BriaCell Completes Manufacturing of Clinical Supplies of Bria-PROS+™ for Prostate Cancer

BriaCell (Nasdaq:BCTX) completed manufacturing clinical supplies of Bria-PROS+™, its next-generation, personalized, off-the-shelf cell-based immunotherapy candidate for prostate cancer.

Rhea-AI Summary

BriaCell (Nasdaq:BCTX) completed manufacturing clinical supplies of Bria-PROS+™, its next-generation, personalized, off-the-shelf cell-based immunotherapy candidate for prostate cancer. A $2 million non-dilutive NCI grant awarded in August 2025 supports manufacturing and planned clinical evaluation.

The company plans a Phase 1/2a prostate cancer trial in the coming months. Preclinical data show activation of adaptive and innate immunity. Bria-PROS+ leverages the Bria-OTS+ platform, which in breast cancer includes a reported durable complete resolution of a lung metastasis in one patient.

Positive

• $2 million non-dilutive NCI grant supports Bria-PROS+ manufacturing and evaluation
• Manufacturing of Bria-PROS+ clinical supplies completed, enabling planned Phase 1/2a trial
• Preclinical data show activation of T cells, dendritic cells, and NK cells
• Bria-PROS+ built on Bria-OTS+ platform with reported durable complete response case

Negative

• Bria-PROS+ remains early-stage with Phase 1/2a trial not yet initiated

Argus May 14 session

-3.11% close to close Open Argus

Details

News Market Reaction – BCTX

On May 14, the day this news came out, BCTX closed 3.11% below the previous close.

Data tracked by StockTitan Argus for the May 14 session.

Key Figures

NCI grant: $2 million Share price: $4.18 Market cap: $29,581,987 +5 more

NCI grant

$2 million

Non-dilutive grant for Bria-PROS+ manufacturing and clinical evaluation

Share price

$4.18

Price before Bria-PROS+ news, up 2.45% over prior close

Market cap

$29,581,987

Equity value prior to Bria-PROS+ manufacturing completion announcement

Patient age

78 years

Age of metastatic breast cancer patient with complete lung metastasis resolution

Bria-OTS doses

4 doses

Number of Bria-OTS single-agent doses before complete lesion resolution

Bria-OTS cycles

17 cycles

Total treatment cycles completed in Bria-OTS breast cancer case

Study duration

12 months

Time on Bria-OTS study for patient with sustained complete response

Follow-up confirmation

11 months

Latest timepoint confirming complete resolution of lung metastasis

Historical Context

5 past events · Latest: May 13

5 events

1. May 13

   Phase 3 site expansion

   24h Move

   +2.5%

   Added Penn Medicine Abramson Cancer Center as site in pivotal Bria-ABC trial.

2. May 12

   Enrollment update

   24h Move

   -1.9%

   Reported Bria-ABC Phase 3 enrollment surpassing 230 patients with 315+ screened.

3. May 07

   Phase 3 site expansion

   24h Move

   -1.2%

   Added NYU Langone’s Perlmutter Cancer Center as clinical site in Bria-ABC study.

4. May 06

   FDA IND clearance

   24h Move

   +2.0%

   Received FDA clearance to initiate Phase 1/2a Bria-BRES+ study in breast cancer.

5. Apr 27

   Conference data

   24h Move

   +3.9%

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

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

Key Terms

immunotherapy, adaptive immunity, innate immunity, t-cells, +4 more

8 terms

immunotherapy medical

"a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

adaptive immunity medical

"demonstrated activation of both adaptive and innate immunity including activation of naïve"

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 including activation of naïve"

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.

t-cells medical

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

T-cells are white blood cells that seek out and destroy infected or abnormal cells and coordinate other immune responses; think of them as the body's internal detectives and first responders. They matter to investors because many drugs and vaccines aim to boost, redirect or control T-cell activity, so changes in T-cell behavior during clinical trials, approvals, or safety reports can directly affect a therapy's potential market value and regulatory outlook.

dendritic cells medical

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

Dendritic cells are immune system sentinels that detect foreign or damaged material, carry pieces of it to other immune cells, and trigger a tailored defensive response. Think of them as security guards who spot an intruder, show a photo to the response team, and call them into action. For investors, therapies or vaccines that target or use dendritic cells can be pivotal in treating infections, cancer, or autoimmune diseases, affecting clinical trial prospects and commercial value.

natural killer (nk) cells medical

"including activation of naïve (resting) 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.

off-the-shelf medical

"next generation, personalized, off-the-shelf, cell-based immunotherapy candidate for prostate cancer"

Off-the-shelf describes products, software, medical devices, or solutions that are commercially available and ready to use without custom design or development. Investors care because off-the-shelf items typically cost less and reach the market faster than bespoke alternatives, reducing project risk and expense; like buying a ready-made appliance instead of commissioning a custom-built one, they offer predictable performance and clearer regulatory and cost forecasts.

investigational new drug (ind) regulatory

"which recently received FDA clearance of its Investigational New Drug (IND) application"

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.

