ARCA biopharma Announces Third Quarter 2017 Financial Results and Provides Business Update
November 09 2017 - 4:05PM
ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
reported financial results for the quarter ended September 30,
2017, and provided a business update.
“With enrollment completed in the GENETIC-AF
clinical trial evaluating Gencaro as potentially the first
genetically-targeted treatment for atrial fibrillation, we are
finishing patient follow-up and anticipate reporting top-line data
late in the first quarter of 2018,” commented Dr. Michael Bristow,
ARCA’s President and Chief Executive Officer. “We are focused on
executing our genetically-targeted approach to cardiovascular drug
development and look forward to furthering our development of
Gencaro as well as initiating additional pharmacogenetic
development programs.”
Third Quarter 2017 Summary Financial
Results
Cash, cash equivalents and marketable
securities totaled $16.0 million as of September 30, 2017,
compared to $23.5 million as of December 31, 2016. ARCA had
approximately 11.75 million outstanding shares of common stock as
of September 30, 2017. ARCA believes that its current cash,
cash equivalents and marketable securities will be sufficient to
fund its operations, at its projected cost structure, through the
end of second quarter of 2018.
Research and development (R&D)
expenses for the three months ended September 30, 2017
totaled $3.5 million compared to $3.7 million for the corresponding
period of 2016, a decrease of approximately $0.2 million.
R&D expense for the nine months ended September 30, 2017
totaled $11.2 million compared to $9.2 million for the
corresponding period of 2016, an increase of approximately $2.0
million. The changes in R&D expenses in the three and
nine month periods ended September 30, 2017 was due primarily to
the increased expense of ARCA’s GENETIC-AF clinical trial.
The Company expects R&D expenses in 2017 to be higher than 2016
as it reached peak patient screening activity and patient
enrollment for the GENETIC-AF clinical trial during 2017.
General and administrative (G&A)
expenses for the three months ended September 30, 2017
were $1.0 million compared to $1.0 million for the corresponding
period in 2016. G&A expenses totaled $3.2 million for the
nine months ended September 30, 2017 as compared to $3.1 million
for the corresponding period in 2016, a net increase of
approximately $79,000. The increase for the nine periods was
comprised primarily of higher consulting costs and professional
fees, partially offset by decreased non-cash, stock-based
compensation expense in 2017, as compared to the corresponding
period in 2016. ARCA expects G&A expenses in 2017 to be
higher than in 2016 due to increased administrative activities to
support the GENETIC-AF clinical trial and costs incurred in the
fourth quarter of 2017 for the acquisition of certain Gencaro
license rights from Aeolus Pharmaceuticals, Inc. which previously
held certain royalty rights on the Gencaro program.
Total operating expenses for
the three months ended September 30, 2017 were $4.5 million
compared to $4.7 million for the corresponding period in
2016. Total operating expenses for the nine months ended
September 30, 2017 were $14.4 million compared to $12.3 million for
the corresponding period in 2016. The changes in total
operating for the nine month periods was primarily due to the
increase in R&D expense due to the increased clinical expense
of the GENETIC-AF clinical trial.
Net loss was $4.4 million, or
$0.39 per share, for the third quarter of 2017 compared to $4.7
million, or $0.51 per share, for the third quarter of 2016.
Net loss for the nine months ended September 30, 2017 was $14.3
million, or $1.43 per share, compared to $12.2 million, or $1.35
per share, for the corresponding period in 2016.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B, multi-center,
randomized, double-blind, superiority clinical trial comparing the
safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate)
for the treatment and prevention of recurrent atrial fibrillation
or flutter (AF/AFL) in heart failure patients with reduced left
ventricular ejection fraction (HFrEF). Eligible patients have
HFrEF, a history of paroxysmal AF (episodes lasting 7 days or less)
or persistent AF (episodes lasting more than 7 days and less than 1
year) in the past 6 months, and the beta-1 389 arginine homozygous
genotype that ARCA believes responds most favorably to
Gencaro. The GENETIC-AF Data and Safety Monitoring Board
(DSMB) conducted a pre-specified interim analysis of all patients
randomized as of June 19, 2017. Based on its efficacy and
safety review, the DSMB recommended completion of the Phase 2B
trial with no changes to the trial design and indicated that there
were no safety concerns.
