BriaCell (NASDAQ: BCTX) boosts R&D as going concern risk emerges
BriaCell Therapeutics Corp. reported results for the quarter ended October 31, 2025, as it advances multiple immuno-oncology programs, including its pivotal Phase 3 Bria‑IMT™ trial in metastatic breast cancer and the Bria‑OTS™ off‑the‑shelf platform.
The company posted a net loss of $8.3 million versus $5.8 million a year earlier, driven mainly by research and development expenses that rose to $6.7 million from $3.7 million. Clinical trial costs reached $4.9 million, including $3.8 million for the Bria‑IMT™ pivotal Phase 3 study and $1.0 million for the Bria‑OTS™ Phase 1/2a trial. General and administrative expenses were $1.6 million, and basic and diluted loss per share was $4.35.
Liquidity tightened: cash and cash equivalents were $2.7 million and short‑term investments $7.5 million, for total assets of $13.1 million and working capital of $8.0 million. Operating cash outflow was $7.7 million in the quarter, shareholders’ equity fell to $9.4 million, and the accumulated deficit reached $119.95 million. Management notes that recurring losses, negative cash flows and reliance on new financings cast substantial doubt on BriaCell’s ability to continue as a going concern, despite having raised $50.9 million of gross equity proceeds in the prior fiscal year and securing a $2.0 million NCI SBIR grant for Bria‑PROS+™.
Operationally, BriaCell continued enrolling its pivotal Bria‑IMT™ Phase 3 trial at 79 U.S. sites, under FDA Fast Track designation, with a fourth consecutive positive Data Safety Monitoring Board recommendation. The company highlighted prior Phase 2 data showing median overall survival of 13.4–16.5 months in metastatic breast cancer cohorts versus 6.7–9.8 months reported in the literature, and indicated that top‑line Phase 3 data and an interim overall survival analysis could be available as early as the first half of 2026, subject to event accrual. BriaCell also advanced its Bria‑OTS+™ platform through preclinical results and a collaboration with Memorial Sloan Kettering’s Therapeutics Accelerator, and expanded a small‑molecule oncology pipeline via BriaPro’s AI‑driven collaboration with Receptor.AI.
Positive
- None.
Negative
- Going concern warning: Management states that recurring operating losses, negative operating cash flow of
$7,704,796 for the quarter, an accumulated deficit of$119,953,129 , and reliance on additional financing “casts substantial doubt” on the company’s ability to continue as a going concern. - Rapid balance sheet deterioration: Between July 31 and October 31, 2025, cash and cash equivalents declined from
$10,493,808 to$2,714,012 , and total shareholders’ equity fell from$17,334,046 to$9,350,404 , reflecting heavy cash burn and expanding losses as clinical programs scale.
Insights
R&D surged as BriaCell pushes pivotal and OTS programs, deepening losses but expanding late‑stage cancer assets.
BriaCell is clearly prioritizing pipeline advancement. Research and development expenses nearly doubled year over year to
The company emphasizes prior Phase 2 Bria‑IMT™ data, including median overall survival of
This strategy expands clinical optionality but comes at a cost: the quarterly net loss widened to
Cash burn and going concern warning highlight near‑term financing risk despite prior $50.9M raise and non‑dilutive grant.
