
Biocept Reports Third Quarter 2020 Financial Results
"Third quarter revenues increased more than four-fold compared with the third quarter of 2019 to
"Offering COVID-19 testing services was the right thing to do, and we fully expect this testing to be an important part of our business until the pandemic subsides," he added. "That said, oncology remains our long-term focus and we continue executing on priorities to build our business for a strong post-pandemic future.
"During the quarter we experienced an anticipated recovery in our oncology testing volume over the second quarter, driven by our new strategy in neuro-oncology. Our Target Selector™ CSF assays are proving to be more sensitive than conventional cytology alone in detecting lung and breast cancer that has metastasized to the brain or central nervous system," said
Third Quarter 2020 and Recent Highlights
Corporate Developments
- Named
Michael C. Dugan , M.D. as Chief Medical Officer and Medical Director with responsibilities for overseeing medical policy decision-making and the operations ofBiocept's CLIA-certified, CAP-accredited, high-complexity molecular laboratory.Dr. Dugan is highly respected in the molecular diagnostics industry and has served in leading medical positions at Exact Sciences,Quest Diagnostics Nichols Institute andRoche Molecular Systems . - Appointed
Samuel D. Riccitelli to Board of Directors.Mr. Riccitelli has more than 35 years of experience in the healthcare industry, including extensive experience in the molecular diagnostics industry, having served in executive-level positions and on the Boards of multiple publicly traded companies.
Commercial Developments and Agreements
- Received more than 100,000 samples for RT-PCR COVID-19 testing in its high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory. The vast majority of results to date have been reported to healthcare providers within 48 hours of sample receipt.
- Announced a positive coverage decision by Highmark, America's fourth largest
Blue Cross Blue Shield affiliate, forBiocept's Target Selector™ liquid biopsy assays for use in the diagnosis and treatment of patients with non-small cell lung cancer (NSCLC). The coverage determination follows two years of evaluation by theAllegheny Health Network Cancer Institute ofBiocept's liquid biopsy assays to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care. - Expanded the agreement with MultiPlan, a healthcare cost management company offering payment integrity and network-based and analytics-based services, to include COVID-19 testing at a pre-negotiated price per test. More than 1 million healthcare providers participate in MultiPlan's networks and 60 million health plan members have access to its services.
Development
Biocept is developing and undertaking patent protection, for a broad-based pathogen collection kit, with specific applications to COVID-19. This tube has been shown to rapidly kill COVID-19, and to preserve COVID-19 RNA for analysis at room temperature for several weeks. It has also been shown to be fully compatible with standard nucleic acid isolation methods.Biocept -developed COVID-19 sample collection tubes are on track for validation and for patent filing by the end of 2020.- Progress is being made under the agreement with Aegea Biotechnologies to develop a new, highly sensitive, next-generation PCR-based COVID-19 assay utilizing the patented Switch-Blocker™ technology. The test is designed for improved analytical performance in order to better assist healthcare providers in screening and managing patients. The collaboration highlights the potential to apply the Switch-Blocker™ technology to molecular diagnostics in COVID-19 and other infectious diseases, in addition to oncology applications.
Industry Conference Presentation
- Presented results from a small prospective study comparing Target Selector™ cerebrospinal fluid (CSF) testing to conventional cytology in patients with NSCLC and leptomeningeal metastasis at the "Hot Topic: Liquid Biopsy" meeting of the
International Association for the Study of Lung Cancer . Study results indicate that Target Selector™ may play an important role in providing valuable information to neuro-oncologists in making treatment decisions for patients with lung cancer metastases to the brain and spinal cord. - Announced the upcoming presentation at the
Society for Neuro-Oncology's SNO2020 Virtual Conference of results from a study using its Target Selector™ CSF assays to analyze cerebrospinal fluid samples of patients with primary lung or breast cancer with either brain or leptomeningeal disease. The conference is being heldNovember 19-21, 2020 .
Intellectual Property
- Awarded a Japanese patent for the use of binding entities in combination with any solid surface to capture and detect any target of interest, including circulating tumor cells (CTCs), from any sample type. This patent combines well with
Biocept's patented microchannel and cell-staining platforms, and provides opportunities for out-licensing technology with a focus on any target of interest, including single-cell analysis and other methodologies. - Awarded
U.S. and Japanese patents for Primer-Switch technology, which is useful for the detection of rare mutations, including cancer biomarkers, found in tissue, blood and cerebrospinal fluid using circulating tumor DNA (ctDNA) analysis through RT-PCR and associated analysis methods, including next-generation sequencing (NGS). - Received a
Hong Kong patent covering the enhanced detection of rare cells, including cancer cells, further expandingBiocept's global patent estate for capturing and detecting rare cells of interest, including CTCs, to aid in the treatment of patients with cancer. - Expanded its
U.S. and international patent portfolio for molecular technologies to 44 issued patents.
