BriaCell Therapeutics Corp 10-Q for FY2025 Q3
BriaCell Therapeutics Corp. (BCTX)
About this 10-Q
BriaCell Therapeutics Corp filed this 10-Q on June 16, 2025, covering the quarter ended April 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended April 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $6.13M
- compared with net income of $1.72M a year earlier
- Diluted EPS
- -$1.64
- compared with $1.61 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For
the quarterly period ended
For the transition period from to
Commission
File No.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
| (Address of Principal Executive Offices, including zip code) |
| (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 | ||
| The Stock Market LLC | ||||
| The Stock Market LLC | ||||
| The 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.
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).
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 | |
| ☒
|
||
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
As of June 16, 2025, there were common shares, no par value per share, of the Company issued and outstanding.
BRIACELL THERAPEUTICS CORP.
Form 10-Q
Table of Contents
| 2 |
PART I-FINANCIAL INFORMATION
Item 1. Financial Statements
BRIACELL THERAPEUTICS CORP.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
| April 30, 2025 | July 31, 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Amounts receivable and prepaid expenses | ||||||||
| Total current assets | ||||||||
| NON-CURRENT ASSETS: | ||||||||
| Equity investment in BC Therapeutics | ||||||||
| Intangible assets, net | ||||||||
| Property and equipment, net | ||||||||
| Long term prepaid expenses | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | $ | ||||||
| Accrued expenses and other payables | ||||||||
| Total current liabilities | ||||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Warrant liability | ||||||||
| Total non-current liabilities | ||||||||
| SHAREHOLDERS’ EQUITY (DEFICIT)(1): | ||||||||
| Share Capital of | ||||||||
| Share-based payment reserve(1) | ||||||||
| Warrant Reserve(1) | ||||||||
| Accumulated other comprehensive loss(1) | ( | ) | ( | ) | ||||
| Non-controlling Interest(1) | ( | ) | ( | ) | ||||
| Accumulated deficit(1) | ( | ) | ( | ) | ||||
| Total shareholders’ equity (deficit)(1) | ( | ) | ||||||
| Total liabilities and shareholders’ equity (deficit) | $ | $ | ||||||
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 NINE MONTHS ENDED APRIL 30, 2025
(Unaudited)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| April 30, | April 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research, development, and clinical trial expenses | $ | $ | $ | |||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Financial income (expenses), net | ( | ) | ||||||||||||||
| Change in fair value of the warrant liability | ||||||||||||||||
| Share of loss on equity investment | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net income (loss) for the period | $ | ( | ) | $ | $ | ( | ) | ( | ) | |||||||
| Net loss attributable to non-controlling interest | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net income (loss) for the period attributable to BriaCell | ( | ) | ( | ) | ( | ) | ||||||||||
| Net income (loss) per share attributable to BriaCell – basic and diluted | $ | ) | $ | $ | ) | $ | ) | |||||||||
| Weighted average number of shares used in computing net basic earnings per share of common stock(1) | ||||||||||||||||
| Weighted average number of shares used in computing net diluted earnings per share of common stock(1) | ||||||||||||||||
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 NINE MONTHS ENDED APRIL 30, 2025
| Number | Amount | capital | reserve | loss | deficit | Interest | (deficit) | |||||||||||||||||||||||||
| Share capital | Additional paid in | Warrant | Accumulated
other comprehensive | Accumulated | Non- Controlling | Total shareholders’ | ||||||||||||||||||||||||||
| Number | Amount | capital | reserve | loss | deficit | Interest | (deficit) | |||||||||||||||||||||||||
| Balance, January 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Issuance of Options | - | |||||||||||||||||||||||||||||||
| Issuance of units | ||||||||||||||||||||||||||||||||
| Net loss for the period | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, April 30, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Share capital | Additional paid in | Warrant | Accumulated
other comprehensive | Accumulated | Non- Controlling | Total shareholders’ | ||||||||||||||||||||||||||
| Number | Amount | capital | reserve | loss | deficit | Interest | (deficit) | |||||||||||||||||||||||||
| Balance, July 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| Issuance of Options | - | |||||||||||||||||||||||||||||||
| Exercise of prefunded warrants | ||||||||||||||||||||||||||||||||
| Exercise of broker warrants | ( | ) | ||||||||||||||||||||||||||||||
| Issuance of units | ||||||||||||||||||||||||||||||||
| Net loss for the period | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, April 30, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| 5 |
| Number | Amount(1) | capital | loss | deficit | interest | (deficit) | ||||||||||||||||||||||
| Share capital(1) | Additional paid in | Accumulated
other comprehensive | Accumulated | Non- controlling | Total shareholders’ equity | |||||||||||||||||||||||
| Number | Amount | capital | loss | deficit | interest | (deficit) | ||||||||||||||||||||||
| Balance, January 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Issuance of options | - | |||||||||||||||||||||||||||
| Income (loss) for the period | - | ( | ) | |||||||||||||||||||||||||
| Balance, April 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Share capital(1) | Additional paid in | Accumulated other comprehensive | Accumulated | Non-
controlling | Total shareholders’ equity | |||||||||||||||||||||||
| Number | Amount | Capital | loss | deficit | interest | (deficit) | ||||||||||||||||||||||
| Balance, July 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| Instruments issued to minority shareholders at the Arrangement Date | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||
| Issuance of options | - | |||||||||||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||
| Balance, April 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||
| (1) | ||
| As a result of the reverse stock split, the number of common shares outstanding as of January 24, 2025, was . |
All share and per-share amounts presented in these condensed consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock split for all periods presented, in accordance with ASC 260.
