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 JanuaryOctober 31, 2023

 

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, CanadaDelaware 47-1099599

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

235 15th 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 15,December 14, 2023, there were 15,518,01815,981,726 shares of the registrant’s common shares, no par value per share, of the Companywere issued and outstanding.

 

 

 

 

 

BRIACELL THERAPEUTICS CORP.

Form 10-Q

Table of Contents

 

 Page
Part I. Financial Information3
   
Item 1.Financial Statements3
 Condensed Consolidated Balance Sheets as of JanuaryOctober 31, 2023 (unaudited) and July 31, 2022 (unaudited)2023 (audited)43
 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Monthsthree months ended JanuaryCondensed Consolidated Balance Sheets as of October 31, 202354
 Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) for the Three and Six Monthsthree months ended JanuaryOctober 31, 202365
 Unaudited Condensed Consolidated Statement of Cash Flows for the Six Monthsthree months ended JanuaryOctober 31, 202376
 Notes to Unaudited Condensed Consolidated Financial Statements87
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1614
Item 3.Quantitative and Qualitative Disclosures Regarding Market Risk2618
Item 4.Controls and Procedures2719
   
Part II. Other Information2719
   
Item 1.Legal Proceedings2719
Item 1A.Risk Factors2819
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2819
Item 3.Defaults Upon Senior Securities2819
Item 4.Mine Safety Disclosures2819
Item 5.Other Information2820
Item 6.Exhibits2820
   
Part III. Signatures2921

 

2
 

PART I-FINANCIAL

INFORMATION

 

Item 1. Financial Statements

 

BRIACELL THERAPEUTICS CORP.

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTSBALANCE SHEETS

 

Condensed Consolidated Balance Sheets as of January 31, 2023 (unaudited) and July 31, 2022 (unaudited)4
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months ended January 31, 20235
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Six Months ended January 31, 20236
Unaudited Condensed Consolidated Statement of Cash Flows for the Six Months ended January 31, 20237
  October 31, 2023  July 31, 2023 
  

(Unaudited)

  (Unaudited) 
ASSETS        
         
CURRENT ASSETS:        
Cash and cash equivalents $13,645,847  $21,251,092 
Amounts receivable  21,410   18,873 
Prepaid expenses  4,740,726   5,678,542 
Total current assets  18,407,983   26,948,507 
         
NON-CURRENT ASSETS:        
Investments  2   2 
Intangible assets, net  211,250   215,068 
Total non-current assets  211,252   215,070 
         
Total assets $18,619,235  $27,163,577 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
Trade payables $433,915  $1,123,739 
Accrued expenses and other payables  612,590   677,718 
Total current liabilities  1,046,505   1,801,457 
         
NON-CURRENT LIABILITIES:        
Warrant liability  15,056,430   29,139,301 
Total non-current liabilities  15,056,430   29,139,301 
         
SHAREHOLDERS’ EQUITY (DEFICIT):        
Share capital of no par value - Authorized: unlimited at October 31, 2023 and July 31, 2023, Issued and outstanding: 15,981,726 shares October 31, 2023 and July 31, 2023, respectively  69,591,784   69,591,784 
Additional paid in capital  7,918,999   7,421,950 
Accumulated other comprehensive loss  (138,684)  (138,684)
Non-controlling interest  (205,111)  - 
Accumulated deficit  (74,650,688)  (80,652,231)
Total shareholders’ equity (deficit)  2,516,300   (3,777,181)
         
Total liabilities and shareholders’ equity (deficit) $18,619,235  $27,163,577 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3
 

 

BRIACELL THERAPEUTICS CORP.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETSSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

         
  January 31, 2023  July 31, 2022 
       
ASSETS        
         
CURRENT ASSETS:        
Cash and cash equivalents $33,500,236  $41,041,652 
Amounts receivable  8,928   24,103 
Prepaid expenses  429,397   1,280,945 
Total current assets  33,938,561   42,346,700 
         
NON-CURRENT ASSETS:        
Investments  2   2 
Intangible assets, net  222,704   230,339 
Total non-current assets  222,706   230,341 
         
Total assets $34,161,267  $42,577,041 
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
Trade payables $582,451  $463,280 
Accrued expenses and other payables  87,962   477,807 
Total current liabilities  670,413   941,087 
         
NON-CURRENT LIABILITIES:        
Warrant liability  34,771,440   31,307,022 
Total non-current liabilities  34,771,440   31,307,022 
         
SHAREHOLDERS’ EQUITY:        
Share Capital of no par value - Authorized: unlimited at January 31, 2023 and July 31, 2022, Issued and outstanding: 15,518,018 shares January 31, 2023 and July 31, 2022, respectively  65,589,293   65,589,293 
Additional paid in capital  6,606,945   5,228,160 
Accumulated other comprehensive loss  (138,684)  (138,684)
Accumulated deficit  (73,338,140)  (60,349,837)
Total shareholders’ (deficit) equity  (1,280,586)  10,328,932 
         
Total liabilities and shareholders’ equity $34,161,267  $42,577,041 
  2023  2022 
  

Three months ended

October 31,

 
  2023  2022 
Operating Expenses:        
Research and development expenses $6,857,257  $3,255,215 
General and administrative expenses  1,645,771   2,147,936 
Total operating expenses  8,503,028   5,403,151 
         
Operating loss  (8,503,028)  (5,403,151)
Financial income, net  14,461,900   4,296,610 
Net income (loss) for the period  5,958,872   (1,106,541)
Net loss attributable to non-controlling interest  (42,671)  - 
Net income (loss) for the period attributable to BriaCell  6,001,543   (1,106,541)
Net income (loss) per share attributable to BriaCell – basic $0.38  $(0.07)
Net income (loss) per share attributable to BriaCell – diluted  (0.50)  (0.07)
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  16,674,891   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 OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JANUARY 21, 2023

(Unaudited)

  2023  2022  2023  2022 
  Three months ended
January 31,
  Six months ended
January 31,
 
  2023  2022  2023  2022 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Operating Expenses:                
Research and development expenses $3,053,357  $1,708,179  $6,308,572  $2,583,815 
General and administrative expenses  1,432,966   1,938,630   3,580,902   3,347,803 
Total operating expenses  4,486,323   3,646,809   9,889,474   5,931,618 
                 
Operating loss  (4,486,323)  (3,646,809)  (9,889,474)  (5,931,618)
Financial income (expenses), net  (7,395,439)  14,807,316   (3,098,829)  (10,441,360)
Income (loss) and Comprehensive income (loss) for the period $(11,881,762) $11,160,507  $(12,988,303)  (16,372,978)
Net loss per share – basic $(0.77) $0.71  $(0.84) $(1.05)
Net income (loss) per share – diluted $(0.77) $0.04  $(0.84) $(1.05)
Weighted average number of shares used in computing net basic earnings per share of common stock  15,518,018   15,788,827   15,518,018   15,547,497 
Weighted average number of shares used in computing net diluted earnings per share of common stock  15,518,018   18,405,614   15,518,018   15,547,497 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

