Company: MBIO
Filing Date: 2025-02-07
Form Type: 424B4
Source: 0001410578-25-000085
Chunk: 28

Company: MUSTANG BIO, INC.
Filing Date: 2025-02-07
Form: 424B4
Chunk 28
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 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 human patients with cancer or other diseases. One of the reasons for the lack of commercial viability could be our inability to obtain regulatory approval for such technologies. CAR T is a new approach to cancer treatment that presents significant challenges. We have concentrated much of our research and development efforts on CAR T technology, and our future success is highly dependent on the successful development of T cell immunotherapies in general and our CAR T technology and product candidates in particular. Because CAR T is a relatively new approach to cancer immunotherapy and cancer treatment generally, developing and commercializing our product candidates subjects us to a number of challenges, including, but not necessarily limited to:

| ● | obtaining regulatory approval from the FDA and other regulatory authorities that may have very limited experience with the commercial development of genetically modified T cell therapies for cancer; |

| ● | developing and deploying consistent and reliable processes for engineering a patient’s T cells ex vivo and infusing the engineered T cells back into the patient; |

| ● | conditioning patients with chemotherapy in conjunction with delivering each of our products, which may increase the risk of adverse side effects of our product candidates; |

| ● | educating medical personnel regarding the potential side effect profile of each of our product candidates; |

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| ● | developing processes for the safe administration of these product candidates, including long-term follow-up for all patients who receive our product candidates; |

| ● | sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates; |

| ● | developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment; |

| ● | establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party payors and government authorities; and |

| ● | developing therapies for types of cancers beyond those addressed by our current product candidates. |

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more