UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended October 31, 2022
☐
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)
Delaware
47-1099599
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
235
15 th Street, Suite 300, West
Vancouver , BC , V7T
2X1
(Address
of Principal Executive Offices, including zip code)
604 - 921-1810
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of each exchange on which registered
Common
shares, no par value
BCTX
The
Nasdaq Stock Market LLC
Warrants
to purchase common shares, no par value
BCTXW
The
Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☐
Large accelerated filer
☐Accelerated
filer
☒
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ☒ No ☐
As
of December 14, 2022, there were 15,518,018 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 October 31, 2022 (unaudited) and July 31, 2022 (audited)
3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended October 31, 2022
4
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended October 31, 2022
5
Unaudited Condensed Consolidated Statement of Cash Flows for the three months ended October 31, 2022
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
23
Item
1.
Legal Proceedings
23
Item
1A.
Risk Factors
23
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
Part III. Signatures
26
2
PART
I-FINANCIAL
INFORMATION
Item
1. Financial Statements
BRIACELL
THERAPEUTICS CORP.
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
October 31, 2022
July 31, 2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 37,451,976
$ 41,041,652
Amounts receivable
29,698
24,103
Prepaid expenses
742,123
1,280,945
Total current assets
38,223,797
42,346,700
NON-CURRENT ASSETS:
Investments
2
2
Intangible assets, net
226,521
230,339
Total non-current assets
226,523
230,341
Total assets
$ 38,450,320
$ 42,577,041
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$ 791,748
$ 463,280
Accrued expenses and other payables
182,302
477,807
Total current liabilities
974,050
941,087
NON-CURRENT LIABILITIES:
Warrant liability
27,141,938
31,307,022
Total non-current liabilities
27,141,938
31,307,022
SHAREHOLDERS’ EQUITY:
Share Capital of no par value - Authorized: unlimited at October 31, 2022 and July 31, 2022, Issued and outstanding: 15,518,018 shares October 31, 2022 and July 31, 2022, respectively
65,589,293
65,589,293
Additional paid in capital
6,340,101
5,228,160
Accumulated other comprehensive loss
( 138,684 )
( 138,684 )
Accumulated deficit
( 61,456,378 )
( 60,349,837 )
Total shareholders’ equity
10,334,332
10,328,932
Total liabilities and shareholders’ equity
$ 38,450,320
$ 42,577,041
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three months ended
October 31,
2022
2021
Operating Expenses:
Research and development expenses
$ 3,255,215
$ 875,636
General and administrative expenses
2,147,936
1,409,173
Total operating expenses
5,403,151
2,284,809
Operating loss
( 5,403,151 )
( 2,284,809 )
Financial income (expenses), net
Interest income
188,353
6,305
Interest expense
-
( 979 )
Change in fair value of warrant liability
4,117,790
( 25,254,036 )
Foreign exchange gain
( 9,533
)
34
Total financial income (expenses), net
$ 4,296,610
$ ( 25,248,676 )
Net loss and comprehensive loss for the period
$ ( 1,106,541 )
$ ( 27,533,485 )
Net loss per share – basic and diluted
$ ( 0.07 )
$ ( 1.81 )
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
15,518,018
15,238,646
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)
FOR
THE THREE MONTHS ENDED OCTOBER 31, 2022
Share capital
Additional paid in
Accumulated other comprehensive
Accumulated
Total
shareholders’
Number
Amount
capital
loss
deficit
Equity
Balance, July 31, 2022
15,518,018
$ 65,589,293
$ 5,228,160
$ ( 138,684 )
$ ( 60,349,837 )
$ 10,328,932
Share based compensation
-
-
1,111,941
-
-
1,111,941
Loss for the period
-
-
-
-
( 1,106,541 )
( 1,106,541 )
Balance, October 31, 2022
15,518,018
$ 65,589,293
$ 6,340,101
$ ( 138,684 )
$ ( 61,456,378 )
$ 10,334,332
Share capital
Additional paid in
Accumulated other comprehensive
Accumulated
Total
shareholders’
Number
Amount
capital
loss
deficit
Equity
Balance, July 31, 2021
15,269,583
$ 54,774,172
$ 2,178,130
$ ( 138,684 )
$ ( 29,141,897 )
$ 27,671,721
Exercise of warrants
100,829
927,407
-
-
-
927,407
Issuance of options
-
-
518,134
-
-
518,134
Loss for the period
-
-
-
-
( 27,533,485 )
( 27,533,485 )
Balance, October 31, 2021
15,370,412
$ 55,701,579
$ 2,696,264
$ ( 138,684 )
$ ( 56,675,382 )
$ 1,583,777
5
BRIACELL
THERAPEUTICS CORP.
CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
Three months ended October 31,
2022
2021
Cash flow from operating activities
Net loss
$ ( 1,106,541 )
$ ( 27,533,485 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
3,818
3,817
Share-based compensation
1,111,941
518,134
Interest expense
-
979
Change in fair value of warrants
( 4,117,790 )
25,254,036
Changes in assets and liabilities:
Increase in amounts receivable
( 5,595 )
( 6,755 )
Decrease in prepaid expenses
538,822
110,105
Increase in accounts payable
328,468
29,334
Decrease in accrued expenses and other payables
( 295,505 )
( 154,763 )
Total cash flow from operating activities
( 3,542,382 )
( 1,778,599 )
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
( 3,589,676 )
( 1,778,599 )
Cash and cash equivalents at beginning of the period
41,041,652
57,268,685
Cash and cash equivalents at end of the period
$ 37,451,976
$ 55,490,086
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
BRIACELL
THERAPEUTICS CORP.
Notes
to financial statements
NOTE 1: GENERAL
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. BriaCell owns the US patent to Bria-IMT™, a whole-cell cancer vaccine (US Patent
No.7674456) (the “Patent”). The Company is currently advancing its immunotherapy program, Bria-IMT™, to complete
a 24-subject Phase I/IIa clinical trial and by research activities in the context of BriaDx™, a companion diagnostic test to
identify patients likely benefitting from Bria-IMT™.
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 10 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 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, 2022 filed with the SEC on October 28 ,
2022. 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.
Prior
to 2021, the Company prepared its financial statements, including its condensed financial statements, in accordance with International
Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board (IASB), as permitted in the United States
based on the Company’s qualification as a “foreign private issuer” under the rules and regulations of the SEC. In connection
with the loss of the Company’s status as a foreign private issuer effective on August 1, 2022, the Company, as a domestic filer,
prepares its consolidated financial statements in accordance with U.S. GAAP, and restated its condensed consolidated financial statements
as of October 31, 2021 to be prepared in accordance with U.S. GAAP.
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 October 31, 2022 was $ 61,456,378 and negative cash flows from operating activities during the three-month period ended
October 31, 2022 was $ 3,542,382 . 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 believes that its existing capital resources
will be adequate to satisfy its expected liquidity requirements for at least twelve months from the issuance of the condensed consolidated
financial statements.
e.
The
Company has a wholly-owned U.S. subsidiary, BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April 3, 2014,
under the laws of the state of Delaware. BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”
and together with BTC the “Subsidiaries”), which was incorporated in September 20, 2012, under the laws of the state
of Delaware. The Company has one operating segment and reporting unit.
f.
Since
January 2020, the Coronavirus outbreak has dramatically expanded into a worldwide pandemic creating macro-economic uncertainty and
disruption in the business and financial markets. Many countries around the world, including Canada and the United States have been
taking measures designated to limit the continued spread of the Coronavirus, including the closure of workplaces, restricting travel,
prohibiting assembling, closing international borders and quarantining populated areas. Such measures present concerns that may dramatically
affect the Company’s ability to conduct its business effectively.
The
Company may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected
by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak of COVID-19. In the event
that clinical trial sites are slowed down or closed to enrolment in our trials, this could have a material adverse impact on our
clinical trial plans and timelines. The Company is continuing to assess its business plans and the impact COVID-19 is having on the
Company’s clinical trial timelines and the Company’s ability to recruit candidates for clinical trials. The extent to
which COVID-19 and global efforts to contain its spread will impact our operations will depend on future developments, which are
highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the outbreak and the actions
taken to contain or treat the coronavirus outbreak. The Company currently believes that the execution of our clinical trials and
research programs are delayed by at least one quarter due to COVID-19.
7
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES
a. Use of estimates :
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that
affect the amounts reported in the 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. 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
June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments—Credit Losses: Measurement of Credit Losses on
Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires
a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The guidance will be effective
for the Company for fiscal years beginning after December 15, 2022. Early adoption is permitted. Effective
August 1, 2021, the Company early adopted ASU 2016-13. Adoption of the new standard did not have a material impact on the financial
statements.
2.
In
August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
- Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s
Own Equity (“ASU 2020-06”). The final guidance issued by the FASB for convertible instruments eliminates two of the three
models in ASC 470-20 that require separate accounting for embedded conversion features. Separate accounting is still required in
certain cases. Additionally, among other changes, the guidance eliminates some of the conditions for equity classification in ASC
815-40-25 for contracts in an entity’s own equity. The guidance also requires entities to use the if-converted method for all
convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments
that may be settled in cash or shares, except for certain liability-classified share-based payment awards. ASU 2020-06 is effective
for the company for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption
is permitted for fiscal years beginning after December 15, 2020. Effective August 1, 2021,
the Company early adopted ASU 2020-06. Adoption of the new standard did not have a material impact on the financial statements.
3.
In
November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosure by Business Entities about Government
Assistance (ASU 2021-10), which improves the transparency of government assistance received by most business entities by requiring
the disclosure of: (1) the types of government assistance received; (2) the accounting for such assistance; and (3) the effect of
the assistance on a business entity’s financial statements. This guidance is effective for financial statements issued for
annual periods beginning after 15 December 2021. Early adoption is permitted. Adoption of the
new standard did not have a material impact on the financial statements.