The accompanying notes are an integral part of the condensed consolidated financial statements.
| 6 |
BRIACELL THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE NINE MONTHS ENDED APRIL 30, 2025
(Unaudited)
| 2025 | 2024 | |||||||
| Nine months ended April 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flow from operating activities | ||||||||
| Net loss for the period | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Share-based compensation | ||||||||
| Share of loss on equity investment | ||||||||
| Change in fair value of warrants | ( | ) | ( | ) | ||||
| Changes in assets and liabilities: | ||||||||
| Decrease in amounts receivable | ||||||||
| (Increase) decrease in prepaid expenses | ( | ) | ||||||
| (Decrease) increase in trade payable | ( | ) | ||||||
| Increase (decrease) in accrued expenses and other payables | ( | ) | ||||||
| Total cash flow from operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Equity Investment in BC Therapeutics | ( | ) | ( | ) | ||||
| Total cash flow from investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from the issuance of units, net of issuance costs | ||||||||
| Total cash flow from financing activities | ||||||||
| Increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of the period | ||||||||
| Cash and cash equivalents at end of the period | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 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
| 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”, “BCTXW” and “BCTXZ”. | |
| b. | BriaCell Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal1 Phase 3 study in metastatic breast cancer. The pivotal Phase 3 study of 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 Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer.
Additionally, BriaCell is conducting a 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™/Bria-OTS+™ (enhanced version) provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer, and a soluble cluster of differentiation 80 (“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.
On
January 3, 2025, the Company’s board of directors approved a
All share and per-share amounts presented in these unaudited condensed consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock split for all periods presented, in accordance with ASC 260. |
| 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)
| d. | Going concern
The
Company continues to devote substantially all of its efforts toward research, development, and clinical 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 April 30, 2025 was $ | |
| 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 received one (1) common share of BriaPro (“BriaPro Share”), 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 % of the issued and outstanding common shares of BriaPro. | ||
| As a result of the Arrangement, there are BriaPro Shares issued and outstanding. The Company now beneficially owns or controls approximately BriaPro Shares, representing 2/3rd of the issued and outstanding BriaPro Shares). | ||
| In addition, pursuant to the Arrangement, each BriaCell warrant in issuance at the time of the Arrangement (“Briacell Legacy Warrant”) shall, in accordance with its terms, entitle the holder thereof to receive, upon the exercise thereof, one BriaCell Share (and post Reverse Stock-Split – 15 Briacell Shares) 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 15 BriaCell Legacy Warrants (post Reverse Stock-Split), 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 15 BriaCell Legacy Warrants
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”). |
| 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)
| In addition, pursuant to the Arrangement, all Briacell option holders in issuance at the time of the Arrangement (“BriaCell Legacy Options”) received the same amount of BriaPro options (“BriaPro Option”) and under the BriaPro incentive plan. There were (pre Reverse Stock Split) Briacell Legacy Options at the time of the Arrangement. The exercise price of the BriaCell Legacy Options was apportioned between the BriaCell Legacy Options and the BriaPro options, as follows: | ||
| Pursuant to the Arrangement, all BriaCell Restricted Shares Units (“RSU”) holders in issuance at the time of the Arrangement 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 $ | ||
| 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. |
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.
| 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)
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 unaudited
condensed consolidated statement of operations and comprehensive loss. The Company has a |
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 reflects 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. No director, officer, employee or consultant has a profit interests awards and therefore this standard has no effect on the Company’s financial statements and disclosures. | |
|
3 | In June 2025, the FASB issued ASU 2025-03 - Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in a Variable-Interest Entity. This standard clarifies that when a business combination is effected primarily by exchanging equity interests and the legal acquiree is a variable-interest entity (“VIE”) that meets the definition of a business, entities must identify the accounting acquirer using the factors in ASC 805-10-55-12 through 55-15, rather than relying solely on the VIE consolidation model. The ASU is effective for years beginning after December 15, 2026, 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. |
| 4. | In January 2025, the FASB issued ASU 2025-01 - Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This standard amends the guidance issued in 2024 to confirm that all public business entities must present the required expense-disaggregation disclosures in annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027. The ASU is effective for years beginning after those dates, but early adoption is permitted. This ASU should be applied on a prospective basis, although retrospective application is permitted. Because the amendment only affects disclosure timing, the Company does not expect this standard to have a material impact on its financial statements and disclosures. |
| 11 |
BRIACELL THERAPEUTICS CORP.
