SAN DIEGO, May 8, 2019 /PRNewswire/ -- Biocept, Inc.
(NASDAQ: BIOC), a leading commercial provider of liquid biopsy
tests designed to provide physicians with clinically actionable
information to improve the outcomes of cancer
patients, reports financial results for the three months ended
March 31, 2019 and provides an update
on its business progress.
"I am pleased to report that we grew our billable samples over
the same period last year and on a sequential basis, increasing
revenue growth as we executed on our commercial strategy," said
Michael Nall, President and CEO of
Biocept. "Among the key contributors to our growth was
broadening our EmpowerTC™ pathology partnership service to include
new biomarkers for use by urologists and uropathologists to aid in
the treatment of prostate cancer. EmpowerTC™ ensures that
local hospitals and physician practices remain in the critical path
of the patient care continuum by enabling them to interpret
cutting-edge liquid biopsy test results processed in our
laboratory."
"We also saw an increase in physician usage of our liquid biopsy
tests for breast cancer monitoring using circulating tumor cells
(CTCs), which differentiate Biocept from other liquid biopsy
companies. In addition, we recognized initial revenue from our
research-use-only (RUO) kits, which we launched in January. To
broaden future usage of these kits we are applying for the CE mark
in Europe, which we expect to
receive in the second half of this year."
"I'm also happy to announce the commercial launch of Target
Selector™ NGS Lung, our multi-gene liquid biopsy panel specifically
developed to detect and monitor actionable biomarkers associated
with lung cancer. This panel was developed under our collaboration
with Thermo Fisher Scientific, and combines our expertise in liquid
biopsy with Thermo Fisher's
next-generation sequencing panel and informatics technology.
Biocept is differentiated as the only commercial liquid
biopsy provider that offers single-biomarker testing,
tumor-specific panels, and CTC analysis. We expect the data
generated from this panel, as well as our other liquid biopsy
offerings to strengthen our collaboration with artificial
intelligence solutions provider Prognos Health," he added.
Review of First Quarter and Recent Highlights
Commercial Business
- Launched expanded pathology partnership service, EmpowerTC™,
with additional prognostic and predictive biomarker tests to enable
urology and uropathology practices to perform liquid biopsy testing
and interpret results generated in Biocept's certified CLIA
laboratory.
- Announced the availability of RUO kits, which enable molecular
laboratories around the world to utilize Target Selector™
circulating tumor DNA (ctDNA) assays to perform liquid biopsy
testing.
Collaborations
- Announced a collaboration with Providence St. Joseph Health,
Southern California, and its
wholly owned affiliates Providence Saint John's Health Center and
John Wayne Cancer Institute, to conduct a study to validate the use
of cerebrospinal fluid with the Target Selector™ platform.
- Entered into an agreement with Agiomix FZ-LLC, a provider of
genomics sample and bioinformatics services for research and
clinical applications, to validate and purchase Biocept's Target
Selector™ RUO kits for use in its laboratory.
Industry Conferences and Study Results
- Announced the publication of case studies in the peer-reviewed
journal, Clinics in Oncology, demonstrating the clinical
utility of Target Selector™ testing in the management of patients
diagnosed with advanced non-small cell lung cancer.
- Presented a poster at the 2019 American Association for Cancer
Research Annual Meeting demonstrating the ability of our Target
Selector™ assay to detect ESR1 mutations with high sensitivity,
resulting in inclusion of the test in a clinical trial sponsored by
a major pharmaceutical company.
Intellectual Property
- Obtained a patent in Japan
covering the use of microchannels for the capture and detection of
any target of interest, including proteins and nucleic acids, as
well as the capture of cancer or other rare cells that can be used
for molecular analysis in blood and other biological fluids.
Corporate
- Raised approximately $17 million
in aggregate net proceeds through two registered direct financings
and an underwritten public offering.
First Quarter Financial Results
Revenues for the first quarter of 2019 were $1.0 million and included $976,000 in commercial test revenue, $42,000 in development services test revenue, and
$6,000 in other revenue. This
compares with revenues of $807,000
for the first quarter of 2018, which included $762,000 in commercial test revenue and
$45,000 in development services test
revenue.
Biocept accessioned 1,325 total samples in the first quarter of
2019, a 13% increase compared with 1,170 total samples in the first
quarter of 2018. Total accessions include billable samples
and samples from research activities, assay validations, and other
non-billable sources. The Company accessioned 1,155 billable
samples in the first quarter of 2019, a 7% increase compared with
1,084 billable samples in the first quarter of 2018.
Cost of revenues for the first quarter of 2019 was $2.6 million compared with $2.4 million for the first quarter of 2018.
The increase was due to an increase in materials cost due to
higher test volumes.
Research and development expenses for the first quarter of 2019
were $1.2 million compared with
$1.1 million for the first quarter of
2018, with the increase due primarily to costs associated with the
development of new individual assays and automation, as well as
validation of our Target Selector™ NGS Lung assay panel under
the collaboration with Thermo Fisher Scientific.
