Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 161

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 161
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 develop our
clinical assets to proof-of-concept stage before securing partners to undertake the most expensive, later stage development.

Our research and development programs may,
like MTX110, be based on one or more of our enabling technologies.

Manufacturing

We do not intend to establish
our own manufacturing capabilities. For clinical trial material we utilize GMP-certified contract manufacturers.

Commercialization

Once proof-of-concept has
been established, we intend to seek to license our products to a partner who would complete the development, and subsequently market and
sale, of the product in an agreed upon licensed territory. In addition to reimbursement of development costs, the partner would be expected
to make milestone payments based on sales targets and royalty payments.

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Pipeline

We
are actively pursuing the development of eRapa in FAP, tolimidone in T1D and MTX110 in three 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.

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 unders