Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 62

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 62
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 price we intend to charge for our products, may grant approval contingent on the performance
of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary
or desirable for the successful commercialization of that product candidate. The regulatory authority may also require the label to contain
warnings, contraindications, or precautions that limit the commercialization of the product. Any of these scenarios could impact the commercial
prospects for one or more of our current or future product candidates.

Any 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.

The research and clinical development, testing,
manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of any product candidate,
including our product candidates, is subject to extensive regulation by the FDA in the United States and by comparable health authorities
in foreign markets. In the United States, we are not permitted to market a product candidate until such product candidate’s BLA
or NDA is approved by the FDA. The process of obtaining approval is uncertain, expensive, often spanning many years, and can vary
substantially based upon the type, complexity and novelty of the products involved. In addition to significant and expensive clinical
testing requirements, our ability to obtain marketing approval for product candidates depends on obtaining the final results of required
non-clinical testing, including characterization of the manufactured components of our product candidates and validation of our manufacturing
processes. The FDA may determine that our product manufacturing processes, testing procedures or equipment and facilities are inadequate
to support approval. Approval policies or regulations may change, and the FDA has substantial discretion in the pharmaceutical approval
process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense
invested in the clinical development of product candidates, regulatory approval is never guaranteed.

The FDA and other regulatory agencies can delay,
limit or deny approval of a product candidate for many reasons, including, but not limited to:

| ● | the FDA or comparable foreign regulatory authorities may disagree with the trial design or implementation of our clinical trials, including proper use of clinical trial methods and methods of data analysis; |

| ● | an inability to establish sufficient data and information to demonstrate to the satisfaction of the FDA that a product candidate is safe and effective for an indication; |

| ●