UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-K

(Mark One)

For the fiscal year ended July 31, 2026

For the Transition Period from [●] to [●]

Commission File Number: 001-40101

BRIACELL THERAPEUTICS CORP.

(Exact name of registrant as specified in its charter)

(604) 921-1810

(Registrant’s telephone number, including area code)

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

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

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

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

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting 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.

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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates based on a closing sale price of $4.30 per share, which was the last sale price of the common shares as of January 30, 2026, the last business day of the registrant’s most recently completed second fiscal quarter, was $37,400,450.

As of October 28, 2026, 8,732,381 shares of the registrant’s common shares, no par value per share, were issued and outstanding.

TABLE OF CONTENTS

Forward-Looking Statements

This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks in the section titled “Risk Factors”, that may cause our or our industry’s 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 these forward-looking statements. In addition, you are directed to factors discussed in the “Business” section and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section, as well as those discussed elsewhere in this Annual Report on Form 10-K.

All of our forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Annual Report on Form 10-K or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on Form 10-K, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained in this Annual Report on Form 10-K will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.

This Annual Report on Form 10-K may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies, clinical trials and publications are reliable, we have not independently verified market and industry data from third-party sources.

Risk Factor Summary

Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors”, together with the other information in this Annual Report on Form 10-K. If any of the following risks actually occurs (or if any of those listed elsewhere in this Annual Report on Form 10-K occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously harmed. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business.

PART I

ITEM 1. BUSINESS

BUSINESS

Overview of the Company

BriaCell Therapeutics Corp. (“Briacell” or the “Company”) is a clinical-stage biotechnology company that is developing novel immunotherapies to transform cancer care. Immunotherapies have come to the forefront in the fight against cancer as they harness the body’s own immune system to recognize and destroy cancer cells. The Company is currently advancing its Bria-IMT™ targeted immunotherapy in combination with an immune check point inhibitor (Retifanlimab®) in a pivotal¹ Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Bria-IMT™ is currently under Fast Track Designation by the U.S. Food and Drug Administration (the “FDA”) intended to accelerate the review process of novel treatments that address unmet medical needs. Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in metastatic breast cancer.

BriaCell has reported benchmark-beating patient survival and clinical benefit in metastatic breast cancer with median overall survival of 13.3 months for the Phase 3 sequence in BriaCell’s metastatic breast cancer patients vs. median overall survival reported in the literature and in its Phase 2 study of Bria-IMT™ combination study with Retifanlimab®. Additionally, BriaCell reported median overall survival of 16.6 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 Corporation (“Incyte”) confirmed tolerability and early-stage efficacy (listed on ClinicalTrials.gov as NCT03328026).

BriaCell Phase 1/2 Study of Bria-OTS™, the Company’s personalized off-the-shelf immunotherapy, 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 it has received from the FDA permission to proceed with Phase 1/2a clinical studies of Bria-BRES+™ for breast cancer and Bria-PROS+™ for prostate cancer with open Investigational New Drug Applications (INDs) for both. BriaCell recently announced progress in developing Bria-OVA+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer, and Bria-MEL+, its personalized whole cell melanoma immunotherapy vaccine candidate has achieved a key genetic engineering milestone advancing the program toward clinical development.

Market

It is estimated by American Cancer Society Cancer Facts and Figures 2026, that approximately 324,580 people (321,910 women and 2,670 men) will be diagnosed with breast cancer in the United States in 2026. That means that every two minutes an American woman is diagnosed with breast cancer and more than 42,670 are projected to die in 2026. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the American Cancer Society estimates that approximately 2,670 new cases of invasive male breast cancer will be diagnosed and approximately 530 men will die from breast cancer in 2026.

According to the May 2026 “Global Oncology Trends 2026” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly $467 billion by the end of 2030.

¹ “Pivotal” is an industry term referring to a Phase 3 clinical study intended to show and confirm the safety and efficacy of a treatment.

² Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022.

About 13% of women will be diagnosed with breast cancer at some point during their lifetime. In 2025, over 4 million women were living with breast cancer in the United States. Approximately 83% of cases present as invasive breast cancer. Approximately 6% of new breast cancer diagnoses are Stage IV (metastatic breast cancer (“MBC”), which has already spread to other organs). Twenty to thirty percent of all women diagnosed with breast cancer will develop MBC. Breast cancer can be subdivided based on receptor status - the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors (HR), and the Her2/neu growth factor receptor (HER2). Based on the latest SEER statistics, 68% were found to be HR+/HER2−, 10% were triple-negative (HR−/HER2−), 10% were HR+/HER2+, and 4% were HR−/HER2+.¹

The majority (64%) of breast cancers diagnosed in 2015-2021 were localized, while the remainder were either regional (spread to lymph nodes; 28%), metastatic/distant (6%), or unknown (2%). Stage at diagnosis is a key determinant for survival outcome, as evidenced by the 5-year relative survival rates for patients with localized, regional, or distant breast cancer of 100%, 87.2%, and 32.6%, respectively. It is estimated that the number of women in the US living with MBC is projected to increase to over 240,000 by 2030². For those with metastatic disease at diagnosis, their 5-year survival rate is 30%.¹ For patients who develop MBC after initially having localized disease, if they had a good response to treatment (i.e. a disease-free interval of more than 24 months), their survival rate is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is less than 24 months, their prognosis is worse.⁴ We currently propose that Bria-IMT’s™ indication will be for the treatment of patients with MBC who have no approved alternative therapies available. Similarly, another study showed that the median overall survival among patients with de novo stage IV MBC was 39.2 months, while for patients with relapsed disease it was 27.2 months.⁵ Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent lines of therapy.⁶ One study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.⁷ More recent data indicates that for patients with MBC who have received 2 or more prior lines of therapy, median survival is 5.9-9.8 months.

For further information on our lead candidate Bria-IMT™ clinical development, see “Bria-IMT™” in the “Products /Pipeline” section.

1 See https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf and SEER Cancer Stat Facts: Female Breast Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/breast.html.

² Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

³ Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

⁴ Lobbezoo, D. J. A. et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res. Treat. 141, 507-514 (2013).

⁵ Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010 Nov; 21(11):2169-74.

⁶ Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist.

⁷ Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

Competition

Currently available therapeutic options for breast cancer offer hope for patients, but there continues to be room for improvement. Evaluating response rates (partial and complete responses = ORR), progression free survival (“PFS”) and overall survival (“OS”) from recent clinical trials in similar late-stage subjects with metastatic or recurrent breast cancer indicate that response rates range from 3-5% with PFS from 1.6 to 2.3 months¹, and OS from ~7 to 14 months².

MBC treated with second or higher lines of therapy has a poor prognosis and few effective therapies that consistently induce long-term remission, which indicates the market demand and clinical need for new and improved therapeutic drugs and treatment options in order to improve these response outcomes and patient survival rates. Thus, Bria-IMT™ has the potential to induce long-term remission, especially in combination with immunotherapies.

There are cancer vaccines in development for breast cancer, including but not limited to TPIV200 (Marker Therapeutics, Inc.), AE-37 (Antigen Express), and Stimuvax (Merck KgA). While these development candidates are aimed at different targets, and AE-37 has published data in the HER2 breast cancer patient population, there is no guarantee that any of these compounds will, in the future, be indicated for treatment of low-to-intermediate HER2 breast cancer patients and become directly competitive with Bria-IMT.

¹ Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744; Tripathy D, et al. JAMA Oncol. 2022 Nov 1;8(11):1700-1701; O’Shaughnessy J, et al. Breast Cancer Res Treat. 2022 Sep;195(2):127-139.

² Rugo, H. S., et al. The Lancet, 402(10411), 1423–1433; Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744.

While there are many biotech companies working to create an effective breast cancer therapeutic vaccine, a significant gap remains in the effectiveness and safety of second or higher lines of therapy. The most studied targeted immunotherapy, Neuvax (Galena), a HER2 peptide vaccine, failed a Phase 3 trial, but there is encouraging data to support at least three ongoing clinical trials combining trastuzumab with HER2 epitope immunogens.¹ The National Cancer Institute (“NCI”) randomized trial adding PANVAC (a poxviral-based immunogen) to docetaxel increased the median PFS from 3.9 months to 7.9 months and is to be used as a basis for larger, more sophisticated clinical trials.² An immunogen targeting a carbohydrate antigen, globo-H, was associated with improved PFS, but only in the subset able to mount antibody responses.³ A Johns Hopkins breast cancer trial using a breast cancer cell line transfected with the gene for GM-CSF has not been positive but, using the same cell line with trastuzumab, 40% of patients enjoyed clinical benefit (CR+PR+stable) at one year.⁴ Finally, the study of targeted cancer immunotherapies in combination with other therapies is receiving much attention, particularly combination with checkpoint inhibitors.⁵

There are several other approaches to developing targeted breast cancer immunotherapies. These include using peptide cocktails, a triple peptide regimen, recombinant HER2, antigen-pulsed dendritic cells, DNA immunogens, whole cell allogeneic GM-CSF secreting SKBR3 or T47D cells, an (HLA)-A2/A3-restricted immunogenic peptide derived from the HER2 protein, oxidized mannan-MUC1, and personalized peptide immunogens.

Among the most promising results in patients with advanced disease have been using whole-cell preparations, particularly if the cells are engineered to express GM-CSF. We are taking this approach and capitalizing on positive initial results with Bria-IMT™ monotherapy in difficult to treat patients using a regimen that both limits regulatory T cell activity (using low dose cyclophosphamide pre-treatment) and boosts the immune response (using post-dose alpha interferon in the inoculation sites). The combination with PD-1 inhibitors is a logical extension of our findings where 21 of 23 MBC patients had demonstrable PD-L1 expression on the circulating tumor cells (“CTCs”) and/or circulating cancer-associated macrophage-like cells (“CAMLs”). The overall strategy, once the initial milestones have been met, to enroll additional patients for product registration, will allow rapid progression of the best therapeutic option to a Biologics License Application (“BLA”).

