SAN DIEGO, Aug. 12, 2020 /PRNewswire/ -- Biocept, Inc.
(Nasdaq: BIOC), a leading provider of molecular technologies
designed to provide physicians with clinically actionable
information to improve the outcomes of patients, reports financial
results for the three and six months ended June 30, 2020 and provides an update on its
business progress.
"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
Michael Nall, President and CEO of
Biocept. "Commercial volume in our core oncology business was
down 16% year-over-year, which is significantly better than the
decline of up to 40% we anticipated in our second quarter
forecast. We reached a low point in oncology testing early in
the second quarter, with subsequent improvement as the quarter
progressed. However, with the resurgence of the pandemic,
physicians report that patient office visits have not returned to
pre-COVID levels, which is continuing to affect our oncology
testing volume. In addition to the launch of our COVID-19
testing service, our better-than-expected performance was driven in
part by new assays that evaluate the cerebrospinal fluid of
patients with breast or lung cancer suspected of brain or central
nervous system metastases. Revenues for the quarter decreased
23% year-over-year, as a result of fewer patient visits to
physician offices attributed to the concerns about COVID 19.
That said, revenues for the first half of 2020 were up 7% over the
prior year, driven by our strong first quarter performance before
the full impact of the pandemic.
"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 Mr.
Nall. "As a long-term strategy, we remain focused on oncology
and believe we are well positioned to weather the pandemic as
we continue to make progress on multiple aspects of our core
business and build for a strong future. We are an established
leader in liquid biopsy with our Target Selector™ assays, providing
information that is critical to physician decision-making for their
patients diagnosed with cancer. We expect that when the
pandemic subsides, our commercial oncology volume will return to
growth. We believe our recently strengthened balance sheet
will support this strategy."
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 to Biocept'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 the
European 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 investigator
Kevin Kalinsky, MD, MS, associate
professor of medicine at Columbia
University Vagelos College of Physicians and Surgeons, and
an oncologist at New York-Presbyterian/Columbia University Irving Medical Center.
Intellectual Property
- Granted patents in Australia
and Brazil 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 $917,000, compared with $1.2 million for the second quarter of 2019, with
the decrease attributable to the impact of the COVID-19
pandemic. Revenues for the second quarter of 2020 included
$841,000 in commercial test revenue,
$38,000 in development services test
revenue and $38,000 in revenue for
distributed products, Target Selector™ RUO kits and CEE-Sure® blood
collection tubes. Revenues for the second quarter of 2019
included $1.1 million in commercial
test revenue, $45,000 in development
services test revenue and $28,000
from RUO kits and blood collection tubes.
Biocept accessioned 1,399 total samples during the second
quarter of 2020, compared with 1,340 total samples during the
second quarter of 2019. The Company accessioned 1,184
billable samples during the second quarter of 2020, compared with
1,211 billable samples during the second quarter of 2019. The
decline in billable samples was attributable to the impact of the
COVID-19 pandemic.
Cost of revenues for the second quarter of 2020 was $2.5 million, compared with $2.7 million for the second quarter of 2019, with
the decrease primarily due to lower revenues attributable to the
impact of the COVID-19 pandemic.
Research and development (R&D) expenses for the second
quarter of 2020 were $1.6 million,
compared with $1.1 million for the
second quarter of 2019, with the increase primarily due to the
launch of COVID-19 PCR testing, laboratory automation projects, and
ongoing development and validation of liquid biopsy panels.
General and administrative (G&A) expenses for the second
quarter of 2020 were $1.9 million,
compared with $1.7 million for the
second quarter of 2019, with the increase due mainly to higher
insurance costs, and higher legal fees primarily related to lease
negotiations, warrant exercises and other matters. Sales and
marketing expenses for the second quarter of 2020 were $1.3 million, compared with $1.6 million for the second quarter of 2019, with
the decrease primarily attributable to lower sales and marketing
activities due to pandemic-related travel restrictions.
Other expense, net for the second quarter of 2020 was
$56,000, compared with $1.9 million for the second quarter of 2019,
which included $1.8 million in
warrant inducement expense.
The net loss attributable to common shareholders for the second
quarter of 2020 was $6.5 million, or
$0.05 per share on 127.2 million
weighted-average shares outstanding. The net loss
attributable to common shareholders for the second quarter of 2019
was $7.8 million, or $0.38 per share on 20.5 million weighted-average
shares outstanding.
Six Month Financial Results
Revenues for the first six months of 2020 were $2.4 million, a 7% increase from $2.2 million for the first six months of 2019,
and included $2.2 million in
commercial test revenue, $99,000 in
development services test revenue and $107,000 in revenue for Target Selector™ RUO kits
and CEE-Sure blood collection tubes.
Operating expenses for the first six months of 2020 were
$15.0 million, and included cost of
revenues of $5.5 million, R&D
expenses of $2.9 million, G&A
expenses of $3.8 million and sales
and marketing expenses of $2.8
million.
The net loss for the first six months of 2020 was $14.8 million, or $0.14 per share on 103.1 million weighted-average
shares outstanding. This compares with a net loss for the
first six months of 2019 of $13.8
million, or $0.83 per share on
16.7 million weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of June 30, 2020 of $24.1
million, compared with $9.3
million as of December 31,
2019. The increase included approximately $27.3 million in net proceeds from three
registered direct offerings in 2020, and exercise of overallotment
of warrants from the December 2019
financing.
Conference Call and Webcast
Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results
and answer questions. The conference call can be accessed by
dialing (855) 656-0927 for domestic callers, (855) 669-9657 for
Canadian callers or (412) 902-4109 for other international callers.
A live webcast of the conference call will be available on
the investor relations page of the company's website at
http://ir.biocept.com/events.cfm.
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
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. Biocept's patented Target
Selector™ liquid biopsy technology platform captures and analyzes
tumor-associated molecular markers in both circulating tumor cells
(CTCs) and in circulating tumor DNA (ctDNA). With thousands of
tests performed, the platform has demonstrated the ability to
identify cancer mutations and alterations to inform physicians
about a patient's disease and therapeutic options.
Additionally, Biocept is offering nationwide COVID-19
polymerase chain reaction (PCR) testing to support public health
efforts during this unprecedented pandemic. For more
information, please visit www.biocept.com.
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
SEC at http://www.sec.gov/.
Investor Contact:
LHA Investor
Relations
Jody Cain
Jcain@lhai.com
(310) 691-7100
BIOCEPT,
INC.
|
CONDENSED BALANCE
SHEETS
|
|
|
|
|
|
|
|
December 31,
|
|
June
30,
|
|
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
|
BIOCEPT,
INC.
|
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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SOURCE Biocept, Inc.