Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 69

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 69
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, which we expect will result in significantly increased government
oversight of clinical trials. Under the FDAAA, companies that violate these and other provisions of the law are subject to substantial
civil monetary penalties, among other regulatory, civil and criminal penalties. The increased attention to drug safety issues may result
in a more cautious approach by the FDA in its review of data from our clinical trials. Data from clinical trials may receive greater scrutiny,
particularly with respect to safety, which may make the FDA or other regulatory authorities more likely to require additional preclinical
studies or clinical trials. If the FDA requires us to conduct additional preclinical studies or clinical trials prior to approving any
of our product candidates, our ability to obtain approval of this product candidate will be delayed. If the FDA requires us to provide
additional clinical or preclinical data following the approval of any of our product candidates, the indications for which this product
candidate is approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize our
product candidates may be otherwise adversely impacted.

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical
trials for one or more of our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate
in these trials as required by the FDA or similar regulatory authorities outside the United States. Some of our competitors have ongoing
clinical trials for product candidates that treat the same indications that we are targeting for our product candidates, and patients
who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.
Available therapies for the indications we are pursuing can also affect enrollment in our clinical trials. Patient enrollment is affected
by other factors including, but not necessarily limited to:

| ● | the severity of the disease under investigation; |

| ● | the eligibility criteria for the study in question; |

| ● | the perceived risks and benefits of the product candidate under study; |

| ● | the efforts to facilitate timely enrollment in clinical trials; |

| ● | the patient referral practices of physicians; |

| ● | the number of clinical trials sponsored by other companies for the same patient population; |

| ● | the ability to monitor patients adequately during and after treatment; and |

| ● | the proximity and availability of clinical trial sites for prospective patients. |

Our inability to enroll a sufficient number of
patients for