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Biocept Q2 Revenues Grow on Increased Test Volume

NEW YORK (GenomeWeb) – Biocept reported Monday after the close of the market a year-over-year increase in second quarter revenues and commercial testing business volume, but also a higher net loss compared to the previous year.

Separately today, the firm announced a new collaboration with the University of California, Irvine to evaluate its liquid biopsy platform in guiding treatment for metastatic cancer patients.

The San Diego-based firm, which markets a variety of molecular diagnostic tests based on detection of circulating tumor cells and circulating tumor DNA, said it accessioned 336 commercial cases in the second quarter ended June 30, up from just three commercial cases during the second quarter of 2014. Including non-commercial assays, the company brought in a total of 525 samples during the quarter.

"Liquid biopsy is still an emerging technology and changing physician behavior takes time," Biocept President and CEO Michael Nall said during a conference call recapping the company's Q2 financial results. "We are taking steps to accumulate the clinical evidence that will support physician adoption and grow our business," he added.

Revenues for the second quarter of 2015 increased to $77,000 from $19,000 in the second quarter of 2014.

Biocept posted a net loss of $4 million, or $.22 per share per share, in the second quarter, up from $3 million, or $.67 per share, in Q2 2014.

The per-share figure reflects an increase in outstanding shares used to calculate its loss per share, from 4.4 million in 2014 to 18 million this year. Biocept went public in February 2014.

According to the company, the increase in net loss was primarily due to higher expenses associated with increased sample volumes and expansion of its sales and marketing organization.

Biocept CFO Bill Kachioff said during the firm's earnings call that a change in CPT codes early this year caused a delay in reimbursement payments for the company on assays accessioned in the first quarter, which in turn impacted revenues in Q2.

"We believe we resolved this issue last month and have resubmitted claims for those assays. We expect to receive additional reimbursement for these claims during the … third quarter of 2015," Kachioff said.

The average reimbursement for cases billed between July and December of 2014 was $612, he added. During this time the primary assay being marketed by the company was its breast cancer test, which included only a few biomarkers.

The company's R&D spending decreased 30 percent year over year to $772,000 from $1.1 million. Its general and administrative costs rose to $1.4 million from $1 million in Q2 2014, while its sales and marketing costs nearly doubled to $851,000 from $423,000.

Biocept exited the quarter with $16.5 million in cash and cash equivalents.

During the quarter, Biocept expanded its fleet of liquid biopsy tests, launching assays targeting important mutations in colorectal cancer, melanoma, and small cell lung cancer. These included tests for KRAS mutations, BRAF mutations, and FGFR1 amplification.

Nall said the company was also recently issued aUSpatent for its blood collection and transport preservative, an "important element of Biocept's technology for both CTC and ctDNA predictive and prognostic genomic analysis," he said.

The preservative significantly reduces clumping of cells that may interfere with their capture when using microchannel devices for up to 96 hours. "With this extended timeframe we can effectively perform testing for patients worldwide," he said.

According to the firm, it is also working currently toward additional validation for its liquid biopsy approach through research collaborations, and has plans to increase physician awareness and adoption with additional featured presentations at important medical conferences.

In June, Biocept announced a research and commercial collaboration with the Sarah Cannon Research Institute to determine the clinical utility of Biocept's OncoCEE technology to detect circulating biomarkers to assess the response of estrogen-positive breast cancer patients' tumors to treatment over time.

As part of the UC-Irvine collaboration announced today, researchers from the company and university will also compare biomarkers detected in blood to tissue biopsy in patients with metastatic cancer, and validate the use of Biocept's liquid biopsy platform in qualifying patients for available targeted therapies.

The partners will also evaluate the potential of the technology to serially monitor tumor mutations during treatment to identify early indicators of drug resistance.