The quarter underscored liquidity pressure. Cash and cash equivalents fell to
Management explicitly states that continued operating losses, negative cash flows and dependence on new capital “casts substantial doubt” on the company’s ability to continue as a going concern, even after raising
Capital structure complexity is increasing through options, RSUs and PSUs. As of October 31, 2025, there were
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As
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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, 2025 (unaudited) and July 31, 2025 (audited) | 3 | |
| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended October 31, 2025 and 2024 | 4 | |
| Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) for the three months ended October 31, 2025 and 2024 | 5 | |
| Unaudited Condensed Consolidated Statement of Cash Flows for the three months ended October 31, 2025 and 2024 | 6 | |
| Notes to Unaudited Condensed Consolidated Financial Statements | 7 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 17 |
| Item 3. | Quantitative and Qualitative Disclosures Regarding Market Risk | 21 |
| Item 4. | Controls and Procedures | 22 |
| Part II. Other Information | 24 | |
| 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 | 23 |
| Item 6. | Exhibits | 23 |
| Part III. Signatures | 24 | |
| 2 |
PART I-FINANCIAL INFORMATION
Item 1. Financial Statements
BRIACELL THERAPEUTICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
| October 31.2025 | July 31, 2025 | |||||||
| (Unaudited) | (Audited) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Short-term investments | ||||||||
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 | $ | $ | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | - | - | ||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Share
Capital of |
||||||||
| Share-based payment reserved | ||||||||
| Warrant reserve | ||||||||
| Accumulated other comprehensive loss | ( |
( |
) | |||||
| Non-controlling interest | ( |
( |
) | |||||
| Accumulated deficit | ( |
( |
) | |||||
| Total shareholders’ equity | ||||||||
| Total liabilities and shareholders’ equity | $ | $ | ||||||
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)
| 2025 | 2024 | |||||||
| Three months ended | ||||||||
| October 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development expenses | $ | |||||||
| General and administrative expenses | ||||||||
| Total operating expenses | ||||||||
| Operating loss | ( | ) | ( | ) | ||||
| Financial income, net | ||||||||
| Change in fair value of the warrant liability | ( | ) | ( | ) | ||||
| Share of loss on equity investment | ( | ) | ( | ) | ||||
| Net loss for the period | $ | ( | ) | $ | ( | ) | ||
| Net loss attributable to non-controlling interest | ( | ) | ( | ) | ||||
| Net loss for the period attributable to BriaCell | ( | ) | ( | ) | ||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average number of shares used in computing net basic and diluted loss per share of common stock | ||||||||
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, 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, July 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| Issuance of Options | - | - | - | - | - | - | ||||||||||||||||||||||||||
| Exercise of prefunded warrants | - | - | - | - | - | - | - | |||||||||||||||||||||||||
| Exercise of broker warrants | - | ( | ) | - | - | - | ||||||||||||||||||||||||||
| Issuance of units | - | - | - | - | ||||||||||||||||||||||||||||
| Net loss for the period | - | - | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||
| Balance, October 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Share capital | Additional paid in | Warrant | Accumulated other comprehensive | Accumulated | Non- Controlling | Total
shareholders’ | ||||||||||||||||||||||||||
| Number | Amount | capital | reserve | loss | deficit | Interest | equity | |||||||||||||||||||||||||
| Balance, July 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Issuance of Options | - | - | - | - | - | - | ||||||||||||||||||||||||||
| Net loss for the period | - | - | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||
| Balance, October 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
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)
| 2025 | 2024 | |||||||
| Three months ended October 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flow from operating activities | ||||||||
| Net loss for the period | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Amortization | ||||||||
| Financial expenses, net | ( | ) | - | |||||
| Depreciation | ||||||||
| Share-based compensation | ||||||||
| Equity losses | ||||||||
| Change in fair value of warrants | ||||||||
| Changes in working capital: | ||||||||
| Decrease in amounts receivable and prepaid expenses | ||||||||
| Decrease in accounts payable | ( | ) | ( | ) | ||||
| Increase 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 shares, 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.
| 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”, “BCTXW” and “BCTXZ”. | |
| 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, 2025, filed with the SEC on October 16, 2025. 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, 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). BriaPro was established to complete a plan of arrangement spinout transaction in August 2023, pursuant to which certain pipeline assets of the Company were spun-out to BriaPro, including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”), resulting in a two-third (2/3) owned subsidiary of the Company with the remaining one-third (1/3) held by the Company’s shareholders (the “Amalgamation” and the “Amalgamation Agreement”) – see also note 7(a). (Sapientia and BTC and BriaPro together, the “Subsidiaries”). |
| 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.
