Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 63

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 63
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 | the FDA may not accept clinical data from trials conducted by individual investigators or in countries where the standard of care is potentially different from that of the United States; |

| ● | the results of clinical trials may not meet the level of statistical significance required by the FDA for approval; |

| ● | the FDA may disagree with the interpretation of data from preclinical studies or clinical trials; |

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| ● | the FDA may determine that our manufacturing processes or facilities or those of third-party manufacturers with which we or our respective collaborators currently contract for clinical supplies and plan to contract for commercial supplies do not satisfactorily comply with cGMPs; or |

| ● | the approval policies or interpretation of regulations of the FDA may significantly change in a manner rendering the clinical data insufficient for approval or the product characteristics or benefit-risk profile unfavorable for approval. |

With respect to foreign markets, approval procedures
vary among countries and, in addition to the aforementioned risks, can involve additional product testing, administrative review periods
and agreements with pricing authorities. In addition, rapid drug and biological development during the COVID-19 pandemic has raised questions
about the safety and efficacy of certain marketed pharmaceuticals and may result in increased cautiousness by the FDA and comparable foreign
regulatory authorities in reviewing new pharmaceuticals based on safety, efficacy or other regulatory considerations and may result in
significant delays in obtaining regulatory approvals. Any delay in obtaining, or inability to obtain, applicable regulatory approvals
would prevent us from commercializing our product candidates. It is also unclear what actions will be taken by the current presidential
administration or through legislative action that could impact the FDA and our ability to obtain regulatory approvals.

Regulatory approval for our product candidates by the FDA, or any similar regulatory authorities outside the United States, is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.

Any regulatory approval is limited to the indications
for use and related treatment of those specific diseases and indications set forth in the approval for which a product is deemed to be
safe and effective by the FDA, or other similar regulatory authorities outside the United States. In addition to the regulatory approval
required for new drug products, new formulations or indications for an approved product also require regulatory approval. If we are not
able to obtain regulatory approval for any desired future indications for our products, our ability to effectively market and sell our
products may be reduced and our business may be adversely affected.

While physicians may choose to prescribe drugs
for