Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 162

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 162
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coring 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 the Cancer Prevention and Research Institute of Texas.

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. Our ongoing multi-center,
double-blind, placebo-controlled Phase 2 study in NMIBC 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 expected to read out in the first half of 2025.

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Tolimidone.
Tolimidone was originally discovered by Pfizer Inc., or Pfizer, and was developed through Phase 2 for the treatment of gastric ulcers.
Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone.
Pfizer discontinued development of the drug due to lack of efficacy for that indication in Phase 2. Tolimidone is a selective activator
of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signaling cascade initiated by
the binding of insulin to its receptor.

We
intend to develop tolimidone for the treatment of