Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 34

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 34
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 Agreement that
has been consumed or transferred to a third party by uBriGene since the closing of the Prior Asset Purchase Agreement.

Finally, on February 7, 2025, we entered into
the First Amendment to the lease agreement with WCS - 377 Plantation Street, Inc., pursuant to which the lease was terminated,
which became effective on February 21, 2025. On February 27, 2025, we announced the relocation of our corporate headquarters to 95 Sawyer
Road, Waltham, Massachusetts. Going forward, we expect to continue to rely on our academic partners and future contract manufacturing
relationships to support cell processing for clinical trials of our CAR T products.

Furthermore, we expect to rely on contract manufacturing
relationships for LV vectors and for the MB-108 oncolytic virus, as well as for any non-CAR T products that we may in-license or acquire
in the future. However, there can be no assurance that we will be able to successfully contract with such manufacturers on terms acceptable
to us, or at all.

Contract manufacturers for these current and potential
future non-CAR T products would be subject to ongoing periodic and unannounced inspections by the FDA, and corresponding state agencies,
to ensure strict compliance with the current Good Manufacturing Practice regulations (“cGMP”) and other state and federal
regulations. Our contractors, if any, in Europe would face similar challenges from the numerous EU and member state regulatory agencies
and authorized bodies. We do not have control over third-party manufacturers’ compliance with these regulations and standards, other
than through contractual obligations. If they are deemed out of compliance with cGMPs, product recalls could result, inventory could be
destroyed, production could be stopped, and supplies could be delayed or otherwise disrupted.

If we need to change manufacturers for these current
and potential future non-CAR T products after commercialization, the FDA and corresponding foreign regulatory agencies must approve these
new manufacturers in advance, which will involve testing and additional inspections to ensure compliance with FDA regulations and standards
and may require significant lead times and delay. Furthermore, switching manufacturers may be difficult because the number of potential
manufacturers is limited. It may be difficult or impossible for us to find a replacement manufacturer quickly or on terms acceptable to
us, or at all.

​

GOVERNMENT AND INDUSTRY REGULATIONS

Numerous governmental authorities, principally
the FDA and corresponding state and foreign regulatory agencies, impose substantial regulations upon the clinical development, manufacture