Company: MBIO
Filing Date: 2025-02-05
Form Type: S-1/A
Source: 0001104659-25-009408
Chunk: 16

Company: MUSTANG BIO, INC.
Filing Date: 2025-02-05
Form: S-1/A
Chunk 16
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 the following: Risks Related to our Finances and Capital Requirements

| ● | We have incurred significant losses since our inception and anticipate that we will incur continued losses for the foreseeable future. |

| ● | There is substantial doubt regarding our ability to continue as a going concern. We will need to raise additional financing in upcoming periods, which may not be available on acceptable terms to us, or at all. Failure to obtain necessary capital when needed may force us to delay, limit or terminate our potential product candidates. |

| ● | We have not generated any revenue from our development stage products, and we do not know when, or if, we will generate any revenue. |

| ● | Our short operating history makes it difficult to evaluate our business and prospects. |

| ● | Our success is contingent on raising additional capital, and our efforts to do so may fail. Even if successful, our future capital raising activities may dilute our current stockholders, restrict our operations, or cause us to relinquish proprietary rights. |

Risks Pertaining to our Business Strategy, Structure and Organization

| ● | Our future growth and success depend on our ability to successfully develop, and, if approved, commercialize our product candidates, which we have yet to do. |

| ● | Our future success is highly dependent on the successful development of our chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technology and oncolytic virus product candidates. |

| ● | Our strategic pivot for our lead product candidate, MB-106, and our disposal of non-core assets, including our facility, may not result in the cost savings we anticipate and could result in total costs and expenses that are greater than expected. |

Risks Inherent in Drug Development and Commercialization

| ● | Preclinical development is highly speculative and carries a high failure risk. |

| ● | We may not receive the required regulatory approvals for any of our product candidates on our projected timelines, if at all, which may result in increased costs and delay our ability to generate revenue. |

| ● | We may not obtain the desired labeling claims or intended uses for product promotion, or favorable scheduling classifications, to successfully promote our product candidates, if approved. |

| ● | If a product candidate demonstrates adverse side effects, we may need to abandon or limit the development of such product candidate. |

| ● | Even if a product candidate is approved, it may be subject to various post-marketing requirements, including studies or clinical trials, and increased regulatory scrutiny. |

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