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 OctoberJanuary 31, 20222024

 

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)

 

DelawareBritish Columbia, Canada 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 Yes No ☐

 

As of December 14, 2022,March 18, 2024, there were 15,518,01815,981,726 common shares, no par value per share, of the Company issued and outstanding.

 

 

 

 
 

BRIACELL THERAPEUTICS CORP.

Form 10-Q

Table of Contents

 

 Page
Part I. Financial Information3
   
Item 1.Financial Statements3
 Condensed Consolidated Balance Sheets as of OctoberJanuary 31, 20222024 (unaudited) and July 31, 2022 (audited)2023 (unaudited)3
 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three monthsThree and Six Months ended OctoberJanuary 31, 202220244
 Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three monthsThree and Six Months ended OctoberJanuary 31, 202220245
 Unaudited Condensed Consolidated Statement of Cash Flows for the three monthsSix Months ended OctoberJanuary 31, 202220246
 Notes to Unaudited Condensed Consolidated Financial Statements7
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations16
Item 3.Quantitative and Qualitative Disclosures Regarding Market Risk22
Item 4.Controls and Procedures23
   
Part II. Other Information2324
   
Item 1.Legal Proceedings2324
Item 1A.Risk Factors2324
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds24
Item 3.Defaults Upon Senior Securities24
Item 4.Mine Safety Disclosures24
Item 5.Other Information24
Item 6.Exhibits24
   
Part III. Signatures2625

 

2
 

 

PART I-FINANCIAL

INFORMATION

 

Item 1. Financial Statements

 

BRIACELL THERAPEUTICS CORP.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

        
 October 31, 2022  July 31, 2022  January 31, 2024  July 31, 2023 
            
ASSETS                
                
CURRENT ASSETS:                
Cash and cash equivalents $37,451,976  $41,041,652  $6,244,528  $21,251,092 
Amounts receivable  29,698   24,103   30,145   18,873 
Prepaid expenses  742,123   1,280,945   5,467,286   5,678,542 
Total current assets  38,223,797   42,346,700   11,741,959   26,948,507 
                
NON-CURRENT ASSETS:                
Investments  2   2   2   2 
Equity investment in BC Therapeutics  281,655   - 
Intangible assets, net  226,521   230,339   207,431   215,068 
Total non-current assets  226,523   230,341   489,088   215,070 
                
Total assets $38,450,320  $42,577,041  $12,231,047  $27,163,577 
                
LIABILITIES AND SHAREHOLDERS’ EQUITY                
                
CURRENT LIABILITIES:                
Trade payables $791,748  $463,280  $3,711,455  $1,123,739 
Accrued expenses and other payables  182,302   477,807   212,870   677,718 
Total current liabilities  974,050   941,087   3,924,325   1,801,457 
                
NON-CURRENT LIABILITIES:                
Warrant liability  27,141,938   31,307,022   16,624,177   29,139,301 
Total non-current liabilities  27,141,938   31,307,022   16,624,177   29,139,301 
                
SHAREHOLDERS’ EQUITY:        
Share Capital of no par value - Authorized: unlimited at October 31, 2022 and July 31, 2022, Issued and outstanding: 15,518,018 shares October 31, 2022 and July 31, 2022, respectively  65,589,293   65,589,293 
Additional paid in capital  6,340,101   5,228,160 
SHAREHOLDERS’ DEFICIT:        
Share Capital of no par value - Authorized: unlimited at January 31, 2024 and July 31, 2023, Issued and outstanding: 15,981,726 shares January 31, 2024 and July 31, 2023, respectively  69,591,784   69,591,784 
Share-based payment reserve  8,419,154   7,421,950 
Accumulated other comprehensive loss  (138,684)  (138,684)  (138,684)  (138,684)
Non-controlling Interest  (244,418)  - 
Accumulated deficit  (61,456,378)  (60,349,837)  (85,945,291)  (80,652,231)
Total shareholders’ equity  10,334,332   10,328,932 
Total shareholders’ deficit  (8,317,455)  (3,777,181)
                
Total liabilities and shareholders’ equity $38,450,320  $42,577,041 
Total liabilities and shareholders’ deficit $12,231,047  $27,163,577 

 

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

 

3
 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JANUARY 31, 2024

(Unaudited)

         
  Three months ended
October 31,
 
  2022  2021 
Operating Expenses:        
Research and development expenses $3,255,215  $875,636 
General and administrative expenses  2,147,936   1,409,173 
Total operating expenses  5,403,151   2,284,809 
         
Operating loss  (5,403,151)  (2,284,809)
Financial income (expenses), net        
Interest income  188,353   6,305 

Interest expense

  -   (979)

Change in fair value of warrant liability

  4,117,790   (25,254,036)
Foreign exchange gain  

(9,533

)  34 
Total financial income (expenses), net $4,296,610  $(25,248,676)
Net loss and comprehensive loss for the period $(1,106,541) $(27,533,485)
Net loss per share – basic and diluted $(0.07) $(1.81)
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock  15,518,018   15,238,646 
  2024  2023  2024  2023 
  Three months ended
January 31,
  Six months ended
January 31,
 
  2024  2023  2024  2023 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Operating Expenses:                
Research and development expenses $8,257,455  $3,053,357  $15,114,712  $6,308,572 
General and administrative expenses  1,571,991   1,432,966   3,217,762   3,580,902 
Total operating expenses  9,829,446   4,486,323   18,332,474   9,889,474 
                 
Operating loss  (9,829,446)  (4,486,323)  (18,332,474)  (9,889,474)
Financial expenses, net  (1,486,119)  (7,395,439)  12,975,781   (3,098,829)
Share of loss on equity investment  (18,345)  -   (18,345)  - 
Net loss for the period $(11,333,910) $(11,881,762) $(5,375,038)  (12,988,303)
Net loss attributable to non-controlling interest  (39,307)  -   (81,978)  - 
Net loss and Comprehensive loss for the period attributable to BriaCell  (11,294,603)  (11,881,762)  (5,293,060)  (12,988,303)
Net loss per share attributable to BriaCell – basic and diluted $(0.71) $(0.77) $(0.33) $(0.84)
Weighted average number of shares used in computing net basic earnings per share of common stock  15,981,726   15,518,018   15,981,726   15,518,018 
Weighted average number of shares used in computing net diluted earnings per share of common stock  15,981,726   15,518,018   15,981,726   15,518,018 

 

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

 

4
 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

FOR THE THREE AND SIX MONTHS ENDED OCTOBERJANUARY 31, 20222024

                         
  Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  Total
shareholders’
 
  Number  Amount  capital  loss  deficit  Equity 
Balance, July 31, 2022  15,518,018  $65,589,293  $5,228,160  $(138,684) $(60,349,837) $    10,328,932 
                         
Share based compensation  -   -   1,111,941   -   -   1,111,941 
Loss for the period  -   -   -   -   (1,106,541)  (1,106,541)
Balance, October 31, 2022  15,518,018  $65,589,293  $6,340,101  $(138,684) $(61,456,378) $10,334,332 
  Number  Amount  capital  loss  deficit  interest  (deficit) 
  Share capital  Additional
paid in
  Accumulated other
comprehensive
  Accumulated  Non-
controlling
  

Total

shareholders’ equity

 
  Number  Amount  capital  loss  deficit  interest  (deficit) 
Balance, October 31, 2023  15,981,726  $69,591,784  $7,918,999  $(138,684) $(74,650,688) $(205,111) $2,516,300 
Issuance of options  -   -   500,155   -   -   -   500,155 
Loss for the period  -   -   -   -   (11,294,603)  (39,307)  (11,333,910)
Balance, January 31, 2024  15,981,726  $69,591,784  $8,419,154  $(138,684) $(85,945,291) $(244,418) $(8,317,455)

  Share capital  Additional
paid in
  Accumulated other
comprehensive
  Accumulated  Non-
controlling
  

Total

shareholders’

 
  Number  Amount  capital  loss  deficit  interest  deficit 
Balance, July 31, 2023  15,981,726  $69,591,784  $7,421,950  $(138,684) $(80,652,231)  -  $(3,777,181)
Instruments issued to minority shareholders at the Arrangement Date  -   -   (36,767)  -   -   (162,440)  (199,207)
Issuance of options  -   -   1,033,971   -   -   -   1,033,971 
Loss for the period  -   -   -   -   (5,293,060)  (81,978)  (5,375,038)
Balance, January 31, 2024  15,981,726  $69,591,784  $8,419,154  $(138,684) $(85,945,291) $(244,418) $(8,317,455)