Cancer immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well as small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both companies with currently approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint inhibitors, as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who have successfully obtained approval for cancer immunotherapy products include Bristol-Myers Squibb Company, Merck & Co., Inc., Genentech, Inc. (a subsidiary of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson/Janssen Pharmaceuticals, Amgen, Novartis, Acerta Pharmaceuticals (a subsidiary of AstraZeneca), Juno Therapeutics, Inc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc.

¹ Mittendorf, E. A.; Peoples, G. E., Injecting Hope-A Review of Breast Cancer Vaccines. Oncology (Williston Park) 2016, 30 (5), 475-81, 485.

² Heery, C. R.; Ibrahim, N. K.; Arlen, P. M.; Mohebtash, M.; Murray, J. L.; Koenig, K.; Madan, R. A.; McMahon, S.; Marte, J. L.; Steinberg, S. M.; Donahue, R. N.; Grenga, I.; Jochems, C.; Farsaci, B.; Folio, L. R.; Schlom, J.; Gulley, J. L., Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol 2015, 1 (8), 1087-95.

³ Huang, C.; Yu, A.; Tseng, L., Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic breast cancer. J Clin Oncol 2016, 34 (15).

⁴ Chen, G.; Gupta, R.; Petrik, S.; Laiko, M.; Leatherman, J. M.; Asquith, J. M.; Daphtary, M. M.; Garrett-Mayer, E.; Davidson, N. E.; Hirt, K.; Berg, M.; Uram, J. N.; Dauses, T.; Fetting, J.; Duus, E. M.; Atay-Rosenthal, S.; Ye, X.; Wolff, A. C.; Stearns, V.; Jaffee, E. M.; Emens, L. A., A feasibility study of cyclophosphamide, trastuzumab, and an allogeneic GM-CSF-secreting breast tumor vaccine for HER2+ metastatic breast cancer. Cancer Immunol Res 2014, 2 (10), 949-61.

⁵ McArthur, H. L.; Page, D. B., Immunotherapy for the treatment of breast cancer: checkpoint blockade, cancer vaccines, and future directions in combination immunotherapy. Clin Adv Hematol Oncol 2016, 14 (11), 922-933.

Companies developing novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and gain market share. For patients with early-stage breast cancer, adjuvant therapy is often given to prevent recurrence and increase the chance of long-term disease-free survival. Adjuvant therapy for breast cancer can include chemotherapy, hormonal therapy, radiation therapy, or combinations thereof. In addition, the HER2 targeted drug trastuzumab (HERCEPTIN), alone or in combination with pertuzumab (PERJETA), both manufactured and marketed by Roche/Genentech, may be given to patients with tumors with high expression of HER2 (IHC 3+), as well as other novel targets such as MUC1, which may be useful in treating breast cancer. In addition, the FDA approved the first ever immunotherapy regimen for breast cancer to the Roche/Genentech PD-L1 checkpoint inhibitor atezolizumab (TECENTRIQ), combined with Celgene’s nab-paclitaxel (ABRAXANE) for TNBC that cannot be removed with surgery and is locally advanced or metastatic.

Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do, and have greater experience in obtaining FDA and other regulatory approvals of treatments and commercializing those treatments. Accordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving widespread market acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize, thus causing limited market share before we can recover the expenses of developing and commercializing our cancer immunotherapy product candidates.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development of cancer immunotherapy product candidates.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, the ability to work with specific clinical contract organizations due to conflicts of interest, and the conduct of trials in the ability to recruit clinical trial sites and subjects for our clinical trials.

We expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price and the availability of reimbursement from government and other third-party payors. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are viewed as safer, more convenient or less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our current product candidates or any other future product candidate, which could result in our competitors establishing a strong market position before we are able to enter the market.

Products/Pipeline

Description of the Business - Clinical and Pre-clinical Trials

Bria-IMT™

About Bria-IMT ™

Bria-IMT™, BriaCell’s lead candidate, is a whole-cell immunotherapy for metastatic breast cancer. Bria-IMT™ in combination with an immune check point inhibitor is undergoing pivotal Phase 3 clinical testing in patients with advanced MBC patients who have failed prior lines of therapy. The pivotal Phase 3 combination study is listed on ClinicalTrials.gov as NCT06072612.

Mechanism of Action of Bria-IMT™

Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy for the treatment of breast cancer. Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells and clinically applied as a targeted immunotherapy. Bria-IMT™ immunotherapy is derived from a grade II (moderately differentiated) tumor which activates the immune system to attack and destroy breast cancer tumors.

Bria-IMT™ is designed to secrete GM-CSF, a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic cells, the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune system, to recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMT™ with other immune system activators including cyclophosphamide (used in low doses to reduce immune suppression), and low-dose local interferon-α, a cytokine that further activates the immune system. This is termed the Bria-IMT™ regimen. We believe this approach of simultaneous activation of the immune system via different pathways will improve the immune system response to attack and destroy cancer cells.

Phase 1/2 Clinical Trial of the Bria-IMT™ regimen in Advanced Metastatic Breast Cancer

BriaCell conducted Phase 1/2a clinical trials (SVMC #01-026 and WRI-GEV-007) of the Bria-IMT™ regimen in patients with advanced breast cancer. In the 2 studies a total of 27 patients were treated. They had failed on the average (median) 5 prior lines of therapy. The treatment was generally well tolerated with local irritation at the inoculation sites the main adverse event judged at least possibly related to study medication. In total, 18 patients were evaluable (had measurable disease and both baseline and on treatment imaging studies). The efficacy data is shown here.

In this study it was also noted that in 21 of 23 patients with circulating tumor cells or cancer-associated macrophage-like cells expressed PD-L1, and immune checkpoint that blocks the activity of activated T cells to kill tumor cells. This led to the design of a combination study where the Bria-IMT™ regimen is given in combination with an immune checkpoint inhibitor (CPI).

Phase 1/2 Clinical Trial of Bria-IMT™ in Combination with Immune Check Point Inhibitors in Advanced Metastatic Breast Cancer

BriaCell has been conducting a Phase 1/2a clinical trial (BRI-ROL-001) of Bria-IMT™, in combination with immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) and retifanlimab, an immune checkpoint inhibitor manufactured by Incyte. The combination study is listed in ClinicalTrials.gov as NCT03328026 under FDA-approved BB-IND 10312 under protocol BRI-ROL-001 at ten clinical sites throughout the United States. The study is now closed to enrollment.

In the Phase 1 part of the study, the Bria-IMT™ regimen was dosed in combination with Keytruda ® in 11 patients and in 11 patients with retifanlimab, with one patient starting on the combination with Keytruda® and crossing-over to the combination with retifanlimab. In the Phase 2 part of the study an additional 32 patients were dosed (54 patients total). In Phase 2 part of the study, the Bria-IMT™ regimen is being dosed in combination with retifanlimab with patients randomized to either receive the Bria-IMT™ regimen first (16 patients) or retifanlimab first (16 patients).

BriaCell also evaluated 2 formulations of Bria-IMT, one treated with interferon gamma and one untreated.

The design of the study is shown here.

The patients had advanced breast cancer as shown here.

Treatment with the combination regimen was generally well tolerated as shown here.

There was no statistically significant difference in Progression Free Survival (PFS) based on order of administration (CPI in cycle 1 or delayed to cycle 2). There was a significant effect of PFS of formulation as shown here.

Data presented at ASCO 2026

https://www.asco.org/abstracts-presentations/261300

The overall survival of the patients for all patients on this study has been evaluated in an ongoing fashion. Since the study was largely on hold during COVID (2020 and 2021), patients dosed in 2019 and 2020 have been followed for a longer time. Therefore survival data has been evaluated for patients dosed before 2022 and since 2022. This should be considered in the context of clinical studies in patients with metastatic breast cancer who have failed at least 2 prior regimens¹.

The Bria-IMT™ regimen, using the Phase 3 formulation, with a CPI has shown a median overall survival (OS) of 13.3 months for all patients by the Kaplan Meier method, as shown in the Figure below. For patients treated since 2022, the median OS was estimated at 16.6 months.

Figure B. Overall Survival of Patients with Metastatic Breast Cancer treated with the Bria-IMT™ regimen using the Phase 3 formulation with a CPI.

Data presented at ASCO 2026

https://www.asco.org/abstracts-presentations/261300

ClinicalTrials.gov ID NCT03328026

1 Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022; Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744.

In its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperformed ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients. In BriaCell’s Phase 2 clinical study in late-stage MBC, 24 of 37 patients treated with the Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 24 patients (13.4 months) and for those treated since 2022 (14.3 months) is similar to those from the phase 3 study of the current ADC standard of care TRODELVY^® (14.4 months) and exceeds those treated with chemotherapy (11.3 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was better than TRODELVY^® and markedly higher than those of chemotherapy.

Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT™ plus CPI versus other drugs in MBC patient subsets.

* Patients treated with the Phase 3 formulation since 2022

** Number of prior chemotherapy-containing regimens

HR+: hormone receptor-positive

TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))

BriaCell has also analyzed the data from the Phase 1/2 study in patients who have failed prior ADC therapy. The results are shown here in comparison to studies of comparable patients in the literature.

*Data is for evaluable patients, n=42 with 12 not evaluable.

