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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended October 31, 2024

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from         to

 

Commission File No. 001-40101

 

BRIACELL THERAPEUTICS CORP.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada   47-1099599

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

235 15th Street, Suite 300, West Vancouver, BC, V7T 2X1

(Address of Principal Executive Offices, including zip code)
 
604-921-1810
(Registrant’s telephone number, including area code)
 
N/A
(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common shares, no par value   BCTX   The Nasdaq Stock Market LLC
         
Warrants to purchase common shares, no par value   BCTXW   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

  ☐ Large accelerated filer ☐Accelerated filer
  ☒ Non-accelerated filer ☒ Smaller reporting company
    ☒ Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ☒ No ☐

 

As of December 16, 2024, 44,204,161 common shares, no par value per share, of the Company were issued and outstanding.

 

 

 

 

 

BRIACELL THERAPEUTICS CORP.

Form 10-Q

Table of Contents

 

  Page
Part I. Financial Information 3
     
Item 1. Financial Statements 3
  Condensed Consolidated Balance Sheets as of October 31, 2024 (unaudited) and July 31, 2024 (audited) 3
  Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended October 31, 2024 4
  Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) for the three months ended October 31, 2024 5
  Unaudited Condensed Consolidated Statement of Cash Flows for the three months ended October 31, 2024 6
  Notes to Unaudited Condensed Consolidated Financial Statements 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 18
Item 3. Quantitative and Qualitative Disclosures Regarding Market Risk 22
Item 4. Controls and Procedures 23
     
Part II. Other Information 23
     
Item 1. Legal Proceedings 23
Item 1A. Risk Factors 23
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
Item 3. Defaults Upon Senior Securities 23
Item 4. Mine Safety Disclosures 23
Item 5. Other Information 24
Item 6. Exhibits 24
     
Part III. Signatures 25

 

2

 

PART I-FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    October 31, 2024     July 31, 2024  
    (Unaudited)     (Audited)  
ASSETS                
                 
CURRENT ASSETS:                
Cash and cash equivalents   $ 5,792,265     $ 862,089  
Amounts receivable and prepaid expenses     2,426,830       2,791,765  
Total current assets     8,219,095       3,653,854  
                 
NON-CURRENT ASSETS:                
Equity Investment in BC Therapeutics     421,975       418,490  
Intangible assets, net     195,978       199,796  
Property and equipment, net     365,336       388,175  
Long term prepaid expenses     1,211,946       1,211,946  
Total non-current assets     2,195,235       2,218,407  
                 
Total assets   $ 10,414,330     $ 5,872,261  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY                
                 
CURRENT LIABILITIES:                
Trade payables   $ 4,233,968     $ 7,170,781  
Accrued expenses and other payables     754,668       290,376  
Total current liabilities     4,988,636       7,461,157  
                 
NON-CURRENT LIABILITIES:                
Warrant liability     1,712,679       1,096,036  
Total non-current liabilities     1,712,679       1,096,036  
                 
SHAREHOLDERS’ EQUITY (DEFICIT):                
Share capital of no par value - Authorized: unlimited at October 31, 2024 and July 31, 2024, Issued and outstanding: 36,183,161 shares October 31, 2024 and 18,284,661 July 31, 2024, respectively     82,040,741       72,166,414  
Share-based payment reserved     9,456,232       9,189,261  
Warrant reserve     3,930,221       1,844,296  
Accumulated other comprehensive loss     (138,684 )     (138,684 )
Non-controlling interest     (329,623 )     (302,522 )
Accumulated deficit     (91,245,872 )     (85,443,697 )
Total shareholders’ equity (deficit)     3,713,015       (2,684,932 )
                 
Total liabilities and shareholders’ equity   $ 10,414,330     $ 5,872,261  

 

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

 

3

 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

    2024     2023  
    Three months ended  
    October 31,  
    2024     2023  
Operating expenses:                
Research and development expenses   $ 3,665,341       6,857,257  
General and administrative expenses     1,487,491       1,645,771  
Total operating expenses     5,152,832       8,503,028  
                 
Operating loss     (5,152,832 )     (8,503,028 )
Financial income, net     11,714       179,822  
Change in fair value of the warrant liability     (616,643 )     14,282,078  
Share of loss on equity investment     (71,515 )     -  
Net income (loss) for the period   $ (5,829,276 )   $ 5,958,872  
Net loss attributable to non-controlling interest     (27,101 )     (42,671 )
Net income (loss) for the period attributable to BriaCell     (5,802,175 )     6,001,543  
Net income (loss) per share attributable to BriaCell – basic   $ (0.22 )   $ 0.38  
Net income (loss) per share attributable to BriaCell – diluted     (0.22 )     (0.50 )
Weighted average number of shares used in computing net basic earnings per share of common stock     26,641,036       15,981,726  
Weighted average number of shares used in computing net diluted earnings per share of common stock     26,641,036       16,674,891  

 

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

 

4

 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

FOR THE THREE MONTHS ENDED OCTOBER 31, 2024

 

    Number     Amount     capital     loss     Equity     interest     (deficit)  
    Share capital     Additional
paid in
    Accumulated other
comprehensive
    Accumulated     Non-
controlling
   

Total

shareholders’
equity

 
    Number     Amount     capital     loss     Equity     interest     (deficit)  
Balance, July 31, 2023     15,981,726     $ 69,591,784    - $ 7,421,950     $ (138,684 )   $ (80,652,231 )     -     $     (3,777,181 )
Instruments issued to minority shareholders at the Arrangement Date     -       -       (36,767 )     -       -       (162,440 )     (199,207 )
Issuance of options     -       -       533,816       -       -       -       533,816  
Income (loss) for the period     -       -    -   -       -       6,001,543       (42,671 )     5,958,872  
Balance, October 31, 2023     15,981,726     $ 69,591,784    - $ 7,918,999     $ (138,684 )   $ (74,650,688 )     (205,111 )   $ 2,516,300  