  Number  Amount  capital  loss  deficit  (deficit) 
  Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  

Total
shareholders’

equity

 
  Number  Amount  capital  loss  deficit  (deficit) 
Balance, October 31, 2022  15,518,018  $65,589,293  $6,340,101  $(138,684) $(61,456,378) $10,334,332 
                         
Issuance of options  -   -   266,844   -   -   266,844 
Loss for the period  -   -   -   -   (11,881,762)  (11,881,762)
Balance, January 31, 2023  15,518,018  $65,589,293  $6,606,945  $(138,684) $(73,338,140) $(1,280,586)

 

  Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  Total
shareholders’
 
  Number  Amount  capital  loss  deficit  Equity 
Balance, July 31, 2021  15,269,583  $54,774,172  $2,178,130  $(138,684) $(29,141,897) $     27,671,721 
Exercise of warrants  100,829   927,407   -   -   -   927,407 
Issuance of options  -   -   518,134   -   -   518,134 
Loss for the period  -   -   -   -   (27,533,485)  (27,533,485)
Balance, October 31, 2021  15,370,412  $55,701,579  $2,696,264  $(138,684) $(56,675,382) $1,583,777 
  Share capital  Additional paid in  Accumulated other comprehensive  Accumulated  

Total
shareholders’

equity

 
  Number  Amount  capital  loss  deficit  (deficit) 
Balance, July 31, 2022  15,518,018  $65,589,293  $5,228,160  $(138,684) $(60,349,837) $10,328,932 
Balance  15,518,018  $65,589,293  $5,228,160  $(138,684) $(60,349,837) $10,328,932 
Issuance of options  -   -   1,378,785   -   -   1,378,785 
Loss for the period  -   -   -   -   (12,988,303)  (12,988,303)
Income (loss) for the period  -   -   -   -   (12,988,303)  (12,988,303)
Balance, January 31, 2023  15,518,018  $65,589,293  $6,606,945  $(138,684) $(73,338,140) $(1,280,586)
Balance  15,518,018  $65,589,293  $6,606,945  $(138,684) $(73,338,140) $(1,280,586)

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

 

5
 

 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE SIX MONTHS ENDED JANUARY 31, 2024

(Unaudited)

 

         2024  2023 
 Three months ended October 31,  Six months ended January 31, 
 2022  2021  2024  2023 
Cash flow from operating activities                
Net loss $(1,106,541) $(27,533,485) $(5,375,038) $(12,988,303)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  3,818   3,817   7,637   7,635 
Share-based compensation  1,111,941   518,134   1,033,971   1,378,785 
Interest expense  -   979 
Share of loss on equity investment  18,345   - 
Change in fair value of warrants  (4,117,790)  25,254,036   (12,714,331)  3,511,712 
Changes in assets and liabilities:                
Increase in amounts receivable  (5,595)  (6,755)  (11,272)  15,175 
Decrease in prepaid expenses  538,822   110,105   (88,744

)

  851,548 
Increase in accounts payable  328,468   29,334 
Increase in trade payable  2,587,716   119,171 
Decrease in accrued expenses and other payables  (295,505)  (154,763)  (464,848)  (389,845)
Total cash flow from operating activities  (3,542,382)  (1,778,599)  (15,006,564)  (7,494,122)
                
Cash flows from investing activities        
Equity Investment in BC Therapeutics (*)  -  - 
Total cash flow from investing activities  

-

  - 
Cash flows from financing activities                
Share and warrant buyback program  (47,294)  -   -   (47,294)
Total cash flow from financing activities  (47,294)  -   -   (47,294)
                
Decrease in cash and cash equivalents  (3,589,676)  (1,778,599)  (15,006,564)  (7,541,416)
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 $37,451,976  $55,490,086  $6,244,528  $33,500,236 

 

(*)$125,000 of this amount was loaned to BC Therapeutics during the year ended July 31, 2023 and an additional $175,000 was loaned to BC Therapeutics between August 1, 2023 and December 20, 2023. The total amount ($300,000) was converted into an investment).

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

 

6
 

BriaCell Therapeutics Corp

BRIACELL THERAPEUTICS CORP.Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 1: GENERAL AND GOING CONCERN

 

 a.BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) was incorporated under the Business Corporations Act (British Columbia) on July 26, 2006 and is listed on the Toronto Stock Exchange (“TSX”) under the symbol “BCT” and on the Nasdaq Capital Market (“NASDAQ”) under the symbols “BCTX” and “BCTXW”.

 

 b.BriaCell Therapeutics Corporation. (the “Company”), is an immuno-oncology biotechnology company. 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 October 31, 2021 to be prepared in accordance with U.S. GAAP.

 

 d.The Company continues to devote substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of OctoberJanuary 31, 20222024 was $61,456,37885,945,291 and negative cash flows from operating activities during the three-monthsix-month period ended OctoberJanuary 31, 20222024 was $3,542,38215,006,564. The Company is planning to finance its operations from its existing and future working capital resources and to continue to evaluate additional sources of capital and financing. The Company believes thatCompany’s ability to continue as a going concern is dependent upon its existing capital resources will be adequateability to satisfyattain future profitable operations and to obtain the necessary financing to meet its expected liquidity requirements for at least twelve monthsobligations arising from the issuancenormal business operations when they come due. The uncertainty of the condensed consolidated financial statements.

e.The Company has a wholly-owned U.S. subsidiary, BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April 3, 2014, under the laws of the state of Delaware. BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia” and together with BTC the “Subsidiaries”), which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company has one operating segment and reporting unit.
f.Since January 2020, the Coronavirus outbreak has dramatically expanded into a worldwide pandemic creating macro-economic uncertainty and disruption in the business and financial markets. Many countries around the world, including Canada and the United States have been taking measures designated to limit the continued spread of the Coronavirus, including the closure of workplaces, restricting travel, prohibiting assembling, closing international borders and quarantining populated areas. Such measures present concerns that may dramatically affect the Company’s ability to conduct its business effectively.
The Company may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak of COVID-19. In the event that clinical trial sites are slowed down or closed to enrolment in our trials, this could have a material adverse impactraise such financial capital casts significant doubt on our clinical trial plans and timelines. The Company is continuing to assess its business plans and the impact COVID-19 is having on the Company’s clinical trial timelines and the Company’s ability to recruit candidates for clinical trials. The extentcontinue as a going concern. These consolidated financial statements do not include any adjustments to which COVID-19the amounts and global effortsclassification of assets and liabilities that might be necessary should the Company not be able to contain its spread will impact our operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak. The Company currently believes that the execution of our clinical trials and research programs are delayed by at least one quarter due to COVID-19.continue as a going concern.

 

7
 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

NOTE 1: GENERAL AND GOING CONCERN (Cont.)

e.The Company has two wholly-owned U.S. subsidiaries: (i) BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April 3, 2014, under the laws of the state of Delaware. (ii) BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”), which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company also has one Canadian subsidiary: BriaPro Therapeutics Corp, (“BriaPro”) which was incorporated on May 15, 2023, was incorporated under the Business Corporations Act (British Columbia). As of July 31, 2023, BriaPro was a wholly-owned subsidiary.

f.

On August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”) pursuant to which certain pipeline assets of the Company, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”), were spun-out to BriaPro Therapeutics Corp. (“BriaPro”), resulting in a 2/3rd owned subsidiary of the Company with the remaining 1/3rd held by BriaCell shareholders (“BriaCell Shareholders”).

Pursuant to the terms of the Arrangement, BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration for the issuance by BriaPro to the Company of BriaPro common shares. Under the terms of the Arrangement, for each BriaCell share held immediately prior to closing, BriaCell Shareholders receive one (1) common share of BriaPro, and one (1) new common share of BriaCell (retiring their old share) having the same terms and characteristics as the existing BriaCell common shares. The Company will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada.

Immediately following the closing of the Arrangement, the Company controls 2/3rd of the BriaPro common shares representing approximately 66.6% of the issued and outstanding common shares of BriaPro.

As a result of the Arrangement, there are 47,945,178 BriaPro common shares issued and outstanding. The Company now beneficially owns or controls approximately 31,963,452 BriaPro common shares, representing 2/3rd of the issued and outstanding BriaPro common shares.

Pursuant to the Arrangement, each BriaCell warrant shall, in accordance with its terms, entitle the holder thereof to receive, upon the exercise thereof, one BriaCell Share and one BriaPro Share for the original exercise price.

