuance of options
-
-
1,378,785
-
-
1,378,785
Loss for the period
-
-
-
-
( 12,988,303 )
( 12,988,303 )
Income (loss) for the period
-
-
-
-
( 12,988,303 )
( 12,988,303 )
Balance, January 31, 2023
15,518,018
$ 65,589,293
$ 6,606,945
$ ( 138,684 )
$ ( 73,338,140 )
$ ( 1,280,586 )
Balance
15,518,018
$ 65,589,293
$ 6,606,945
$ ( 138,684 )
$ ( 73,338,140 )
$ ( 1,280,586 )
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 SIX MONTHS ENDED JANUARY 31, 2024
(Unaudited)
2024
2023
Six months ended January 31,
2024
2023
Cash flow from operating activities
Net loss
$ ( 5,375,038 )
$ ( 12,988,303 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
7,637
7,635
Share-based compensation
1,033,971
1,378,785
Share of loss on equity investment
18,345
-
Change in fair value of warrants
( 12,714,331 )
3,511,712
Changes in assets and liabilities:
Increase in amounts receivable
( 11,272 )
15,175
Decrease in prepaid expenses
( 88,744 )
851,548
Increase in trade payable
2,587,716
119,171
Decrease in accrued expenses and other payables
( 464,848 )
( 389,845 )
Total cash flow from operating activities
( 15,006,564 )
( 7,494,122 )
Cash flows from investing activities
Equity Investment in BC Therapeutics ( * )
-
-
Total cash flow from investing activities
-
-
Cash flows from financing activities
Share and warrant buyback program
-
( 47,294 )
Total cash flow from financing activities
-
( 47,294 )
Decrease in cash and cash equivalents
( 15,006,564 )
( 7,541,416 )
Cash and cash equivalents at beginning of the period
21,251,092
41,041,652
Cash and cash equivalents at end of the period
$ 6,244,528
$ 33,500,236
(*) $ 125,000 of this amount 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
Therapeutics Corporation. (the “Company”), 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 and
is expected to start before end of 2023. 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 January 31, 2024 was $ 85,945,291 and negative cash flows from operating activities during the six-month period ended
January 31, 2024 was $ 15,006,564 . 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.
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. (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, was incorporated under the Business Corporations
Act (British Columbia). As of July 31, 2023, BriaPro was a wholly-owned subsidiary.
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 March 2022, the FASB issued ASU 2022-02 - Financial
Instruments—Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures. This standard eliminates the
accounting guidance on TDRs for creditors in ASC 310-40 and amends the guidance on “vintage disclosures” to require disclosure
of current period gross write-offs by year of origination. The ASU also updates the requirements related to accounting for credit losses
under ASC 326 and adds enhanced disclosures for creditors with respect to loan refinancings and restructurings for borrowers experiencing
financial difficulty. The amendments in this update are effective for fiscal years beginning after December 15, 2022, including interim
periods within those fiscal years, for any entities that have adopted ASU 2016-13 - Financial Instruments - Credit Losses (Topic
326): Measurement of Credit Losses on Financial Instruments. 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.
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, 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 and the second option expires on June
30, 2024 (“BC Therapeutics 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 %.
Subsequent
to January 31, 2024, the Company exercised the first option on February 1, 2024 and now holds 51 %
of BC Therapeutics.
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.
Changes
in the Company’s 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)
300,000
Share of losses:
Operating expenses
( 18,345 )
Balance – January 1, 2024
$ 281,655
The
following amounts represent the Company’s 37.5 % share of the assets and liabilities of BC Therapeutics:
SCHEDULE
OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As of
January 31, 2024
Current assets: Cash
$ 4,196
Net assets
$ 4,196
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 January
31, 2024, and July 31, 2023:
SCHEDULE
OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair Value Measurements at
January 31, 2024
July 31, 2023
Level 1
Level 2
Total
Level 1
Level 2
Total
Financial Assets:
Cash and cash equivalents
6,244,528
-
6,244,528
21,251,092
-
21,251,092
Total assets measured at fair value
$ 6,244,528
$ -
$ 6,244,528
$ 21,251,092
$ -
$ 21,251,092
Financial liabilities:
Warrants liability
6,936,320
9,687,857
16,624,177
9,742,023
19,397,278
29,139,301
Total liabilities measured at fair value
$ 6,936,320
$ 9,687,857
$ 16,624,177
$ 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 six-month period ended January 31, 2024.
c.
