Company: CERO
Filing Date: 2025-07-21
Form Type: S-1
Source: 0001213900-25-066152
Chunk: 19

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-07-21
Form: S-1
Chunk 19
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, 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 New Keystone Purchase Agreement, we entered into the New Keystone Registration Rights Agreement, pursuant to which we agreed to provide Keystone with customary registration rights related to the shares issued under the New 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 we hold our response until after receipt of such letter (the “Hold Letter”). We received the Hold Letter on July 26, 2024 and submitted a complete response letter to the FDA on October 21, 2024 in which we requested a meeting to address the FDA’s questions. On November 15, 2024, we received notice from the FDA that the IND for CER-1236 was cleared. In May 2025, we initiated our Phase 1 clinical trial, designed to evaluate the safety, potential therapeutic utility and applicable dose of CER-1236 in patients with acute myeloid leukemia. 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. In July 2025, CER-1236 received an FDA Orphan Drug Designation for the treatment of acute myeloid leukemia. 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 trading price for Common Stock closed under $0.10 and was the tenth consecutive trading day to do so. On October 24, 2024