FOR THE THREE AND SIX MONTHS ENDED JANUARYOCTOBER 31, 2023

 

                                          
 Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  

Total
shareholders’

equity

  Share capital Additional paid in Accumulated other comprehensive Accumulated  

Total

shareholders’

 
 Number  Amount  capital  loss  deficit  (deficit)  Number Amount capital loss deficit equity 
Balance, October 31, 2022  15,518,018  $65,589,293  $6,340,101  $(138,684) $(61,456,378) $10,334,332 
Balance, July 31, 2022  15,518,018  $65,589,293  $5,228,160  $(138,684) $(60,349,837)-$   10,328,932 
                                                
Issuance of options  -   -   266,844   -   -   266,844   -   -   1,111,941   -   -   1,111,941 
Loss for the period  -   -   -   -   (11,881,762)  (11,881,762)  -   -   -   -   (1,106,541)- (1,106,541)
Balance, January 31, 2023  15,518,018  $65,589,293  $6,606,945  $(138,684) $(73,338,140) $(1,280,586)
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’

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 
Issuance of options  -   -   1,378,785   -   -   1,378,785 
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)
                      
  Share capital  Additional
paid in
  Accumulated other
comprehensive
  Accumulated  

Non-
controlling

  

Total

shareholders’equity

 
  Number  Amount  capital  loss  

Equity

  interest  (deficit) 
Balance, July 31, 2023  15,981,726  $69,591,784  $7,421,950  $(138,684) $(80,652,231)  -  $    (3,777,181)
Balance  15,981,726  $69,591,784  $7,421,950  $(138,684) $(80,652,231)  -  $(3,777,181)
Instruments issued to minority shareholders at the Arrangement Date  -   -   (36,767)  -   -   

(162,440

)  (199,207)
Issuance of options  -   -   533,816   -   -   -  533,816 
Income (loss) for the period  

-

   

-

   

-

   

-

   

6,001,543

  

(42,671

)  

5,958,872

 
Balance, October 31, 2023  15,981,726  $69,591,784  $7,918,999  $(138,684) $(74,650,688)  (205,111) $2,516,300 
Balance  15,981,726  $69,591,784  $7,918,999  $(138,684) $(74,650,688)  (205,111 )  $2,516,300 

 

  Share capital Additional paid in Accumulated other comprehensive Accumulated Total
shareholders’
  Number Amount capital loss deficit equity
Balance, October 31, 2021  15,370,412  $55,701,579  $2,696,264  $(138,684) $(56,675,382) $1,583,777 
Exercise of representation warrants  107,471   376,832   -   -   -   376,832 
Exercise of private placement warrants  800,000   9,910,089   -   -   -   9,910,089 
Exercise of public offering warrants  33,065   1,677,631   -   -   -   1,677,631 
Issuance of options  -   -   814,876   -   -   814,876 
Shares repurchased and cancelled  (364,306)  (4,704,423)  -   -   (4,393,591)  (9,098,014)
Income for the period  -   -   -   -   11,160,507   11,160,507 
Balance, January 31, 2022  15,946,642  $62,961,708  $3,511,140  $(138,684) $(49,908,466) $16,425,698 

  Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  Total
shareholders’ equity
 
  Number  Amount  capital  loss  deficit  (deficit) 
Balance, July 31, 2021  15,269,583   $54,774,172  $2,178,130  $(138,684) $(29,141,897) $ (27,671,721)
Balance  15,269,583   $54,774,172  $2,178,130  $(138,684) $(29,141,897) $ (27,671,721)
Exercise of representation warrants  208,300   1,304,239    -   -  -   1,304,239 
Exercise of private placement warrants  800,000   9,910,089    -   -  -   9,910,089 
Exercise of public offering warrants  33,065   1,677,631    -   -  -   1,677,631 
Issuance of options  -   -   1,333,010    -  -   1,333,010 
Shares repurchased and canceled  (364,306)  (4,704,423)   -  -   (4,393,591)  (9,098,014)
Loss for the period  -   -   -   -   (16,372,978)  (16,372,978)
Income (loss) for the period  -   -   -   -   (16,372,978)  (16,372,978)
Balance, January 31, 2022  15,946,642  $62,961,708 $ 3,511,140 $ (138,684)$ (49,908,466) $16,425,698 
Balance  15,946,642  $62,961,708 $ 3,511,140 $ (138,684)$ (49,908,466) $16,425,698 

The accompanying notes are an integral part of the condensed consolidated financial statements.

65
 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE SIX MONTHS ENDED JANUARY 31, 2023

(Unaudited)

 

         2023  2022 
 Six months ended January 31,  Three months ended October 31, 
 2023 2022  2023  2022 
Cash flow from operating activities                
Net loss  $(12,988,303) $(16,372,978)
Net income (loss) for the period $5,958,872  $(1,106,541)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization   7,635   7,636   3,818   3,818 
Share-based compensation   1,378,785   1,333,010   533,816   1,111,941 
Interest expense   -   979   -   - 
Gain from government grant  -   (3,388)
Change in fair value of warrants   3,511,712   10,456,148   (14,282,078)  (4,117,790)
Changes in assets and liabilities:                
Increase in amounts receivable   15,175   (14,592)  (2,537)  (5,595)
Decrease in prepaid expenses   851,548   210,022   937,816   538,822 
Increase in trade payable   119,171   314,143 
(Decrease) increase in accounts payable  (689,824)  328,468 
Decrease in accrued expenses and other payables   (389,845)  (265,788)  (65,128)  (295,505)
Total cash flow from operating activities  (7,494,122)  (4,334,808)  (7,605,245)  (3,542,382)
                
Cash flows from financing activities                
Share and warrant buyback program   (47,294)  (10,056,273)  -   (47,294)
Repayment government grant  -   (23,577)
Proceeds from exercise of warrants  -   5,127,658 
Total cash flow from financing activities  (47,294)  (4,952,192)  -   (47,294)
                
Decrease in cash and cash equivalents  (7,541,416)  (9,287,000)  (7,605,245)  (3,589,676)
Cash and cash equivalents at beginning of the period   41,041,652   57,268,685   21,251,092   41,041,652 
Cash and cash equivalents at end of the period  $33,500,236  $47,981,685  $13,645,847  $37,451,976 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

76
 

BRIACELL THERAPEUTICS CORP.

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

(Unaudited)(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)

 

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 the Company also trades on the Nasdaq Capital Market (“NASDAQ”) under the symbols “BCTX” and “BCTXW”.

 b.BriaCell Therapeutics Corporation. (the “Company”), 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 Bria-IMT targeted immunotherapy program Bria-IMT™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™, to completeand a 24-subject Phase I/IIa clinical trial and by research activities insoluble CD80 protein therapeutic which acts both as a stimulator of the context of BriaDx™, a companion diagnostic test to identify patients likely benefitting from Bria-IMT™.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 108 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, 20222023, filed with the SEC on October 28 , 2022.25, 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.

