
Biocept Reports Second Quarter 2020 Financial Results
"Due to our decision to initiate COVID-19 testing, overall commercial volume during the second quarter increased slightly versus the prior year, even with the impact of the pandemic," said
"For the immediate future, COVID-19 testing is an important part of our business and I'm pleased to report that we have received over 11,000 specimens to date," he added. "We have secured components to date for approximately 50,000 COVID-19 specimen collection kits to support current testing and expect to begin shipping our own COVID-19 specimen collection kits to our lab services customers later this year, which will contain our proprietary VEE-SURE™ viral transport media. These kits will be available for use in our lab or can be sold to other labs. We are excited about our recent development agreement with Aegea Biotechnologies to utilize Switch-Blocker™ technology to develop tests that could increase sensitivity in detecting SARS-CoV-2, the virus that causes COVID-19, and provide additional information on specific strain types.
"We are proud to support public health efforts by offering COVID-19 testing and plan to develop and offer these critical products and services for as long as they are needed," said
Second Quarter 2020 and Recent Highlights
Commercial Launches
- Launched COVID-19 testing and have received over 11,000 specimens to date. The vast majority of results to date have been reported to healthcare providers within 48 hours. The collection kits for RT-PCR SARS-CoV-2 testing have been assembled by
Biocept with components sourced from another provider. Specimens are shipped overnight toBiocept's high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory. The lab is using Thermo Fisher Scientific's FDA-approved for EUA (Emergency Use Authorization) testing TaqPath™ molecular diagnostic platform and kit. Biocept is developing its own COVID-19 specimen collection kits for distribution to clients and expects those kits to be available later in 2020.- Launched research-use-only (RUO) kits that allow molecular laboratories worldwide to detect oncogene mutations in tissue and liquid biopsies through the analysis of Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies, as well as circulating tumor DNA (ctDNA) gained from blood. Our first RUO kit with the ability to use tissue and liquid biopsy samples is designed for the detection of EGFR mutations, which 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 geographies that recognize the CE Mark. Molecular assay kits detect key oncogene mutations through the analysis of both FFPE tissue and ctDNA. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer. - Expanded menu of molecular assay kit offerings with the launch of a Target Selector™ kit to detect BRAF mutations. Similar to the EGFR kit, the BRAF RUO kit detects key oncogene mutations through the analysis of both FFPE tissue gained from surgical biopsies, as well as ctDNA gained from blood. The BRAF mutation is among the most frequently evaluated biomarkers across many solid tumors, including lung cancer and melanoma.
Development Agreement
- Entered into a development 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.
Commercial Agreements
- Entered into an agreement with reference-based pricing network
Medical Cost Containment Professionals, LLC to process out-of-network claims for Target Selector™ liquid biopsy testing. Claims will be adjudicated through this network at pre-negotiated pricing in a timely manner, helping to accelerate collections while reducing the length of time receivables remain outstanding. Expanded Multiplan Health Insurance contract to now include Target Selector™ NGS panel for breast and lung cancer, as well as coverage for COVID-19 testing. Multiplan is an independent PPO network, with 4,500 acute care hospitals, 110,000 ancillary care facilities and 550,000 healthcare practitioners.- Signed semi-exclusive agreement with skilled nursing facility network with over 50+ sites in multiple states to provide COVID-19 testing to residents and employees.
Biocept is one of two laboratories selected.
Industry Conference Presentation
- Presented data affirming the ability of the Target Selector™ platform to identify potentially actionable mutations in the cerebrospinal fluid of patients whose cancer has metastasized to the central nervous system at the
American Society for Clinical Oncology (ASCO) 2020 Virtual Scientific Program. The data were presented in a poster by the study's principal investigatorKevin Kalinsky , MD, MS, associate professor of medicine atColumbia University Vagelos College of Physicians and Surgeons , and an oncologist atNew York-Presbyterian/Columbia University Irving Medical Center .
Intellectual Property
- Granted patents in
Australia andBrazil for the Primer Switch technology, which is useful for ctDNA analysis using RT-PCR and associated methods, including next-generation sequencing (NGS). - Awarded Canadian patent covering the enhanced detection of rare cells, including cancer cells, from a biological fluid sample such as blood or cerebrospinal fluid, expanding the Company's global patent estate to 40 for use in its molecular diagnostics business.
Corporate Developments
- Announced plans to relocate the Company's corporate offices and laboratory to a new 39,000 square foot facility in
San Diego by the end of 2020. The move aligns with the strategy of supporting growth while reducing overhead expense, and is expected to be completed without disruption to workflow. - Raised net proceeds of
$9.6 million through a registered direct offering of common stock priced at-the-market.
