Cero Therapeutics Holdings, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Cero Therapeutics Holdings, Inc. has filed its 2023 annual report on Form 10-K, detailing its corporate information and compliance with SEC filing requirements.</b>

AI Summary

CERO THERAPEUTICS HOLDINGS, INC. (CEROW) filed a Annual Report (10-K) with the SEC on April 2, 2024. Cero Therapeutics Holdings, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located in South San Francisco, California. Common stock trades on the Nasdaq Global Market under the symbol CERO, and warrants trade on the Nasdaq Capital Market under the symbol CEROW. The filing indicates the company has submitted all required reports for the preceding 12 months and has been subject to such filing requirements for the past 90 days. Cero Therapeutics Holdings, Inc. has submitted electronically every Interactive Data File required by Rule 405 of Regulation S-T during the preceding 12 months.

Why It Matters

For investors and stakeholders tracking CERO THERAPEUTICS HOLDINGS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Cero Therapeutics' financial and operational status for the fiscal year 2023, which is crucial for investors to assess the company's performance and outlook. The confirmation of compliance with SEC filing requirements and electronic data submission indicates the company is current with its regulatory obligations, which is a positive sign for transparency and governance.

Risk Assessment

Risk Level: low — CERO THERAPEUTICS HOLDINGS, INC. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate negative or positive financial disclosures beyond routine corporate information, indicating a low level of immediate risk from this specific filing.

Analyst Insight

Investors should review the full 10-K filing for detailed financial statements, risk factors, and management's discussion and analysis to form an informed opinion on Cero Therapeutics' current standing and future prospects.

Key Numbers

• 20231231 — Fiscal Year End (Reported period)
• 20240402 — Filing Date (Date of submission)
• 001-40877 — SEC File Number (Commission file number)
• 81-4182129 — IRS Number (Registrant's IRS Employer Identification No.)
• 650-407-2376 — Business Phone (Registrant's telephone number)

Key Players & Entities

• CERO THERAPEUTICS HOLDINGS, INC. (company) — Filer name
• 0001213900-24-029051 (other) — Accession Number
• 20231231 (date) — Fiscal year end
• 20240402 (date) — Filing date
• 0001870404 (other) — Central Index Key
• 2836 (other) — Standard Industrial Classification
• DE (other) — State of Incorporation
• CERO (other) — Trading Symbol for Common Stock

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the annual financial statements.
• 2024-04-02: Filing Date — Date the Form 10-K was officially filed with the SEC.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share CERO Nasdaq Global Market Wa
• $10 billion — everal years and are expected to exceed $10 billion globally by 2030. We believe that the

Filing Documents

• ea0201955-10k_cerothera.htm (10-K) — 1821KB
• ea020195501ex3-6_cerothera.htm (EX-3.6) — 326KB
• ea020195501ex4-5_cerothera.htm (EX-4.5) — 92KB
• ea020195501ex10-13_cerothera.htm (EX-10.13) — 310KB
• ea020195501ex10-14_cerothera.htm (EX-10.14) — 135KB
• ea020195501ex10-15_cerothera.htm (EX-10.15) — 72KB
• ea020195501ex10-16_cerothera.htm (EX-10.16) — 72KB
• ea020195501ex10-17_cerothera.htm (EX-10.17) — 43KB
• ea020195501ex19-1_cerothera.htm (EX-19.1) — 131KB
• ea020195501ex21-1_cerothera.htm (EX-21.1) — 2KB
• ea020195501ex31-1_cerothera.htm (EX-31.1) — 10KB
• ea020195501ex31-2_cerothera.htm (EX-31.2) — 9KB
• ea020195501ex32-1_cerothera.htm (EX-32.1) — 9KB
• ea020195501ex97-1_cerothera.htm (EX-97.1) — 32KB
• image_001.jpg (GRAPHIC) — 391KB
• image_002.jpg (GRAPHIC) — 235KB
• image_003.jpg (GRAPHIC) — 62KB
• image_004.jpg (GRAPHIC) — 283KB
• image_005.jpg (GRAPHIC) — 210KB
• image_006.jpg (GRAPHIC) — 258KB
• image_007.jpg (GRAPHIC) — 224KB
• image_008.jpg (GRAPHIC) — 410KB
• image_009.jpg (GRAPHIC) — 319KB
• image_010.jpg (GRAPHIC) — 124KB
• image_011.jpg (GRAPHIC) — 182KB
• 0001213900-24-029051.txt (&nbsp;) — 15150KB
• cero-20231231.xsd (EX-101.SCH) — 48KB
• cero-20231231_cal.xml (EX-101.CAL) — 26KB
• cero-20231231_def.xml (EX-101.DEF) — 290KB
• cero-20231231_lab.xml (EX-101.LAB) — 436KB
• cero-20231231_pre.xml (EX-101.PRE) — 278KB
• ea0201955-10k_cerothera_htm.xml (XML) — 565KB

