[Part I](index=6&type=section&id=Part%20I) [Business](index=6&type=section&id=Item%201.%20Business) Oncocyte Corporation is a precision diagnostics company focused on oncology and transplantation, with core products VitaGraft, DetermaIO, and DetermaCNI [Products and Technology](index=7&type=section&id=Item%201.%20Business%20-%20Products%20and%20Technology) The company's portfolio features DetermaIO for immunotherapy, DetermaCNI for cancer monitoring, and VitaGraft for transplant surveillance - **DetermaIO**: A gene expression test computing a proprietary IO Score from 27 genes to identify immunotherapy beneficiaries, validated in four tumor types and across major ICIs[22](index=22&type=chunk)[9](index=9&type=chunk) - **DetermaCNI**: A therapy response monitoring test using a proprietary genome-wide copy number instability (CNI) score from cell-free DNA (cfDNA), not requiring an initial tumor tissue sample[12](index=12&type=chunk) - **VitaGraft**: A transplant monitoring test measuring both percentage and absolute quantification of donor-derived cell-free DNA (dd-cfDNA), with positive Medicare coverage for Kidney in August 2023 and commercial launch in January 2024[25](index=25&type=chunk)[200](index=200&type=chunk) [Reimbursement and Competition](index=9&type=section&id=Item%201.%20Business%20-%20Reimbursement%20and%20Competition) Securing Medicare and private payer reimbursement is critical, facing competition from established biomarkers and other dd-cfDNA tests - Medicare reimbursement approval, managed by Medicare Administrative Contractors (MACs) through Local Coverage Determinations (LCDs), is a critical factor for the company's business[145](index=145&type=chunk) - The company is currently an out-of-network provider with all commercial payers, potentially leading to lower reimbursement rates and slower payment cycles until in-network contracts are negotiated[59](index=59&type=chunk)[171](index=171&type=chunk) - DetermaIO's primary competitors are PD-L1 expression testing and Tumor Mutational Burden (TMB), which the company believes have significant limitations in predicting immunotherapy response[30](index=30&type=chunk) - VitaGraft competes with other donor-derived cell-free DNA tests, differentiating itself through digital PCR, faster turnaround time, and native absolute quantification[62](index=62&type=chunk) [Intellectual Property](index=12&type=section&id=Item%201.%20Business%20-%20Intellectual%20Property) The company protects its technologies via patents, trade secrets, and know-how, but faces risks from patent validity challenges - The company's IP strategy combines patents, trade secrets (especially for its mathematical algorithms), and non-disclosure agreements with employees and consultants[175](index=175&type=chunk)[176](index=176&type=chunk) - Through the acquisition of Chronix, the company obtained rights to 10 patent families for detecting cell-free tumor DNA and quantifying donor-derived cell-free DNA, with patents expiring between April 2031 and October 2034[33](index=33&type=chunk) - The company faces legal uncertainty regarding the patentability of its diagnostic tests due to Supreme Court decisions like *Mayo v. Prometheus* and *AMP v. Myriad*, which limit patents on natural phenomena and correlations[177](index=177&type=chunk)[67](index=67&type=chunk)[36](index=36&type=chunk) [Government Regulation](index=14&type=section&id=Item%201.%20Business%20-%20Government%20Regulation) The company's CLIA-regulated LDTs face potential FDA oversight as medical devices, alongside state, international, and data privacy laws - The company's tests are currently regulated as Laboratory Developed Tests (LDTs) under CLIA, which establishes quality standards for laboratories[40](index=40&type=chunk)[71](index=71&type=chunk) - The FDA has proposed a rule to regulate LDTs as medical devices, phasing out enforcement discretion over four years, potentially requiring premarket review and increasing costs[41](index=41&type=chunk)[73](index=73&type=chunk)[582](index=582&type=chunk) - The company is subject to various state laboratory licensing requirements, which can be more stringent than federal CLIA regulations[49](index=49&type=chunk)[80](index=80&type=chunk) - Operations are subject to numerous data privacy and security laws, including HIPAA, HITECH, CCPA, and international laws like GDPR[196](index=196&type=chunk)[54](index=54&type=chunk)[86](index=86&type=chunk) - The company must comply with federal and state anti-fraud and abuse laws, such as the Anti-Kickback Statute, the Stark Law, and EKRA, governing relationships with healthcare providers[91](index=91&type=chunk)[199](index=199&type=chunk)[93](index=93&type=chunk) - The company's core focus is on three main product lines: VitaGraft for transplant monitoring, DetermaIO for immunotherapy response, and DetermaCNI for cancer treatment monitoring[474](index=474&type=chunk)[201](index=201&type=chunk) - In February 2023, the company divested its DetermaRx test by selling a 70% stake in its subsidiary Razor Genomics, eliminating associated development and commercialization costs[7](index=7&type=chunk)[20](index=20&type=chunk)[478](index=478&type=chunk) Key Product Addressable Markets | Product | Description | Total Addressable Market (TAM) | | :--- | :--- | :--- | | **DetermaIO** | Predicts response to Immune Checkpoint Inhibitors (ICIs) | $3.0 billion (clinical use) | | **DetermaCNI** | Monitors therapy response via blood-based testing | $6.0 billion (emerging