Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 42

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 42
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 Phase 3 trial in FAP in
the third quarter of 2025. The Phase 2 trial in NMIBC, now being conducted as an IIT by the University of Texas, San Antonio, is ongoing.
Tolimidone, which was in-licensed in December 2023, is a Phase 2 asset which we are developing for T1D. MTX110 is currently in Phase 1
development for three rare / orphan brain cancers but has been de-prioritized due to resource constraints.

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Our aim is to 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.

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.

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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