** Data is for evaluable patients, n = 17 with 6 not evaluable.

References: Data is shown for the intent to treat population for the control group treated with treatment of physician’s choice, which is the comparator in the BriaCell phase 3 study

1. Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744.

2. Tripathy D, Tolaney SM, Tagliaferri M. Etirinotecan Pegol Treatment for Patients With Metastatic Breast Cancer and Brain Metastases-Reply. JAMA Oncol. 2022 Nov 1;8(11):1700-1701. jamaoncol.2022.4346. PMID: 36136348. This paper describes patients with brain metastases.

3. O’Shaughnessy J, et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139.

During the course of this study, BriaCell has had several remarkable responders. The data for 2 of them is shown here.

Patient 06-005 had failed 13 prior regimens. She had baseline breast cancer metastases behind the left eye (orbit), in the outside lining of the brain (dura mater) and the adrenal gland. Following 6 months of treatment the orbital tumor completely resolved and the others improved. She was judged an overall partial responder.

Imaging for Patient 06-005

Patient 11-018 had failed 8 prior regimens including the ADC Enhertu®. She had a right orbital tumor causing extensive proptosis (eye bulging) & brain (temporal lobe) metastasis. There was a complete resolution of the temporal lobe metastasis and a marked reduction in the orbital lesion with resolution of proptosis and improvement in eye pain.

Baseline tumor status

Marked tumor reduction at 11 months

She remained on study for 24 months

Imaging for Patient 11-018

Overall BriaCell has treated 7 patients with intracranial (inside the skull) metastatic disease who had measurable disease. The intracranial overall response rate (iORR) is 71%, which compares very favorably with the data for comparable patients in the literature. Some of this data is shown here.

Intracranial responses for patients treated with Bria-IMT™

Note that the iORR in comparable patients typically <20%. (see Niwinska A, Pogoda K, Jagiello-Gruszfeld A, Duchnowska R. Intracranial Response Rate in Patients with Breast Cancer Brain Metastases after Systemic Therapy. Cancers (Basel). 2022 Feb 15;14(4):965 and Tripathy D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Diéras V, Müller V, Du Y, Currie SL, Hoch U, Tagliaferri M, Hannah AL, Cortés J; ATTAIN Investigators. Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase III ATTAIN Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1047-1052.)

Phase 3 Clinical Trial of Bria-IMT™ in Combination with Immune Check Point Inhibitors in Advanced Metastatic Breast Cancer compared with Treatment of Physician’s Choice (Bria-ABC)

BriaCell has been conducting a Phase 3 clinical trial (Bria-ABC) of Bria-IMT™, in combination with immune checkpoint inhibitor retifanlimab, an immune checkpoint inhibitor manufactured by Incyte. The combination study is listed in ClinicalTrials.gov as NCT06072612 under FDA-approved BB-IND 10312. The primary endpoint is overall survival.

Bria-IMT™ is currently under Fast Track Designation by 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 the FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer.

The FDA has agreed that improvement in overall survival in the Bria-IMT™ combination arm as compared to the physician’s choice of treatment arm will be the primary endpoint of the study. The study is expected to enroll 177 patients in the Bria-IMT™ combination therapy arm and 177 patients in the treatment of physician’s choice arm. To gather additional information on the Bria-IMT™ regimen alone, 50 patients are expected to be enrolled in this regimen and will be eligible for combination therapy following their initial post treatment evaluation. These patients will not be included in the primary analysis. The study will have an interim evaluation for efficacy which could result in early completion of the study. We expect frequent and responsive FDA communication under our Fast Track status during our pivotal Phase 3 study. The overall design of the study is shown here.

The first interim analysis will be at 144 events (mortalities). If the hazard ratio (HR) is ≤ 0.6, BriaCell will submit a Biologics License Application (BLA). If the HR is > 0.6, the study will continue to completion with HR target of 0.7. Either of these could result in full approval of the Bria-IMT™ CPI combination regimen in advanced metastatic breast cancer.

The successful completion of the pivotal study would allow BriaCell to subsequently submit a Biologics License Application and accelerate the path to commercialization. The Phase 3 study has multiple locations throughout the USA as noted in the ClinicalTrials.gov listing https://clinicaltrials.gov/study/NCT06072612.

The independent Data Safety Monitoring Board (DSMB), a group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has periodically reviewed safety data from BriaCell’s pivotal randomized Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor (CPI) combination regimen (ClinicalTrials.gov NCT06072612) in metastatic breast cancer. As of September 14, 2026, the DSMB had issued seven consecutive positive recommendations, in each case identifying no safety concerns and recommending continuation of the study.

On April 22, 2025, the Company announced its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612) has consented over 100 and has enrolled over 75 patients.

On April 30, 2025, BriaCell reported “Late-Breaker” Phase 3 data at AACR 2025. Positive tolerability profile and potential response biomarkers were identified. Phase 3 clinical data showed potential predictive biomarkers for treatment response, first identified in the Phase 2 study. Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits. Positive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) were linked to longer progression-free survival (PFS) in Phase 3 patients. Presence of Circulating Tumor Cells (CTC) after patients’ initial Phase 3 treatment supports their role as negative prognostic marker (p = 0.04). The Bria-IMT Phase 3 regimen was well-tolerated with a preferred tolerability profile.

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. For a description of the August 2025 share consolidation, see “Financings and share consolidations” below.

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, and on October 21, 2025, we announced a related collaboration with MSK’s Therapeutics Accelerator program that includes support for manufacturing, IND development and clinical protocol work for a planned Phase 1 study of Bria-BRES+ in 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 September 14, 2026, BriaCell announced that the independent Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, issued its seventh consecutive positive recommendation following review of clinical data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612). The Data Safety Monitoring Board (DSMB) stated no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus a CPI in MBC.

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 Allogeneic 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 were 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.

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

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

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.

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 through 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.

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.

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 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 the Bria-ABC pivotal breast cancer study had surpassed 230 patients.

On May 22, 2026, BriaCell announced positive clinical data from three clinical data poster presentations and three publication-only abstracts at the 2026 ASCO Annual Meeting. The presentations included two poster presentations featuring data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor, Bria-ABC (ClinicalTrials.gov identifier: NCT06072612), and one poster highlighting further analyses of Phase 2 data. Final Phase 2 Bria-IMT median overall survival (OS) was reported at 16.6 months (with Phase 3 formulation). Positive Quality of Life (QOL) data from the ongoing Phase 3 study in heavily pre-treated metastatic breast cancer (MBC) patients was presented. Additionally, Biomarker analyses from the ongoing Phase 3 study confirmed predictors of anti-cancer response seen in Phase 2.

Final Bria-IMT™ Phase 2 data presented at the 2026 ASCO Annual Meeting showed 55% >1 year and 27% >2-year survival in heavily pre-treated metastatic breast cancer (MBC) patients treated with Bria-IMT regimen selected for Phase 3. TWiST analysis, which measures time without disease symptoms or significant treatment-related toxicity, showed clinically meaningful benefit in heavily pre-treated MBC patients in the ongoing Phase 3 study. Biomarker analyses from the ongoing Phase 3 study further validated potential predictors of anti-cancer response initially reported in Phase 2 study.

The details of the presentations are listed below.

Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months.

Clinical Data: 32 Phase 2 Bria-IMT patients were randomized to receive immune checkpoint inhibitor (CPI) in the first cycle or delayed to the second cycle. Two Bria-IMT formulations were also evaluated. Patients had median age of 61 (range 41-80) and had received median 6 prior therapies (range 2-13). Treatment was well tolerated with injection site reactions, mostly mild in severity, the most frequent side effect. The clinical benefit rate was 62% overall in long-term survivors. Of patients treated with the Phase 3 formulation, 10 of 21 (48%) survived over a year.

Median overall survival (“OS”) was 13.3 months for patients who initiated checkpoint inhibitor (“CPI”) therapy in Cycle 1 (as is being done in the Phase 3 Bria-ABC study) versus 7.4 months for those who initiated CPI therapy in Cycle 2 with estimated 12-month and 24-month OS rates being 50% and 25% for initiating CPI in the first cycle. Among patients who developed an immune response, as measured by delayed-type hypersensitivity (“DTH”), median OS was 11.9 months in DTH-positive patients versus 4.7 months in DTH-negative patients, with 48% versus 0% 12-month survival, respectively. Estimated 12-month and 24-month OS rates were 41% and 24%, respectively, for the entire Phase 2 population. For patients treated with the Phase 3 regimen, the median OS was 16.6 months with >55% OS at 1 year and >27% at 2 years (see Figure 1 below. Note that the CPI at C1 and IP w/o IFNγ is the Phase 3 Bria-IMT regimen). There were no treatment-related discontinuations and no unexpected safety signals.

Figure 1: Phase 2 study overall survival by sequence and formulation demonstrating extended OS with CPI at C1 and IP w/o IFNγ (Bria-IMT Phase 3 regimen) 

Conclusions: In heavily pretreated MBC patients, Bria-IMT demonstrated an excellent safety profile and the emergence of a long-term survivor cohort. Durable survival rates were observed beyond 12 and 24 months. Differential survival favored the Phase 3 formulation, DTH positivity, lower baseline circulating tumor cell (CTC) levels, and early CPI sequencing. These findings support prospective validation of DTH and CTC as predictive biomarkers for effectiveness of the Bria-IMT regimen and the continued use of the Phase 3 formulation in the ongoing Phase 3 study Bria-ABC. The clinical findings further confirmed the preferred formulation for the ongoing pivotal Phase 3 study.

Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer. Summary: Heavily pretreated MBC patients in the pivotal Bria-ABC study demonstrated stable global health and key functional domains. Measurements included quality of life (QOL) and time without symptoms or toxicity (TWiST). Blinded data indicated that QOL was preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure. Clinical data demonstrates meaningful benefits without significant toxicity. Ongoing follow up will further characterize durability of patient-reported outcomes and clinical correlation. Data further supports decentralized care and potential home self-administration of the Bria-IMT+CPI regimen.

Study patients were heavily pretreated, consistent with BriaCell’s prior Phase 2 population, with a median of 6 prior systemic therapies (range: 2–14), including prior ADCs in 84%, CPIs in 27%, and CDK4/6 inhibitors in 61%. Blinded Phase 3 data suggest sustained quality of life despite advanced disease and poor prognostic characteristics. TWiST analysis demonstrated meaningful time alive without disease symptoms or significant treatment-related toxicity, supporting a favorable benefit-risk profile.

Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC Phase 3 trial for advanced metastatic breast cancer: An ongoing analysis.

Summary: In an ongoing analysis of heavily treated MBC patients, we observed that in the entire blinded population, 65% of patients had stability/drop in Cancer-Associated Macrophage-Like cells (CAMLs) and this significantly correlated with better progression free survival (PFS).

Results:

In this ongoing blinded analysis of heavily pretreated metastatic breast cancer patients, stable or decreased CAML counts from baseline to Cycle 3 were observed in 60% of evaluable patients and significantly correlated with improved PFS. Baseline CTC positivity was associated with more rapid progression. These findings support further evaluation of CAML dynamics as a potential early blood-based biomarker of clinical outcomes in the Phase 3 Bria-ABC study.

On June 25, 2026, BriaCell announced that it has entered into a Memorandum of Understanding (“MoU”), with Uneedle, a microneedle based drug-delivery device company in the Netherlands, to support the continued use and commercial readiness of Uneedle’s proprietary microneedle technology for intradermal administration of BriaCell’s lead Phase 3 clinical candidate, Bria-IMT, for the treatment of metastatic breast cancer.

The MoU reflects the continued commitment of BriaCell and Uneedle to collaborate on the potential regulatory and commercial development of BriaCell’s cell-based immunotherapy Bria-IMT. The non-binding MoU is intended to establish a plan that details scaling of Uneedle’s microneedle devices for use in commercial quantities. All activities and projections described herein are contingent upon successful regulatory approval of BriaCell’s lead Phase 3 clinical candidate, Bria-IMT, in the relevant jurisdictions.

On July 7, 2026, BriaCell announced that it has engaged Charles River Associates (CRA) (Nasdaq: CRAI) and Kaleio, Inc. to support commercial strategy, market access evaluation and brand planning for Bria-IMT. Charles River Associates (CRA) was engaged to evaluate epidemiology, pricing, prescriber dynamics, and market access potential for Bria-IMT in metastatic breast cancer in the US. Kaleio was engaged to support brand strategies and customized commercial-readiness solutions.

On July 16, 2026, BriaCell announced that the Odette Cancer Centre at Sunnybrook Health Sciences Centre, a leading cancer center in Toronto, Ontario, Canada, has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).

On September 8, 2026, BriaCell announced that Memorial Sloan Kettering Cancer Center (MSK) has joined BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor in metastatic breast cancer (ClinicalTrials.gov identifier: NCT06072612).

Manufacturing

We do not own or operate manufacturing facilities to produce our product candidates. We currently depend on third-party contract manufacturers for all our required raw materials, active pharmaceutical ingredients, and finished product candidate for our clinical trials. We currently employ internal resources and third-party consultants to manage our manufacturing contractors.

Bria-IMT™ is currently manufactured under current Good Manufacturing Practices (“cGMP”) pursuant to agreements with University of California, Davis (“UC Davis”) and with FujiFilm Diosynth Biotechnology (“Fuji”), which is located in Thousand Oaks, California.

Pursuant to the Company’s master services agreement with Fuji, dated May 9, 2023, to manufacture Bria-IMT™, for anticipated use in clinical studies including the Phase 3 study. Fuji is a leading contract manufacturing organization with experience in the manufacturing of cellular therapies for clinical trials. Under the terms of the agreement, Fuji will be responsible for GMP manufacturing of Bria-IMT™ for anticipated use in clinical studies. Fuji’s expert team will be working closely with BriaCell’s scientific and product development teams to ensure timely production of Bria-IMT™ in compliance with applicable regulatory requirements by the FDA.

On July 15, 2026, BriaCell announced a manufacturing arrangement with FUJIFILM Biotechnologies California, a leading contract development and manufacturing organization (CDMO) specializing in cell therapies, to support the ongoing pivotal Phase 3 clinical development and potential future commercial supply of BriaCell’s lead clinical candidate, Bria-IMT.

Production and Marketing Plan

Bria-IMT™ cells grow in simple tissue culture media and are irradiated prior to inoculation. Fuji and the UC Davis GMP facility have developed a frozen formulation where the cells are grown, harvested and irradiated, followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation. Each lot of Bria-IMT™ is tested for potency (i.e. GM-CSF production), identity (i.e. HER2+ and ER/PR-) and adventitious agents to rule out contamination with infectious agents. To date, there have been no issues with these tests.

Marketing will target oncologists who are well-versed in the use of immunotherapy and especially breast cancer treatment centers. The initial target will be patients with metastatic or recurrent breast cancer who have failed at least two prior treatment regimens. We plan to develop the clinical data for Bria-IMT™ and to use this information to reach out to oncologists seeking additional therapeutic options for their patients. We will include in this effort a physician education campaign targeting the oncologists most likely to treat metastatic breast cancer. As these physicians become more aware of the data regarding Bria-IMT™ in breast cancer, we will make sure they also understand how best to use Bria-IMT™ in combination with other therapies that have complementary synergistic mechanisms of action. This will also come from the clinical studies described above focusing on combination therapy. Partnering with established pharmaceutical companies is also an option that we intend to pursue. Our eventual goal is to reach all oncologists who treat late-stage breast cancer.

Bria-OTS™

BriaCell Phase 1/2 Study of Bria-OTS™, also known as Bria-BRES™, in metastatic breast cancer is open. The Phase 1/2 clinical study is listed on ClinicalTrials.gov as NCT06471673.

Development of Additional Immunotherapy Cell Lines

Bria-OTS™, the Company’s personalized, off-the-shelf immunotherapy, advanced meaningfully during the reporting period.

On February 3, 2025, the Company announced a clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere in the first metastatic breast cancer (MBC) patient treated with Bria-OTS™ as a single agent. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer.

On April 24, 2025, BriaCell Confirmed 100% Resolution of Lung Metastasis with Bria-OTS. Complete resolution of lung metastasis confirmed at 4 months follow-up in a hormone receptor positive (HR+) breast cancer patient. Treatment well-tolerated and the patient remained on study with stable disease elsewhere. Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study.

On May 27, 2025, BriaCell announced that the Bria-OTS Phase 1/2 Study cleared safety evaluation, and BriaCell dosed its first patient in Bria-OTS combination with an immune checkpoint inhibitor. Specifically, Bria-OTS has cleared its safety evaluation in the Phase 1/2 study monotherapy dosage setting. Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic breast cancer. The first Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis.

On June 2, 2025, BriaCell presented a poster at the American Society of Clinical Oncology (ASCO) meeting on clinical data from Bria-OTS™ study in metastatic breast cancer (MBC).

Poster Title: Trial in progress: A study of Bria-OTS™ cellular immunotherapy in metastatic recurrent breast cancer

In a dose-escalation Phase 1/2 study, heavily pre-treated MBC patients received Bria-OTS monotherapy (single agent Bria-OTS cells only). The Phase 1 segment enrolled and treated 3 patients with the first patient achieving a confirmed resolution of a breast cancer lung metastasis and remaining on study with single agent Bria-OTS. Following successful completion of safety evaluations, BriaCell has initiated the combination cohort dosing the first patient with Bria-OTS plus checkpoint inhibitor (CPI).

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 were 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)

Bria-PROS+™ and Bria-BRES+™

On November 7, 2025, BriaCell presented robust anti-cancer activity of Bria-OTS+ in breast (Bria-BRES+™) and prostate (Bria-PROS+™) 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.

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 to 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 15^th, 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.

On August 5, 2026, BriaCell announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer. FDA clearance of Investigational New Drug (IND) application enables BriaCell to initiate Phase 1/2a clinical study of Bria-PROS+ in prostate cancer.

On August 24, 2026, BriaCell announced that Bria-MEL+™, its personalized whole cell melanoma immunotherapy vaccine candidate, has achieved a key genetic engineering milestone, advancing the program toward clinical development. Melanoma remains a significant unmet medical need, with approximately 112,000 new cases and 8,510 deaths expected in the US in 2026.

Soluble CD80

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 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. As of July 31, 2026, the fair value of the sCD80 and related assets was estimated by an independent third-party valuation to be approximately $1.78 million.

License Agreements

On August 4, 2022, BriaCell secured an exclusive license from the University of Maryland, Baltimore County (UMBC) to develop and commercialize sCD80 as a biologic agent for the treatment of cancer (the “UMBC Licensing Agreement”). As described above under “BriaPro Therapeutics and Antibody Development,” BriaCell sold its rights under the UMBC Licensing Agreement to BriaPro in the Transaction, which closed on March 31, 2026.

Plan of Arrangement for BriaPro Therapeutics Corp.

