|OncoCyte Provides Corporate Update and Reports First Quarter 2019 Financial Results|
Completes successful Analytical Validation study and initiates CLIA Validation study
On track for commercial availability of DetermaVu™ in 2H 2019
Conference Call Today at
“During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu™ through clinical development,” commented
“With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu™ in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu™, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company.”
Remaining Validation Pathway for DetermaVu™:
First Quarter 2019 Financial Highlights
For the first quarter ended
Operating expenses for the three months ended
The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.
Research and development expenses for the quarter ended
General and administrative expenses for the three months ended
Sales and marketing expenses for the three months ended
The Company will host a conference call today,
The dial-in number in the U.S./
DetermaVu™ is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant.
DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of
DetermaVu™ is a trademark of
OncoCyte 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 pertaining to the implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for
Non-GAAP Financial Measures
This earnings release includes operating expenses prepared in accordance with accounting principles generally accepted in
Furthermore, management uses these non-GAAP financial measures in the aggregate to establish budgets and operational goals, to manage OncoCyte’s business and to evaluate its performance and its programs.