Company: MBIO
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001410578-25-000028
Chunk: 22

Company: MUSTANG BIO, INC.
Filing Date: 2025-01-15
Form: S-1
Chunk 22
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, we are unable to predict the timing or amount of increased expenses or when or if, we will be able to achieve profitability. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if:

| ● | one or more of our product candidates receive regulatory approval and are approved for commercial sale, due to our need to establish the necessary commercial infrastructure to launch and commercialize this product candidate without substantial delays, including hiring sales and marketing personnel and contracting with third parties for manufacturing, testing, warehousing, distribution, cash collection and related commercial activities; |

| ● | we are required by the FDA or foreign regulatory authorities to perform studies in addition to those currently expected; |

| ● | there are any delays in completing our clinical trials or the development of any of our product candidates; |

| ● | we execute other collaborative, licensing or similar arrangements that require us to make payments to collaborators or licensors; |

| ● | there are variations in the level of expenses related to our future development programs; |

| ● | there are any product liability or intellectual property infringement lawsuits in which we may become involved; and |

| ● | there are any regulatory developments affecting product candidates of our competitors. |

Our ability to become profitable depends upon our ability to generate revenue. To date, 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 ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:

| ● | obtain regulatory approval for one or more of our product candidates, or any future product candidate that we may license or acquire; |

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| ● | manufacture or have manufactured commercial quantities of one or more of our product candidates or any future product candidate, if approved, at acceptable cost levels; and |

| ● | develop a commercial organization and the supporting infrastructure required to successfully market and sell one or more of our product candidates or any future product candidate, if approved. |

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our Company could also cause you to lose all or part of your investment in our Securities. There is substantial doubt