Company: BDRX
Filing Date: 2025-12-11
Form Type: F-1/A
Source: 0001214659-25-017944
Chunk: 37

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-11
Form: F-1/A
Chunk 37
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 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 announced
that the FDA had granted fast track designation for eRapa. Fast track designation is intended to facilitate the development and expedite
the review of drugs to treat serious conditions and fill an unmet medical need.

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 T1D. As a lyn kinase activator, tolimidone has been shown in preclinical experiments to have a role in beta cell
survival and proliferation. If replicated in clinical studies, tolimidone could have the potential to be disease modifying and change
the treatment paradigm for T1D. T1