opportunity) | | **VitaGraft** | Monitors transplant graft health via dd-cfDNA | $2.0 billion (reimbursed market) | - A key strategic element is the development of distributable kitted formats of its technologies for research use only (RUO), expected through direct sales, partnerships, and licensing[18](index=18&type=chunk) - The company operates CLIA-certified laboratories in Nashville, Tennessee, and a research and development facility in Göttingen, Germany[31](index=31&type=chunk)[159](index=159&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including going concern doubt, regulatory changes, reimbursement uncertainty, and IP challenges - **Going Concern**: There is substantial doubt about the company's ability to continue as a going concern due to its history of operating losses, negative cash flows, and the need to raise additional funding[249](index=249&type=chunk)[250](index=250&type=chunk) - **Financial Performance**: The company has incurred operating losses since inception, with a net loss of **$27.8 million in 2023** and an accumulated deficit of **$289.9 million** as of December 31, 2023[254](index=254&type=chunk) - **Regulatory Risk**: A primary risk is the potential for the FDA to end its enforcement discretion for LDTs and regulate the company's tests as medical devices, which would increase costs, delay commercialization, and require more stringent approvals[579](index=579&type=chunk)[582](index=582&type=chunk) - **Reimbursement Risk**: Commercial success is highly dependent on obtaining and maintaining sufficient third-party payer coverage and reimbursement from Medicare and private insurers, which is uncertain and may be inadequate[512](index=512&type=chunk)[513](index=513&type=chunk) - **Intellectual Property Risk**: The company's financial success depends on its ability to protect its patents and trade secrets, which face challenges from competitors and potential invalidation based on recent legal precedents regarding diagnostic methods[361](index=361&type=chunk)[364](index=364&type=chunk) - **Operational Risk**: The company's near-term revenues depend on the successful commercialization of a small number of diagnostic tests, facing challenges related to physician adoption, competition, and limited marketing and sales resources[261](index=261&type=chunk)[264](index=264&type=chunk)[266](index=266&type=chunk) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[438](index=438&type=chunk) [Cybersecurity](index=50&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cyber risk management program, overseen by the Audit Committee, to manage cybersecurity threats - The company has a cyber risk management program to identify, assess, and mitigate cybersecurity threats[439](index=439&type=chunk) - The Audit Committee of the Board of Directors oversees cybersecurity risks, with management briefing the committee at least semi-annually[441](index=441&type=chunk) [Properties](index=50&type=section&id=Item%202.%20Properties) The company leases executive offices in Irvine, CA, a CLIA lab in Nashville, TN, and an R&D facility in Göttingen, Germany - Principal executive offices are leased in Irvine, CA, with the lease expiring in September 2027; a portion was subleased effective September 2023[442](index=442&type=chunk) - The company operates a CLIA-certified laboratory and office space in Nashville, TN, under leases expiring in January 2027[443](index=443&type=chunk) - A research and development facility is maintained in Göttingen, Germany[443](index=443&type=chunk) [Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material pending litigation or legal proceedings - The company reports no material pending litigation[444](index=444&type=chunk) [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[445](index=445&type=chunk) [Part II](index=51&type=section&id=Part%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=51&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "OCX," has never paid dividends, and does not anticipate doing so - The company's common stock is traded on The Nasdaq Capital Market under the ticker symbol "OCX"[448](index=448&type=chunk) - No cash dividends have been declared or paid on common stock, and none are expected in the foreseeable future[449](index=449&type=chunk) [[RESERVED]](index=51&type=section&id=Item%206.%20%5BRESERVED%5D) This item is reserved - Not applicable[473](index=473&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Oncocyte reported a 57% revenue increase to $1.5 million in 2023, with a reduced net loss, but faces going concern doubts despite recent capital raises Summary Results of Operations (2023 vs. 2022) | Metric | 2023 (In thousands) | 2022 (In thousands) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Net Revenue** | $1,503 | $958 | $545 | 57% | | **Loss from Operations** | $(25,136) | $(17,997) | $(7,139) | 40% | | **Loss from Continuing Operations** | $(24,855) | $(18,612) | $(6,243) | 34% | | **Loss from Discontinued Operations** | $(2,926) | $(54,290) | $51,364 | -95% | | **Net Loss** | $(27,781) | $(72,902) | $45,121 | -62% | - The **57% increase in revenue** was primarily driven by a **$509,000 (53%) increase** in Pharma Services revenue[486](index=486&type=chunk)[498](index=498&type=chunk) - General and administrative expenses decreased by **$10.7 million (49%)**, mainly due to lower stock-based compensation and headcount reductions initiated in late 2022 and early 2023[491](index=491&type=chunk) - The company recognized a **$6.8 million impairment loss in 