Biodexa Pharmaceuticals PLC has received approval from Health Canada to expand its registrational Phase 3 Serenta trial for familial adenomatous polyposis (FAP) into Canada. The expansion aims to accelerate enrolment for the study, which targets a condition with no approved therapeutic options and where life-altering surgery remains the standard of care.

The Serenta trial is currently active in 29 recruiting clinical centers across the US and five European countries. Canada is expected to add three or four new centers to the study. The trial plans to enrol 168 patients, with 73 patients enrolled as of June 29, 2026.

Stephen Stamp, Chief Executive Officer of Biodexa, highlighted the recent acceleration in enrolment due to the opening of European centers. He noted that the addition of Canada supports the company's enrolment goals and that Serenta has been positively received by clinicians and FAP patients.

The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas. The trial is a double-blind, placebo-controlled study designed to evaluate eRapa, a proprietary oral capsule formulation of rapamycin, which acts as an mTOR inhibitor.

Key Trial Details

About Familial Adenomatous Polyposis

FAP is characterized by the proliferation of polyps in the colon and/or rectum, typically occurring in the mid-teens. Without treatment, the condition usually leads to colorectal cancer. The incidence is reported as one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US, with plans to seek similar designation in Europe.

Biodexa Pharmaceuticals PLC adjourned its Annual General Meeting (AGM) on June 17, 2026, due to a lack of quorum, preventing shareholders from voting on proposed resolutions. The clinical stage biopharmaceutical company, focused on gastrointestinal cancers, was unable to proceed with the meeting originally scheduled for 11.00am BST. Consequently, the company has rescheduled the AGM to ensure proper governance and shareholder participation.

In accordance with the Company's articles of association, the AGM cannot be reconvened for 10 clear days. The re-scheduled meeting will take place at 11.00am BST on June 30, 2026, at the Company's offices located at 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ. This delay allows the company to regroup and ensure the necessary attendance requirements are met for the statutory proceedings.

Proxies submitted in time for the original AGM will remain valid for the re-scheduled AGM. This provision ensures that shareholders who had already appointed proxies do not need to resubmit their instructions, maintaining continuity in representation. The agenda for the meeting remains unchanged, addressing the matters originally set before the shareholders.

Meeting Details

Biodexa Pharmaceuticals PLC is developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. Its lead development programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 for Gastrointestinal Stromal Tumors (GIST), and tolimidone for type 1 diabetes. The company's headquarters and R&D facility are located in Cardiff, UK.