Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 138

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 8
Chunk 138
---
CERO THERAPEUTICS HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2025

(Unaudited)

NOTE
1 – ORGANIZATION AND DESCRIPTION OF THE BUSINESS

Nature
of Operations – CERo Therapeutics Holdings, Inc. (NASDAQ: CERO) (“CERo”, “Successor” or the “Company”),
F/K/A Phoenix Biotech Acquisition Corp. (“PBAX”) was incorporated in Delaware on June 8, 2021. PBAX was formed for the purpose
of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with
one or more businesses (a “business combination”).

The
Company is an 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