Oncocyte(OCX)

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Oncocyte(OCX) - 2020 Q4 - Earnings Call Transcript
2021-03-17 00:31
Oncocyte Corporation (NASDAQ:OCX) Q4 2020 Results Conference Call March 16, 2021 4:30 PM ET Company Participants Bob Yedid - IR, LifeSci Advisors, LLC Ronnie Andrews - President and CEO Mitch Levine - CFO Dr. Doug Ross - Chief Science Officer Padma Sundar - Chief Commercial Officer Conference Call Participants Mike Matson - Needham & Company Mark Massaro - BTIG Steven Mah - Piper Sandler Thomas Flaten - Lake Street Capital Markets Bruce Jackson - Benchmark Company Paul Knight - KeyBanc Operator Greetings, a ...
OncoCyte (OCX) Investor Presentation - Slideshow
2020-12-02 16:50
Company Mission and Growth Engines - Oncocyte's mission is to provide actionable answers at critical decision points across the cancer care continuum, improving patient outcomes by optimizing diagnosis and treatment[7] - Oncocyte focuses on high-value, unanswered clinical questions in lung cancer, representing a > $3 billion market opportunity[9] - DetermaIO™ is a novel molecular test assessing the tumor micro-environment (TME) to predict immunotherapy response, launched as Research Use Only (RUO)[9] - DetermaRx™ is the first and only molecular test identifying Non-Small Cell Lung Cancer (NSCLC) patients at high risk of recurrence post-surgery[9] DetermaRx and Lung Cancer - The global market for early-stage lung cancer testing is estimated at > $450 million, serving ~350,000 early-stage non-squamous NSCLC patient treatment decisions annually[21] - 30-50% of early-stage NSCLC patients recur after surgical resection[21] - In a study, 48% of NCCN "low Risk" patients were reclassified to high-risk by DetermaRx[37] - DetermaRx high-risk patients, upon treatment, had a Disease-Free Survival (DFS) of 92.8%[37] DetermaIO and Immunotherapy - The annual addressable testing market for IO therapy is ~$3 billion in the US alone[55] - Up to 55% of patients receiving IO therapy derive no benefit but are exposed to side effects, representing ~$60 billion in healthcare investment with no patient benefit by 2025[55] - In a study, DetermaIO showed a Hazard Ratio (HR) of 0.31 (95% CI 0.14 to 0.68; p=0.004) for Progression Free Survival (PFS) compared to PD-L1 and TMB in lung cancer[63] - In a TNBC study from MD Anderson, DetermaIO-positive patients were 4x more likely to respond than DetermaIO-negative patients (Odds Ratio 4.13, 95% CI 1.36 – 13.47, p<0.015)[65]
Oncocyte(OCX) - 2020 Q3 - Earnings Call Transcript
2020-11-13 03:13
OncoCyte Corporation (NASDAQ:OCX) Q3 2020 Earnings Conference Call November 12, 2020 4:30 PM ET Company Participants Bob Yedid - Managing Director-LifeSci Advisors Ronnie Andrews - President and Chief Executive Officer Mitch Levine - Chief Financial Officer Dr. Doug Ross - Chief Medical Officer Padma Sundar - Senior Vice President of Commercial Conference Call Participants Mark Massaro - BTIG Paul Knight - KeyBanc Capital Markets Stephen Unger - Needham & Company Steven Mah - Piper Sandler & Co. Bruce Jacks ...
Oncocyte(OCX) - 2020 Q3 - Quarterly Report
2020-11-12 21:50
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, 2020 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 of ...
Oncocyte(OCX) - 2020 Q2 - Earnings Call Transcript
2020-07-30 02:31
Oncocyte Corporation (NASDAQ:OCX) Q2 2020 Earnings Conference Call July 29, 2020 4:30 PM ET Company Participants Bob Yedid – Managing Director-LifeSci Advisors Ronnie Andrews – President and Chief Executive Officer Mitch Levine – Chief Financial Officer Al Parker – Chief Operating Officer Dr. Doug Ross – Chief Medical Officer Padma Sundar – Senior Vice President of Commercial Conference Call Participants Thomas Flaten – Lake Street Capital Markets Steve Unger – Needham Steven Mah – Piper Sandler Bruce Jacks ...
