Form 10-Q BriaCell Therapeutics For: Apr 30
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 | ||||
| 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 ☐ No
As of June 9, 2026, common shares, no par value per share, of the Company were issued and outstanding.
BRIACELL THERAPEUTICS CORP.
Form 10-Q
Table of Contents
| 2 |
PART I-FINANCIAL INFORMATION
Item 1. Financial Statements
BRIACELL THERAPEUTICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
| April 30, 2026 | 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)
| Three months ended April 30, | Nine months ended April 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research, development, and clinical trial expenses, net | $ | $ | $ | $ | ||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Financial (income) expenses, net | ( | ) | ||||||||||||||
| Change in fair value of the warrant liability | ||||||||||||||||
| Unrealized gain on investment | ||||||||||||||||
| Share of loss on equity investment | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss for the period | $ | ( | ) | $ | ( | ) | $ | ( | ) | ( | ) | |||||
| Net loss attributable to non-controlling interest | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss and Comprehensive 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 earnings per share of common stock | ||||||||||||||||
| Weighted average number of shares used in computing net diluted earnings 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 AND NINE MONTHS ENDED APRIL 30, 2026
| Share capital | Additional paid in | Warrant | Accumulated other comprehensive | Accumulated | Non- Controlling | Total shareholders’ | ||||||||||||||||||||||||||
| Number | Amount | capital | reserve | loss | deficit | Interest | equity | |||||||||||||||||||||||||
| Balance, January 31, 2026 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Issuance of Options, RSU and PSU | - | |||||||||||||||||||||||||||||||
| Change in ownership of BriaPro | - | ( | ) | |||||||||||||||||||||||||||||
| Net loss for the period | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, April 30, 2026 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| 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 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Issuance of Options, RSU and PSU | - | |||||||||||||||||||||||||||||||
| Exercise of prefunded warrants | ||||||||||||||||||||||||||||||||
| Issuance of units, net | ||||||||||||||||||||||||||||||||
| Change in ownership of BriaPro | - | ( |
) | |||||||||||||||||||||||||||||
| Net loss for the period | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance, April 30, 2026 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| 5 |
| Share capital | Additional paid in | Warrant | Accumulated other comprehensive | Accumulated | Non- Controlling | Total shareholders’ | ||||||||||||||||||||||||||
| Number | Amount | capital | reserve | loss | deficit | Interest | equity | |||||||||||||||||||||||||
| Balance, January 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Issuance of Options | - | |||||||||||||||||||||||||||||||
| Exercise of prefunded warrants | ||||||||||||||||||||||||||||||||
| 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 | equity | |||||||||||||||||||||||||
| 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 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
| 6 |
BRIACELL THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
| Nine months ended April 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss for the period | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Amortization | ||||||||
| Financial income, net | ( | ) | ||||||
| Depreciation | ||||||||
| Share-based compensation | ||||||||
| Share of loss on equity investment | ||||||||
| Change in fair value of warrants | ( | ) | ( | ) | ||||
Unrealized gain on investment | ( | ) | ||||||
| Changes in working capital: | ||||||||
| Increase (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 | ||||||||
| Purchase of equipment | ( | ) | ||||||
| Purchase of short-term investments | ( | ) | ||||||
| Proceeds from short-term investments | ||||||||
| 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.
| 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” “BCTXZ”, and “BCTXL”. | |
| b. | 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 pivotal Phase 3 study in metastatic breast cancer. Bria-IMT™ is currently under Fast Track Designation by the U.S. Food and Drug Administration (the “FDA”) intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in metastatic breast cancer. A completed Bria-IMT™ Phase 2 combination study with retifanlimab (an anti-PD1 antibody manufactured by Incyte) confirmed tolerability and early efficacy. BriaCell reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with a median overall survival of 13.4 months in BriaCell’s metastatic breast cancer patients vs. 6.7-9.8 months for similar patients reported in the literature in its Phase 2 study of Bria-IMT™ combination study with retifanlimab at the 2025 American Society of Clinical Oncology (ASCO) meeting. BriaCell is also developing personalized off-the-shelf immunotherapies, Bria-OTS™ and Bria-OTS+™, which provides a platform technology to develop personalized off-the-shelf immunotherapies for numerous types of cancer including breast cancer, prostate cancer, lung cancer, and melanoma. BriaCell has an ongoing Phase 1/2 Study of Bria-OTS™, also known as Bria-BRES™, in metastatic breast cancer. BriaCell also has an open Investigational New Drug application (IND) for the clinical evaluation of Bria-BRES+™, the first of the Bria-OTS+™ enhanced personalized off-the-shelf immunotherapies approved for clinical evaluation in patients with advanced metastatic breast cancer. BriaCell also has completed manufacturing of the Bria-PROS+™ cell line for prostate cancer. | |
| 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 April 30, 2026 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 two Canadian subsidiaries (i) 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 1(f) below. (Sapientia and BTC and BriaPro together, the “Subsidiaries”), and (ii) Briacell Therapeutics AU Pty Ltd, a wholly owned subsidiary in Australia, established on January 28, 2026, which is currently inactive. | |
| f. | On February 18, 2026, the Company and BriaPro, announced that they have entered into a definitive purchase agreement (the “Purchase Agreement”) pursuant to which BriaPro has agreed to purchase BriaCell’s exclusive license to develop and commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and other associated assets (the “Transaction”).
