On April 1, 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 fourth quarter and year ended December 31, 2018 and provided a corporate update (Press release, Oncocyte, APR 1, 2019, View Source [SID1234534867]).
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"OncoCyte has made outstanding progress since our last quarterly update to investors, reporting positive results from our DetermaVu R&D Validation Study which demonstrated that DetermaVu is a commercially viable assay with the potential to change the treatment paradigm in lung cancer diagnostics," said William Annett, President and Chief Executive Officer of OncoCyte. "Importantly, these results also confirmed the Company’s unique Immune System Interrogation approach provides an exquisitely sensitive and consistent signal for the diagnosis of early stage lung cancer. We are excited to investigate the broader application of this technology across multiple solid tumors moving forward and remain highly focused on executing the few remaining steps required for commercialization of DetermaVu later this year."
Highlights
Successfully transitioned to the Ion Torrent next-generation sequencing platform for robust and reproducible results
Reported positive results from blinded, prospective R&D Validation Study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%
R&D Validation study served as proof of concept for unique Immune System Interrogation approach with potential applicability across many types of solid tumors
On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available second half of 2019
Completed a successful equity raise for gross proceeds of $40.25 million which provides the resources to execute the development and commercialization of DetermaVu
Remaining Validation Pathway for DetermaVu:
1H 2019: Analytical Validation – with results expected shortly, this study will establish the performance characteristics of the system as established in the Clinical and Laboratory Standard Institute Guidelines that cover quantitation, precision, reproducibility and interfering substances
1H 2019: CLIA Laboratory Validation study – will rerun between 100 and 120 patient samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems
Mid-year 2019: Clinical Validation study – will run approximately 300 to 350 blinded, prospectively-collected blood samples to establish the DetermaVu performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting
2H 2019: Commercial availability of DetermaVu
Post-launch (2020 initiation): Clinical Utility study – follow-on real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system
Fourth Quarter and Annual 2018 Financial Results
At December 31, 2018, OncoCyte had cash and cash equivalents of $8.0 million and marketable equity securities valued at $0.4 million, for a total of $8.4 million of liquid assets. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.4 million in net proceeds from an underwritten public offering.
For the quarter ended December 31, 2018, OncoCyte reported a net loss of $4.5 million, or ($0.11) per share, compared to a net loss of $4.0 million, or ($0.13) per share, in the fourth quarter of 2017.
For 2018, OncoCyte reported a net loss of $15.8 million, or ($0.42) per share, compared to $19.4 million, or ($0.64) per share, in 2017.
Operating expenses for the three months ended December 31, 2018 were $4.0 million as reported, and were $3.5 million on an as adjusted basis. Operating expenses for 2018 were $15.2 million as reported and were $12.5 million on an as adjusted basis.
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 fourth quarter of 2018 were $1.2 million compared to $1.5 million for the same period in 2017, a decrease of $0.3 million. Research and development expenses for the year ended December 31, 2018 were $6.5 million, compared to $7.2 million during 2017, a decrease of $0.7 million. The decreases were primarily attributable to laboratory and other expenses related to diagnostic tests for diseases other than lung cancer as OncoCyte devoted substantially all of its research and development efforts to DetermaVu during 2018.
General and administrative expenses for the fourth quarter of 2018 were $2.6 million compared to $1.8 million for the same period in 2017. The $0.8 million increase was mainly attributable to personnel and related compensation, primarily related to the hiring of OncoCyte’s Chief Financial Officer and its Chief Operating Officer.
General and administrative expenses for the year ended December 31, 2018 decreased to $7.0 million from $9.2 million during 2017, a decrease of $2.2 million. During the year ended December 31, 2017, OncoCyte incurred a noncash expense of $4.1 million for the issuance of new warrants to certain investors who exercised outstanding warrants. OncoCyte did not incur a similar expense during 2018. Personnel and related compensation expenses increased by $1.1 million during 2018, primarily related to the hiring of the executives noted above, an increase of $0.5 million in legal, investor relations, financing and other related expenses, and an increase of $0.3 million in noncash stock-based compensation expense due to increased stock option grants.
Sales and marketing expenses for the fourth quarter of 2018 were $0.3 million compared to $0.6 million for the same period in 2017, a decrease of $0.3 million. Sales and marketing expenses for the full-year 2018 were $1.7 million compared to $2.4 million during 2017, a decrease of $0.7 million. These decreases were primarily due the decrease in consulting, marketing, and related expenses 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, April 1, 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 13689139. 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 after imaging modalities (LDCTs) that detect suspicious lung nodules and before downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on 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 recent Medicare study, 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.