Oncocyte(OCX) - 2020 Q2 - Quarterly Report
2020-07-29 20:35
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, 2020 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 of incor ...
Oncocyte(OCX) - 2020 Q1 - Quarterly Report
2020-05-12 20:41
PART 1—FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents OncoCyte's unaudited condensed consolidated interim financial statements, including balance sheets, statements of operations, comprehensive loss, cash flows, and detailed notes for Q1 2020 and FY2019 [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Condensed Consolidated Balance Sheets (in thousands) | ASSETS (in thousands) | March 31, 2020 | December 31, 2019 | | :---------------------- | :------------- | :---------------- | | Cash and cash equivalents | $16,577 | $22,072 | | Total current assets | $18,139 | $22,956 | | Total assets | $59,503 | $39,859 | | LIABILITIES AND SHAREHOLDERS' EQUITY (in thousands) | March 31, 2020 | December 31, 2019 | | Total current liabilities | $6,928 | $4,440 | | Total liabilities | $22,878 | $9,021 | | Total shareholders' equity | $36,625 | $30,838 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Condensed Consolidated Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Total revenue | $16 | $- | | Total costs and operating expenses | $8,447 | $3,997 | | Loss from operations | $(8,431) | $(3,997) | | Net loss | $(7,732) | $(3,864) | | Net loss per share; basic and diluted | $(0.13) | $(0.08) | | Weighted average shares outstanding | 61,459 | 46,647 | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) Condensed Consolidated Statements of Comprehensive Loss (in thousands) | (in thousands) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :------------- | :-------------------------------- | :-------------------------------- | | NET LOSS | $(7,732) | $(3,864) | | COMPREHENSIVE LOSS | $(7,732) | $(3,864) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(6,870) | $(6,718) | | Net cash provided by (used in) investing activities | $(6,191) | $47 |\n| Net cash provided by financing activities | $7,565 | $37,894 | | NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | $(5,496) | $31,223 | | Cash, cash equivalents and restricted cash: At end of the period | $18,277 | $39,257 | [Notes to Condensed Consolidated Interim Financial Statements](index=9&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20INTERIM%20FINANCIAL%20STATEMENTS) [1. Organization, Description of the Business and Liquidity](index=9&type=section&id=1.%20Organization,%20Description%20of%20the%20Business%20and%20Liquidity) OncoCyte Corporation is a molecular diagnostics company focused on developing and commercializing proprietary laboratory-developed tests (LDTs) for cancer, prioritizing lung cancer, and relies on financing to support operations - **OncoCyte Corporation** is a molecular diagnostics company focused on developing and commercializing proprietary laboratory-developed tests (LDTs) for unmet medical needs across the cancer care continuum, with lung cancer as its first indication[18](index=18&type=chunk) - Key products include **DetermaRx™** (treatment stratification for early-stage non-small cell lung cancer), **DetermaDx™** (non-invasive blood test for lung nodules), and **DetermaIO™** (gene expression assay for checkpoint inhibitor response, acquired via Insight Genetics)[19](index=19&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk) - The company has incurred operating losses and negative cash flows since inception, with an accumulated deficit of **$101.5 million** as of March 31, 2020[24](index=24&type=chunk) - OncoCyte believes its current cash, cash equivalents, marketable equity securities, and access to additional capital through an ATM Agreement are sufficient to fund operations for at least the next **twelve months** from the financial statement issuance date[26](index=26&type=chunk) - The company will need to raise additional capital to finance operations, development, and commercialization of its diagnostic tests, and may pursue marketing arrangements with other diagnostic companies to reduce capital needs and risks[27](index=27&type=chunk)[28](index=28&type=chunk) [2. Basis of Presentation and Summary of Significant Accounting Policies](index=10&type=section&id=2.