Under
the terms of the Purchase Agreement, BriaPro gains the worldwide rights to develop and commercialize sCD80 as a therapeutic agent
for the treatment of cancer, while the University of Maryland, Baltimore County (“UMBC”) holds all rights, title
and interest in the inventions and the patent, except for certain rights retained by the United States Government. BriaPro will pay
As
part of the Transaction, BriaCell will make available to BriaPro up to $
As
consideration for the transfer of the exclusive license and the Credit Facility, BriaPro issued to BriaCell
common shares, increasing BriaCell’s interest in BriaPro
to approximately |
| 8 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES
a. Use of estimates:
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the 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. 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 | ||
| 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. |
| 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. |
| 9 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Cont.)
| 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 $ 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 (“BC Therapeutic Options”) through to June 30, 2024. In accordance with ASC 321 and ASC 815, the BC Therapeutics Options were 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: %, and expected lives ranging from years to years. | ||
Following the Initial Investment, the Company and BC Therapeutics signed three amendments, each time, extending the BC Therapeutic Options expiry date and increasing the amount of capital that the Company can invest at the same price per share of $. BC Therapeutic Options now expire on June 2027. The most recent BC Therapeutic Option received was 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: % and expiry date: years. This amount has been included in the Company’s investment with a corresponding credit to unrealized gain on investment in the condensed consolidated statements of operations and comprehensive loss.
During the nine-month period ended April 30,
2026, the Company exercised the BC Therapeutic Options totaling $
At each exercise date, the portion of the BC Therapeutic Options being exercised was revalued using the Black-Scholes Option Price Model and the change in fair value was recorded in the condensed consolidated statements of operations and comprehensive loss. On April 30, 2026, the Company revalued the remaining balance of the BC Therapeutic Options in accordance with the Black Scholes Option Price Model, using the following assumptions: Share price: $, Exercise price: $, Dividend yield: %, Risk free interest rate: %, Volatility: % and expiry date: years. The change in fair value was recorded in the condensed consolidated statements of operations and comprehensive loss.
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. | ||
| As
of April 30, 2026, 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. |
| 10 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 3: INVESTMENT IN BC THERAPEUTICS INC. (Cont.)
Changes in the Company’s equity investment in BC Therapeutics is summarized as follows:
| Balance – August 1, 2024 | $ | |||
| Funding (including the value of the BC Therapeutics Options) | ||||
| Share of losses | ( | ) | ||
| Balance – July 31, 2025 | ||||
| Exercise of BC Therapeutic Options during the period (funding) | ||||
| Fair value of BC Therapeutics Options on February 1, 2026 | ||||
| Change in fair value during the period | ( |
) | ||
| Share of losses | ( | ) | ||
| Balance – April 30, 2026 | $ |
The
following amounts represent the Company’s
As of April 30, 2026 | ||||
| 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 April 30, 2026, 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 April
30, 2026, | ||
| 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 April 30, 2026 and July 31, 2025:
| Fair Value Measurements at | ||||||||||||||||||||||||
| April 30, 2026 | 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 | $ | $ | $ | $ | $ | $ | ||||||||||||||||||
| 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 5: FAIR VALUE MEASUREMENTS (Cont.)
The Company classifies 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.
As
of April 30, 2026 and July 31, 2025, the Company held Level 1 short-term investments measured using quoted prices in active markets.
As of April 30, 2026, the Company’s short-term investments had coupon rates ranging from
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: |
| 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. | ||
| 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 issued the following shares during the nine-month period ended April 30, 2026:
On
January 15, 2026, the Company closed a public offering for the purchase and sale of
units of the Company for aggregate gross proceeds of approximately
$
In
connection with the January 2026 Offering, the Company issued
Between January 15, 2026 and January 21, 2026, the Pre-Funded Warrants were exercised on a cashless basis into common shares.
The
fair value of the
The
fair value of the placement agent warrants was determined to be $ The amounts were credited to the warrant reserve at the date of the January 2026 Offering. |
| 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.)
c. Share Purchase Warrants
Number of warrants outstanding | Weighted average exercise price | |||||||
| Balance, July 31, 2025 | $ | |||||||
| Expired | ( | ) | ||||||
| Granted in the January 2026 Offering | ||||||||
| Balance, April 30, 2026 | ||||||||
| (ii) | As of April 30, 2026, warrants outstanding were as follows: |
Number of Warrants | Exercise Price | Exercisable At April 30, 2026 | Expiry Date | |||||||||
| (*) | $ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
d. Compensation Warrants
| (i) | A summary of changes in compensation warrants for the nine-month period ended April 30, 2026 is presented below: |
Number of warrants outstanding |
Weighted average exercise price |
|||||||
| Balance, July 31, 2025 | ||||||||
| Expired | ( |
) | ||||||
| Granted in the January 2026 Offering | ||||||||
| Balance, April 30, 2026 | $ | |||||||
| (ii) | As of April 30, 2026, compensation warrants outstanding were as follows: |
Number of Warrants | Exercise Price | Exercisable At April 30, 2026 | Expiry Date | |||||||||
| (*) | $ | |||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| (*) |
| 13 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 6: SHAREHOLDERS’ EQUITY (Cont.)
e. Warrant liability continuity
The following table presents the summary of the changes in the fair value of the warrants:
| Warrants liability | ||||
| Balance as of August 1, 2025 | $ | |||
| Change in fair value during the period | ( | ) | ||
| Balance as of April 30, 2026 | $ | |||
| April 30, 2026 | 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 April 30, 2026 were as follows:
August 31, 2023 (Effective Date) |
April 30, 2026 | |||||||
| Share price | $ | $ | ||||||
| Exercise price | $ | - | $ | |||||
| Expected life (years) | - | $ | - | |||||
| Volatility | % | - | % | |||||
| Dividend yield | % | % | ||||||
| Risk free rate | % | - | % | |||||
| 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)
| 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 nine-month period ended April 30, 2026 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, 2025 | $ | $ | ||||||||||||||
| Granted (i) | ||||||||||||||||
| Expired | ( | ) | ||||||||||||||
| Balance as of April 30, 2026 | ||||||||||||||||
| Exercisable as of April 30, 2026 | $ | $ | ||||||||||||||
| (i) |
On February 1, 2026, the Company granted stock options to employees and members of the scientific advisory board at an exercise price of $ per share. All options vest in equal quarterly installments over two years, with the first vesting date on May 1, 2026. The options expire on February 1, 2031. The grant-date fair value of the award was $. The fair value of options granted was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of %, expected term of years, risk-free interest rate of %, dividend yield of %, and a stock price of $ on the grant date. |
| c. | As of April 30, 2026, there were $ of total unrecognized share-based compensation costs related to stock options, restricted share units (RSUs), and performance share units (PSUs) that are expected to be recognized over a period of up to years. |
| 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.)
