NASDAQ: BCTX
BriaCell Therapeutics Corp.CIK 0001610820 · SIC 2834 · Pharmaceutical Preparations
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… About this business →
Every 8-K is open in full. Other 10-Ks and 10-Qs show a 3-bullet preview. A free account reads 3 more full reports a month. Generating a report requires a verified account.
Sign up freeWant to see a complete report first? Today's free report (EPM 10-K) is open in full — no account needed.
Summary not yet generated.
Summary not yet generated.
Partner
Trade BCTX commission-free
Open an account, get a free stock.
Investing involves risk. Free stock terms apply.
net income -$7.2M. BriaCell accelerates Phase 3 enrollment, advances next-gen pipeline
5 material changes detected. Sign up free to read the summary.
BriaCell raises $4.71M through sale of 1.45M shares at $3.25, diluting existing holders
3 material changes detected. Sign up free to read the summary.
BriaCell prices $4.7M primary offering of 1.45M shares at $3.25, below last sale
7 material changes detected. Sign up free to read the summary.
BriaCell files routine Q2 2026 financials via Canadian subsidiary disclosure
2 material changes detected. Sign up free to read the summary.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Summary not yet generated.
Latest financial statements
From 10-K filed Oct 28, 2026 (period ending Jul 31, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.
Consolidated Statements of Operations and Comprehensive Loss
| Description | Year ended July 31, 2026 | Year ended July 31, 2025 |
|---|---|---|
| Operating expenses: | ||
| Research, development, and clinical trial expenses, net | 29,236,508 | 21,270,678 |
| General and administrative expenses | 6,817,729 | 5,934,125 |
| Total operating expenses | 36,054,237 | 27,204,803 |
| Operating loss | (36,054,237) | (27,204,803) |
| Financial income (expenses), net | 601,461 | 114,511 |
| Change in fair value of the warrant liability | 298,734 | 758,364 |
| Unrealized gain on short-term investment | 92,227 | - |
| Share of loss on equity investment | (263,477) | (224,212) |
| Net loss for the year | (35,325,292) | (26,556,140) |
| Net loss attributable to non-controlling interest | (421,030) | (244,273) |
| Net loss for the year attributable to BriaCell | (34,904,262) | (26,311,867) |
| Net loss per share attributable to BriaCell basic and diluted | (6.97) | (62.19) |
| Weighted average number of shares used in computing net basic earnings per share of common shares | 5,010,907 | 423,114 |
| Weighted average number of shares used in computing net diluted earnings per share of common shares | 5,010,907 | 423,114 |
Consolidated Balance Sheets
| Description | July 31, 2026 | July 31, 2025 |
|---|---|---|
| ASSETS | ||
| CURRENT ASSETS: | ||
| Cash and cash equivalents | 9,852,435 | 10,493,808 |
| Short-term investments | 10,688,277 | 7,372,473 |
| Amounts receivable and prepaid expenses | 1,504,228 | 2,060,295 |
| Total current assets | 22,044,940 | 19,926,576 |
| NON-CURRENT ASSETS: | ||
| Equity investment in BC Therapeutics | 730,028 | 524,278 |
| Intangible assets, net | 169,254 | 184,525 |
| Property and equipment, net | 319,804 | 296,819 |
| Long term prepaid expenses | 315,703 | 717,508 |
| Total non-current assets | 1,534,789 | 1,723,130 |
| Total assets | 23,579,729 | 21,649,706 |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||
| CURRENT LIABILITIES: | ||
| Trade payables | 6,994,539 | 3,283,703 |
| Accrued expenses and other payables | 987,109 | 694,285 |
| Total current liabilities | 7,981,648 | 3,977,988 |
| NON-CURRENT LIABILITIES: | ||
| Warrant liability | 38,939 | 337,672 |
| Total non-current liabilities | 38,939 | 337,672 |
| CONTINGENT LIABILITIES AND COMMITMENTS | ||
| SHAREHOLDERS’ EQUITY (DEFICIT): | ||
| Share Capital of no par value Authorized: unlimited at July 31, 2026 and 2025; Issued and outstanding: 8,708,029 and 1,883,906 shares at July 31, 2026 and 2025, respectively | 120,914,482 | 101,739,923 |
| Share-based payment reserve | 11,879,317 | 10,316,140 |
| Warrant reserve | 30,405,598 | 17,719,026 |
| Accumulated other comprehensive loss | (138,684) | (138,684) |
| Non-controlling interest | (841,745) | (546,795) |
| Accumulated deficit | (146,659,826) | (111,755,564) |
| Total shareholders’ equity | 15,559,142 | 17,334,046 |
| Total liabilities and shareholders’ equity | 23,579,729 | 21,649,706 |
Consolidated Statements of Cash Flows