 

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 January 31, 2022 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 JanuaryOctober 31, 2023 was $73,338,14074,650,688 and negative cash flows from operating activities during the six-monththree-month period ended JanuaryOctober 31, 2023 was $7,494,1227,605,245. 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.

8

 e.The Company has atwo wholly-owned U.S. subsidiary,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” and together with BTC the “Subsidiaries”), which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company also has one operating segment and reporting unit.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”).

 

f.

Since January 2020,Pursuant to the Coronavirus outbreakterms of the Arrangement, BriaPro has dramatically expanded intoacquired 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 worldwide pandemic creating macro-economic uncertaintyresult of the Arrangement, there are 47,945,178 BriaPro common shares issued and disruptionoutstanding. 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 businessholder thereof to receive, upon the exercise thereof, one BriaCell Share and financial markets. Many countries aroundone BriaPro Share for the world, including Canadaoriginal 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 United StatesBriaPro options, as follows:

Each one (1) BriaPro Option to acquire one (1) Share shall have been taking measures designatedan exercise price equal to limit the continued spreadproduct obtained by multiplying the original exercise price of the Coronavirus, includingBriaCell Option by the closurequotient obtained by dividing (A) the fair market value of workplaces, restricting travel, prohibiting assembling, closing international bordersa BriaPro Share at the Effective Date by (B) the aggregate fair market value of a BriaCell Share and quarantining populated areas. Such measures present concerns that may dramatically affecta BriaPro Share at the Effective Date.

Pursuant to the Arrangement, all BriaCell 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 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 bycontrol, 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 Companyassets is continuing to assess its business plans and the impact COVID-19 is havingbeing recorded on the Company’s clinical trial timelinesbasis (carry value) 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 predictednot 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.fair market value.

7

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)

 

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

 

a.Use of estimates:

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the condensed consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.

 

b.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.

9

 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. At oral argument on January 19, 2023, Justice Cohen granted in part and denied in part Alpha’s partial motion to dismiss BriaCell’s Amended Counterclaim and Affirmative Defenses. In relevant part, Justice Cohen refused to dismiss any of BriaCell’s substantive counterclaims, allowing BriaCell to continue to prosecute its Unjust Enrichment, Money Had and Received, Recovery of Excess, and Implied Covenant of Good Faith and Fair Dealing claims against Alpha. At this time, the parties cannot estimate the value of their respective claims and damages.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 currentlywas on a month-to-month lease arrangement for office and lab space in Philadelphia, PA, in the amount of approximately $16,00016,500 per month. Commencing September 1, 2023 a new lease will commence, replacing the current month-to-month agreement with a 12-month commitment (ending August 31, 2024) of approximately $36,000 per month.

10

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 JanuaryOctober 31, 2023 and July 31, 2022:2023:

SCHEDULE OF FAIR VALUE ON A RECURRING BASIS 

 Fair Value Measurements at  Fair Value Measurements at 
 January 31, 2023 July 31, 2022  October 31, 2023 July 31, 2023 
 Level 1 Level 2 Total Level 1 Level 2 Total  Level 1 Level 2 Total Level 1 Level 2 Total 
Financial Assets:                                                
Cash and cash equivalents  33,500,236  -  33,500,236  41,041,652  -  41,041,652   13,645,847   -   13,645,847   21,251,092   -   21,251,092 
                                     
Total assets measured at fair value $33,500,236  -  33,500,236 $41,041,652  $-  $41,041,652  $13,645,847  $-  $13,645,847  $21,251,092  $-  $21,251,092 
                                     
Financial liabilities:                                     
Warrants liability 11,652,356 23,119,084 34,771,440 11,151,608 20,155,414 31,307,022   4,394,042   10,662,388   15,056,430   9,742,023   19,397,278   29,139,301 
                                           
Total liabilities measured at fair value $11,652,356  23,119,084  34,771,440 $11,151,608 $20,155,414 $31,307,022  $4,394,042  $10,662,388  $15,056,430  $9,742,023  $19,397,278  $29,139,301 

 

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

 

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-monththree-month period ended JanuaryOctober 31, 2023.

 

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 six month period ended January 31,2023, 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 six-month period ended January 31,2023. All of the warrants and shares repurchased have been cancelled.

11

NOTE 5: SHAREHOLDERS’ EQUITY (Cont.)

d. Share Purchase Warrants

A summary of changes in share purchase warrants for the six-month period ended January 31, 2023 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, January 31, 2023  8,121,950   5.76 
(i)There were no changes in share purchase warrants for the three-month period ended October 31, 2023 as presented below:

  

Number of

warrants

outstanding

  

Weighted

average exercise

price

 
Balance, July 31, 2023 and October 31, 2023  8,121,650  $5.76 

 

d. Share Purchase Warrants (continued)

As of January 31, 2023, warrants outstanding were as follows:

 SCHEDULE OF WARRANTS OUTSTANDING

Number of
Warrants
  Exercise Price  Exercisable At
January 31, 2023
  Expiry Date
 51,698  $4.06   51,698  November 16, 2025
 3,897,109  $5.31   3,897,109  February 26, 2026April 26, 2026
 4,173,143  $6.19   4,173,143  December 7, 2026
 8,121,950       8,121,950   
(ii)As of October 31, 2023, warrants outstanding were as follows:

 

Number of

Warrants

  Exercise Price(*)  

Exercisable At

October 31, 2023

  Expiry Date
 51,698  $3.91   51,698  November 16, 2025
 3,896,809  $5.31   3,896,809  February 26, 2026April 26, 2026
 4,173,143  $6.19   4,173,143  December 7, 2026
 8,121,650       8,121,650   

(*)See note 3(a).

e.d. Compensation Warrants

 (i)There were no changes to compensation warrants for the six-monththree-month period ended JanuaryOctober 31, 2023.

 

 (ii)As at Januaryof October 31, 2023, compensation warrants outstanding were as follows:

SCHEDULE OF WARRANTS OUTSTANDING

Number of

Warrants

  Exercise Price(*)  

Exercisable At

October 31, 2023

  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   

 

Number of
Warrants
  Exercise Price  Exercisable At
January 31, 2023
  Expiry Date
 4,890  $4.06   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 3(a).

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)

f.NOTE 5:SHAREHOLDERS’ EQUITY (Cont.)

e. Warrant liability continuity

 

The following table presents the summary of the changes in the fair value of the warrants:

 SCHEDULE OF CHANGE IN FAIR VALUE OF WARRANTS

  Warrants liability 
    
Balance as of August 1, 2022 $31,307,022 
Warrant buyback program $(47,294)
Change in fair value during the period $3,511,712 
     
Balance as of January 31, 2023 $34,771,440 
  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 $(14,282,078)
     
Balance as of October 31, 2023 $15,056,430 

 

The key inputs used in the valuation of the non-public warrants as of JanuaryOctober 31, 2023 and at July 31, 20222023 were as follows:

12

NOTE 5:SHAREHOLDERS’ EQUITY (Cont.)

