Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 43

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 43
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FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated,
FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence
of one in 5,000 to 10,000 in the United States and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the United
States and we plan to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby
underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

The results of the Phase 2
study were presented at two leading scientific conferences in the second quarter of 2024. Following a positive end-of-Phase 2 meeting
with the FDA, we have requested a Type C meeting with the FDA to finalize the protocol for a Phase 3 multi-center, double-blind, placebo-controlled
study in FAP. The Phase 3 study, which is expected to be registrational, plans to recruit approximately 168 patients across 30 or more
sites, with a primary endpoint being time to a defined progression free survival event. The study is expected to recruit over 18 months
and is supported by a non-dilutive grant of $17.0 million from CPRIT.

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 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 multi-center, double-blind, placebo-controlled Phase
2 study in NMIBC, now being conducted as an IIT by the University of Texas, San Antonio, is expected to enroll up to 166 patients with
primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported
by a $3.0 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, is ongoing.

On February 10, 2025, we