Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 84

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 84
---
 measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing.

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.

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 or future product candidates. 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 product candidates, if approved. Legislative
and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for drugs.
We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance, or interpretations
will be changed, or what the impact of such changes on the marketing approvals of any current or future product candidates, if any, may
be. In addition, increased Congressional scrutiny and scrutiny by the current presidential administration of the FDA’s approval
process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing
testing and other requirements.

Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business or the business of our partners.

The ability of the FDA to review and approve new
products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel,
ability to accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
in recent years as a result. In addition, government funding of other government agencies that fund research and development activities
is subject to the political process, which is inherently fluid and unpredictable. There is added uncertainty in light of actions that
may be taken by the current presidential administration or Congress with respect to the FDA.

Disruptions at the FDA and other agencies may
also slow the time necessary for new drugs to be