 SCHEDULE OF VALUATION OF NON PUBLIC WARRANTS

 January 31, 2023 July 31, 2022  October 31, 2023 July 31, 2023 
          
Share price $7.48  $6.50  $4.25  $6.69 
Exercise price $3.07-6.19 $4.23-6.19  $5.31-6.19  $5.31-6.19 
Expected life (years) 2.79-3.85 3.58-4.35   2.32-3.10   2.58-3.35 
Volatility 100% 100%  100%  100%
Dividend yield 0% 0%  0%  0%
Risk free rate 3.62% 2.68%  4.92%  4.51%

The key inputs used in the valuation of the of the BriaPro Warrant Shares as of October 31, 2023 were as follows:

SCHEDULE OF VALUATION OF WARRANTS

  

August 31, 2023

(Effective Date)

  

October 31, 2023

 
       
Share price $0.0365  $0.0365 
Exercise price $0.0206-0.0308  $0.0206-0.0308 
Expected life (years)  2.21-3.27   2.05-3.10 
Volatility  100%  100%
Dividend yield  0%  0%
Risk free rate  4.40%  4.50%

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 Sharesshares 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 and remains subject to final approval from the Toronto Stock Exchange.shareholders.

b.The following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan for six-monththree-month period ended JanuaryOctober 31, 2023 and related information:

SCHEDULESUMMARY 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   3.59  $447,090 
                 
Granted (i)  180,100   6.28   4.51   - 
                 
Balance as of January 31, 2023  1,670,400   6.21   3.69   $2,121,408 
                 
Exercisable as of January 31, 2023  1,424,010  $6.13   3.58  $1,922,414 

(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.
  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 October 31, 2023  2,131,400   6.16   3.30   - 
                 
Exercisable as of October 31, 2023  1,693,718  $6.17   3.02  $- 

 

The weighted-average grant date per-share fair value of stock options granted during six-month period ended January 31, 2023 was $4.93. As of JanuaryOctober 31, 2023, there are $1,269,8782,056,830 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to 1.51.50 years.

 

1311
 

 

BriaCell Therapeutics Corp

NOTE 6:SHARE-BASED COMPENSATION (Cont.)

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 and six month period ended January 31, 2023 and 2022:

SCHEDULE OF FAIR VALUE MEASUREMENT OF EQUITY-SETTLED SHARE OPTIONS

  Three months ended
January 31,
  Six months ended
January 31,
 
  2023  2022  2023  2022 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Dividend yield  0%  0%  0%  0%
Expected volatility of the share prices  100%  100%  100%  100%
Risk-free interest rate  4.23%  1.47%   4.23%  0.80%-1.47%
Expected term (in years)  5   5   5   5 

d.The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of JanuaryOctober 31, 2023.

SCHEDULESUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS

Exercise
price
Exercise
price
  Options
outstanding
as of
January 31,
2023
 Weighted
average
remaining
contractual
term
(years)
 Options
exercisable
as of
January 31,
2023
 Weighted
average
remaining
contractual
term
(years)
  Expiry Date

Exercise

price

 

Options

outstanding as of

October 31, 2023

 

Weighted

average

remaining

contractual

term (years)

 

Options

exercisable as of

October 31, 2023

 

Weighted

average

remaining

contractual

term (years)

  Expiry Date
                   
$6.28   180,100   4.51   45,025   4.51  August 02, 20276.03   440,000   4.64   110,000   4.64  June 20, 2028
$4.71 31,000 4.31 11,625 4.31 May 20, 20277.16   21,000   4.33   7,875   4.33  February 27, 2028
$7.51 150,000 4.04 75,000 4.04 February 16, 20276.04   180,100   3.76   112,563   3.76  August 02, 2027
$8.47 524,700 3.95 508,800 3.95 January 13, 20274.71   31,000   3.56   23,250   3.56  May 20, 2027
$7.74 12,600 3.75 11,560 3.75 November 01, 20277.51   150,000   3.29   131,250   3.29  February 16, 2027
$5.74 100,000 3.59 100,000 3.59 September 01, 20268.47   524,700   3.20   524,700   3.20  January 13, 2027
$4.24 60,000 3.22 60,000 3.22 April 19, 20267.15   12,600   3.00   12,080   3.00  November 01, 2026
$4.24  612,000 3.16  612,000 3.16 March 29, 20265.74   100,000   2.84   100,000   2.84  September 01, 2026
$4.24   60,000   2.47   60,000   2.47  April 19, 2026
$4.24   612,000   2.41   612,000   2.41  March 29, 2026
   1,670,400    1,424,010       2,131,400       1,693,718      

 

d.As result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of October 31, 2023:

SCHEDULE OF OPTION ISSUED AND OUTSTANDING

Exercise

Price

  

Options

outstanding as of October 31, 2023

  

Options

exercisable as of

October 31, 2023

  Expiry Date
          
$0.0933   440,000   110,000  June 20, 2028
$0.1108   21,000   7,875  February 27, 2028
$0.0984   180,100   112,563  August 02, 2027
$0.0729   31,000   23,250  May 20, 2027
$0.1162   150,000   131,250  February 16, 2027
$0.1310   524,700   524,700  January 13, 2027
$0.1165   12,600   12,080  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   1,693,718   

e.Restricted Share Unit Plan

 

The following table summarizes the number of RSU’s granted to directors under the Omnibus plan for six-month period ended Januaryas of October 31, 2023:

SCHEDULESUMMARY OF RESTRICTED STOCK UNITS GRANTED

  Number of
RSU’s
outstanding
  Aggregate
intrinsic value
 
Balance, July 31, 2022  -  $- 
Granted (i)  19,200   123,072 
Balance, January 31, 2023  19,200  $143,616 
  

Number of

RSU’s

outstanding

  

Aggregate

intrinsic value

 
Balance, July 31, 2023  19,200  $123,072 
Balance, October 31, 2023  19,200  $81,600 

 

f.(i)On August 2,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, 2023 and 2022 the Company issued 19,200 RSU’s to the CEO. The RSU’s vested immediately.is comprised as follows:

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES

  2023  2022 
  

Three months ended

October 31,

 
  2023  2022 
       
Research and development expenses $257,809   350,256 
General and administrative expenses  276,007   761,685 
Total share-based compensation $533,816   1,111,941 

 

1412
 

 

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, 2023 and 2022 is comprised as follows:

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES

  2023  2022  2023  2022 
  Three months ended
January 31,
  Six months ended
January 31,
 
  2023  2022  2023  2022 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Research and development expenses $225,091   109,453  $575,347   109,453 
General and administrative expenses  41,753   705,423   803,438   1,223,557 
Total share-based compensation $266,844   814,876  $1,378,785   1,333,010 

NOTE 7:FINANCIAL INCOME (EXPENSES), NETBriaCell Therapeutics Corp

SCHEDULE OF FINANCIAL INCOME (EXPENSE), NETNotes to the Condensed Consolidated Financial Statements