| Description | Year ended July 31, 2026 | Year ended July 31, 2025 |
|---|---|---|
| Cash flow from operating activities: | ||
| Net loss for the year | (35,325,292) | (26,556,140) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Amortization | 15,271 | 15,271 |
| Financial income, net | (14,804) | (56,473) |
| Depreciation | 104,064 | 91,356 |
| Share-based compensation | 1,735,389 | 776,879 |
| Share of loss on equity investment | 263,477 | 224,212 |
| Change in fair value of warrants | (298,733) | (758,364) |
| Unrealized gain on BC Therapeutics investment | (92,227) | - |
| Changes in working capital: | ||
| Decrease (increase) in amounts receivable | (3,246) | 733,629 |
| Decrease (increase) in prepaid expenses | 961,118 | 492,279 |
| (Decrease) increase in accounts payable | 3,710,836 | (3,887,078) |
| Increase (decrease) in accrued expenses and other payables | 292,824 | 753,909 |
| Net cash used in operating activities | (28,651,323) | (28,170,520) |
| Cash flow from investing activities: | ||
| Purchase of property and equipment | (127,049) | - |
| Purchase of short-term investments, net | (24,590,000) | (7,316,000) |
| Proceeds from short-term investments | 21,289,000 | - |
| Equity investment in BC Therapeutics | (377,000) | (330,000) |
| Net cash used in investing activities | (3,805,049) | (7,646,000) |
| Cash flow from financing activities: | ||
| Proceeds from exercise of warrants | - | 821,015 |
| Proceeds from issuance of shares, net of issuance costs ($2,894,567 and $6,277,240, respectively) | 31,814,999 | 44,627,224 |
| Net cash provided by financing activities | 31,814,999 | 45,448,239 |
| Increase (decrease) in cash and cash equivalents | (641,373) | 9,631,719 |
| Cash and cash equivalents at beginning of year | 10,493,808 | 862,089 |
| Cash and cash equivalents at end of year | 9,852,435 | 10,493,808 |
Amounts as printed on the EDGAR/iXBRL face. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗
About BriaCell Therapeutics Corp.
Source: Item 1 (Business) from the 10-K filed October 28, 2026. Description as filed by the company with the SEC.
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).
Read full description ↓
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.
4
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.
5
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.
6
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.
7
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
8
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.
Evaluable
Patients
HLA
Match
Disease
Control (CR, PR, and SD)
Disease
Control in Immune Responders (DTH)
N=5
≥
2
80%
(4/5)
100%
(4/4)
N=18
Any
50%
(9/18)
60%
(9/15)
●
27
total heavily pre-treated (median 5 prior regimens) metastatic breast cancer patients were treated with Bria-IMT monotherapy regimen,
18 evaluable.
●
The
presence of HLA-type matching between the Bria-IMTTM cells and the patient correlates with response to Bria-IMT. Note
that HLA molecules are responsible for presenting antigens to T cells and they are involved in the initiation of immune responses.
●
Immune
response measured by delayed-type hypersensitivity (DTH) to Bria-IMT correlates with disease control.
●
Tolerability
was excellent with no dose-limiting toxicities.
●
Clinical
benefit was demonstrated: 1 Partial response (PR) and 8 Stable Disease (SD) in 15 evaluable immune responders.
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).
9
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.
10
The
patients had advanced breast cancer as shown here.
N
(%)
Age,
Median (Range)
61
(38-81) years
BMI,
Median (Range)
28.1
(18.1-42.7)
Race/Ethnicity
●
White
42
(78%)
●
Black
6
(11%)
●
Hispanic
10
(19%)
●
Asian
3
(6%)
●
Other
3
(6%)
ECOG
●
ECOG 0
29
(54%)
●
ECOG 1
25
(46%)
Tumor
Grade
●
Grade 1
6
(11%)
●
Grade 2
15
(28%)
●
Grade 3
30
(56%)
●
Unknown
3
(5%)
Prior
systemic therapy, Median (Range)
6
(2-13)
Previous
therapies
●
Antibody Drug Conjugate
23
(44%)
●
Checkpoint Inhibitor
11
(20%)
●
CDK4/6 inhibitors
34
(63%)
Metastatic
or Recurrent Target Lesion sites
●
Brain
4
(7%)
●
Liver
25 (46%)
●
Lung
10
(19%)
●
Bone
12
(22%)
●
Other
27
(50%)
Metastatic
Breast Cancer Subtype
●
HER2+
2
(4%)
●
HR+/HER2-
31
(57%)
●
TNBC
17
(31%)
●
HER2low/HR+
4
(7%)
11
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
12
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.
13
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.
