Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 2409

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 5
Chunk 2409
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 to 2,551,020 shares of common stock, at a combined public offering price of $1.96 per share and warrant.
In connection with the offering, on February 5, 2025, we entered into the SPA with the investors. Such transaction is referred to as the
“February 2025 Offering.” The shares of Common Stock and the Warrants described above and the shares of Common Stock underlying
the Warrants were offered pursuant to the Registration Statement on Form S-1 (File No. 333-284007), as amended, which was declared effective
by the Securities and Exchange Commission on February 5, 2025. In connection with this offering, we received net proceeds of approximately
$4.5 million.

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 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.

Nasdaq Notices of Non-compliance
and Nasdaq Panel Decision

On July 19, 2024, the Company
received a letter (the “Bid Price Requirement Letter”) from the staff at The Nasdaq Global Market notifying the Company that,
for the 30 consecutive trading days prior to the date of the Bid Price Requirement Letter, the closing bid price for the