Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 83

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 83
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-Centered Outcomes Research Institute
to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along 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 spending.

Since its enactment, there have been executive,
judicial, and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments
to the ACA in the future. Drug pricing continues to be a subject of debate at the executive

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and legislative levels of U.S. government. The
American Rescue Plan Act of 2021 signed into law by President Biden on March 14, 2021 includes a provision that eliminated the statutory
cap on rebates drug manufacturers pay to Medicaid beginning in January 2024. With the elimination of the rebate cap, manufacturers may
be required to compensate states in an amount greater than what the state Medicaid programs pay for the drug. Additionally, the Inflation
Reduction Act of 2022 (“IRA”) contains substantial drug pricing reforms, including the establishment of a drug price negotiation
program within the U.S. Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum
fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements
on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires
manufacturers to provide discounts on Part D drugs. Substantial penalties can be assessed for noncompliance with the drug pricing provisions
in the IRA. Although the IRA exempts orphan drugs that treat only one rare disease from the drug pricing negotiation provisions, we do
not know if additional drug pricing reforms could eliminate this exemption. The IRA could have the effect of reducing the prices we can
charge and reimbursement we receive for our product candidates, if approved, thereby reducing our profitability, and could have a material
adverse effect on our financial condition, results of operations, and growth prospects. The effect of the IRA on our business and the
pharmaceutical industry in general is not yet known.

At the state level, legislatures have increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency