Biocept Reports Third Quarter 2015 Financial Results
"During the third quarter we launched proprietary quantitative assays that target important mutations in colorectal cancer, melanoma and small cell lung cancer, building on what we believe to be the largest number of commercial biomarker assays using a combination of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) for clinical use of any company focused on liquid biopsies," said
"The emerging market for liquid biopsy is moving toward standard of care and we are strengthening our leadership position to capitalize on this opportunity," he added. "Through collaborations with respected research institutions, we are accumulating clinical data that validates the high specificity and sensitivity of our assays for biomarker detection and for monitoring changes in mutations over time. Our findings are being presented to oncologists at leading scientific conferences, such as the recent
"As we execute on our plan, we find physician adoption of our liquid biopsy products continues to gain momentum, with commercial sample volume reaching a record 482 for the quarter, a 43% increase from the prior quarter. All of this supports our commitment of improving patient outcome while reducing the cost of healthcare," concluded
Third Quarter and Recent Operational Highlights
Commercial Biomarker Launches
- Launched the Target Selector™ assay for KRAS mutations, expanding our commercial biomarker assays to include colorectal cancer and increasing biomarker detection for other solid tumors.
- Launched the Target Selector™ assay for BRAF mutations, expanding our commercial assays to include melanoma and increasing biomarker detection for other solid tumors.
- Expanded our blood-based biomarker assay menu with FGFR1 amplification, which has been identified in breast cancer and in both small cell and non-small cell lung cancers.
Collaborations
- Partnered with the University of
California ,Irvine to evaluate biomarkers detected from blood-based versus tissue biopsies in patients with metastatic cancers. The collaboration is intended to validate the use of our liquid biopsies to qualify patients for targeted therapies and to establish a framework for monitoring tumor mutations during cancer treatment to aid in treatment decision making. - Announced the addition to our
Scientific Advisory Board of Dr. Marileila Varella Garcia from theUniversity of Colorado atDenver , an expert in the molecular and cytogenetic analysis of cancer.
Industry Conferences
- Announced that clinical validation results will be presented at the
Association for Molecular Pathology Annual Meeting demonstrating that rare genetic events used in monitoring and treating patients with lung cancer can be reliably detected using blood instead of surgical tissue biopsies. - Presented study data at the
International Association for the Study of Lung Cancer's 16th AnnualWorld Conference on Lung Cancer demonstrating that our proprietary CTC capture technology is compatible for detecting RNA-based targets such as ALK, a known driver of non-small cell lung cancer. The study was conducted in collaboration with Insight Genetics using its proprietary ALK detection assay. - Presented clinical data at the
World Conference on Lung Cancer from a study conducted with researchers at theMoores Cancer Center at the University ofCalifornia ,San Diego indicating our Target Selector™ assay has high concordance with tumor status in patients with metastatic lung cancer. - Presented data at the Next Generation Dx Summit with our collaborator
Hatim Husain , M.D. from theMoores Cancer Center discussing the use of liquid biopsies to identify PDL-1 and CMET expression in lung cancer. Checkpoint inhibition with anti-PD1 and anti-PDL1 antibodies is a significant component of the prediction for lung cancer.
Healthcare Payer Agreements
- Announced a participation agreement with
MultiPlan , making our liquid biopsy diagnostics services available to the approximate 68 million healthcare consumers accessing its network.MultiPlan is a national provider of healthcare cost management solution with nearly 900,000 healthcare providers under contract and approximately 40 million claims processed each year. - Secured agreements with preferred provider organizations
Stratose and Galaxy Health Network to provide their members access to our liquid biopsy diagnostic services.
Patent
- Received a U.S. patent allowance covering the use of antibodies in the capture of cells such as CTCs from blood, as well as other biological fluids, using our patented microchannel capture device. This is a key component of our Cell Enrichment and Extraction (CEE™) platforms.
Third Quarter Financial Results
We accessioned 482 commercial cases during the third quarter of 2015, up from 96 commercial cases during the third quarter of 2014. Development services case volume grew to 37 in the third quarter of 2015 from 3 development services assays performed in the third quarter of 2014.