Treatment
Breast
Cancer Type
Median # of prior
lines of therapy
Median OS
(months)
Bria-IMT™ plus CPI*
HR+
6
14.3
TRODELVY®1 (sacituzumab govitecan-hziy)
HR+
4
14.4
Single agent chemotherapy
HR+
4
11.3
Bria-IMT™ plus CPI*
TNBC
6
16.1
TRODELVY®1 (sacituzumab govitecan-hziy)
TNBC
3 **
11.8
Single agent chemotherapy
TNBC
3 **
6.9
*
Patients treated with the Phase 3 formulation since 2022
**
Number of prior chemotherapy-containing regimens
1.
https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf
Abbreviations:
HR+:
hormone receptor-positive
TNBC:
Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth
factor receptor 2 (HER2))
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.
14
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.
●
~4
months median progression-free survival (PFS) twice that seen in comparable patients treated with best available therapy, including
antibody-drug conjugate (ADC) resistant patients1,2,3
●
Clinical
benefit seen in 55% of evaluable patients in all subtypes of breast cancer
Ø
Compared
with 7-10% in comparable patients treated with best available therapy (the comparator for Phase 3)
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
Ø
Extensive
proptosis (eye bulging) & brain (temporal lobe) metastasis
Marked
tumor reduction at 11 months
Ø
Near
complete proptosis resolution at 3 months with orbit (eye socket) tumor: 42 mm → 28 mm
Ø
Brain
temporal lobe tumor: 22 mm → 0
Ø
Overall,
56% reduction (PR)
Ø
Improvement
in eye pain and reduction in tumor markers
15
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.)
16
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.
17
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.
18
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
Patient/Subtype
Months
Since Study Start
Age
Number
of Prior Regimens
Cycles
of Bria-IMT
01-009/ER+/PR+/HER2low
47
74
5
14
07-001/ER+/PR+/HER2low
30
55
7
8
15-001/ER+/PR-/HER2-
30
62
3
12
11-018/ER+/PR+/HER2+
(Highlighted below)
27
66
8; including
ENHERTU
35
15-005/ER+/PR+/HER2-
(Highlighted below)
27
44
5
6
15-006/ER+/PR-/HER2-
(Highlighted below)
25
64
8; including
TRODELVY
4
15-004/ER+/PR+/HER2-
25
50
3
6
11-019/ER+/PR+/HER2low
23
63
9; including
TRODELVY
6
07-014/ER+/PR+/HER2low
>18
62
9; including
TRODELVY
5
Note
that Trodelvy and Enhertu are antibody-drug conjugates recently approved for late-stage breast cancer.
19
Table
2: Comparable analysis of 1- and 2-year survival for the BriaCell Phase 2 study using the Phase 3 formulation since 2022 independent
of subsequent treatment
Breast
cancer
Median
prior
Median
OS
%
Survival at:
Reference
type
lines
of therapy
(months)
1
year
2
years
Bria-IMT
™ plus CPI
All
types
61%
HR+
33%
TNBC
6%
HER2+
6
15.6
52%
32%
Cortes
et al. 1
All
types
57% HR+
18-19% TNBC
18-20% HER2+
4
9.1-9.3
~38-40%
7-14%
Kazmi
et al. 2
All
types
51-52% HR+
25-29% TNBC
9-24% HER2+
2
7.2-9.8
30-38%
11.9-14%
Bardia
et al. (TPC) 3
TNBC
4
6.9
~23%
6%
Bardia
et al. (Trodelvy) 3
TNBC
4
11.8
50%
21%
Rugo
et al (TPC) 4
HR+
HER2-
4
11.2
47%
21%
Rugo
et al (Trodelvy) 4
HR+
HER2-
4
14.4
60%
25%
1.
Cortes J, et al. Annals of Oncology 2018 (estimated from Kaplan-Meier curve)
2.
Kazmi S, et al. Breast Cancer Res Treat. 2020
3.
Bardia A, et al. J Clin Oncol. 2024 (estimated from Kaplan-Meier curve)
4.
Rugo HS, et al. The Lancet. 2023 (estimated from Kaplan-Meier curve)
Abbreviations:
HR+:
hormone receptor-positive
TNBC:
Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor
receptor 2 (HER2))
HER2+:
Human epidermal growth factor receptor 2 positive
HR+
HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC:
Treatment of Physicians Choice
On
January 28, 2026, BriaCell reported patients’ images showing regression and resolution of metastasized tumors and immune activation
in patients with orbital (eye), temporal lobe (brain), liver, and spinal involvement. Survival details on these and other select patients
in its Phase 2 study, along with comparable populations, were previously reported.
Images
below confirm clinical responses seen in patients with metastatic orbital (eye), temporal (brain), liver, and spine lesions.
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).
20
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.
21
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
22
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.
23
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:
●
≥1
circulating tumor cells (CTC)s were found in 25% at baseline (BL) and 20% at the first on-treatment assessment(T1)
●
≥1
Cancer-associated macrophage-like cells (CAMLs) were found in 93% at BL & 93% at T1
●
≥1
CTC significantly correlated with progression free survival (PFS) at BL, but not at T1
●
A
decrease or stable CAML counts between BL and T1 (seen in 60% of patients) significantly correlated with better progression-free
survival
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.
