Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 35

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 35
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and, if approved, marketing of our product candidates, as well as our ongoing research and development activities. None of our product
candidates has been approved for sale in any market. Before marketing in the U.S., any drug that we develop must undergo rigorous pre-clinical
testing and clinical trials and an extensive regulatory approval process implemented by the FDA under the FDCA. The FDA regulates, among
other things, the pre-clinical and clinical testing, safety, efficacy, approval, manufacturing, record keeping, adverse event reporting,
packaging, labeling, storage, advertising, promotion, export, and the sale and distribution of biopharmaceutical products.

U.S. Drug Development

The regulatory review and approval process is
lengthy, expensive and uncertain. We are required to submit extensive preclinical and clinical data and supporting information to the
FDA for each indication or use to establish a product candidate’s safety and efficacy before we can secure FDA approval to market
or sell a product in the U.S. The approval process takes many years, requires the expenditure of substantial resources and may involve
ongoing requirements for post-marketing studies or surveillance. Before commencing clinical trials in humans, we must submit an IND to
the FDA containing, among other things, preclinical data, chemistry, manufacturing and control information, and an investigative plan.
Our submission of an IND may not result in FDA authorization to commence a clinical trial. Clinical testing must meet requirements for
institutional review board oversight, informed consent and good clinical practices, and must be conducted pursuant to an IND, unless exempted.

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Table of Contents

FDA Expedited Review and Approval Programs

FDA has various programs, including fast track
designation, regenerative medicine advanced therapy (RMAT) designation, breakthrough therapy designation (BTD), accelerated approval,
and priority review that are intended to expedite the process for the development and FDA review of drugs that are intended for the treatment
of serious or life-threatening diseases or conditions and demonstrate the potential to address existing unmet medical needs. The purpose
of these programs is to provide important new drugs to patients earlier than under standard FDA review procedures.

To be eligible for fast track designation, the
FDA must determine, based on the request of a sponsor, that a drug is intended to treat a serious or life-threatening disease or condition
and based on preclinical or preliminary clinical data that demonstrates the potential to address an unmet medical need in the intended
patient population. The FDA will