Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 212

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 212
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 arrangements. Significant efforts to change the PBM industry as it currently exists in the
United States may affect the entire pharmaceutical supply chain and the business of other stakeholders, including biopharmaceutical developers
like us. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures
could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

We cannot predict the likelihood,
nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the
United States or abroad. We expect that additional federal, state, and foreign healthcare reform measures will be adopted in the future,
any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result
in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

Competition

We also face competition from numerous sources including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Many of our competitors may have significantly greater research capabilities, as well as financial, product development, manufacturing, and marketing resources.

There are no currently approved
products with an FAP indication although certain non-steroidal anti-inflammatory drugs may be prescribed off-label. Panbela Therapeutics,
Inc. and Recursion Pharmaceuticals, Inc. are developing products for FAP. Standard of care treatment for NMIBC usually involves transurethral resection of the tumor followed by intravesical Bacillus Calmette-Gu érin therapy. A number of companies are developing therapeutics for NMIBC including Janssen Pharmaceuticals, CG Oncology, Inc. and Protara Therapeutics, Inc.

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There are relatively few products
available for the treatment of T1D. Exogenous insulin in its various forms is used to compensate for the lack of endogenous insulin common
to all T1D patients. More recently, teplizumab, the first disease-modifying treatment of T1D, has been approved for the delay of Stage
3 T1D. A number of companies are researching potentially disease-modifying approaches to T1D including stem cell therapies by Vertex Pharmaceuticals,
Inc. and CRISPR Therapeutics AG and SAB Biotherapeutics, Inc. is developing an immunotherapeutic. The JDRF T1D Fund has invested in approximately
30 private companies