Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 65

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 65
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 may result in fines and civil penalties, suspension of production, restrictions on imports
and exports, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval, and would limit the
availability of our product and customer confidence in our product. Any manufacturing

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defect or error discovered after products have
been produced and distributed could result in even more significant consequences, including costly recalls, re-stocking costs, damage
to our reputation and potential for product liability claims.

If the contract manufacturers upon whom we may
rely to manufacture one or more of our product candidates, and any future product candidate we may in-license, fails to deliver the required
commercial quantities on a timely basis at commercially reasonable prices, we would likely be unable to meet demand for our approved product
and we would lose potential revenues.

If serious adverse or unacceptable side effects are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit the development of some of our product candidates.

If one or more of our product candidates or any
future product candidate are associated with undesirable side effects or adverse events in clinical trials or have characteristics that
are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the adverse
events, undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
In our industry, many compounds that initially showed promise in early stage testing have later been found to cause serious adverse events
that prevented further development of the compound. In the event that our clinical trials reveal a high or unacceptable severity and prevalence
of adverse events, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us
to cease further development or deny approval of one or more of our product candidates or any future product candidate for any or all
targeted indications. The FDA could also issue a letter requesting additional data or information prior to making a final decision regarding
whether or not to approve a product candidate. The number of requests for additional data or information issued by the FDA in recent years
has increased and has resulted in substantial delays in the approval of several new drugs. Adverse events or undesirable side effects
caused by one or more of our product candidates or any future product candidate could also result in the inclusion of unfavorable information
in our product labeling or in denial of regulatory approval by the FDA