Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 15

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 15
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atumorally. These preclinical studies aimed
to provide a deeper understanding of this combination approach to support the potential benefit of a combination study that will evaluate
HSV-1 OV (MB-108) and IL13Rα2-directed CAR-T cells (MB-101).

In October 2023, we received a safe-to-proceed
“approval” 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 evaluation 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. We are
currently exploring with COH and Nationwide the possibility of conducting an investigator-sponsored single-institution trial under the
COH IND to treat patients with IL13Ra2+ recurrent GBM and high-grade astrocytoma with MB-109 that could potentially be initiated in the
fourth quarter of 2025.

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Table of Contents

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 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.

MB-101 (IL13Rα2 CAR T Cell Program for Glioblastoma)

GBM is the most common brain and central nervous
system (“CNS”) cancer,