24
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.
25
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™
Bria-OTS™:
Personalized Off-the-Shelf Immunotherapy
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.
●
We
believe Bria-IMT™ is most effective in human leukocyte antigen (HLA) matched patients
●
Bria-OTS™
is engineered to express 15 unique HLA types through 4 independent cell lines
●
Provides
matched treatment to greater than 99% of patients
●
Simple
saliva test provides HLA matching for personalized off-the-shelf Bria-OTS™ immunotherapy
●
HLA
matched off-the-shelf therapy is faster and less costly than other expensive and complex personalized immunotherapies
●
BriaCell
announced that the first patient treated with the Bria-OTS™ cells had a complete resolution of a breast cancer tumor that had
metastasized to the lung. This response was sustained at the 6 month timepoint.
●
Ongoing
collaboration with the NCI to investigate the Bria-OTS™ mechanism of action
●
BriaCell
has filed numerous US and international patents for Bria-OTS™
●
On
May 28, 2024, BriaCell announced a clinical supply agreement with BeiGene for Bria-OTS™ first in human study. This study will
evaluate the effects of Bria-OTS™ in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated
metastatic breast cancer.
Development
of Additional Immunotherapy Cell Lines
●
An
enhanced version (expressing also co-stimulatory molecules and cytokines) termed Bria-OTS+™ is in development for prostate
cancer (Bria-PROS+™), lung cancer (Bria-LUNG+™), and melanoma (Bria-MEL+™) as well as breast cancer (Bria-BRES+™)
●
In
September 2024, BriaCell announced positive pre-IND meeting with FDA for Bria-PROS+™ for prostate cancer
●
BriaCell
received a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to further develop Bria-OTS+™
●
FDA
has cleared INDs for Bria-BRES+™ (May 2026) and Bria-PROS+™ (August 2026)
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.
26
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)
27
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 15th, 2026, BriaCell announced that it is making
progress in developing Bria-OVA+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for ovarian cancer.
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.
28
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:
●
BP-80
(soluble CD80) - Immunotherapy for Cancer.
●
B7H3/Bria-TILsRx™:
Multi-Specific Binding Reagents – Targeted Immunotherapy for Cancer.
●
Small
Molecule Program: Protein Kinase C delta (PKCδ) Inhibitors being developed with Receptor AI.
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.
29
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
30
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.
31
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, 235-15th
Street, West Vancouver, BC V7T 2X1, and its corporate and research offices in the United States are located at 2929 Arch Street
3rd 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:
●
completion
of preclinical laboratory tests and animal studies1 performed in accordance with the FDA’s current Good Laboratory
Practices (“GLP”) regulations;
●
submission
to the FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials may
begin and must be updated annually or when significant changes are made;
●
approval
by an independent Institutional Review Board (“IRB”) or ethics committee at each clinical site before the trial is begun;
●
performance
of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product
candidate for its intended purpose;
●
preparation
of and submission to the FDA of a Biologics License Application (“BLA”), after completion of all pivotal clinical trials;
32
●
satisfactory
completion of an FDA Advisory Committee review, if applicable;
●
a
determination by the FDA within 60 days of its receipt of a BLA to file the application for review;
●
satisfactory
completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced
to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s
continued safety, purity and potency, and of selected clinical investigations to assess compliance with current Good Clinical Practices
(“GCP”); and
●
FDA
review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States,
which must be updated annually when significant changes are made.
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.
33
For
purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.
●
Phase
1-The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.
These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product
in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
●
Phase
2-The investigational product is administered to a limited patient population with a specified disease or condition to evaluate
the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple
Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.
In some cases, the FDA will grant preliminary marketing authorization for drugs treating areas of high unmet medical need based on
Phase 2 clinical trials. If granted, they will also require confirmatory Phase 3 evaluation post-marketing. BriaCell is evaluating
Bria-IMT in patients with breast cancer who have failed at least two prior lines of therapy. In this population there is no approved
therapy. Therefore, the development plan for Bria-IMT is an area of high unmet medical need. It is anticipated that BriaCell will
not need to complete Phase 3 clinical trials prior to submitting the marketing application for Bria-IMT in patients with advanced
breast cancer who have failed at least two prior lines of therapy. In this case, a confirmatory Phase 3 evaluation post-marketing
will be required. It is anticipated that this would consist of a randomized, controlled clinical trial of Bria-IMT in combination
with immune checkpoint inhibitors compared with best available therapy. However, this design is subject to negotiation with the FDA.
●
Phase
3-The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically
significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical
trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to
provide an adequate basis for product approval.
●
Phase
4-In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved
to gain more information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA.
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.
34
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.
35
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.
36
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.
37
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.
38
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.
39
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.