 

    Number     Amount     CAPITAL     Reserve     INCOME (LOSS)     DEFICIT     Interest     (DEFICIT)  
    Share capital     Additional
paid in
    Warrant    

Accumulated other
comprehensive

    Accumulated     Non-
Controlling
   

Total

shareholders’
equity

 
    Number     Amount     capital     reserve    

loss

    deficit     Interest    

(deficit)

 
Balance, July 31, 2024     18,284,661     $ 72,166,414     $ 9,189,261     $ 1,844,296     $ (138,684 )   $ (85,443,697 )   $ (302,522 )   $ (2,684,932 )
Issuance of Options     -       -       266,971       -       -       -       -       266,971  
Exercise of prefunded warrants     100,000       -       -       -       -       -       -       -  
Exercise of broker warrants     345,000       442,677       -       (149,426     -       -       -       293,251  
Issuance of units     17,453,500       9,431,650       -       2,235,351       -       -       -       11,667,001  
Net loss for the period     -       -       -       -       -       (5,802,175 )     (27,101 )     (5,829,276 )
Balance, October 31, 2024     36,183,161     $ 82,040,741     $ 9,456,232     $ 3,930,221     $ (138,684 )   $ (91,245,872 )   $ (329,623 )   $ 3,713,015  

 

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

 

5

 

BRIACELL THERAPEUTICS CORP.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(Unaudited)

 

    2024     2023  
    Three months ended
October 31,
 
    2024     2023  
Cash flow from operating activities                
Net income (loss) for the period   $ (5,829,276 )   $ 5,958,872  
Adjustments to reconcile net loss to net cash used in operating activities:                
Amortization     3,818       3,818  
Depreciation     22,839       -  
Share-based compensation     266,971       533,816  
Equity losses     71,515       -  
Change in fair value of warrants     616,643       (14,282,078 )
Changes in assets and liabilities:                
Decrease (increase) in amounts receivable     736,788       (2,537 )
(Increase) decrease in prepaid expenses     (371,853 )     937,816  
Decrease in accounts payable     (2,936,813 )     (689,824 )
Increase (decrease) in accrued expenses and other payables     464,292       (65,128 )
Total cash flow from operating activities     (6,955,076 )     (7,605,245 )
                 
Cash flows from Investing activities                
Equity investment in BC Therapeutics     (75,000 )     -  
Total cash flow from investing activities     (75,000 )     -  
                 
Cash flows from financing activities                
Proceeds from exercise of warrants     293,251       -  
Proceeds from the issuance of shares, net of issuance costs     11,667,001       -  
Total cash flow from financing activities     11,960,252       -  
                 
Increase (decrease) in cash and cash equivalents     4,930,176       (7,605,245 )
Cash and cash equivalents at beginning of the period     862,089       21,251,092  
Cash and cash equivalents at end of the period   $ 5,792,265     $ 13,645,847  

 

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

 

6

 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 1: GENERAL AND GOING CONCERN

 

  a. BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) was incorporated under the Business Corporations Act (British Columbia) on July 26, 2006 and is listed on the Toronto Stock Exchange (“TSX”) under the symbol “BCT”. The Company also trades on the Nasdaq Capital Market (“NASDAQ”) under the symbols “BCTX” and “BCTXW”.
     
  b. BriaCell is an immuno-oncology biotechnology company. The Company is currently advancing its Bria-IMT targeted immunotherapy program against end-stage breast cancer to Phase 3 study which has been approved by the FDA. BriaCell is also developing a personalized off-the-shelf immunotherapy, Bria-OTS™, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.
     
  c. Basis of presentation of the financial statements:
     
    The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain information or footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments consisting of a normal recurring nature which are necessary for a fair presentation of the financial position, operating results, and cash flows for the periods presented.
     
    The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report for the year ended July 31, 2024, filed with the SEC on October 28, 2024. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.

 

  d.

Going concern

 

The Company continues to devote substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of October 31, 2024 was $91,245,872 and negative cash flows from operating activities during the three-month period ended October 31, 2024 was $6,955,076. The Company is planning to finance its operations by exploring additional sources of capital and financing, while managing its existing working capital resources. The Company’s ability to continue as a going concern is dependent upon its ability to attain future profitable operations and to obtain the necessary financing to meet its obligations arising from normal business operations when they come due. The uncertainty of the Company’s ability to raise such financial capital casts substantial doubt on the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should the Company not be able to continue as a going concern. See note 5(b) for details of an $8.5 million gross and $5.0 million gross offering that was completed in September 2024 and October 2024, respectively.

     
  e. The Company has two wholly-owned U.S. subsidiaries: (i) BriaCell Therapeutics Corp. (“BTC”), which was incorporated in April 3, 2014, under the laws of the state of Delaware, and (ii) BTC has a wholly-owned subsidiary, Sapientia Pharmaceuticals, Inc. (“Sapientia”), which was incorporated in September 20, 2012, under the laws of the state of Delaware. The Company also has one Canadian subsidiary: BriaPro Therapeutics Corp, (“BriaPro”) which was incorporated on May 15, 2023, under the Business Corporations Act (British Columbia). See also note 1f. (Sapientia and BTC and BriaPro together, the “Subsidiaries”).
     
  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 in issuance at the time of the Arrangement 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. Warrants issued by the Company, subsequent to the Arrangement are not subject to the terms above.

 

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.

