Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 22

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 22
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-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 100% (N=6),
with no occurrence of CRS above grade 1 and no ICANS of any grade, despite not using prophylactic tocilizumab or dexamethasone.

In March 2024, we announced plans to collaborate
with Fred Hutch for a proof-of-concept Phase 1 investigator-sponsored clinical trial evaluating MB-106 in autoimmune diseases.

In March 2024, we were granted the Regenerative
Medicine Advanced Therapy (“RMAT”) designation by the FDA for the treatment of relapsed or refractory CD20 positive WM and
FL, based on potential improvement in response as seen in clinical data to date. Drugs eligible for RMAT designation are those intended
to treat, modify, reverse or cure a serious or life-threatening disease or condition, and that present preliminary clinical evidence indicating
the drug has the potential to address unmet medical needs for such disease or condition. RMAT designation provides regenerative medicine
advanced therapy products with the same benefits to expedite the development and review of a marketing application that are available
to drugs that receive Breakthrough Therapy Designation.

In June 2024, we announced that updated data for
MB-106 in the Phase 1/2 Fred Hutch investigator-sponsored trial showed a favorable safety and efficacy profile in 10 patients with WM.