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 March 31, 2017,
and provided a business update.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
“We’ve made great progress so far this year,
recently achieving enrollment of the 200th patient in the
GENETIC-AF clinical trial. The strategies we’ve implemented have
increased the rate of patient enrollment. We’d like to thank the
investigators and the study patients, whose support and enthusiasm
suggests a high unmet medical need for this patient population and
potentially a substantial market opportunity if Gencaro is
approved,” commented Dr. Michael Bristow, ARCA’s President and
Chief Executive Officer. “We are focused on the upcoming DSMB
interim efficacy analysis that will determine the next steps for
this adaptive, seamless design trial – transitioning to Phase 3 and
enrolling an additional 370 patients; completing Phase 2B with 250
patients; or, stopping immediately for futility. We expect
the outcome of this interim efficacy analysis in September
2017.”
Dr. Bristow further commented, “Atrial
fibrillation is considered an epidemic cardiovascular disease based
on the pace of increase in incidence in the United States and
industrialized countries. There is also increasing evidence that
compared to heart failure with sinus rhythm, heart failure with
atrial fibrillation responds differently to medical therapy and
needs to be approached as a separate disorder. We believe that a
precision medicine approach to drug development in atrial
fibrillation-heart failure, tailoring medical treatment to the
individual genetic characteristics of patient subgroups, can
potentially enable more effective therapies, improve patient
outcomes and reduce healthcare costs.”
First Quarter 2017 Summary Financial
Results
Cash, cash equivalents and marketable
securities totaled $19.2 million as of March 31, 2017,
compared to $23.5 million as of December 31, 2016. 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 2017. ARCA had approximately
9.2 million outstanding shares of common stock as of March 31,
2017.
Research and development (R&D)
expenses for the three months ended March 31, 2017 totaled
$3.2 million compared to $2.6 million for the corresponding period
of 2016, an increase of approximately $0.7 million. The
increase in R&D expenses in the first quarter of 2017 as
compared to the first quarter of 2016 was primarily due to
increased expenses for the GENETIC-AF clinical trial, including
contract research organization costs, clinical site initiation and
monitoring activities, patient visit costs and increased costs to
support expanding the trial into Europe. The Company expects
R&D expenses in 2017 to be higher than 2016 as it activates new
clinical sites and enrolls additional patients in the GENETIC-AF
clinical trial.
General and administrative (G&A)
expenses for the three months ended March 31, 2017 were
$1.1 million compared to $1.1 million for the corresponding period
in 2016, a net increase of approximately $60,000. The
increase in expenses during the first quarter of 2017 was comprised
primarily of higher consulting costs. This increase is
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 as it increases administrative activities to support the
GENETIC-AF clinical trial.
Total operating expenses for
the three months ended March 31, 2017 were $4.4 million compared to
$3.7 million for the corresponding period in 2016. The
increase in total operating expenses during the first quarter of
2017 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 $4.3 million, or
$0.48 per share, for the first quarter of 2017 compared to $3.6
million, or $0.40 per share, for the first quarter of 2016.
GENETIC-AF Clinical Trial
GENETIC-AF is an adaptive, seamless design Phase
2B/3, multi-center, randomized, double-blind, clinical superiority
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 will 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 primary
endpoint of the study is time to first event of symptomatic AF/AFL
or all-cause mortality. The trial is currently enrolling
patients in the United States, Canada and Europe.
Phase 2B Interim Efficacy
Analysis
The GENETIC-AF Data Safety Monitoring Board
(DSMB) will perform a pre-specified interim analysis of unblinded
efficacy data when at least 150 patients have evaluable data.
A randomized patient has evaluable data either when they experience
their first composite endpoint event, AF/AFL or all-cause
mortality, or after completion of the 24-week primary endpoint
follow-up period. The analysis will be conducted to evaluate the
evidence for safety and superior efficacy of Gencaro versus the
active comparator, metoprolol succinate (TOPROL-XL).
The prospectively defined features of this
analysis include an estimate of Gencaro effectiveness relative to
TOPROL-XL and an assessment of safety as characterized by adverse
events. The relative benefit estimate will utilize Bayesian
statistical methods to calculate the predictive probability of the
Phase 3 patient cohort hazard ratio (a measure of an effect of an
intervention on an outcome of interest over time) based on the
interim Phase 2B data. Prospectively defined ranges of predictive
probabilities have been predetermined to define three potential
outcomes based on the projection of the Phase 2B interim
results:
1) transition the trial to Phase 3 based on a
likelihood of achieving a statistically significant hazard ratio in
favor of Gencaro (evidence of an effectiveness signal consistent
with pretrial assumptions) and enroll up to a total of 620 patients
(including the Phase 2B patients);2) completion of the Phase 2B
stage of the trial including 24-week follow-up of all randomized
subjects (approximately 250 patients), based on an intermediate
result that is potentially favorable but does not support
transition of the trial to Phase 3; or,3) immediate termination of
the trial due to futility.
ARCA, in collaboration with the trial Steering
Committee, will determine the most appropriate path forward for the
trial based on the DSMB recommendation from this interim
analysis. The unblinded statistical data available to the
DSMB will not be disclosed to the Company or the public. ARCA
expects the outcome of this interim efficacy analysis in September
2017.
Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained
cardiac arrhythmia, is considered an epidemic cardiovascular
disease and a major public health burden. The estimated
number of individuals with AF globally in 2010 was 33.5 million.
According to the 2017 American Heart Association report on
Cardiovascular Disease, approximately 5.2 million people in the
United States had atrial fibrillation in 2015, with medical and
indirect costs totaling an estimated $31 billion.
Hospitalization rates for AF increased by 23% among U.S. adults
from 2000 to 2010 and hospitalizations account for the majority of
the economic cost burden associated with AF.
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. 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. 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 that the data from 150 patients will support a
recommendation that the GENETIC-AF trial transition to Phase 3, the
potential timeline for GENETIC-AF trial activities and related
recommendations of the DSMB, potential timing for patient
enrollment in the GENETIC-AF trial, the sufficiency of ARCA’s
capital to support its operations, 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.
|
ARCA BIOPHARMA, INC. |
BALANCE SHEET DATA |
(in thousands) |
(unaudited) |
|
|
March 31, 2017 |
December 31, 2016 |
Cash,
cash equivalents & marketable securities |
$ |
19,211 |
$ |
23,515 |
Working
capital |
$ |
17,336 |
$ |
19,049 |
Total
assets |
$ |
20,589 |
$ |
24,629 |
Total
stockholders’ equity |
$ |
18,036 |
$ |
22,194 |
|
|
ARCA BIOPHARMA, INC. |
|
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2017 |
|
|
2016 |
|
|
(in thousands, except shareand
per share amounts) |
|
Costs
and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
3,246 |
|
|
$ |
2,594 |
|
General and administrative |
|
1,135 |
|
|
|
1,074 |
|
Total costs and expenses |
|
4,381 |
|
|
|
3,668 |
|
Loss from operations |
|
(4,381 |
) |
|
|
(3,668 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
45 |
|
|
|
21 |
|
Interest expense |
|
(2 |
) |
|
|
— |
|
Net loss |
$ |
(4,338 |
) |
|
$ |
(3,647 |
) |
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
10 |
|
|
|
6 |
|
Comprehensive loss |
$ |
(4,328 |
) |
|
$ |
(3,641 |
) |
|
|
|
|
|
|
|
|
Net
loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.40 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
9,094,276 |
|
|
|
9,053,186 |
|
Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabio.com
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