Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 61

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 61
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 ethics committee or a data
safety monitoring committee overseeing the clinical trial, any clinical trial site with respect to that site, or the FDA or other regulatory
authorities, due to a number of factors, including, but not necessarily limited to:

| ● | failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; |

| ● | inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold; |

| ● | stopping rules contained in the protocol; |

| ● | unforeseen safety issues or any determination that the clinical trial presents unacceptable health risks; and |

| ● | lack of adequate funding to continue the clinical trial. |

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Table of Contents

Changes in regulatory requirements and guidance
also may occur, and we may need to amend clinical trial protocols to reflect these changes. Amendments may require us to resubmit clinical
trial protocols to IRBs for re-examination, which may in turn impact the costs and timing of, and the likelihood of successfully completing,
a clinical trial. If we experience delays in the completion of, or if we must suspend or terminate, any clinical trial of any product
candidate, our ability to obtain regulatory approval for that product candidate will be delayed, and the commercial prospects, if any,
for the product candidate may suffer as a result. In addition, many of these factors may also ultimately lead to the denial of regulatory
approval of a product candidate.

Product candidates that we advance into clinical trials may not receive regulatory approval.

Pharmaceutical development has inherent risks.
We will be required to demonstrate through well-controlled clinical trials that product candidates are effective with a favorable benefit-risk
profile for use in their target indications before seeking regulatory approvals for their commercial sale. Success in early clinical trials
does not mean that later clinical trials will be successful, as product candidates in later-stage clinical trials may fail to demonstrate
sufficient safety or efficacy despite having progressed through initial clinical testing. Also, we may need to conduct additional clinical
trials that are not currently anticipated. Companies frequently suffer significant setbacks in advanced clinical trials, even after earlier
clinical trials have shown promising results. As a result, product candidates that we advance into clinical trials may not receive regulatory
approval.

In addition, even if our product candidates were
to obtain approval, regulatory authorities may approve any such product candidates or any future product candidate for fewer or more limited
indications than we request, may not approve the