8
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 3: CONTINGENT LIABILITIES AND COMMITMENTS
a.
Legal
proceedings:
On
May 19, 2021, Alpha Capital Anstalt (“Alpha”) filed a lawsuit in the New York State Supreme Court, Commercial Division, New
York County against BriaCell Therapeutics Corp. (“BriaCell”), alleging that BriaCell breached a loan contract when it refused
to reprice and extend the term of warrants purported held by Alpha in spring 2021, seeking monetary and injunctive relief for delivery
of those amended warrants. Counterclaiming and defending against Alpha’s complaint, BriaCell alleges that Alpha’s loan to
BriaCell is unenforceable both because the loan is criminally usurious under New York law and because Alpha acted as an unregistered
securities dealer in violation of American securities law. BriaCell also has alleged that Canadian securities law, regulation, and rules
prohibited it from amending the warrants to comply with Alpha’s spring 2021 demands. On May 11, 2022, Alpha moved to dismiss BriaCell’s
operative Amended Counterclaim. The parties have fully briefed that motion, and the Court has calendared oral argument on that motion
for February 7, 2023. Expert discovery is ongoing and may affect the value of the parties’ respective claims and damages.
The
Company disagrees with Alpha’s claims, is defending these claims, and has filed a counter claim. At this time, whilst it is impossible
to provide any guarantee as to the outcome of the lawsuit, it is the Company’s assessment, based on advice from the Company’s
legal counsel at this time, and based on the information known by the Company, that it’s more likely than not that BriaCell will
not have to pay Alpha in the litigation.
b.
Lease
The
Company is currently on a month-to-month lease arrangement for office and lab space in Philadelphia, PA, in the amount of approximately
$ 16,000 per month.
NOTE 4: FAIR VALUE MEASUREMENTS
The
following table presents information about our financial instruments that are measured at fair value on a recurring basis as of October
31, 2022 and July 31, 2022:
SCHEDULE
OF FAIR VALUE ON A RECURRING BASIS
Fair Value Measurements at
October 31, 2022
July 31, 2022
Level 1
Level 2
Total
Level 1
Level 2
Total
Financial Assets:
Cash and cash equivalents
37,451,976
-
37,451,976
41,041,652
-
41,041,652
Total assets measured at fair value
$ 37,451,976
$ -
$ 37,451,976
$ 41,041,652
$ -
$ 41,041,652
Financial liabilities:
Warrants liability
10,794,992
16,346,946
27,141,938
11,151,608
20,155,414
31,307,022
Total liabilities measured at fair value
$ 10,794,992
$ 16,346,946
$ 27,141,938
$ 11,151,608
$ 20,155,414
$ 31,307,022
We
classify our cash and cash equivalents and the liability in respect of publicly traded warrants within Level 1 because we use quoted
market prices in active markets.
The
fair value of the warrant liability for non-public warrants is measured using inputs other than quoted prices included in Level 1 that
are observable for the liability either directly or indirectly, and thus are classified as Level 2 financial instruments.
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 5: SHAREHOLDERS’ EQUITY
f. 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 three-month period ended October 31, 2022.
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:
SHAREHOLDERS’
EQUITY (Cont.)
c.
Share buyback program
On
September 9, 2021 the Company approved a repurchase program whereby the Company may purchase through the facilities of the TSX Venture
or NASDAQ (i) up to 1,341,515 common shares (the “Common Shares”) and (ii) up to 411,962 publicly traded BCTXW warrants (the
“Listed Warrants”) in total, representing 10 % of the 13,415,154 Common Shares and 10 % of the 4,119,622 Listed Warrants comprising
the “public float” as of September 8, 2021, over the next 12 months (the “Buyback”). Independent Trading Group
(ITG) Inc. will act as the Company’s advisor and dealer manager in respect of the Buyback. The Company received final regulatory
approval on September 22, 2021. On September 27, 2022 the Company completed the share buyback program, repurchasing a total of 1,031,672
shares with a value of $ 9,098,014 (net of commissions), none of which were repurchased during the three month period ended October 31,2022,
and 259,059 publicly traded warrants for $ 1,121,011 (net of commissions) with a fair value of $ 1,130,808 of which 15,736 were repurchased
and cancelled during the three-month period ended October 31,2022. All of the warrants and shares repurchased have been cancelled.
d.
Share Purchase Warrants
A
summary of changes in share purchase warrants for the three-month period ended October 31, 2022 is presented below:
SUMMARY
OF CHANGES IN WARRANTS
Number of
warrants
outstanding
Weighted
average exercise
price
Balance, July 31, 2022
8,137,686
$ 5.76
Repurchased and cancelled
( 15,736 )
( 5.31 )
Balance, October 31, 2022
8,121,950
5.76
11
BriaCell
Therapeutics Corp
Notes
to the Condensed Consolidated Financial Statements
(Unaudited,
expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE
5:
SHAREHOLDERS’
EQUITY (Cont.)
d.
