On May 14, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, BioTime, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398606 [SID1234536260]).
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"During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu through clinical development," commented William Annett, President and Chief Executive Officer of OncoCyte. "In addition to the previously-reported positive results of our R&D Validation study, we recently announced positive results from our Analytical Validation study of DetermaVu. We have moved quickly into the next phase and expect to complete CLIA Laboratory Validation soon. We will then proceed to the final study before commercialization, an approximately 440 patient blinded prospective Clinical Validation study."
"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."
Highlights
Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study
Announced a late-breaking abstract and discussion session at the American Thoracic Society 2019 International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%
Completed a successful equity raise of $37.3 million in net proceeds which provides the funding to complete the development of DetermaVu and initiate commercialization efforts.
On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available in the second half of 2019
Remaining Validation Pathway for DetermaVu:
2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory
Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting
2H 2019: Anticipated commercial availability of DetermaVu
Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu as a confirmatory diagnostic test for lung cancer
First Quarter 2019 Financial Highlights
At March 31, 2019, OncoCyte had cash, cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering.
For the first quarter ended March 31, 2019, OncoCyte incurred a net loss of $3.9 million, or $(0.08) per share, as compared to $3.8 million, or $(0.12) per share, for the three months ended March 31, 2018.
Operating expenses for the three months ended March 31, 2019 were $4.0 million, and $3.2 million on an as-adjusted basis, as compared to $3.9 million, or $3.4 million on an as adjusted basis, for the same period in 2018.
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 March 31, 2019 were $1.3 million as compared to $1.5 for the same period in 2018, relatively unchanged quarter over quarter, as OncoCyte continued to focus resources on the development and commercialization of DetermaVu.
General and administrative expenses for the three months ended March 31, 2019 were $2.4 million, as compared to $1.7 million for the same period in 2018, an increase of $0.7 million. This increase is primarily attributable to $0.4 million in personnel and related expenses and $0.3 million in stock-based
compensation expense due to increased grants of equity awards.
Sales and marketing expenses for the three months ended March 31, 2019 were $0.2 million, as compared to $0.7 million for the same period in 2018, a decrease of $0.5 million, primarily attributable to a decrease in marketing personnel and consultants as OncoCyte concentrated its resources on the development of DetermaVu rather than on marketing related activities.
Conference Call
The Company will host a conference call today, May 14, 2019, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.
The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source
About DetermaVu
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. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.
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 Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.
DetermaVu is a trademark of OncoCyte Corporation.