Upon the exercise of BriaCell Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount for each one (1) BriaPro Share so issued that is equal to the exercise price under the BriaCell Warrant multiplied by the fair market value of one (1) BriaPro Share at the Effective Date divided by the total fair market value of one (1) BriaCell Share and one (1) BriaPro Share at the Effective Date (“BriaPro Warrant Shares”).

Pursuant to the Arrangement, all Briacell option holders received the same amount of BriaPro options (“BriaPro Option”) and under the BriaPro incentive plan. The exercise price of the BriaCell options was apportioned between the BriaCell options and the BriaPro options, as follows:

Each one (1) BriaPro Option to acquire one (1) Share shall have an exercise price equal to the product obtained by multiplying the original exercise price of the BriaCell Option by the quotient obtained by dividing (A) the fair market value of a BriaPro Share at the Effective Date by (B) the aggregate fair market value of a BriaCell Share and a BriaPro Share at the Effective Date.

Pursuant to the Arrangement, all BriaCell Restricted Shares Units (“RSU”) holders received the same amount of BriaPro RSU’s under the BriaPro incentive plan.

Transition Services Agreement

On August 31, 2023, the Company and BriaPro executed a transition services agreement (the “Agreement”), pursuant to which BriaCell will provide certain research and development and head office services (the “Services”) to BriaPro for a fixed monthly fee of $20,000.

Briacell and BriaPro acknowledged the transitional nature of the Services and accordingly, as promptly as practicable, BriaPro agreed to use commercially reasonable efforts to transition each Service to its own internal organization or to obtain alternate third party providers to provide the Services.

In accordance with US GAAP’s Accounting Standards Codification 505 “Equity”, the Arrangement was determined to be a spinoff of nonmonetary assets which did not constitute a business. However, since the assets were transferred to an entity under the Company’s control, the assets is being recorded on the Company’s basis (carry value) and not at fair market value.

8

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 2:SIGNIFICANT ACCOUNTING POLICIES

 

a.Use of estimates:

 

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

 

b.Equity method investments:

Investments in entities over which the Company does not have a controlling financial interest but has significant influence, are accounted for using the equity method, with the Company’s share of losses reported in loss from equity method investments on the statements of loss and comprehensive loss. Equity method investments are recorded at cost, plus the Company’s share of undistributed earnings or losses, and impairment, if any, within interest in equity investees on the statements of financial position.

c. Recently issued and adopted accounting standards:

 

As an “emerging growth company,” the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The Company has elected to use this extended transition period under the JOBS Act. The adoption dates discussed below reflects this election. The pronouncements below relate to standards that impact the Company.

 

 1.

In June 2016,March 2022, the FASB issued ASU No. 2016-13 (Topic 326), 2022-02 - Financial Instruments—Credit Losses: MeasurementLosses (Topic 326): Troubled Debt Restructurings and Vintage Disclosures. This standard eliminates the accounting guidance on TDRs for creditors in ASC 310-40 and amends the guidance on “vintage disclosures” to require disclosure of Credit Losses on Financial Instruments, which replacescurrent period gross write-offs by year of origination. The ASU also updates the existing incurred loss impairment modelrequirements related to accounting for credit losses under ASC 326 and adds enhanced disclosures for creditors with an expected credit loss modelrespect to loan refinancings and requires arestructurings for borrowers experiencing financial asset measured at amortized cost to be presented at the net amount expected to be collected.difficulty. The guidance will beamendments in this update are effective for the Company for fiscal years beginning after December 15, 2022. Early adoption is permitted. Effective August 1, 2021, the Company early adopted ASU 2016-13. Adoption of the new standard did not have a material impact on the financial statements.

2.In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The final guidance issued by the FASB for convertible instruments eliminates two of the three models in ASC 470-20 that require separate accounting for embedded conversion features. Separate accounting is still required in certain cases. Additionally, among other changes, the guidance eliminates some of the conditions for equity classification in ASC 815-40-25 for contracts in an entity’s own equity. The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. ASU 2020-06 is effective for the company for fiscal years beginning after December 15, 2023, and2022, including interim periods within those fiscal years. Early adoption is permittedyears, for fiscal years beginning after December 15, 2020. Effective August 1, 2021, the Company earlyany entities that have adopted ASU 2020-06. Adoption2016-13 - Financial Instruments - Credit Losses (Topic 326): Measurement of the newCredit Losses on Financial Instruments. The adoption of this standard did not result in amended disclosures in the Company’s Condensed Consolidated Financial Statements, nor did this standard have a material impact 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 transparencyCompany’s results 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.operations.

 

89
 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)

2.

In July 2023, the FASB issued 2023-03 — Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation (Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022, EITF Meeting, and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X: Income or Loss Applicable to Common Stock (SEC Update). The adoption of this standard did not result in amended disclosures in the Company’s Condensed Consolidated Financial Statements, nor did this standard have a material impact the Company’s results of operations.

NOTE 3: INVESTMENT IN BC THERAPEUTICS INC.

On December 21, 2021, the Company and BC Therapeutics, Inc. (“BC Therapeutics” or “the Investee”) entered a share purchase agreement (“SPA”), pursuant to which the Company invested $300,000 at $1.25 per BC Therapeutics share for a 37.5% interest in the Investee. Pursuant to the SPA, Briacell also received two options to invest an additional $225,000 per option at $1.25 per BC Therapeutics share. The first option expires on February 15, 2024 and the second option expires on June 30, 2024 (“BC Therapeutics Options”). In accordance with ASC 321 and ASC 815, the BC Therapeutics Options were valued at $76,350 in accordance with the Black Scholes Option Price Model, using the following assumptions: Share price: $1.25, Exercise price: $1.25, Dividend yield: 0%, Risk free interest rate: $4.902%, Volatility: 100%.

Subsequent to January 31, 2024, the Company exercised the first option on February 1, 2024 and now holds 51% of BC Therapeutics.

BC Therapeutics has a board of four representatives, with two representatives appointed by BriaCell and two representatives appointed by the existing shareholders. All significant decisions related to BC Therapeutics require the approval of at least a majority of the board members.

Changes in the Company’s Investment in BC Therapeutics is summarized as follows:

SCHEDULE OF CHANGES IN INVESTMENT

     
Balance – August 1, 2023 $- 
Funding (including the value of the BC Therapeutics Options)  300,000 
Share of losses:    
Operating expenses  (18,345)
Balance – January 1, 2024 $281,655 

The following amounts represent the Company’s 37.5% share of the assets and liabilities of BC Therapeutics:

SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS

  

As of

January 31, 2024

 
Current assets: Cash $4,196 
Net assets $4,196 

 

NOTE 3:4: CONTINGENT LIABILITIES AND COMMITMENTS

 

 a.Legal proceedings:BriaPro Warrants

 

On May 19, 2021, Alpha Capital Anstalt (“Alpha”) filed a lawsuitAs detailed in note 1(f), upon the New York State Supreme Court, Commercial Division, New York County againstexercise of BriaCell Therapeutics Corp. (“BriaCell”), alleging thatWarrants, BriaCell breached a loan contract when it refusedshall, as agent for BriaPro, collect and pay to reprice and extend the termBriaPro an amount 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 loanup to BriaCell is unenforceable both because the loan is criminally usurious under New York law and because Alpha acted as an unregistered securities dealer in violation of American securities law. BriaCell also has alleged that Canadian securities law, regulation, and rules prohibited it from amending the warrants to comply with Alpha’s spring 2021 demands. On May 11, 2022, Alpha moved to dismiss BriaCell’s operative Amended Counterclaim. The parties have fully briefed that motion, and the Court has calendared oral argument on that motion for February 7, 2023. Expert discovery is ongoing and may affect the value of the parties’ respective claims and damages.$241,164

The Company disagrees with Alpha’s claims, is defending these claims, and has filed a counter claim. At this time, whilst it is impossible to provide any guarantee as to the outcome of the lawsuit, it is the Company’s assessment, based on advice from the Company’s legal counsel at this time, and based on the information known by the Company, that it’s more likely than not that BriaCell will not have to pay Alpha in the litigation..

 

 b.Lease

 

The Company is currently onin a month-to-month lease arrangement12-month commitment (ending August 31, 2024) for office and lab space in Philadelphia, PA, incosting the amount ofcompany approximately $16,00036,000 per month.

