Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 48

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 48
---
 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. Trial subject enrollment is affected by other factors including:

| • | the severity and difficulty of diagnosing the disease under investigation; |

| • | the eligibility and exclusion criteria for the trial in question; |

| • | the size of the patient population and process for identifying patients; |

| • | our ability to recruit clinical trial investigators with the appropriate competencies and experience; |

| • | the design of the trial protocol; |

| • | the perceived risks and benefits of the product candidate in the trial in relation to other available 
 therapies, including any new products that may be approved for the indications we are investigating;  |

| 25 |

| • | the availability of competing commercially available therapies and other competing therapeutic candidates’ 
 clinical trials for the disease or condition under investigation;                                          |

| • | the willingness of patients to be enrolled in our clinical trials; |

| • | the risk that subjects enrolled in