Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 11

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 1
Chunk 11
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 innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment
of cancer. The Company’s proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics
of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire
to achieve optimized cancer therapy. The Company is in early clinical development but has not yet begun product commercialization. The
Company’s efforts will focus on continued product development, including clinical development, to support regulatory approval to
commercialize and subsequent product commercialization.

In
November 2024, the U.S. Food and Drug Administration (“FDA”) cleared the Company’s Investigational New Drug Application
for Phase 1 clinical trial of its lead compound, CER-1236, in acute myelogenous leukemia (“AML”), and in May 2025 announced
the first patient was dosed with CER-1236 in a Phase 1/1b trial of AML. In June 2025, the Company announced the completion of the initial
evaluation of the first patient in its Phase 1/1b trial without any dose-limiting toxicity and dosed the second AML patient in July 2025.

We submitted a second Investigational
New Drug (“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.

Reverse
Stock Splits – On January 8, 2025, the Company effected a reverse stock split of our shares of common stock at a ratio of 1-for-100
and on June 13, 2025, the Company effected a reverse stock split of our shares of common stock at a ratio of 1-for-20 (the “Reverse
Stock Splits”). The Company’s common stock continued to trade on Nasdaq on a post-split basis under the Company’s existing
trading symbol, “CERO”.

All
of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options
and warrants exercisable for common stock in these financial statements have been adjusted, on a retroactive basis, to reflect the Reverse
Stock Splits.

Business
Combination Agreement - On June 6, 2023, CERo Therapeutics, Inc. (“Predecessor”), which was incorporated in Delaware
on September 23, 2016, and based in South San Francisco, California,