  2023  2022  2023  2022 
  

Three months ended

January 31,

  Six months ended
January 31,
 
  2023  2022  2023  2022 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Interest income $240,595   12,081  $428,948   18,386 
Interest expense  -   -   -   (979)
Change in fair value of warrant liability  (7,629,502)  14,797,888   (3,511,712)  (10,456,148)
Gain on government grant  -   3,388   -   3,388 
Foreign exchange loss  (6,532)  (6,041)  (16,065)  (6,007)
Loss on extinguishment of debt  -   -   -   - 
Financial income (expenses), net $(7,395,439) $14,807,316  $(3,098,829) $(10,441,360)

(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)

 

NOTE8: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 experiencedcompany reported a loss in three and six month ended Januaryfor the three-month period ending October 31, 2022, leading to the exclusion of potentially dilutive ordinary shares. Conversely, a gain was recorded for the three-month period ending October 31, 2023, and forresulting in the six months ended January 31, 2022; henceinclusion of all potentially dilutive ordinary shares were excluded during those periods due to their anti-dilutive effect.shares.

SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE

  2023  2022 
  

Three months ended

October 31,

 
  2023  2022 
  (Unaudited)  (Unaudited) 
Basic EPS        
Numerator:        
Net income (loss) $6,001,543  $(1,106,541)
Denominator:        
Shares used in computation of basic earnings per share  15,981,726   15,518,018 
Basic EPS $0.38  $(0.07)
Diluted EPS        
Numerator:        
Net income (loss) attributable to common stock, basic $6,001,543  $(1,106,541)
Adjustment: Change in fair value of warrant liability  

(14,282,078

)  - 
Net (loss) attributable to common stock, diluted $(8,280,535) $(1,106,541)
Denominator:        
Shares used in computing net EPS of common stock, basic  15,981,726   15,518,018 
Stock Options  211,434   - 
Warrants  481,731   - 
Shares used in computation of diluted earnings per share  16,674,891   15,518,018 
Diluted EPS $(0.50) $(0.07)

NOTE 8: FINANCIAL INCOME (EXPENSES), NET

SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET

  2023  2022  2023  2022 
  

Three months ended

January 31,

  

Six months ended

January 31,

 
  2023  2022  2023  2022 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Basic EPS                
Numerator:                
Net income (loss) $(11,881,762) $11,160,507  $(12,988,303) $(16,372,978)
Denominator:                
Shares used in computation of basic earnings per share  15,518,018   15,788,827   15,518,018   15,547,497 
Basic EPS $(0.77) $0.71  $(0.84) $(1.05)
Diluted EPS                
Numerator:                
Net income (loss) attributable to common stock, basic and diluted $(11,881,762) $704,359  $(12,988,303) $(16,372,978)
Denominator:                
Shares used in computing net EPS of common stock, basic  15,518,018   15,788,827   15,518,018   15,547,497 
Stock Options  -   337,644   -   - 
Warrants  -   2,279,143   -   - 
Shares used in computation of diluted earnings per share  

15,518,018

   18,405,614   15,518,018   15,547,497 
Diluted EPS $(0.77) $0.04  $(0.84) $(1.05)
  2023  2022 
  

Three months ended

October 31,

 
  2023  2022 
Interest income $190,815  $188,353 
Change in fair value of warrant liability  14,282,078   4,117,790 
Foreign exchange loss  (10,993)  (9,533)
Financial income, net $14,461,900  $4,296,610 

 

NOTE 9: SUBSEQUENT EVENTS

The Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements through December 14, 2023, 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.

 

1513
 

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, 20222023 (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 secondfirst quarter of fiscal 2023 in comparison to the secondfirst quarter of fiscal 2022.2023.

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“Company”), is an immuno-oncologya clinical-stage biotechnology company with a strong focus onthat is developing novel immunotherapies to transform cancer immunotherapy.care. Immunotherapies have come to the forefront in the fight against cancer sinceas 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 ourits Bria-IMT™ targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™ in combination with an immune checkpointcheck point 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 priorpivotal1 Phase 3 study in 2004-2006 by Dr. Charles Wiseman, the scientific founder, former memberadvanced metastatic breast cancer. BriaCell recently reported benchmark-beating patient survival and clinical benefit in advanced metastatic breast with median overall survival of the board of directors of the Company (the “Board”) and principal scientific advisor. Encouraging results were obtained, especially13.5 months in a patient who matched Bria-IMT™ at HLA alleles and had a grade II tumor. In 2017-2018 BriaCell evaluated 23 patients withBriaCell’s 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 patients vs. 6.7-9.8 months for similar patients reported in patients who matchthe literature2. A completed Bria-IMT™ at least at one HLA allele and/or if they had grade I or grade II tumors. APhase 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 checkpoint inhibitor pembrolizumab (KEYTRUDA®) was initiated on September 2018. BriaCell purchased the KEYTRUDA® for this studysystem as BriaCell does not havewell as 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.

16

It is estimated by the National Cancer Institute that in 2022, approximately 287,500 women were 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 died 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 co-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 the Bria-IMT™ indication will be for the treatment of patients with MBC who have failed other approved therapies. 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.inhibitor.

 

Recent Developments

 

On August 4, 2022,31, 2023, the Company closed the previously announced that it has secured an exclusive license from Universityplan of Maryland, Baltimore County (UMBC)arrangement spinout transaction (the “Arrangement”) pursuant to developwhich certain pipeline assets of the Company, including Bria-TILsRx™ and commercialize Soluble CD80 (sCD80) asprotein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”), were spun-out to BriaPro Therapeutics Corp. (“BriaPro”), resulting in a biologic agent for2/3rd owned subsidiary of the treatment of cancer.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 novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus FacultyCompany will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada.

Computershare Investor Services Inc. (“Computershare”) will forward replacement certificates to each Company shareholder that is entitled to receive certificates, representing their allotted number of BriaPro common shares and BriaCell common shares in accordance with the Arrangement. Letters of transmittal have been mailed to registered holders of BriaCell common shares, which must be completed and returned to Computershare together with the share certificates of BriaCell common shares 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 demonstratedthe address specified in the same studies, sCD80’s unique actions may involve both awakeningletter of transmittal in order for Company shareholders to receive common shares of BriaPro and boostingnew common shares of BriaCell. A copy of the immune systemletter of transmittal is also available under the Company’s profile on SEDAR at www.sedar.com.

As noted above, 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 approximately 47,945,178 BriaPro common shares issued and outstanding. 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.

1 “Pivotal” is an industry term referring to recognizea Phase 3 clinical study intended to show and destroy tumor cells.

confirm the safety and efficacy of a treatment.

 

1714
 

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.

Bria-IMT™ regimen combined with Incyte’s retifanlimab

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 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 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.

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.

18

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.

