Mustang Bio (MBIO) risk factors, FY2025 10-K

Risks Related to Our Finances and Capital Requirements

1. 01Our limited operating history makes it difficult to evaluate our business and prospects
2. 02SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3
3. 03Raising additional capital, including through lending arrangements, may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights
4. 04We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives
5. 05We are a "smaller reporting company," and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
6. 06Our ability to use our pre-change net operating loss carryforwards and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation

Risks Related to Our Business Strategy, Structure, and Organization

1. 07We currently have no products for sale. We are heavily dependent on the success of our product candidates, and we cannot give any assurances that any of our product candidates will receive regulatory approval or be successfully commercialized
2. 08Our 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
3. 09CAR T is a relatively new approach to cancer treatment that presents significant challenges 44% rewritten
4. 10We 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 profitable or for which there is a greater likelihood of success
5. 11Delays in the commencement or conduct of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval
6. 12Suspensions or delays in the completion of clinical testing could result in increased costs, and delay or prevent our ability to complete development of that product candidate or generate product revenues, if approved
7. 13Product candidates that we advance into clinical trials may not receive regulatory approval
8. 14Any product candidates we advance into clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize product candidates
9. 15Regulatory approval for our product candidates by the FDA, or any similar regulatory authorities outside the United States, is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated
10. 16If serious adverse events are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit the development of some of our product candidates21% rewritten
11. 17Even if one or more of our product candidates receives regulatory approval, it and any other products we may market will remain subject to substantial regulatory scrutiny
12. 18We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business
13. 19Public concern regarding the safety of drug products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs
14. 20If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
15. 21If our competitors develop treatments for any of our product candidates’ target indications and those competitor products are approved more quickly, marketed more successfully or demonstrated to be more effective, the commercial opportunity for our product candidate will be reduced or eliminated
16. 22If any of our product candidates are successfully developed but, if approved, do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that any such product candidates generate from sales will be limited
17. 23Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our products profitably
18. 24If we are unable to establish sales, marketing and distribution capabilities or to enter into agreements with third parties to market and sell our product candidates, we may be unsuccessful in commercializing our product candidates, if they are approved
19. 25We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for one or more of our product candidates or a future product candidate, if approved, we may license or acquire and may have to limit their commercialization
20. 26Product candidates, even if successfully developed and commercialized, may be effective only in combating certain specific types of cancer, and the market for drugs designed to combat such cancer type(s) may be small and unprofitable
21. 27Negative public opinion and increased regulatory scrutiny of the therapies that underpin many of our product candidates may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates
22. 28Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operationsNew

Risks Related to Reliance on Third Parties

1. 29We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or complying with applicable regulatory requirements 26% rewritten
2. 30will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, if approvedNew
3. 31We are currently reliant on COH, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates
4. 32Future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that may receive marketing approval on a timely and competitive basis
5. 33We do not independently conduct our LV vector production and we currently rely, and expect to continue to rely, on third parties with respect to the manufacture of this item
6. 34We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable
7. 35We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms 23% rewritten
8. 36Collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return62% rewritten

Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries

1. 37We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital89% rewritten
2. 38along with funding for such research; and established a Center for Medicare and Medicaid Innovation (“CMMI”) at the CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spendingNew
3. 39Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictableNew
4. 40If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks Related to Intellectual Property and Potential Disputes Thereof

1. 41If we are unable to obtain and maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired
2. 42We depend on our licensors to maintain and enforce the intellectual property covering certain of our product candidates . We have limited, if any, control over the resources that our licensors can or will devote to securing, maintaining, and enforcing patents protecting our product candidates
3. 43Protecting our proprietary rights is difficult and costly, and we may be unable to ensure their protection
4. 44We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and an unfavorable outcome in any litigation would harm our business
5. 45If we or our licensors are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business
6. 46Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
7. 47If we fail to comply with our obligations under our intellectual property licenses and third-party funding arrangements, we could lose rights that are important to our business53% rewritten
8. 48We may be subject to claims that our employees and/or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients
9. 49If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
10. 50We in-license intellectual property pertaining to certain product candidates from third parties. As such, any dispute with the licensors or the non-performance of such license agreements may adversely affect our ability to develop and commercialize the applicable product candidates

Risks Relating to Our Control by Fortress

1. 51Fortress controls a voting majority of our common stock
2. 52Fortress has the right to receive a significant grant of shares of our common stock annually which will result in the dilution of your holdings of common stock upon each grant, which could reduce their value
3. 53We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress
4. 54The dual roles of our directors who also serve in similar roles with Fortress could create a conflict of interest and will require careful monitoring by our independent directors
5. 55General Risks and Risks Associated with Ownership of our Common StockNew
6. 56If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, and could result in financial, legal, business, and reputational harm to us69% rewritten
7. 57not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations, or hostile foreign governments or agenciesNew
8. 58Our growth is subject to economic and geopolitical conditions31% rewritten
9. 59We may not be able to manage our business effectively if we are unable to attract and retain key personnel
10. 60The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits, or we could lose key data which could cause us to curtail or cease operations56% rewritten
11. 61The market price for our common stock has been volatile and may continue to fluctuate or may decline significantly in the future29% rewritten
12. 62We may become involved in securities class action litigation that could divert management’s attention and harm our business
13. 63If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock may be delisted from Nasdaq96% rewritten
14. 64On February 10, 2025, we completed a best-efforts public offering for net proceeds of approximately $6.8 million, and we were subsequently notified by the Staff that we had regained compliance with the Equity Rule and are subject to mandatory monitoring by a Nasdaq Hearings Panel for one yearNew