Company: BDRX
Filing Date: 2025-11-17
Form Type: POS AM
Source: 0001214659-25-016809
Chunk: 10

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: POS AM
Chunk 10
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, or NMIBC, type 1 diabetes, or T1D, and rare/orphan cancers of the brain.

In April 2024 we licensed
eRapa, a proprietary formulation of rapamycin, from Rapamycin Holdings, Inc. d/b/a Emtora Biosciences, Inc., or Emtora. Rapamycin is
an mTOR 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. The Phase 2 study of eRapa in NMIBC is ongoing. On February 10, 2025, we announced that the United States Food and
Drug Administration, or 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. On November 3, 2025, we announced the approval of the CTA by the EMA for the Phase 3 study in Europe.

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