 

7

 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 2: SIGNIFICANT ACCOUNTING POLICIES

 

a. Use of estimates:

 

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

 

b. Prepaid expenses

 

    The Company has prepaid certain expenses in respect of its pivotal phase III trial and estimates the period over which such expenses will be incurred. As of July 31, 2024, the Company revised its estimate of the time to completion in respect of this trial. Amounts estimated to be expenses in more than 12 months have been classified to long-term prepaid expenses.

 

c. The useful life of property and equipment

 

    Property and equipment are depreciated over their useful lives. Useful lives are based on management’s estimates of the period that the assets will be used which are periodically reviewed for continued appropriateness. Changes to estimates can result in significant variations in the amounts charged to the consolidated statement of operations and comprehensive loss in specific periods.

 

d. Investment equity method:

 

    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 the loss from equity method investments on the statements of operation and comprehensive loss. The Company has a 54.6% interest in BC Therapeutics. Management evaluates whether it has control over the investee in accordance with the guidance of ASC 810, which requires judgment to assess factors such as power over significant activities of the investee, exposure to variable returns, and the ability to affect those returns. Based on this evaluation, management determines whether control or significant influence is present for accounting purposes.

 

e. 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 reflect this election. The pronouncements below relate to standards that impact the Company.
     
1. In December 2023, the FASB issued ASU 2023-09 - Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard modifies the rules on income tax disclosures to require entities to disclose specific categories in the rate reconciliation, the income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions. The ASU is effective for years beginning after December 15, 2024, but early adoption is permitted. This ASU should be applied on a prospective basis, although retrospective application is permitted. The Company is currently evaluating the impact of this standard on its financial statements and disclosures.
     
  2. In March 2024, the FASB issued ASU 2024-01 - Compensation—Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards. This standard clarifies whether profits interest and similar awards fall within the scope of stock-based compensation guidance as defined in ASC Topic 718, introducing examples to demonstrate this. The ASU includes scenarios where profits interest awards are classified as equity instruments or liability awards and situations where they fall outside ASC Topic 718, being accounted for under ASC Topic 710. The ASU is effective for years beginning after December 15, 2024, but early adoption is permitted. This ASU should be applied on a prospective basis, although retrospective application is permitted. The Company is currently evaluating the impact of this standard on its financial statements and disclosures.

 

8

 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 3: 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 initially provided a loan of $300,000 to BC Therapeutics, with no interest to be paid. Subsequently, in accordance with the SPA, this loan was converted into an equity investment in BC Therapeutics at a rate of $1.25 per share, resulting in a 37.5% ownership interest (“Initial Investment”).
     
    Pursuant to the SPA (“Initial Investment”), Briacell also received two options to invest an additional $225,000 per option at $1.25 per BC Therapeutics share. The first option expired on February 15, 2024 (“First BC Therapeutics Option”) and the second option expired on June 30, 2024 (“Second BC Therapeutics Options”, together, the “BC Therapeutic Options”). In accordance with ASC 321 and ASC 815, the BC Therapeutics Options were valued at $76,350 in accordance with the Black Scholes Option Price Model, using the following assumptions: Share price: $1.25, Exercise price: $1.25, Dividend yield: 0%, Risk free interest rate: 4.902%, Volatility: 100%.
     
    BC Therapeutics has a board of four representatives, with two representatives appointed by BriaCell and two representatives appointed by the existing shareholders. All significant decisions related to BC Therapeutics require the approval of at least a majority of the board members.
     
    The Company initially acquired a significant interest in BC Therapeutics on February 1, 2024, by exercising the First BC Therapeutics Option, increasing its ownership to 51.2%. On August 7, 2024, following the expiration of the original Second BC Therapeutics Option, the Company and BC Therapeutics amended the SPA to introduce new options, allowing the exercise in tranches of at least 20,000 shares at $1.25 per share. During the quarter ended October 31, 2024, the Company exercised this option in three tranches, totaling $75,000 for 60,000 shares. As of October 31, 2024, the Company holds 480,000 shares in BC Therapeutics, representing 54.6% of the total issued and outstanding shares.
     
    In accordance with ASC 810, the Company continues to account for the investment under the equity method of accounting as the Company does not exercise control over BC Therapeutics.

 

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

 

SCHEDULE OF CHANGES IN INVESTMENT

Balance – August 1, 2023   $ -  
Funding (including the value of the BC Therapeutics Options)     525,000  
Share of losses     (106,510 )
Balance – July 31, 2024     418,490  
Funding     75,000  
Share of losses     (71,515 )
Balance – October 31, 2024   $ 421,975  

 

The following amounts represent the Company’s 54.6% share of the assets of BC Therapeutics:

  SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS

   

As of

October 31, 2024

 
Current assets: Cash   $ 2,805  
Net assets   $ 2,805  

 

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 4: CONTINGENT LIABILITIES AND COMMITMENTS

 

  a.

BriaPro Warrants

     
    Upon the exercise of BriaCell Warrants, BriaCell shall, as agent for BriaPro, collect and pay to BriaPro an amount based on an agreed formula (detailed in note 1(f)). As of October 31, 2024, this amount totaled up to $241,164 and is eliminated on consolidation.
     
  b. Lease
     
    The Company was previously in a 12-month commitment for office and lab space in Philadelphia, PA, costing approximately $38,110 per month. The lease expired on August 31, 2024, and as of October 2024, the Company continues to occupy the space on a month-to-month basis under the same terms.