Revenues for the third quarter of 2015 increased by
Cost of revenues was
R&D expenses for the third quarter of 2015 decreased 48% to
General and administrative (G&A) expenses for the third quarter of 2015 were
Sales and marketing expenses for the third quarter of 2015 were
The net loss for the third quarter of 2015 was
Nine Month Financial Results
We accessioned 1,065 commercial assays during the first nine months of 2015, up from 110 during the same period in 2014. Revenues for the first nine months of 2015 were
Total costs and expenses increased to
The net loss for the first nine months of 2015 was
We reported cash and cash equivalents of
Conference Call and Webcast
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About
Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend" or "project," or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements as to physician adoption of our liquid biopsy products, our ability to expand access to our
assays, our ability to fortify our patent portfolio, improvement of clinical outcomes, our impact on diagnostic standard of care and healthcare costs, and our ability to advance our commercial strategy, strengthen our leadership position in the liquid biopsy industry and further enhance our product portfolio, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our
CONDENSED BALANCE SHEETS | |||||||||||
|
| ||||||||||
2014 |
2015 | ||||||||||
(unaudited) |
|||||||||||
ASSETS |
|||||||||||
Cash and cash equivalents |
$ |
5,364,582 |
$ |
12,541,919 |
|||||||
Accounts receivable |
10,600 |
40,360 |
|||||||||
Inventories, net |
188,728 |
302,005 |
|||||||||
Prepaid expenses and other current assets |
338,721 |
456,894 |
|||||||||
TOTAL CURRENT ASSETS |
5,902,631 |
13,341,178 |
|||||||||
FIXED ASSETS, NET |
662,422 |
855,208 |
|||||||||
TOTAL ASSETS |
$ |
6,565,053 |
$ |
14,196,386 |
|||||||
LIABILITIES AND SHAREHOLDERS' EQUITY/(DEFICIT) |
|||||||||||
CURRENT LIABILITIES |
$ |
1,430,783 |
$ |
3,390,747 |
|||||||
NON-CURRENT LIABILITIES, NET |
5,354,839 |
3,877,362 |
|||||||||
TOTAL LIABILITIES |
6,785,622 |
7,268,109 |
|||||||||
SHAREHOLDERS' EQUITY/(DEFICIT) |
(220,569) |
6,928,277 |
|||||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY/(DEFICIT) |
$ |
6,565,053 |
$ |
14,196,386 |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) | |||||||||||
For the three months ended September 30, |
For the nine months ended September 30, | ||||||||||
2014 |
2015 |
2014 |
2015 | ||||||||
REVENUES |
$ |
10,274 |
$ |
164,856 |
$ |
57,794 |
$ |
391,626 | |||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
538,181 |
1,159,710 |
1,555,861 |
3,320,467 | |||||||
Research and development |
1,310,905 |
677,729 |
3,427,513 |
2,073,391 | |||||||
General and administrative |
1,060,812 |
1,630,608 |
3,970,579 |
4,281,883 | |||||||
Sales and marketing |
812,005 |
1,055,653 |
1,246,507 |
2,616,218 | |||||||
Total costs and expenses |
3,721,903 |
4,523,700 |
10,200,460 |
12,291,959 | |||||||
LOSS FROM OPERATIONS |
(3,711,629) |
(4,538,844) |
(10,142,666) |
(11,900,333) | |||||||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(148,165) |
(137,150) |
(1,841,039) |
(430,215) | |||||||
LOSS BEFORE INCOME TAXES |
(3,859,794) |
(4,495,994) |
(11,983,705) |
(12,330,548) | |||||||
INCOME TAXES |
— |
(199) |
(800) |
(1,478) | |||||||
NET LOSS & COMPREHENSIVE LOSS |
$ |
(3,859,794) |
$ |
(4,496,193) |
$ |
(11,984,505) |
$ |
(12,332,026) | |||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(0.87) |
$ |
(0.24) |
$ |
(3.12) |
$ |
(0.78) | |||
- Diluted |
$ |
(0.87) |
$ |
(0.24) |
$ |
(3.12) |
$ |
(0.78) | |||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
4,449,603 |
18,727,806 |
3,845,540 |
15,735,907 | |||||||
- Diluted |
4,449,603 |
18,727,806 |
3,845,540 |
15,735,907 |
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