Oncocyte CORP 10-K Filing

Ticker: IMDX · Form: 10-K · Filed: Apr 16, 2024 · CIK: 1642380

Sentiment: neutral

Filing Stats: 4,360 words · 17 min read · ~15 pages · Grade level 16.1 · Accepted 2024-04-15 21:55:32

Key Financial Figures

Filing Documents

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 22 Item 1B. Unresolved Staff Comments 46 Item 1C. Cybersecurity 46 Item 2.

Properties

Properties 46 Item 3.

Legal Proceedings

Legal Proceedings 46 Item 4. Mine Safety Disclosures 46 Part II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 47 Item 6. [Reserved] 47 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 48 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 60 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 61 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 108 Item 9A.

Controls and Procedures

Controls and Procedures 108 Item 9B. Other Information 109 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 109 Part III. Item 10. Directors, Executive Officers, and Corporate Governance 110 Item 11.

Executive Compensation

Executive Compensation 110 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 110 Item 13. Certain Relationships and Related Transactions, and Director Independence 110 Item 14. Principal Accountant Fees and Services 110 Part IV. Item 15. Exhibits and Financial Statement Schedules 111 Item 16. Form 10-K Summary 116

Signatures

Signatures 117 2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain 1995, including, but not limited to, statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Oncocyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "plan," "project," "seek," "should," "strategy," "target," "will," "would") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Oncocyte, particularly those mentioned in this Annual Report on Form 10-K for the year ended December 31, 2023 (this "Report") under "Risk Factors". Except as required by law, Oncocyte undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such The

forward-looking statements include, among other things, statements about

forward-looking statements include, among other things, statements about: the timing and potential achievement of future milestones; the timing and our ability to obtain and maintain coverage and reimbursements from the Centers for Medicare and Medicaid Services and other third-party payers; our plans to pursue research and development of diagnostic test candidates; the potential commercialization of diagnostic tests currently in development; the timing and success of future clinical research and the period during which the results of the clinical research will become available; the potential receipt of revenue from current sales of our diagnostic tests and/or diagnostic tests in development; our assumptions regarding obtaining reimbursement and reimbursement rates of our current diagnostic tests and/or diagnostic tests in development; our estimates regarding future orders of tests and our ability to perform a projected number of tests; our estimates and assumptions around the patient populations, market size and price points for reimbursement for our diagnostic tests our estimates regarding future revenues, operating expenses, and future capital requirements; our intellectual property position; the impact of government laws and regulations; and our competitive position. Unless the context otherwise requires, all references to "Oncocyte," "we," "us," "our," "the Company" or similar words refer to Oncocyte Corporation, together with our consolidated subsidiaries. The description or discussion, in this Report, of any contract or agreement is a summary only and is qualified in all respects by reference to the full text of the applicable contract or agreement. DetermaIO, DetermaCNI, and VitaGraft are trademarks of Oncocyte, regardless of whether the "TM" symbol accompanies the use of or reference to the applicable trademark in this Report. INDUSTRY AND MARKET DATA This Report contains market data and industry forecasts that were obtai

View Full Filing

View this 10-K filing on SEC EDGAR

View on Read The Filing