On August 31, 2023, the Company closed a plan of arrangement spinout transaction (the “Arrangement”). Pursuant to the Arrangement, certain pipeline assets of the Company were spun-out to BriaPro Therapeutics Corp. (“BriaPro”), including Bria-TILsRx™ and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer (the “BriaPro Assets”), resulting in a two-thirds (2/3) owned subsidiary of the Company with the remaining one-third (1/3) held by the Company’s shareholders. BriaPro has acquired the entire right and interest in and to the BriaPro Assets in consideration for the issuance by BriaPro to the Company of BriaPro’s common shares. Under the terms of the Arrangement, for each common share of the Company held immediately prior to closing, the shareholders of the Company received one common share of BriaPro, and one new common share of the Company (retiring their old share) having the same terms and characteristics as the existing common shares of the Company. The Company’s common shares and public warrants remained listed on the Nasdaq Capital Market and the common shares remained listed on the Toronto Stock Exchange, and BriaPro is an unlisted reporting issuer in Canada. As part of the Arrangement, the Company obtained a third-party independent valuation for BriaPro which amounted to $1.75 million. Based on the number of issued shares of BriaPro, this amounts to $0.0365 per BriaPro share.

BriaPro is a pre-clinical stage immunotherapy company developing binding agents and proteins with the intention to boost the ability of the body’s own cancer-fighting cells to destroy cancerous tumors. Using artificial intelligence (“AI”) with Receptor AI, BriaPro will identify drug candidates.

The lead drug discovery candidates for BriaPro includes:

The power of AI in drug candidate selection has been hailed by experts and investments in AI-driven drug discovery companies have tripled over the past four years, reaching $24.6 billion in 2022.² Using AI technology to identify the next blockbuster therapies can help eliminate some of the guesswork that typically requires hundreds of lab experiments-often spread over many years-to identify promising molecules.

Instead of coming up with tens of thousands of compounds to figure out, computers suggest testing ten compounds in a lab, then getting feedback from the lab results. The machines learn from those results to make a better prediction to provide the next hundred candidates for testing and ultimately filter to one molecule.

Over the course of the next year, BriaPro expects to initiate clinical study of BP-80 in patients with advanced solid tumors. BriaPro expects to screen several different multi specific binding reagents for activity in vitro as well as in mouse models of cancer. BriaPro also expects to advance one candidate into IND enabling studies. Human clinical studies are expected to be initiated in the first half of 2028. In parallel, BriaPro will continue to optimize the structure of its proprietary protein kinase C delta inhibitors and advance to the candidate selection stage. Human clinical studies are expected to be initiated in the second half of 2028.

On April 10, 2025, BriaPro announced a new initiative in antibody therapeutics. The subsidiary is developing high-affinity antibodies directed against B7-H3, an immune checkpoint molecule implicated in cancer progression and expressed on many tumor types. This initiative leverages molecular modeling techniques and is backed by provisional U.S. patent filings, with international filings under the Patent Cooperation Treaty anticipated. The antibodies are expected to be incorporated into the proprietary Bria-TILsRx™ platform, which is designed to activate tumor-infiltrating lymphocytes within the tumor microenvironment.

On July 29, 2025, BriaCell’s Subsidiary, BriaPro, filed patent application for immuno-oncology platform with novel multitargeting agents. TILsRx platform is designed to overcome immune suppression and T cell exhaustion to activate tumor-infiltrating lymphocytes (TILs). Multivalent technology enables simultaneous engagement of multiple cancer-associated and immune pathway targets. A preferred tolerability profile is expected due to selective cancer cell targeting within the tumor microenvironment (TME). TILsRx platform early agents include antibodies to B7-H3, an immune checkpoint found in several cancers including prostate, lung, breast, pancreatic, and ovarian. The platform integrates T cell engagers and immune checkpoint modulators, with the goal of both enhancing anti-tumor immune responses and selectively blocking inhibitory signals that often suppress T cell activity. This program represents a diversification of BriaCell’s pipeline into next-generation antibody modalities and underscores the Company’s leadership in immuno-oncology innovation.

On February 18, 2026, the Company and BriaPro, 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”).

On October 6, 2026, BriaCell and BriaPro announced that four abstracts featuring preclinical research from their respective immunotherapy programs have been selected for poster presentations at the Society for Immunotherapy of Cancer (SITC) 41st Anniversary Annual Meeting, taking place November 4-8, 2026, in Phoenix, AZ.

Intellectual Property

The proprietary nature of, and protection for, the Company’s current and/or any future product candidates, processes and know-how are important to its business, as is its ability to operate without infringing on the proprietary rights of others, and to prevent others from infringing its proprietary rights. The Company seeks patent protection in the U.S. and internationally for its current and future product candidates it may develop through other technology. In order to protect its proprietary technologies, the Company relies on combinations of applications for patent and trade secret protection, as well as confidentiality agreements with employees, consultants, and third parties.

Bria-IMT™

Filed with the United States Patent and Trademark Office (USPTO) on June 14, 2004, U.S. Patent No. 7,674,456 B2 issued on March 9, 2010 and includes claims to the following:

1. Compositions comprising SV-BR cells; and

2. Therapeutic methods of using said compositions

The patent expires May 31, 2028 and patent term extension under Hatch-Waxman potentially applies (additional five years).

Bria-OTS™

On February 27, 2017, BriaCell™ filed an international patent application under the Patent Cooperation Treaty (PCT) to further expand its intellectual property portfolio underlying the Company’s current and anticipated pipeline of whole-cell cancer immunotherapeutics including Bria-IMT™ and Bria-OTS™. The PCT application (PCT/US2017/019757) claims priority to two provisional patent applications filed by the Company with the USPTO in 2016. It, in essence, provides the framework for additional whole-cell cancer immunotherapeutics beyond Bria-IMT™ and strategies for patient-specific selection of the most likely effective whole-cell immunotherapeutic. The PCT application entered the National Phase in the second half of 2018 and has been granted in Japan, Australia, New Zealand, and the US.

BriaCell was awarded a Japanese patent on June 21, 2021 (JP Patent No. 6901505, extends to February 27, 2037) covering composition of matter and kits for its whole-cell cancer immunotherapy technology in Japan.

BriaCell was also awarded an Australian patent on November 10, 2022 (AU Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer immunotherapy technology in Australia.

In addition, BriaCell was awarded a US patent on January 24, 2023 (US Patent No. 11,559,574 B2 with the term extending to May 25, 2040) covering composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer.

Furthermore, BriaCell was awarded a New Zealand patent on October 3, 2023 (NZ Patent No. 745327, extends to February 27, 2037) covering composition of matter, method of use, and kits for its whole-cell cancer immunotherapy technology in New Zealand.

BriaCell was awarded another New Zealand patent on June 4, 2025 (NZ Patent No. 785587, extends to February 27, 2037) covering methods of patient-specific selection of the most likely effective whole-cell cancer immunotherapy based on HLA allele profile matching.

On March 2, 2023, BriaCell filed an international patent application under the PCT to further expand its intellectual property portfolio underlying the Company’s development of innovative immunotherapeutic strategies for the treatment of advanced solid tumors including Bria-OTS™ that has been engineered to express co-stimulatory molecules and immunomodulatory cytokines. The PCT application (PCT/US2023/014337) published on September 7, 2023 as International Publication No. WO 2023/167973 A1. The PCT application entered the National Phase in the second half of 2024.

On March 29, 2024, BriaCell and the National Cancer Institute (NCI) filed an international patent application under the PCT directed to engineered mammalian dendritic cells that express exogenous MHC class II alleles for the development of innovative dendritic cell-based immunotherapeutic strategies.

Soluble CD80

The patents held under UMBC Licensing Agreement are as follows (recently tranferred form Briacell to BriaPro):

USPN 8,956,619 B2

USPN 9,650,429 B2

USPN 10,377,810 B2

On February 6, 2025, BriaCell filed an international patent application under the PCT directed to whole-cell cancer vaccines expressing highly immunogenic post-translational modified antigens. The PCT application (PCT/US2025/014759) published on August 14, 2025 as International Publication No. WO 2025/171109 A1.

Employees

As of the date of this filing, we had thirty-one full-time employees, located in various US states including: NY, FL, PA, SC, NV, NJ and MN. We also have international employees located in Canada and Israel.

For the year ended July 31, 2026, the average number of employees was twenty-six, of whom four were executive management.

Research and Development Activities and Costs

For information regarding our clinical studies, please see above under the caption “Products/Pipeline.”

For the years ended July 31, 2026 and 2025, we incurred $28,631,397 and $21,150,628, respectively, of net research and development expenses (excluding share-based compensation allocated to research and development employees)

Property, Plant and Equipment

The Company does not own any real property. BriaCell’s corporate offices in Canada are located at Suite 300, Bellevue Centre, 235-15^th Street, West Vancouver, BC V7T 2X1, and its corporate and research offices in the United States are located at 2929 Arch Street 3^rd Floor, Philadelphia, PA 19104.

We consider our current office and laboratory space sufficient to meet our anticipated needs for the foreseeable future and suitable for the conduct of our business.

During the year ended July 31, 2026, we purchased certain laboratory equipment in the gross amount of $127,049.

Government Regulation

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of biologics such as those we are developing. Along with third-party contractors, we will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our current or future product candidates. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of time and financial resources. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label.

The process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following:

The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our current or future product candidates will be granted on a timely basis, if at all. Prior to beginning the first clinical trial with a product candidate, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the clinical trial until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by a Data & Safety Monitoring Board (“DSMB”) organized by the clinical trial sponsor, which provides authorization for whether or not a clinical trial may move forward at designated check points based on access to certain data from the clinical trial, and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects, or based on other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical trial results to public registries.

¹ Note that the FDA has waived the requirement for animal studies as Bria-IMT™, Bria-BRES™ and Bria-PROS+™ are human cellular vaccines and data from animal studies would be uninterpretable.