About ARCA biopharma
ARCA biopharma is dedicated to developing
genetically-targeted therapies for cardiovascular diseases through
a precision medicine approach to drug development. ARCA’s
lead product candidate, GencaroTM (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of patients
with atrial fibrillation and HFrEF, currently in a Phase 2B
clinical trial. ARCA has identified common genetic variations
that it believes predict individual patient response to Gencaro,
giving it the potential to be the first genetically-targeted atrial
fibrillation prevention treatment. ARCA has a collaboration
with Medtronic, Inc. for support of the GENETIC-AF trial. The
Gencaro development program has been granted Fast Track designation
by the FDA. For more information, please visit
www.arcabio.com.
Safe Harbor Statement
This press release contains "forward-looking
statements" for purposes of the safe harbor provided by the Private
Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding, the
potential timeline for GENETIC-AF trial activities, potential
timing for the announcement of topline data for the Phase 2B
GENETIC-AF trial, the sufficiency of ARCA’s capital to support its
operations, the expected features and characteristics of Gencaro,
including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat AF, future treatment options for patients with AF, and the
potential for Gencaro to be the first genetically-targeted AF
prevention treatment. Such statements are based on
management's current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, the
risks and uncertainties associated with: ARCA’s financial resources
and whether they will be sufficient to meet its business objectives
and operational requirements; results of earlier clinical trials
may not be confirmed in future trials; the protection and market
exclusivity provided by ARCA’s intellectual property; risks related
to the drug discovery and the regulatory approval process; and, the
impact of competitive products and technological changes.
These and other factors are identified and described in more detail
in ARCA’s filings with the Securities and Exchange Commission,
including without limitation ARCA’s annual report on Form 10-K for
the year ended December 31, 2016, and subsequent filings.
ARCA disclaims any intent or obligation to update these
forward-looking statements.
Investor & Media
Contact:Derek Cole720.940.2163derek.cole@arcabio.com
|
ARCA BIOPHARMA, INC.BALANCE
SHEET DATA (in
thousands)(unaudited) |
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
Cash, cash equivalents
& marketable securities |
$15,951 |
|
$23,515 |
Working capital |
$13,832 |
|
$19,049 |
Total assets |
$16,921 |
|
$24,629 |
Total stockholders’
equity |
$14,352 |
|
$22,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ARCA BIOPHARMA, INC.STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except share and per share
amounts) |
|
Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,488 |
|
|
$ |
3,720 |
|
|
$ |
11,242 |
|
|
$ |
9,227 |
|
General and administrative |
|
987 |
|
|
|
992 |
|
|
|
3,173 |
|
|
|
3,094 |
|
Total costs and expenses |
|
4,475 |
|
|
|
4,712 |
|
|
|
14,415 |
|
|
|
12,321 |
|
Loss from operations |
|
(4,475 |
) |
|
|
(4,712 |
) |
|
|
(14,415 |
) |
|
|
(12,321 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
44 |
|
|
|
53 |
|
|
|
128 |
|
|
|
121 |
|
Interest expense |
|
(2 |
) |
|
|
— |
|
|
|
(6 |
) |
|
|
— |
|
Net loss |
$ |
(4,433 |
) |
|
$ |
(4,659 |
) |
|
$ |
(14,293 |
) |
|
$ |
(12,200 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
2 |
|
|
|
(19 |
) |
|
|
16 |
|
|
|
(6 |
) |
Comprehensive loss |
$ |
(4,431 |
) |
|
$ |
(4,678 |
) |
|
$ |
(14,277 |
) |
|
$ |
(12,206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.43 |
) |
|
$ |
(1.35 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
11,502,654 |
|
|
|
9,068,376 |
|
|
|
9,982,739 |
|
|
|
9,062,516 |
|
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