Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP

December 1, 2025 Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first three patients by the University of Bonn, Germany into its pivotal Phase 3 Serenta trial of eRapa in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. Commenting, Dr Robert Hüneburg, gastroenterologist and lead investigator at the University Hospital, Bonn (Germany) said “We are pleased to be the first European center to be activated and to have enrolled the first three patients into the European arm of the Serenta trial.

GlobeNewsWire • Dec 1, 2025

Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP

November 24, 2025 Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who currently have no approved non-surgical therapeutic alternatives.

GlobeNewsWire • Nov 24, 2025

Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion

November 3, 2025 Biodexa Announces Approval of CTA in Europe for Phase 3 Serenta Trial in FAP First European patient expected to be enrolled in 4Q 2025 Addressable US - European Market Put at $7 Billion Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the approval of a Clinical Trial Application (CTA) by the European Medicines Agency (EMA) of its pivotal Phase 3 Serenta trial in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of much of the gastrointestinal tract.

GlobeNewsWire • Nov 3, 2025

Biodexa to Host Breakfast Symposium on FAP Mechanisms and Chemoprevention Trial Issues at CGA – IGC Conference on October 11, 2025

October 6, 2025 Biodexa to Host Breakfast Symposium on FAP Mechanisms and Chemoprevention Trial Issues at CGA – IGC Conference on October 11, 2025 Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, will host a breakfast symposium at the Collaborative Group of the Americas on Inherited Gastrointestinal Cancer (CGA-IGC) annual meeting in St Louis, MO on October 9-11, 2025. The symposium presentation, titled “FAP mechanisms and Chemoprevention Trial Issues” will be delivered by guest speaker Dr Patrick Lynch MD, Professor of Medicine (Rtd), Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center.

GlobeNewsWire • Oct 6, 2025

Interim results for the six months ended June 30, 2025

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.

GlobeNewsWire • Sep 12, 2025

Biodexa Moves Into Phase 3 With eRapa For FAP With First Patients Enrolled

On Track To Be First Mover In $7Bn Addressable Market With No Current Therapeutic Options By: Benzinga Staff Writer CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP), a debilitating disease of the lower GI tract.

Accesswire • Sep 8, 2025

Biodexa Pharmaceuticals PLC Unsponsored ADR (BDRX) Upgraded to Buy: What Does It Mean for the Stock?

Biodexa Pharmaceuticals PLC Unsponsored ADR (BDRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Zacks Investment Research • Sep 3, 2025

Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

August 18, 2025 Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) Opportunity to be First Mover in $7.3Bn Addressable Market Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only current treatment option is sequential resection of the gastrointestinal tract.

GlobeNewsWire • Aug 18, 2025

ADR Ratio Change Effective

July 31, 2025 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) ADR Ratio Change Effective ADSs Outstanding Post Ratio Change 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 the previously announced ratio change of its American Depositary Receipts (“ADR”) from one (1) ADR representing ten thousand (10,000) ordinary shares, to the new ratio of one (1) ADR representing one hundred thousand (100,000) ordinary shares (the "Ratio Change"), became effective at the open of business on July 31, 2025 (U.S. Eastern Time).  For ADR holders, the Ratio Change will have the same effect as a one-for-ten reverse ADR split.

GlobeNewsWire • Jul 31, 2025

How Biodexa Is Racing To Get Its Phase 3 Program in FAP Under Way And Gain First-Mover Advantage in a $7Bn Addressable Market

CARDIFF, UK / ACCESS Newswire / July 28, 2025 / Familial Adenomatous Polyposis (FAP) is an inherited condition that puts people at a much greater risk of developing colon cancer. If left untreated, there is a near 100% likelihood that the person will develop colon or rectum cancer.

Accesswire • Jul 28, 2025