For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

Phase 1, Phase 2 and Phase 3 testing may not be completed successfully within a specified period, if at all, and there can be no assurance that the data collected will support FDA approval or licensure of the product. Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

BLA Submission and Review by the FDA

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from pertinent preclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of the product, or from a number of alternative sources, including studies initiated by investigators. The submission of a BLA requires payment of a substantial user fee to FDA, and the sponsor of an approved BLA is also subject to annual product and establishment user fees. These fees are typically increased annually. A waiver of user fees may be obtained under certain limited circumstances.

Once a BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing, or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts the application for filing. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and whether the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

The testing and approval process requires substantial time, effort and financial resources, and each may take several years to complete. The FDA may not grant approval on a timely basis, or at all, and we may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our products. After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval. A Complete Response Letter may request additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.

A sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs and biological products that meet certain criteria. Specifically, new drugs and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. For a product candidate with Fast Track designation, the FDA may consider sections of the BLA for review on a rolling basis before the complete application is submitted if relevant criteria are met. A Fast Track designated product candidate may also qualify for priority review, under which the FDA sets the target date for FDA action on the BLA at six months after the FDA accepts the application for filing. Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. If criteria are not met for priority review, the application is subject to the standard FDA review period of 10 months after FDA accepts the application for filing. Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

Under the Accelerated Approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to predict clinical benefit, or a clinical endpoint that can be measured earlier than irreversible morbidity or mortality and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. Post-marketing studies or completion of ongoing studies after marketing approval are generally required to verify the biologic’s clinical benefit in relationship to the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.

In addition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough therapy, it may take actions appropriate to expedite the development and review of the application. Breakthrough designation also allows the sponsor to file sections of the BLA for review on a rolling basis.

Fast Track, Priority Review and Breakthrough Therapy designations do not change the standards for approval but may expedite the development or approval process.

Other Healthcare Laws and Compliance Requirements

Our sales, promotion, medical education and other activities following product approval will be subject to regulation by numerous regulatory and law enforcement authorities in the United States in addition to the FDA, including potentially the Federal Trade Commission, the Department of Justice, the Centers for Medicare and Medicaid Services, other divisions of the Department of Health and Human Services, and state and local governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute, the Foreign Corrupt Practices Act, the False Claims Act (“FCA”), the Veterans Health Care Act, physician payment transparency laws, privacy laws, security laws, and additional state laws similar to the foregoing.

The federal Anti-Kickback Statute prohibits, among other things, the offer, receipt, or payment of remuneration in exchange for or to induce the referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal health care programs. Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free or reduced price items and services. The government has enforced the Anti-Kickback Statute to reach large settlements with healthcare companies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. Many states have similar laws that apply to their state health care programs as well as private payors.

The FCA imposes liability on persons who, among other things, present or cause to be presented false or fraudulent claims for payment by a federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent, that are for services not provided as claimed, or for services that are not medically necessary. Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result in significant monetary penalties and treble damages. For example, the federal government is using the FCA, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, in connection with the promotion of products for unapproved uses and other sales and marketing practices. The government has obtained multi-million and multibillion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes. In addition, companies have been forced to implement extensive corrective action plans, and have often become subject to consent decrees or corporate integrity agreements, restricting the manner in which they conduct their business. The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) also created federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Affordable Care Act”), among other things, imposed new reporting requirements on drug manufacturers for payments or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit required information may result in civil monetary penalties. Certain states also mandate implementation of commercial compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

We may also be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology and Clinical Health Act (“HITECH”) and their respective implementing regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increases the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gives state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect.

If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to it, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results. Also, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining or retaining business. We cannot assure you that our internal control policies and procedures will protect us from reckless or negligent acts committed by our employees, future distributors, partners, collaborators or agents. Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution and have a negative impact on our business, results of operations and reputation.

Coverage and Reimbursement

Sales of pharmaceutical products depend significantly on the availability of third-party coverage and reimbursement. Third-party payors include government health administrative authorities, managed care providers, private health insurers and other organizations. Although we currently believe that third-party payors will provide coverage and reimbursement for our product candidates, if approved, these third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive clinical studies to demonstrate the comparative cost-effectiveness of our product candidates. Seeking coverage and reimbursement from third-party payors can be time consuming and expensive. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable basis.

Foreign Regulation

In addition to regulations in the United States, we are and will be subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions governing, among other things, clinical trials and commercial sales and distribution of our products, if approved.

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have processes that require the submission of a clinical trial application much like an IND prior to the commencement of human clinical trials. In Europe, for example, a clinical trial application (“CTA”) must be submitted to the competent national health authority and to independent ethics committees in each country in which a company plans to conduct clinical trials. Once the CTA is approved in accordance with a country’s requirements, clinical trials may proceed in that country.

The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, even though there is already some degree of legal harmonization in the European Union (the “E.U.”) member states resulting from the national implementation of underlying E.U. legislation. In all cases, the clinical trials are conducted in accordance with GCP and other applicable regulatory requirements.

To obtain regulatory approval of a new drug or medicinal product in the E.U., a sponsor must obtain approval of a marketing authorization application. The way in which a medicinal product can be approved in the E.U. depends on the nature of the medicinal product.

The centralized procedure results in a single marketing authorization granted by the European Commission that is valid across the E.U., as well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) officially designated as “orphan drugs” and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines. The centralized procedure may at the request of the applicant also be used for human drugs which do not fall within the above mentioned categories if the human drug (a) contains a new active substance which was not authorized in the European Community; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization in the centralized procedure is in the interests of patients or animal health at the European Community level.

Under the centralized procedure in the E.U., the maximum timeframe for the evaluation of a marketing authorization application by the EMA is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the Committee for Medicinal Products for Human Use (“CHMP”)), with adoption of the actual marketing authorization by the European Commission thereafter. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria: (i) the seriousness of the disease to be treated, (ii) the absence of an appropriate alternative therapeutic approach, and (iii) anticipation of exceptional high therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion issued thereafter.

The Mutual Recognition Procedure (“MRP”) for the approval of human drugs is an alternative approach to facilitate individual national marketing authorizations within the E.U. The MRP may be applied for all human drugs for which the centralized procedure is not obligatory. The MRP is applicable to the majority of conventional medicinal products, and is based on the principle of recognition of an already existing national marketing authorization by one or more member states.

The characteristic of the MRP is that the procedure builds on an already existing marketing authorization in a member state of the E.U. that is used as reference in order to obtain marketing authorizations in other E.U. member states. In the MRP, a marketing authorization for a drug already exists in one or more member states of the E.U. and subsequently marketing authorization applications are made in other E.U. member states by referring to the initial marketing authorization. The member state in which the marketing authorization was first granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied for act as concerned member states.

The MRP is based on the principle of the mutual recognition by E.U. member states of their respective national marketing authorizations. Based on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member states. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment is completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling and package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary of product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement of the agreement.

Should any E.U. member state refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious risk to public health, the issue will be referred to a coordination group. Within a timeframe of 60 days, member states shall, within the coordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for arbitration. The opinion of this EMA Committee is then forwarded to the Commission, for the start of the decision-making process. As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee on Human Medicinal Products or Veterinary Medicinal Products, as appropriate.

For other countries outside of the E.U., such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with GCP and the other applicable regulatory requirements.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Financings and share consolidations Summary

During the fiscal year ended July 31, 2026, BriaCell completed several financings, raising a total of approximately $34.7 million in gross proceeds before deducting fees and expenses. These transactions significantly bolstered the Company’s capital position, enhancing its ability to fund ongoing clinical trials, advance its pipeline programs, and support operational needs. The financings also demonstrate continued investor confidence in BriaCell’s immunotherapy platforms and clinical progress.

On June 2, 2026, the Company closed a public offering for the purchase and sale of 1,449,300 common shares of the Company for aggregate gross proceeds of approximately $4.7 million before deducting placement agent fees and other offering expenses (the “June 2026 Offering”). Each common share was sold at a public offering price of $3.25 per share. In connection with the June 2026 Offering, the Company issued 72,465 placement agent warrants. The placement agent warrants are immediately exercisable at an exercise price of $4.06 per share and expire five years from the date of issuance.

On January 15, 2026, the Company closed a public offering for the purchase and sale of 5,366,726 units of the Company for aggregate gross proceeds of approximately $30.0 million before deducting placement agent fees and other offering expenses (the “January 2026 Offering”). Each unit consisted of one common share (or one pre-funded warrant (“Pre-Funded Warrants”) in lieu thereof) and one warrant to purchase one common share of the Company at a combined purchase price of $5.59 per unit. 4,327,530 common shares and 1,039,196 Pre-Funded Warrants were issued. The warrants have an exercise price of $6.93 per share, are immediately exercisable, and expire five years from the date of issuance (“January 2026 Warrants”). The aggregate exercise price of the Pre-Funded Warrants, except for a nominal exercise price of $0.001 per share, was pre-funded to the Company and, consequently, no additional consideration (other than the nominal exercise price of $0.001 per share) shall be required to be paid by the holder to effect any exercise of the Pre-Funded Warrants. The fair value of the Pre-Funded Warrants was based on the Company’s share price as at the corresponding valuation date. The common shares (or Pre-Funded Warrants) and January 2026 Warrants were purchased together in the offering but were issued separately. Total issuance costs associated with the offering were approximately $2,125,100, excluding the fair value of placement agent warrants.

In connection with the January 2026 Offering, the Company issued 161,001 placement agent warrants. The placement agent warrants are immediately exercisable at an exercise price of $8.39 per share and expire five years from the date of issuance.

