Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 38

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 38
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 inhibitor. As a central regulator of cell metabolism, growth, proliferation and survival, the mTOR pathway is activated during various cellular processes including tumor formation and angiogenesis. Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. A Phase 2 study of eRapa in NMIBC, now being conducted as an IIT by the University of Texas, San Antonio, 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.In May 2025, we announced the receipt of an additional grant of $3.0 million from the Cancer Prevention and Research Institute
of Texas, or CPRIT, to support the registrational Phase 3 program of eRapa in FAP, which, along with the prior grants received from CPRIT
and the Company match, we expect will fund substantially all costs of the Phase 3 study.

The Phase 3 study
of eRapa in FAP is a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo, conducted in approximately
30 clinical sites across the United States and Europe. On June 25, 2025, we announced the activation of the first clinical study
site for our Phase 3 clinical study in patients with FAP, which is actively screening patients. On July 14, 2025, we announced the filing
of a Clinical Trial Application, or CTA, with the European Medicines Agency, or EMA, for the Phase 3 study, which is required to begin
a clinical trial in Europe, and on August 18, 2025, we announced the enrollment of the first two patients in the Phase 3 study by the
Pan American Center for Oncology in San Juan, Puerto Rico. On November 3, 2025, we announced the approval of the CTA by the EMA for the
Phase 3 study in Europe.

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. Lyn kinase modulates key intracellular functions such as proliferation, differentiation, apoptosis, migration and