10

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 4:5: FAIR VALUE MEASUREMENTS

 

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of OctoberJanuary 31, 20222024, and July 31, 2022:2023:

SCHEDULE OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS 

 Fair Value Measurements at  Fair Value Measurements at 
 October 31, 2022  July 31, 2022  January 31, 2024  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  37,451,976   -   37,451,976   41,041,652   -   41,041,652   6,244,528   -   6,244,528   21,251,092   -   21,251,092 
                                                
Total assets measured at fair value $37,451,976  $-  $37,451,976  $41,041,652  $-  $41,041,652  $6,244,528  $-  $6,244,528  $21,251,092  $-  $21,251,092 
                                                
Financial liabilities:                                                
Warrants liability  10,794,992   16,346,946   27,141,938   11,151,608   20,155,414   31,307,022   6,936,320   9,687,857   16,624,177   9,742,023   19,397,278   29,139,301 
                                                
Total liabilities measured at fair value $10,794,992  $16,346,946  $27,141,938  $11,151,608  $20,155,414  $31,307,022  $6,936,320  $9,687,857  $16,624,177  $9,742,023  $19,397,278  $29,139,301 

 

We classify our

The Company classifies its cash and cash equivalents and the liability in respect of publicly traded warrants within Level 1 because we use quoted market prices in active markets.

 

The fair value of the warrant liability for non-public warrants is measured using inputs other than quoted prices included in Level 1 that are observable for the liability either directly or indirectly, and thus are classified as Level 2 financial instruments.

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 5:6: SHAREHOLDERS’ EQUITY

 

f.Authorized share capital

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 three-monthsix-month period ended OctoberJanuary 31, 2022.2024.

 

c. Share Purchase Warrants

SUMMARY OF CHANGES IN WARRANTS

(i)There were no changes in share purchase warrants for the six-month period ended January 31, 2024 as presented below:

  

Number of

warrants

outstanding

  

Weighted

average exercise

price

 
Balance, July 31, 2023 and January 31, 2024  8,121,650  $5.76 

SCHEDULE OF WARRANTS OUTSTANDING

(ii)As of January 31, 2024, warrants outstanding were as follows:

Number of

Warrants

  Exercise Price(*)  

Exercisable At

January 31, 2024

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

(*)See note 4(a).

1011
 

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:

NOTE 6: SHAREHOLDERS’ EQUITY (Cont.)

d. Compensation Warrants

(i)There were no changes to compensation warrants for the six-month period ended January 31, 2024.

(ii)As of January 31, 2024, compensation warrants outstanding were as follows:

SCHEDULE OF WARRANTS OUTSTANDING

Number of

Warrants

  Exercise Price(*)  

Exercisable At

January 31, 2024

  Expiry Date
 4,890  $3.91   4,890  November 16, 2025
 17,074  $5.31   17,074  February 26, 2026
 24,688  $6.19   24,688  June 7, 2026
 46,652       46,652   

(*)See note 4(a).

 

c. Share buyback programe. Warrant liability continuity

 

On September 9, 2021The following table presents the Company approved a repurchase program whereby the Company may purchase through the facilitiessummary 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”)changes in total, representing 10% of the13,415,154 Common Shares and 10% of the 4,119,622 Listed Warrants comprising the “public float” as of September 8, 2021, over the next 12 months (the “Buyback”). Independent Trading Group (ITG) Inc. will act as the Company’s advisor and dealer manager in respect of the Buyback. The Company received final regulatory approval on September 22, 2021. On September 27, 2022 the Company completed the share buyback program, repurchasing a total of 1,031,672 shares with a value of $9,098,014 (net of commissions), none of which were repurchased during the three month period ended October 31,2022, and 259,059 publicly traded warrants for $1,121,011 (net of commissions) with a fair value of $1,130,808 of which 15,736 were repurchased and cancelled during the three-month period ended October 31,2022. All of the warrants and shares repurchased have been cancelled.warrants:

SCHEDULE OF CHANGE IN FAIR VALUE OF WARRANTS

  Warrants liability 
    
Balance as of August 1, 2023 $29,139,301 
Fair value of BriaPro Warrant Shares at Effective Date $199,207 
Change in fair value during the period $(12,714,331)
     
Balance as of January 31, 2024 $16,624,177 

 

d. Share Purchase WarrantsThe key inputs used in the valuation of the non-public warrants as of January 31, 2024 and at July 31, 2023 were as follows:

A summary of changes in share purchase warrants for the three-month period ended October 31, 2022 is presented below:

SUMMARY OF CHANGES IN WARRANTS

  Number of
warrants
outstanding
  Weighted
average exercise
price
 
Balance, July 31, 2022  8,137,686  $5.76 
Repurchased and cancelled  (15,736)  (5.31)
Balance, October 31, 2022  8,121,950   5.76 

 

1112
 

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:

NOTE 6: SHAREHOLDERS’ EQUITY (Cont.)

d. Share Purchase Warrants (continued)

As of October 31, 2022, warrants outstanding were as follows:

SCHEDULE OF WARRANTS OUTSTANDING

Number of
Warrants
  Exercise Price  

Exercisable At
October 31, 2022

  Expiry Date
 51,698  $3.97   51,698  November 16, 2025
 3,897,109  $5.31   3,897,109  February 26, 2026April 26, 2026
 4,173,143  $6.19   4,173,143  December 7, 2026
 8,121,950       8,121,950   

e. Compensation Warrants

(i)There were no changes to compensation warrants for the three-month period ended October 31, 2022.

(ii)As at October 31, 2022, compensation warrants outstanding were as follows:

 SCHEDULE OF WARRANTS OUTSTANDING

Number of
Warrants
  Exercise Price  Exercisable At
October 31, 2022
  Expiry Date
 4,890  $3.97   4,890  November 16, 2025
 17,074  $5.31   17,074  February 26, 2026
 24,688  $6.19   24,688  June 7, 2026
 46,652       46,652   

12

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

NOTE 5:SHAREHOLDERS’ EQUITY (Cont.)

f. Warrant liability continuity

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

SCHEDULE OF CHANGE IN FAIR VALUEVALUATION OF WARRANTS

  Warrants liability 
    
Balance as of August 1, 2022 $31,307,022 
Warrant buyback program $(47,294)
Change in fair value during the period $(4,117,790)
     
Balance as of October 31, 2022 $27,141,938 
  January 31, 2024  July 31, 2023 
       
Share price $4.12  $6.69 
Exercise price $5.31-6.19  $5.31-6.19 
Expected life (years)  1.79-2.85  2.58-3.35 
Volatility  100%  100%
Dividend yield  0%  0%
Risk free rate  3.99-4.21%  4.51%

 

The key inputs used in the valuation of the non-public warrantsof the BriaPro Warrant Shares as of OctoberJanuary 31, 2022 and at July 31, 20222024 were as follows:

SCHEDULE OF VALUATION OF NON PUBLIC WARRANTS

 October 31, 2022 July 31, 2022  

January 31,

2024

  

August 31,

2023

(Effective Date)

 
         
Share price $5.50  $6.50  $0.0365  $0.0365 
Exercise price $3.97-6.19  $4.23-6.19    $0.0206-0.0308  $0.0206-0.0308 
Expected life (years)  3.32-4.10   3.58-4.35     1.79-2.85  2.21-3.27 
Volatility  100%  100%  100% 100%
Dividend yield  0%  0%  0% 0%
Risk free rate  4.23%  2.68%  3.99-4.00% 4.40%

NOTE 6:7: SHARE-BASED COMPENSATION

a.

On August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan), which will permit the Company to grant incentive stock options, preferred share units, restricted share units (“RSU’s”),RSU, and deferred share units (collectively, the “Awards”) for the benefit of any employee, officer, director, or consultant of the Company or any subsidiary of the Company. The maximum number of 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. TheOn February 9, 2023, the Omnibus Plan remains subject to approvalwas approved by the shareholders of the Company (the “Shareholders”) and final approval of the Toronto Stock Exchange (“Exchange”) and no new grants will be made under  the Company’s existing Stock Option Plan upon receipt of such approvals (“Approvals”).

The Company may make grants under the Omnibus Plan, however, the grants cannot be settled until the Approvals have been received.shareholders.

 

b.The following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan for three-monthsix-month period ended OctoberJanuary 31, 20222023 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   3.84  $447,090 
                 
Granted (i)  180,100   6.14   4.76   - 
                 
Balance as of October 31, 2022  1,670,400   6.19   3.94   - 
                 
Exercisable as of October 31, 2022  1,373,053  $6.10   3.81  $- 

(i)On August 2, 2022, the Company granted 180,100 options, under the Stock Option Plan, to directors, officers and employees with an exercise price of CAD$8.38. The options vest quarterly in advance over a two-year period and expire on August 2, 2027. The fair value of the 180,100 stock options issued was $887,362. 142,100 of the options were issued to officers of the Company. The fair value of the stock options issued to the officers was $700,134.
  Number of options  

Weighted

average

exercise price

  

Weighted

average

remaining

contractual term

(in years)

  

Aggregate

intrinsic value

 
             
Balance as of July 31, 2023  2,131,400  $6.19   3.55  $1,065,700 
                 
Balance as of January 31, 2024  2,131,400   6.18   3.05   - 
                 
Exercisable as of January 31, 2024  1,797,000  $6.19   2.83  $- 

 

The weighted-average grant date per-share fair value of stock options granted during three-month period ended October 31, 2022 was $4.93. As of OctoberJanuary 31, 2022,2024 there are $1,536,7221,556,676 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to 1.751.25 years.