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the basis of presentation for the unaudited condensed consolidated interim financial statements, prepared in accordance with U.S. GAAP and SEC regulations, detailing key accounting policies including business combinations, fair value measurements, goodwill, intangible assets, royalty obligations, investments, and revenue recognition - The unaudited condensed consolidated interim financial statements are prepared in accordance with **U.S. GAAP** for interim financial information and **SEC Form 10-Q** instructions[29](index=29&type=chunk) - On **January 31, 2020**, Insight became a wholly-owned subsidiary, and its operations are now consolidated with OncoCyte's[31](index=31&type=chunk) - Business combinations are accounted for using the acquisition method, recognizing assets and liabilities at fair value, with goodwill representing the excess of purchase price over net identifiable assets[34](index=34&type=chunk)[35](index=35&type=chunk) - In-process research and development (**IPR&D**) projects acquired in a business combination are capitalized as indefinite-lived intangible assets until completion or abandonment, then amortized over their useful life or written off[36](index=36&type=chunk) - Revenue recognition commenced on **January 1, 2020**, primarily from pharma services by the Insight subsidiary and cash-basis receipts from **DetermaRx™** testing[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - **DetermaRx™** revenue is recognized on a cash basis due to uncertainty of payment, but is expected to shift to an accrual basis after Medicare coverage and pricing are established (effective **June 14, 2020**)[45](index=45&type=chunk) - Marketable equity securities (Lineage and AgeX shares) are measured at fair value and reported as current assets, with unrealized gains/losses recorded in other income/expenses[50](index=50&type=chunk) Marketable Equity Securities (in thousands) | Item | March 31, 2020 | March 31, 2019 | | :------------------------------------ | :------------- | :------------- | | Unrealized gain (loss) on marketable equity securities | $(53) | $178 | [3. Selected Balance Sheet Components](index=15&type=section&id=3.%20Selected%20Balance%20Sheet%20Components) This note provides a detailed breakdown of selected balance sheet components, including restricted cash, prepaid expenses, other current assets, deposits, other noncurrent assets, accrued expenses, and other current liabilities, highlighting changes between March 31, 2020, and December 31, 2019 Cash, Cash Equivalents, and Restricted Cash (in thousands) | Item | March 31, 2020 | December 31, 2019 | | :------------------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $16,577 | $22,073 | | Restricted cash | $1,700 | $1,700 | | Total cash, cash equivalents, and restricted cash | $18,277 | $23,773 | Prepaid Expenses and Other Current Assets (in thousands) | Item | March 31, 2020 | December 31, 2019 | | :------------------------------------ | :------------- | :---------------- | | Prepaid insurance | $943 | $80 | | Prepaid vendors, deposits and service agreements | $261 | $389 | | Other | $20 | $36 | | Total prepaid expenses and other current assets | $1,224 | $505 | Accrued Expenses and Other Current Liabilities (in thousands) | Item | March 31, 2020 | December 31, 2019 | | :------------------------------------ | :------------- | :---------------- | | Accrued compensation | $1,029 | $1,287 | | Accrued insurance | $616 | $- | | Cash holdback liability | $600 | $-
Oncocyte(OCX) - 2019 Q4 - Annual Report
2020-03-25 21:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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 of incorpora ...
OncoCyte (OCX) Investor Presentation - Slideshow
2020-01-28 19:57
| --- | --- | --- | --- | |-------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | WHERE TOMORROW LIVES. | | | | | | | | | | Investor Presentation January 2020 | | | | Forward looking statements Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" and similar expressions) are forward-looking statements. These statements include those ...
Oncocyte(OCX) - 2019 Q3 - Earnings Call Transcript
2019-11-15 04:12
OncoCyte Corporation. (NASDAQ:OCX) Q3 2019 Results Earnings Conference Call November 14, 2019 4:30 PM ET Company Participants Bob Yedid - LifeSci Advisors Ronald Andrews - CEO, President Al Parker - Chief Operating Officer Mitchell Levine - CFO Padma Sundar - Senior Vice President of Marketing and Market Access Tony Kalajian - Chief Accounting Officer Conference Call Participants Paul Knight - Janney Montgomery Scott Bill Quirk - Piper Jaffray Thomas Flaten - Lake Street Capital Markets Bruce Jackson - The ...