Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 88

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 88
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 | reliance on the third party for regulatory, compliance and quality assurance; |

| • | the possible breach of the manufacturing agreement by the third party; |

| • | the possible misappropriation of our proprietary information, including our trade secrets and know-how; 
 and                                                                                                     |

| • | the possible termination or nonrenewal of the agreement by the third party at a time that is costly or 
 inconvenient for us.                                                                                   |

We or our third-party manufacturers
may encounter shortages in the raw materials or APIs necessary to produce our product candidates in the quantities needed for our clinical
trials or, if our product candidates are approved, in sufficient quantities for commercialization or to meet an increase in demand, as
a result of capacity constraints or delays or disruptions in the market for the raw materials or active pharmaceutical ingredients, including
shortages caused by the purchase of such raw materials or APIs by our competitors or others. The failure by us or our third-party manufacturers
to obtain the raw materials or APIs necessary to manufacture sufficient quantities of our product candidates, may have a material adverse
effect on our business.

Our third-party manufacturers
are subject to inspection and approval by regulatory authorities before we can commence the manufacture and sale of any of our product
candidates, and thereafter are subject to ongoing inspection from time to time. Our third-party manufacturers may not be able to comply
with cGMP regulations or similar regulatory requirements outside of the United States. Our failure, or the failure of our third-party
manufacturers, to comply with applicable regulations could result in regulatory actions, such as the issuance of notices of inspectional
observations, warning letters or sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays,
suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or commercial products (if any),
operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products. If any
of our third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, our ability to develop and commercialize
our product candidates could suffer significant interruptions.

| 44 |

Any disruption, such as a
fire, natural hazards or vandalism at our CMOs, or any impacts on our CMOs due to health pandemics, could significantly interrupt our
manufacturing capability. We currently do not have alternative production plans in place or disaster-recovery facilities available. In
case of a disruption, we will have to establish alternative