| d. | The following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of April 30, 2026 |
Exercise price | Options outstanding as of April 30, 2026 | Weighted average remaining contractual term (years) | Options exercisable as of April 30, 2026 | Weighted average remaining contractual term (years) | Expiry Date | |||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| $ | ||||||||||||||||||||
| e. | As result of the Arrangement, BriaPro Options were issued and are outstanding as of April 30, 2026: |
Exercise Price | Options outstanding as of April 30, 2026 | Options exercisable as of April 30, 2026 | Expiry Date | |||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| $ | ||||||||||||
| f. | Restricted Share Units |
| Number of | ||||||||
| RSU’s | Aggregate | |||||||
| outstanding | intrinsic value | |||||||
| Balance, July 31, 2025 | $ | |||||||
| Granted (i) | ||||||||
| Balance, April 30, 2026 | $ | |||||||
| (i) |
| Number of | ||||||||
| RSU’s | Aggregate | |||||||
| outstanding | intrinsic value | |||||||
| Balance, July 31, 2025 | $ | |||||||
| Granted (i) | ||||||||
| Balance, April 30, 2026 | $ | |||||||
| (i) |
| 16 |
BriaCell Therapeutics Corp
Notes to the Condensed Consolidated Financial Statements
(Unaudited, expressed in US Dollars, except share and per share data and unless otherwise indicated)
NOTE 7: SHARE-BASED COMPENSATION (Cont.)
g. Performance Share Units
| Number of | ||||||||
| PSU’s | Aggregate | |||||||
| outstanding | intrinsic value | |||||||
| Balance, July 31, 2025 | $ | |||||||
| Granted (i) | ||||||||
| Balance, April 30, 2026 | $ | |||||||
| (i) | On August 1, 2025, the Company granted performance-based stock units (“PSUs”) to the Chief Executive Officer (“CEO”), Chief Financial Officer (“CFO”), Chief Medical Officer (“CMO”), and Chief Scientific Officer (“CSO”) under the Omnibus Plan. These PSUs contain performance conditions tied to the advancement of the Company’s Bria-IMT Phase 3 program, the Bria-OTS program, and certain corporate and governance objectives. The grant-date fair value of the PSUs awarded to these officers totaled $. The PSUs awarded to the CMO and CSO include milestones related to the Bria-OTS program, with grant-date fair values of $ each. The CFO’s PSUs relate to corporate and financial reporting objectives, with a grant-date fair value of $.
On September 24, 2025, the Company granted PSUs to a director under the Omnibus Plan. These PSUs contain performance conditions related to the Company’s corporate, strategic, and governance objectives. The grant-date fair value of this award was $, determined using the closing price of the Company’s common stock on the grant date.
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 April 30, 2026, management has determined that achievement of the applicable performance conditions remains probable. Compensation cost is recognized over the requisite service period on a graded vesting (tranche-by-tranche) basis.
During the nine-month period ended April 30, 2026, the Company achieved the performance condition related to the CFO’s PSU’s. As a result PSUs granted to the CFO vested and became issuable during the period. |
| h. | The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine-month period ended April 30, 2026 and 2025 is comprised as follows: |
| Three months ended April 30, | Nine months ended April 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Research, development, and clinical trial expenses | $ | $ | ||||||||||||||
| General and administrative expenses | ||||||||||||||||
| Total share-based compensation | $ | $ | ||||||||||||||
NOTE 8: FINANCIAL INCOME, NET
Three months ended April 30, | Nine months ended April 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Interest income | $ | $ | ||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Foreign exchange gain (loss) | ( | ) | ( | ) | ||||||||||||
| Financial income, net | $ | $ | ( | ) | $ | $ | ||||||||||
NOTE 9: RESEARCH, DEVELOPMENT, AND CLINICAL TRIAL EXPENSES, NET
| (i) | On
August 25, 2025, the Company announced that it had been awarded a $
The grant reimburses certain qualifying research and development expenditures incurred by the Company in connection with the program. In accordance with the Company’s accounting policy for government assistance, amounts received under the grant are recognized as a reduction of research and development expenses in the period in which the related costs are incurred.
During
the three and nine months ended April 30, 2026, the Company received $
As
of April 30, 2026, the Company may receive up to an additional $ |
NOTE 10: SUBSEQUENT EVENT
The Company evaluated the possibility of subsequent events existing in the Company’s unaudited condensed consolidated financial statements through June 9, 2026, 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 June 2, 2026, the Company closed a public offering for the purchase and sale of common shares of the Company for aggregate gross proceeds of approximately $ |
| 17 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
References to the “Company,” “our,” “us” or “we” refer to BriaCell Therapeutics Corp. The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Introduction
This Management’s Discussion and Analysis (“MD&A”) should be read together with other information, including our unaudited condensed interim consolidated financial statements and the related notes to those statements included in Part I, Item 1 of this Quarterly Report (the “Condensed Consolidated Financial Statements”), our consolidated financial statements appearing in our Annual Report on Form 10-K for the year ended July 31, 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 nine months and third quarter of fiscal 2026 in comparison to the nine months and third quarter of fiscal 2025. | |
| ● | 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 pivotal 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 months 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. 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.
| 18 |
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.
Throughout this time period, there were several important updates on the ongoing pivotal Phase 3 study of Bria-IMT™ in patients with advanced metastatic breast cancer, including accelerating enrollment, adding additional clinical sites, and several positive Data Safety Monitoring Board meetings. Some of these are detailed below.
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.