Share Purchase Warrants (continued)
As
of October 31, 2022, warrants outstanding were as follows:
SCHEDULE
OF WARRANTS OUTSTANDING
Number of
Warrants
Exercise Price
Exercisable
At
October 31, 2022
Expiry Date
51,698
$ 3.97
51,698
November 16, 2025
3,897,109
$ 5.31
3,897,109
February 26, 2026 – April 26, 2026
4,173,143
$ 6.19
4,173,143
December 7, 2026
8,121,950
8,121,950
e.
Compensation Warrants
(i) There
were no changes to compensation warrants for the three-month period ended October 31, 2022.
(ii) As
at October 31, 2022, compensation warrants outstanding were as follows:
SCHEDULE OF WARRANTS OUTSTANDING
Number of
Warrants
Exercise Price
Exercisable At
October 31, 2022
Expiry Date
4,890
$ 3.97
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
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
5:
SHAREHOLDERS’
EQUITY (Cont.)
f.
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, 2022
$ 31,307,022
Warrant buyback program
$ ( 47,294 )
Change in fair value during the period
$ ( 4,117,790 )
Balance as of October 31, 2022
$ 27,141,938
The
key inputs used in the valuation of the non-public warrants as of October 31, 2022 and at July 31, 2022 were as follows:
SCHEDULE
OF VALUATION OF NON PUBLIC WARRANTS
October 31, 2022
July 31, 2022
Share price
$ 5.50
$ 6.50
Exercise price
$ 3.97 - 6.19
$ 4.23 - 6.19
Expected life (years)
3.32 - 4.10
3.58 - 4.35
Volatility
100 %
100 %
Dividend yield
0 %
0 %
Risk free rate
4.23 %
2.68 %
NOTE 6: SHARE-BASED COMPENSATION
a. On
August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan),
which will permit the Company to grant incentive stock options, preferred share units, restricted
share units (“RSU’s”), and deferred share units (collectively, the “Awards”)
for the benefit of any employee, officer, director, or consultant of the Company or any subsidiary
of the Company. The maximum number of Shares available for issuance under the Omnibus Plan
shall not exceed 15 % of the issued and outstanding Shares, from time to time, less the number
of Shares reserved for issuance under all other security-based compensation arrangements
of the Company, including the existing Stock Option Plan. The Omnibus Plan remains subject
to approval by the shareholders of the Company (the “Shareholders”) and final
approval of the Toronto Stock Exchange (“Exchange”) and no new grants will be
made under the Company’s existing Stock Option Plan upon receipt of such approvals
(“Approvals”).
The
Company may make grants under the Omnibus Plan, however, the grants cannot be settled until the Approvals have been received.
b.
The
following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan
for three-month period ended October 31, 2022 and related information:
SCHEDULE
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, 2022
1,490,300
$ 6.20
3.84
$ 447,090
Granted (i)
180,100
6.14
4.76
-
Balance as of October 31, 2022
1,670,400
6.19
3.94
-
Exercisable as of October 31, 2022
1,373,053
$ 6.10
3.81
$ -
(i) On
August 2, 2022, the Company granted 180,100 options, under the Stock Option Plan, to directors,
officers and employees with an exercise price of CAD$ 8.38 . The options vest quarterly in
advance over a two -year period and expire on August 2, 2027 . The fair value of the 180,100
stock options issued was $ 887,362 . 142,100 of the options were issued to officers of the
Company. The fair value of the stock options issued to the officers was $ 700,134 .
The
weighted-average grant date per-share fair value of stock options granted during three-month period ended October 31, 2022 was $ 4.93 .
As of October 31, 2022, there are $ 1,536,722 of total unrecognized costs related to share-based compensation that is expected to be recognized
over a period of up to 1.75 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
6:
SHARE-BASED
COMPENSATION (Cont.)
c.
The
following table lists the inputs to the Black-Scholes option-pricing model used for the fair value measurement of equity-settled
share options for the above options plans for the three month period ended October 31, 2022 and 2021:
SCHEDULE
OF FAIR VALUE MEASUREMENT OF EQUITY-SETTLED SHARE OPTIONS
Three months ended
October 31,
2022
2021
Dividend yield
0 %
0 %
Expected volatility of the share prices
100 %
100 %
Risk-free interest rate
4.23 %
0.80 %
Expected term (in years)
5
5
d.
The
following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of October
31, 2022.
