Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 85

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 85
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Shares and/or Depositary Shares to decline and, if judgments exceed our insurance coverage, could decrease our cash and have a material
adverse effect our business, results of operations, financial condition and prospects.

Risks Related to our Relationships with Third Parties

We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.

We are, and may continue to
be, reliant on other parties for the successful development and commercialization of many of our product candidates. We rely upon CROs
and clinical investigators for the conduct of our clinical trials and upon contract laboratories for execution of our preclinical studies,
and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and trials
is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs or
collaboration partners does not relieve us of our regulatory responsibilities. We also rely on third parties to assist in conducting our
preclinical studies in accordance with good laboratory practices, or GLP, and requirements with respect to animal welfare. We and our
CROs or collaboration or licensing partners are required to comply with GCP, which are regulations and guidelines enforced by the MHRA,
the FDA, the EMA and comparable foreign regulatory authorities for all of our products in clinical development. Regulatory authorities
enforce GCP regulations, and other regulations applicable to clinical trials and investigational drug or biological products, through
periodic inspections of trial sponsors, CROs, principal investigators and trial sites. If we or any of our CROs or partners fail to comply
with applicable GCP regulations or other clinical trial regulations, the data generated in our clinical trials may be deemed unreliable
and the EMA, the MHPA, the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before
approving our marketing applications. We cannot be assured that upon inspection by a given regulatory authority, that such regulatory
authority will determine that any of our clinical trials comply with GCP requirements or other applicable regulations. In addition, our
clinical trials must be conducted with product produced under cGMP requirements. Failure to comply with these regulations may require
us to repeat preclinical and clinical trials, which would delay the regulatory approval process.

Our CROs and