Significant estimates include the determination of the fair value of warrant liabilities, which are measured using valuation models that require assumptions such as share price volatility, expected term, and risk-free interest rates. Changes in these inputs could materially impact the valuation of the warrant liability and the amounts recognized in the condensed consolidated financial statements. |
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, 2025, 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 |
e. Segment reporting:
| The Company manages its business activities on a consolidated basis and operates as one reportable segment. The Company’s operations are focused on the research and development of its immunotherapy product candidates and related supporting activities. The Chief Executive Officer is identified as the Company’s Chief Operating Decision Maker (“CODM”). | ||
| The accounting policies of the segment are the same as those used in the condensed consolidated financial statements. The CODM evaluates the Company’s performance and allocates resources using consolidated financial information, including net loss and cash flow forecasts. The Company’s significant expenses, which consist primarily of research and development and general and administrative expenses, are consistent with the captions presented on the consolidated statements of operations and comprehensive loss. |
f. Share-based compensation:
| The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation – Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. | ||
| The Company has selected the Black-Scholes option-pricing model as the most appropriate fair value method for its option awards. The Company recognizes forfeitures of equity-based awards as they occur. Restricted share units use the share price on the grant date to determine the fair value of the restricted share unit award. | ||
| For performance-based stock units (“PSUs”) that do not contain market conditions, the Company measures the grant-date fair value using the closing price of the common stock on the date of grant. Compensation cost for these awards is recognized over the requisite service period based on the number of awards that are expected to vest. Management evaluates the probability of achieving the applicable performance conditions each reporting period and adjusts the expense recognition accordingly. | ||
| As of the date of this report, the Company has issued stock options, RSUs, and PSUs that do not contain market conditions. |
g. 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. |
| 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)
| 1. | 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. | |
| 2. | 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. |
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 $ | ||
| Pursuant
to the SPA (“Initial Investment”), Briacell also received two options to invest an additional $ | ||
| 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
As
of October 31, 2025, the Company holds | ||
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.
|
| 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)
Changes in the Company’s equity investment in BC Therapeutics is summarized as follows:
SCHEDULE OF CHANGES IN INVESTMENT
| Balance – August 1, 2024 | $ | |||
| Funding (including the value of the BC Therapeutics Options) | ||||
| Share of losses | ( | ) | ||
| Balance – July 31, 2025 | ||||
| Funding (including the value of the BC Therapeutics Options) | ||||
| Share of losses | ( | ) | ||
| Balance – October 31, 2025 | $ |
The following amounts represent the Company’s 65% share of the assets of BC Therapeutics (July 31, 2025 – 63.1%):
SCHEDULE OF ASSETS AND LIABILITIES OF BC THERAPEUTICS
As of October 31, 2025 | ||||
| Current assets: Cash | $ | |||
| Net assets | $ | |||
NOTE 4: CONTINGENT LIABILITIES AND COMMITMENTS
| a. | BriaPro Warrants | |
Upon
the exercise of certain BriaCell warrants that were outstanding at the time of the Amalgamation
Agreement with BriaPro (“Briacell Legacy Warrants”), BriaCell shall, as agent
for BriaPro, collect and pay to BriaPro an amount based on an agreed formula. As of July
31, 2025, this amount totaled of up to $
Pursuant to the Amalgamation Agreement, each BriaCell warrant in issuance at the time of the Amalgamation (“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 Splits, as defined below– 150 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 150 BriaCell Legacy Warrants (post Reverse Splits), 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 150 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”). On a Reverse Split basis, as of July 31, 2025,
| ||
| b. | Lease | |
| The
Company has a month-to-month commitment for office and lab space in Philadelphia, PA, costing approximately $ |
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, 2025 and July 31, 2025:
SCHEDULE OF FINANCIAL INSTRUMENTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
| Fair Value Measurements at | ||||||||||||||||||||||||
| October 31, 2025 | July 31, 2025 | |||||||||||||||||||||||
| Level 1 | Level 2 | Total | Level 1 | Level 2 | Total | |||||||||||||||||||
| Financial Assets: | ||||||||||||||||||||||||
| Cash and cash equivalents | - | - | ||||||||||||||||||||||
| Short-term investments | - | - | ||||||||||||||||||||||
| Total assets measured at fair value | $ | $ | - | $ | $ | $ | - | $ | ||||||||||||||||
| Financial liabilities: | ||||||||||||||||||||||||
| Warrants liability | ||||||||||||||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
| 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)
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 Company also holds Level 1 short-term investments with coupon rates
ranging between
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 unlimited number of common shares with
b. Issued share capital
| (i) | Reverse Stock Split: |
| On
January 3, 2025, the Company’s board of directors approved a reverse stock split of the Company’s common shares on a
|
As a result of the Reverse Splits, every one hundred and fifty (150) 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 Splits. Instead, any fractional common shares resulting from the January 2025 Reverse Split were deemed to have been tendered to the Company for cancellation for no consideration.
Following
the January 2025 Reverse Split, the number of common shares outstanding were
The Reverse Splits 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.
