Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 45

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 45
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 We may face unforeseen challenges in our product candidate development strategy, and we can provide no assurances
that any of our clinical trials will be conducted as planned or completed on schedule, or at all, that we will ultimately be successful
in our current and future clinical trials, or that our product candidates will be able to receive regulatory approval. A failure of one
or more clinical trials can occur at any stage of testing, which may result from a multitude of factors, including, among other things,
flaws in study design, dose selection issues, placebo effects, patient enrollment criteria and failure to demonstrate favorable safety
or efficacy. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials,
and preliminary or interim results of a clinical trial do not necessarily predict final results. For example, it is not uncommon for product
candidates to exhibit unforeseen safety or efficacy issues when tested in humans despite promising results in preclinical animal model
studies. Accordingly, we cannot assure you that any clinical trials that we may conduct will demonstrate consistent or adequate efficacy
and safety to support marketing approval. In general, the FDA and regulatory authorities outside the United States require two adequate
and well-controlled clinical trials demonstrating safety and effectiveness, including a Phase 3 clinical trial, before granting marketing
approval of a drug product.

Many companies in the pharmaceutical
industry have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing
and early-stage clinical trials, and we cannot be certain that we will not face similar setbacks. Moreover, preclinical and clinical data
are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed
satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. Furthermore,
the failure of any product candidates that we develop to demonstrate safety and efficacy in any clinical trial could negatively impact
the perception of other product candidates that we develop or cause regulatory authorities to require additional testing before approving
any of our product candidates.

| 24 |

If we are required to conduct
additional clinical trials or other testing our product candidates, if we are unable to successfully complete clinical trials of our product
candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, if there are safety
concerns or if we determine that the observed safety or efficacy profile would not be competitive in the marketplace, we may:

| • | incur unplanned costs; |