Mustang Bio (MBIO) risk factors, FY2024 10-K

Risks Related to Our Finances and Capital Requirements

1. 01Our short operating history makes it difficult to evaluate our business and prospects
2. 02We will require substantial additional funding which may not be available to us on acceptable terms, or at all. If we fail to raise the necessary additional capital, we may be unable to complete the development and commercialization of our product candidates or continue our development programs
3. 03SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3
4. 04Raising additional capital, including through lending arrangements, may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights
5. 05We 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
6. 06We are a "smaller reporting company," and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
7. 07Our ability to use our pre-change NOLs 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. 08We 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. 09Our 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. 10CAR T is a relatively new approach to cancer treatment that presents significant challenges
4. 11We 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. 12Delays in the commencement or conduct of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval
6. 13Suspensions 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. 14Product candidates that we advance into clinical trials may not receive regulatory approval
8. 15Any 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. 16Regulatory 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. 17defect or error discovered after products have been produced and distributed could result in even more significant consequences, including costly recalls, re-stocking costs, damage to our reputation and potential for product liability claims
11. 18If serious adverse or unacceptable side effects 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 candidates
12. 19Even 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
13. 20We 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
14. 21Public 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
15. 22If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
16. 23If 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
17. 24If 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
18. 25Reimbursement 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
19. 26If 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
20. 27We 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
21. 28Product 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
22. 29Negative 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

Risks Related to Reliance on Third Parties

1. 30We 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
2. 31We are currently reliant on COH, Fred Hutch, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates
3. 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
4. 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 these items
5. 34We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable
6. 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
7. 36Collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return

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 capital
2. 38State law equivalents of each of the above federal laws, such as the Anti-Kickback Statute and False Claims Act, and state laws concerning security and privacy of health care information, which may differ in substance and application from state-to-state thereby complicating compliance efforts
3. 39If 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. 40If 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. 41We 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. 42Protecting our proprietary rights is difficult and costly, and we may be unable to ensure their protection
4. 43We 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. 44If 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. 45Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
7. 46If 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 business
8. 47We 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. 48If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
10. 49We 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. 50Fortress controls a voting majority of our common stock
2. 51Fortress 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. 52We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress
4. 53The 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. 54Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity
6. 55If 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 us
7. 56Our business could be adversely affected by the effects of health pandemics or epidemics, which could cause significant disruptions in our operations
8. 57Our growth is subject to economic and geopolitical conditions
9. 58We may not be able to manage our business effectively if we are unable to attract and retain key personnel
10. 59We rely on information technology, and any internet or internal computer system failures, inadequacies, interruptions or compromises of our systems or the security of confidential information could damage our reputation and harm our business
11. 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 operations
12. 61The market price for our common stock has been volatile and may continue to fluctuate or may decline significantly in the future
13. 62our ability to obtain additional financing to advance our development operations
14. 63We may become involved in securities class action litigation that could divert management’s attention and harm our business
15. 64If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock may be delisted from Nasdaq