Company: BDRX
Filing Date: 2025-09-12
Form Type: 424B3
Source: 0001214659-25-013675
Chunk: 6

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-09-12
Form: 424B3
Chunk 6
---
 well-tolerated with a significant 24%
reduction in the total polyp burden at six months compared with baseline and an overall 83% non-progression rate. At 12 months, 21 of
28 (75%) patients were deemed to be non-progressors with a median reduction in polyp burden of 17%. In Cohort 2, the dosage regimen for
Phase 3, eight of nine (89)% of patients were deemed non-progressors at 12 months with a median reduction in polyp burden of 29%. Over
the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and
95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance.

The Phase
3 registrational study (NCT06950385) is a double-blind placebo-controlled design, recruiting 168 high risk patients diagnosed with germline
or phenotypic FAP. The primary clinical endpoint is first progression free survival event which will comprise composite endpoints including
major surgery. We had a successful ‘Type C’ meeting with the FDA in January 2025 to finalise the protocol. The first clinical
site was initiated in June 2025 and the first patients enrolled by the Pan American Center for Oncology Trials in San Juan, Puerto Rico
in August 2025. Europe is following closely behind; our contract research organisation, Precision for Medicine, was appointed in March
2025. Orphan Drug Designation for eRapa in FAP was granted by the European Commission in May 2025. A Clinical Trial Application was filed
with the European Medicines Agency for the Serenta trial in July 2025 which, if approved, will facilitate the start of patient recruitment
in Europe in 4Q25.

Non-muscle Invasive Bladder Cancer (“NMIBC”)

NMIBC refers
to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the
bladder tumor followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk
of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women.

The ongoing
multi-centre, double-blind, placebo-controlled Phase 2 study in NMIBC