General and administrative expenses for the first quarter of
2019 were $1.7 million versus
$1.9 million for the first quarter of
2018, and sales and marketing expenses for the first quarter of
2019 were $1.4 million, versus
$1.6 million for the first quarter of
2018. The decreases in both general and administrative expenses and
sales and marketing expenses reflect the Company's cost containment
initiatives.
The net loss for the first quarter of 2019 was $5.9 million, or $0.61 per share on 9.8 million weighted-average
shares outstanding. This compares with a net loss for the first
quarter of 2018 of $6.4 million, or
$3.33 per share on 1.9 million
weighted-average shares outstanding.
Biocept reported cash and cash equivalents as of March 31, 2019 of $14.8
million, compared with $3.4
million as of December 31,
2018, with the increase due to equity capital raises
conducted in the first quarter of 2019.
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 webcast will be
available for 90 days.
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
10130332.
About Biocept
Biocept, Inc. is a molecular diagnostics company with
commercialized assays for lung, breast, gastric, colorectal and
prostate cancers, and melanoma. The Company uses its
proprietary liquid biopsy technology to provide physicians with
information for treating and monitoring patients diagnosed with
cancer. The Company's patented Target Selector™ liquid biopsy
technology platform captures and analyzes tumor-associated
molecular markers in both circulating tumor cells (CTCs) and in
plasma (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. For additional 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 grow our
business and drive adoption of our products, our ability to broaden
the future usage of our RUO kits and our ability to receive a CE
mark, and the success of our collaboration with Prognos Health,
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,
|
|
March
31,
|
|
2018
|
|
2019
|
|
|
|
|
(unaudited)
|
ASSETS
|
|
|
|
|
|
Cash
|
$
|
3,423,373
|
|
$
|
14,762,198
|
Accounts
receivable, net
|
|
1,574,325
|
|
|
1,877,861
|
Inventories,
net
|
|
587,222
|
|
|
577,284
|
Prepaid expenses
and other current assets
|
|
425,961
|
|
|
270,248
|
TOTAL CURRENT
ASSETS
|
|
6,010,881
|
|
|
17,487,591
|
FIXED ASSETS,
NET
|
|
2,739,422
|
|
|
1,292,061
|
LEASE RIGHT-OF-USE
ASSETS
|
|
—
|
|
|
3,112,280
|
TOTAL
ASSETS
|
$
|
8,750,303
|
|
$
|
21,891,932
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES, NET
|
$
|
4,609,647
|
|
$
|
6,425,604
|
NON-CURRENT
LIABILITIES, NET
|
|
1,098,137
|
|
|
1,452,244
|
TOTAL
LIABILITIES
|
|
5,707,784
|
|
|
7,877,848
|
SHAREHOLDERS'
EQUITY
|
|
3,042,519
|
|
|
14,014,084
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
|
8,750,303
|
|
$
|
21,891,932
|
BIOCEPT,
INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
For the three months ended March
31,
|
|
2018
|
|
2019
|
|
(unaudited)
|
|
(unaudited)
|
NET
REVENUES
|
$
|
806,943
|
|
$
|
1,024,239
|
COSTS AND
EXPENSES
|
|
|
|
|
|
Cost of
revenues
|
$
|
2,434,886
|
|
$
|
2,599,364
|
Research and
development expenses
|
|
1,070,581
|
|
|
1,223,291
|
General and
administrative expenses
|
|
1,938,664
|
|
|
1,681,837
|
Sales and marketing
expenses
|
|
1,636,542
|
|
|
1,374,560
|
Total costs and
expenses
|
|
7,080,673
|
|
|
6,879,052
|
LOSS FROM
OPERATIONS
|
|
(6,273,730)
|
|
|
(5,854,813)
|
INTEREST AND OTHER
INCOME/(EXPENSE), NET
|
|
(82,674)
|
|
|
(61,974)
|
LOSS BEFORE INCOME
TAXES
|
|
(6,356,404)
|
|
|
(5,916,787)
|
INCOME
TAXES
|
|
—
|
|
|
—
|
NET LOSS AND
COMPREHENSIVE LOSS
|
$
|
(6,356,404)
|
|
$
|
(5,916,787)
|
Deemed dividend
related to warrants down round provision
|
|
—
|
|
|
(99,743)
|
NET LOSS
ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
$
|
(6,356,404)
|
|
$
|
(6,016,530)
|
NET LOSS PER
SHARE
|
|
|
|
|
|
- Basic
|
$
|
(3.33)
|
|
$
|
(0.61)
|
- Diluted
|
$
|
(3.33)
|
|
$
|
(0.61)
|
WEIGHTED AVG
NUMBER OF SHARES OUTSTANDING
|
|
|
|
|
|
- Basic
|
|
1,911,282
|
|
|
9,792,093
|
- Diluted
|
|
1,911,282
|
|
|
9,792,093
|
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SOURCE Biocept, Inc.