Cero Therapeutics Holdings, Inc. is a biotechnology company focused on developing therapies, especially innovative approaches involving bi-functional T-cells, with a strategic emphasis on research, development, and regulatory approvals.

# CERO THERAPEUTICS HOLDINGS, INC. Company Summary

**Business Focus:**
- Cero Therapeutics Holdings, Inc. is a biotechnology company focused on the development of therapies, with particular emphasis on innovative approaches within the biopharmaceutical industry.
- The company possesses licenses to share technologies related to creating bi-functional T-cells, which are part of their research and development efforts.

**Key Operations & Activities:**
- The company has engaged in multiple financing activities and collaborative agreements to fund its research and clinical development.
- It has entered into several strategic agreements, including collaboration and option agreements, licensing, and purchase agreements.
- Cero is involved in ongoing efforts to obtain regulatory approvals for its therapies and product candidates, such as IND (Investigational New Drug) submissions to the FDA.

**Workforce and Customers:**
- As of April 24, 2025, the company has approximately 5,578,791 shares of common stock outstanding.
- The company has a leadership team with a total of 8 directors and executive officers, with a focus on biotech, investment, and clinical development expertise.
- The company does not specify the number of customers, as it appears to be in the development stage with no established commercial customer base.

**Financials:**
- The detailed financial data such as revenue, net income, or number of customers has not been included in the provided document.
- No specific revenue, income, or customer count data is available in the excerpt.
- The company has raised capital through several financings, including issuances of preferred stock, warrants, and direct stock offerings, totaling millions of dollars.

**Additional Details:**
- The company operates under multiple stock plans, including equity incentive plans for employees and directors.
- It maintains governance policies, including director independence, risk oversight, and related-party transaction procedures.
- The company has not held an annual meeting of stockholders during 2024.

**Note:**
- The company is classified as a "smaller reporting company" and an "emerging growth company."
- The information provided focuses on corporate governance, executive compensation, and strategic financing arrangements rather than operational or financial performance metrics such as revenue or profits.

A biotechnology company developing innovative CER-T cell therapeutics for cancer treatment, particularly in hematological malignancies and solid tumors.

## Company Overview

### Business Model and Focus
- **Industry**: Biotechnology, specifically in cancer treatment through innovative immunotherapy.
- **Core Technology**: The company develops next-generation **engineered T cell therapeutics** known as **CER-T cells**. These cells integrate features from both the innate and adaptive immune systems, enhancing the immune response against tumors.
- **Lead Product**: **CER-1236**, which targets phosphatidylserine (PS) on tumor cells, enabling phagocytosis and enhanced immune activation.

### Goals
- The goal is to address unmet medical needs in **hematological malignancies** (e.g., Acute Myeloid Leukemia (AML), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)) and **solid tumors** (e.g., non-small cell lung cancer (NSCLC), ovarian cancer).

### Market Opportunity
- **Patient Population**:
  - Approximately 20,240 new cases of AML anticipated in the U.S. in 2023 with a mortality rate of 56.3%.
  - Around 4,800 new cases of MCL and approximately 19,000 cases of CLL are expected.
  - Solid tumors accounted for over 1.7 million of the 1.9 million newly diagnosed cancer cases in 2022.

### Financial Information
- **Employees**: 
  - As of April 1, 2024, the company had **nine employees** (eight full-time and one part-time).
- **Financial Performance**:
  - **Revenue**: Currently, the company has not generated any revenue, as it is in the preclinical stage.
  - **Net Losses**: The company reported net losses of approximately **$7.5 million** for the year ended December 31, 2023, and **$11.8 million** for 2022. The accumulated deficit stands at **$42.2 million** as of December 31, 2023.
- **Funding**: The company has primarily funded its operations through proceeds from equity securities in private financings.

### Current Development Stage
- The company is nearing completion of extensive **preclinical testing and studies** for CER-1236, with the aim to file an **Investigational New Drug (IND)** application in **2024**. 
- The data suggests that CER-1236 exhibits target-dependent activation, anti-tumor cytokine production, phagocytosis of tumor cells, and a distinct immune profile that could enhance its functionality compared to existing therapies.

### Strategic Goals
- The company aims to leverage existing CAR-T technology while developing its proprietary CER-T therapy and ultimately provide innovative treatment solutions for various cancers. It plans to explore strategic partnerships for selected indications to maximize its pipeline's value.

### Regulatory Oversight
- The immunotherapy products under development are subject to robust regulatory frameworks that govern the clinical development and approval process. The company is in the process of preparing for regulatory submissions and is aiming for swift advancement through clinical trials.

### Clinical Development Plans
- Initial clinical trials are focused on relapsed or refractory AML patients and difficult-to-treat B-cell malignancies. Following successful trials in hematological cancers, the company plans to expand the clinical development of CER-1236 to include solid tumors. 

This summary outlines the innovative approach that the company is taking to develop cancer therapies, highlighting its financial status, workforce, market potential, and strategic objectives while underlining the challenges it faces in the regulatory and competitive landscape.

CERO THERAPEUTICS HOLDINGS, INC.

10-K / April 28, 2025

10-K / April 2, 2024

10-K / April 28, 2025

CERO THERAPEUTICS HOLDINGS, INC. Company Summary