Bria-IMT™
On November 25, 2025, BriaCell highlighted positive Phase 2 & Phase 3 clinical data at SABCS® 2025 with poster presentations at the San Antonio Breast Cancer Symposium (December 10, 2025) which highlighted positive Phase 2 safety and efficacy signals and positive biomarker findings in both the Phase 2 and the pivotal Phase 3 studies. On December 9, 2025, BriaCell announced that patient enrollment is on track for 1H2026 topline data readout with over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC).
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine Maturing positive Phase 2 data continue to support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further evaluating this immunotherapy and the role of biomarkers in predicting patient response.
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer. BriaCell’s data suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer.
Copies of the posters are available at https://briacell.com/scientific-publications/.
On December 10, 2025, BriaCell presented three posters highlighting robust survival and clinical benefit data in Phase 2, plus positive key biomarker data from the pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI) at the San Antonio Breast Cancer Symposium (SABCS®) 2025. Data from the Phase 3 study continues to support biomarkers to identify patients who benefit from treatment with BriaCell’s regimen. Additionally, maturing Phase 2 study data continues to support meaningful clinical benefit of the Bria-IMT regimen with outstanding long-term survival. Importantly, no toxicity related discontinuations was reported in the Phase 3 study. Summaries of the studies are shown here.
On December 18, 2025, BriaCell announced that its Phase 3 Bria-IMT™ clinical trial in metastatic breast cancer was prominently and independently featured in the Nature Medicine Year In Review’s publication, “ Eleven clinical trials that will shape medicine in 2026”. Nature Medicine asked leading researchers to name their top clinical trial for 2026, from long-awaited vaccines for infectious diseases to new treatments for advanced cancers and long COVID. BriaCell’s Phase 3 clinical trial in metastatic breast cancer featured as “clinical trial to watch in 2026”
On January 27, 2026, BriaCell Highlighted extended >18-47 months survival in Phase 2 metastatic breast cancer patients. 9 of 25 BriaCell patients treated since 2022 remained alive >18-47 months post enrollment, markedly exceeding benchmarks reported for standard of care therapies in similar patient populations. No Bria-IMT™ related discontinuations was reported to that date. Bria-IMT regimen continues under Fast Track Designation from US FDA.
| 19 |
New positive Phase 2 survival data highlighted multiple patients surpassing expected benchmarks for metastatic breast cancer and survival length over 18 months in 9 cases as of their last assessment.
Table 1: Ongoing Long-Term Survivors
| Patient/Subtype | Months Since Study Start | Age | Number of Prior Regimens | Cycles of Bria-IMT | ||||
| 01-009/ER+/PR+/HER2low | 47 | 74 | 5 | 14 | ||||
| 07-001/ER+/PR+/HER2low | 30 | 55 | 7 | 8 | ||||
| 15-001/ER+/PR-/HER2- | 30 | 62 | 3 | 12 | ||||
| 11-018/ER+/PR+/HER2+ (Highlighted below) | 27 | 66 | 8; including ENHERTU | 35 | ||||
| 15-005/ER+/PR+/HER2- (Highlighted below) | 27 | 44 | 5 | 6 | ||||
| 15-006/ER+/PR-/HER2- (Highlighted below) | 25 | 64 | 8; including TRODELVY | 4 | ||||
| 15-004/ER+/PR+/HER2- | 25 | 50 | 3 | 6 | ||||
| 11-019/ER+/PR+/HER2low | 23 | 63 | 9; including TRODELVY | 6 | ||||
| 07-014/ER+/PR+/HER2low | >18 | 62 | 9; including TRODELVY | 5 |
Note that Trodelvy and Enhertu are antibody-drug conjugates recently approved for late-stage breast cancer.
Table 2: Comparable analysis of 1- and 2-year survival for the BriaCell Phase 2 study using the Phase 3 formulation since 2022 independent of subsequent treatment
| Breast cancer | Median prior | Median OS | % Survival at: | |||||||
| Reference | type | lines of therapy | (months) | 1 year | 2 years | |||||
| Bria-IMT ™ plus CPI | All types 61% HR+ 33% TNBC 6% HER2+ | 6 | 15.6 | 52% | 32% | |||||
| Cortes et al. 1 | All types 57% HR+ 18-19% TNBC 18-20% HER2+ | 4 | 9.1-9.3 | ~38-40% | 7-14% | |||||
| Kazmi et al. 2 | All types 51-52% HR+ 25-29% TNBC 9-24% HER2+ | 2 | 7.2-9.8 | 30-38% | 11.9-14% | |||||
| Bardia et al. (TPC) 3 | TNBC | 4 | 6.9 | ~23% | 6% | |||||
| Bardia et al. (Trodelvy) 3 | TNBC | 4 | 11.8 | 50% | 21% | |||||
| Rugo et al (TPC) 4 | HR+ HER2- | 4 | 11.2 | 47% | 21% | |||||
| Rugo et al (Trodelvy) 4 | HR+ HER2- | 4 | 14.4 | 60% | 25% | |||||
1. Cortes J, et al. Annals of Oncology 2018 (estimated from Kaplan-Meier curve)
2. Kazmi S, et al. Breast Cancer Res Treat. 2020
3. Bardia A, et al. J Clin Oncol. 2024 (estimated from Kaplan-Meier curve)
4. Rugo HS, et al. The Lancet. 2023 (estimated from Kaplan-Meier curve)
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2))
HER2+: Human epidermal growth factor receptor 2 positive
HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC: Treatment of Physicians Choice
On January 28, 2026, BriaCell reported patients’ images showing regression and resolution of metastasized tumors and immune activation in patients with orbital (eye), temporal lobe (brain), liver, and spinal involvement. Survival details on these and other select patients in its Phase 2 study, along with comparable populations, were previously reported.