 

NOTE 5: FAIR VALUE MEASUREMENTS

 

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of October 31, 2024 and July 31, 2024:

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

    Fair Value Measurements at  
    October 31, 2024     July 31, 2024  
    Level 1     Level 2     Total     Level 1     Level 2     Total  
Financial Assets:                                                
Cash and cash equivalents     5,792,265       -       5,792,265       862,089       -       862,089  
                                                 
Total assets measured at fair value   $ 5,792,265     $ -     $ 5,792,265     $ 862,809     $ -     $ 862,089  
                                                 
Financial liabilities:                                                
Warrants liability     1,207,621       505,058       1,712,679       760,657       335,379       1,096,036  
                                                 
Total liabilities measured at fair value   $ 1,207,621     $ 505,058     $ 1,712,679     $ 760,657     $ 335,379     $ 1,096,036  

 

We classify our cash and cash equivalents and the liability in respect of publicly traded warrants within Level 1 because we use quoted market prices in active markets.

 

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

 

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 6: SHAREHOLDERS’ EQUITY

 

a. Authorized share capital

 

The authorized share capital consists of an unlimited number of common shares with no par value.

b. Issued share capital

 

  (i) The Company issued the following shares during the three-month period ended October 31, 2024:

 

  1. On September 12, 2024, the Company completed a registered direct offering for the purchase and sale of 12,325,000 common shares of the Company at an offering price of $0.69 per share, for aggregate gross proceeds of approximately $8.5 million before deducting placement agent fees and other offering expenses (the “September 2024 Offering”).
     
    In connection with the September 2024 Offering, the Company issued 616,250 placement agent warrants with an exercise price of $0.8625 per share. These placement agent warrants are exercisable beginning on March 11, 2025, and expire five years from the date of issuance. The fair value of the broker warrants was determined to be $247,800 using the Black-Scholes option pricing model, with the following assumptions: share price - $0.63; exercise price - $0.8625; expected life – 5 years; annualized volatility - 109%; dividend yield - 0%; risk-free rate – 3.469%, non-marketability discount – 16.38%.
     
    The amount was credited to the warrant reserve at the date of the September 2024 Offering.

 

2. On October 2, 2024, the Company closed a registered direct offering for the purchase and sale of 5,128,500 common shares of the Company and warrants to purchase up to an aggregate of 5,128,500 common shares of the Company for aggregate gross proceeds of $5 million before deducting placement agent fees and other offering expenses (the “October 2024 Offering”). Each common share was sold together with one warrant to purchase one common share at a combined purchase price of $0.975. The warrants have an exercise price of $0.85 per share, are immediately exercisable, and expire five years from the date of issuance (“October 2024 Warrants”).

 


In connection with the October 2024 Offering, the Company issued 256,425 placement agent warrants. The placement agent warrants are immediately exercisable at an exercise price of $1.21875 per share and expire five years from the date of issuance.

 

The fair value of the 5,128,500 October 2024 Warrants was determined to be $2,211,266 using the Black-Scholes option pricing model, with the following assumptions: share price - $0.54; exercise price - $0.85; expected life – 5 years; annualized volatility - 121%; dividend yield - 0%; risk-free rate – 3.553%.

 

The fair value of the 256,425 placement agent warrants was determined to be $204,128 using the Black-Scholes option pricing model, with the following assumptions: share price - $1.01; exercise price - $1.22; expected life – 5 years; annualized volatility - 112%; dividend yield - 0%; risk-free rate – 3.561%.

 

The amounts were credited to the warrant reserve at the date of the October 2024 Offering.

 

During October 2024, 345,000 October 2024 Warrants with an exercise price of $0.85 were exercised for gross proceeds of $293,250. The Company issued 345,000 common shares in respect of the exercise of these warrants.

 

11

 

c. Share Purchase Warrants

 

A summary of changes in share purchase warrants for the three-month period ending October 31, 2024 is presented below:

 

SUMMARY OF CHANGES IN WARRANTS

    Number of options outstanding     Weighted average exercise price (*)  
Balance, July 31, 2024     10,524,585     $ 4.92  
Exercised     (345,000 )     (0.85 )
Granted in the October 2024 Offering     5,128,500       0.85  
Balance, October 31, 2024     15,308,085     $ 3.65  

 

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

 

SCHEDULE OF WARRANTS OUTSTANDING

Number of

Warrants

    Exercise Price(*)    

Exercisable At

October 31, 2024

    Expiry Date
  51,698     $ 3.89       51,698     November 16, 2025
  3,896,809     $ 5.31       3,896,809     February 26, 2026 – April 26, 2026
  4,173,143     $ 6.19       4,173,143     December 7, 2026
  2,402,935     $ 2.11       (*)-     November 17, 2029
  4,783,500     $ 0.85       4,783,500     October 2, 2029
  15,308,085               12,898,150      

 

(*) Exercisable from November 17, 2024.

 

d. Compensation Warrants

 

  (i)

A summary of changes in compensation warrants for the three-month period ended October 31, 2024 is presented below:

 

SUMMARY OF CHANGES IN WARRANTS

   

Number of warrants

outstanding

   

Weighted average

exercise price (*)

 
Balance, July 31, 2024     96,652       3.92  
Granted in the September 2024 Offering     616,250       0.86  
Granted in the October 2024 Offering     256,425       1.22  
Balance, October 31, 2024     969,327     $ 1.26  

 

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

 

SCHEDULE OF WARRANTS OUTSTANDING

Number of

Warrants

    Exercise Price    

Exercisable At

October 31, 2024

    Expiry Date
  4,890     $ 3.89       4,890     November 16, 2025
  17,074     $ 5.31       17,074     February 26, 2026
  24,688     $ 6.19       24,688     June 7, 2026
  50,000     $ 2.32       (*)-   May 17, 2029
  616,250     $ 0.86       (**)-   March 13, 2030
  256,425     $ 1.22       256,425     October 2, 2029
  969,327               303,077      

 

(*) Exercisable from November 17, 2024.
(**) Exercisable from March 11, 2025.

