BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer

BriaCell (Nasdaq: BCTX) received FDA clearance of an Investigational New Drug application to begin a Phase 1/2a clinical study of Bria-BRES+ in metastatic breast cancer.

Rhea-AI Summary

BriaCell (Nasdaq: BCTX) received FDA clearance of an Investigational New Drug application to begin a Phase 1/2a clinical study of Bria-BRES+ in metastatic breast cancer. The company has prepared clinical supplies and plans to start dosing in the coming months. Bria-BRES+ incorporates added immune-activating components and showed multiarm immune activation in preclinical data. BriaCell cites a prior Bria-OTS patient with a confirmed complete resolution of a lung metastasis after treatment.

Positive

• FDA clearance of IND to initiate Phase 1/2a study in metastatic breast cancer
• Clinical supplies of Bria-BRES+ prepared and dosing planned in coming months
• Preclinical data showed activation of T cells, dendritic cells, and NK cells

Negative

• Clinical program remains early-stage (Phase 1/2a), with unproven efficacy in larger populations
• Efficacy evidence includes a single-patient confirmed lesion resolution and preclinical results, not randomized data

Argus May 6 session

+1.97% close to close Open Argus

Details

News Market Reaction – BCTX

On May 6, the day this news came out, BCTX closed 1.97% above the previous close.

Data tracked by StockTitan Argus for the May 6 session.

Market Context

This announcement adds FDA-cleared Bria‑BRES+ to BriaCell’s expanding metastatic breast cancer portf...

Analysis

This announcement adds FDA-cleared Bria‑BRES+ to BriaCell’s expanding metastatic breast cancer portfolio, following Bria‑IMT Phase 3 efforts and Bria‑OTS case reports with 100% lung metastasis resolution lasting 11 months. Recent filings highlight increased R&D spend and going‑concern language alongside strengthened cash balances from equity offerings. Investors monitoring this story may focus on upcoming Phase 1/2a enrollment, durability of clinical responses across more patients, and alignment between trial progress and available funding.

Key Figures

Clinical phase: Phase 1/2a Patient age: 78-year-old Doses to response: 4 doses +5 more

Clinical phase

Phase 1/2a

Planned Bria-BRES+ study in metastatic breast cancer

Patient age

78-year-old

Advanced metastatic breast cancer Bria-OTS case described

Doses to response

4 doses

Four doses of Bria-OTS single-agent therapy before complete response

Tumor resolution

100% resolution

Complete resolution of lung metastasis with Bria-OTS monotherapy

Initial response time

2 months

Complete response first observed at 2 months of Bria-OTS therapy

Response durability

11 months

Lesion response confirmed through 11 months of follow-up

Treatment cycles

17 cycles

Patient received 17 cycles of Bria-OTS during the study

Time on study

12 months

Patient completed 12 months on the Bria-OTS study

Historical Context

5 past events · Latest: Apr 27

5 events

1. Apr 27

   ASCO data preview

   24h Move

   +3.9%

   Announced six metastatic breast cancer data items for ASCO 2026 presentations.

2. Apr 21

   Preclinical results

   24h Move

   -0.8%

   Reported robust Bria-OTS+ preclinical activity across breast and prostate models.

3. Apr 20

   AACR clinical data

   24h Move

   -9.3%

   Presented Phase 3 quality-of-life and Phase 2 biomarker data at AACR 2026.

4. Jan 13

   Clinical case outcome

   24h Move

   +42.9%

   Detailed 11‑month complete resolution of lung metastasis in Bria-OTS patient.

5. Dec 18

   Phase 3 trial profile

   24h Move

   +3.2%

   Phase 3 Bria-IMT trial highlighted among key 2026 studies in Nature Medicine.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug (ind), phase 1/2a, personalized immunotherapy, cell-based immunotherapy, +4 more

8 terms

investigational new drug (ind) regulatory

"FDA clearance of Investigational New Drug (IND) application opens path"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

phase 1/2a medical

"opens path to commence Phase 1/2a clinical study for Bria-BRES+"

Phase 1/2a is an early stage in testing new medicines or treatments, combining two steps into one process. It helps researchers quickly assess whether a treatment is safe and shows signs of working, while also gathering initial information on the best dosage. For investors, this stage indicates how close a potential new therapy is to becoming available and its initial safety profile.

personalized immunotherapy medical

"Bria-BRES+ is BriaCell’s next generation personalized immunotherapy for breast cancer"

