UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-37648 Oncocyte Corporation (Exact name of registrant as specified in its charter) | Title of each class | Trading Symbo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-37648 Oncocyte Corporation (Exact name of registrant as specified in its charter) California 27-1041563 (State or othe ...

Part I [Business](index=7&type=section&id=Item%201.%20Business) Oncocyte is a precision diagnostics company focused on oncology and transplantation, strategically divesting DetermaRx to prioritize core products and navigate regulatory and reimbursement challenges - Oncocyte is a precision diagnostics company developing proprietary molecular technologies in oncology and transplantation, with labs in Nashville, TN, and Göttingen, Germany[18](index=18&type=chunk)[20](index=20&type=chunk) - In February 2023, the company sold approximately **70%** of its Razor Genomics subsidiary, retaining a **30%** equity interest, to focus on other strategic priorities[23](index=23&type=chunk)[291](index=291&type=chunk) Oncocyte's Key Product Portfolio | Product | Area | Description | Market Opportunity (Est.) | | :--- | :--- | :--- | :--- | | **DetermaIO** | Oncology | Gene expression test to predict patient response to immunotherapy | $3 Billion (Clinical TAM) | | **DetermaCNI** | Oncology | Blood-based test to monitor therapy response using copy number instability (CNI) | $6 Billion (US Clinical) | | **VitaGraft** | Transplant | Measures donor-derived cell-free DNA (dd-cfDNA) to monitor organ graft health | $2 Billion (US Reimbursed) | - Commercial success relies heavily on securing reimbursement from Medicare and private third-party payers, with DetermaRx being its only commercialized clinical test as of year-end 2022[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) - The business is subject to extensive government regulation, including CLIA, potential FDA oversight for LDTs, and data privacy laws like HIPAA and GDPR[76](index=76&type=chunk)[78](index=78&type=chunk)[105](index=105&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including substantial operating losses, capital needs, commercialization hurdles, regulatory complexities, and internal control deficiencies - The company has a history of significant operating losses, with a **net loss of $72.9 million** in 2022 and an **accumulated deficit of $260.7 million** as of December 31, 2022, anticipating the need for additional capital[144](index=144&type=chunk)[145](index=145&type=chunk) - Oncocyte received a Nasdaq notice in August 2022 for failing to meet the **$1.00 minimum bid price**, subsequently transferring its listing to The Nasdaq Capital Market and receiving an additional 180-day compliance period from February 7, 2023[251](index=251&type=chunk)[252](index=252&type=chunk)[255](index=255&type=chunk) - A material weakness in internal control over financial reporting was identified, specifically deficiencies in the review process for third-party valuations, potentially leading to material financial statement misstatements[249](index=249&type=chunk) - Commercial success is highly dependent on obtaining and maintaining sufficient coverage and reimbursement from third-party payers, which remains uncertain and potentially limited[202](index=202&type=chunk) - The company's LDTs, historically under FDA enforcement discretion, face potential legislative changes or policy shifts that could impose more stringent and costly pre-market review requirements[196](index=196&type=chunk)[199](index=199&type=chunk) [Unresolved Staff Comments](index=52&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - Not applicable[266](index=266&type=chunk) [Properties](index=52&type=section&id=Item%202.%20Properties) Oncocyte's principal offices are in Irvine, California, with a CLIA-certified lab in Nashville, Tennessee, and subleased lab space in Brisbane, California - The company's main offices and lab are in Irvine, CA, with an additional CLIA-certified lab in Nashville, TN[267](index=267&type=chunk) [Legal Proceedings](index=52&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings - The company is not presently involved in any material litigation or proceedings[268](index=268&type=chunk) [Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[269](index=269&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=53&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Oncocyte's common stock trades on The Nasdaq Capital Market under "OCX" after a February 2023 transfer, with no history or anticipation of cash dividends, and approximately 309 holders of record as of March 22, 2023 - The company's common stock transferred from The Nasdaq Global Market to The Nasdaq Capital Market on **February 7, 2023**, continuing to trade under the symbol "OCX"[271](index=271&type=chunk) - The company has not declared or paid any cash dividends on its common stock[272](index=272&type=chunk) Securities Authorized for Issuance under Equity Compensation Plans (as of Dec 31, 2022) | Plan Category | Number of Shares to be Issued upon Exercise | Weighted Average Exercise Price ($) | Number of Shares Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Oncocyte Stock Option Plans Approved by Shareholders | 9,168,000 | 2.96 | 10,804,000 | [Selected Financial Data](index=53&type=section&id=Item%206.%20%5BRESERVED.%5D) This item is reserved and no information is provided - This item is marked as [RESERVED.][278](index=278&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=54&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights strategic shifts and workforce reductions, reporting a **$72.9 million net loss** in 2022, with management believing recent financing provides sufficient liquidity for 12 months - The company initiated two workforce reductions in 2022, eliminating over **40%** of full-time employees and incurring **$1.9 million** in severance costs to preserve cash[289](index=289&type=chunk)[290](index=290&type=chunk) - In December 2022, the company agreed to sell approximately **70%** of its Razor Genomics subsidiary, classifying it as a discontinued operation to eliminate associated development and commercialization costs[291](index=291&type=chunk)[292](index=292&type=chunk) - Management believes the company has sufficient cash to fund operations