On January 27, 2025, the Company issued a press release announcing the consolidation of the issued and outstanding common shares of the Company on the basis of one (1) post-consolidation common share for every fifteen (15) pre-consolidation common shares became effective under the corporate law of British Columbia, Canada on January 24, 2025. The post-consolidation common shares commenced trading on the Toronto Stock Exchange and the Nasdaq Capital Market at market open on January 29, 2025, under new CUSIP number 107930208.

On August 21, 2025, the Company issued a press release announcing the consolidation of the issued and outstanding common shares of the Company on the basis of one (1) post-Consolidation common share for every ten (10) pre-consolidation common shares which became effective under the corporate law of British Columbia, Canada on August 25, 2025. The post-Consolidation common shares commenced trading on the Toronto Stock Exchange and The Nasdaq Capital Market at market open on August 25, 2025, under the new CUSIP number 107930307.

ITEM 1A. RISK FACTORS

An investment in our securities involves a high degree of risk. An investor should carefully consider the risks described below as well as other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission (“SEC”). The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also impair our business operations. If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our securities could decline, and investors in our company may lose all or part of their investment.

Risks Related to Our Business

Pre-clinical studies and initial clinical trials are not predictive of future results

Pre-clinical tests and Phase 1/2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules.

Regulatory authorities may disagree with our analysis of data or may require the conduct of additional studies or analyses before permitting further development or marketing approval. Favorable results in early trials may not be repeated in later trials. Differences in trial design, patient populations, endpoints, statistical methodologies, or other variables between studies may lead to inconsistent results or render comparisons unreliable. Moreover, early-stage trials are often conducted with small patient cohorts drawn from limited and relatively homogeneous populations; as a result, these findings may not predict outcomes in larger or more diverse patient populations or in the commercial setting.

A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting and also may not predict the ability of our products to achieve their intended goals, or to do so safely.

We are reliant on third-parties to carry out a large portion of our business

The Company does not expect to have any in-house manufacturing or marketing capability. To be successful, a product must be manufactured and packaged in commercial quantities in compliance with regulatory requirements and in reasonable time frames and at accepted costs. The Company intends to contract with third parties to manufacture its products. No assurance can be given that the Company or its suppliers will be able to meet its supply requirements.

The Company has limited in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical trials. The Company is significantly reliant on third-party consultants and contractors to provide the requisite advice and management. There can be no assurance that the clinical trials and product development will not encounter delays which could adversely affect prospects for the Company’s success.

To be successful, an approved product must also be successfully marketed. The market for the Company’s products may be large and will require substantial sales and marketing capability. At the present time, the Company does not have any internal capability to market its products. The Company may enter into one or more strategic partnerships or collaborative arrangements with established pharmaceutical companies or other companies with marketing and distribution expertise to address this need. If necessary, the Company will establish arrangements with various partners for geographical areas. There can be no assurance that the Company can market or can enter into a satisfactory arrangement with a third party to market a product in a manner that would assure its acceptance in the marketplace. However, if a satisfactory arrangement with a third party to market and/or distribute a product is obtained; the Company will be dependent on the corporate collaborator(s) who may not devote sufficient time, resources and attention to the Company’s programs, which may hinder efforts to market the products.

Should the Company not establish marketing and distribution strategic partnerships and collaborative arrangements on acceptable terms, and undertake some or all those functions, the Company will require significant additional human and financial resources and expertise to undertake these activities, the availability of which is not guaranteed. The Company will rely on third parties for the timely supply of raw materials, equipment, contract manufacturing, and formulation or packaging services. Although the Company intends to manage these third-party relationships to ensure continuity and quality, some events beyond the Company’s control could result in complete or partial failure of these goods and services. Any such failure could have a material adverse effect on the financial conditions and result of operation of the Company.

Due to the complexity of the process of developing biopharmaceutical products, the Company’s business may depend on arrangements with pharmaceutical and biotechnology companies, corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, technology rights, manufacturing, marketing and commercialization of its products. Such agreements could obligate the Company to diligently bring potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the costs of filing and prosecuting patent applications. There can be no assurance that the Company will be able to establish or maintain collaborations that are important to its business on favorable terms, or at all.

A number of risks arise from the Company’s potential dependence on collaborative agreements with third parties. Product development and commercialization efforts could be adversely affected if any collaborative partner terminates or suspends its agreement with the Company, causes delays, fails to on a timely basis develop or manufacture in adequate quantities a substance needed in order to conduct clinical trials, fails to adequately perform clinical trials, determines not to develop, manufacture or commercialize a product to which it has rights, or otherwise fails to meet its contractual obligations. The Company’s collaborative partners could pursue other technologies or develop alternative products that could compete with the products the Company is developing.

The Company has signed Non-Disclosure Agreements (“NDA”) with many different third parties, as is customary in the industry. There is no guarantee that, despite the terms of the NDA which bind third parties, the Company will ultimately be able to prevent such third parties from breaching their obligations under the NDA. Use of the Company’s confidential information in an unauthorized manner is likely to negatively affect the Company.

Risks Related to Our Intellectual Property

We may not successfully develop, maintain and protect our proprietary products and technologies

BriaCell’s success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. BriaCell files patent applications in the United States and other countries as part of its global strategy to protect its intellectual property and maintains certain U.S. and Non-U.S. patents in its intellectual property portfolio. However, patents provide only limited protection of BriaCell’s intellectual property. The assertion of patent protection involves complex legal and factual determinations and is therefore uncertain and can be expensive. BriaCell cannot provide assurances that patents will be granted with respect to any of its pending patent applications, or that the scope of any of its granted patents, or any patents granted in the future, will be sufficiently broad to offer meaningful protection, or that it will develop and file patent applications on additional proprietary technologies that are patentable, or, if patentable, that any patents will be granted from such patent applications. BriaCell’s current or future patents could be successfully challenged, invalidated or circumvented. This could result in BriaCell’s patent rights failing to create an effective competitive barrier. Losing a significant patent or failing to get a patent to issue from a pending patent application that BriaCell considers significant could have a material adverse effect on BriaCell’s business. The laws governing the scope of patent coverage in various countries continue to evolve. The laws of some foreign countries may not protect BriaCell’s intellectual property rights to the same extent as the laws of the United States. BriaCell has applied for patent protection only in selected countries. Therefore, third parties may be able to replicate BriaCell technologies covered by BriaCell’s patent portfolio in countries in which it does not have patent protection.

BriaCell’s future success and competitive position depends in part upon its ability to maintain its intellectual property portfolio. There can be no assurance that any patents will be issued on any existing or future patent applications.

We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates

There is a substantial amount of litigation over patent and other intellectual property rights in the biotechnology industry. Whether or not a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. Our management is presently unaware of any other parties’ patents and proprietary rights which our products under development would infringe. Searches typically performed to identify potentially infringed patents of third parties are often not conclusive and, because patent applications can take many years to issue, there may be applications now pending, which may later result in issued patents which our current or future products may infringe or be alleged to infringe. In addition, our competitors or other parties may assert that our product candidates and the methods employed may be covered by patents held by them. If any of our products infringes a valid patent, we could be prevented from manufacturing or selling such product unless we are able to obtain a license or able to redesign the product in such a manner as to avoid infringement. A license may not always be available or may require us to pay substantial royalties. We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect BriaCell from prior infringement. Infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate and can divert our management’s attention from operating our business.

The steps we have taken to protect our intellectual property may not be adequate, which could have a material adverse effect on our ability to compete in the market

BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. In addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment of inventions provisions, as appropriate, in our agreements with our employees, consultants, and service providers, to protect and otherwise seek to control access to, and distribution of, our proprietary information. These measures may not be adequate to protect our intellectual property from unauthorized disclosure, third-party infringement or misappropriation, for the following reasons:

Specifically, with respect to non-compete agreements, both state law and precedent varies greatly from state to state and we may be unable to enforce these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our former employees gained while working for us. If our intellectual property is disclosed or misappropriated, it could harm our ability to protect our rights and could have a material adverse effect on our business, financial condition and results of operations.

We may need to initiate lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market

We rely on patents, confidentiality and trade secrets to protect a portion of our intellectual property and our competitive position. Patent law relating to the scope of claims in the technology fields in which we operate is still evolving and, consequently, patent positions in the biotechnology/pharmaceutical industry can be uncertain. In order to protect or enforce our patent rights, we may initiate patent and related litigation against third parties, such as infringement suits or requests for injunctive relief. BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. Any lawsuits that we initiate could be expensive, take significant time and divert our management’s attention from other business concerns and the outcome of litigation to enforce our intellectual property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable. Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, or adversely affect its ability to distribute any products that are subject to such litigation. In addition, we may provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, including attorney fees, if any, may not be commercially valuable. The occurrence of any of these events could have a material adverse effect on our business, financial condition and results of operations.

We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers

Many of our employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or any employee or contractor have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of his or her former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain therapeutic candidates, which could severely harm our business, financial condition and results of operations. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Although there are currently no approved generic cell therapies that BriaCell is aware of, if the FDA or comparable foreign regulatory authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

Once a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications in the United States. In support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for the reference listed drug has expired. The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”). Specifically, in cases where such exclusivity has been granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years, unless the submission is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug.

While we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period that is less than five years. If the FDA were to award NCE exclusivity to someone other than us, we believe that we would still be awarded three year “Other” exclusivity protection from generic competition, which is awarded when an application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by an applicant and essential for approval. Manufacturers may seek to launch these generic products following the expiration of the applicable marketing exclusivity period, even if we still have patent protection for our product. If we do not maintain patent protection and data exclusivity for our product candidates, our business may be materially harmed.