Third Quarter Financial Results
Revenues for the third quarter of 2020 were
Cost of revenues for the third quarter of 2020 was
The net loss attributable to common shareholders for the third quarter of 2020 was
Nine Month Financial Results
Revenues for the first nine months of 2020 were
Operating expenses for the first nine months of 2020 were
The net loss for the first nine months of 2020 was
Conference Call and Webcast
A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10149217. A replay of the webcast will be available for 90 days.
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 our ability to provide physicians with clinically actionable information to improve the outcomes of cancer patients, the future role of COVID-19 testing in our business, the sensitivity of our Target Selector CSF assays in detecting lung and breast cancer and the value of such assays as a diagnostic tool and in profiling biomarkers to help physicians with treatment selection, the potential growth of our new clinical programs focused on neuro-oncology testing, the timing of our COVID-19 sample collection tubes validation and patent filing, the potential of our development agreement with Aegea Biotechnologies, including the potential to utilize Switch-Blocker™ technology to develop a new, highly sensitive, next-generation PCR-based COVID-19 and molecular diagnostics for other infectious diseases, the potential role of Target Selector in providing information to neuro-oncologists in making treatment decisions for patients with lung cancer metastases to the brain and spinal cord, and our upcoming presentation at the
Investor Contact:
LHA Investor Relations
Jcain@lhai.com
(310) 691-7100
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CONDENSED BALANCE SHEETS |
|||||
|
|
||||
2019 |
2020 |
||||
(unaudited) |
|||||
ASSETS |
|||||
Cash |
$ |
9,301,406 |
$ |
16,857,941 |
|
Accounts receivable, net |
3,527,078 |
7,954,625 |
|||
Inventories, net |
767,986 |
3,315,789 |
|||
Prepaid expenses and other current assets |
296,127 |
697,946 |
|||
TOTAL CURRENT ASSETS |
13,892,597 |
28,826,301 |
|||
FIXED ASSETS, NET |
1,504,330 |
1,607,177 |
|||
LEASE RIGHT-OF-USE ASSETS |
2,335,717 |
2,371,157 |
|||
TOTAL ASSETS |
$ |
17,732,644 |
$ |
32,804,635 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES, NET |
$ |
5,558,812 |
$ |
10,113,652 |
|
NON-CURRENT LIABILITIES, NET |
973,189 |
1,337,686 |
|||
TOTAL LIABILITIES |
6,532,001 |
11,451,338 |
|||
SHAREHOLDERS' EQUITY |
11,200,643 |
21,353,297 |
|||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
17,732,644 |
$ |
32,804,635 |
|
|
|||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|||||||||||
For the three months ended September 30, |
For the nine months ended September 30, |
||||||||||
2019 |
2020 |
2019 |
2020 |
||||||||
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
||||||||
NET REVENUES |
$ |
1,529,262 |
$ |
6,586,144 |
$ |
3,744,824 |
$ |
8,950,160 |
|||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
$ |
2,832,735 |
$ |
5,859,370 |
$ |
8,105,422 |
$ |
11,323,668 |
|||
Research and development expenses |
1,163,546 |
1,087,741 |
3,535,116 |
3,989,133 |
|||||||
General and administrative expenses |
1,700,380 |
3,023,337 |
5,058,525 |
6,839,467 |
|||||||
Sales and marketing expenses |
1,462,335 |
1,434,481 |
4,451,628 |
4,232,867 |
|||||||
Total costs and expenses |
7,158,996 |
11,404,929 |
21,150,691 |
26,385,135 |
|||||||
LOSS FROM OPERATIONS |
(5,629,734) |
(4,818,785) |
(17,405,867) |
(17,434,975) |
|||||||
WARRANT INDUCEMENT, INTEREST AND OTHER EXPENSE |
(62,028) |
(59,549) |
(2,018,691) |
(2,274,000) |
|||||||
LOSS BEFORE INCOME TAXES |
(5,691,762) |
(4,878,334) |
(19,424,558) |
(19,708,975) |
|||||||
INCOME TAXES |
— |
— |
— |
— |
|||||||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(5,691,762) |
$ |
(4,878,334) |
$ |
(19,424,558) |
$ |
(19,708,975) |
|||
Deemed dividend related to warrants down round provision |
— |
— |
(99,743) |
(2,774) |
|||||||
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS |
$ |
(5,691,762) |
$ |
(4,878,334) |
$ |
(19,524,301) |
$ |
(19,711,749) |
|||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(2.47) |
$ |
(0.43) |
$ |
(10.96) |
$ |
(1.48) |
|||
- Diluted |
$ |
(2.47) |
$ |
(0.43) |
$ |
(10.96) |
$ |
(1.48) |
|||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
2,301,819 |
11,324,289 |
1,780,727 |
13,333,427 |
|||||||
- Diluted |
2,301,819 |
11,324,289 |
1,780,727 |
13,333,427 |
|||||||
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