Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 10

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 10
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: NCT05360238). In 2023,
we received Safety Review Committee approval to continue dose escalation in all three active arms of the ongoing Mustang-sponsored Phase
1 trial. We presented the latest results, demonstrating a favorable safety profile, complete response rate, and durability, from the ongoing
Mustang-sponsored Phase 1 trial at the 2023 American Society of Hematology (“ASH”) Annual Meeting. Pursuant to termination
of the lease for our cell processing center in Worcester, MA, we are exploring with Fred Hutch the possibility of initiating a Phase 1
trial in autoimmune diseases as an investigator-sponsored single-institution study at Fred Hutch in the fourth quarter of 2025.

In October 2023, we received a safe-to-proceed
letter from the FDA for our MB-109 IND application allowing us to initiate a Phase 1, open-label, non-randomized, multicenter study of
MB-109 in patients with IL13Rα2+ recurrent GBM and high-grade astrocytoma. In this Phase 1 clinical study, we intend to evaluate
the combination of CAR-T cells (MB-101) and the herpes simplex virus type 1 oncolytic virus (MB-108) in patients with IL13Rα2+ high-grade
gliomas. The design of this study involves first a lead-in cohort, wherein patients are treated with MB-101 alone without prior MB-108
administration. After successful confirmation of the safety profile of MB-101 alone, the study will then investigate increasing doses
of intratumorally administered MB-108 followed by dual intratumoral (ICT) and intraventricular (ICV) administration of MB-101.

On November 7, 2024, we announced that the FDA
granted Orphan Drug Designation to Mustang for MB-108, a herpes simplex virus type 1 (“HSV-1”) oncolytic virus, for the treatment
of malignant glioma. The Orphan Drug Designation provides certain incentives, such as tax

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credits toward the cost of clinical trials upon
approval and prescription drug user fee waivers. If a product receives Orphan Drug Status from the FDA, that product is entitled to seven
years of market exclusivity for the disease in which it has Orphan Drug Designation, which is independent from intellectual property protection.

We are currently exploring with COH and Nationwide
the possibility of conducting an investigator-sponsored single-in