Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 77

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 77
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 through periodic inspections of trial sponsors, clinical investigators and trial sites. If we or any of our CROs fail
to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable
foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot
assure you that upon inspection by a regulatory authority, such regulatory authority will determine that any of our clinical trials

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complies with GCP regulations. In addition, our
clinical trials must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations may require
us to repeat clinical trials, which would delay the regulatory approval process. We also are required to register certain clinical trials
and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes.
Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

The third parties with whom we have contracted
to help perform our preclinical studies and/or clinical trials may also have relationships with other entities, some of which may be our
competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical
studies or clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be
delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully
commercialize our product candidates, if approved.

If any of our relationships with these third-party
CROs or site management organizations terminates, we may not be able to enter into arrangements with alternative CROs or site management
organizations or to do so on commercially reasonable terms. Switching or adding additional CROs or site management organizations involves
additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO or site management
organization commences work. As a result, delays could occur, which could compromise our ability to meet our desired development timelines.

We are currently reliant on COH, Fred Hutch, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates.

A substantial portion of our research and development
has been and will continue to be conducted by COH, Fred Hutch, Nationwide, and UAB pursuant to a sponsored