Images below confirm clinical responses seen in patients with metastatic orbital (eye), temporal (brain), liver, and spine lesions.
| 20 |
Example 1: Patient 11-018
A 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, heavily pretreated with 8 prior lines of therapy, including an antibody-drug conjugate (Enhertu), remains alive 27 months post-enrollment. At baseline, she presented with metastatic involvement of the right orbit (behind the eye), right temporal lobe of the brain and multiple skeletal sites. Following treatment, she achieved complete resolution of the temporal lobe metastasis, substantial improvement in the orbital lesion and stable disease in the bone. She remained on study for 26 months after initiating treatment and receiving 35 cycles of therapy. Images though 20 months for this patient have been previously described (link). Shown here are updated images through 2 years with measurements superimposed (through 18 months for the temporal lobe brain metastases).
Example 1 Images (Patient 11-018): Bria-IMT treatment resulted in complete resolution of the right temporal lobe lesion and continued regression of the right orbital (behind the eye) tumor. Measurements of lesion sizes are shown.
LA = long axis. SA = short axis.
Example 2: Patient 15-005:
A 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, previously treated with 5 prior lines of therapy. At baseline, she presented with metastases to the spine. She completed 6 cycles of therapy achieving stable disease as her best response and remains in survival follow-up 27 months after study entry.
Before BriaCell Treatment Image A: CD8 ImmunoPET image
Pre-treatment imaging of cervical (neck) lymph nodes with moderate uptake indicating presence of some CD8+ cytotoxic (“killer”) T cells.
After BriaCell Treatment Image B: CD8 ImmunoPET image
Post treatment enhancement of cervical (neck) lymph nodes indicating immune system activation and increased presence of CD8+ cytotoxic T cells.
Example 2 Images (Patient 15-005): CD8 ImmunoPET images pre (A) and post (B) Bria-IMT treatment
Example 3: Patient 15-006:
A 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, heavily pre-treated with 8 prior lines of therapy, including the antibody-drug conjugate Trodelvy, remains alive 25 months post-enrollment. At baseline, presented with hepatic metastasis.
Before BriaCell Treatment Image A: A liver metastasis (lower arrow) is “cold,” indicating minimal to no CD8+ cytotoxic T cells in the tumor while enlarged lymph nodes (upper arrow) show moderate uptake.
After BriaCell Treatment Image B: Swelling (induration) around the metastasis (lower arrow) demonstrates the liver metastasis has become “hot”, indicating marked CD8+ cytotoxic T cell infiltration while further lymph node enlargement is consistent with increased activity (upper arrow) indicating increased CD8+ T cells.
| 21 |
Example 3 Images (Patient 15-006): Combined MRI and CD8 ImmunoPET images Pre (A) and Post (B) Bria-IMT treatment
The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median six prior therapies) who received the Bria-IMT regimen plus a checkpoint inhibitor. Of these, 37 patients were treated with the same formulation now being evaluated in the pivotal Phase 3 study (NCT06072612). Significantly, no Bria-IMT related discontinuations have been reported to date.No Bria-IMT™ related discontinuations reported to date. Bria-IMT regimen continues under Fast Track Designation from US FDA.
On February 17, 2026, BriaCell received its fifth positive recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 study in metastatic breast cancer. Independent DSMB has identified no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor. This fifth consecutive positive DSMB recommendation supports the favorable safety profile observed to date.
On April 20, 2026, BriaCell presented positive Phase 3 quality of life (QOL) data in heavily pretreated metastatic breast cancer patients with prior failed ADC, CPI, and CDK4/6 inhibitor treatments at the 2026 American Association for Cancer Research (AACR) annual meeting. The data showed preservation of quality QOL in patients who had been on multiple prior failed therapy attempts. Additionally, we showed identification of potential prognostic biomarkers upon further analyses of Phase 2 Bria-IMT™ study data.
On April 27, 2026, BriaCell announced that it has six clinical data presentations at the American Society of Clinical Oncology (ASCO 2026) meeting.
On May 7, 2026, and May 13, 2026, BriaCell announced the addition of NYU Langone Health’s Perlmutter Cancer Center and Penn Medicine’s Abramson Cancer Center, respectively, as clinical sites in the Bria-ABC pivotal breast cancer study. On May 12, 2026, BriaCell announced that enrollment in that the Bria-ABC pivotal breast cancer study had surpassed 230 patients.
Bria-OTS and Bria-OTS+
On November 7, 2025, BriaCell presented robust anti-cancer activity of Bria-OTS+ in breast and prostate cancer models at the Society for Immunotherapy of Cancer (SITC) 2025. Bria-OTS+ represents a novel, cost-effective, off-the-shelf potent next generation cancer therapy platform. Next generation Bria-OTS+ platform demonstrated rapid, potent and durable anti-cancer activity by activating both innate and adaptive immune responses. Increased tumor cell cytotoxicity induced by both Bria-BRES+™ (breast cancer) and Bria-PROS+™ (prostate cancer) was reported. In summary, preclinical data reinforces broad potential of Bria-OTS+ platform across multiple indications. BriaCell added that lead candidates Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) are completing GMP manufacturing for planned clinical trials. As a reminder, $2 million National Cancer Institute (NCI) Small Business Innovative Research (SBIR) award supports manufacturing and planned clinical evaluation of Bria-PROS+.
On January 13, 2026, BriaCell reported sustained complete resolution of lung metastasis in Bria-OTS Patient (Figure 1 as shown below). 11-month sustained complete resolution of lung metastasis was observed in Bria-OTS Phase 1/2a metastatic breast cancer study. No treatment limiting toxicities reported. The patient maintained stable disease at all other evaluable sites.
Figure 1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the right lung of the metastatic breast cancer (MBC) patient following 2 months of therapy and confirmed at 4, 6, and 11 months of therapy1 (axial and coronal views)
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On April 21, 2026, BriaCell presented positive data from its preclinical Bria-OTS+ platform at the 2026 AACR meeting showing that Bria-OTS+ platform provided early, potent and durable activation of innate and adaptive immunity in in-vitro cancer cell line models. Additionally, our data showed immune cells activated by Bria-OTS+ exhibited serial killing activity across multiple rounds of tumor cell challenge.
