Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 288

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 2
Chunk 288
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 plan includes:

●Recruiting additional qualified accounting personnel
with expertise in financial reporting and complex financial instruments;

●Engaging third-party consultants to assist with
technical accounting matters; and

●Implementing enhanced financial reporting systems
and internal controls.

Execution of this remediation plan is contingent upon the availability
of adequate financial resources.

Changes
in Internal Control Over Financial Reporting

During
the most recently completed fiscal quarter, there has been no change in our internal control over financial reporting that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting.

40

PART
II - OTHER INFORMATION

Item
1. Legal Proceedings

From
time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities.
Although the results of litigation and claims cannot be predicted with certainty, as of June 30, 2025, we do not believe we are party
to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably
expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because
of defense and settlement costs, diversion of management resources and other factors.

Item
1a. Risk Factors

Except
as set forth below, there have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year
ended December 31, 2024, filed with the SEC on April 15, 2025. Any of these factors could result in a significant or material adverse
effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem
immaterial may also impair our business or results of operations.

We
may pursue orphan drug designation for certain of our product candidates, and we may not be able to obtain such designation, or obtain
or maintain the benefits of such designation including orphan drug exclusivity, and even if we do, that exclusivity may not prevent regulatory
authorities from approving other competing products.

In
June 2025, the FDA granted orphan drug designation to CER-1236 for the treatment of AML. We may seek orphan designation for additional
product candidates in the future; however, we may never receive such designations. Under the Orphan Drug Act, the FDA may designate a
product as an orphan drug if it is a drug or biologic intended to treat a rare disease