BriaCell is 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

Patent Issuance

On January 10, 2023, the Company announced that it received an Issue Notification from the United States Patent and Trademark Office for the composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer. The patent issued on January 24, 2023 as US Patent No. 11,559,574 with the term extending to May 25, 2040. Additionally, BriaCell was awarded an Australian patent (Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer immunotherapy technology in Australia.

Intellectual Property: US Patent No. 11,559,574, titled “Whole-cell cancer vaccines and methods for selection thereof,” will issue on January 24, 2023, and covers the composition of matter and method of use of BriaCell’s personalized off-the-shelf whole-cell immunotherapies. The novel technology involves the development of several HLA specific whole-cell immunotherapies in advance, and selection of the appropriate off-the-shelf (i.e. pre-made) immunotherapies for each patient (i.e. personalized therapy) based on the patient’s HLA type using a fast and easy saliva test. Once issued, the patent will provide intellectual property protection through May 25, 2040, and a patent term extension under Hatch-Waxman potentially applies (which would extend such protection for an additional five years).

Additionally, BriaCell was awarded Australian Patent No. 2017224232, titled “Whole-cell cancer vaccines and methods for selection thereof,” for claims covering composition of matter and method of use for BriaCell’s whole-cell immunotherapy for cancer in Australia.

BriaCell currently holds multiple issued patents and pending patent applications to cover its whole-cell immunotherapy’s composition of matter and method of use worldwide. For a summary of BriaCell’s issued patents, please visit https://briacell.com/patents/ ..

Bria-OTS™ Program Timelines

FDA has provided guidance regarding the development of cells and final cell-bank testing for BriaCell’s Bria-OTS™ clinical-grade cell lines. Once completed in accordance with FDA’s requirements, BriaCell expects to initiate the Bria-OTS™ study under an Investigational New Drug Application (IND) in the first half of 2023.

Clinical Sites

The following clinical sites are actively enrolling patients for BriaCell’s ongoing Phase II combination study:

Carle Cancer Institute, Urbana, Illinois
American Oncology Network, LLC (AON), Baltimore, Maryland
Mayo Clinic, Jacksonville, Florida
Hoag, Newport Beach, California
Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, Miami, Florida
Atlantic Health System, Morristown and Overlook Hospitals, Morristown and Summit, New Jersey
Tranquil Clinical Research, Webster, Texas
Mary Crowley Cancer Research center, Dallas, Texas
Providence Medical Group, Santa Rosa, California
Cancer Center of Kansas, Wichita, Kansas

20

End of Phase II Meeting with the Food and Drug Administration

On January 18, 2023 BriaCell received agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell’s lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.

BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.

Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.

Updated Clinical Data

On Feb. 23, 2023 BriaCell reported updated survival data from its previously disclosed group of 12 patients (11 patients enrolled in 2021/2022) in the ongoing Phase II clinical trial evaluating Bria-IMT™ in combination with Incyte’s retifanlimab for the treatment of advanced metastatic breast cancer.

9 of 11 (82%) patients remain alive from 2021/2022 dosing, suggesting strong survival benefits.

7 of 11 (64%) patients showed either disease control or progression-free survival (“PFS”) benefits compared with their most recent prior therapy regimen suggesting clinical benefit, including survival and delayed cancer progression in this very difficult to treat patient population.

Median PFS of 3.5 months (with one subject ongoing) compares favorably with other recent studies of patients with advanced disease including other approved agents in earlier lines of therapy (Tripathy “ATTAIN” 2022, Perez 2015 “BEACON”, Cortes 2018, O’Shaughnessy 2022 “ASCENT”).

Regimen remains well tolerated with no dose limiting toxicities.

This clinical data from BriaCell’s combination regimen highlights survival benefits in a cohort (3rd line or later) with a life expectancy of merely months or weeks in some cases. Patients in this cohort had failed a median of 5 other treatments prior to enrolling in BriaCell’s study. Other reportable benefits such as less pain and better quality of life were also observed in these patients.

Subsets of top-responding patients: 4 of 5 patients with Grade I/II cancer, and 6 of 8 hormone receptor positive (HR+) patients had either disease control or improved PFS suggesting potentially better responding subgroup/s of patients. These subgroups represent large segments of the advanced breast cancer patient population.

Enrollment update: 9 additional patients have been screened/enrolled in the study, incremental to the 12 patients announced in December 2022. With patients continuing to enroll and remain on the treatment, more data including overall survival data will be disclosed at regular intervals.

21

Other Corporate Matters

On Feb. 09, 2023 BriaCell announced the results of its annual general and special meeting of shareholders of the Company (the “Shareholders”) for the year ended July 31, 2022 held on February 9, 2023 (the “Meeting”). A total of 6,663,370 common shares of the Company (the “Common Shares”) were voted, representing 42.94% of the Company’s issued and outstanding Common Shares. At the Meeting, the Shareholders overwhelmingly voted in favor of all proposed resolutions that consisted of the following:

1.Appointment of MNP LLP as auditors of the Company for the ensuing year and authorizing the directors to fix their remuneration;
2.Election of Dr. William V. Williams, Mr. Jamieson Bondarenko, Mr. Marc Lustig, Dr. Jane A. Gross, Dr. Rebecca Taub, Mr. Vaughn C. Embro-Pantalony, and Mr. Martin E. Schmieg as directors of the Company;
3.Approval of the Company’s new omnibus equity incentive plan (the “Omnibus Plan”);
4.Ratification of restricted share units awarded under the Omnibus Plan; and
5.Approval and adoption of an amendment to the Articles of the Company to require the presence, in person or by proxy, of two or more shareholders representing at least 33 1/3% of the outstanding shares entitled to be voted in order to constitute a quorum at any meeting of shareholders, and to remove the quorum exception for succeeding meetings of shareholders.

Having received Shareholder approval, the Company’s Omnibus Plan remains subject to final approval from the Toronto Stock Exchange. The formal report on voting results with respect to all matters voted upon during the Meeting will be filed on the Company’s SEDAR profile at www.sedar.com .

22

Results of Operations for the Three Months Ended JanuaryOctober 31, 2023, and 2022

 

  Three months ended January 31, 
  2023  2022 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses $3,053,357  $1,708,179 
General and administrative expenses  1,432,966   1,938,630 
Total operating expenses  

4,486,323

   

3,646,809

 
         
Operating loss  (4,486,323)  (3,646,809)
Financial income (expenses), net        
Interest income  240,595   12,081 
Change in fair value of warrant liability  (7,629,502)  14,797,888 
Gain on government grant  -   3,388 
Foreign exchange gain  (6,532)  (6,041)
Total financial income (expenses), net  (7,395,439)  14,807,316 
Prodit (loss) and Comprehensive profit (loss) for the period $(11,881,762) $11,160,507 
Net loss per share – basic and diluted $(0.77) $0.71 
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock  15,518,018   15,788,827 

  Three months ended October 31, 
  2023  2022 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses $6,857,257  $3,255,215 
General and administrative expenses  1,645,771   2,147,936 
Total operating expenses  8,503,028   5,403,151 
         