for at least the next **12 months**, supported by capital raises in 2022 and a subsequent **$13.9 million** offering in April 2023[360](index=360&type=chunk)[361](index=361&type=chunk) Key Operating Results (in thousands) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Revenues (Continuing Operations) | $958 | $2,198 | | Loss from Continuing Operations | $(18,612) | $(43,610) | | Loss from Discontinued Operations | $(54,290) | $(20,487) | | **Net Loss** | **$(72,902)** | **$(64,097)** | - The company recorded a full **goodwill impairment charge of $18.7 million** in 2022, concluding its fair value was less than its carrying value after the decision to sell Razor Genomics[352](index=352&type=chunk)[586](index=586&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=70&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Oncocyte is not required to provide the information for this item - As a smaller reporting company, this disclosure is not required[371](index=371&type=chunk) [Financial Statements and Supplementary Data](index=71&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2022 and 2021, highlighting critical audit matters and reflecting a **$72.9 million net loss** in 2022 and significant asset changes - The independent auditor's report identified two Critical Audit Matters: (1) Valuation of Contingent Consideration Liabilities and (2) Assessment of Held for Sale and Discontinued Operations Classification and Impairment Charge for the Razor Genomics divestiture[382](index=382&type=chunk)[385](index=385&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $19,993 | $32,948 | | Total current assets | $25,536 | $39,143 | | Goodwill | $0 | $18,684 | | Total Assets | $100,091 | $159,563 | | Contingent consideration liabilities | $45,662 | $76,681 | | Total Liabilities | $60,497 | $94,346 | | Accumulated deficit | $(260,676) | $(187,774) | | Total Shareholders' Equity | $34,292 | $65,217 | Consolidated Statement of Operations Highlights (in thousands) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Net revenue (continuing) | $958 | $2,198 | | Loss from operations | $(17,997) | $(53,725) | | Loss from continuing operations | $(18,612) | $(43,610) | | Loss from discontinuing operations | $(54,290) | $(20,487) | | **Net Loss** | **$(72,902)** | **$(64,097)** | Consolidated Statement of Cash Flows Highlights (in thousands) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(45,568) | $(35,941) | | Net cash used in investing activities | $(4,340) | $(13,961) | | Net cash provided by financing activities | $35,806 | $78,364 | | **Net (Decrease) Increase in Cash** | **$(14,102)** | **$28,462** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=136&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no disagreements with its accountants on accounting and financial disclosure - Not applicable[727](index=727&type=chunk) [Controls and Procedures](index=136&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of December 31, 2022, due to a material weakness in internal control over financial reporting, and is implementing remediation plans - Management concluded that disclosure controls and procedures were not effective as of **December 31, 2022**[732](index=732&type=chunk) - A material weakness was identified due to insufficient accounting resources and a failure to design and maintain effective controls for complex and non-routine transactions[734](index=734&type=chunk) - The company is implementing remediation plans, including designing new controls and continuing to engage external consultants for support[736](index=736&type=chunk) [Other Information](index=137&type=section&id=Item%209B.%20Other%20Information) No other information is reported under this item - None[737](index=737&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=137&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[738](index=738&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=138&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2023 Proxy Statement - Information is incorporated by reference from the registrant's 2023 Proxy Statement[740](index=740&type=chunk) [Executive Compensation](index=138&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the company's 2023 Proxy Statement - Information is incorporated by reference from the registrant's 2023 Proxy Statement[743](index=743&type=chunk) [Security Ownership of Certain Beneficial Owners and Management, and Related Stockholder Matters](index=138&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%2C%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management is incorporated by reference from the company's 2023 Proxy Statement - Information is incorporated by reference from the registrant's 2023 Proxy Statement[744](index=744&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=138&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's 2023 Proxy Statement - Information is incorporated by reference from the registrant's 2023 Proxy Statement[745](index=745&type=chunk) [Principal Accountant Fees and Services](index=138&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's 2023 Proxy Statement - Information is incorporated by reference from the registrant's 2023 Proxy Statement[746](index=746&type=chunk) Part IV [Exhibit and Financial Statement Schedules](index=139&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists financial statements filed with the Form 10-K and provides a comprehensive index of all exhibits, including various agreements and required certifications - This section contains the list of financial statements and an index of all exhibits filed with the report[748](index=748&type=chunk) [Form 10-K Summary](index=144&type=section&id=Item%2016.%20Form%2010-K%20Summary) No summary is provided under this item - None[754](index=754&type=chunk)

OncoCyte Corporation (NASDAQ:OCX) Q4 2022 Earnings Conference Call April 3, 2023 8:30 AM ET Company Participants Caroline Corner - Investor Relations, Westwicke Joshua Riggs - President and Chief Executive Officer Anish John - Chief Financial Officer Conference Call Participants Tyler Anderson - Piper Sandler Mark Massaro - BTIG Joseph Conway - Needham & Company Mason Carrico - Stephens Inc Bruce Jackson - The Benchmark Company David Westenberg - Piper Sandler Operator Good day and welcome to the OncoCyte ...

