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OncoCyte Net Loss Widens in Q2

NEW YORK (GenomeWeb) – OncoCyte said after the close of the market on Tuesday that its second quarter net loss swelled year over year as it continues to advance its flagship liquid biopsy test toward commercialization.

For the three months ended June 30, the Alameda, California-based diagnostic developer incurred a net loss of $4.5 million, or $.12 per share, compared to a loss of $3.8 million, or $.13 per share, in the year-ago period. Analysts on average had expected a loss per share of $.09.

OncoCyte did not report any Q2 revenues, the same as in the year-ago quarter.

The company's Q2 R&D expenses grew 15 percent to $2.3 million from $2.0 million, and included a $600,000 noncash impairment charge for noncore, intangible assets that OncoCyte had acquired for therapeutic uses but not longer plans to develop or commercialize.

OncoCyte's SG&A expenses rose 19 percent to $1.9 million from $1.6 million.

The firm ended the quarter with $10.3 million in cash and cash equivalents and $728,000 in marketable securities.

Prior to the end of Q2, OncoCyte received net proceeds of $3.3 million from an at-market registered direct offering of common stock and warrants.

OncoCyte said that it projects that its cash position, coupled with prudent expense management, will be sufficient to execute its near-term strategy and the continued development of DetermaVu, the its liquid biopsy lung cancer diagnostic test.

"We achieved our primary goal during the first half of 2018 — putting our DetermaVu development program back on track," OncoCyte President and CEO William Annett said in a statement. "We are now beginning to take the next steps in the development plan and remain encouraged that DetermaVu could address an estimated $4.7 billion annual US market for a confirmatory lung cancer liquid biopsy test."

The company noted that during Q2 it generated "encouraging" study results for DetermaVu and selected a new, undisclosed next-generation sequencing clinical diagnostic testing platform that has demonstrated "consistent data and increased test performance."

OncoCyte said that it also discovered, filed patents on, and tested a new set of 190 biomarkers that could help distinguish malignant from benign lung nodules. Most recently the company incorporated these new biomarkers into a next-generation version of DetermaVu that appear to be more robust than those used in an earlier panel.

OncoCyte is planning to initiate a series of studies, which, if successful, will lead to a prospective, blinded R&D validation study on approximately 250 patient samples to assess the performance of a second-generation algorithm on the new sequencing platform. Completion of this study is targeted for late 2018.

If that study is successful, OncoCyte will follow with an analytical validation study and a CLIA validation study of DetermaVu in its CLIA laboratory, then initiate a blinded prospective clinical validation study. Completion of the clinical validation study is targeted for the first half of 2019, OncoCyte said.