Operating loss  (8,503,028)  (5,403,151)
Financial income, net        
Interest income  190,815   188,353 
Change in fair value of warrant liability  14,282,078   (4,117,790)
Foreign exchange gain  (10,993)  (9,533)
Total financial income, net  14,461,900   4,296,610 
Income (loss) for the period  5,958,872   (1,106,541)
Losses attributable to noncontrolling interest  (42,671)  - 
Income (loss) for the period attributable to BriaCell  6,001,543   (1,106,541)
Net earnings (loss) per share attributable to BriaCell – basic $0.38  $(0.07)
Net earnings (loss) per share attributable to BriaCell – diluted  (0.50)   (0.07)
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  16,674,891   15,518,018 

Research and Development Costs

 

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory;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,  Three months ended October 31, 
 2023 2022  2023 2022 
          
Clinical trials $1,438,231  $635,195  $3,627,290  $1,603,096 
Pre-clinical projects  745,236   599,007   2,068,979   863,166 
Chemical, Manufacturing and Control Costs (“CMC Costs”)  331,590   178,012   547,197   410,018 
Other  538,300   295,965   613,791   378,935 
 $3,053,357  $1,708,179  $6,857,257  $3,255,215 

 

Our clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial. Clinical trial expenses increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

 

Pre-clinical projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, Bria-PROS™, and Bria-PROS™.pre-clinical work on our BriaPro Assets. Our pre-clinical costs have increased in 2023 as we hired more staff to accelerate our existing pre-clinical program and added an additionadditional pre-clinical program (sCD80).

 

CMC costs include the manufacturing of Bria-IMT™ and Bria-OTS™ and all quality control and quality assurance testing on the investigational product. CMC costs increased in 2023 to support the addition patients in our trials.

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 2023 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, 
  2023  2022 
       
Clinical trial sites and investigational drug costs $1,288,577  $1,022,705 
Wages and salaries  1,282,441   524,108 
Laboratory Rent  48,000   25,800 
Supplies  207,061   20,762 
Professional fees  2,187   5,351 
Insurance product  -   - 
Share-based compensation  225,091   109,453 
  $3,053,357  $1,708,179 

For the three-month period ended January 31, 2023, total research costs amounted to $3,053,357, as compared to $1,708,179 for the three-month period ended January 31, 2022. 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 $1,022,705 in 2022 to $1,288,577 in 2023. Laboratory costs increase during 2023 as well, including the hiring of additional lab employees which increased from $524,108 in 2022 to $1,282,441 in 2023 and increased supplies from $20,762 in 2022 to $207,061 in 2023. Finally, the increase in share based compensation (non-cash) expenses, from $109,453 in 2022 to $225,091 in 2023 also contributed to the increase in research and development expenses.

General and Administrative Expenses

For the three-month period ended January 31, 2023, general and administrative expenses amounted to $1,432,966 as compared to $1,938,630 for the three-month period ended January 31, 2022. The decrease relates primarily to decrease in share based compensation (non-cash) expense.

Financial income (expenses), net

For the three-month period ended January 31, 2023, financial expense, net, amounted to $7,395,439, as compared to income of $14,807,316 for the three-month period ended January 31, 2022. The large difference is due to the change in value of the Company’s warrant liability which amounted to a loss of $7,629,502 in the three-month period ending January 31, 2023, and a gain of $14,797,888 in the three-month period ending January 31, 2022.

Loss for the period

The Company reported a loss for the three-month period ended January 31, 2023, of $11,881,762, as compared to a gain of $11,160,507 for the three-month period ended January 31, 2022. The loss in 2023 is due to a significant increase in the fair value of the warrant liability with the addition of increased operational spending. The gain in the prior period is due to the large decrease in fair value of the warrant liability.

23

Results of Operations for the Six Months Ended January 31, 2023 and 2022

  Six months ended January 31, 
  2023  2022 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses  6,308,572   2,583,815 
General and administrative expenses  3,580,902   3,347,803 
Total operating expenses  9,889,474   5,931,618 
         
Operating loss  (9,889,474)  (5,931,618)
Interest income  428,948   18,386 
Interest expense  -   (979)
Change in fair value of warrant liability  (3,511,712)  (10,456,148)
Gain of government grant  -   3,388 
Foreign exchange gain  (16,065)  (6,007)
Total financial expenses, net  (3,098,829)  (10,441,360)
Loss and Comprehensive loss for the period $(12,988,303) $(16,372,978)
Net loss per share – basic and diluted $(0.84) $(1.05)
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock  15,518,018   15,547,497 

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, 
  2023  2022 
       
Clinical trials $3,041,327  $960,804 
Pre-clinical projects  1,608,402   906,067 
CMC Costs  741,608   269,264 
Other  917,235   447,679 
  $6,308,572  $2,583,815 

Our clinical trial expenses include our immunotherapy program, Bria-IMT™, a 46-subject Phase I/IIa clinical trial. Clinical trial expenses increased in 2023 as we recruited more patients into the Bria-IMT™ trial and began setting up the Bria-OTS™ trial.

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 addition pre-clinical program (sCD80).

CMC costs include the manufacturing of Bria-IMT™ and Bria-OTS™. CMC costs increased in 2023 to support the additional patients in our trials.

 

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 2023 as we investigated additional potential pre-clinical projects.

 

15

The following is a breakdown of our research and development costs by nature of expenses:

 Six months ended January 31,  Three months ended October 31, 
 2023  2022  2023 2022 
          
Clinical trial sites and Investigational drug costs $3,330,516  $1,497,780 
Clinical trial sites and investigational drug costs $5,397,438  $2,041,939 
Wages and salaries  1,998,985   809,648   1,020,725   716,544 
Laboratory Rent  96,000   55,954   88,480   48,000 
Supplies  300,425   80,391   89,023   93,364 
Professional fees  7,299   28,933   3,782   5,112 
Insurance product  -   1,656 
Share-based compensation  575,347   109,453   257,809   350,256 
 $6,308,572  $2,583,815  $6,857,257  $3,255,215 

 

For the six-monththree-month period ended Januaryending October 31, 2023, research costs amounted to $6,308,572, as compared to $2,583,815 for$6,857,257, a significant increase from the six-month$3,255,215 incurred during the same period ended January 31,in 2022. The rise in these costs isThis upturn was primarily attributed tofueled by the continued expansion of the Company’s Bria-IMT™ trial and heightened costs associated with clinical trials specifically our Bria-IMT™ trial. Clinical Trials and investigational drug costs increaseddrugs, surging from $1,497,780$2,041,939 in 2022 to $3,330,516$5,397,438 in 2023. LaboratoryConcurrently, laboratory costs increase during 2023 as well, includingincreased due to the hiringrecruitment of additional lab employees, which increasedgrowing from $809,648$48,000 to $88,480. Notably, non-cash share-based compensation expenses decreased from $350,256 in 2022 to $1,998,985$257,809 in 2023, and increased supplies from $80,391 in 2022 to $300,425 in 2023. Finally,mitigating some of the increase in share based compensation (non-cash) expenses, from $109,453 in 2022 to $575,347 in 2023 also contributed to theoverall increase in research and development expenses.