Competition that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

Risks Related to Regulations

Changes in legislation and regulations may affect our revenue and profitability

Existing and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company evaluates the implications of new rules and responds to new requirements. Failure to comply with new rules and regulations could result in enforcement actions or the assessment of other penalties. New laws and regulations could make it more difficult to obtain certain types of insurance, including director’s and officer’s liability insurance, and the Company may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage remains available.

The impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Board, or as executive officers. The Company may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which could cause the Company’s general and administrative costs to increase beyond what the Company currently has planned. Although the Company evaluates and monitors developments with respect to new rules and laws, the Company cannot predict or estimate the amount of the additional costs the Company may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide assurances that such additional costs will render the Company compliant with such new rules and laws.

If we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize our therapeutic candidates

To date, we have not marketed, distributed or sold an approved product. Our therapeutic candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization of drugs. We may not obtain marketing approval for any of our therapeutic candidates in a timely manner or at all. In connection with the clinical trials for our product candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or throughout licensing arrangements, we face the risk that:

Any delay or failure in obtaining the required regulatory approvals will materially and adversely affect our ability to generate future revenues from a particular product candidate. Any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the size of the market for the product. We and our licensees, as applicable, also are, and will be, subject to numerous foreign regulatory requirements that govern the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional testing requirements for our therapeutic candidates.

If the third parties on which we rely to conduct our clinical trials and clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for, or commercialize, our product candidates

We do not have the ability to independently conduct our clinical trials for our product candidates and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory clearance for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented

We may not be able to initiate, continue or complete clinical trials for our product candidates if we or they are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA.

Patient enrollment is affected by factors including:

We generally focus our development activities on genetically or biomarker defined patients most likely to respond to our therapies. As a result, the potential patient populations for our clinical trials are narrowed, and we may experience difficulties in identifying and enrolling a sufficient number of patients in our clinical trials.

Ongoing or unanticipated geopolitical may have clinical trial sites could also negatively impact our ability to initiate, enroll and retain patients in, and conduct clinical trials.

We rely clinical trial sites to ensure the proper and timely conduct of our clinical trials, and while we have agreements governing their committed activities, we have limited influence over their actual performance. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether, or result in increased development costs for our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.

Modifications to our product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained

Modifications to our product candidates, after they have been approved for marketing, if at all, or to any other pharmaceutical product that we may develop in the future, may require new regulatory clearance, or approvals, and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained. The FDA requires pharmaceutical products manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance. A manufacturer may determine in conformity with applicable regulations and guidelines that a modification may be implemented without pre-clearance by the FDA; however, the FDA can review a manufacturer’s decision and may disagree. The FDA may also on its own initiative determine that a new clearance or approval is required. If the FDA requires new clearances or approvals of any pharmaceutical product or medical device for which we or our licensees receive marketing approval, if any, we or our licensees may be required to recall such product and to stop marketing the product as modified, which could require us or our licensees to redesign the product and will have a material adverse effect on our business, financial condition and results of operations. In these circumstances, we may be subject to significant enforcement actions.

The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any regulatory authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that clinical trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval. Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we or our licensees will encounter problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials of our most advanced therapeutic candidates will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to:

A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates, we do not know whether any Phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate do not produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations. Further, negative clinical trial results for a product candidate with respect to one indication may impact the potential or perceived potential of other indications. If our product candidates fail to demonstrate satisfactory characteristics in late-stage clinical trials, it could have a material adverse effect on our business, financial condition and results of operations.

The pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement and access to drugs, which could adversely affect our future revenues and profitability

To the extent our products are developed, commercialized, and successfully introduced to market, they may not be considered cost-effective and third-party or government reimbursement might not be available or sufficient. Globally, governmental and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.

In the U.S., we are subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these pricing pressures. The Affordable Care Act instituted comprehensive health care reform, and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions), and impose new and/or increased taxes. The future of the Affordable Care Act and its constituent parts are uncertain at this time.

In almost all markets, pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of our products and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities. Reimbursement decisions from one or more of the European markets may impact reimbursement decisions in other European markets. A variety of factors are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments, that the product represents good value for money for the health service it provides, and that treatment with the product works at least as well as currently available treatments.

The continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as well as the availability of capital.

United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions

HIPAA, and the regulations that have been issued under it, and similar laws outside the United States, contains substantial restrictions and requirements with respect to the use and disclosure of individuals’ protected health information. The HIPAA privacy rules prohibit “covered entities,” such as healthcare providers and health plans, from using or disclosing an individual’s protected health information, unless the use or disclosure is authorized by the individual or is specifically required or permitted under the privacy rules. Under the HIPAA security rules, covered entities must establish administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of electronic protected health information maintained or transmitted by them or by others on their behalf. While we do not believe that we will be a covered entity under HIPAA, we believe many of our customers will be covered entities subject to HIPAA. Such customers may require us to enter into business associate agreements, which will obligate us to safeguard certain health information we obtain in the course of our relationship with them, restrict the manner in which we use and disclose such information and impose liability on us for failure to meet our contractual obligations.

In addition, under HITECH, which was signed into law as part of the U.S. stimulus package in February 2009, certain of HIPAA’s privacy and security requirements are now also directly applicable to “business associates” of covered entities and subject them to direct governmental enforcement for failure to comply with these requirements. We may be deemed as a “business associate” of some of our customers. As a result, we may be subject as a “business associate” to civil and criminal penalties for failure to comply with applicable privacy and security rule requirements. Moreover, HITECH created a new requirement obligating “business associates” to report any breach of unsecured, individually identifiable health information to their covered entity customers and imposes penalties for failing to do so.

In addition to HIPAA, most U.S. states have enacted patient confidentiality laws that protect against the disclosure of confidential medical information, and many U.S. states have adopted or are considering adopting further legislation in this area, including privacy safeguards, security standards, and data security breach notification requirements. These U.S. state laws, which may be even more stringent than the HIPAA requirements, are not supplanted by the federal requirements, and we are therefore required to comply with them to the extent they are applicable to our operations.

These and other possible changes to HIPAA or other U.S. federal or state laws or regulations, or comparable laws and regulations in countries where we conduct business, could affect our business and the costs of compliance could be significant. Failure by us to comply with any of the standards regarding patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including civil monetary penalties and in some circumstances, criminal penalties. In addition, such failure may damage our reputation and adversely affect our ability to retain customers and attract new customers.

The protection of personal data, particularly patient data, is subject to strict laws and regulations in many countries. The collection and use of personal health data in the E.U. is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (the “Data Protection Directive”). The Data Protection Directive imposes a number of requirements, including an obligation to seek the consent of individuals to whom the personal data relates, the information that must be provided to the individuals, notification of data processing obligations to the competent national data protection authorities of individual E.U. member states and the security and confidentiality of the personal data. The Data Protection Directive also imposes strict rules on the transfer of personal data out of the E.U. to the U.S. Failure to comply with the requirements of the Data Protection Directive and the related national data protection laws of the E.U. member states may result in fines and other administrative penalties and harm our business. We may incur extensive costs in ensuring compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning of the Data Protection Directive.

If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations

A provision of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer, payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare, Medicaid or any other federal healthcare program. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor may be subject to scrutiny. The federal Anti-Kickback Statute is very broad in scope and many of its provisions have not been uniformly or definitively interpreted by existing case law or regulations. In addition, most of the states have adopted laws similar to the federal Anti-Kickback Statute, and some of these laws are even broader than the federal Anti-Kickback Statute in that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the source of payment. Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

All of our future financial relationships with U.S. healthcare providers, purchasers, formulary managers, and others who provide products or services to federal healthcare program beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar state laws. We believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws. However, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business. In addition, if our arrangements were found to violate the federal Anti-Kickback Statute or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition.

There are other federal and state laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. Moreover, we may be subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. Moreover, there are analogous state laws. Violations of these laws can result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

Moreover, the provisions of the Foreign Corrupt Practices Act of 1977 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more aggressive and frequent investigations and enforcement by both the SEC and the Department of Justice. A determination that our operations or activities violated U.S. or foreign laws or regulations could result in imposition of substantial fines, interruption of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or equitable sanctions. In addition, lawsuits brought by private litigants may also follow as a consequence.

In both domestic and foreign markets, the development, formulation, manufacturing, packaging, labeling, handling, distribution, import, export, licensing, sale and storage of pharmaceuticals and medical devices are affected by a body of laws, governmental regulations, administrative determinations, including those by Health Canada and the FDA, court decisions and similar constraints.

Such laws, regulations and other constraints can exist at the federal, provincial or local levels in Canada and at all levels of government in foreign jurisdictions. There can be no assurance that the Company and the Company’s partners are in compliance with all of these laws, regulations and other constraints. The Company and its partners may be required to incur significant costs to comply with such laws and regulations in the future, and such laws and regulations may have an adverse effect on the business. The failure of the Company or its partners to comply with current or future regulatory requirements could lead to the imposition of significant penalties or claims and may have a material adverse effect on the business. In addition, the adoption of new laws, regulations or other constraints or changes in the interpretations of such requirements might result in significant compliance costs or lead the Company and its partners to discontinue product development and could have an adverse effect on the business.

We may not succeed in completing the development of our products, commercializing our products or generating significant revenues

Since commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates. Our ability to generate revenues and achieve profitability depends on our ability to successfully complete the development of our products, obtain market approval and generate significant revenues. The future success of our business cannot be determined at this time, and we do not anticipate generating revenues from product sales for the foreseeable future. In addition, we face a number of challenges with respect to our future commercialization efforts, including, among others, that: