Company: MBIO
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001410578-25-000028
Chunk: 30

Company: MUSTANG BIO, INC.
Filing Date: 2025-01-15
Form: S-1
Chunk 30
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ization, of our technologies and any product candidates that may occur would require us to successfully perform a variety of functions, including:

| ● | developing our technology platform; |

| ● | identifying, developing, formulating, manufacturing and, if approved, commercializing product candidates; |

| ● | entering into successful licensing and other arrangements with product development partners; |

| ● | participating in regulatory approval processes, including ultimately gaining approval to market a drug product, which may not occur; |

| ● | obtaining sufficient quantities of our product candidates from our third-party manufacturers to meet clinical trial needs and, if approved, to meet commercial demand at launch and thereafter; |

| ● | establishing and maintaining agreements with wholesalers, distributors and group purchasing organizations on commercially reasonable terms; |

| ● | conducting sales and marketing activities including hiring, training, deploying and supporting our sales force and creating market demand for our product candidates through our own marketing and sales activities, and any other arrangements to promote our product candidates that we may establish; |

| ● | maintaining patent protection and regulatory exclusivity for our product candidates; and |

| ● | raising additional required capital on acceptable terms. |

Our operations have historically been limited to organizing the Company, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data or clinical data for various product candidates. These operations provide a limited basis for you to assess our ability to continue to develop our technology, identify product candidates, develop and commercialize any product candidates we are able to identify and enter into successful collaborative arrangements with other companies, as well as for you to assess the advisability of investing in our securities. Each of these requirements will require substantial time, effort and financial resources. Each of our product candidates will require additional clinical development, management of clinical and manufacturing activities, regulatory approval in the jurisdictions in which we plan to market the product, obtaining manufacturing supply, building a commercial organization, and significant marketing efforts before we generate any revenues from product sales, which may not occur. We are not permitted to market or promote any of our product candidates in the U.S. or any other jurisdiction before we receive regulatory approval from the FDA or comparable foreign regulatory authority, respectively, and we may never receive such regulatory approval for any of our product candidates. Our approach to the development of our product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value. Our product candidates are emerging technologies and, consequently, it is conceivable that such technologies may ultimately fail to develop into commercially viable therapies to treat