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 3: INVESTMENT IN BC THERAPEUTICS INC.
| On December 21, 2023, 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 $ 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 $ per share, resulting in a % ownership interest (“Initial Investment”). | ||
| Pursuant to the SPA (“Initial Investment”), Briacell also received two options to invest an additional $ per option at $ 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 initially valued at $ in accordance with the Black Scholes Option Price Model, using the following assumptions: Share price: $, Exercise price: $, Dividend yield: %, Risk free interest rate: %, Volatility: %. | ||
| 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 %. 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 shares at $ per share. On March 18, 2025, the SPA was amended a second
time, such that the Second BC Therapeutics Option is increased to shares and expires
in June 2026 (a one year extension). During the nine-month period ended April 30, 2025, the
Company exercised this option in totaling $
As
of April 30, 2025, the Company holds of the issued and outstanding shares in BC Therapeutics, representing a | ||
| 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) | ||||
| Share of losses | ( |
) | ||
| Balance – July 31, 2024 | ||||
| Funding | ||||
| Share of losses | ( |
|||
| Balance – April 30, 2025 | $ | |||
The following amounts represent the Company’s 60.9% share of the assets of BC Therapeutics:
SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As of April 30, 2025 |
||||
| Current assets: Cash | $ | |||
| Net assets | $ | |||
| 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 4: CONTINGENT LIABILITIES AND COMMITMENTS
| a. | BriaPro Warrants |
Upon
the exercise of 15 BriaCell Legacy 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 April 30, 2025, this amount totaled up to $
| b. | Lease |
The
Company was previously in a
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 April 30, 2025, and July 31, 2024:
SCHEDULE OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
| Fair Value Measurements at | ||||||||||||||||||||||||
| April 30, 2025 | July 31, 2024 | |||||||||||||||||||||||
| Level 1 | Level 2 | Total | Level 1 | Level 2 | Total | |||||||||||||||||||
| Financial Assets: | ||||||||||||||||||||||||
| Cash and cash equivalents | ||||||||||||||||||||||||
| Total assets measured at fair value | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
| Financial liabilities: | ||||||||||||||||||||||||
| Warrant liability | ||||||||||||||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
The Company classifies its cash and cash equivalents and the liability in respect of publicly traded warrants within Level 1 because we use quoted market prices in active markets.
The fair value of the warrant liability for non-public warrants is measured using inputs other than quoted prices included in Level 1 that are observable for the liability either directly or indirectly, and thus are classified as Level 2 financial instruments.
NOTE 6: SHAREHOLDERS’ EQUITY
a. Authorized share capital
The
authorized share capital consists of an number of common shares with
b. Issued share capital
| (i) | Reverse Stock Split: |
| 1. | On January 3, 2025, the Company’s board of directors approved a reverse stock split (the “Reverse Split”) of the Company’s common shares on a 1-for-15 basis, which became effective on January 24, 2025 (the “Effective Date”). The Company’s post-split common shares began trading on The Nasdaq Capital Market (“Nasdaq”) and the Toronto Stock Exchange (“TSX”) at market open on January 29, 2025, under the existing ticker symbols “BCTX” (Nasdaq) and “BCT” (TSX”) with a new CUSIP number (107930208). |
| 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)
| As a result of the Reverse Split, every fifteen (15) pre-split common shares issued and outstanding were automatically combined into one (1) new common share. No fractional common shares were issued in connection with the Reverse Split. Instead, any fractional common shares resulting from the Reverse Split were deemed to have been tendered to the Company for cancellation for no consideration. | ||
| Following the Reverse Split, the number of common shares outstanding as of the Effective Date was . | ||
| The Reverse Split also resulted in a proportional adjustment to the number of common shares issuable upon the exercise of the Company’s outstanding warrants, stock options, and other convertible securities, as well as an adjustment to the exercise prices and conversion prices, as applicable. | ||
| The Reverse Split was implemented to ensure compliance with Nasdaq’s minimum bid price requirement and did not impact the par value of the Company’s common shares or the Company’s authorized share capital. | ||
| All share and per share amounts in the accompanying consolidated financial statements and related notes have been retroactively adjusted to reflect the Reverse Split for all periods presented. |
| (ii) | The Company issued the following shares during the nine-month period ended April 30, 2025: |
| 1. | On
September 12, 2024, the Company completed a registered direct offering for the purchase and sale of common shares of the
Company at an offering price of $ per share, for aggregate gross proceeds of approximately $ |
| In connection with the September
2024 Offering, the Company issued |
| 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 common shares of the Company and warrants to purchase up to
an aggregate of | |
| In connection with the October 2024 Offering,
the Company issued | ||
| The fair value of the | ||
| The fair value of the | ||
| The amounts were credited to the warrant reserve at the date of the October 2024 Offering. |
| 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)
| 3. | On December 13, 2024, the Company closed a
public offering for the purchase and sale of common shares of the Company and warrants to purchase up to an aggregate of | |
| In connection with the December 2024 Offering,
the Company issued | ||
| The fair value of the | ||
| The fair value of the | ||
| The amounts were credited to the warrant reserve at the date of the December 2024 Offering. | ||
| 4. | On February 5, 2025, the Company closed a
public offering for the purchase and sale of common shares of the Company at an offering price of $ per share, for aggregate
gross proceeds of approximately $ | |
| In connection with the February 2025 Offering,
the Company issued | ||
| The amount was credited to the warrant reserve at the date of the February 2025 Offering. |
| 5. | On April 28, 2025, the Company closed an underwritten public
offering for the purchase and sale of units for aggregate gross proceeds of approximately $ |
In
connection with the April 2025 Offering, the Company issued
The
fair value of the
| 15 |
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)
The
fair value of the
The amounts were credited to the warrant reserve at the date of the April 2025 Offering.
