Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 79

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 79
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 supply chain, including imposition of tariffs, and impact our or our
third-party manufacturers’ ability to obtain raw materials or other products necessary to manufacture our product candidates. There
are a limited number of suppliers for raw materials and equipment that we use (or that are used on our behalf) to manufacture our product
candidates, and there may be a need to assess alternate suppliers to prevent a possible disruption

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of the manufacture of the materials and equipment
necessary to produce our product candidates for our preclinical and clinical trials, and if approved, ultimately for commercial sale.
We do not have any control over the process or timing of the acquisition of these raw materials or equipment by our third-party manufacturers.
Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing preclinical or clinical
trial due to the need to replace a third-party manufacturer could considerably delay completion of our preclinical or clinical trials,
product testing and potential regulatory approval of our product candidates. If our manufacturers or we are unable to purchase these raw
materials or equipment after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates
would be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product
candidates.

The facilities used by contract manufacturers
to potentially manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we
submit a New Drug Application (“NDA”) or BLA to the FDA. We are required by law to establish adequate oversight and control
over raw materials, components and finished products furnished by our contract manufacturers, but we do not control the day-to-day manufacturing
operations of, and are dependent on, the contract manufacturers for compliance with current Good Manufacturing Practices (“cGMP”)
regulations for manufacture of our product candidates. Third-party manufacturers may not be able to comply with the cGMP regulations or
similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with
applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, restrictions on imports
and exports, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates
or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

One or more of the product candidates that