Company: BDRX
Filing Date: 2025-12-08
Form Type: F-1/A
Source: 0001214659-25-017719
Chunk: 18

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-08
Form: F-1/A
Chunk 18
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 Orphan Drug Designation for eRapa in FAP. Orphan Drug Designation in the European Union is granted
by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. It is intended to encourage
the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. If approved
for marketing, this designation will provide 10 years of marketing exclusivity and also provide special incentives for sponsors, including
eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.

For more information on recent
developments with respect to eRapa, see “—Company Overview.”

Contingent Liability

As previously disclosed in
the Notes to the Consolidated Unaudited Interim Financial Information for the six-month period ended June 30, 2025, we were involved in
a dispute with a former advisor regarding fees. The dispute was resolved through a settlement, the terms of which included a payment made
to the former advisor on September 29, 2025.

Our Strategy

In early 2023, we decided
to re-position the Company as therapeutics (as opposed to drug delivery) company and we began looking for additional assets to complement
our MTX110 programs. The delivery of proof-of-concept clinical data is the primary focus of our business model going forward.

Our proprietary drug delivery
technologies are no longer a key priority for the Company.

Development

Our intention is to build
a balanced portfolio of clinical-stage development assets, ideally with a focus on rare / orphan indications. eRapa was in-licensed in
April 2024 and is being developed for FAP and NMIBC. We expect to begin enrolling a multi-center registrational Phase 3 trial in FAP in
the third quarter of 2025. The Phase 2 trial in NMIBC, now being conducted as an Investigator Initiated Trial, or 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.

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