Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 60

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 60
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 or will be completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage and our future clinical trials may not be successful.The commencement or conduct of clinical trials can be delayed for a
variety of reasons, including, but not necessarily limited to, delays in:

| ● | commencing a clinical trial as a result of regulatory authority action; |

| ● | identifying, recruiting and training suitable clinical investigators; |

| ● | reaching and preserving agreements on acceptable terms with prospective clinical research organizations (“CROs”) and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites; |

| ● | obtaining sufficient quantities of a product candidate for use in clinical trials; |

| ● | obtaining Institutional Review Board (“IRB”) or ethics committee approval to conduct a clinical trial at a prospective site; |

| ● | developing and validating companion diagnostics on a timely basis, if required; |

| ● | adding new clinical sites once a trial has begun; |

| ● | change in the principal investigator or other key staff overseeing the clinical trial at a given site; |

| ● | identifying, recruiting and enrolling patients to participate in a clinical trial; or |

| ● | retaining (or replacing) patients who have initiated a clinical trial but who may withdraw due to adverse events from the therapy, insufficient efficacy, fatigue with the clinical trial process, personal issues, or other reasons. |

Any delays in the commencement of our clinical
trials will delay our ability to pursue regulatory approval for product candidates. In addition, many of the factors that cause, or lead
to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

Suspensions or delays in the completion of clinical testing could result in increased costs and delay or prevent our ability to complete development of that product candidate or generate product revenues, if approved.

Once a clinical trial has begun, patient recruitment
and enrollment may be slower than we anticipate due to the nature of the clinical trial plan, the proximity of patients to clinical sites,
the eligibility criteria for participation in the study or other factors. Clinical trials may also be delayed as a result of ambiguous
or negative interim results or difficulties in obtaining sufficient quantities of product manufactured in accordance with regulatory requirements
and on a timely basis. Further, a clinical trial may be modified, suspended or terminated by us, an IRB, an