SCHEDULE
OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise
price
Options
outstanding
as of
October 31,
2022
Weighted
average
remaining
contractual
term
(years)
Options
exercisable
as of
October 31,
2022
Weighted
average
remaining
contractual
term
(years)
Expiry Date
$ 6.14
180,100
4.76
22,513
4.76
August 02, 2027
$ 4.71
31,000
4.56
7,750
4.56
May 20, 2027
$ 7.51
150,000
4.29
56,250
4.29
February 16, 2027
$ 8.47
524,700
4.20
503,500
4.20
January 13, 2027
$ 7.74
12,600
4.00
11,040
4.00
November 01, 2027
$ 5.74
100,000
3.84
100,000
3.84
September 01, 2026
$ 4.24
60,000
3.47
60,000
3.47
April 19, 2026
$ 4.24
612,000
3.41
612,000
3.41
March 29, 2026
1,670,400
1,373,053
e. Restricted Share
Unit Plan
The
following table summarizes the number of RSU’s granted to directors under the Omnibus plan for three-month period ended October
31, 2022:
SCHEDULE
OF RESTRICTED STOCK UNITS GRANTED
Number
of
RSU’s
outstanding
Aggregate
intrinsic value
Balance, July 31, 2022
-
$ -
Granted (i)
19,200
123,072
Balance, October 31, 2022
19,200
$ 105,600
(i) On
August 2, 2022, the Company issued 19,200 RSU’s to the CEO. The RSU’s vested
immediately.
f. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three-month period ended October 31, 2022 and 2021 is comprised as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSES
Three months ended
October 31,
2022
2021
Research and development expenses
$ 350,256
-
General and administrative expenses
761,685
518,134
Total share-based compensation
$ 1,111,941
518,134
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: 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 experienced
a loss in three-month period ended October 31, 2022 and 2021; hence all potentially dilutive ordinary shares were excluded due to their
anti-dilutive effect.
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
Three months ended
October 31,
2022
2021
Numerator:
Net loss available to shareholders of ordinary shares
$ ( 1,106,541 )
$ ( 27,533,485 )
Denominator:
Shares used in computing net loss per ordinary shares, basic and diluted
15,518,018
15,238,646
Net loss per share attributable
to ordinary shareholders, basic and diluted
$ ( 0.07 )
$ ( 1.81 )
NOTE 8: SUBSEQUENT EVENTS
The
Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements
through December 14, 2022, the date that the 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.
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, 2022 (the “Annual Report”) and Part I, Item 1A, Risk Factors, of the Annual
Report. This MD&A provides additional information on our business, recent developments, financial condition, cash flows and results
of operations, and is organized as follows:
●
Part
1 - Business Overview. This section provides a general description of our business, which we believe is important in understanding
the results of our operations, financial condition, and potential future trends.
●
Part
2 - Results of Operations. This section provides an analysis of our results of operations for the first quarter of fiscal 2023
in comparison to the first quarter of fiscal 2022.
●
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.
16
Overview
BriaCell
(the “ Company ”) is an immuno-oncology biotechnology company with a strong focus on cancer immunotherapy. Immunotherapies
have come to the forefront in the fight against cancer since they harness the body’s own immune system to recognize and destroy
cancer cells. BriaCell owns the U.S. patent to SV-BR-1-GM (“ Bria-IMT™ ”), a whole-cell targeted immunotherapy
for cancer (U.S. Patent No. 7,674,456), as well as patents related to PKCδ inhibitors (U.S. Patent Nos. 9,364,460 and 9,572,793).
The Company is currently advancing our targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™
in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™, to identify patients most likely to
benefit from Bria-IMT™. The Bria-IMT™ regimen was evaluated in four patients in a prior study in 2004-2006 by Dr. Charles
Wiseman, the scientific founder, former member of the board of directors of the Company (the “ Board ”) and principal
scientific advisor. Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at HLA-DR alleles and had
a grade II tumor. In 2017-2018 BriaCell evaluated 23 patients with advanced breast cancer with the Bria-IMT™ regimen and obtained
confirmation of the ability of the Bria-IMT™ regimen to induce regression of metastatic breast cancer in patients who match Bria-IMT™
at least at one HLA allele and/or if they had grade I or grade II tumors. A combination study with the immune checkpoint inhibitor pembrolizumab
(KEYTRUDA®) was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September
2018. BriaCell purchased the KEYTRUDA® for this study as BriaCell does not have an agreement with Merck & Co., Inc. for the supply
of KEYTRUDA®. Eleven patients were dosed in the combination therapy trial with Bria-IMT™ and the immune checkpoint inhibitor
KEYTRUDA® and subsequently dosing with this combination was discontinued. The study was modified under an amended protocol which
evaluates the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs retifanlimab (anti-PD-1 antibody
similar to pembrolizumab). The study is ongoing.
It
is estimated by the National Cancer Institute that in 2022, approximately 287,500 women will be diagnosed with breast cancer in the United
States. That means that every two minutes an American woman is diagnosed with breast cancer and more than 43,000 are projected to die
in 2022. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of
men getting breast cancer is about 1 in 1,000, and the American Cancer Society estimates that approximately 2,710 new cases of invasive
male breast cancer will be diagnosed and approximately 530 men will die from breast cancer in 2022.
According
to the May 2019 “Global Oncology Trends 2021” report by the IQVIA Institute, the global market for cancer drugs (including
immunotherapy drugs) is expected to reach nearly $269 billion by the end of 2025, growing at a compound annual growth rate (“ CAGR ”)
of 10% between 2021 and 2025, of which about 20% is expected to be immuno-oncology drugs.
