Company: CERO
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001213900-25-044335
Chunk: 108

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-15
Form: 10-Q
Item: Item 2
Chunk 108
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 Financing

On April 21, 2025, the Company
consummated a private placement of 6,250 shares of Series D Preferred Stock pursuant to the Securities Purchase Agreement, for aggregate
proceeds of approximately $5 million, paid through the transfer of certain Transfer Shares (as defined in the Securities
Purchase Agreement) in lieu of cash, and agreed to issue up to 3,750 additional shares of Series D Preferred Stock for cash proceeds of
up to $3 million at one or more additional closings. Each additional closing is at the option of the investors upon notice to the Company
and subject to satisfaction of customary closing conditions.

On April 22, 2025, the Company
filed the Certificate of Designations of Rights and Preferences of the Series D Preferred Stock (the “Certificate of Designations”)
for the purpose of designating and establishing the Company’s Series D Preferred Stock. The Certificate of Designations was filed
pursuant to the Securities Purchase Agreement, dated April 21, 2025, with certain accredited investors named therein. The Certificate
of Designations became effective on April 22, 2025.

Investigational New Drug
Application Submission

On June 28, 2024, the Company
submitted an Investigational New Drug Application (“IND”) for its product candidate, CER-1236, to FDA. On July 26, 2024, the
Company was 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 began clinical trials in May 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,