All share and per share amounts in the accompanying condensed consolidated financial statements and related notes have been retroactively adjusted to reflect both the January 2025 Reverse Split and the August 2025 Reverse Split for all periods presented.
| (ii) | The
Company did |
| 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 6: SHAREHOLDERS’ EQUITY (Cont.)
c. Share Purchase Warrants
| (i) | There
were |
| (ii) | As of October 31, 2025, share purchase warrants outstanding were as follows: |
SCHEDULE OF WARRANTS OUTSTANDING
Number of Warrants | Exercise Price | Exercisable At October 31, 2025 | Expiry Date | |||||||||
| (*) | $ | |||||||||||
| (*) | $ | |||||||||||
| (*) | $ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
d. Compensation Warrants
| (i) | There
were |
| (ii) | As of October 31, 2025, compensation warrants outstanding were as follows: |
SCHEDULE OF WARRANTS OUTSTANDING
Number of Warrants | Exercise Price | Exercisable At October 31, 2025 | Expiry Date | |||||||||
| (*) | $ | |||||||||||
| (*) | $ | |||||||||||
| (*) | $ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
| 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, 2025 | $ | |||
| Change in fair value during the period | ||||
| Balance as of October 31, 2025 | $ | |||
The key inputs used in the valuation of the non-public warrants as of October 31, 2025 and at July 31, 2025 were as follows:
SCHEDULE OF VALUATION OF PUBLIC OFFERING BROKER WARRANTS
| October 31, 2025 | July 31, 2025 | |||||||
| 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 October 31, 2025 were as follows:
SCHEDULE OF BRIA PRO WARRANTS
August 31, 2023 (Effective Date) | October 31, 2025 | |||||||
| Share price | $ | $ | ||||||
| Exercise price | $ | $ | ||||||
| Expected life (years) | $ | |||||||
| Volatility | % | % | ||||||
| Dividend yield | % | % | ||||||
| Risk free rate | % | % | ||||||
| 13 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 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”), performance-based share units
(“PSUs”), 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 three-month period ended October 31, 2025 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, 2025 | $ | $ | - | |||||||||||||
| Granted (i) | - | |||||||||||||||
| Balance as of October 31, 2025 | - | |||||||||||||||
| Exercisable as of October 31, 2025 | $ | $ | - | |||||||||||||
| (i) |
As
of October 31, 2025, there are $
| 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, 2025 |
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise price | Options outstanding as of October 31, 2025 | Weighted average remaining contractual term (years) | Options exercisable as of October 31, 2025 | Weighted average remaining contractual term (years) | Expiry Date | |||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| d. | As
result of the Arrangement, |
SCHEDULE OF OUTSTANDING AND EXERCISABLE OPTIONS
Exercise Price | Options outstanding as of October 31, 2025 | Options exercisable as of October 31, 2025 | Expiry Date | |||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| e. | Restricted Share Units |
The following table summarizes the number of RSU’s granted to directors under the Omnibus Plan for three-month period ended October 31, 2025:
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED
| Number of | ||||||||
| RSU’s | Aggregate | |||||||
| outstanding | intrinsic value | |||||||
| Balance, July 31, 2025 | - | $ | - | |||||
| Granted (i) | ||||||||
| Balance, October 31, 2025 | $ | |||||||
| (i) |
| 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)
NOTE 7: SHARE-BASED COMPENSATION (Cont.)
f. Performance Share Units
The following table summarizes the number of PSU’s granted under the Omnibus Plan for three-month period ended October 31, 2025:
SCHEDULE OF PERFORMANCE SHARE UNITS GRANTED
| Number of | ||||||||
| PSU’s | Aggregate | |||||||
| outstanding | intrinsic value | |||||||
| Balance, July 31, 2025 | - | $ | - | |||||
| Granted (i) | ||||||||
| Balance, October 31, 2025 | $ | |||||||
| (i) |
On September 24, 2025, the Company granted
The fair value of all PSU awards was determined using the closing price of the Company’s common stock on the respective grant dates. In accordance with ASC 718, management evaluates the probability of achieving each performance condition at each reporting date. As of October 31, 2025, management has determined that achievement of the applicable performance conditions is probable. Compensation cost is recognized over the requisite service period on a graded vesting (tranche-by-tranche) basis.