On May 6, 2026, BriaCell announced that it has received FDA clearance initiate clinical evaluation of Bria-BRES+™ in advanced metastatic breast cancer. The IND application opens the path to commence Phase 1/2a clinical study for Bria-BRES+ in metastatic breast cancer. Bria-BRES+ is BriaCell’s next generation personalized immunotherapy for breast cancer, and features additional immune activating components designed to enhance clinical efficacy. BriaCell has prepared clinical supplies of Bria-BRES+ and plans to initiate a Phase 1/2a clinical study in metastatic breast cancer in the coming months.
On May 14, 2026, BriaCell announced that it has completed manufacturing clinical supplies of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy candidate for prostate cancer. On May 15th, 2026, BriaCell announced that it is making progress in developing Bria-OVA+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer.
BriaPro
On February 18, 2026, the Company and BriaPro Therapeutics Corp. (“BriaPro”), a announced that we have entered into a definitive purchase agreement (the “Purchase Agreement”) pursuant to which BriaPro has agreed to purchase BriaCell’s exclusive license to develop and commercialize Soluble CD80 (“sCD80”) as a biologic agent for the treatment of cancer and other associated assets (the “Transaction”).
Background
BriaCell originally secured the exclusive license from the University of Maryland, Baltimore County (“UMBC”) on August 2, 2022. The novel technology, originally developed by Suzanne Ostrand-Rosenberg, Ph.D., Emeritus Faculty at UMBC, and member of BriaCell’s scientific advisory board, is titled “Soluble CD80 as a Therapeutic to Reverse Immune Suppression in Cancer Patients” and is covered under USPN 8,956,619 B2, USPN 9,650,429 B2, and USPN 10,377,810 B2. In animal models, sCD80 was well-tolerated and stopped tumor growth by potentially restoring natural anti-tumor immunity (see Lucas A Horn, et al. and Samuel T Haile et al. in collaboration with Dr. Ostrand-Rosenberg). Additionally, strong anti-tumor activity of sCD80 has been reported in multiple tumor types (see Lucas A Horn, et al.). Importantly, as demonstrated in the same studies, sCD80’s unique actions may involve both awakening and boosting the immune system to recognize and destroy tumor cells.
The Transaction
Under the terms of the Purchase Agreement, BriaPro gains the worldwide rights to develop and commercialize sCD80 as a therapeutic agent for the treatment of cancer, while UMBC holds all rights, title and interest in the inventions and the patent, except for certain rights retained by the United States Government. BriaPro will pay 2% royalties to UMBC upon the commercialization of the product plus other development costs.
As part of the Transaction, BriaCell will make available to BriaPro up to $3 million to fund research and development efforts (the “Credit Facility”). Each drawdown under the Credit Facility will be subject to BriaCell’s approval regarding the use of funds.
As consideration for the transfer of the exclusive license and the Credit Facility, BriaPro will issue to BriaCell 23,972,589 Common Shares at an aggregate value of approximately C$1.18M, increasing BriaCell’s interest in BriaPro to approximately 78% post-transaction. On March 5, 2026, the disinterested shareholders of BriaPro approved the Transaction and the Transaction closed on March 31, 2026.
Results of Operations for the Three and Nine Months Ended April 30, 2026, and 2025
| Three months ended April 30, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development expenses | $ | 5,966,673 | 4,810,196 | |||||
| General and administrative expenses | 1,654,121 | 1,518,059 | ||||||
| Total operating expenses | 7,620,794 | 6,328,255 | ||||||
| Operating loss | (7,620,794 | ) | (6,328,255 | ) | ||||
| Financial income (expense), net | 186,970 | (9,762 | ) | |||||
| Change in fair value of the warrant liability | 123,242 | 175,826 | ||||||
| Unrealized gain on investment | 137,830 | - | ||||||
| Share of loss on equity investment | (64,303 | ) | (62,738 | ) | ||||
| Net loss for the period | $ | (7,237,055 | ) | $ | (6,224,929 | ) | ||
| Net loss attributable to non-controlling interest | (72,548 | ) | (98,027 | ) | ||||
| Net loss for the period attributable to BriaCell | (7,164,507 | ) | (6,126,902 | ) | ||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | (0.99 | ) | $ | (16.42 | ) | ||
| Weighted average number of shares used in computing net basic and diluted earnings per share of common stock | 7,250,487 | 373,067 | ||||||
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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 April 30, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Clinical trial sites and investigational drug costs | $ | 3,980,115 | $ | 3,175,543 | ||||
| Wages and salaries | 1,492,067 | 1,303,157 | ||||||
| Laboratory Rent | 130,500 | 114,330 | ||||||
| Supplies | 157,096 | 157,184 | ||||||
| Depreciation | 29,193 | 22,839 | ||||||
| Professional fees | 1,703 | 650 | ||||||
| Share-based compensation | 175,999 | 36,493 | ||||||
| $ | 5,966,673 | $ | 4,810,196 | |||||
For the three-month period ended April 30, 2026, total research and development expenses were $5,966,673, compared to $4,810,196 for the three-month period ended April 30, 2025. The increase was primarily driven by higher clinical trial sites and investigational drug costs, which increased to $3,980,115 in 2026 from $3,175,543 in 2025, reflecting expanded clinical development activities. Wages and salaries also increased to $1,492,067 from $1,303,157, due to higher personnel costs supporting ongoing research programs. Laboratory rent increased to $130,500 from $114,330, while depreciation expense increased to $29,193 from $22,839. Share-based compensation increased significantly to $175,999 in 2026 from $36,493 in 2025, reflecting a higher level of equity-based awards granted during the period.
Our clinical trial expenses are broken down as follows:
| Three months ended April 30, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Bria-IMT™ Pivotal Phase 3 study | $ | 3,149,348 | $ | 2,708,394 | ||||
| Bria-IMT™ Phase 1/2a | 159,579 | 300,013 | ||||||
| Bria-OTS™ Phase 1/2a | 1,040,724 | 182,344 | ||||||
| $ | 4,349,651 | $ | 3,190,751 | |||||
Clinical trial expenses for the three months ended April 30, 2026, were $4,349,651, compared to $3,190,751 during the same period in 2025. The increase reflects continued investment in the Bria-IMT™ pivotal Phase 3 program and ongoing advancement of the Bria-OTS™ Phase 1/2a program as it progresses through early clinical development. Together, these programs account for the majority of the year-over-year increase in clinical trial expenses.
