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 June 30, 2017, and
provided a business update.
“We continue to make progress in the GENETIC-AF
clinical trial with more than 250 patients now randomized,”
commented Dr. Michael Bristow, ARCA’s President and Chief Executive
Officer. “We are awaiting the outcome of the ongoing DSMB interim
efficacy analysis that will recommend the next steps for this
adaptive, seamless design trial - transitioning to Phase 3 and
enrolling an additional 370 patients; completing Phase 2B with
approximately 250 patients; or, stopping immediately for
futility. We expect the outcome of this important clinical
milestone in August.”
Second Quarter 2017 Summary Financial
Results
Cash, cash equivalents and marketable
securities totaled $16.0 million as of June 30, 2017,
compared to $23.5 million as of December 31, 2016. ARCA had
approximately 10.1 million outstanding shares of common stock as of
June 30, 2017. Subsequent to June 30, 2017, the Company sold
an aggregate of 1,634,158 shares of common stock through its
existing “at the market offering”, raising net proceeds of
approximately $3.9 million. As of July 25, 2017, ARCA has
sold all shares available under the prospectus to its registration
statement on Form S-3 (No. 333-217459) and does not currently
anticipate making any additional sales under this facility.
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.
Research and development (R&D)
expenses for the three months ended June 30, 2017 totaled
$4.5 million compared to $2.9 million for the corresponding period
of 2016, an increase of approximately $1.6 million. R&D
expense for the six months ended June 30, 2017 totaled $7.8 million
compared to $5.5 million for the corresponding period of 2016, an
increase of approximately $2.2 million. The increase in
R&D expense in the three and six month periods ended June 30,
2017 was due primarily to the increased expense of ARCA’s 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 June 30, 2017 were
$1.1 million compared to $1.0 million for the corresponding period
in 2016, a net increase of approximately $23,000. G&A
expenses totaled $2.2 million for the six months ended June 30,
2017 as compared to $2.1 million for the corresponding period in
2016, a net increase of approximately $84,000. The increase
for the three and six month periods is comprised primarily of
higher consulting costs and professional fees. These
increases are partially offset by decreased non-cash, stock-based
compensation expense in 2017, as compared to the corresponding
periods 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 June 30, 2017 were $5.6 million compared to
$3.9 million for the corresponding period in 2016. Total
operating expenses for the six months ended June 30, 2017 were $9.9
million compared to $7.6 million for the corresponding period in
2016. The increase in total operating for the three and six
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 $5.5 million, or
$0.59 per share, for the second quarter of 2017 compared to $3.9
million, or $0.43 per share, for the second quarter of 2016.
Net loss for the six months ended June 30, 2017 was $9.9 million,
or $1.07 per share, compared to $7.5 million, or $0.83 per share,
for the corresponding period in 2016.
GENETIC-AF Clinical Trial
GENETIC-AF is an adaptive, seamless design Phase
2B/3, 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 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 GENETIC-AF trial design has been
reviewed by the FDA. The trial is currently enrolling
patients in the United States, Canada and Europe.
Phase 2B Interim Efficacy
Analysis
The GENETIC-AF Data and Safety Monitoring Board
(DSMB) is performing a pre-specified interim analysis of unblinded
efficacy data. The primary 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 primary analysis method will generate predictive
probability of success (PPoS) values that will be compared to
prespecified PPoS boundaries constructed from Bayesian statistical
modeling. Prospectively defined PPoS ranges 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, 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, if
the PPoS results fall below the boundary for completion as a Phase
2 trial.
ARCA, in collaboration with the GENETIC-AF
Steering Committee, will determine the most appropriate path
forward for the trial based on the DSMB recommendation from this
interim analysis. The Company expects to announce the DSMB’s
recommendation based on this interim analysis in August 2017.
The unblinded statistical data available to the DSMB will not be
disclosed to ARCA or the public.
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. The Gencaro development program
has been granted Fast Track designation by the U.S. Food and Drug
Administration (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 that the data from the interim analysis will support a
recommendation that the GENETIC-AF trial transition to Phase 3 or
the completion of Phase 2, 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.
(Tables Follow)
ARCA BIOPHARMA, INC. |
BALANCE SHEET DATA |
(in thousands) |
(unaudited) |
|
|
June 30, 2017 |
|
December 31, 2016 |
Cash,
cash equivalents & marketable securities |
$ |
16,007 |
|
$ |
23,515 |
Working
capital |
$ |
14,136 |
|
$ |
19,049 |
Total
assets |
$ |
17,296 |
|
$ |
24,629 |
Total
stockholders’ equity |
$ |
14,747 |
|
$ |
22,194 |
ARCA BIOPHARMA, INC. |
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(unaudited) |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,508 |
|
|
$ |
2,913 |
|
|
$ |
7,754 |
|
|
$ |
5,507 |
|
General and administrative |
|
1,051 |
|
|
|
1,028 |
|
|
|
2,186 |
|
|
|
2,102 |
|
Total costs and expenses |
|
5,559 |
|
|
|
3,941 |
|
|
|
9,940 |
|
|
|
7,609 |
|
Loss from operations |
|
(5,559 |
) |
|
|
(3,941 |
) |
|
|
(9,940 |
) |
|
|
(7,609 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
39 |
|
|
|
47 |
|
|
|
84 |
|
|
|
68 |
|
Interest expense |
|
(2 |
) |
|
|
— |
|
|
|
(4 |
) |
|
|
— |
|
Net loss |
$ |
(5,522 |
) |
|
$ |
(3,894 |
) |
|
$ |
(9,860 |
) |
|
$ |
(7,541 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
4 |
|
|
|
7 |
|
|
|
14 |
|
|
|
13 |
|
Comprehensive loss |
$ |
(5,518 |
) |
|
$ |
(3,887 |
) |
|
$ |
(9,846 |
) |
|
$ |
(7,528 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.59 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.07 |
) |
|
$ |
(0.83 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
9,324,822 |
|
|
|
9,065,922 |
|
|
|
9,210,186 |
|
|
|
9,059,554 |
|
Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabio.com
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