Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 82

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 82
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 assurance of financial return.

Establishing strategic collaborations is difficult
and time-consuming. Our discussions with potential collaborators may not lead to the establishment of collaborations on favorable terms,
if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual
property position. In addition, there has been a significant number of recent business combinations among large pharmaceutical companies
that have resulted in a reduced number of potential future collaborators. Even if we successfully establish new collaborations, these
relationships may never result in the successful development or commercialization of product candidates or the generation of sales revenue.
To the extent that we enter into collaborative arrangements, the related product revenues are likely to be lower than if we directly marketed
and sold products. Such collaborators may also consider alternative product candidates or technologies for similar indications that may
be available to collaborate on and whether such a collaboration could be more attractive than the one with us for any future product candidate.

<div align='center'>Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries</div>

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We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.

In the United States and certain foreign jurisdictions,
there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that
could prevent or delay marketing approval of our product candidate, restrict or regulate post-approval activities, and affect our ability
to profitably sell any product candidates for which we obtain marketing approval. The Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Reconciliation Act of 2010 (the “PPACA” or collectively, the “ACA”), substantially
regulates the way healthcare is financed by both governmental and private insurers in the United States. Among other things, the ACA increased
the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%; required collection of rebates
for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers
who sell certain “branded prescription drugs” to specified federal government programs; implemented a new methodology under
which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled,
implanted, or injected; expanded the eligibility criteria for Medicaid programs; created a new Patient