 

13
��

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

NOTE 6:SHARE-BASED COMPENSATION (Cont.)

c.The following table lists the inputs to the Black-Scholes option-pricing model used for the fair value measurement of equity-settled share options for the above options plans for the three month period ended October 31, 2022 and 2021:

SCHEDULE OF FAIR VALUE MEASUREMENT OF EQUITY-SETTLED SHARE OPTIONS

  Three months ended
October 31,
 
  2022  2021 
Dividend yield  0%  0%
Expected volatility of the share prices  100%  100%
Risk-free interest rate  4.23%  0.80%
Expected term (in years)  5   5 

d.The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of October 31, 2022.

SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS

Exercise
price
  

Options
outstanding
as of
October 31,
2022

  

Weighted
average
remaining
contractual
term
(years)

  

Options
exercisable
as of
October 31,
2022

  

Weighted
average
remaining
contractual
term
(years)

  Expiry Date
                
$6.14   180,100   4.76   22,513   4.76  August 02, 2027
$4.71   31,000   4.56   7,750   4.56  May 20, 2027
$7.51   150,000   4.29   56,250   4.29  February 16, 2027
$8.47   524,700   4.20   503,500   4.20  January 13, 2027
$7.74   12,600   4.00   11,040   4.00  November 01, 2027
$5.74   100,000   3.84   100,000   3.84  September 01, 2026
$4.24   60,000   3.47   60,000   3.47  April 19, 2026
$4.24   612,000   3.41   612,000   3.41  March 29, 2026
     1,670,400       1,373,053       

e.Restricted Share Unit Plan

The following table summarizes the number of RSU’s granted to directors under the Omnibus plan for three-month period ended October 31, 2022:

SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

  

Number of
RSU’s
outstanding

  Aggregate
intrinsic value
 
Balance, July 31, 2022  -  $- 
Granted (i)  19,200   123,072 
Balance, October 31, 2022  19,200  $105,600 

(i)On August 2, 2022, the Company issued 19,200 RSU’s to the CEO. The RSU’s vested immediately.

f. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three-month period ended October 31, 2022 and 2021 is comprised as follows:

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES

         
  Three months ended
October 31,
 
  2022  2021 
       
Research and development expenses $350,256   - 
General and administrative expenses  761,685   518,134 
Total share-based compensation $1,111,941   518,134 

14

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 7: SHARE-BASED COMPENSATION (Cont.)

BASIC

c.The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of January 31, 2024.

SUMMARY OF OUTSTANDING AND DILUTED NET LOSS PER SHAREEXERCISABLE OPTIONS

Exercise

price

  

Options

outstanding as of

January 31, 2024

  

Weighted

average

remaining

contractual

term (years)

  

Options

exercisable as of

January 31, 2024

  

Weighted

average

remaining

contractual

term (years)

  Expiry Date
                
$6.03   440,000   4.39   165,000   4.39  June 20, 2028
$7.16   21,000   4.08   10,500   4.08  February 27, 2028
$6.04   180,100   3.51   135,075   3.51  August 02, 2027
$4.71   31,000   3.31   27,125   3.31  May 20, 2027
$7.51   150,000   3.04   150,000   3.04  February 16, 2027
$8.47   524,700   2.95   524,700   2.95  January 13, 2027
$7.15   12,600   2.75   12,600   2.75  November 01, 2026
$5.74   100,000   2.59   100,000   2.59  September 01, 2026
$4.24   60,000   2.22   60,000   2.22  April 19, 2026
$4.24   612,000   2.16   612,000   2.16  March 29, 2026
     2,131,400       1,797,000       

d.As result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of January 31, 2024:

SCHEDULE OF OPTION ISSUED AND OUTSTANDING

Exercise

Price

  

Options

outstanding as of January 31, 2024

  

Options

exercisable as of

January 31, 2024

  Expiry Date
          
$0.0933   440,000   165,000  June 20, 2028
$0.1108   21,000   10,500  February 27, 2028
$0.0984   180,100   135,075  August 02, 2027
$0.0729   31,000   27,125  May 20, 2027
$0.1162   150,000   150,000  February 16, 2027
$0.1310   524,700   524,700  January 13, 2027
$0.1165   12,600   12,600  November 01, 2026
$0.0888   100,000   100,000  September 01, 2026
$0.0656   60,000   60,000  April 19, 2026
$0.0656   612,000   612,000  March 29, 2026
     2,131,400   1,797,000   

e.Restricted Share Unit Plan

The following table summarizes the number of RSU’s granted to directors under the Omnibus plan as of January 31, 2024:

SUMMARY OF RESTRICTED STOCK UNITS GRANTED

  

Number of

RSU’s

outstanding

  

Aggregate

intrinsic value

 
Balance, July 31, 2023  19,200  $123,072 
Balance, January 31, 2024  19,200  $79,104 

14

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

NOTE 7: SHARE-BASED COMPENSATION (Cont.)

 

Basic net income (loss) per ordinary share is computed by dividing net income (loss)f. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for each reporting period by the weighted-average number of ordinary shares outstanding during each year. Diluted net income (loss) per ordinary share is computed by dividing net income (loss) for each reporting period by the weighted average number of ordinary shares outstanding during the period, plus dilutive potential ordinary shares considered outstanding during the period, in accordance with ASC No. 260-10 “Earnings Per Share”. The Company experienced a loss in three-monththree and six-month period ended OctoberJanuary 31, 20222024 and 2021; hence all potentially dilutive ordinary shares were excluded due to their anti-dilutive effect.2023 is comprised as follows:

 SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARESHARE-BASED COMPENSATION EXPENSES

         
  

Three months ended

October 31,

 
  2022  2021 
       
Numerator:        
Net loss available to shareholders of ordinary shares $(1,106,541) $(27,533,485)
Denominator:        
Shares used in computing net loss per ordinary shares, basic and diluted  15,518,018   15,238,646 
Net loss per share attributable to ordinary shareholders, basic and diluted $(0.07) $(1.81)
  2024  2023  2024  2023 
  Three months ended
January 31,
  Six months ended
January 31,
 
  2024  2023  2024  2023 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Research and development expenses $234,253   225,091  $492,062   575,347 
General and administrative expenses  265,902   41,753   541,909   803,438 
Total share-based compensation $500,155   266,844  $1,033,971   1,378,785 

NOTE 8: FINANCIAL INCOME (EXPENSES), NET

SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET

  2024  2023  2024  2023 
  

Three months ended

January 31,

  Six months ended
January 31,
 
  2024  2023  2024  2023 
  (Unaudited)  (Unaudited)  (Unaudited)  (Unaudited) 
Interest income $81,595   240,595  $272,410   428,948 
Change in fair value of warrant liability  (1,567,747)  (7,629,502)  12,714,331   (3,511,712)
Foreign exchange gain (loss)  33   (6,532)  (10,960)  (16,065)
Financial income (expenses), net $(1,486,119) $(7,395,439) $12,975,781  $(3,098,829)

 

NOTE 8:9: SUBSEQUENT EVENTSEVENT

 

The Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements through December 14, 2022,March 18, 2024, the date that the condensed consolidated financial statements were available for issuance. The Company is not aware of any subsequent events which would require recognition or disclosure in the consolidated financial statements.statements, except as follows:

a.As disclosed in note 3, subsequent to January 31, 2024, on February 1, 2024 the Company exercised an option to acquire an additional interest in BC Therapeutics and now owns 51%.

15
 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

References to the “Company,” “our,” “us” or “we” refer to BriaCell Therapeutics Corp. The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.

Introduction

 

This Management’s Discussion and Analysis (“MD&A”) should be read together with other information, including our unaudited condensed interim consolidated financial statements and the related notes to those statements included in Part I, Item 1 of this Quarterly Report (the “Condensed Consolidated Financial Statements”), our consolidated financial statements appearing in our Annual Report on Form 10-K for the year ended July 31, 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 first half and second quarter of fiscal 20232024 in comparison to the first half and second 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.