Share Purchase Warrants
SUMMARY OF CHANGES IN WARRANTS
(i)
There
were no changes in share purchase warrants for the six-month period ended January 31, 2024 as presented below:
Number of
warrants
outstanding
Weighted
average exercise
price
Balance, July 31, 2023 and January 31, 2024
8,121,650
$ 5.76
SCHEDULE
OF WARRANTS OUTSTANDING
(ii)
As
of January 31, 2024, warrants outstanding were as follows:
Number
of
Warrants
Exercise
Price(*)
Exercisable
At
January
31, 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 six-month period ended January 31, 2024.
(ii)
As
of January 31, 2024, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number of
Warrants
Exercise Price(*)
Exercisable At
January
31, 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
$ ( 12,714,331 )
Balance as of January 31, 2024
$ 16,624,177
The
key inputs used in the valuation of the non-public warrants as of January 31, 2024 and at July 31, 2023 were as follows:
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.)
SCHEDULE
OF VALUATION OF WARRANTS
January
31, 2024
July
31, 2023
Share
price
$ 4.12
$ 6.69
Exercise
price
$ 5.31 - 6.19
$ 5.31 - 6.19
Expected
life (years)
1.79 - 2.85
2.58 - 3.35
Volatility
100 %
100 %
Dividend
yield
0 %
0 %
Risk
free rate
3.99 - 4.21 %
4.51 %
The
key inputs used in the valuation of the of the BriaPro Warrant Shares as of January 31, 2024 were as follows:
SCHEDULE
OF VALUATION OF WARRANTS
January 31,
2024
August 31,
2023
(Effective Date)
Share
price
$ 0.0365
$
0.0365
Exercise
price
$ 0.0206 - 0.0308
$
0.0206 - 0.0308
Expected
life (years)
1.79 - 2.85
2.21 - 3.27
Volatility
100 %
100
%
Dividend
yield
0 %
0
%
Risk
free rate
3.99 - 4.00 %
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 six-month period ended January 31, 2023 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 January 31, 2024
2,131,400
6.18
3.05
-
Exercisable as of January 31, 2024
1,797,000
$ 6.19
2.83
$ -
As
of January 31, 2024 there are $ 1,556,676 of total unrecognized costs related to share-based compensation that is expected to be recognized
over a period of up to 1.25 years.
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 January
31, 2024.
SUMMARY
OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding as of
January 31, 2024
Weighted
average
remaining
contractual
term (years)
Options
exercisable as of
January 31, 2024
Weighted
average
remaining
contractual
term (years)
Expiry Date
$ 6.03
440,000
4.39
165,000
4.39
June 20, 2028
$ 7.16
21,000
4.08
10,500
4.08
February 27, 2028
$ 6.04
180,100
3.51
135,075
3.51
August 02, 2027
$ 4.71
31,000
3.31
27,125
3.31
May 20, 2027
$ 7.51
150,000
3.04
150,000
3.04
February 16, 2027
$ 8.47
524,700
2.95
524,700
2.95
January 13, 2027
$ 7.15
12,600
2.75
12,600
2.75
November 01, 2026
$ 5.74
100,000
2.59
100,000
2.59
September 01, 2026
$ 4.24
60,000
2.22
60,000
2.22
April 19, 2026
$ 4.24
612,000
2.16
612,000
2.16
March 29, 2026
2,131,400
1,797,000
d.
As
result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of January 31, 2024:
SCHEDULE
OF OPTION ISSUED AND OUTSTANDING
Exercise
Price
Options
outstanding as of January 31, 2024
Options
exercisable as of
January 31, 2024
Expiry Date
$ 0.0933
440,000
165,000
June 20, 2028
$ 0.1108
21,000
10,500
February 27, 2028
$ 0.0984
180,100
135,075
August 02, 2027
$ 0.0729
31,000
27,125
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
1,797,000
e.
Restricted
Share Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of January 31, 2024:
SUMMARY
OF RESTRICTED STOCK UNITS GRANTED
Number of
RSU’s
outstanding
Aggregate
intrinsic value
Balance, July 31, 2023
19,200
$ 123,072
Balance, January 31, 2024
19,200
$ 79,104
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 six-month
period ended January 31, 2024 and 2023 is comprised as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSES
2024
2023
2024
2023
Three months ended
January 31,
Six months ended
January 31,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Research and development expenses
$ 234,253
225,091
$ 492,062
575,347
General and administrative expenses
265,902
41,753
541,909
803,438
Total share-based compensation
$ 500,155
266,844
$ 1,033,971
1,378,785
NOTE
8: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE
OF FINANCIAL INCOME (EXPENSES), NET
2024
2023
2024
2023
Three months ended
January 31,
Six months ended
January 31,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
(Unaudited)
(Unaudited)
Interest income
$ 81,595
240,595
$ 272,410
428,948
Change in fair value of warrant liability
( 1,567,747 )
( 7,629,502 )
12,714,331
( 3,511,712 )
Foreign exchange gain (loss)
33
( 6,532 )
( 10,960 )
( 16,065 )
Financial income (expenses), net
$ ( 1,486,119 )
$ ( 7,395,439 )
$ 12,975,781
$ ( 3,098,829 )
NOTE
9: SUBSEQUENT EVENT
The
Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements
through March 18, 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:
a.