 

12

 

BriaCell Therapeutics Corp

Notes to the Condensed Consolidated Financial Statements

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

 

NOTE 6: SHAREHOLDERS’ EQUITY (Cont.)

 

e. Warrant liability continuity

 

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

 

SCHEDULE OF CHANGE IN FAIR VALUE OF WARRANTS

    Warrants liability  
       
Balance as of August 1, 2024   $ 1,096,036  
Change in fair value during the period   $ 616,643  
         
Balance as of October 31, 2024   $ 1,712,679  

 

The key inputs used in the valuation of the non-public warrants as of October 31, 2024 and at July 31, 2024 were as follows:

 

SCHEDULE OF VALUATION OF NON-PUBLIC WARRANTS

    October 31, 2024     July 31, 2024  
             
Share price   $ 0.81     $ 0.75  
Exercise price   $ 5.31-6.19     $

5.31-6.19

 
Expected life (years)     1.32-2.10     1.57-2.35  
Volatility     93-106 %     77-79 %
Dividend yield     0 %     0 %
Risk free rate     4.19-4.29 %     4.27 %

 

The key inputs used in the valuation of the of the BriaPro Warrant Shares as of October 31, 2024 were as follows:

 

SCHEDULE OF BRIA PRO WARRANTS

    August 31, 2023
(Effective Date)
    October 31, 2024  
             
Share price   $ 0.0365     $ 0.0365  
Exercise price   $ 0.0206-0.0308   $ 0.0206-0.0308
Expected life (years)     2.21-3.27       1.05-2.10  
Volatility     100 %     93-106 %
Dividend yield     0 %     0 %
Risk free rate     4.40 %     3.07 %

 

13

 

NOTE 7: SHARE-BASED COMPENSATION

 

  a.

On August 2, 2022, the Company approved an omnibus equity incentive plan (“Omnibus Plan), which will permit the Company to grant incentive stock options, preferred share units, restricted share units (“RSU’s”), and deferred share units (collectively, the “Awards”) for the benefit of any employee, officer, director, or consultant of the Company or any subsidiary of the Company. The maximum number of shares available for issuance under the Omnibus Plan shall not exceed 15% of the issued and outstanding Shares, from time to time, less the number of Shares reserved for issuance under all other security-based compensation arrangements of the Company, including the existing Stock Option Plan. On February 9, 2023, the Omnibus Plan was approved by the shareholders.

 

  b. The following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan for three-month period ended October 31, 2024 and related information:

 

SUMMARY OF NUMBER OF OPTIONS GRANTED

    Number of options    

Weighted

average

exercise price

   

Weighted

average

remaining

contractual term

(in years)

   

Aggregate

intrinsic value

 
                         
Balance as of July 31, 2024     2,131,400     $ 6.16       2.52     $           -  
                                 
Balance as of October 31, 2024     2,131,400       6.15       2.27       -  
                                 
Exercisable as of October 31, 2024     2,018,775     $ 6.16       2.20     $ -  

 

As of October 31, 2024, there are $519,598 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to 6 months.

 

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.)

 

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

 

SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS

Exercise

price

   

Options

outstanding as of

October 31, 2024

   

Weighted

average

remaining

contractual

term (years)

   

Options

exercisable as of

October 31, 2024

   

Weighted

average

remaining

contractual

term (years)

    Expiry Date
                               
$ 6.03       440,000       3.64       330,000       3.64     June 20, 2028
$ 7.16       21,000       3.33       18,375       3.33     February 27, 2028
$ 6.04       180,100       2.76       180,100       2.76     August 02, 2027
$ 4.71       31,000       2.56       31,000       2.56     May 20, 2027
$ 7.51       150,000       2.29       150,000       2.29     February 16, 2027
$ 8.47       524,700       2.20       524,700       2.20     January 13, 2027
$ 7.15       12,600       2.00       12,600       2.00     November 01, 2026
$ 5.74       100,000       1.84       100,000       1.84     September 01, 2026
$ 4.24       60,000       1.47       60,000       1.47     April 19, 2026
$ 4.24       612,000       1.41       612,000       1.41     March 29, 2026
          2,131,400               2,018,775              

 

15

 

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

 

SUMMARY OF OUTSTANDING AND EXERCISABLE OPTIONS

Exercise

Price

   

Options

outstanding as of October 31, 2024

   

Options

exercisable as
of October 31, 2024

    Expiry Date
                   
$ 0.0933       440,000       330,000     June 20, 2028
$ 0.1108       21,000       18,375     February 27, 2028
$ 0.0984       180,100       180,100     August 02, 2027
$ 0.0729       31,000       31,000     May 20, 2027
$ 0.1162       150,000       150,000     February 16, 2027
$ 0.1310       524,700       524,700     January 13, 2027
$ 0.1165       12,600       12,600     November 01, 2026
$ 0.0888       100,000       100,000     September 01, 2026
$ 0.0656       60,000       60,000     April 19, 2026
$ 0.0656       612,000       612,000     March 29, 2026
          2,131,400       2,018,775      

 

e. Restricted Share Unit Plan

 

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

 

SCHEDULE OF RESTRICTED STOCK UNITS GRANTED

   

Number of

RSU’s

outstanding

   

Aggregate

intrinsic value

 
Balance, July 31, 2024     19,200     $ 14,400  
Balance, October 31, 2024     19,200     $ 15,552  

 

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, 2024 and 2023 is comprised as follows:

 

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES

    2024     2023  
   

Three months ended

October 31,

 
    2024     2023  
             
Research and development expenses   $ 32,718       257,809  
General and administrative expenses     234,253       276,007  
Total share-based compensation   $ 266,971       533,816  

 

16

 

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 8: BASIC AND DILUTED NET LOSS PER SHARE

 

Basic net income (loss) per ordinary share is computed by dividing net income (loss) for each reporting period by the weighted-average number of ordinary shares outstanding during each year. Diluted net income (loss) per ordinary share is computed by dividing net income (loss) for each reporting period by the weighted average number of ordinary shares outstanding during the period, plus dilutive potential ordinary shares considered outstanding during the period, in accordance with ASC No. 260-10 “Earnings Per Share”. The company reported a loss for the three-month period ending October 31, 2023, leading to the exclusion of potentially dilutive ordinary shares. Conversely, a gain was recorded for the three-month period ending October 31, 2024, resulting in the inclusion of all potentially dilutive ordinary shares.

