Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 85

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 85
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 reviewed and/or approved by necessary government agencies, which would adversely affect
our business or the business of our partners. The U.S. government has shut down several times in the past, and certain regulatory
agencies, such as the FDA, have had to furlough nonessential FDA employees and stop routine activities. If a prolonged government shutdown
occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have
a material adverse effect on our business. If the timing of FDA’s review and approval of new products is delayed, the timing of
our or our partners’ development process may be delayed, which could result in delayed milestone revenues and materially harm our
operations or business.

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Table of Contents

Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party
payors in the U.S. and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we
obtain marketing approval. Our future arrangements with third-party payors and customers may expose us to broadly applicable fraud and
abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False
Claims Act, which may constrain the business or financial arrangements and relationships through which we sell, market and distribute
any product candidates for which we obtain marketing approval. In addition, we may be subject to transparency laws and patient privacy
regulation by the federal and state governments and by governments in foreign jurisdictions in which we conduct our business. The applicable
federal, state and foreign healthcare laws and regulations that may affect our ability to operate include, but are not necessarily limited
to:

| ● | The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either (1) the referral of an individual to a person for furnishing any item or service for which payment is available under a federal