16

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 check point inhibitor (Retifanlimab) in a pivotal1 Phase 3 study in advanced metastatic breast cancer. Bria-IMT™ is currently under Fast Track Designation by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer. BriaCell reported benchmark-beating patient survival and a companion diagnostic test, BriaDx™, to identify patients most likely toclinical benefit from Bria-IMT™. The Bria-IMT™ regimen was evaluated in four patients in a prior study in 2004-2006 by Dr. Charles Wiseman, the scientific founder, former member of the board of directors of the Company (the “Board”) and principal scientific advisor. Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at HLA-DR alleles and had a grade II tumor. In 2017-2018 BriaCell evaluated 23 patients with advanced metastatic breast cancer with the Bria-IMT™ regimen and obtained confirmationmedian overall survival of the ability of the Bria-IMT™ regimen to induce regression of13.4 months in BriaCell’s advanced metastatic breast cancer patients vs. 6.7-9.8 months for similar patients reported in patients who matchthe literature in its Phase 2 study of Bria-IMT™ at least at one HLA allele and/or if they had grade I or grade II tumors. A combination study with retifanlimab at the 2023 San Antonio Breast Cancer Symposium. A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy. BriaCell is also developing a personalized off-the-shelf immunotherapy, Bria-OTS™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September 2018. BriaCell purchased the KEYTRUDA® for this 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.inhibitor.

 

It1“Pivotal” is estimated byan industry term referring to a Phase 3 clinical study intended to show and confirm the National Cancer Institute that in 2022, approximately 287,500 women will be diagnosed with breast cancer in the United States. That means that every two minutes an American woman is diagnosed with breast cancersafety and more than 43,000 are projected to die in 2022. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime riskefficacy 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.a treatment.

According to the May 2019 “Global Oncology Trends 2021” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly $269 billion by the end of 2025, growing at a compound annual growth rate (“CAGR”) of 10% between 2021 and 2025, of which about 20% is expected to be immuno-oncology drugs.

About 12.9% percent of women will be diagnosed with breast cancer at some point during their lifetime. In 2018, there were an estimated 3,676,262 women living with female breast cancer in the United States. Approximately 81% of cases present as invasive breast cancer. Approximately 6% of new breast cancer diagnoses are Stage IV (metastatic breast cancer (“MBC”), which has already spread to other organs). Twenty to thirty percent of all women diagnosed with breast cancer will develop MBC. Breast cancer can be subdivided based on receptor status - the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors (HR), and the Her2/neu growth factor receptor (HER2). Based on the latest SEER statistics, 74.6% were found to be HR+/HER2−, 10.8% were triple-negative (HR−/HER2−), 10.5% were HR+/HER2+, and 4.0% were HR−/HER2+.1

It is estimated that over 150,000 women in the US are living with MBC. For those with metastatic disease at diagnosis, their 5-year survival rate is 27%. For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e. a disease-free interval of more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is less than 24 months, their prognosis is worse.4 We currently propose that Bria-IMT’s™ indication will be for the treatment of patients with MBC who have failed at least two lines of therapy. Similarly, another study showed that the median overall survival among patients with de novo stage IV MBC was 39.2 months, while for patients with relapsed disease it was 27.2 months. Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent lines of therapy. One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.

1716
 

 

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”).

 

The novel technology, originally developedPursuant 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 Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and memberBriaPro to the Company of BriaCell’s scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al. and Samuel T Haile et al. in collaboration with Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn, et al.). Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.

BriaPro common shares. Under the terms of the agreement,Arrangement, for each BriaCell gainsshare 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 worldwide rights to developsame terms and commercialize sCD80, while UMBC maintains ownership ofcharacteristics as the patents.existing BriaCell common shares. The Company will pay royalties to UMBC uponremain listed on the commercialization of the product plus patent management costs. The licensing agreement was coordinated by UMBC’s Office of Technology Development.NASDAQ Stock Market and Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada.

 

On September 7, 2022,

As noted above, immediately following the closing of the Arrangement, the Company announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 10-12, 2022, in Boston, MA.

The Company’s data showed clinical benefit including extended survival time and tumor reductions in heavily pre-treated advanced breast cancer patients who matched our lead candidate, Bria-IMT™, at HLA type/s, and these findings guided the development of further optimized off-the-shelf personalized immunotherapies for advanced breast cancer and other cancers.

On September 14, 2022, the Company announced that it has signed an agreement with Caris Life Sciences® (Caris), a leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare.

The goal is to develop immunotherapies that are personalized for each patient, and Caris’ extensive library of clinical data, cutting-edge biomarker technology, and expertise will be invaluable  in achieving our objectives,”  The Company expects Caris’ unique platform to help us identify patients who do not respond to existing treatments and are more likely to benefit from the Company’s immunotherapy treatments.

Under the termscontrolled 2/3rd 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 cancerBriaPro common shares representing approximately 66.6% of certain genetically defined subgroups.the issued and outstanding common shares of BriaPro As a result of the Arrangement, there were approximately 47,945,178 BriaPro common shares issued and outstanding immediately following consummation of the Arrangement. The partnership between BriaCellCorporation now beneficially owns or controls approximately 31,963,452 BriaPro common shares, representing 2/3rd of the issued 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.outstanding BriaPro common shares.

 

On October 12, 2022 the Company announced that it added Mayo Clinic, Jacksonville, Florida as a clinical site in the3, 2023, BriaCell initiated its pivotal 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 study3 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.

This information was summarized in BriaCell’s poster session at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 10-12, 2022, in Boston, Massachusetts. The poster session highlights BriaCell’s novel off-the-shelf personalized cellular therapy approach to immunotherapy treatment.

Title: An off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors.
Abstract Number: 257
Location: Omni Boston Hotel, 450 Summer Street, Boston, Massachusetts 02210, Poster Hall, Hall C
Date and Time: November 10, 2022, 9:00 am – 9:00 pm

Bria-IMT™ regimen combined with Incyte’s retifanlimab

Seventy percent of evaluable patients participating in the Phase I/IIa clinical study showed either disease control or progression-free survival (PFS) benefits compared with their last therapy regimen. Disease control rate (DCR) of 57% (4/7) was observed in evaluable patients, measured as the percentage of patients who have achieved certain clinical end points (i.e. complete response, partial response and stable disease). DCR is used in cancer clinical trials to measure the clinical effectiveness of a treatment. PFS is the time period during which a patient’s cancer does not get worse, commonly used as a key survival and efficacy measurement compared to the PFS values of their previous therapy regimen.

Prior to enrollment in the study, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated or were in the terminal stage ofmetastatic breast cancer, further underscoring the uniquely positive outcome BriaCell’s treatment has achieved. The 12 patients had each failed at least 2 prior systemic therapy regimens (including chemotherapy, biological and “targeted” therapy).

Disease control rates of the study are impressive in our view, suggesting robust clinical efficacy of the combination treatment. Importantly, we are very encouraged by the early PFS data in our ongoing study, since it is commonly known in cancer therapy that PFS values typically drop from one therapy to the next in advanced cancers. Please note that the PFS data is early data, as patients continue to remain in the study. The positive PFS trend BriaCell has observed in this patient cohort highlights the effectiveness of BriaCell’s treatment without harmful side effects.

Cancer. The study recently awarded U.S. Foodwill evaluate the efficacy and Drug Administration fast track designation, continues with additional clinical data forthcoming.

In summary, these findings show evidencesafety 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 retifanlimaban immune check point inhibitor (Retifanlimab) in patients who have failed at least two approved therapies for the disease. Bria-IMT™ is currently under Fast Track Designation by the U.S. FDA intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer. FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the physician’s choice of treatment arm will be the primary endpoint of the study. The study will enroll 177 patients in the Bria-IMT™ combination therapy arm and 177 patients in the treatment of advanced breast cancer patients.

Evidence of immune system activation by Bria-OTS+™physician’s choice arm. To gather additional information on the Bria-IMT™ regimen alone, 50 patients will be enrolled in this regimen and Bria-PROS™

BriaCell’s poster presentation highlightswill be eligible for combination therapy following their initial post treatment evaluation. BriaCell expects frequent and responsive FDA communication under its Fast Track status during the 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 activationpivotal Phase 3 study. The successful completion of the components ofpivotal Phase 3 study would allow BriaCell to subsequently submit a Biologics License Application and accelerate the immune system such as naïve T cells, and 2) indirect activation of the immune system components via production of immune activating molecules.