For the three-month period ended April 30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $3,149,348, compared to $2,708,394 in 2025. The increase reflects the study’s continued progression through an advanced, cost-intensive stage, including expanded patient enrollment, increased clinical site activity, CRO services, central laboratory work, and clinical supply management. The level of spending is consistent with maintaining study momentum as the program advances toward planned interim analyses.
For the three-month period ended April 30, 2026, Bria-IMT™ Phase 1/2a expenses were $159,579, compared to $300,013 in 2025. The decrease reflects the continued wind-down of the program following completion of primary activities in fiscal 2024, with current-period costs primarily related to residual close-out procedures, data management, and limited follow-up activities. Expenses are expected to remain modest as final wrap-up items are completed.
For the three-month period ended April 30, 2026, Bria-OTS™ Phase 1/2a expenses were $1,040,724, compared to $182,344 in 2025. The substantial increase reflects continued advancement of the OTS program in early clinical development. Current-period costs include expanded development and manufacturing activities, GMP production of Bria-BRES+ and Bria-PROS+, regulatory and analytical support, and operational activities necessary to support ongoing evaluation of the next-generation Bria-OTS+ platform. The increased investment aligns with the program’s progression and the expansion of OTS across multiple solid tumor indications.
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General and Administrative Expenses
For the three-month period ended April 30, 2026, general and administrative expenses were $1,654,121, compared to $1,518,059 for the three-month period ended April 30, 2025. The increase was primarily attributable to higher shareholder communications expense, which increased from $146,616 in 2025 to $307,058 in 2026, higher share-based compensation of $256,208 in 2026 compared to $188,322 in 2025, increased consulting expenses from $44,222 in 2025 to $98,621 in 2026, and higher wages and salaries, which increased from $325,926 in 2025 to $359,873 in 2026. These increases were partially offset by lower professional fees, insurance expense, regulatory, filing and transfer agent fees, and travel expenses.
Financial income, net
For the three-month period ended April 30, 2026, the Company recorded net financial income of $186,970, compared to net financial expense of $9,762 in the same period of 2025. The increase is mainly attributable to higher interest income and lower interest expense. For the three-month period ended April 30, 2026, financial income was comprised of $219,220 of interest income, $29,631 of interest expense and $2,619 foreign exchange loss.
Profit (loss) for the period
For the three-month period ended April 30, 2026, the Company reported a net loss of $7,237,055, compared to $6,224,929 for the same period in 2025. The higher loss primarily reflects higher operating expenses, including 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.
Results of Operations for the Nine Months Ended April 30, 2026 and 2025
| Nine months ended April 30, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating Expenses: | ||||||||
| Research, development, and clinical trial expenses | $ | 18,704,005 | $ | 14,160,314 | ||||
| General and administrative expenses | 4,770,998 | 4,490,216 | ||||||
| Total operating expenses | 23,475,003 | 18,650,530 | ||||||
| Operating loss | (23,475,003 | ) | (18,650,530 | ) | ||||
| Financial income, net | 430,205 | 69,310 | ||||||
| Change in fair value of the warrant liability | 265,818 | 366,024 | ||||||
| Unrealized gain on investment | 137,830 | - | ||||||
| Share of loss on equity investments | (171,126 | ) | (176,837 | ) | ||||
| Net loss for the period | $ | (22,812,276 | ) | (18,392,033 | ) | |||
| Net loss attributable to non-controlling interest | (228,384 | ) | (171,536 | ) | ||||
| Net loss for the period attributable to BriaCell | (22,583,892 | ) | (18,220,497 | ) | ||||
| Net loss per share attributable to BriaCell – basic and diluted | $ | (5.73 | ) | $ | (67.08 | ) | ||
| Weighted average number of shares used in computing net basic and diluted earnings per share of common stock | 3,942,959 | 271,639 | ||||||
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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, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Clinical trial sites and Investigational drug costs | $ | 12,642,837 | $ | 9,732,786 | ||||
| Wages and salaries | 4,677,662 | 3,544,267 | ||||||
| Laboratory Rent | 385,610 | 342,990 | ||||||
| Supplies | 568,727 | 341,878 | ||||||
| Depreciation | 74,871 | 68,517 | ||||||
| Professional fees | 15,852 | 9,826 | ||||||
| Share-based compensation | 338,446 | 120,050 | ||||||
| $ | 18,704,005 | $ | 14,160,314 | |||||
For the nine-month period ended April 30, 2026, research, development, and clinical trial expenses were $18,704,005, compared to $14,160,314 for the same period in 2025. The increase was primarily driven by higher clinical trial sites and investigational drug costs, which increased from $9,732,786 in 2025 to $12,642,837 in 2026, reflecting the advancement of the Company’s clinical development programs. Wages and salaries increased from $3,544,267 in 2025 to $4,677,662 in 2026, due to increased headcount and personnel supporting clinical and development activities. Laboratory rent increased from $342,990 in 2025 to $385,610 in 2026, while supplies increased from $341,878 in 2025 to $568,727 in 2026, reflecting higher clinical and laboratory activity. Share-based compensation increased from $120,050 in 2025 to $338,446 in 2026, reflecting a higher level of equity-based awards outstanding during the period.