As of October 31, 2025, no PSUs were vested or issuable, as all awards remained subject to their performance conditions. See Note 9 for PSUs that vested subsequent to the balance sheet date. |
| g. | 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, 2025, and 2024 is comprised as follows: |
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSES
Three months ended October 31, | ||||||||
| 2025 | 2024 | |||||||
| Research and development expenses | $ | |||||||
| General and administrative expenses | ||||||||
| Total share-based compensation | $ | |||||||
NOTE 8: FINANCIAL INCOME (EXPENSES), NET
SCHEDULE OF FINANCIAL INCOME (EXPENSES), NET
| 2025 | 2024 | |||||||
Three months ended October 31, | ||||||||
| 2025 | 2024 | |||||||
| Interest income | $ | $ | ||||||
| Unrealized gain on short-term investments | - | |||||||
| Foreign exchange loss | ( | ) | ||||||
| Financial income, net | $ | $ | ||||||
NOTE 9: SUBSEQUENT EVENTS
Subsequent to the balance sheet date,
| 16 |
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, 2025 (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 2025 in comparison to the first 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. (“Briacell” or 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) in a pivotal1 Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). 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 has 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 months2 for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab. Additionally, BriaCell reported median overall survival of 16.5 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor in patients treated with the Phase 3 formulation since 2022 (post-COVID). A completed Bria-IMT™ Phase 1/2 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early-stage efficacy (listed on ClinicalTrials.gov as NCT03328026).
BriaCell Phase 1/2 Study of Bria-OTS™, BriaCell’s personalized off-the-shelf immunotherapy, also known as Bria-BRES™, in metastatic breast cancer is ongoing (listed on ClinicalTrials.gov as NCT06471673). The first patient treated with 4 inoculations of cells (single agent) demonstrated complete resolution of a lung metastasis. BriaCell is currently developing Bria-OTS™ and its advanced form, Bria-OTS+™, as a platform technology for personalized off-the-shelf immunotherapies for numerous types of cancer. In September 2024, the Company announced BriaCell had received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ for prostate cancer.
| 17 |
Recent Developments
During the period from August 1, 2025 through to the date of this report, we announced a number of corporate, financing and R&D developments. On August 21, 2025, our board approved a consolidation of the Company’s issued and outstanding common shares on the basis of one post-consolidation common share for every ten pre-consolidation common shares, primarily to help ensure continued compliance with Nasdaq Capital Market listing requirements. The consolidation became effective on August 25, 2025, with the post-consolidation common shares commencing trading on the Toronto Stock Exchange and Nasdaq on that date.
We also strengthened our non-dilutive funding and external collaborations. On August 13, 2025, we announced acceptance into Memorial Sloan Kettering Cancer Center’s (MSK’s) 2025 Therapeutics Accelerator Cohort program for the Bria-OTS+™ platform, which includes the Bria-BRES+™ product candidate for breast cancer.
On August 25, 2025, we reported that we had been awarded a US$2.0 million Small Business Innovation Research (SBIR) grant from the U.S. National Cancer Institute (NCI) to advance Bria-PROS+™ in prostate cancer, providing non-dilutive funding to support manufacturing and planned clinical evaluation activities for this program
On October 21, 2025, we further announced a collaboration with MSK’s Therapeutics Accelerator program focused on the Bria-OTS+ platform. The collaboration includes support for manufacturing, IND development and clinical protocol work for a planned Phase 1 study of Bria-BRES+ in breast cancer, and is intended to help accelerate clinical development of Bria-OTS+ across multiple cancer indications.
We continued to advance our pivotal Phase 3 clinical study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer (MBC). On October 13, 2025, we announced plans to present positive biomarker data from this ongoing trial at the ESMO 2025 Congress, highlighting that biomarkers identified in our prior Phase 2 study showed similar trends in the Phase 3 setting, and that a delayed-type hypersensitivity response appeared to be associated with longer progression-free survival in a blinded analysis of Phase 3 patients, with no new safety or tolerability issues identified.globenewswire.com On October 21, 2025, we reported that 79 clinical sites across 23 U.S. states were enrolling patients in the Phase 3 study, including new participation by Dartmouth Cancer Center, Cedars-Sinai Medical Center and Winship Cancer Institute of Emory University, and indicated that top-line data could be available as early as the first half of 2026, subject to event accrual.globenewswire.com On October 22, 2025, we disclosed that the independent Data Safety Monitoring Board (DSMB) had issued a fourth consecutive positive recommendation following review of safety data from the Phase 3 trial, identifying no safety concerns and recommending that the study continue without modification; the trial is being conducted under U.S. FDA Fast Track designation.