As disclosed in note 3, subsequent to January 31, 2024, on February 1, 2024 the Company exercised an option
to acquire an additional interest in BC Therapeutics and now owns 51 %.
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.
17
Results
of Operations for the Three Months Ended January 31, 2024 and 2023
Three months ended
January 31,
2024
2023
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 8,257,455
$ 3,053,357
General and administrative expenses
1,571,991
1,432,966
Total operating expenses
9,829,446
4,486,323
Operating loss
(9,829,446 )
(4,486,323 )
Financial expenses, net
(1,486,119 )
(7,395,439 )
Share of loss on equity investments
(18,345 )
-
Net loss for the period
$ (11,333,910 )
$ (11,881,762 )
Net loss attributable to non-controlling interest
(39,307 )
-
Net loss for the period attributable to BriaCell
(11,294,603 )
(11,881,762 )
Net loss per share attributable to BriaCell – basic and diluted
$ (0.71 )
$ (0.77 )
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 January 31,
2024
2023
Clinical trials
$ 4,359,850
$ 1,438,231
Pre-clinical projects
2,992,990
745,236
Chemical, Manufacturing and Control Costs (“CMC Costs”)
420,112
331,590
Other
484,503
538,300
$ 8,257,455
$ 3,053,357
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. 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:
Three months ended January 31,
2024
2023
Clinical trial sites and investigational drug costs
$ 6,200,980
$ 1,288,577
Wages and salaries
1,401,679
1,282,441
Laboratory Rent
108,000
48,000
Supplies
312,543
207,061
Professional fees
-
2,187
Share-based compensation
234,253
225,091
$ 8,257,455
$ 3,053,357
18
For
the three-month period ended January 31, 2024, total research costs amounted to $8,257,455 as compared to $3,053,357 for the three-month
period ended January 31, 2023. The 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 $1,288,577 in 2023 to $6,200,980
in 2024. Laboratory costs increase during 2024 as well, including the hiring of additional lab employees which increased from $1,282,441
in 2023 to $1,401,679 in 2024 and increased supplies from $207,061 in 2023 to $312,543 in 2024. Finally, the increase in share-based
compensation (non-cash) expenses, from $225,091 in 2023 to $234,253 in 2024 also contributed to the increase in research and development
expenses.
General
and Administrative Expenses
For
the three-month period ended January 31, 2024, general and administrative expenses amounted to $1,571,991 as compared to $1,432,966 for
the three-month period ended January 31, 2023. The increase relates primarily to shareholder communication expenses and in share-based compensation (non-cash) expense, offset by a decrease in insurance expenses and professional fees.
Financial
income (expenses), net
For
the three-month period ended January 31, 2024, financial expense, net, amounted to $1,486,119 as compared to $7,395,439 for the three-month
period ended January 31, 2023. The large difference is due to the change in value of the Company’s warrant liability which amounted
to a loss of $1,567,746 in the three-month period ending January 31, 2024, and a loss of $7,629,502 in the three-month period ending
January 31, 2023.
Loss
for the period
The
Company reported a loss for the three-month period ended January 31, 2024, of $11,294,603, as compared to a loss of $11,881,762 for the
three-month period ended January 31, 2023. The loss in 2024 is due to a significant increase in operational spending. The loss in the
prior period is primarily due to the large increase in fair value of the warrant liability.
