Company: CERO
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001213900-25-044335
Chunk: 61

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-05-15
Form: 10-Q
Item: Item 1
Chunk 61
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 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, 2025.

Nasdaq Notices of Non-compliance
and Nasdaq Panel Decision

As previously disclosed,
on January 17, 2025, the Company received a letter setting forth the determination of a panel convened by Nasdaq (the “Nasdaq Panel”)
granting the Company’s request for an extension (the “Extension”) to regain compliance with certain continued listing
requirements of the Nasdaq Stock Market until April 22, 2025 (the “Extension Date”). The Company presented its plan (the “Plan”)
for regaining compliance with such requirements at a hearing conducted on December 17, 2025. The Company’s Plan included completion
of a reverse stock split, which occurred on January 8, 2025, and transferring the listing of its securities to the Nasdaq Capital Market,
which was completed on February 12, 2025, and certain other conditions, including the satisfaction of the $2.5 million minimum stockholders’
equity requirement for continued listing on the Nasdaq Capital Market.

In addition, as previously disclosed, from November 2024 through January
2025, the Company raised approximately $2.3 million of net proceeds from its equity line of credit entered into November 2024, and an
additional approximately $4.3 million of net proceeds from its public offering of shares of common stock, pre