Company: BDRX
Filing Date: 2025-12-11
Form Type: F-1/A
Source: 0001214659-25-017944
Chunk: 36

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-11
Form: F-1/A
Chunk 36
---
 make milestone payments based on sales targets and royalty payments.

Pipeline and Platform Technologies

We are actively pursuing the
development of eRapa in FAP and tolimidone in T1D. Due to resource constraints, MTX110 has been de-prioritized in the three orphan brain
cancer indications. Our development pipeline is as follows:

Current Clinical Stage Assets

eRapa.eRapa is a proprietary
oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has
been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated
during tumorgenesis. Rapamycin is approved in the United States for organ rejection in renal transplantation as Rapamune®(Pfizer).
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.

| 26 |

FAP is characterized as a
proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating
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