Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 46

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 46
---
 with regulatory requirements or otherwise meet their contractual 
 obligations in a timely manner, or at all;                                                                                         |

| • | delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional   
 regulatory oversight around clinical development generally or with respect to our technology in particular; or |

| • | varying interpretations of data by the FDA and similar foreign regulatory agencies. |

In addition, because we have
limited financial and personnel resources and are focusing primarily on developing our lead product candidates, we may forgo or delay
pursuit of other future product candidates that may prove to have greater commercial potential and may fail to capitalize on viable commercial
products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a future product
candidate, we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements
in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product
candidates.

The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that we advance in clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval.

The research and development
of drugs and biological products is expensive and extremely risky. Only a small percentage of product candidates that enter the development
process ever receive marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates,
we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. The outcome of clinical
testing is uncertain. 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