Company: MBIO
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001410578-25-000028
Chunk: 32

Company: MUSTANG BIO, INC.
Filing Date: 2025-01-15
Form: S-1
Chunk 32
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 indications may not yield any commercially viable products. If we do not accurately and/or effectively evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

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Risks Inherent in Drug Development and Commercialization Delays in the commencement or conduct of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval. Clinical trials are expensive and can take many years to complete, and the outcome is inherently uncertain. We cannot guarantee that any clinical trials will be conducted as planned 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