Second Quarter Financial Results
Revenues for the second quarter of 2020 were
Cost of revenues for the second quarter of 2020 was
Research and development (R&D) expenses for the second quarter of 2020 were
Other expense, net for the second quarter of 2020 was
The net loss attributable to common shareholders for the second quarter of 2020 was
Six Month Financial Results
Revenues for the first six months of 2020 were
Operating expenses for the first six months of 2020 were
The net loss for the first six 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 10145918. A replay of the webcast will be available for 90 days.
About
Biocept is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. Biocept uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer.
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 perform COVID-19 testing and the likelihood of such test volume to be sustainable, our ability to provide and the timing of availability of our own COVID-19 specimen collection kits, the potential of our recent development agreement with Aegea Biotechnologies, including the potential to utilize Switch-Blocker™ technology to develop tests that could increase sensitivity in detecting SARS-CoV-2, and our ability to weather the COVID-19 pandemic and return commercial volume to normal levels and grow our business following the pandemic subsiding, 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 |
$ |
24,053,269 |
|
Accounts receivable, net |
3,527,078 |
3,179,217 |
|||
Inventories, net |
767,986 |
973,684 |
|||
Prepaid expenses and other current assets |
296,127 |
852,067 |
|||
TOTAL CURRENT ASSETS |
13,892,597 |
29,058,237 |
|||
FIXED ASSETS, NET |
1,504,330 |
1,336,726 |
|||
LEASE RIGHT-OF-USE ASSETS |
2,335,717 |
2,623,449 |
|||
TOTAL ASSETS |
$ |
17,732,644 |
$ |
33,018,412 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES, NET |
$ |
5,558,812 |
$ |
5,631,559 |
|
NON-CURRENT LIABILITIES, NET |
973,189 |
1,301,910 |
|||
TOTAL LIABILITIES |
6,532,001 |
6,933,469 |
|||
SHAREHOLDERS' EQUITY |
11,200,643 |
26,084,943 |
|||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
17,732,644 |
$ |
33,018,412 |
|
|||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|||||||||||
For the three months ended June 30, |
For the six months ended June 30, |
||||||||||
2019 |
2020 |
2019 |
2020 |
||||||||
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
||||||||
NET REVENUES |
$ |
1,191,323 |
$ |
917,471 |
$ |
2,215,562 |
$ |
2,364,020 |
|||
COSTS AND EXPENSES |
|||||||||||
Cost of revenues |
$ |
2,673,323 |
$ |
2,517,902 |
$ |
5,272,687 |
$ |
5,464,760 |
|||
Research and development expenses |
1,148,280 |
1,588,716 |
2,371,571 |
2,901,392 |
|||||||
General and administrative expenses |
1,676,310 |
1,911,239 |
3,358,147 |
3,815,672 |
|||||||
Sales and marketing expenses |
1,614,732 |
1,333,271 |
2,989,292 |
2,798,386 |
|||||||
Total costs and expenses |
7,112,645 |
7,351,128 |
13,991,697 |
14,980,210 |
|||||||
LOSS FROM OPERATIONS |
(5,921,322) |
(6,433,657) |
(11,776,135) |
(12,616,190) |
|||||||
WARRANT INDUCEMENT, INTEREST AND OTHER EXPENSE |
(1,894,690) |
(55,646) |
(1,956,664) |
(2,214,451) |
|||||||
LOSS BEFORE INCOME TAXES |
(7,816,012) |
(6,489,303) |
(13,732,799) |
(14,830,641) |
|||||||
INCOME TAXES |
— |
— |
— |
— |
|||||||
NET LOSS AND COMPREHENSIVE LOSS |
$ |
(7,816,012) |
$ |
(6,489,303) |
$ |
(13,732,799) |
$ |
(14,830,641) |
|||
Deemed dividend related to warrants down round provision |
— |
— |
(99,743) |
(2,774) |
|||||||
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS |
$ |
(7,816,012) |
$ |
(6,489,303) |
$ |
(13,832,542) |
$ |
(14,833,415) |
|||
NET LOSS PER SHARE |
|||||||||||
- Basic |
$ |
(0.38) |
$ |
(0.05) |
$ |
(0.83) |
$ |
(0.14) |
|||
- Diluted |
$ |
(0.38) |
$ |
(0.05) |
$ |
(0.83) |
$ |
(0.14) |
|||
WEIGHTED AVG NUMBER OF SHARES OUTSTANDING |
|||||||||||
- Basic |
20,466,224 |
127,173,744 |
16,670,184 |
103,086,834 |
|||||||
- Diluted |
20,466,224 |
127,173,744 |
16,670,184 |
103,086,834 |
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