We also expanded our clinical data-generation activities for Bria-IMT at major oncology conferences. In November and December 2025, we announced a series of forthcoming presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS®). On November 18 and November 25, 2025, we reported that three BriaCell posters had been accepted, which together will present updated overall survival data from the Phase 2 study of Bria-IMT plus CPI in MBC and positive biomarker findings from the pivotal Phase 3 study.app.researchpool.com+1 On December 2, 2025, we confirmed that these SABCS presentations, scheduled for December 10, 2025, will highlight survival and clinical benefit data from the Phase 2 program as well as key Phase 3 biomarker data, and reiterated that an interim overall survival analysis in the pivotal Phase 3 trial is expected in the first half of 2026.
In parallel, we continued to develop our next-generation Bria-OTS+™ off-the-shelf cell-based immunotherapy platform. On October 3, 2025, we announced plans to present preclinical data on Bria-OTS+ at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, followed on November 4, 2025 by a release describing a SITC poster to showcase anti-tumor activity of Bria-OTS+ in breast and prostate cancer models, and the ongoing GMP manufacturing of lead candidates Bria-BRES+ and Bria-PROS+ in preparation for clinical trials.globenewswire.com+2BriaCell+2 On November 7, 2025, we reported preclinical results presented at SITC 2025 indicating that Bria-OTS+ induced rapid and durable anti-cancer activity in preclinical models by engaging both innate and adaptive immune responses, and that both Bria-BRES+ and Bria-PROS+ increased tumor cell cytotoxicity in these models.
Finally, we continued to broaden our pipeline beyond cell-based immunotherapies. On November 20, 2025, we announced a collaboration between our subsidiary BriaPro Therapeutics Corp. and Receptor.AI to apply Receptor.AI’s artificial intelligence platform to design highly selective anti-cancer kinase inhibitor candidates. The collaboration is intended to expand BriaPro’s small-molecule oncology pipeline and complements our existing cell-based programs, with the goal of accelerating development of next-generation cancer therapeutics with improved efficacy and safety profiles.
Results of Operations for the Three Months Ended October 31, 2025, and 2024
| Three months ended | ||||||||
| October 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development expenses | $ | 6,683,643 | 3,665,341 | |||||
| General and administrative expenses | 1,639,300 | 1,487,491 | ||||||
| Total operating expenses | 8,322,943 | 5,152,832 | ||||||
| Operating loss | (8,322,943 | ) | (5,152,832 | ) | ||||
| Financial income, net | 158,646 | 11,714 | ||||||
| Change in fair value of the warrant liability | (69,201 | ) | (616,643 | ) | ||||
| Share of loss on equity investment | (44,830 | ) | (71,515 | ) | ||||
| Net loss for the period | $ | (8,278,328 | ) | $ | (5,829,276 | ) | ||
| Net loss attributable to non-controlling interest | (80,763 | ) | (27,101 | ) | ||||
| Net loss for the period attributable to BriaCell | (8,197,565 | ) | (5,802,175 | ) | ||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | (4.35 | ) | $ | (32.67 | ) | ||
| Weighted average number of shares used in computing net basic and diluted earnings per share of common stock | 1,883,906 | 177,606 | ||||||
| 18 |
Research and Development Costs
Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory and (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials.