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

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Add on Google Not now

• Bria-PROS+ is BriaCell’s next generation personalized off-the-shelf immunotherapy for prostate cancer
• Immune stimulating components of Bria-PROS+ enhance anti-tumor responses
• BriaCell has completed manufacturing clinical supplies of Bria-PROS+ and plans to initiate a Phase 1/2a clinical study in prostate cancer in the coming months
  
  

PHILADELPHIA and VANCOUVER, British Columbia, May 14, 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, announces that it has completed manufacturing clinical supplies of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy candidate for prostate cancer.

In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.

“We are pleased to announce the completion of clinical supply manufacturing for Bria-PROS+, our next generation personalized immunotherapy candidate for prostate cancer,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The design of Bria-PROS+ is intended to support enhanced immune system activation while maintaining a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we seek to develop new treatment options for prostate cancer patients who do not respond to available therapies.”

As reported in BriaCell’s recent AACR preclinical poster presentation, Bria-PROS+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes these preclinical findings support further clinical evaluation as a potential immunotherapy for prostate cancer. Bria-PROS+ is based on the same Bria-OTS+ platform as Bria-BRES+, BriaCell’s next generation breast cancer immunotherapy candidate, which recently received FDA clearance of its Investigational New Drug (IND) application.

Bria-PROS+ builds on Bria-Cell’s Bria-OTS clinical program in breast cancer, 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.

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 completion of clinical supply manufacturing for Bria‑PROS+, the planned initiation of a Phase 1/2a clinical study, 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

FAQ

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

What did BriaCell (NASDAQ:BCTX) announce about Bria-PROS+ on May 14, 2026?

BriaCell announced it completed manufacturing clinical supplies of its prostate cancer immunotherapy candidate Bria-PROS+ and plans a Phase 1/2a study. According to BriaCell, this milestone follows a $2 million non-dilutive NCI grant awarded in August 2025 to support manufacturing and clinical evaluation.

What is Bria-PROS+ prostate cancer immunotherapy from BriaCell (BCTX)?

Bria-PROS+ is a next-generation, personalized, off-the-shelf, cell-based immunotherapy candidate for prostate cancer. According to BriaCell, immune-stimulating components are designed to enhance anti-tumor responses and support robust immune system activation while aiming to maintain a favorable safety profile in future clinical evaluation.

When will BriaCell start the Phase 1/2a Bria-PROS+ prostate cancer trial?

BriaCell plans to initiate a Phase 1/2a clinical study of Bria-PROS+ in prostate cancer in the coming months. According to BriaCell, completion of clinical supply manufacturing and prior NCI grant funding position the company to advance this first-in-human evaluation once trial preparations are finalized.

What preclinical data support Bria-PROS+ for prostate cancer at BriaCell (BCTX)?

Preclinical findings show Bria-PROS+ activated both adaptive and innate immunity, including naïve T cells, dendritic cells, and NK cells. According to BriaCell, these immune-activation results from an AACR poster presentation support further clinical evaluation of Bria-PROS+ as a potential immunotherapy option for prostate cancer.

How is Bria-PROS+ related to Bria-OTS+ and Bria-BRES+ in BriaCell’s pipeline?

Bria-PROS+ is based on the same Bria-OTS+ platform that underlies Bria-BRES+, BriaCell’s breast cancer candidate. According to BriaCell, Bria-BRES+ recently received FDA IND clearance, and the platform also yielded a reported durable complete lung metastasis resolution in one Bria-OTS breast cancer patient.

What does the $2 million NCI grant mean for BriaCell (BCTX) and Bria-PROS+?

The $2 million non-dilutive NCI grant helps fund Bria-PROS+ manufacturing and planned clinical evaluation without issuing new equity. According to BriaCell, the award, granted in August 2025, supports advancing this prostate cancer immunotherapy candidate into a Phase 1/2a clinical study in the near term.