We are impressed with the data showing very strong immune responses for both Bria-OTS+™ and Bria-PROS™. We expect both Bria-OTS+™ and Bria-PROS™path to boost the immune system response and produce strong anti-tumor responses in patients with advanced breast cancer and prostate cancer, respectively.commercialization.

 

1917
 

Results of Operations for the Three Months Ended OctoberJanuary 31, 2022,2024 and 20212023

 

  Three months ended
October 31,
 
  2022  2021 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses $3,255,215  $875,636 
General and administrative expenses  2,147,936   1,409,173 
Total operating expenses  5,403,151   2,284,809 
         
Operating loss  (5,403,151)  (2,284,809)

Financial income (expenses), net

        
Interest income  188,353   6,305 
Interest expense  -   

(979

)

Change in fair value of warrant liability

  4,117,790   (25,254,036)

Foreign exchange gain

  (9,533)  34 
Total financial income (expenses), net  4,296,610   (25,248,676)
Loss and Comprehensive loss for the period $(1,106,541) $(27,533,485)
Net loss per share – basic and diluted $(0.07) $(1.81)
Weighted average number of shares used in computing net basic and diluted earnings per share of common stock  15,518,018   15,238,646 
  Three months ended
January 31,
 
  2024  2023 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses $8,257,455  $3,053,357 
General and administrative expenses  1,571,991   1,432,966 
Total operating expenses  9,829,446   4,486,323 
         
Operating loss  (9,829,446)  (4,486,323)
Financial expenses, net  (1,486,119)  (7,395,439)
Share of loss on equity investments  (18,345)  - 
Net loss for the period $(11,333,910) $(11,881,762)
Net loss attributable to non-controlling interest  (39,307)  - 
Net loss for the period attributable to BriaCell  (11,294,603)  (11,881,762)
Net loss per share attributable to BriaCell – basic and diluted $(0.71) $(0.77)

Research and Development Costs

 

Research costs are comprised primarily of (i) Salariessalaries and wages to Company employees at our laboratory; and (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.

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

  Three months ended January 31, 
  2024  2023 
       
Clinical trials $4,359,850  $1,438,231 
Pre-clinical projects  2,992,990   745,236 
Chemical, Manufacturing and Control Costs (“CMC Costs”)  420,112   331,590 
Other  484,503   538,300 
  $8,257,455  $3,053,357 

Our clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial. Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e. a longer than expected overall survival). Additionally, our costs increased significantly compared with the same period in 2023 for much higher set up costs for the pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation for the upcoming clinical studies of Bria-OTS™.

Pre-clinical projects include expenses incurred in our off-the-shelf personalized immunotherapies, including Bria-OTS+™, and Bria-PROS™. Our pre-clinical costs have increased in 2024 as we hired more staff to accelerate our existing pre-clinical program and added an additional pre-clinical program (sCD80).

Other costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development expenditure. Other costs increased in 2024 as we investigated additional potential pre-clinical projects.

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

  Three months ended January 31, 
  2024  2023 
       
Clinical trial sites and investigational drug costs $6,200,980  $1,288,577 
Wages and salaries  1,401,679   1,282,441 
Laboratory Rent  108,000   48,000 
Supplies  312,543   207,061 
Professional fees  -   2,187 
Share-based compensation  234,253   225,091 
  $8,257,455  $3,053,357 

18

For the three-month period ended January 31, 2024, total research costs amounted to $8,257,455 as compared to $3,053,357 for the three-month period ended January 31, 2023. The rise in these costs is primarily attributed to the continued expansion of the Company’s clinical trials, specifically our Bria-IMT™ trial. Clinical trials and investigational drug costs increased from $1,288,577 in 2023 to $6,200,980 in 2024. Laboratory costs increase during 2024 as well, including the hiring of additional lab employees which increased from $1,282,441 in 2023 to $1,401,679 in 2024 and increased supplies from $207,061 in 2023 to $312,543 in 2024. Finally, the increase in share-based compensation (non-cash) expenses, from $225,091 in 2023 to $234,253 in 2024 also contributed to the increase in research and development expenses.

General and Administrative Expenses

For the three-month period ended January 31, 2024, general and administrative expenses amounted to $1,571,991 as compared to $1,432,966 for the three-month period ended January 31, 2023. The increase relates primarily to shareholder communication expenses and in share-based compensation (non-cash) expense, offset by a decrease in insurance expenses and professional fees.

Financial income (expenses), net

For the three-month period ended January 31, 2024, financial expense, net, amounted to $1,486,119 as compared to $7,395,439 for the three-month period ended January 31, 2023. The large difference is due to the change in value of the Company’s warrant liability which amounted to a loss of $1,567,746 in the three-month period ending January 31, 2024, and a loss of $7,629,502 in the three-month period ending January 31, 2023.

Loss for the period

The Company reported a loss for the three-month period ended January 31, 2024, of $11,294,603, as compared to a loss of $11,881,762 for the three-month period ended January 31, 2023. The loss in 2024 is due to a significant increase in operational spending. The loss in the prior period is primarily due to the large increase in fair value of the warrant liability.

Results of Operations for the Six Months Ended January 31, 2024 and 2023

  Six months ended
January 31,
 
  2024  2023 
  (Unaudited)  (Unaudited) 
Operating Expenses:        
Research and development expenses $15,114,712  $6,308,572 
General and administrative expenses  3,217,762   3,580,902 
Total operating expenses  18,332,474   9,889,474 
         
Operating loss  (18,332,474)  (9,889,474)
Financial expenses, net  12,975,781   (3,098,829)
Share of loss on equity investments  (18,345)  - 
Net loss for the period $(5,375,038)  (12,988,303)
Net loss attributable to non-controlling interest  (81,978)  - 
Net loss for the period attributable to BriaCell  (5,293,060)  (12,988,303)
Net loss per share attributable to BriaCell – basic and diluted $(0.33) $(0.84)
Weighted average number of shares used in computing net basic earnings per share of common stock  15,981,726   15,518,018 
Weighted average number of shares used in computing net diluted earnings per share of common stock  15,981,726   15,518,018 

19

Research and Development Costs

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory; and (ii) Clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.

 

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

  Six months ended January 31, 
  2024  2023 
       
Clinical trials $7,987,140  $3,041,327 
Pre-clinical projects  5,061,969   1,608,402 
CMC Costs  967,309   741,608 
Other  1,098,294   917,235 
  $15,114,712  $6,308,572 

Our clinical trial expenses include the extra costs for our immunotherapy program, Bria-IMT™, Phase I/IIa clinical trial. Clinical trial expenses increased in 2024 as patients stayed in the trial for a longer period of time (i.e. longer than expected overall survival). Additionally, our costs increased significantly compared with those in the same period in 2023 for much higher set up costs for the pivotal Phase 3 study of Bria-IMT™ combination regimen with Retifanlimab in advanced breast cancer, and additional expenses in preparation for the upcoming clinical studies of Bria-OTS™.

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

CMC Costs include the manufacturing of Bria-IMT™ and Bria-OTS™. CMC Costs increased in 2024 to support the pivotal Phase 3 study, and the upcoming clinical studies of Bria-OTS™.

Other costs are ancillary expenses we incur such as costs to maintain our patents, investigation of early-stage projects, scientific advisory board expenses, contracts with vendors for pre-clinical work, and administration costs associated with all our research and development expenditure. Other costs increased in 2024 as we investigated additional potential pre-clinical projects.

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

  Six months ended January 31, 
  2024  2023 
       
Clinical trial sites and Investigational drug costs $11,598,418  $3,330,516 
Wages and salaries  2,422,404   1,998,985 
Laboratory Rent  196,480   96,000 
Supplies  401,566   300,425 
Professional fees  3,782   7,299 
Share-based compensation  492,062   575,347 
  $15,114,712  $6,308,572 

For the six-month period ended Octoberending January 31, 2022,2024, research costs amounted to $3,255,215 as compared to $875,636 for$15,114,712, a significant increase from the $6,308,572 incurred during the same period ended October 31, 2021. The rise in cost is attributed to2023. This upturn was primarily fuelled by the continued expansion of the Company’s Phase 2 trial, and initiation of the Phase 3 trial of the Bria-IMT™ regimen, and heightened costs associated with clinical trials and investigational drugs, surging from $3,330,516 in 2023 to $11,598,418 in 2024. Concurrently, laboratory costs increased due to the increased activity in the lab, including the hiringrecruitment of additional lab employees, growing from $96,000 to $196,480. Notably, non-cash share-based compensation expenses decreased from $575,347 in 2023 to $492,062 in 2024, mitigating some of the overall increase in research and the addition of share based compensation (non-cash)development expenses.