The following is a breakdown of our research and development costs by nature of expenses:
| Three months ended October 31, | ||||||||
| 2025 | 2024 | |||||||
| Clinical trial sites and investigational drug costs | $ | 4,863,199 | $ | 2,439,667 | ||||
| Wages and salaries | 1,303,702 | 949,089 | ||||||
| Laboratory Rent | 124,610 | 114,330 | ||||||
| Supplies | 276,657 | 99,430 | ||||||
| Depreciation | 22,839 | 22,839 | ||||||
| Professional fees | 9,205 | 7,268 | ||||||
| Share-based compensation | 83,431 | 32,718 | ||||||
| $ | 6,683,643 | $ | 3,665,341 | |||||
For the three-month period ended October 31, 2025, total research and development expenses were $6,683,643, compared to $3,665,341 for the three-month period ended October 31, 2024. The increase was primarily driven by higher clinical trial sites and investigational drug costs, which rose from $2,439,667 in 2024 to $4,863,199 in 2025. The increase reflects the progression of the pivotal Phase 3 trial, including higher patient-related costs, expanded site activity, and increased investigational product usage. Wages and salaries increased from $949,089 in 2024 to $1,303,702 in 2025, reflecting higher headcount and additional personnel required to support clinical operations and ongoing development programs. Laboratory rent increased to $124,610 in 2025, compared to $114,330 in 2024, due to expanded utilization of laboratory space and related facility charges. Supplies increased from $99,430 in 2024 to $276,657 in 2025, reflecting increased consumable usage driven by greater clinical and laboratory activity during the current period. Depreciation expense was consistent year over year at $22,839 for both periods. Professional fees increased from $7,268 in 2024 to $9,205 in 2025, primarily due to higher consulting, regulatory, and scientific support related to advancing clinical development. Share-based compensation increased from $32,718 in 2024 to $83,431 in 2025, reflecting a higher level of equity-based awards outstanding during the period.
Our clinical trial expenses are broken down as follows:
| Three months ended October 31, | ||||||||
| 2025 | 2024 | |||||||
| Bria-IMT™ Pivotal Phase 3 study | $ | 3,792,951 | $ | 2,446,461 | ||||
| Bria-IMT™ Phase 1/2a | 163,204 | 184,042 | ||||||
| Bria-OTS™ Phase 1/2a | 988,038 | 77,588 | ||||||
| $ | 4,944,193 | $ | 2,708,091 | |||||
Clinical trial expenses for the three months ended October 31, 2025, were $4,944,193, compared to $2,708,091 during the same period in 2024. The increase reflects higher spending across both the Bria-IMT™ pivotal Phase 3 program and the Bria-OTS™ Phase 1/2a program. Phase 3 costs increased as the study advanced, enrolled more patients, and required greater clinical support, while Bria-OTS™ expenses rose substantially as the program moved into the clinic. Together, these programs account for the majority of the year-over-year increase in clinical trial expenses.
For the three-month period ended October 31, 2025, Bria-IMT™ Pivotal Phase 3 Study costs were $3,792,951, compared to $2,446,461 in 2024. The increase reflects the study moving into a more cost-intensive stage, with higher charges related to CRO services, enrolling and treating more patients, central lab work, and clinical supply management. Several scheduled billing milestones also fell within the current quarter, contributing to the higher spend as the Phase 3 program progresses.
For the three-month period ended October 31, 2025, Bria-IMT™ Phase 1/2a expenses were $163,204, compared to $184,042 in 2024. The decrease reflects the continued wind-down of the program following its completion in fiscal 2024, with current-period activity limited to residual close-out and data-related tasks. Costs remain modest and are expected to taper further as final wrap-up items are completed.
For the three-month period ended October 31, 2025, Bria-OTS™ Phase 1/2a expenses were $988,038, compared to $77,588 in 2024. The substantial increase reflects the rapid advancement of the OTS program as we move into the clinic. Current-period costs include expanded preclinical development activities, enrolling and treating more patients, GMP manufacturing of Bria-BRES+ and Bria-PROS+, and increased regulatory, analytical, and operational work needed to support the next-generation Bria-OTS+ platform. The investment aligns with the program’s progression toward first-in-human evaluation and the broader expansion of OTS across multiple solid tumor indications.
| 19 |
General and Administrative Expenses
For the three-month period ended October 31, 2025, general and administrative expenses were $1,639,300, compared to $1,487,491 for the same period in 2024. The increase was driven primarily by higher shareholder communications costs and increased wages and salaries, partly offset by lower professional fees, consulting, insurance, and travel expenses.
Financial income (expenses), net
For the three-month period ended October 31, 2025, the Company recorded net financial income of $158,646, compared to $11,714 in the same period of 2024. The increase is mainly attributable to higher interest income and an unrealized gain on short-term investments during the current period. For the three-month period ended October 31, 2025, financial income was comprised of $48,482 of interest income, an $89,487 unrealized gain on short-term investments, and a $20,677 foreign exchange gain. For the three-month period ended October 31, 2024, financial income consisted of $13,050 of interest income and a $1,336 foreign exchange loss. The year-over-year increase reflects higher cash and cash equivalents available for investment, resulting in increased interest income, as well as unrealized gains recognized on the Company’s short-term investment portfolio during the current quarter.
