| GENERAL AND GOING CONCERN |
NOTE
1: GENERAL AND GOING CONCERN
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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”. |
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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. |
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c. |
Basis
of presentation of the financial statements: |
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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. |
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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. |
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d. |
Going
concern |
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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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e.
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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. |
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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
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 issued to BriaCell 23,972,589
common shares, 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. |
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)
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