As of April 30, 2025,
| 6. | During the nine-month period ended April 30, 2025, a total
of October 2024 Warrants with an exercise price of $ were exercised, generating gross proceeds of $ |
c. Share Purchase Warrants
SUMMARY OF CHANGES IN WARRANTS
Number of options outstanding |
Weighted average exercise price |
|||||||
| Balance, July 31, 2024 | $ | |||||||
| Exercised | ( |
) | ( |
) | ||||
| Granted in the October 2024 Offering | ||||||||
| Granted in the December 2024 Offering | ||||||||
| Granted in the April 2025 Offering | ||||||||
| Balance, April 30, 2025 | $ | |||||||
| (ii) | As of April 30, 2025, warrants outstanding were as follows: |
Number of Warrants |
Exercise Price | Exercisable At April 30, 2025 |
Expiry Date | |||||||||
| (*) |
$ | |||||||||||
| (*) |
$ | – | ||||||||||
| (*) |
$ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
| 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)
d. Compensation Warrants
| (i) | A summary of changes in compensation warrants for the nine-month period ending April 30, 2025 is presented below: |
SUMMARY OF CHANGES IN WARRANTS
Number of warrants outstanding |
Weighted average exercise price |
|||||||
| Balance, July 31, 2024 | ||||||||
| Granted in the September 2024 Offering | ||||||||
| Granted in the October 2024 Offering | ||||||||
| Granted in the December 2024 Offering | ||||||||
| Granted in the February 2025 Offering | ||||||||
| Granted in the April 2025 Offering | ||||||||
| Balance, April 30, 2025 | $ | |||||||
| (ii) | As of April 30, 2025, compensation warrants outstanding were as follows: |
SCHEDULE OF WARRANTS OUTSTANDING
Number of Warrants |
Exercise Price | Exercisable At April 30, 2025 |
Expiry Date | |||||||||
| (*) |
$ | |||||||||||
| (*) |
$ | |||||||||||
| (*) |
$ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
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 | $ | |||
| Change in fair value during the period | $ | ( |
||
| Balance as of April 30, 2025 | $ | |||
| 17 |
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)
The key inputs used in the valuation of the non-public warrants as of April 30, 2025 and at July 31, 2024 were as follows:
SCHEDULE OF VALUATION OF NON-PUBLIC WARRANTS
| April 30, 2025 | July 31, 2024 | |||||||
| Share price | $ | $ | ||||||
| Exercise price | $ | - | $ | - | ||||
| Expected life (years) | - | - | ||||||
| Volatility | - | % | - | % | ||||
| Dividend yield | % | % | ||||||
| Risk free rate | - | % | % | |||||
The key inputs used in the valuation of the of the BriaPro Warrant Shares as of April 30, 2025 were as follows:
SCHEDULE OF BRIA PRO WARRANTS
| August
31, 2023 (Effective Date) |
April 30, 2025 | |||||||
| Share price | $ | $ | ||||||
| Exercise price | $ | - | $ | - | ||||
| Expected life (years) | - | - | ||||||
| Volatility | % | - | % | |||||
| Dividend yield | % | % | ||||||
| Risk free rate | % | - | % | |||||
| 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 | |
| b. | The following table summarizes the number of options granted to directors, officers, employees and consultants under the option plan for nine-month period ended April 30, 2025 and related information: |
| Number of options | Weighted average exercise price |
Weighted average remaining contractual term (in years) |
Aggregate intrinsic value |
|||||||||||||
| Balance as of July 31, 2024 | $ | $ | ||||||||||||||
| Granted (i) | ||||||||||||||||
| Forfeited | ( |
) | ||||||||||||||
| Balance as of April 30, 2025 | ||||||||||||||||
| Exercisable as of April 30, 2025 | $ | $ | ||||||||||||||
| (i) |
| 18 |
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)
As of April 30, 2025, there are no unrecognized costs related to share-based compensation.
| c. | The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of April 30, 2025. |
Exercise price |
Options outstanding as of April 30, 2025 |
Weighted average remaining contractual term (years) |
Options exercisable as of April 30, 2025 |
Weighted average remaining contractual term (years) |
Expiry Date | |||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| d. | As result of the Arrangement, 2,131,400 BriaPro Options were issued and are outstanding as of April 30, 2025: |
Exercise Price |
Options outstanding as of April 30, 2025 |
Options exercisable as of April 30, 2025 |
Expiry Date | |||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| 19 |
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)
| e. | Restricted Share Unit Plan |
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED
Number of RSU’s outstanding |
Aggregate intrinsic value |
|||||||
| Balance, July 31, 2024 | $ | |||||||
| Granted(i) | ||||||||
| Balance, April 30, 2025 | $ | |||||||
| (i) |
Additionally, on the same date, the Company granted RSUs to a consultant, which fully vested on April 16, 2025.