About
12.9% percent of women will be diagnosed with breast cancer at some point during their lifetime. In 2018, there were an estimated 3,676,262
women living with female breast cancer in the United States. Approximately 81% of cases present as invasive breast cancer. Approximately
6% of new breast cancer diagnoses are Stage IV (metastatic breast cancer (“ MBC ”), which has already spread to other
organs). Twenty to thirty percent of all women diagnosed with breast cancer will develop MBC. Breast cancer can be subdivided based on
receptor status - the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors (HR),
and the Her2/neu growth factor receptor (HER2). Based on the latest SEER statistics, 74.6% were found to be HR+/HER2−, 10.8% were
triple-negative (HR−/HER2−), 10.5% were HR+/HER2+, and 4.0% were HR−/HER2+. 1
It
is estimated that over 150,000 women in the US are living with MBC. For those with metastatic disease at diagnosis, their 5-year survival
rate is 27%. For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e. a
disease-free interval of more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but
if their disease-free interval is less than 24 months, their prognosis is worse. 4 We currently propose that Bria-IMT’s™
indication will be for the treatment of patients with MBC who have failed at least two lines of therapy. Similarly, another study showed
that the median overall survival among patients with de novo stage IV MBC was 39.2 months, while for patients with relapsed disease it
was 27.2 months. Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent
lines of therapy. One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line
therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.
17
Recent
Developments
On
August 4, 2022, the Company announced that it has secured an exclusive license from University of Maryland, Baltimore County (UMBC) to
develop and commercialize Soluble CD80 (sCD80) as a biologic agent for the treatment of cancer.
The
novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s
scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and
covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped tumor
growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al. and Samuel T Haile et al. in collaboration with
Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn,
et al.). Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune
system to recognize and destroy tumor cells.
Under
the terms of the agreement, BriaCell gains the worldwide rights to develop and commercialize sCD80, while UMBC maintains ownership of
the patents. BriaCell will pay royalties to UMBC upon the commercialization of the product plus patent management costs. The licensing
agreement was coordinated by UMBC’s Office of Technology Development.
On
September 7, 2022, the Company announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting,
held November 10-12, 2022, in Boston, MA.
The
Company’s data showed clinical benefit including extended survival time and tumor reductions in heavily pre-treated advanced breast
cancer patients who matched our lead candidate, Bria-IMT™, at HLA type/s, and these findings guided the development of further
optimized off-the-shelf personalized immunotherapies for advanced breast cancer and other cancers.
On
September 14, 2022, the Company announced that it has signed an agreement with Caris Life Sciences® (Caris), a leading molecular
science and technology company actively developing and delivering innovative solutions to revolutionize healthcare.
The
goal is to develop immunotherapies that are personalized for each patient, and Caris’ extensive library of clinical data, cutting-edge
biomarker technology, and expertise will be invaluable in achieving our objectives,” The Company expects Caris’
unique platform to help us identify patients who do not respond to existing treatments and are more likely to benefit from the Company’s
immunotherapy treatments.
Under
the terms of the agreement, Caris will help BriaCell with efficient patient identification, accelerating enrollment for its current Phase
I/II clinical trial in advanced metastatic breast cancer of certain genetically defined subgroups. The partnership between BriaCell and
Caris leverages Caris’ Right-In-Time (RIT) Clinical Trial Network, a group of over 495 oncology sites that are able to quickly
identify and enroll eligible patients in biomarker-directed clinical trials. This service offers patients and physicians access to the
most cutting-edge precision medicine in development. Additionally, through Caris’ comprehensive molecular profiling (Whole Exome
and Whole Transcriptome Sequencing), Caris will perform tumor profiling for the patients enrolled in the clinical trial.
On
October 12, 2022 the Company announced that it added Mayo Clinic, Jacksonville, Florida as a clinical site in the Phase I/II study of
BriaCell’s lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab, in advanced breast cancer.
On
November 10, 2022, the Company announced positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients.
Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study
of Bria-IMT™ in combination with Incyte’s retifanlimab.
● Bria-IMT™
regimen in combination with Incyte’s retifanlimab produced evidence of disease control,
tumor shrinkage, and potential survival benefit amongst BriaCell’s recent 12 patient
cohort in advanced breast cancer.
● The
regimen remains well tolerated as recently reported in Phase I evaluation.
18
● 70%
of patients showed either disease control or progression-free survival (PFS) benefits compared
with their last therapy.
● Prior
to enrollment, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated
with at least 2 prior therapy regimens, further underscoring BriaCell’s positive patient
outcomes.
This
information was summarized in BriaCell’s poster session at the Society for Immunotherapy of Cancer (SITC) 37 th Annual
Meeting, held November 10-12, 2022, in Boston, Massachusetts. The poster session highlights BriaCell’s novel off-the-shelf personalized
cellular therapy approach to immunotherapy treatment.