Results
of Operations for the Six Months Ended January 31, 2024 and 2023
Six months ended
January 31,
2024
2023
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 15,114,712
$ 6,308,572
General and administrative expenses
3,217,762
3,580,902
Total operating expenses
18,332,474
9,889,474
Operating loss
(18,332,474 )
(9,889,474 )
Financial expenses, net
12,975,781
(3,098,829 )
Share of loss on equity investments
(18,345 )
-
Net loss for the period
$ (5,375,038 )
(12,988,303 )
Net loss attributable to non-controlling interest
(81,978 )
-
Net loss for the period attributable to BriaCell
(5,293,060 )
(12,988,303 )
Net loss per share attributable to BriaCell – basic and diluted
$ (0.33 )
$ (0.84 )
Weighted average number of shares used in computing net basic earnings per share of common stock
15,981,726
15,518,018
Weighted average number of shares used in computing net diluted earnings per share of common stock
15,981,726
15,518,018
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:
Six months ended January 31,
2024
2023
Clinical trials
$ 7,987,140
$ 3,041,327
Pre-clinical projects
5,061,969
1,608,402
CMC Costs
967,309
741,608
Other
1,098,294
917,235
$ 15,114,712
$ 6,308,572
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:
Six months ended January 31,
2024
2023
Clinical trial sites and Investigational drug costs
$ 11,598,418
$ 3,330,516
Wages and salaries
2,422,404
1,998,985
Laboratory Rent
196,480
96,000
Supplies
401,566
300,425
Professional fees
3,782
7,299
Share-based compensation
492,062
575,347
$ 15,114,712
$ 6,308,572
For
the six-month period ending January 31, 2024, research costs amounted to $15,114,712, a significant increase from the $6,308,572
incurred during the same period in 2023. This upturn was primarily fuelled by the expansion of the Company’s Phase 2 trial,
and initiation of the Phase 3 trial of the Bria-IMT™ regimen, and heightened costs associated with clinical trials and
investigational drugs, surging from $3,330,516 in 2023 to $11,598,418 in 2024. Concurrently, laboratory costs increased due to the
recruitment of additional employees, growing from $96,000 to $196,480. Notably, non-cash share-based compensation expenses decreased
from $575,347 in 2023 to $492,062 in 2024, mitigating some of the overall increase in research and development expenses.
General
and Administrative Expenses
For
the six-month period ended January 31, 2024, general and administrative expenses amounted to $3,217,762 as compared to $3,580,902 for
the six-month period ended January 31, 2023. This reduction is mainly attributed to a decrease in non-cash share-based compensation expenses,
which declined from $803,438 in 2023 to $541,909 in 2024 and insurance expenses which declined from $847,241 in 2023 to $583,997 in 2024.
Financial
income (expenses), net
For
the six-month period ending January 31, 2024, net financial income amounted to $12,975,781, a significant increase from the loss of $3,098,829
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 $12,714,331 for the six-month period ended January 31, 2024, compared to a loss of $3,511,712 in the six-month period ended January
31, 2023.
20
Loss
for the period
The
Company reported a loss for the period ended January 31, 2024, of $5,375,038, as compared to $12,988,303 for the period ended January
31, 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 January 31, 2024, the Company has total assets of $12,231,047 (July 31, 2023 - $27,163,577) and a positive working capital balance
of $7,817,634 (July 31, 2023 -$25,147,050). The Company had negative cash flows from operating activities during the
six-month period ended January 31, 2024 of $15,006,564.
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 January 31, 2024, the Company has working capital of $7,817,634 (July 31, 2023 - $25,147,050) and an accumulated deficit of $85,945,291
(July 31, 2023 - $80,652,231).
As
of January 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash
on deposit with banks, investments in money market funds, investments in U.S. 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.
During
the six-month period ended January 31, 2024, the Company’s overall position of cash and cash equivalents decreased by $15,006,563
from the six-month period ended January 31, 2023 (including effects of foreign exchange). This decrease in cash can be attributed to
the following:
The
Company’s net cash used in operating activities during the six-month period ended January 31, 2024, was $15,006,564, as compared
to $7,494,122 for the six-month period ended January 31, 2023.
Cash
used in financing activities for the six-month period ended January 31, 2024, was nil, as compared to $47,294 for the six-month period
ended January 31, 2023.
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 six-month period ended January 31, 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 objectives of the Board are to set policies that seek to reduce risk as far as possible without
unduly affecting the Company’s competitiveness and flexibility.
The
type of risk exposure and the way in which such exposure is managed is as follows:
Credit
Risk
The
Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration
with respect to financial instruments is remote.
Liquidity
Risk
The
Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come
due. As of January 31, 2024, the Company has total assets of $12,231,047 (July 31, 2023 - $27,163,577 ) and a positive working capital
balance of $7,817,634 (July 31, 2023 –$25,147,050).
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 January 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, and accrued expenses and other payables approximate
their fair values due to their short terms to maturity.
Cash
and cash equivalents are valued using quoted market prices in active markets. The fair value of the warrant liability is determined based
on the nature of the warrant. For publicly traded warrants we use the quoted market price and for all other warrants we use the Black-Scholes
pricing model.
Item
4. Controls and Procedures.
Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934 under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly
Report on Form 10-Q. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal accounting
and financial officer have concluded that as of January 31, 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 January 31, 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 January 31, 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.
March 18, 2024
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
March 18, 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.