
Biocept Reports First Quarter 2020 Financial Results
"Revenue for the first quarter was
"Importantly, we believe we are well positioned to weather the pandemic, which is impacting testing volume industrywide, and for a return to growth as shelter-in-place restrictions are lifted and physician offices and labs reopen," he added. "We are an established leader in liquid biopsy and our Target Selector™ assays and products provide critical information to physicians in treatment decision-making. We expect that when it is safe for patients diagnosed with cancer to continue to seek treatment, our commercial volume will return to a more normal level. We are particularly pleased with our strengthened balance sheet, having raised approximately
First Quarter 2020 and Recent Highlights
Commercial Launches
- Announced the availability of Target Selector™ assays to evaluate cerebrospinal fluid (CSF) for the presence of circulating tumor cells (CTCs) and biomarkers, which may be indicators of brain metastases. Of patients diagnosed with breast and lung cancer, up to 30% and 36%, respectively, will develop brain metastases. The validations study for our CSF assay was conducted in collaboration with
Providence St. Joseph Health ,Southern California , and its wholly owned affiliatesProvidence St. John's Health Center andJohn Wayne Cancer Institute . - Launched the availability of research-use-only (RUO) kits that allow molecular laboratories worldwide to detect oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies. The first RUO kit with the ability to use tissue and liquid biopsy samples is designed for the detection of EGFR mutations that are among the most frequently evaluated biomarkers of lung cancer. RUO kits for other oncogene mutations are planned for future launches.
- Awarded CE-IVD Mark for the Target Selector™ molecular assay EGFR Kit. The CE Mark confirms that Target Selector™ kits meet the requirements of the European In-Vitro Diagnostic Devices Directive and allows
Biocept to commercialize these kits throughout theEuropean Union and other CE Mark geographies. Molecular assay kits detect key oncogene mutations through the analysis of both FFPE tissue as well as ctDNA. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer. - Announced the validation for COVID-19 testing.
Biocept operates a high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory inSan Diego , with specialized, licensed molecular lab staff who have been trained in performing the COVID-19 testing. The lab will be using ThermoFisher Scientific's FDA-approved for EUA (Emergency Use Authorization) testing TaqPath™ molecular diagnostic platform and kit for SARS-CoV-2 (COVID-19). Due to the national shortage,Biocept's clients have had difficulty gaining specimen collection kits to send toBiocept for testing and to date, we have not been able to perform any COVID 19 testing. In order to address this and provide needed testing,Biocept intends to manufacture its own collection kits for distribution to clients and expects those kits to be available in June.
Commercial Agreements
- Signed laboratory services agreements with two large
California -based independent physician associations (IPAs) to provideBiocept's Target Selector™ liquid biopsy testing services.
- Announced publication of clinical data in the
Journal of Clinical Pathology that further validatesBiocept's Target Selector™ qPCR Assay using Switch Blocker technology to identify cancer-related mutations in liquid biopsy samples. Study results showed a very high concordance betweenBiocept's liquid biopsy testing and tissue biopsy and best-in-class detection of alterations down to a single mutant copy in both analytical and clinical settings.
Intellectual Property
- Awarded
U.S. patent covering antibody and microchannel technology and enhanced detection of cancer cells. This new patent expandsBiocept's intellectual property estate for capturing and detecting rare cells of interest, including CTCs, to aid in the management of patients with cancer. - Granted Australian and Brazilian patents providing intellectual property protection for its Primer Switch technology that is useful for ctDNA analysis using reverse-transcription PCR and associated methods, including next-generation sequencing (NGS).
Corporate Developments
- Promoted
Cory J. Dunn to Senior Vice President of Commercial Operations.Ms. Dunn joinedBiocept as Vice President of Marketing inOctober 2018 .
First Quarter Financial Results
Revenues for the first quarter of 2020 were
Cost of revenues for the first quarter of 2020 was
Research and development (R&D) expenses for the first quarter of 2020 were
Other expense, net for the first quarter of 2020 was
The net loss attributable to common shareholders for the first quarter 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 10143445. 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, our ability to weather the COVID-19 pandemic and return commercial volume to normal levels and grow our business following the lifting of shelter-in-place restrictions, our ability to launch additional RUO kits for other oncogene mutations, and our ability to provide COVID-19 testing, 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 Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with 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 |
$ |
21,493,192 |
|
Accounts receivable, net |
3,527,078 |
3,418,897 |
|||
Inventories, net |
767,986 |
918,698 |
|||
Prepaid expenses and other current assets |
296,127 |
429,131 |
|||
TOTAL CURRENT ASSETS |
13,892,597 |
26,259,918 |
|||
FIXED ASSETS, NET |
1,504,330 |
1,463,128 |
|||
LEASE RIGHT-OF-USE ASSETS |
2,335,717 |
2,089,284 |
|||
TOTAL ASSETS |
$ |
17,732,644 |
$ |
29,812,330 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES, NET |
$ |
5,558,812 |
$ |
6,031,796 |
|
NON-CURRENT LIABILITIES, NET |
973,189 |
1,050,429 |
|||
TOTAL LIABILITIES |
6,532,001 |
7,082,225 |
|||
SHAREHOLDERS' EQUITY |
11,200,643 |
22,730,105 |
|||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
17,732,644 |
$ |
29,812,330 |
|
|||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|||||
For the three months ended March 31, |
|||||
2019 |
2020 |
||||
(unaudited) |
(unaudited) |
||||
NET REVENUES |
$ |
1,024,239 |
$ |
1,446,549 |
|
COSTS AND EXPENSES |
|||||
Cost of revenues |
$ |
2,599,364 |
$ |
2,946,858 |
|
Research and development expenses |
1,223,291 |
1,312,676 |
|||
General and administrative expenses |
1,681,837 |
1,904,433 |
|||
Sales and marketing expenses |
1,374,560 |
1,465,115 |
|||
Total costs and expenses |
6,879,052 |
7,629,082 |
|||
LOSS FROM OPERATIONS |
(5,854,813) |
(6,182,533) |
|||
INTEREST AND OTHER INCOME/(EXPENSE), NET |
(61,974) |
(2,158,805) |
|||
LOSS BEFORE INCOME TAXES |
(5,916,787) |
(8,341,338) |
|||
INCOME TAXES |
— |
— |
|||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(5,916,787) |
$ |
(8,341,338) |
|
Deemed dividend related to warrants down round provision |
(99,743) |
(2,774) |
|||
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS |
$ |
(6,016,530) |
$ |
(8,344,112) |
|
NET LOSS PER SHARE |
|||||
- Basic |
$ |
(0.61) |
$ |
(0.11) |
|
- Diluted |
$ |
(0.61) |
$ |
(0.11) |
|
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||
- Basic |
9,792,093 |
78,999,924 |
|||
- Diluted |
9,792,093 |
78,999,924 |
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