On April 28, 2017 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests to aid in the early detection of cancer, reported its financial results for the quarter ended March 31, 2017(Press release, BioTime, APR 28, 2017, View Source [SID1234518721]). In addition, OncoCyte announced it will conduct an investor call on May 22, 2017 at 4:30pm ET/1:30 pm PT after its lead investigator Dr. Anil Vachani presents data from the 300 patient R&D Validation study at the American Thoracic Society 2017 International Conference (ATS) in Washington D.C.

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"We made significant progress during the first quarter towards the commercialization of our lung cancer diagnostic product, including initiating a search for a head of our sales organization as well as beginning the expansion of our sales, marketing and market access teams," commented William Annett, Chief Executive Officer. "We believe the data on our lung cancer test being presented in May demonstrates the robustness of our science and strengthens our market position."

"We plan to provide investors with an overview of the results from the 300 patient R&D Validation study on our conference call following the presentation. We believe the total addressable market for our lung cancer diagnostic test could be over $4 billion, and that we are positioned to be the first company to provide a highly accurate non-invasive confirmatory blood test to address this market. Our focus over the next few months is to complete the development process, obtain CLIA certification of our laboratory, and prepare for our anticipated commercial launch in the second half of the year."

Significant First Quarter Accomplishments

Reported the successful results of the R&D Validation study for its lung cancer diagnostic test. The results, based on the analysis of samples from approximately 300 patients, confirmed previously reported data presented by The Wistar Institute at the CHEST 2016 Annual Meeting in October. The data from the study exceed levels OncoCyte believes necessary for a commercially successful test.

Reported that it locked its prediction algorithm and intends to move to the Clinical Validation phase of development—the last phase before commercial launch.

Submitted the application for CLIA certification of OncoCyte’s laboratory where the assay will be run.

Announced that its breast cancer test is developing ahead of schedule, and began a follow-up, multi-center study to further develop and verify the results of the earlier studies.
Near-term Milestones

OncoCyte is continuing to make progress and has several upcoming events and milestones related to the development of its lung cancer diagnostic:

Poster presentation of lung cancer diagnostic R&D Validation study at the (ATS) International Conference. The data will be presented by Dr. Anil Vachani, an Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, at 2:15 p.m. ET on May 22, 2017.

Conference call to report on 300-patient R&D Validation study, to be held at 4:30pm ET on May 22, 2017.

Establishment of a medical advisory committee (MAC), headed by top lung cancer specialists. The MAC will advise OncoCyte on clinical unmet needs and future development strategy.

CLIA certification and California state clinical laboratory license, which OncoCyte expects to receive during the second quarter of 2017.

Clinical Validation study to confirm and replicate OncoCyte’s findings in a commercial CLIA lab setting.

Expansion of OncoCyte’s commercial capabilities in sales and marketing, revenue cycle management and reimbursement.

Launch of lung cancer test during second half of 2017 assuming successful completion of the Clinical Validation and CLIA certification.
First Quarter 2017 Financial Results

For the quarter ended March 31, 2017, OncoCyte incurred a net loss of $4.7 million, or $0.16 per share, compared to a net loss of $2.9 million, or $0.12 per share, in 2016. The $4.7 million net loss includes a $1.1 million noncash expense, or $0.04 per share, related to issuance of warrants to certain shareholders as an inducement to exercise warrants. During the first quarter OncoCyte used $3.3 million in operating activities compared to $2.2 million from the comparative prior quarter.

Research and development expenses for the quarter ended March 31, 2017 were $1.8 million compared to $1.7 million for the same period in 2016. Overall the slight increase in research and development expenses was due to increased staffing and laboratory expenses.

General and administrative expenses increased to $2.0 million from $1.0 million for the same period in 2016. Sales and marketing expenses increased to $0.7 million from $0.2 million. The increases were attributable to a $1.1 million noncash expense for the issuance of warrants as well as increased staffing for the expected commercial launch of OncoCyte’s lung cancer diagnostic during second half of 2017.

At March 31, 2017, OncoCyte had liquid assets of $13 million, including $11.4 million of cash and cash equivalents, and available-for-sale securities valued at $1.6 million.