 

SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE

    2024     2023  
   

Three months ended

October 31,

 
    2024     2023  
    (Unaudited)     (Unaudited)  
Basic EPS                
Numerator:                
Net income (loss)   $ (5,802,175 )   $ 6,001,543  
Denominator:                
Shares used in computation of basic earnings per share     26,641,036       15,981,726  
Basic EPS   $ (0.22 )   $ 0.38  
Diluted EPS                
Numerator:                
Net income (loss) attributable to common stock, basic   $ (5,802,175 )   $ 6,001,543  
Adjustment: Change in fair value of warrant liability     -       (14,282,078 )
Net (loss) attributable to common stock, diluted   $ (5,802,175 )   $ (8,280,535 )
Denominator:                
Shares used in computing net EPS of common stock, basic     26,641,036       15,981,726  
Stock Options     -       211,434  
Warrants     -       481,731  
Shares used in computation of diluted earnings per share     26,641,036       16,674,891  
Diluted EPS   $ (0.22 )   $ (0.50 )

 

NOTE 9: FINANCIAL INCOME (EXPENSES), NET

 

SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET

    2024     2023  
   

Three months ended

October 31,

 
    2024     2023  
Interest income   $ 13,050     $ 190,815  
Foreign exchange loss     (1,336 )     (10,993 )
Financial income, net   $ 11,714     $ 179,822  

 

NOTE 10: SUBSEQUENT EVENTS

 

a. Between December 3, 2024 and December 10, 2024, a 620,900 October 2024 Warrants were exercised into 620,900 common shares of the Company, generating gross proceeds of $527,765.

 

b. On December 13, 2024, the Company closed a public offering for the purchase and sale of 7,400,000 common shares of the Company and warrants to purchase up to an aggregate of 7,400,000 common shares of the Company for aggregate gross proceeds of approximately $5.55 million before deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”). Each common share was sold together with one warrant to purchase one common share at a combined purchase price of $0.75. The warrants have an exercise price of $0.9375 per share, and are immediately exercisable for a period of five years from the closing date. In addition, the Company issued 370,000 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price of $0.9375.

 

17

 

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, 2024 (the “Annual Report”) and Part I, Item 1A, Risk Factors, of the Annual Report. This MD&A provides additional information on our business, recent developments, financial condition, cash flows and results of operations, and is organized as follows:

 

  Part 1 - Business Overview. This section provides a general description of our business, which we believe is important in understanding the results of our operations, financial condition, and potential future trends.
     
  Part 2 - Results of Operations. This section provides an analysis of our results of operations for the first quarter of fiscal 2024 in comparison to the first quarter of fiscal 2023.
     
  Part 3 - Financial Liquidity and Capital Resources. This section provides an analysis of our cash flows and outstanding debt and commitments. Included in this analysis is a discussion of the amount of financial capacity available to fund our ongoing operations and future commitments.

 

We prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S. GAAP. Our unaudited Condensed Consolidated Financial Statements, and the financial information contained herein, are reported in U.S Dollars.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other SEC filings.

 

Overview

 

BriaCell is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab) in a pivotal Phase 3 study in metastatic breast cancer. Bria-IMT™ is currently under Fast Track Designation by the U.S. Food and Drug Administration(the “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 metastatic breast cancer. BriaCell reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with median overall survival of 13.4 months in BriaCell’s metastatic breast cancer patients vs. 6.7-9.8 months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at the 2023 San Antonio Breast Cancer Symposium. A completed Bria-IMT™ Phase 1 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy. BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble CD80 protein therapeutic which acts both as a stimulator of the immune system as well as an immune checkpoint inhibitor.

 

18

 

Recent Developments

 

On October 15, 2024, the Company provided an update on its pivotal Phase 3 study in metastatic breast cancer - 35 clinical sites (18 main and 17 satellite) are active and enrolling patients. Additional sites are in various stages of start-up. Interim data will be analyzed once 144 events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT™ in MBC patients. Secondary analyses include comparison of the Bria-IMT™ combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. The Bria-IMT™ combination regimen has received FDA Fast Track designation.

 

On October 22, 2024, the Company reported that in the Company’s Phase 2 clinical study, patients treated with the same Bria-IMT™ regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for similar patients (see Table 1). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well.

 

On November, 21, 2024, the Company announced that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS™ alone and in combination with immune check point inhibitor tislelizumab® (manufactured and supplied by BeiGene, Ltd.) for the treatment of metastatic breast cancer. Bria-OTS™ is an enhanced form of Bria-IMT™, currently in pivotal Phase 3 study for metastatic breast cancer.

 

On November 23, 2024, Marc Lustig resigned from the board of directors of the Company.

