Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 67

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 67
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Table of Contents

the approved labeling. The FDA and other applicable
regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we market any
approved product in a way which is not consistent with the approved labeling, we may be subject to enforcement action for off-label marketing.
Violations of the Federal Food, Drug and Cosmetics Act (“FDCA”) relating to the promotion of prescription drugs may lead to
investigations, civil claims, and/or criminal charges alleging violations of federal and state health care fraud and abuse laws, as well
as state consumer protection laws.

In addition, later discovery of previously unknown
adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements,
may yield various results, including:

| ● | restrictions on such products, operations, manufacturers or manufacturing processes; |

| ● | restrictions on the labeling or marketing of a product; |

| ● | restrictions on product distribution or use; |

| ● | requirements to conduct post-marketing studies or clinical trials; |

| ● | warning letters, untitled letters, Form 483s, import alerts, and/or inspection observations; |

| ● | withdrawal of the products from the market; |

| ● | refusal to approve pending applications or supplements to approved applications that we submit; |

| ● | recall of products; |

| ● | fines, restitution or disgorgement of profits; |

| ● | suspension or withdrawal of marketing or regulatory approvals; |

| ● | suspension of any ongoing clinical trials; |

| ● | refusal to permit the import or export of our products; |

| ● | product seizure; or |

| ● | injunctions, consent decrees, and/or the imposition of civil or criminal penalties. |

The FDA’s policies may change, and additional
government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, or negatively
affect those products for which we may have already received regulatory approval, if any. There is added uncertainty in light of actions
that may be taken by the current presidential administration or Congress with respect to the FDA. If we are slow or unable to adapt to
changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
we may be subject to the various actions listed above, including losing any marketing approval that we may have obtained.

We will need to obtain FDA approval of any proposed product brand names, and any failure or delay