Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 264

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 264
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, 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 Common Stock
had not been in compliance with the Bid Price Requirement. On October 23, 2024, the trading price for CERo common stock closed under $0.10
and was the tenth consecutive trading day to do so. On October 24, 2024, the Company received a letter from the staff at The Nasdaq Global
Market notifying the Company that, because its Common Stock had a closing bid price of $0.10 or less for ten consecutive trading days,
it was no longer eligible to rely upon the 180-day cure period set forth in the Bid Price Requirement Letter.

On July 19, 2024, the Company
also received the MVPHS Letter notifying the Company that, for the 30 consecutive trading days prior to the date of the MVPHS Letter,
the Common Stock had not been in compliance with the MVPHS Requirement.

Such letters are in addition
to