Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 42

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 42
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 take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial
process. The results of any preclinical studies and early clinical trials of our product candidates may not be predictive of the results
of later-stage clinical trials, even after seeing promising results in earlier clinical trials. Product candidates in later stages of
clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial
clinical trials. A number of companies in the biopharmaceutical industry, including many with greater resources and experience than us,
have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising
results in earlier trials.

We have determined not to
conduct additional clinical trials in humans, other than pilot trials to establish proof of concept in indications other than those for
which the drug is approved. We expect our licensing partners will be responsible for future clinical trials. We and any of our current
or potential licensing partners may experience delays in ongoing or future clinical trials and we do not know whether planned clinical
trials will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all.

There is no assurance that
current or future clinical trials of our product candidates, will be successful or will generate positive clinical data and we may not
receive marketing approval from the FDA, European Commission, or other regulatory authorities for any of our product candidates. We have
limited experience submitting NDAs, biologics license applications, or BLAs, and investigational new drug applications, or INDs, to the
FDA, as well as clinical trial applications, or CTAs, or marketing authorization applications, or MAAs, to the EMA. eRapa, Tolimidone
and MTX110 are both at a relatively early stage in their clinical development. There can be no assurance that the FDA will permit any
of our future NDAs, BLAs, or INDs, including the NDA for eRapa, tolimidone or MTX110 or any future INDs for our other product candidates,
to go into effect in a timely manner or at all. Without an IND or CTA for a product candidate, we will not be permitted to conduct clinical
trials in the United States or the European Union, respectively, of such product candidate.

Drug
or biological product development is a difficult, long, time-consuming, expensive and uncertain process, and delay or failure can occur
at