Biodexa Pharmaceuticals reports patent allowance and Phase 3 trial plans.

Biodexa Pharmaceuticals reported interim results for the six months ended June 30, 2025. The company announced the allowance of a patent application for oral rapamycin nanoparticle preparations and the appointment of Precision for Medicine as the clinical research organization for the European component of the registrational Phase 3 study of eRapa in FAP. The company also had a successful Type C meeting with the US FDA.

Biodexa Pharmaceuticals (NASDAQ: BDRX) has reported its interim results for the six months ended June 30, 2025. The company announced several significant milestones, including the allowance of a patent application for oral rapamycin nanoparticle preparations, the appointment of Precision for Medicine as the clinical research organization for the European component of the registrational Phase 3 study of eRapa in Familial Adenomatous Polyposis (FAP), and a successful Type C meeting with the US FDA.

Biodexa's interim results highlight the company's strategic shift in capital allocation towards its lead candidate, eRapa, for FAP. eRapa, a proprietary oral formulation of rapamycin, has progressed to Phase 3 following successful regulatory interactions. The company's R&D expenses decreased by 24% to £1.67 million, reflecting reduced spending on their glioblastoma program in favor of their more advanced FAP asset.

The company secured important regulatory milestones, including Orphan Drug Designation in Europe for eRapa in FAP and a successful Type C meeting with the FDA regarding their Phase 3 protocol. These developments significantly de-risk their clinical path forward. Financially, Biodexa ended the period with £4.04 million in cash after securing a $35 million Equity Line of Credit (ELOC) with C/M Capital Master Fund, of which $8.56 million had been utilized by period-end. The cash burn rate improved with net cash used in operations decreasing to £3.30 million (vs. £4.81 million in H1 2024).

Biodexa's pipeline diversification continues with tolimidone advancing to Phase 2a for Type 1 Diabetes while development of MTX110 has been deprioritized due to resource constraints, indicating management's focus on capital efficiency and prioritization of programs with near-term value inflection points. The enrollment of first patients in the pivotal Serenta trial for eRapa in FAP represents the most significant operational achievement, positioning Biodexa to address an orphan indication with no currently approved therapeutic options.

Additionally, $3 million in non-dilutive grant funding from the Cancer Prevention & Research Institute of Texas provides validation and financial support for their FAP program. The company's CEO and CFO, Stephen Stamp, commented, "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 Clinical Trial Application with the EMA, which sets us up to begin enrolment in the Serenta trial in Europe in the fourth quarter."