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES
| Three
months ended April 30, |
Nine
months ended April 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Research, development, and clinical trial expenses | $ | $ | ||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total share-based compensation | $ | $ | ||||||||||||||
NOTE 8: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET
Three months ended April 30, |
Nine
months ended April 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Interest income | $ | $ | ||||||||||||||
| Interest Expense | ( |
) | ( |
|||||||||||||
| Foreign exchange gain (loss) | ( |
) | ( |
) | ||||||||||||
| Financial income (expenses), net | $ | ( |
) | $ | $ | $ | ||||||||||
NOTE 9: SUBSEQUENT EVENT
The Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements through June 16, 2025, the date that the condensed consolidated financial statements were available for issuance. The Company is not aware of any subsequent events which would require recognition or disclosure in the consolidated financial statements, except as follows:
| a. | On May 8, 2025, subsequent to quarter-end, the remaining pre-funded warrants were exercised on a cashless basis, resulting in the issuance of common shares. |
| 20 |
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 half and second quarter of fiscal 2025 in comparison to the first half and second quarter of fiscal 2024. | |
| ● | Part 3 - Financial Liquidity and Capital Resources. This section provides an analysis of our cash flows and outstanding debt and commitments. Included in this analysis is a discussion of the amount of financial capacity available to fund our ongoing operations and future commitments. |
We prepare and report our unaudited Condensed Consolidated Financial Statements in accordance with U.S. GAAP. Our unaudited Condensed Consolidated Financial Statements, and the financial information contained herein, are reported in U.S Dollars.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other SEC filings.
Overview
BriaCell Therapeutics Corp. (the “Company”), is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab, manufactured and supplied by Incyte) in a pivotal1 Phase 3 study (ClinicalTrials.gov identifier: NCT06072612) in metastatic breast cancer. The pivotal Phase 3 study of 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 Phase 3 study, following review by FDA, could lead to full approval of the Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer.
1”Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.
| 21 |
Additionally, BriaCell is conducting a Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of Bria-OTS™, BriaCell’s personalized next generation immunotherapy, in metastatic breast cancer and other cancers. 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™/Bria-OTS+™, provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer.
Recent Developments
On January 3, 2025, the Company announced that the board of directors has approved the consolidation (the “Consolidation”) of the Company’s issued and outstanding common shares (the “Common Shares”) on the basis of one (1) post-Consolidation Common Share for every fifteen (15) pre-Consolidation Common Shares. The Consolidation is being implemented to ensure that the Company continues to comply with the listing requirements of The Nasdaq Capital Market (the “Nasdaq”). The effective date of the consolidation was January 29, 2025.
On February 3, 2025, the Company announced an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere, The patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer.
On February 5, 2025, the Company closed a public offering for the purchase and sale of 762,500 common shares of the Company for aggregate gross proceeds of approximately $3.05 million before deducting placement agent fees and other offering expenses (the “February 2025 Offering”). Each common share was sold at a public offering price of $4.00 per share. In addition, the Company issued 38,125 agent warrants. The agent warrants are immediately exercisable for a period of five years from the closing date at an exercise price of $5.00 per share.
On April 10, 2025, the Company announced that its majority owned subsidiary, BriaPro Therapeutics Corp. (“BriaPro”), is developing novel, high affinity antibodies to B7-H3, a key player in cancer progression, using molecular modeling techniques. BriaPro has filed provisional US patent applications for the corresponding technology and plans on filing an international patent application under the Patent Cooperation Treaty (PCT).
As both an immune checkpoint molecule that regulates T cell activity and a cell surface molecule expressed on many types of cancer cells, B7-H3 is a promising drug target. BriaPro plans on developing anti-B7-H3 antibodies for multiple cancer indications and plans to incorporate them into its Bria-TILsRx™ platform—a proprietary antibody platform designed to redirect and activate T cells within the tumor microenvironment. This platform integrates both T cell engagers, which promote T cell-mediated tumor killing, and tumor-targeted immune checkpoint modulators, which selectively block inhibitory signals on tumor infiltrating lymphocytes (TILs) to enhance their anti-tumor activity.
On April 16, 2025, the Company announced new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients. In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY® (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY® but still markedly higher (70%) than those of chemotherapy.Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™ plus CPI versus other drugs in MBC patient subsets
| 22 |
| Reference | Breast Cancer Type | Median # of prior lines of therapy | Median OS (months) | |||||||
| Bria-IMT™ plus CPI* | HR+ | 6 | 17.3 | |||||||
| TRODELVY®1 | HR+ | 4 | 14.4 | |||||||
| (sacituzumab govitecan-hziy) | Single agent chemotherapy | 4 | 11.3 | |||||||
| Bria-IMT™ plus CPI* | TNBC | 6 | 11.4 | |||||||
TRODELVY®1 | TNBC | 3 | ** | 11.8 | ||||||
| Single agent chemotherapy | 3 | ** | 6.9 | |||||||
* Patients treated with the Phase 3 formulation
** Number of prior chemotherapy-containing regimens
| 1. | https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf |
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))
On April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients. BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.
On April 24, 2025, BriaCell Confirmed 100% Resolution of Lung Metastasis with Bria-OTS (Figure 1). Complete resolution of lung metastasis confirmed at 4 months follow-up in a hormone receptor positive (HR+) breast cancer patient. Treatment well-tolerated and the patient remained on study with stable disease elsewhere. Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study.Figure 1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the lung of the MBC patient following 2 months of therapy and confirmed at 4 months of therapy1 (axial and coronal views)
1 Note that the other white dots in the lungs are blood vessels.
| 23 |
As shown, the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months. The updated images supersede those previously reported.
On April 28, 2025, the Company closed an underwritten public offering for the purchase and sale of 3,066,666 units for aggregate gross proceeds of approximately $13.8 million before deducting underwriting discounts, commissions, and other offering expenses (the “April 2025 Offering”). Of those units, 2,405,966 were “regular” units, each consisting of one common share and one five-year publicly traded warrant at a combined purchase price of $4.50 per unit, and 660,700 were “pre-funded” units, each consisting of one pre-funded warrant (at a $0.001 strike) and one five-year publicly traded warrant at a combined purchase price of $4.499 per unit. All warrants have an exercise price of $5.25 per share, are immediately exercisable, and expire five years from the date of issuance (“April 2025 Warrants”). The April 2025 Warrants trade on the NASDAQ under the symbol “BCTXZ.”