Personalized immunotherapy is a medical treatment that trains a patient’s own immune system to recognize and attack their specific disease, often by creating therapies tailored to that person’s unique genetic or cellular markers. Think of it like a custom-made key cut to fit a single lock: it can be more precise and effective than one-size-fits-all drugs, but it also tends to be expensive, complex to develop, and subject to strict regulatory review—factors that strongly affect investment risk and potential reward.

cell-based immunotherapy medical

"personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer"

A therapy that uses living immune cells, often taken from a patient or donor and modified in a lab, to seek out and destroy disease such as cancer. Think of it as training and equipping a person’s own soldiers to better recognize and fight a specific enemy; for investors it matters because these treatments can command high prices and large market demand but also carry substantial development costs, regulatory hurdles, and variable clinical success that affect company value.

adaptive immunity medical

"demonstrated activation of both adaptive and innate immunity"

Adaptive immunity is the part of the immune system that learns to recognize specific germs and builds lasting memory so the body can respond faster and stronger on future encounters; think of it as a security system that adds new “faces” to a trusted list. For investors, adaptive immunity matters because it underpins vaccines, long-term treatment strategies and clinical trial outcomes, which can affect the value and prospects of biotech and healthcare companies.

innate immunity medical

"demonstrated activation of both adaptive and innate immunity"

Innate immunity is the body's first, broad line of defense against infection, made up of cells and chemical signals that recognize and respond quickly to unfamiliar germs without prior exposure — like a security guard and a smoke alarm reacting immediately. For investors, differences in innate immune response shape the market for drugs, vaccines, diagnostics and tests, influence clinical trial outcomes and regulatory reviews, and therefore affect company value and risk.

natural killer (nk) cells medical

"activation of naïve T-cells, dendritic cells and natural killer (NK) cells"

Natural killer (NK) cells are a type of white blood cell that act like the immune system’s security guards, spotting and destroying infected or abnormal cells without needing prior training. For investors, NK cells matter because they are central to many drug and diagnostic programs—especially in cancer and infectious disease—affecting trial results, regulatory decisions, manufacturing complexity and the commercial potential of therapies that boost or use these cells.

lung metastasis medical

"sustained complete resolution of a lung metastasis in Bria-OTS™ patient"

Lung metastasis is when cancer cells from another part of the body spread and form new tumors in the lungs, like seeds carried by wind taking root in new soil. For investors, mention of lung metastasis in clinical data or company disclosures matters because it changes how effective a treatment appears, affects patient survival and trial outcomes, and therefore can alter a drug’s approval chances, market opportunity and a company’s valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• FDA clearance of Investigational New Drug (IND) application opens 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
  

PHILADELPHIA and VANCOUVER, British Columbia, May 06, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to report it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.

“We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The unique design of Bria-BRES+ offers the potential for a favorable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options.”

As reported in BriaCell’s recent AACR preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.

BriaCell’s Bria-BRES+ builds on its Bria-OTS™ breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.

Figure 1: As previously reported in January 2026, 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)

¹ Note that the other white dots in the lungs are blood vessels.

About BriaCell Therapeutics Corp.

BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the FDA clearance of the IND application and the planned initiation of a Phase 1/2a clinical study of Bria‑BRES+, and expectations regarding the potential clinical benefits of the Bria‑OTS+ platform, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company's most recent Management’s Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com 

Investor Relations Contact:
investors@briacell.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cf1af19a-fd92-49b4-8e39-fb9b1c4191a7

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did BriaCell (BCTX) announce about Bria-BRES+ on May 6, 2026?

BriaCell announced FDA clearance to begin a Phase 1/2a IND study of Bria-BRES+ in metastatic breast cancer. According to the company, clinical supplies are prepared and dosing is planned in the coming months.

When will BriaCell (BCTX) start the Phase 1/2a study of Bria-BRES+?

The company plans to initiate the Phase 1/2a study in the coming months. According to BriaCell, clinical supplies are already prepared to support initial dosing timelines.

What preclinical immune activity did BriaCell report for Bria-BRES+ (BCTX)?

BriaCell reported Bria-BRES+ activated both adaptive and innate immunity, including naïve T cells, dendritic cells, and NK cells. According to the company, these signals appeared in their AACR preclinical poster data.

How strong is the clinical evidence cited by BriaCell (BCTX) for Bria-BRES+?

Evidence cited is preclinical activation data plus a single-patient clinical observation of a lung metastasis resolution. According to BriaCell, the clinical observation was confirmed at multiple follow-ups but is not broad clinical proof.

What is Bria-BRES+ and how does it differ from Bria-OTS (BCTX)?

Bria-BRES+ is described as a next-generation, personalized, off-the-shelf cell-based immunotherapy with additional immune-activating components. According to BriaCell, it builds on Bria-OTS by aiming for broader immune activation.