Title:
An off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors.
Abstract Number: 257
Location: Omni Boston Hotel, 450 Summer Street, Boston, Massachusetts 02210, Poster Hall, Hall C
Date and Time: November 10, 2022, 9:00 am – 9:00 pm
Bria-IMT™
regimen combined with Incyte’s retifanlimab
Seventy
percent of evaluable patients participating in the Phase I/IIa clinical study showed either disease control or progression-free survival
(PFS) benefits compared with their last therapy regimen. Disease control rate (DCR) of 57% (4/7) was observed in evaluable patients,
measured as the percentage of patients who have achieved certain clinical end points (i.e. complete response, partial response and stable
disease). DCR is used in cancer clinical trials to measure the clinical effectiveness of a treatment. PFS is the time period during which
a patient’s cancer does not get worse, commonly used as a key survival and efficacy measurement compared to the PFS values of their
previous therapy regimen.
Prior
to enrollment in the study, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated or were in the terminal
stage of breast cancer, further underscoring the uniquely positive outcome BriaCell’s treatment has achieved. The 12 patients had
each failed at least 2 prior systemic therapy regimens (including chemotherapy, biological and “targeted” therapy).
Disease
control rates of the study are impressive in our view, suggesting robust clinical efficacy of the combination treatment. Importantly,
we are very encouraged by the early PFS data in our ongoing study, since it is commonly known in cancer therapy that PFS values typically
drop from one therapy to the next in advanced cancers. Please note that the PFS data is early data, as patients continue to remain in
the study. The positive PFS trend BriaCell has observed in this patient cohort highlights the effectiveness of BriaCell’s treatment
without harmful side effects.
The
study, recently awarded U.S. Food and Drug Administration fast track designation, continues with additional clinical data forthcoming.
In
summary, these findings show evidence of clinical and survival benefits in heavily pre-treated advanced breast cancer patients, suggesting
an additive or synergistic effect of Bria-IMT™ in combination with PD-1 inhibitors, and supporting the strategy of using the Bria-IMT™
combination regimen with retifanlimab for the treatment of advanced breast cancer patients.
Evidence
of immune system activation by Bria-OTS+™ and Bria-PROS™
BriaCell’s
poster presentation highlights the development details and activities of BriaCell’s next generation (enhanced version) off-the-shelf
personalized immunotherapies.
BriaCell
has recently developed its novel next generation off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™,
that are designed to produce several immune activating molecules in addition to their original immune activating mechanisms for increased
efficacy. This represents a significant advancement in BriaCell’s novel off-the-shelf personalized immunotherapy technology.
Both
Bria-OTS+™ for advanced breast cancer, and Bria-PROS™ for advanced prostate cancer, were able to activate naïve T cells,
suggesting their potential capabilities to produce very strong immune responses in patients. Results show that the very strong immune
responses observed may be due to: 1) direct activation of the components of the immune system such as naïve T cells, and 2) indirect
activation of the immune system components via production of immune activating molecules.
We
are impressed with the data showing very strong immune responses for both Bria-OTS+™ and Bria-PROS™. We expect both Bria-OTS+™
and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients with advanced breast cancer
and prostate cancer, respectively.
19
Results
of Operations for the Three Months Ended October 31, 2022, and 2021
Three months ended
October 31,
2022
2021
(Unaudited)
(Unaudited)
Operating Expenses:
Research and development expenses
$ 3,255,215
$ 875,636
General and administrative expenses
2,147,936
1,409,173
Total operating expenses
5,403,151
2,284,809
Operating loss
(5,403,151 )
(2,284,809 )
Financial income (expenses), net
Interest income
188,353
6,305
Interest expense
-
(979
)
Change in fair value of warrant liability
4,117,790
(25,254,036 )
Foreign exchange gain
(9,533 )
34
Total financial income (expenses), net
4,296,610
(25,248,676 )
Loss and Comprehensive loss for the period
$ (1,106,541 )
$ (27,533,485 )
Net loss per share – basic and diluted
$ (0.07 )
$ (1.81 )
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock
15,518,018
15,238,646
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.
For
the period ended October 31, 2022, research costs amounted to $3,255,215 as compared to $875,636 for the period ended October 31, 2021.
The rise in cost is attributed to the continued expansion of the Company’s clinical trials, the increased activity in the lab,
including the hiring of additional lab employees, and the addition of share based compensation (non-cash) expenses.
General
and Administrative Expenses
For
the period ended October 31, 2022, general and administrative expenses amounted to $2,147,936 as compared to $1,409,173 for the period
ended October 31, 2021. These increases relate primarily to increased insurance premiums, share based compensation (non-cash), professional
fees, and salaries due the hiring more personnel.
Financial
income (expenses), net
For
the period ended October 31, 2022, financial income, net, amounted to $4,296,610 as compared to an expense of $25,248,676 for the period
ended October 31, 2021. The large difference is due to the change in value of the Company’s warrant liability which amounted to
a gain of $4,117,790 in the three-month period ending October 31, 2022 and a loss of $25,254,036 in the three-month period ending October
31, 2021. The Company recorded $188,353 in interest income in the three-month period ending October 31, 2022 as compared to $6,305 in
the three-month period ending October 31, 2021.
