Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 208

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 208
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The Affordable Care Act
also expanded the Public Health Service’s 340B drug pricing program, which requires participating manufacturers to agree to charge
statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient
drugs. The Affordable Care Act expanded the 340B program to include additional types of covered entities: certain freestanding cancer
hospitals, critical access hospitals, rural referral centers, and sole community hospitals, each as defined by the Affordable Care Act.
Because the 340B ceiling price is determined based on AMP and Medicaid drug rebate data, revisions to the Medicaid rebate formula and
AMP definition could cause the required 340B discounts to increase.

The American Rescue Plan
Act of 2021 eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s AMP, for single source
and innovator multiple source drugs, beginning January 1, 2024. Payment methodologies may be subject to changes in healthcare legislation
and regulatory initiatives as well. For example, CMS may develop new payment and delivery models, such as bundled payment models.

Recently, there has been
heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. Such scrutiny has resulted
in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,
bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of
drugs under Medicare, and reform government program reimbursement methodologies for pharmaceutical products.

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
measures, and in some cases, designed to encourage importation from other countries and bulk purchasing.

We expect that additional
federal, state, and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal
and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced
demand for our products, once approved, or additional pricing pressures.

Employees and Human Capital Resources

As of December 2, 2024,
we had six full-time employees, all are conducting Research and Development. Our employees are not represented by labor unions or covered
by collective bargaining agreements and we consider our relationship with our employees to be good.

Compensation