 

General and Administrative Expenses

 

For the six-month period ended OctoberJanuary 31, 2022,2024, general and administrative expenses amounted to $2,147,936$3,217,762 as compared to $1,409,173$3,580,902 for the six-month period ended OctoberJanuary 31, 2021. These increases relate primarily2023. This reduction is mainly attributed to increaseda decrease in non-cash share-based compensation expenses, which declined from $803,438 in 2023 to $541,909 in 2024 and insurance premiums, share based compensation (non-cash), professional fees, and salaries due the hiring more personnel.expenses which declined from $847,241 in 2023 to $583,997 in 2024.

 

Financial income (expenses), net

 

For the six-month period ended Octoberending January 31, 2022,2024, net financial income net, amounted to $4,296,610 as compared to an expense$12,975,781, a significant increase from the loss of $25,248,676 for$3,098,829 recorded in the same period ended October 31, 2021. The largeof 2023. This substantial difference is dueprimarily attributed to the change in the value of the Company’s warrant liability, which amounted tois directly affected by the shortened life of the warrants and decrease in share price, resulting in a gain of $4,117,790 in$12,714,331 for the three-monthsix-month period ending Octoberended January 31, 2022 and2024, compared to a loss of $25,254,036$3,511,712 in the three-monthsix-month period ending Octoberended January 31, 2021. The Company recorded $188,353 in interest income in the three-month period ending October 31, 2022 as compared to $6,305 in the three-month period ending October 31, 2021.2023.

 

20
 

 

Loss for the period

 

The Company reported a loss for the period ended OctoberJanuary 31, 2022,2024, of $1,106,541,$5,375,038, as compared to $27,533,485$12,988,303 for the period ended OctoberJanuary 31, 2021.2023. The reduced loss in 2022 is2024 was primarily due to a significant increase in operational spending, offset by a large gain resulting from the decrease in the fair value of the warrant liability offset by increased operational spending. The higherliability. In contrast, the larger loss in the prior period iswas primarily due to the largehigher operational spending and an increase 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 OctoberJanuary 31, 2022,2024, the Company has total assets of $38,450,320$12,231,047 (July 31, 20222023 - $42,577,041)$27,163,577) and a positive working capital balance of $37,249,747$7,817,634 (July 31, 20222023 -$41,405,613)25,147,050). The Company had negative cash flows from operating activities during the six-month period ended January 31, 2024 of $15,006,564.

 

The Company is planning to finance its research and developmental activities from its existing and future working capital resources and will continue to evaluate additional sources of capital and financing. The Company believes that its existing capital resources will be adequate to satisfy its expected liquidity requirements for at least twelve months from the issuanceuncertainty of the consolidatedCompany’s ability to raise such financial statements.capital casts significant doubt on the Company’s ability to continue as a going concern.

 

Liquidity and Capital Resources

 

As of OctoberJanuary 31, 2022,2024, the Company has working capital of $37,249,747$7,817,634 (July 31, 20222023 - $41,405,613)$25,147,050) and an accumulated deficit of $61,456,378$85,945,291 (July 31, 20222023 - $60,349,837)$80,652,231).

 

As of OctoberJanuary 31, 2022,2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash on deposit with banks, investments in money market funds, investments in U.S. government securities, U.S. government agency securities, and investment grade corporate debt securities. 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 OctoberJanuary 31, 2022,2024, the Company’s overall position of cash and cash equivalents decreased by $18,038,110$15,006,563 from the six-month period ended OctoberJanuary 31, 20212023 (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 OctoberJanuary 31, 2022,2024, was $3,542,382$15,006,564, as compared to $1,778,599$7,494,122 for the six-month period ended OctoberJanuary 31, 2021.2023.

 

Cash used in financing activities for the six-month period ended OctoberJanuary 31, 2022,2024, was $47,294nil, as compared to $nil$47,294 for the six-month period ended OctoberJanuary 31, 2021.2023.

21
 

 

Off-Balance Sheet Arrangements

 

None.

 

Tabular Disclosure of Contractual Obligations

 

None.

 

Critical Accounting Policies and Estimates

 

There have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section in our Annual Report.

 

New Accounting Policies Adopted

 

The Company did not adopt any new accounting policies during the six-month period ended OctoberJanuary 31, 2022.2024.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

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

 

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

 

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

 

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

 

Credit riskRisk

 

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 OctoberJanuary 31, 2022,2024, the Company has total assets of $38,450,320$12,231,047 (July 31, 20222023 - $42,577,041)$27,163,577 ) and a positive working capital balance of $37,249,747$7,817,634 (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. The Company does not believe it is exposed to material interest rate risk as it has no interest-bearing debt.

 

Price risk

 

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

 

22
 

 

Exchange risk

 

The Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in Canadian Dollars (mainly costs relating to being a public company in Canada) and, therefore, the Company is exposed to foreign currency risk at the end of the reporting period through its Canadian denominated accountstrade payable and cash. As of OctoberJanuary 31, 2022,2024, a 5% depreciation or appreciation of the Canadian dollar against the US dollar would not have a material effect on the in total loss and comprehensive loss.

 

Fair Values

 

The carrying values of cash and cash equivalents, amounts receivable, trade payable, 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 the nature of the warrant. For publicly traded warrants we use the quoted market price and for all other warrants we use the Black-Scholes pricing model.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

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

 

Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal accounting and financial officer have concluded that as of OctoberJanuary 31, 2022,2024, our disclosure controls and procedures were not effective as a result of material weaknesses in our internal control over financial reporting. We are implementing plans to improve these material weaknesses, including implementation of independent review and approval of transactions and reconciliations in certain processes through hiring additional personnel and segregating duties amongst our team. We are instituting processes to document and retain evidence to support reviews and reconciliations.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 OctoberJanuary 31, 2022,2024, 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.

23

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings.

None.

 

Item 1A. Risk Factors.

 

As of the date of this Quarterly Report on Form 10-Q, there have been no material changes from the risk factors previously disclosed in our Annual Report for the year ended July 31, 2022.2023.

23

 

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

 

Issuer PurchasesThere were no unregistered sales of Equity Securities

On September 9, 2021 the Company approved a repurchase program whereby the Company may purchase through the facilities of the TSX Venture or NASDAQ (i) up to 1,341,515 Common Shares and (ii) up to 411,962 Listed Warrants in total, representing 10% of the 13,415,154 Common Shares and 10% of the 4,119,622 Listed Warrants comprising the “public float” as of September 8, 2021, over the next 12 months. The Company received final regulatory approval on September 22, 2021. On September 27, 2022 the Company completed the share buyback program, repurchasing a total of 1,031,672 shares with a value of $9,098,014 (net of commissions), none of which were repurchased during the three month period ended October 31,2022, and 259,059 Listed Warrants for $1,121,011 (net of commissions) with a fair value of $1,130,808 of which 15,736 were repurchased and cancelled during the three-month period ended October 31,2022. All of theequity securities repurchased have been cancelled.

The following table contains information for the Listed Warrants repurchased during the three months ended OctoberJanuary 31, 2022.2024

Month  Total Number of
Warrants Purchased
   Average
Price Paid
Per
Warrant
   Total Number of
Warrants Purchased
as Part of Publicly
Announced Plans or
Programs
   Approximate Dollar
Value of Warrants
that May Yet Be
Purchased Under the
Plans or Programs  
 
August 2022  8,836  $2.99   252,159  $477,811 
September 2022  6,900  $2.89   259,059   - 
October 2022  -  $-   259,059   - 
Total  15,736  $2.95   259,059  $- 

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not Applicable.

 

Item 5. Other Information.

 

None.

 

Item 6. Exhibits

 

The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.

24

EXHIBIT INDEX

 

Exhibit Description
31.1 Certification of Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2 Certification of Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
32.1 Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
32.2 Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101.INS Inline XBRL Instance Document*
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.SCH Inline XBRL Taxonomy Extension Schema Document*
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB Inline XBRL Taxonomy Extension Labels Linkbase Document*
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

*Filed herewith.

 

2524
 

SIGNATURES

 

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 BRIACELL THERAPEUTICS CORP.
   
December 14, 2022March 18, 2024By:/s/ William V. Williams
 Name:William V. Williams
 Title:Chief Executive Officer
  (Principal Executive Officer)
   
December 14, 2022March 18, 2024By:/s/ Gadi Levin
 Name:Gadi Levin
 Title:Chief Financial Officer
  (Principal Financial and Accounting Officer)Officer)

 

2625