OncoCyte Corporation (NASDAQ:OCX) Q3 2022 Results Conference Call November 10, 2022 4:30 PM ET Company Participants Caroline Corner - Investor Relations Ronnie Andrews - President and Chief Executive Officer Anish John - Chief Financial Officer Conference Call Participants David Westenberg - Piper Sandler Mark Massaro - BTIG Thomas Flaten - Lake Street Mason Carrico - Stephens Bruce Jackson - Benchmark Company Operator Good day, and welcome to the OncoCyte Conference Call to discuss the Third Quarter 2022 F ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-37648 Oncocyte Corporation (Exact name of registrant as specified in its charter) California 27-1041563 (State or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-37648 Oncocyte Corporation (Exact name of registrant as specified in its charter) California 27-1041563 (State or other ...

Financial Data and Key Metrics Changes - Consolidated revenues for Q2 2022 were approximately $2.1 million, up $0.7 million quarter-over-quarter and a slight increase compared to the same period a year ago [37] - GAAP net loss for Q2 2022 was $8.3 million or $0.07 per share, a decrease of $2 million quarter-over-quarter and an increase of $2.2 million compared to the same period a year ago [45] - Non-GAAP operating loss for Q2 2022 was $11.2 million, an increase of $3.4 million compared to the same period a year ago [44] Business Line Data and Key Metrics Changes - Revenues associated with DetermaRx were $0.8 million, down $0.2 million sequentially but up $0.2 million year-over-year [37] - Pharma Services business generated $0.2 million in Q2 2022, a decrease of $0.1 million quarter-over-quarter but an increase of $0.1 million year-over-year [38] - DetermaRx sample volumes were 66% above the prior year, driving towards the goal of doubling 2021 volumes and revenues in 2022 [33] Market Data and Key Metrics Changes - The company signed on one of the largest liver transplant centers in the U.S. as part of the early adopter program for the VitaGraft product [13] - The liver transplant center is estimated to perform between 300 to 500 liver transplants annually, indicating a significant market opportunity [99] Company Strategy and Development Direction - The company is focused on reducing operating expenses and cash burn, with anticipated annual operating cost reductions of over $12 million [9] - A strategic shift has been made to prioritize shorter-term revenue opportunities and reduce the number of clinical trials over the next 18 to 24 months [48] - The company plans to launch the VitaGraft liver and kidney products in Q4 2022, pending reimbursement decisions [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating current market headwinds and emphasized a well-constructed plan to deliver on critical product launches over the next 6 to 8 quarters [53] - The anticipated cash burn rate is expected to decline below $10 million in the first half of 2023 and further below $8 million in the second half of 2023 [53][81] Other Important Information - The company raised $32.8 million in net proceeds from an underwritten offering of common stock early in Q2 2022 [46] - The company is exploring non-dilutive forms of capital, including capital lease lines and licensing tests in ex-U.S. markets [47] Q&A Session Summary Question: Can you provide insight on the control over the liver and kidney reimbursement timelines? - Management indicated that they expect to receive responses for both liver and kidney reimbursement submissions around September to October [59][62] Question: What does the change in management roles mean for day-to-day operations? - Management clarified that while the CEO will focus more on corporate development and investor relations, the new COO will handle daily operations [65][67] Question: Is there a delay in DetermaIO due to needing more patient data? - Management confirmed that DetermaIO is on track for submission this fall, with no additional patient data needed for the current tumor types [70] Question: What is the expected ramp-up for the VitaGraft product? - Management expects a rapid revenue ramp for the VitaGraft product in 2023, with significant market interest already noted [79] Question: What is the focus for the Pharma Services business? - Management stated that while there has been a pullback on commercial efforts, long-term relationships with pharma partners will continue to drive the business [91]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number 1-37648 Oncocyte Corporation (Exact name of registrant as specified in its charter) California 27-1041563 (State or othe ...

OncoCyte Corporation (NASDAQ:OCX) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Ronnie Andrews – President and Chief Executive Officer Mitch Levine – Chief Financial Officer Troy Williams – LifeSci Advisors Conference Call Participants Mike Matson – Needham & Company Mark Massaro – BTIG David Westenberg – Piper Sandler Paul Knight – KeyBanc Capital Markets Thomas Flaten – Lake Street Capital Markets Mason Carrico – Stephens Inc. Bruce Jackson – The Benchmark Company Operator ...