In connection with the April 2025 Offering, the Company issued 153,333 representative’s warrants. The representative’s warrants are immediately exercisable at an exercise price of $5.625 per share and expire five years from the date of issuance.
On April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025. Positive tolerability profile and potential response biomarkers were identified. Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in Phase 2 study. Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits. Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were linked to longer progression-free survival (PFS) in Phase 3 patients. Presence of Circulating Tumor Cells (CTC) after patients’ initial Phase 3 treatment supports their role as negative prognostic marker (p = 0.04). The Bria-IMT Phase 3 regimen was well-tolerated with a preferred tolerability profile.
On May 23, 2025, BriaCell reported that its abstracts showcased positive survival and clinical benefit data at ASCO 2025. Phase 2 survival and clinical benefit data met or exceeded outcomes of FDA-approved therapies in comparable metastatic breast cancer patients, with no treatment-related discontinuations. Successful completion of the pivotal Phase 3 study may support Biologics License Application, Priority Review, Full Approval, and Commercialization.
On May 27, 2025, BriaCell announced that the Bria-OTS Phase 1/2 Study cleared safety evaluation, and BriaCell dosed its first patient in Bria-OTS combination with an immune checkpoint inhibitor. Specifically, Bria-OTS has cleared its safety evaluation in the Phase 1/2 study monotherapy dosage setting. Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic breast cancer. The first Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis.
| 24 |
Results of Operations for the Three Months Ended April 30, 2025 and 2024
| Three
months ended April 30, |
||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating Expenses: | ||||||||
| Research, development, and clinical trial expenses | $ | 4,810,196 | $ | 7,657,632 | ||||
| General and administrative expenses | 1,518,059 | 1,572,016 | ||||||
| Total operating expenses | 6,328,255 | 9,229,648 | ||||||
| Operating loss | (6,328,255) | (9,229,648 | ) | |||||
| Financial expenses, net | (9,762) | 13,215 | ||||||
| Change in fair value of the warrant liability | 175,826 | 10,945,672 | ||||||
| Share of loss on equity investments | (62,738) | (36,997 | ) | |||||
| Net loss for the period | $ | (6,224,929) | $ | 1,692,242 | ||||
| Net loss attributable to non-controlling interest | (98,027) | (23,517 | ) | |||||
| Net loss for the period attributable to BriaCell | (6,126,902) | 1,715,759 | ||||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | (1.64) | $ | 1.61 | ||||
Research, Development, and Clinical Trial Costs
Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and in clinical development; 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, development, and clinical trial costs by nature of expenses:
| Three months ended April 30, | ||||||||
| 2025 | 2024 | |||||||
| Clinical trial sites and investigational drug costs | $ | 3,175,543 | $ | 6,165,072 | ||||
| Wages and salaries | 1,303,157 | 1,090,902 | ||||||
| Laboratory Rent | 114,330 | 109,500 | ||||||
| Supplies | 157,184 | 165,264 | ||||||
| Depreciation | 22,839 | - | ||||||
| Professional fees | 650 | 581 | ||||||
| Share-based compensation | 36,493 | 126,313 | ||||||
| $ | 4,810,196 | $ | 7,657,632 | |||||
For the three-month period ended April 30, 2025, total research, development, and clinical trial costs amounted to $4,810,196 as compared to $7,657,632 for the three-month period ended April 30, 2024. This reduction was primarily driven by lower clinical trial sites and investigational drug costs, which decreased from $6,165,072 in 2024 to $3,175,543 in 2025. 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 increased considerably, from $1,090,902 in 2024 to $1,303,157 in 2025, reflecting the hiring of additional employees. Laboratory rent increased to $114,330 in 2025, up from $109,500 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $165,264 in 2024 to $157,184 in 2025, driven by lowered spending. Depreciation expenses of $22,839 were recognized in 2025, reflecting investments in capital assets to support research activities. Professional fees increased to $650 in 2025, compared to $581 in 2024. Notably, share-based compensation expenses decreased significantly, from $126,313 in 2024 to $36,493 in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
| 25 |
Clinical trial expenses for the period are as follows:
| Three months ended April 30, | ||||||||
| 2025 | 2024 | |||||||
| Bria-IMT™ Pivotal Phase 3 study | $ | 2,708,394 | $ | 3,764,521 | ||||
| Bria-IMT™ Phase 1/2a | 300,013 | 898,528 | ||||||
| Bria-OTS™ Phase 1/2a | 182,344 | - | ||||||
| $ | 3,190,751 | $ | 4,359,850 | |||||
Clinical trial expenses for the three months ended April 30, 2025, were $3,190,751, compared to $4,359,850 during the same period in 2024. The slight decrease is primarily attributable to the conclusion of the Bria-IMT™ Phase 1/2a clinical trial in fiscal 2024, resulting in lower associated costs. As expenses for the Bria-IMT™ Phase 1/2a trial declined, resources have been increasingly directed toward the pivotal Phase 3 study, which remains our primary focus. At the same time, we have begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
For the three-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs amounted to $2,708,394, a decrease from $3,764,521 in 2024. This decrease reflects the planned phasing of expenditures within the pivotal study; the prior-year quarter included higher up-front activities, whereas current spending is concentrated on ongoing patient recruitment, treatment, and data-management costs as we push toward key milestones.