Profit (loss) for the period
For the three-month period ended October 31, 2025, the Company reported a net loss of $8,278,328, compared to $5,829,276 for the same period in 2024. The higher loss primarily reflects increased research and development spending as the Company continued to advance its pivotal Phase 3 trial, including higher clinical-site activity, investigational product costs, and supporting operational infrastructure. These increased development expenses were partially offset by improved financial income during the period.
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, 2025, and a positive working capital balance of $8,030,634 (July 31, 2025 positive balance of $15,948,588).
As of October 31, 2025, the Company has total assets of $13,075,050 (July 31, 2025 - $ 21,649,706), a positive working capital of $8,030,634 (July 31, 2025 – positive balance of $15,948,588) and an accumulated deficit of $119,953,129 (July 31, 2025 - negative balance of $ 111,755,564).
As of October 31, 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 2025, 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.
| 20 |
During the period ended October 31, 2025, the Company’s overall position of cash and cash equivalents decreased by $7,779,796 from the period ended July 31, 2025 (including effects of foreign exchange). This decrease in cash can be attributed to the following:
The Company’s net cash used in operating activities during the period ended October 31, 2025, was $7,704,796 as compared to $6,955,076 for the period ended October 31, 2024.
Cash gained in financing activities for the period ended October 31, 2025, was nil as compared to 11,960,252 for the period ended October 31, 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 October 31, 2025.
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, 2025, the Company has total assets of $13,075,050 (July 31, 2025 - $21,649,706) and a positive working capital balance of $8,030,634 (July 31, 2025 – positive working capital balance of $15,948,588).
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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 October 31, 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.
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, 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 October 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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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, 2025.
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, 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
| 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. |
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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 11, 2025 | By: | /s/ William V. Williams |
| Name: | William V. Williams | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| December 11, 2025 | By: | /s/ Gadi Levin |
| Name: | Gadi Levin | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
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FAQ
What were BriaCell Therapeutics (BCTX) key financial results for the quarter ended October 31, 2025?
For the three months ended October 31, 2025, BriaCell reported a net loss of
How much did BriaCell Therapeutics (BCTX) spend on research and development and clinical trials in Q1 2025?
Research and development expenses for the quarter were $6,683,643, up from
What is BriaCell Therapeutics’ (BCTX) cash position and working capital as of October 31, 2025?
As of October 31, 2025, BriaCell held $2,714,012 in cash and cash equivalents and $7,461,960 in short‑term investments. Total current assets were
Why does BriaCell Therapeutics (BCTX) disclose substantial doubt about its ability to continue as a going concern?
BriaCell notes that it devotes substantially all efforts to research and development and has sustained operating losses, which it expects to continue. As of October 31, 2025, accumulated deficit was $119,953,129 and negative cash flows from operating activities for the quarter were $7,704,796. Although the company raised
What progress did BriaCell Therapeutics (BCTX) report on its Bria‑IMT™ Phase 3 metastatic breast cancer trial?
BriaCell is conducting a pivotal Phase 3 study of Bria‑IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer under FDA Fast Track designation. As of October 21, 2025, 79 clinical sites across 23 U.S. states were enrolling patients. An independent Data Safety Monitoring Board issued a fourth consecutive positive recommendation, finding no safety concerns and advising that the study continue without modification. The company indicated that top‑line data could be available as early as the first half of
What pipeline and collaboration updates did BriaCell Therapeutics (BCTX) highlight in this quarter?
BriaCell continued to develop its Bria‑OTS+™ off‑the‑shelf cell‑based immunotherapy platform, including preclinical data presented at the Society for Immunotherapy of Cancer 2025 meeting showing rapid and durable anti‑tumor activity in breast and prostate cancer models. The company joined Memorial Sloan Kettering Cancer Center’s 2025 Therapeutics Accelerator cohort for Bria‑OTS+™ and announced a collaboration with the Accelerator to support manufacturing, IND development and clinical protocols for Bria‑BRES+™. It also reported a
How significant is share-based compensation and equity overhang at BriaCell Therapeutics (BCTX)?
Share‑based compensation expense for the quarter was $294,686, up from
