Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 47

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 47
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 of a drug price negotiation program within the U.S. Department
of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected
drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable
under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on Part
D drugs. Orphan drugs that treat only one rare disease are exempt from the IRA’s drug negotiation program. Substantial penalties
can be assessed for noncompliance with the drug pricing provisions in the IRA.

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Table of Contents

At the state level, legislatures have increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing. 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 or additional pricing pressures.

These and other healthcare reform measures that
may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive
for any current product or future product candidate. Any reduction in reimbursement from Medicare or other government healthcare programs
may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare
reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products. Legislative and regulatory
proposals have been made to expand post-approval requirements and restrict sales and promotional activities for drugs. It is uncertain
whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or
what the impact of such may be. In addition, increased Congressional scrutiny of the FDA’s approval process may significantly delay
or prevent marketing approval, as well as subject the industry to more stringent product labeling and post-marketing testing and other
requirements. It is also unclear what impact any changes made by the new presidential administration will have on the industry. Such actions
may impact the development and commercialization of drug products.

International Regulation

In addition to regulations in the U.S., there
are a variety of foreign