2023** related to IPR&D and leasehold improvements, compared to an **$18.7 million goodwill impairment in 2022**[493](index=493&type=chunk)[494](index=494&type=chunk) - The company's financial state raises substantial doubt about its ability to continue as a going concern, addressed by raising approximately **$13.9 million in April 2023** and an additional **$15.8 million in April 2024** through private placements[605](index=605&type=chunk)[607](index=607&type=chunk)[609](index=609&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=64&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Oncocyte is not required to provide information for this item - Not applicable as the company is a smaller reporting company[652](index=652&type=chunk) [Financial Statements and Supplementary Data](index=65&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited financial statements, auditor reports, and notes detailing accounting policies, business combinations, and subsequent events Consolidated Balance Sheet Highlights (As of Dec 31) | Account | 2023 (In thousands) | 2022 (In thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $9,432 | $19,993 | | **Total Current Assets** | $10,698 | $25,536 | | **Intangible assets, net** | $56,595 | $61,633 | | **Total Assets** | $74,892 | $100,091 | | **Contingent consideration liabilities** | $39,900 | $45,662 | | **Total Liabilities** | $49,298 | $60,497 | | **Total Shareholders' Equity** | $20,468 | $34,292 | - **Going Concern**: The auditors' report includes an explanatory paragraph highlighting substantial doubt about the company's ability to continue as a going concern due to recurring operating losses and negative cash flows[658](index=658&type=chunk) - **Subsequent Events (April 2024)**: The company entered into a collaboration agreement with Bio-Rad for transplant products and a securities purchase agreement for a private placement expected to raise gross proceeds of approximately **$15.8 million**[552](index=552&type=chunk)[635](index=635&type=chunk) - **Discontinued Operations (Razor)**: The results of the Razor subsidiary (DetermaRx test) are reported as discontinued operations, generating a net loss of **$2.9 million in 2023** (up to sale date) and **$54.3 million in 2022**[547](index=547&type=chunk)[549](index=549&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=123&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company changed its auditor to Marcum LLP in September 2023, with no disagreements and a remediated material weakness - The company changed its independent registered public accounting firm from WithumSmith+Brown, PC to Marcum LLP on September 29, 2023[325](index=325&type=chunk)[326](index=326&type=chunk) - There were no disagreements with the former auditor, Withum, on accounting principles or practices[327](index=327&type=chunk) - A previously disclosed material weakness in internal controls was remediated prior to June 30, 2023[327](index=327&type=chunk) [Controls and Procedures](index=123&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2023 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[387](index=387&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[390](index=390&type=chunk) - No changes in internal control over financial reporting occurred during the fourth quarter of 2023 that materially affected, or are reasonably likely to materially affect, internal controls[331](index=331&type=chunk) [Other Information](index=124&type=section&id=Item%209B.%20Other%20Information) The company reported no other information for this item - None[392](index=392&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=124&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[394](index=394&type=chunk) [Part III](index=125&type=section&id=Part%20III) [Directors, Executive Officers, and Corporate Governance](index=125&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the forthcoming 2024 Proxy Statement[397](index=397&type=chunk) [Executive Compensation](index=125&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the forthcoming 2024 Proxy Statement[400](index=400&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=125&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the forthcoming 2024 Proxy Statement[401](index=401&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=125&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the forthcoming 2024 Proxy Statement[402](index=402&type=chunk) [Principal Accountant Fees and Services](index=125&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement - Information is incorporated by reference from the forthcoming 2024 Proxy Statement[403](index=403&type=chunk) [Part IV](index=126&type=section&id=Part%20IV) [Exhibits and Financial Statement Schedules](index=126&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements and provides an index of all exhibits filed or incorporated by reference into the Form 10-K - This item lists the consolidated financial statements filed under Item 8[407](index=407&type=chunk) - Provides an index of all exhibits filed with the report, including merger agreements, financing agreements, and equity incentive plans[411](index=411&type=chunk) [Form 10-K Summary](index=131&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable to the company - Not applicable[467](index=467&type=chunk)

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, 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) (State or other jurisdiction (I. ...

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]