Material Event Form 8 K

Item 8.01. Other Events.

On July 26, 2024, CERo Therapeutics Holdings, Inc., a Delaware corporation (the "Company"), was informed by telephone, subsequently confirmed in writing (the "FDA Communication"), that the Food and Drug Administration (the "FDA") has placed a clinical hold on the Company's Investigational New Drug Application ("IND") with respect to its product candidate, CER-1236. The FDA indicated that the clinical hold has been placed as a result of insufficient data provided with regard to two issues within pharmacology and toxicology of CER-1236.

The FDA indicated that, within 30 calendar days, it would provide a detailed official hold letter and requested that the Company hold its response until after receipt of such letter (the "Hold Letter").

The Company plans to work expeditiously to resolve this clinical hold so that CER-1236 may proceed to the clinic, including by beginning scientific experimental activities to address the two issues based upon the FDA Communication, as well as earlier discussions with the FDA. Notwithstanding the FDA Communication and pending receipt of the Hold Letter, the Company continues to believe that it will be able to initiate the planned clinical trial by the end of 2024.