 

General and Administrative Expenses

 

For the six-monththree-month period ended Januaryending October 31, 2023, general and administrative expenses amounted to $3,580,902 as compared$1,645,771, showing a decrease from $2,147,936 in the same period of 2022. This reduction is mainly attributed to $3,347,803 for the six-month period ended January 31, 2022. These increases relate primarilya decrease in non-cash share-based compensation expenses, which declined from $761,685 in 2022 to increased insurance premiums, professional fees, and salaries.$276,007 in 2023.

Financial income (expenses), net

 

For the six-monththree-month period ended Januaryending October 31, 2023, net financial expense, net,income amounted to $3,098,829, as compared to $10,441,360 for$14,461,900, a significant increase from the six-month$4,296,610 recorded in the same period ended January 31,of 2022. The largeThis substantial difference is dueprimarily attributed to the change in the value of the Company’s warrant liability, which amountedis directly affected by the shortened life of the warrants and decrease in share price, resulting in a gain of $14,282,078 for the three-month period ended October 31, 2023, compared to a lossgain of $3,511,712$4,117,790 in the six-monththree-month period ending January 31, 2023, and a loss of $10,456,148 in the six-month period ending January 31, 2022. The Company recorded $428,948 in interest income in the six-month period ending January 31, 2023, as compared to $18,386 in the six-month period ending Januaryended October 31, 2022.

 

24

LossProfit (loss) for the period

 

TheFor the three-month period ended October 31, 2023, the Company reported a profit of $5,958,872 compared to a loss of $1,106,541 for the same period ended January 31, 2023, of $12,988,303, as compared to $16,372,978 for the period ended January 31,in 2022. The lossprofit in 2023 isprimarily resulted from increased operational spending, offset by a large gain due to a significant increasethe decrease in the fair value of the warrant withliability. In contrast, the addition of increased operational spending. The higher loss in the prior period iswas primarily due to the larger increasea smaller change in fairthe 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 JanuaryOctober 31, 2023, the Company has total assets of $34,161,267$18,619,235 (July 31, 20222023 - $42,577,041)$27,163,577) and a positive working capital balance of $33,268,148$17,361,478 (July 31, 20222023 -$41,405,613)25,147,050).

 

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 condensed consolidated financial statements.

16

 

Liquidity and Capital Resources

 

As of JanuaryOctober 31, 2023, the Company has working capital of $33,268,148$17,361,478 (July 31, 20222023 - $41,405,613)$25,147,050) and an accumulated deficit of $73,338,140$74,560,688 (July 31, 20222023 - $60,349,837)$80,652,231).

 

As of JanuaryOctober 31, 2023, 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. 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 successfulsuccessful.

 

During the six-month period ended JanuaryOctober 31, 2023, the Company’s overall position of cash and cash equivalents decreased by $14,481,449$7,605,245 from the six-month period ended JanuaryOctober 31, 2022 (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 JanuaryOctober 31, 2023, was $7,494,122,$7,605,245 as compared to $4,334,808$3,542,382 for the six-month period ended JanuaryOctober 31, 2022.

 

Cash used in financing activities for the six-month period ended JanuaryOctober 31, 2023, was $47,294,nil as compared to $4,952,192$47,294 for the six-month period ended JanuaryOctober 31, 2022.

 

2517
 

 

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 JanuaryOctober 31, 2023.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

The Company’s financial instruments consist of cash and cash equivalents, amounts receivable, investments, warrant liability, short term loans, trade payable, , and accrued expenses and other payables. Unless otherwise noted, it is management’s opinion that the Company is not exposed to significant interest or credit risks arising from these financial instruments. The fair value of these financial instruments approximates their carrying values, unless otherwise noted.

 

Management understands that the Company is exposed to financial risk arising from fluctuations in foreign exchange rates and the degree of volatility of these rates as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs relating to being a public company in Canada), and the Company’s functional and presentation currency is the US dollar. The Company does not use derivative instruments to reduce its exposure to foreign currency risk.

 

The Company is exposed in varying degrees to a variety of financial instrument related risks. The Board of Directors approves and monitors the risk management process. The overall objectives of the Board are to set policies that seek to reduce risk as far as possible without unduly affecting the Company’s competitiveness and flexibility.

 

The type of risk exposure and the way in which such exposure is managed is as follows:

 

Credit risk

 

The Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration with respect to financial instruments is remote.

 

Liquidity Risk

 

The Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come due. As of JanuaryOctober 31, 2023, the Company has total assets of $34,161,267$18,619,235 (July 31, 20222023 - $42,577,041)$27,163,577) and a positive working capital balance of $33,368,149$17,361,478 (July 31, 20222023 –$41,405,613)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. TheLoans payable include both fixed and variable interest rates; however, the Company does not believe it is exposed to material interest rate risk as it has no interest-bearing debt.risk.

 

Price risk

 

As the Company has no revenues, price risk is remote.

 

2618
 

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 tradeaccounts payable and cash. As of JanuaryOctober 31, 2023, 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, warrant liability, short term loans, and accrued expenses and other payables approximate their fair values due to their short terms to maturity.

 

The cashCash and cash equivalents are valued using quoted market prices in active markets. The fair value of the warrant liability is determined based on nature of the warrant. For publicly traded warrants we use the quoted market price and for all other warrants we use the Black-Scholes pricing model.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

 

Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal accounting and financial officer have concluded that as of JanuaryOctober 31, 2023, our disclosure controls and procedures were not effective as a result of material weaknesses in our internal control over financial reporting. We continue to implement plans that are improving 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.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 JanuaryOctober 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except for our remediation efforts described above.reporting.

 

PART II - OTHER INFORMATION

 

Item 1. 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. At oral argument on January 19, 2023, Justice Cohen granted in part and denied in part Alpha’s partial motion to dismiss BriaCell’s Amended Counterclaim and Affirmative Defenses. In relevant part, Justice Cohen refused to dismiss any of BriaCell’s substantive counterclaims, allowing BriaCell to continue to prosecute its Unjust Enrichment, Money Had and Received, Recovery of Excess, and Implied Covenant of Good Faith and Fair Dealing claims against Alpha. At this time, the parties cannot estimate the value of their respective claims and damages.

 

None.

27

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 is more likely than not that BriaCell will not have to pay Alpha in the litigation.

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, 2022.2023.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.There were no unregistered sales of equity securities during the three months ended October 31, 2023.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not Applicable.

19

 

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.

 

2820
 

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 15,December 14, 2023By:/s/ William V. Williams
 Name:William V. Williams
 Title:Chief Executive Officer
  (Principal Executive Officer)
   
March 15,December 14, 2023By:/s/ Gadi Levin
 Name:Gadi Levin
 Title:Chief Financial Officer
  (Principal Financial and Accounting Officer)Officer)

 

2921