Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 80

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 80
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 we
may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number
of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the
part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements
in place for redundant supply. If our current contract manufacturers cannot perform as agreed, we may be required to replace such manufacturers.
We may incur added costs and delays in identifying and qualifying any replacement manufacturers.

Future dependence upon others for the manufacture
of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that
may receive marketing approval on a timely and competitive basis.

We also expect to rely on third parties to distribute
drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing
approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of
potential product revenue.

We rely on third parties to conduct all aspects of our LV vector production and these third parties may not perform satisfactorily.

We do not independently conduct our LV vector
production and we currently rely, and expect to continue to rely, on third parties with respect to the manufacture of these items.

Our reliance on these third parties for manufacturing
LV vector reduces our control over these activities but will not relieve us of our responsibility to ensure compliance with all required
regulations and study protocols. For products that we develop and, if approved, commercialize, we will remain responsible for ensuring
that each of our IND-enabling studies and clinical studies is conducted in accordance with the study plan and protocols, and that our
LV vectors are manufactured in accordance with GMP as applied in the relevant jurisdictions.

If these third parties do not successfully carry
out their contractual duties, meet expected deadlines, conduct our studies in accordance with regulatory requirements or our stated study
plans and protocols, or manufacture our LV vectors in accordance with GMP, we will not be able to complete, or may be delayed in completing,
the preclinical and clinical studies and manufacturing process validation activities required to support future IND, market authorization
application and BLA submissions and approval of our product candidates, or to support commercialization of our products, if approved.
Many of our agreements with these third parties contain termination provisions that allow these third parties to terminate their relationships
with us at any time. If we need to enter into