Company: MBIO
Filing Date: 2025-02-07
Form Type: 424B4
Source: 0001410578-25-000085
Chunk: 40

Company: MUSTANG BIO, INC.
Filing Date: 2025-02-07
Form: 424B4
Chunk 40
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 lower prices than branded therapies and are generally preferred by hospital formularies and managed care providers of health services. We anticipate that, if approved, our product candidates will face increasing competition in the form of generic versions of branded products of competitors, including those that have lost or will lose their patent exclusivity. In the future, we may face additional competition from a generic form of our own candidates when the patents covering them begin to expire, or earlier if the patents are successfully challenged. If we are unable to demonstrate to physicians and payers that the key differentiating features of our product candidates translate to overall clinical benefit or lower cost of care, we may not be able to compete with generic alternatives. If any of our product candidates are successfully developed but, if approved, do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that any such product candidates generate from sales will be limited. Even if our product candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors and the medical community. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally would also be necessary for commercial success. The degree of market acceptance of any approved products would depend on a number of factors, including, but not necessarily limited to:

| ● | the efficacy and safety as demonstrated in clinical trials; |

| ● | the timing of market introduction of such approved product as well as competitive products; |

| ● | the clinical indications for which the product is approved; |

| ● | acceptance by physicians, major operators of cancer clinics and patients of the product as a safe and effective treatment; |

| ● | the safety of such product candidates seen in a broader patient group, (i.e., based on actual use); |

| ● | the availability, cost and potential advantages of alternative treatments, including less expensive generic drugs; |

| ● | the availability of adequate reimbursement and pricing by third-party payors and government authorities; |

| ● | changes in regulatory requirements by government authorities for our product candidates; |

| ● | the relative convenience and ease of administration of the product candidate for clinical practices; |

| ● | the product labeling or product insert required by the FDA or regulatory authority in other countries, including any contradictions, warnings, drug interactions, or other precautions; |

| ● | changes in the standard of care for the targeted indications for our product candidate or future product candidates, which could reduce the marketing impact of any labeling or marketing claims that we could make