 

On December 13, 2024, the Company closed a public offering for the purchase and sale of 7,400,000 common shares of the Company and warrants to purchase up to an aggregate of 7,400,000 common shares of the Company for aggregate gross proceeds of approximately $5.55 million before deducting underwriting discounts, commissions, and other offering expenses (the “December 2024 Offering”). Each common share was sold together with one warrant to purchase one common share at a combined purchase price of $0.75. The warrants have an exercise price of $0.9375 per share, and are immediately exercisable for a period of five years from the closing date. In addition, the Company issued 370,000 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price of $0.9375.

 

Results of Operations for the Three Months Ended October 31, 2024, and 2023

 

    Three months ended  
    October 31,  
    2024     2023  
Operating expenses:                
Research and development expenses   $ 3,665,341       6,857,257  
General and administrative expenses     1,487,491       1,645,771  
Total operating expenses     5,152,832       8,503,028  
                 
Operating loss     (5,152,832 )     (8,503,028 )
Financial income, net     11,714       179,822  
Change in fair value of the warrant liability     (616,643 )     14,282,078  
Share of loss on equity investment     (71,515 )     -  
Net income (loss) for the period   $ (5,829,276 )   $ 5,958,872  
Net loss attributable to non-controlling interest     (27,101 )     (42,671 )
Net income (loss) for the period attributable to BriaCell     (5,802,175 )     6,001,543  
Net income (loss) per share attributable to BriaCell – basic   $ (0.22 )   $ 0.38  
Net income (loss) per share attributable to BriaCell – diluted     (0.22 )     (0.50 )
Weighted average number of shares used in computing net basic earnings per share of common stock     26,641,036       15,619,676  
Weighted average number of shares used in computing net diluted earnings per share of common stock     26,641,036       16,674,891  

 

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.

 

19

 

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

 

    Three months ended October 31,  
    2024     2023  
             
Clinical trial sites and investigational drug costs   $ 2,439,667     $ 5,397,438  
Wages and salaries     949,089       1,020,725  
Laboratory Rent     114,330       88,480  
Supplies     99,430       89,023  
Depreciation     22,839       -  
Professional fees     7,268       3,782  
Share-based compensation     32,718       257,809  
    $ 3,665,341     $ 6,857,257  

 

For the three-month period ending October 31, 2024, research costs amounted to $3,665,341, a significant decrease from the $6,857,257 incurred during the same period in 2023. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which decreased from $5,397,438 in 2023 to $2,439,667 in 2024. The decrease reflects the conclusion of the Bria-IMT™ Phase 1/2a trial and a focus on optimizing expenditures for the pivotal Phase 3 trial. Wages and salaries decreased slightly, from $1,020,725 in 2023 to $949,089 in 2024, reflecting resource allocation adjustments. Laboratory rent increased to $114,330 in 2024, up from $88,480 in 2023, due to expanded use of facilities to support ongoing research. Supplies also increased, from $89,023 in 2023 to $99,430 in 2024, driven by higher operational needs. Depreciation expenses of $22,839 were recognized in 2024, reflecting investments in capital assets to support research activities. Professional fees increased to $7,268 in 2024, compared to $3,782 in 2023, primarily due to consulting and support for clinical operations. Notably, share-based compensation expenses decreased significantly, from $257,809 in 2023 to $32,718 in 2024, contributing to the overall reduction in research and development expenses.

 

Our clinical trial expenses are broken down as follows:

 

    Three months ended October 31,  
    2024     2023  
Bria-IMT™ Pivotal Phase 3 study   $ 2,185,543     $ 2,278,258  
Bria-IMT™ Phase 1/2a     142,496       1,214,440  
Indirect research and development expenses allocated to trials     111,628       134,592  
    $ 2,439,667     $ 3,627,290  

 

Clinical trial expenses for the three months ended October 31, 2024, were $2,439,667, compared to $3,627,290 during the same period in 2023. The decrease in expenses is primarily attributable to the conclusion of patient recruitment and related activities in the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024. This reduction in costs aligns with our transition to the pivotal Phase 3 study of Bria-IMT™, which has become the primary focus of our clinical development efforts.

 

For the three-month period ending October 31, 2024, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,185,543, remaining consistent with the prior year’s $2,278,258. This consistency reflects our strategic decision to optimize spending while focusing expenditures on this pivotal trial, underscoring our commitment to prioritizing the Phase 3 study as the cornerstone of our clinical development program. Resources were effectively allocated toward patient recruitment, trial operations, and preparation for key milestones.

 

For the three-month period ending October 31, 2024, Bria-IMT™ Phase 1/2a costs amounted to $142,496, a significant decrease compared to $1,214,440 during the same period in 2023. This decrease is attributed to the trial’s conclusion in fiscal 2024, with only minimal remaining expenses related to final data analysis and study close-out activities.

 

For the three-month period ending October 31, 2024, indirect research and development expenses allocated to trials amounted to $111,628, compared to $134,592 in the prior year. This reduction is primarily due to streamlined trial operations and a shift in resource allocation toward the pivotal Phase 3 study.

 

We remain focused on advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to direct resources accordingly to ensure its timely progression.

 

General and Administrative Expenses

 

For the three-month period ending October 31, 2024, general and administrative expenses amounted to $1,487,491, showing a decrease from $1,645,771 in the same period of 2023. The decrease in general and administrative expenses primarily stems from lower insurance premiums, professional fees and share-based compensation expenses. The Company has reduced general and administrative expenses in order to devote more resources to its clinical program.