For the three-month period ended April 30, 2025, Bria-IMT™ Phase 1/2a costs were $300,013, a significant decline from $898,528 in 2024, as the trial has now concluded. The remaining expenses primarily relate to final data analysis and study close-out activities.
For the three-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $182,344, compared to $nil in 2024. The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
General and Administrative Expenses
For the three-month period ended April 30, 2025, general and administrative expenses amounted to $1,518,059, compared to $1,572,016 for the same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting in overall stable general and administrative expenses quarter over quarter.
Financial income (expenses), net
For the three-month period ended April 30, 2025, financial expense amounted to $9,762, compared to income of $13,215 for the three-month period ended April 30, 2024. Financial expense for the 2025 period consisted of $26,632 in interest income offset by $585 foreign exchange loss and interest expense of $36,979 . In comparison, financial income for the 2024 period included $15,606 in interest income and a $2,391 foreign exchange loss. The decrease in financial income to a loss from 2024 to 2025 was primarily due to higher interest expense in 2025 compared to nil in 2024.
Loss for the period
The Company reported a loss of $6,224,929 for the three-month period ended April 30, 2025, compared to income of $1,692,242 for the same period in 2024. The swing to a net loss was primarily driven by a significantly smaller non-cash gain from the change in fair value of the warrant liability, which declined from $10,945,672 in 2024 to $175,826 in 2025. Additionally, research, development, and clinical trial expenses decreased from $7,657,632 in 2024 to $4,810,196 in 2025, mainly due to lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™ Phase 1/2a trial, partially offsetting the impact of the reduced warrant-liability gain.
| 26 |
Results of Operations for the Nine Months Ended April 30, 2025 and 2024
| Nine
months ended April 30, |
||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating Expenses: | ||||||||
| Research, development, and clinical trial expenses | $ | 14,160,314 | $ | 22,772,344 | ||||
| General and administrative expenses | 4,490,216 | 4,789,778 | ||||||
| Total operating expenses | 18,650,530 | 27,562,122 | ||||||
| Operating loss | (18,650,530) | (27,562,122 | ) | |||||
| Financial expenses, net | 69,310 | 274,665 | ||||||
| Change in fair value of the warrant liability | 366,024 | 23,660,003 | ||||||
| Share of loss on equity investments | (176,837) | (55,342 | ) | |||||
| Net loss for the period | $ | (18,392,033) | (3,682,796 | ) | ||||
| Net loss attributable to non-controlling interest | (171,536) | (105,495 | ) | |||||
| Net loss for the period attributable to BriaCell | (18,220,497) | (3,577,301 | ) | |||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | (6.70) | $ | (3.36 | ) | |||
Research, Development, and Clinical Trial 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, development, and clinical trial costs by nature of expenses:
| Nine months ended April 30, | ||||||||
| 2025 | 2024 | |||||||
| Clinical trial sites and Investigational drug costs | $ | 9,732,786 | $ | 17,763,490 | ||||
| Wages and salaries | 3,544,267 | 3,513,306 | ||||||
| Laboratory Rent | 342,990 | 305,980 | ||||||
| Supplies | 341,878 | 566,830 | ||||||
| Depreciation | 68,517 | - | ||||||
| Professional fees | 9,826 | 4,363 | ||||||
| Share-based compensation | 120,050 | 618,375 | ||||||
| $ | 14,160,314 | $ | 22,772,344 | |||||
For
the nine-month period ending April 30, 2025, research, development and clinical trial costs amounted to $14,160,314, a significant decrease
from the $22,772,344 incurred during the same period in 2024. This reduction was primarily driven by lower clinical trial sites and investigational
drug costs, which decreased from $17,763,490 in 2024 to $9,732,786 in 2025. 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 increased slightly, from $3,513,306
in 2024 to $3,544,267 in 2025, reflecting the hiring of additional employees. Laboratory rent increased to $342,990 in 2025, up from
$305,980 in 2024, due to expanded use of facilities to support ongoing research. Supplies decreased, from $566,830 in 2024 to $341,878
in 2025, driven by lowered spending. Depreciation expenses of $68,517 were recognized in 2025, reflecting investments in capital assets
to support research activities. Professional fees increased to $9,826 in 2025, compared to $4,363 in 2024, primarily due to consulting
and support for clinical operations. Notably, share-based compensation expenses decreased significantly, from $618,375 in 2024 to $120,050
in 2025, contributing to the overall reduction in research, development, and clinical trial expenses.
| 27 |
Clinical trial expenses for the period are as follows:
| Nine months ended April 30, | ||||||||
| 2025 | 2024 | |||||||
| Bria-IMT™ Pivotal Phase 3 study | $ | 8,797,505 | $ | 8,651,728 | ||||
| Bria-IMT™ Phase 1/2a | 699,356 | 3,998,461 | ||||||
| Bria-OTS™ Phase 1/2a | 325,539 | - | ||||||
| $ | 9,822,400 | $ | 12,650,189 | |||||
Clinical trial expenses for the nine-month period ended April 30, 2025, were $9,822,400, compared to $12,650,189 during the same period in 2024. This decrease reflects the completion of the Bria-IMT™ Phase 1/2a trial and the planned phasing of expenditures within the pivotal Phase 3 study, which remains our primary focus. While resources have been increasingly directed toward Phase 3, we have also begun incurring costs related to the Bria-OTS™ Phase 1/2a trial, which commenced in August 2024.