Business

Business 1 ITEM 1A.

Risk Factors

Risk Factors 31 ITEM 1B. Unresolved Staff Comments 86 ITEM 1C. Cybersecurity 86 ITEM 2.

Properties

Properties 87 ITEM 3.

Legal Proceedings

Legal Proceedings 87 ITEM 4. Mine Safety Disclosures 87 PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 88 ITEM 6. [Reserved] 89 ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 89 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 94 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 94 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 94 ITEM 9A.

Controls and Procedures

Controls and Procedures 94 ITEM 9B. Other Information 95 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 95 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 96 ITEM 11.

Executive Compensation

Executive Compensation 105 ITEM 12.

Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters 110 ITEM 13. Certain Relationships and Related Party Transactions, and Director Independence 112 ITEM 14. Principal Accountant Fees and Services 113 PART IV ITEM 15. Exhibits and Financial Statement Schedules 114 ITEM 16. Form 10-K Summary 116

Signatures

Signatures 117 i CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act") . All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials, research and development ("R&D") costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify

forward-looking statements by terms such as "may," "will," "should," "would," "expect,"

forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "believe," "estimate," "predict," "potential," or "continue" or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report include, but are not limited to, our financial performance; our ability to obtain additional cash and the sufficiency of our existing cash, cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements, including the development and, if approved, commercialization of our product candidates; our ability to realize the benefits expected from the business combination (the "Business Combination") pursuant to the Business Combination Agreement, dated as of June 4, 2023, as amended from time to time (as amended, the "Business Combination Agreement"), by and among CERo Therapeutics, Inc. ("Legacy CERo"), Phoenix Biotech Acquisition Corp. ("PBAX") and PBCE Merger Sub, Inc. ("Merger Sub"); successfully defend litigation that may be instituted against us in connection with the Business Combination; the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; the scope, progress, results and costs of developing CER-1236 or any other product candidates we may develop, and conducting preclinical studies and clinical trials; the timing and costs involved in obtaining and maintaining regulatory approval of CER-1236 or any other product candidates we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations or accelerated approvals for our drug candidates for various indications; current and future agreements with third parties in connection with the development and commercialization of CER-1236 or any other future product candidate;

Business

Item 1. Business. Overview We are an innovative immunotherapy company advancing the development of next-generation engineered T cell therapeutics for the treatment of cancer. Our proprietary approach to T cell engineering, which enables us 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. Our novel cellular immunotherapy platform is designed to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what we refer to as CER-T cells. We believe the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor T ("CAR-T") cell therapies, for use spanning both hematological malignancies and solid tumors. We are nearing completion of extensive preclinical testing and studies which are needed to obtain regulatory clearance to initiate human clinical trials with CER-1236, and have engaged in a pre-IND meeting with the Federal Drug Administration (the "FDA"). We anticipate filing an investigational new drug ("IND") application and, if allowed to proceed, initiating clinical trials for our lead drug candidate, CER-1236, in 2024. However, manufacturing delays or other delays with IND-enabling studies, among other factors, may impact the timing and approval of such trials. The ability to enhance the activity of T cells against human cancers through genetic engineering has been among the most significant advances in cancer therapy in the last decade. One of the more promising therapeutic uses of T cells to emerge has been CAR-T cell technology. Yet as remarkable a development as CAR-T cell therapy has been, its use has been largely limited to the treatment of certain hematological cancers due to CAR-T cells' limited ability to proliferate

View Full Filing

View this 10-K filing on SEC EDGAR