Company: CERO
Filing Date: 2025-05-27
Form Type: POS AM
Source: 0001213900-25-047469
Chunk: 19

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-27
Form: POS AM
Chunk 19
---
, including the effectiveness of the registration statement of which this prospectus forms a part. We will control the timing and amount of any sales of Common Stock to Keystone. Actual sales of shares of Common Stock to Keystone under the Keystone Purchase Agreements will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding and our operations. Concurrent with the execution of the November 2024 Keystone Purchase Agreement, we entered into the November 2024 Keystone Registration Rights Agreement, pursuant to which we agreed to provide Keystone with customary registration rights related to the shares issued under the November 2024 Keystone Purchase Agreement. Investigational New Drug Application On June 28, 2024, we submitted an investigational new drug application (“IND”) for its product candidate, CER-1236, to the FDA. On July 26, 2024, we were informed by the FDA that it has placed a clinical hold on the IND. 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 received the Hold Letter on July 26, 2024 and submitted a complete response letter to the FDA on October 21, 2024 in which the Company requested a meeting to address the FDA’s questions. On November 15, 2024 the Company received notice from the FDA that the IND for CER-1236 was cleared. The Company currently anticipates beginning clinical trials in the first half of 2025. We submitted a second IND application for the investigation of CER-T cell therapy in NSCLC and ovarian cancer, which was accepted by the FDA on March 27, 2025. 2 Nasdaq Notices of Non-compliance and Nasdaq Panel Decision On July 19, 2024, we received a letter (the “Bid Price Requirement Letter”) from the staff at The Nasdaq Global Market notifying us that, for the 30 consecutive trading days prior to the date of the Bid Price Requirement Letter, the closing bid price for the Common Stock had not been in compliance with the Bid Price Requirement. On October 23, 2024, the