Biodexa Pharmaceuticals Reports Strong Progress in Pipeline and Financials

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company, announced its interim results for the six months ended June 30, 2026. The company reported significant progress in its pipeline and financial performance, highlighting key operational highlights and financial updates.

In February 2026, Biodexa in-licensed MTX240 (formerly OPB-171755) from Otsuka Pharmaceutical Co., Limited, marking a strategic move to expand its portfolio in gastrointestinal cancers. The company launched a global Early Access Program for eRapa, a proprietary oral formulation of rapamycin, in March 2026, through a partnership with Tanner Pharma Group. Additionally, Biodexa received approval from Health Canada to expand the Serenta trial into Canada in June 2026. Fiona Sharp was promoted to Chief Financial Officer and Company Secretary, joining the Board of Directors in January 2026.

Post-period-end, Biodexa completed a fundraise on July 1, 2026, raising gross proceeds of $3.5 million through a combination of a registered direct offering, warrant inducement, and PIPE offering. As of the date of publication, 92 out of a planned 168 subjects have been enrolled in the Serenta trial.

Financially, Biodexa reported increased R&D costs to £2.92 million in the first half of 2026, up from £1.67 million in the same period of 2025. Administrative costs decreased to £1.74 million, primarily due to foreign exchange movements. Net cash used in operating activities (after changes in working capital) was £4.61 million, compared to £3.30 million in the previous year. The company's cash balance at June 30, 2026, stood at £3.23 million.

Stephen Stamp, CEO of Biodexa, commented, "We have made significant strides in the first six months. We accelerated the enrolment in our registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis, achieving 50% enrolment in early August, which places us ahead of any competitive development programs. Additionally, the in-licensing of MTX240 for GIST has the potential to treat patients irrespective of their KIT or PDGFR mutation. We are working to initiate a Phase 1b/2a trial to establish a safe and effective dose and an efficacy signal before the end of 2027."

The company's main focus in the first half of 2026 was on expanding its Phase 3 trial of eRapa in FAP and initiating activities for the re-start of a Phase 1 trial of MTX240 in GIST. eRapa, a proprietary oral formulation of rapamycin, is designed to address the poor bioavailability, variable pharmacokinetics, and toxicity associated with the currently available forms of rapamycin. The Phase 3 trial, branded "Serenta," is a double-blind, placebo-controlled design, recruiting 168 high-risk subjects diagnosed with germline or phenotypic FAP. Two centers in Canada are expected to begin enrolling in the fourth quarter of 2026.

Biodexa also reported progress in its ongoing investigator-initiated two-center, double-blind, placebo-controlled Phase 2 trial in non-muscle invasive bladder cancer (NMIBC), fully enrolled at 166 patients. The study, supported by a $3.0 million non-dilutive grant from the National Cancer Institute, is expected to read out in the fourth quarter of 2026.