20
Loss
for the period
The
Company reported a loss for the period ended October 31, 2022, of $1,106,541, as compared to $27,533,485 for the period ended October
31, 2021. The loss in 2022 is due to a significant decrease in the fair value of the warrant liability offset by increased operational
spending. The higher loss in the prior period is due to the large increase in fair value of the 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 October 31, 2022, the Company has total assets of $38,450,320 (July 31, 2022 - $42,577,041) and a positive working capital balance
of $37,249,747 (July 31, 2022 -$41,405,613).
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 Company believes that its existing capital resources will be adequate
to satisfy its expected liquidity requirements for at least twelve months from the issuance of the consolidated financial statements.
Liquidity
and Capital Resources
As
of October 31, 2022, the Company has working capital of $37,249,747 (July 31, 2022 - $41,405,613) and an accumulated deficit of $61,456,378
(July 31, 2022 - $60,349,837).
As
of October 31, 2022, 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 period ended October 31, 2022, the Company’s overall position of cash and cash equivalents decreased by $18,038,110 from the
period ended October 31, 2021 (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 period ended October 31, 2022, was $3,542,382 as compared to $1,778,599
for the period ended October 31, 2021.
Cash
used in financing activities for the period ended October 31, 2022, was $47,294 as compared to $nil for the period ended October 31,
2021.
21
Off-Balance
Sheet Arrangements
None.
Tabular
Disclosure of Contractual Obligations
None.
Critical
Accounting Policies and Estimates
There
have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section
in our Annual Report.
New
Accounting Policies Adopted
The
Company did not adopt any new accounting policies during the period ended October 31, 2022.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
The
Company’s financial instruments consist of cash and cash equivalents, amounts receivable, 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 October 31, 2022, the Company has total assets of $38,450,320 (July 31, 2022 - $42,577,041) and a positive working capital
balance of $37,249,747 (July 31, 2022 –$41,405,613).
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 accounts payable and cash. As of October 31, 2022, 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, amounts receivable, trade payable, and accrued expenses and other payables
approximate their fair values due to their short terms to maturity.
The
cash and cash equivalents are valued using quoted market prices in active markets.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the
end of the period covered by this Quarterly Report on Form 10-Q. Our management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives
and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on such evaluation, our principal executive officer and principal accounting and financial officer have concluded that as
of October 31, 2022, our disclosure controls and procedures were not effective as a result of material weaknesses in our internal control
over financial reporting. We are implementing plans to improve these material weaknesses, including implementation of independent review and
approval of transactions and reconciliations in certain processes through hiring additional personnel and segregating duties amongst our
team. We are instituting processes to document and retain evidence to support reviews and reconciliations.
Changes
in Internal Control over Financial Reporting
There
have not been material changes in our internal control over financial reporting during the quarter ended October 31, 2022, that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except for our remediation efforts described above.
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, 2022.
23
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
Issuer
Purchases of Equity Securities
On
September 9, 2021 the Company approved a repurchase program whereby the Company may purchase through the facilities of the TSX Venture
or NASDAQ (i) up to 1,341,515 Common Shares and (ii) up to 411,962 Listed Warrants in total, representing 10% of the 13,415,154 Common
Shares and 10% of the 4,119,622 Listed Warrants comprising the “public float” as of September 8, 2021, over the next 12 months.
The Company received final regulatory approval on September 22, 2021. On September 27, 2022 the Company completed the share buyback program,
repurchasing a total of 1,031,672 shares with a value of $9,098,014 (net of commissions), none of which were repurchased during the three
month period ended October 31,2022, and 259,059 Listed Warrants for $1,121,011 (net of commissions) with a fair value of $1,130,808 of
which 15,736 were repurchased and cancelled during the three-month period ended October 31,2022. All of the securities repurchased have
been cancelled.
The
following table contains information for the Listed Warrants repurchased during the three months ended October 31, 2022.
Month
Total
Number of
Warrants Purchased
Average
Price Paid
Per
Warrant
Total
Number of
Warrants Purchased
as Part of Publicly
Announced Plans or
Programs
Approximate Dollar
Value of Warrants
that May Yet Be
Purchased Under the
Plans or Programs
August 2022
8,836
$ 2.99
252,159
$ 477,811
September 2022
6,900
$ 2.89
259,059
-
October 2022
-
$ -
259,059
-
Total
15,736
$ 2.95
259,059
$ -
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.
24
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.
25
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
BRIACELL
THERAPEUTICS CORP.
December
14, 2022
By:
/s/
William V. Williams
Name:
William
V. Williams
Title:
Chief
Executive Officer
(Principal
Executive Officer)
December
14, 2022
By:
/s/
Gadi Levin
Name:
Gadi
Levin
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer )
26
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.