Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 46

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 46
---
| • | 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 our clinical trials, including to add additional patients or arms, which could result
in increased costs and expenses or delays. Significant clinical trial delays also could shorten any periods during which we may have the
exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our
ability to successfully commercialize our product candidates and may harm our business and results of operations.

We or our collaborators may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, which could delay or prevent our receipt of necessary regulatory approvals.

Successful and timely completion
of clinical trials will require that we or our collaborators sponsoring trials for our product candidates enroll a sufficient number of
patients. Patient enrollment, which is an important factor in the timing of clinical trials, is affected by many factors, including the
size and nature of the patient population and competition for patients eligible for our clinical trials with competitors, which may have
ongoing clinical trials for product candidates that are under development to treat the same indications as one or more of our product
candidates or approved products for the conditions for which we are developing our product candidates.

Trials may be subject to delays
as a result of patient enrollment taking longer than anticipated or patient withdrawal. We may not be able to initiate or continue clinical
trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these
trials as required by the FDA, EMA, or comparable foreign regulatory authorities. We cannot predict how successful we or our collaborators
will be at enrolling subjects in future clinical trials