-Launching First Products in 1H 2024-
-Conference Call on Thursday, November 9, 2023, at 5:00 a.m. PT / 8:00 a.m. ET-
Third Quarter and Recent Highlights
- VitaGraft™ Kidney, the Company’s kidney transplant diagnostic test, received a positive coverage decision from CMS coverage; commercial revenue is expected beginning in 1H 2024.
- Significant new clinical data was presented at the European Society of Organ Transplant Conference demonstrating the VitaGraft assay detects antibody-mediated transplant rejection 10 months sooner than commonly used monitoring protocols (p<0.001).
- Cash burn declined to $3.6 million and is projected to remain below a $5 million quarterly average.
- $14.2 million in cash, cash equivalents, and marketable securities as of September 30, 2023.
- VitaGraft Liver, Oncocyte’s second transplant test, continues under review for CMS coverage at MolDX.
Josh Riggs, CEO of Oncocyte, commented, “Oncocyte received a positive coverage decision from CMS during the third quarter for the Company’s innovative VitaGraft Kidney. This is the test that was recently demonstrated to detect signs of transplant organ rejection a full 10 months earlier than standard of care methods. Going into next year we expect the startup of revenues from the VitaGraft Kidney test and our RUO product, GraftAssure.”
“Financially, we reduced our cash burn to $3.6 million in the third quarter, the lowest level in several years and a reflection of the sharp reductions in non-revenue related activities that we instituted earlier in the year. Going forward, we expect to maintain this lower level of cash burn and remain below $5 million on a quarterly basis. With $14.2 million in cash, cash equivalents, and marketable securities, a declining cash burn, and multiple products nearing commercialization, we believe that Oncocyte is well positioned for growth in 2024 and the years beyond,” concluded Mr. Riggs.
Third Quarter 2023 Financial Results
Consolidated revenue for the third quarter of 2023 was approximately $0.4 million primarily due to increased revenue from Pharma Services. Cost of revenue was approximately $0.2 million.
Net consolidated operating loss for the three months ended September 30, 2023, was $6.5 million compared to a net consolidated operating loss of $1.7 million for the third quarter of 2022, which included a positive non-cash benefit of $6.1 million for change in fair value of contingent consideration.
Research and Development expense for the third quarter was $2.2 million compared to $1.5 million in the third quarter of 2022, an increase of 48%, driven by continued focused investment in developing manufacturable versions of assays including DetermaIO™, VitaGraft, and DetermaCNI™.
General and Administrative expense for the third quarter was $2.5 million compared to $5.7 million in the year ago period, a decrease of 56%, primarily due to decreased stock-based compensation and personnel expenses.
Sales and Marketing expense for the third quarter was $0.7 million compared to $0.4 million in the comparable period of 2022, an increase of 76%. The increase was driven by a continued ramp in sales, marketing and commercialization activities related to the recent coverage decision and expected upcoming launch of VitaGraft Kidney.
For Oncocyte’s complete financial results for the third quarter ended September 30, 2023, see the Company’s Quarterly Form 10-Q to be filed with the Securities and Exchange Commission on November 9, 2023.
Webcast and Conference Call Information
Oncocyte will host a conference call to discuss the third quarter 2023 financial results prior to market open on Thursday, November 9, 2023 at 5:00 a.m. Pacific Time / 8:00 a.m. Eastern Time. The live call may be accessed via telephone by dialing toll free (888) 550-5422 for both domestic and international callers. Once dialed in, ask to be joined to the Oncocyte Corporation call.
The live webinar of the call may be accessed by visiting the “Events & Presentation” section of the Company’s website at https://investors.oncocyte.com.
Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. DetermaIO™ is a gene expression test that assesses the tumor microenvironment in order to predict response to immunotherapies. VitaGraft™ is a blood-based solid organ transplantation monitoring test, and pipeline test DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy. For more information, visit https://oncocyte.com/
VitaGraft™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, expected revenues and commercial launch of VitaGraft Kidney and GraftAssure in 2024, plans to maintain a cash burn of below $5 million on a quarterly basis, the belief that Oncocyte is well positioned for growth in 2024 and the years beyond, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials, changes to regulatory oversight and/or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests. Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
SOURCE: Oncocyte Corporation
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