Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 37

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 37
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-controlled clinical trials that establishing
that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that
can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity
or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or
lack of alternative treatments. As a condition of approval, the FDA may require a sponsor of a drug receiving accelerated approval to
perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint
and under the Food and Drug Omnibus Reform Act of 2022 (FDORA), the FDA is now permitted to require, as appropriate, that such trials
be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval.
Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a drug or indication approved under accelerated
approval if, for example, the confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, the FDA generally
requires, unless otherwise informed by the agency, pre-approval of promotional materials, which could adversely impact the timing of the
commercial launch of the product.

Even if a product candidate qualifies for one
or more of these programs, the FDA may later decide that the product candidate no longer meets the conditions for qualification or decide
that the time period for FDA review or approval will not be shortened. Furthermore, fast track designation, priority review, accelerated
approval and breakthrough therapy designation, do not change the standards for approval and may not ultimately expedite the development
or approval process.

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Table of Contents

Clinical Trials

To support a new drug application (“NDA”)
or biologics license application (“BLA”) approval, clinical trials are typically conducted in the following sequential phases:

| ● | Phase 1: The drug is administered to a small group of humans, either healthy volunteers or patients, for the first time to test for safety, dosage tolerance, absorption, metabolism, excretion and clinical pharmacology. |

| ● | Phase 2: Studies are conducted on a larger number of patients to assess the efficacy of the product, to ascertain dose tolerance and the optimal dose range, and to gather additional data relating to safety and potential adverse events. |

| ● | Phase 3: Studies establish safety and