 

Financial income (expenses), net

 

For the three-month period ending October 31, 2024, net financial income amounted to $11,714, a significant decrease from the $179,822 recorded in the same period of 2023. Financial income for the three-month period ending October 31, 2024 primarily consists of interest income of $13,050, offset by a foreign exchange loss of $1,336. In comparison, For the three-month period ending October 31, 2023, interest income was $190,815, while foreign exchange losses totaled $10,993. The decrease in financial income from 2023 to 2024 reflects lower interest income due to reduced cash and cash equivalents available for investment in interest-bearing funds

 

Profit (loss) for the period

 

For the three-month period ended October 31, 2024, the Company reported a loss of $5,829,276 compared to a gain of $5,958,872 for the same period in 2023. The loss in the three-month period ended October 31, 2024, primarily resulted from the significant change in the fair value of the warrant liability, which accounted for a loss of $616,643 in 2024 compared to a gain of $14,282,078 in 2023. This highlights the substantial impact that warrant liability valuation has on the Company’s overall financial performance, despite decreased operational spending during the period, particularly in research and development.

 

20

 

Liquidity, Capital Resources and Going Concern Uncertainty

 

The financial statements have been prepared on a going concern basis, which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to continue to raise adequate financing and to commence profitable operations in the future.

 

As of October 31, 2024, and a positive working capital balance of $3,230,459 (July 31, 2024 negative balance of $3,807,303).

 

As of October 31, 2024, the Company has total assets of $10,414,330 (July 31, 2024 - $5,872,261), a positive working capital of $3,230,459 (July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $91,245,872 (July 31, 2024 - $85,443,697).

 

As of October 31, 2024, the Company’s capital resources consist primarily of cash and cash equivalents, comprising mostly of cash on deposit with banks, investments in money market funds, investments in U.S. government securities, U.S. government agency securities, and investment grade corporate debt securities. Our investment policy and strategy are focused on preservation of capital and supporting our liquidity requirements.

 

Historically, the Company has financed its operation through private and public placement of equity securities, as well as debt financing. The Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives. Management believes that it can be successful in obtaining additional capital; however, there can be no assurance that the Company will be able to do so. There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a going concern. To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. To this end, for several months during calendar year 2024, certain directors and officers agreed to defer payment of their directors’ fees/compensation until we completed a financing, after which, these fees were paid in full. Further, certain officers have indicated their willingness to receive a portion of their compensation in equity of the Company, subject to applicable Nasdaq rules. In addition, we continue to reduce expenditure on certain non-core activities whilst maintaining our focus on our Phase 3 Bria-IMT™ pivotal study in advanced metastatic breast cancer.

 

During the period ended October 31, 2024, the Company’s overall position of cash and cash equivalents increased by $4,930,176 from the period ended July 31, 2024 (including effects of foreign exchange). This increase in cash can be attributed to the following:

 

The Company’s net cash used in operating activities during the period ended October 31, 2024, was $6,955,076 as compared to $7,605,245 for the period ended October 31, 2023.

 

Cash gained in financing activities for the period ended October 31, 2024, was 11,960,252 as compared to nil for the period ended October 31, 2023.

 

21

 

Off-Balance Sheet Arrangements

 

None.

 

Tabular Disclosure of Contractual Obligations

 

None.

 

Critical Accounting Policies and Estimates

 

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

 

New Accounting Policies Adopted

 

The Company did not adopt any new accounting policies during the period ended October 31, 2024.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

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

 

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

 

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

 

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

 

Credit risk

 

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

 

Liquidity Risk

 

The Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come due. As of October 31, 2024, the Company has total assets of $10,414,330 (July 31, 2024 - $5,872,261) and a positive working capital balance of $3,230,459 (July 31, 2024 - negative working capital balance of $3,807,303).

 

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. Loans payable include both fixed and variable interest rates; however, the Company does not believe it is exposed to material interest rate risk.

 

Price risk

 

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

 

22

 

Exchange risk

 

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

 

Fair Values

 

The carrying values of cash and cash equivalents, trade payable, warrant liability, short term loans, and accrued expenses and other payables approximate their fair values due to their short terms to maturity.

 

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

 

Item 4. Controls and Procedures.

 

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 October 31, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There have not been material changes in our internal control over financial reporting during the quarter ended October 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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, 2024.

 

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

 

There were no unregistered sales of equity securities during the three months ended October 31, 2024.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not Applicable.

 

23

 

Item 5. Other Information.

 

None.

 

Item 6. Exhibits

 

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

 

EXHIBIT INDEX

 

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

 

* Filed herewith.

 

24

 

SIGNATURES

 

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

 

  BRIACELL THERAPEUTICS CORP.
     
December 16, 2024 By: /s/ William V. Williams
  Name: William V. Williams
  Title: Chief Executive Officer
    (Principal Executive Officer)
     
December 16, 2024 By: /s/ Gadi Levin
  Name: Gadi Levin
  Title: Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

25

EX-31.1 2 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATIONS

 

I, William V. Williams, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of BriaCell Therapeutics Corp.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

December 16, 2024 /s/ William V. Williams
  William V. Williams
 

President and Chief Executive Officer

(Principal Executive Officer)

 

 

EX-31.2 3 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATIONS

 

I, Gadi Levin, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of BriaCell Therapeutics Corp.;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

December 16, 2024 /s/ Gadi Levin
  Gadi Levin
 

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 

 

 
EX-32.1 4 ex32-1.htm

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, William V. Williams, President and Chief Executive Officer of BriaCell Therapeutics Corp. (the “Company”), hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

1. The Quarterly Report on Form 10-Q of the Company for the period ended October 31, 2024 (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

December 16, 2024 /s/ William V. Williams
  William V. Williams
 

President and Chief Executive Officer

(Principal Executive Officer)

 

 
EX-32.2 5 ex32-2.htm

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Gadi Levin, Chief Financial Officer of BriaCell Therapeutics Corp. (the “Company”), hereby certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

1. The Quarterly Report on Form 10-Q of the Company for the period ended October 31, 2024 (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

December 16, 2024 /s/ Gadi Levin
  Gadi Levin
 

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)