Clinical trial expenses for the period are as follows:
| Nine months ended April 30, | ||||||||
| 2026 | 2025 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Bria-IMT™ Pivotal Phase 3 study | $ | 10,816,541 | $ | 8,797,505 | ||||
| Bria-IMT™ Phase 1/2a | 519,986 | 699,356 | ||||||
| Bria-OTS™ Phase 1/2a | 2,965,488 | 325,539 | ||||||
| $ | 14,302,014 | $ | 9,822,400 | |||||
Clinical trial expenses for the nine months ended April 30, 2026, were $14,302,014, compared to $9,822,400 during the same period in 2025. The increase reflects sustained investment in the Bria-IMT™ pivotal Phase 3 program and significant advancement of the Bria-OTS™ Phase 1/2a program as it progresses through early clinical development. These programs continue to be the primary drivers of the year-over-year increase in clinical trial expenses.
For the nine-month period ended April 30, 2026, Bria-IMT™ Pivotal Phase 3 Study costs were $10,816,541, compared to $8,797,505 in 2025. The increase reflects continued patient enrollment, expansion of clinical sites, increased clinical site activity, CRO services, central laboratory testing, and clinical supply management associated with the ongoing progression of the Phase 3 study. Spending levels during the period are consistent with maintaining operational momentum as the trial advances toward planned interim analyses.
For the nine-month period ended April 30, 2026, Bria-IMT™ Phase 1/2a expenses were $519,986, compared to $699,356 in 2025. The decrease reflects the continued wind-down of the program following completion of primary activities in fiscal 2024. Current-period costs primarily relate to residual close-out procedures, data management, and limited follow-up activities. Expenses are expected to decline further as final wrap-up activities conclude.
For the nine-month period ended April 30, 2026, Bria-OTS™ Phase 1/2a expenses were $2,965,488, compared to $325,539 in 2025. The substantial increase reflects continued advancement of the OTS program into early clinical development. Costs incurred during the period include expanded development and manufacturing activities, GMP production of Bria-BRES+ and Bria-PROS+, regulatory and analytical support, and operational activities necessary to support ongoing evaluation of the next-generation Bria-OTS+ platform. The increased investment aligns with the program’s progression and expansion across multiple solid tumor indications.
General and Administrative Expenses
For the nine-month period ended April 30, 2026, general and administrative expenses amounted to $4,770,998, compared to $4,490,216 for the same period in 2025. The increase was primarily driven by higher shareholder communications expenses, which increased from $425,804 in 2025 to $860,951 in 2026, as well as higher wages and salaries, which increased from $951,371 in 2025 to $1,228,753 in 2026. These increases were partially offset by lower professional fees, which decreased from $875,632 in 2025 to $667,463 in 2026, and lower travel expenses, which decreased from $265,617 in 2025 to $106,439 in 2026.
Financial income, net
For the nine-month period ended April 30, 2026, financial income amounted to $430,205, compared to $69,310 for the nine-month period ended April 30, 2025. Financial income for the 2026 period consisted of $462,827 in interest income, an interest expense of $29,631 and a $2,991 foreign exchange loss. In comparison, financial income for the 2025 period included $86,514 in interest income, an interest expense of $36,979 and a $19,775 foreign exchange gain. The increase in financial income from 2025 to 2026 was primarily due to higher interest income, reflecting increased cash and cash equivalents available for investment in interest-bearing funds.
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Loss for the period
The Company reported a loss of $22,812,276 for the nine-month period ended April 30, 2026, compared to $18,392,033 for the same period in 2025. The increase in loss was primarily driven by higher research, development and clinical trial expenses, which rose to $18,704,005 in 2026 from $14,160,314 in 2025 as the Company advanced its clinical programs.
Liquidity, Capital Resources and Going Concern Uncertainty
As of April 30, 2026, the company had a positive working capital balance of $21,802,678 (July 31, 2025 positive balance of $15,948,588).
As of April 30, 2026, the Company has total assets of $27,071,310 (July 31, 2025 - $ 21,649,706), working capital of $21,802,678 (July 31, 2025 – positive balance of $15,948,588) and an accumulated deficit of $134,339,456 (July 31, 2025 - $111,755,564).
As of April 30, 2026, 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.
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 April 30, 2026 was $134,339,456 and negative cash flows from operating activities during the nine-month period ended April 30, 2026 was $22,692,452. The Company is planning to finance its operations by exploring additional sources of capital and financing, while managing its existing working capital resources. During the year ended July 31, 2025, the Company raised $50.9 million in gross proceeds from equity financings and, in January 2026, completed a public offering generating approximately $30 million in gross proceeds. However, the Company’s ability to continue as a going concern is dependent upon its ability to attain future profitable operations and to continue to obtain the necessary financing to meet its obligations arising from normal business operations when they come due. The uncertainty of the Company’s ability to raise such financial capital casts substantial doubt on the Company’s ability to continue as a going concern. These condensed consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should the Company not be able to continue as a going concern.
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During the period ended April 30, 2026, the Company’s overall position of cash and cash equivalents decreased by $3,613,587 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 nine-month period ended April 30, 2026, was $22,692,452 as compared to $20,038,075 for the nine-month period ended April 30, 2025.
Net cash used in investing activities during the nine-month period ended April 30, 2026, was $8,795,576 as compared to $225,000 for the nine-month period ended April 30, 2025. During 2026, this was primarily from the net purchase of short-term investments.
Cash gained in financing activities for the nine-month period ended April 30, 2026, was 27,874,441 as compared to 31,891,239 for the nine-month period ended April 30, 2025. During both periods, this was primarily from the proceeds of the issuance of shares in various financings.
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, 2026.
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, 2026, the Company has total assets of $27,071,310 (July 31, 2025 - $21,649,706) and a working capital balance of $21,802,678 (July 31, 2025 – 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 April 30, 2026, a 5% depreciation or appreciation of the Canadian dollar against the US dollar would not have a material effect on the 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 April 30, 2026, 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, 2026, 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 April 30, 2026.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not Applicable.
Item 5. Other Information.
During the three months ended April
30 2026, no director or officer of the Company
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. |
| 30 |
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 9, 2026 | By: | /s/ William V. Williams |
| Name: | William V. Williams | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
| June 9, 2026 | By: | /s/ Gadi Levin |
| Name: | Gadi Levin | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
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ATTACHMENTS / EXHIBITS