On May 15, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported financial and operating results for the first quarter ended March 31, 2018 (Press release, Oncocyte, MAY 15, 2018, View Source [SID1234526638]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have completed initial sample testing and begun analyzing the data collected in the confirmation study of our DetermaVu lung cancer diagnostic test. This study is being conducted on alternative diagnostic testing platforms using newly discovered biomarkers and seeks to confirm previous results," said William Annett, President and Chief Executive Officer. "We are on track to meet our mid-year timeline for the results of this study. If the remaining DetermaVu studies are successful, our goal remains to complete the final Clinical Validation study in 2018."
As recently reported, OncoCyte discovered and filed patent applications for an additional 190 novel lung cancer biomarkers that may enable DetermaVu to provide better differentiation between malignant and benign lung nodules for improved lung cancer diagnosis. Our current study is analyzing a combination of the biomarkers OncoCyte used in earlier studies and newly discovered biomarkers. All 160 study samples have now been run on two established commercial diagnostic testing platforms and the data are being analyzed.
The outcome of the study will determine whether the 190 novel biomarkers will further increase the accuracy of DetermaVu and whether the diagnostic testing platforms being tested will provide consistent and robust support for the further clinical development studies that are necessary for commercialization.
Timeline and Upcoming Milestones
Data analysis from all 160 samples is expected to be completed by mid-year, at which time a decision will be made as to the diagnostic testing platform the Company will use going forward. Once the appropriate platform is selected, OncoCyte will work to optimize and lock a new algorithm based on the diagnostic testing platform and the new panel of biomarkers selected for the test, and then conduct an R&D Validation Study which will include an Analytic Validation Study. All samples necessary for carrying out these studies are in-house, enabling rapid advancement through each study. If these studies are successful, the Company will conduct a Clinical Validation study, which it expects to complete in 2018.
Other Recent Developments
Bolstered the balance sheet through a $10 million private placement of common stock with two current investors.
Discovered and filed patent applications for 190 novel lung cancer biomarkers that may enhance OncoCyte’s lung cancer test and enable better differentiation of malignant from benign lung nodules for improved lung cancer diagnosis.
Enhanced abilities to rapidly prototype, evaluate, and develop lung cancer diagnostic products through the continued growth of our well-characterized lung cancer clinical sample bank.
Strengthened the Board of Directors by adding Ronald Andrews, Jr., an executive with over 30 years’ experience in the molecular diagnostics and genomics industries. In addition, Cavan Redmond, a Director since 2015, was appointed Chairman of the Board.
First Quarter 2018 Financial Results
For the first quarter ended March 31, 2018, OncoCyte incurred a net loss of $3.8 million, or $0.12 per share, compared to a net loss of $4.7 million, or $0.16 per share, in the first quarter of 2017.
Operating expenses for the three months ended March 31, 2018 were $3.9 million, and were $3.4 million on an as adjusted basis.
Research and development expenses for the quarter ended March 31, 2018 were $1.5 million compared to $1.8 million for the same period in 2017, a decrease of $0.3 million. This decrease is primarily attributable to decreases in compensation and related expenses, including stock-based compensation expenses.
General and administrative expenses for the three months ended March 31, 2018 were $1.8 million compared to $2.0 million for the same period in 2017, a decrease of $0.2 million. This decrease is mainly attributable to a $1.1 million shareholder noncash expense for the issuance of certain warrants during the three months ended March 31, 2017. The decrease was partially offset by increases in legal, compliance and business development costs, and compensation related expenses, including noncash stock-based compensation expense primarily related to stock options granted to an executive hired in the fourth quarter of 2017.
At March 31, 2018, OncoCyte had cash and cash equivalents of $12.6 million and marketable securities valued at $0.95 million. An additional $2 million was received on May 10, 2018 as the final installment of a stock purchase commitment in a private placement of common stock during March 2018. The Company believes its resources, coupled with prudent expense management, are sufficient to execute its near-term strategies.
Cash used in operations was approximately $2.75 million for the first quarter of 2018, as reported, or just over $900,000 per month, which represents a reduced annualized cash used in operations compared to 2017.
Conference Call
OncoCyte will host a conference call today, May 15, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.
The dial-in number in the U.S./Canada is 800-263-0877; for international participants, the number is +1-323-794-2094. For all callers, please refer to Conference ID 6365614. To access the live webcast, go to the investor relations section on the Company’s website, View Source
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial +1-719-457-0820. Use the Conference ID 6365614. Additionally, the archived webcast will be available at View Source