Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 11

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 11
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stitution trial under the COH IND to treat patients with IL13Rα2+
recurrent GBM and high-grade astrocytoma with MB-109 that could potentially be initiated in the fourth quarter of 2025. Because cell processing
for MB-101 will revert back to COH – where the product continues to be manufactured today for other investigator-sponsored clinical
trials being conducted by COH in malignant brain tumors (NCT04003649, NCT04661384, NCT04510051), we believe that it is reasonable to assume
that the FDA will not require the aforementioned lead-in cohort. Should this, indeed, be the case, the first patient enrolled will receive
the combination of MB-101 and MB-108, which will represent a considerable savings of time and money – as well as afford the potential
benefit of both therapies to every patient treated on study

In the first quarter of 2024, we completed a successful
End-of-Phase 1 meeting with the FDA regarding a potential pivotal Phase 2 single-arm clinical trial for the treatment of WM. Per the discussions,
the FDA agreed with the proposed overall design of the pivotal trial for Waldenstrom macroglobulinemia (“WM”) at the recommended
dose of 1 x 107 CAR-T cells/kg and requested only minimal modifications to the
study protocol. No additional nonclinical studies are expected prior to Phase 2 or a Biologics License Application (“BLA”)
filing, although the need for additional nonclinical studies after completion of Phase 2 and prior to submission of a BLA is subject to
discussions with FDA. Due to limited resources, and as a result of the reduction in work force described below, we do not expect to initiate
our pivotal Phase 2 single-arm clinical trial of MB-106 for the treatment of WM trial in 2025. Subject to available funds, we intend to
rely on third party service providers to conduct study and manufacturing services to advance our priority potential product candidates.

Also in the first quarter of 2024, we completed
enrollment of the indolent lymphoma arm in our multicenter Phase 1 trial. The tenth and final patient enrolled on that arm was a patient
with follicular lymphoma (FL) who achieved a complete response following treatment with 1 x 107
CAR-T cells/kg. As a result, the overall complete response rate for FL in the Phase 1 portion of this trial was sustained at