Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 93

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 93
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 if we are able to alter our process so as to use other materials
or equipment, such a change may lead to a delay in our clinical development and/or commercialization plans. If such a change occurs for
product candidate that is already in clinical testing, the change may require us to perform both in vitro or in vivo comparability studies
and to collect additional data from patients prior to undertaking more advanced clinical trials. These factors could cause the delay of
studies or trials, regulatory submissions, required approvals or commercialization of product candidates that we develop, cause us to
incur higher costs and prevent us from commercializing our product candidates successfully.

| 45 |

Our counterparties may become insolvent.

There is a risk that parties
with whom we trade or have other business relationships with (including partners, joint venturers, customers, suppliers, subcontractors
and other parties) may become insolvent. This may be due to general economic conditions or factors specific to that company. In the event
that a party with whom we trade becomes insolvent, this could have an adverse impact on our revenues and profitability.

Our relationships with customers, healthcare providers, physicians, prescribers, purchasers, third party payors, charitable organizations and patients are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Although we do not currently
have any products on the market, upon commercialization of any of our product candidates, if approved, we will be subject to additional
healthcare statutory and regulatory requirements and oversight by federal and state governments in the United States as well as foreign
governments in the jurisdictions in which we conduct our business. Healthcare providers, physicians and third-party payors in the United
States and elsewhere play a primary role in the recommendation and prescription of drug and biological products. Arrangements with third-party
payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations,
including, without limitation, the federal Anti-Kickback Statute, or AKS, and the False Claims Act, or FCA, which may constrain the business
or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular,
the research of any of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well
as certain business arrangements in the healthcare industry, are