For the nine-month period ended April 30, 2025, Bria-IMT™ Pivotal Phase 3 Study costs totaled $8,797,505, up from $8,651,728 in 2024. The increase highlights our commitment to accelerating trial progress, with efforts focused on expanding patient recruitment, treatment, site activation, and data-management activities to support the study’s advancement.
Bria-IMT™ Phase 1/2a costs declined to $699,356, a sharp reduction from $3,998,461 in 2024, reflecting the trial’s conclusion. The remaining costs are tied to final reporting, regulatory submissions, and study close-out activities.
For the nine-month period ended April 30, 2025, Bria-OTS™ Phase 1/2a costs totaled $325,539, compared to $nil in 2024. The increase is due to the initiation of the Bria-OTS™ Phase 1/2a trial in August 2024.
We remain committed to advancing the pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer and continue to allocate resources strategically to ensure its successful execution.
General and Administrative Expenses
For the nine-month period ended April 30, 2025, general and administrative expenses amounted to $4,490,216, compared to $4,789,778 for the same period in 2024. The slight decrease was primarily due to operational efficiencies, which offset other cost fluctuations, resulting in overall stable general and administrative expenses period over period.
Financial income (expenses), net
For the nine-month period ended April 30, 2025, financial income amounted to $69,310, compared to $274,665 for the nine-month period ended April 30, 2024. Financial income for the 2025 period consisted of $86,514 in interest income and a $19,775 foreign exchange gain offset by interest expense of $36,979. In comparison, financial income for the 2024 period included $288,016 in interest income, offset by a $13,351 foreign exchange loss. The decrease in financial income from 2024 to 2025 was primarily due to lower interest income, reflecting reduced cash and cash equivalents available for investment in interest-bearing funds.
Loss for the period
The Company reported a loss of $18,392,033 for the nine-month period ended April 30, 2025, compared to $3,682,796 in 2024. The increase was primarily due to a significantly smaller gain on the fair value of the warrant liability, which was $366,024 in 2025 compared to $23,660,003 in 2024. This impact outweighed the reduction in research, development, and clinical trial expenses, which decreased from $22,772,344 in 2024 to $14,160,314 in 2025, mainly due to lower clinical-trial and investigational-drug costs following the completion of the Bria-IMT™ Phase 1/2a trial.
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.
| 28 |
As of April 30, 2025, and a positive working capital balance of $10,454,565 (July 31, 2024 negative balance of $3,807,303).
As of April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261), a positive working capital of $10,454,565 (July 31, 2024 – negative balance of $3,807,303) and an accumulated deficit of $103,664,194 (July 31, 2024 - $85,443,697).
As of April 30, 2025, 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 April 30, 2025, the Company’s overall position of cash and cash equivalents increased by $11,598,164 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 April 30, 2025, was $20,038,075 as compared to $20,090,398 for the period ended April 30, 2024.
Cash gained in financing activities for the period ended April 30, 2025, was 31,891,239 as compared to nil for the period ended April 30, 2024.
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 April 30, 2025.
| 29 |
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 April 30, 2025, the Company has total assets of $17,001,798 (July 31, 2024 - $5,872,261) and a positive working capital balance of $10,454,565 (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.
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 April 30, 2025, 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.
| 30 |
Cash and cash equivalents are valued using quoted market prices in active markets. The fair value of the warrant liability is determined based on the nature of the warrant. For publicly traded warrants we use the quoted market price and for all other warrants we use the Black-Scholes pricing model.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our principal executive officer and principal accounting and financial officer have concluded that as of April 30, 2025, 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 April 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 31 |
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 quarter ended April 30, 2025
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
None.
Item 6. Exhibits
The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q.
EXHIBIT INDEX
| * | Filed herewith. |
| 32 |
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. | ||
| June 16, 2025 | By: | /s/ William V. Williams |
| Name: | William V. Williams | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| June 16, 2025 | By: | /s/ Gadi Levin |
| Name: | Gadi Levin | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
| 33 |
Exhibit 31.1
CERTIFICATION
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. |
| June 16, 2025 | /s/ William V. Williams |
| William V. Williams | |
President and Chief Executive Officer | |
| (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
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 (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. |
| June 16, 2025 | /s/ Gadi Levin |
| Gadi Levin | |
Chief Financial Officer | |
| (Principal Financial and Accounting Officer) |
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
In connection with the Quarterly Report on Form 10-Q of BriaCell Therapeutics Corp. (the “Company”) for the quarter ended April 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, William V. Willams, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
(1) 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.
| June 16, 2025 | /s/ William V. Williams |
| William V. Williams | |
President and Chief Executive Officer | |
| (Principal Executive Officer) |
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
In connection with the Quarterly Report on Form 10-Q of BriaCell Therapeutics Corp. (the “Company”) for the quarter ended April 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Gadi Levin, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of knowledge:
(1) 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.
| June 16, 2025 | /s/ Gadi Levin |
| Gadi Levin | |
Chief Financial Officer | |
| (Principal Financial and Accounting Officer) |