Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 47

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 47
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 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; |

| • | be delayed in obtaining marketing approval for product candidates we develop; |

| • | not obtain marketing approval at all; |

| • | obtain marketing approval in some countries and not in others; |

| • | obtain approval for indications or patient populations that are not as broad as intended or desired; |

| • | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |

| • | be subject to additional post-marketing testing requirements; or |

| • | have the product removed from the market after obtaining marketing approval. |

Our product development costs
will also increase if we experience delays in clinical trials or in obtaining marketing approvals. We do not know whether any of our clinical
trials will continue or begin as planned, will need to be restructured or will be completed on schedule, or at all. We may also decide
to change the design or protocol of one or more of