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BDRX

BiodexaD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-03-28
Investor release

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Earnings documents stored for BDRX.

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Investor releaseQuarter not tagged2026-03-28

Preliminary Results for the Year Ended 31 December 2025

GlobeNewswire

March 27, 2026 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2025 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical-stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, announces its audited preliminary results for the year ended 31 December 2025. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO Fiona Sharp, CFO Tel: +44 (0)29 2048 0180 www.biodexapharma.com About Biodexa The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes. eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signaling. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on managemen...

Investor releaseQuarter not tagged2025-09-12

Interim results for the six months ended June 30, 2025

GlobeNewswire

September 12, 2025 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Interim results for the six months ended June 30, 2025 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces its unaudited interim results for the six months ended June 30, 2025 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended June 30, 2025: Allowance by the US Patent and Trademark Office of patent application No. 17/391-495 “Oral Rapamycin Nanoparticle Preparations and Use”, exclusively licensed to the Company by Emtora Biosciences . Appointment of Precision for Medicine, LLC as the clinical research organization to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP. A successful Type C meeting with the US Food and Drug Administration regarding the protocol for the Company’s registrational Phase 3 study of eRapa in FAP. Orphan Drug Designation granted for eRapa in FAP by the European Commission. Recruitment of the first patient in a Phase 2a study of tolimidone in Type 1 Diabetes in an Investigator Initiated Trial conducted by the University of Alberta Diabetes Institute. Selection of ‘Serenta’ as the brand name for its Phase 3 clinical study of eRapa in FAP together with launch of a dedicated website, www.serentatrial.com, to provide information and resources for patients, caregivers, and healthcare professionals. Activation of the first clinical study site in the US for its Serenta trial in patients with FAP. Post period end: Filing of a Clinical Trial Application with the European Medicines Agency for its Serenta trial in patients with FAP. Enrolment of first patients in the Serenta trial by the Pan American Center for Oncology Trials in San Juan, Puerto Rico. FINANCIAL HIGHLIGHTS Commenting, Stephen Stamp, CEO and CFO, said “The first half was extremely productive. Having secured Fast Track designation and successfully negotiated our way through a Type C meeting with the FDA, in August we enrolled the first patients into our pivotal Serenta trial of eRapa in FAP. In parallel, we secured orphan designation from the European Commission for eRapa in FAP in Europe and filed a Cl...

Investor releaseQuarter not tagged2025-06-27

Results of Annual General Meeting

GlobeNewswire

June 27, 2023 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Results of Annual General Meeting Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces that at its Annual General Meeting held yesterday, all resolutions put to the Company’s shareholders were duly passed. The full text of, inter alia, the resolutions proposed and passed at the Annual General Meeting can be found in the Notice of the Annual General Meeting on the Company's website at https://biodexapharma.com/investors/corporate-governance//#agms. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non Muscle Invasive Bladder Cancer: tolimidone, under development as a for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-d...

Investor releaseQuarter not tagged2025-04-11

Preliminary Results for the Year Ended 31 December 2024

GlobeNewswire

April 11, 2025 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2024 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces its audited preliminary results for the year ended 31 December 2024. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO, CFO Tel: +44 (0)29 2048 0180www.biodexapharma.com About Biodexa Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective activator of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more informa...

Investor releaseQuarter not tagged2025-03-19

With Fast Track Designation in Hand, a Successful Protocol Discussion with FDA, and CROs in Place, Biodexa is on Track to Initiate its Funded Phase 3 Trial in FAP Next Quarter

ACCESS Newswire

CARDIFF, UNITED KINGDOM / ACCESS Newswire / March 19, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). In just the last few weeks, Biodexa received Fast Track designation from the FDA, conducted a successful Type C (pre-Phase 3 protocol finalization) meeting with the FDA and appointed a clinical research organization (CRO) to conduct the European component of its registrational Phase 3 trial. A CRO for the U.S. component was appointed earlier. FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon removed. If left untreated there is a high likelihood the person will develop colon or rectum cancer. Biodexa hopes to help with eRapa, a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. "Too much mTOR has been linked to cancer and has been shown to be over-expressed in FAP polyps - thereby underscoring the rationale for using an mTOR inhibitor like eRapa to treat FAP", noted Stephen Stamp, Biodexa's CEO and CFO. Phase 3 Study Commencing Next Quarter Biodexa, which has already received Fast Track designation by the FDA for the drug, completed a successful Phase 2 trial of eRapa, demonstrating a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Biodexa said patients in cohort 2, the dosage regimen that will be used in Phase 3, experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The Phase 3 study will be a double-blind placebo-controlled design recruiting approximately 168 high-risk patients diagnosed with germline or ph...

As of 2026-05-18 • Updated weeklySource: Earnings sourceIngestion runbook