ARCA biopharma Announces Fiscal Year 2019 Financial Results and Provides Corporate Update
19 February 2020 - 8:30AM
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 year ended December 31, 2019 and
provided a corporate update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “During 2019, we continued to advance
development of Gencaro as a potential genetically-targeted
treatment for heart failure patients with atrial fibrillation. In
published or submitted for presentation/publication material, we
have identified important new effectiveness evidence from the
GENETIC-AF trial that have enhanced our understanding of the
clinical profile of Gencaro. These data have allowed us to broaden
the design of the single, pivotal Phase 3 clinical trial that was
developed after consultation with the U.S. Food and Drug
Administration via a Special Protocol Assessment agreement. There
are currently no FDA approved drug therapies indicated for the
treatment of atrial fibrillation in heart failure patients with
left ventricular ejection fraction values greater than 40%.
Based on our clinical data to date, we believe Gencaro has the
potential to help address this substantial unmet medical
need. We look forward to further evaluating the
pharmacogenetic benefits of Gencaro for patients with our targeted
genetic profile in PRECISION-AF, the Phase 3 clinical trial, which,
subject to obtaining additional financing, we plan to initiate in
the fourth quarter of 2020.”
Pipeline Update – Second Half
Review
GencaroTM (bucindolol
hydrochloride) - a pharmacologically unique beta-blocker and mild
vasodilator being developed as a potential genetically-targeted
treatment for atrial fibrillation (AF) in patients with heart
failure (HF).
- The U.S. Food and Drug Administration (FDA) issued a Special
Protocol Assessment (SPA) agreement for a single Phase 3 clinical
trial (PRECISION-AF) to examine Gencaro as a genetically-targeted
therapy for the prevention of AF recurrence in certain heart
failure patients.
- PRECISION-AF is designed as a double-blind, active-controlled,
multicenter, international, adaptive study comparing Gencaro with
TOPROL-XL (metoprolol succinate) for the prevention of AF
recurrence or all-cause mortality in approximately 400 heart
failure patients who have left ventricular injection fraction
(LVEF) values ≥ 40% and ≤ 55% and the genotype which ARCA
believes responds best to Gencaro (ADRB1 Arg389Arg).
- Clinical data from the GENETIC-AF Phase 2B clinical trial was
published in the Journal of the American College of Cardiology:
Heart Failure in May 2019 and was presented at the Heart Failure
Society of America (HFSA) Annual Scientific Meeting in
September 2019. These data indicate that the response to
Gencaro may be greater in HF patients with less severe left
ventricular dysfunction, a patient population with no FDA approved
drug therapeutic options for AF prevention or heart failure.
- Subject to securing additional financing, ARCA anticipates
initiating PRECISION-AF in the fourth quarter of 2020.
AB171 – a thiol-substituted
isosorbide mononitrate being developed as a potential
genetically-targeted treatment for HF and peripheral arterial
disease (PAD).
- Subject to securing additional financing, the Company
anticipates conducting non-clinical studies to support a potential
IND submission and initiation of clinical development in 2021.
2019 Summary Financial
Results
Cash and cash equivalents were
$8.4 million as of December 31, 2019, compared to $6.6 million as
of December 31, 2018. ARCA believes that its current cash and cash
equivalents will be sufficient to fund its operations, at its
current cost structure, after giving effect to potential cost
reductions, through the end of the third quarter of 2020.
Research and development (R&D)
expenses for the year ended December 31, 2019 were
$1.8 million compared to $4.2 million for 2018. The $2.4
million decrease was primarily due to decreased clinical expenses
following the completion of the GENETIC-AF clinical trial. If
the PRECISION-AF clinical trial is initiated in the second half of
2020, R&D expense in 2020 is expected to be higher than
2019.
General and administrative (G&A)
expenses were $4.0 million for 2019 compared to
$3.9 million for 2018. The Company expects G&A
expenses in 2020 to be consistent with those in 2019 as it
maintains administrative activities to support its ongoing
operations.
Total operating expenses for
2019 were $5.8 million compared to $8.1 million for 2018. The
decrease in total operating expenses was primarily attributable to
the decrease in R&D expense due to the completion of the
GENETIC-AF clinical trial.
Net loss was $5.5 million, or
$4.15 per basic and diluted share, for 2019 compared to $7.9
million, or $10.31 per basic and diluted share, for 2018.
The Company will need to raise additional
capital, and/or complete a partnership or other possible strategic
transaction, to fund future operations and develop Gencaro or any
other product candidates.
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 atrial
fibrillation in heart failure patients. 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 AF prevention treatment. The U.S. FDA
has granted the Gencaro development program Fast Track designation
and a Special Protocol Assessment (SPA) agreement for a single
Phase 3 clinical trial. ARCA is also developing AB171, a
thiol-substituted isosorbide mononitrate, as a potential
genetically-targeted treatment for heart failure and peripheral
arterial disease. For more information, please visit
www.arcabio.com or follow the Company on LinkedIn.
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 ability of ARCA’s
financial resources to support its operations through the end of
the third quarter of 2020, potential future development plans for
Gencaro, the expected features and characteristics of Gencaro or
AB171, including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat AF, AB171’s potential to treat HF or PAD, 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; ARCA may
not be able to raise sufficient capital on acceptable terms, or at
all, to continue development of Gencaro or to otherwise continue
operations in the future; 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, 2019, 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)
|
December 31, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
$8,363 |
|
$6,608 |
Working capital |
$7,554 |
|
$5,984 |
Total assets |
$8,536 |
|
$6,825 |
Total stockholders’ equity |
$7,610 |
|
$6,032 |
|
|
|
|
|
|
|
|
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(unaudited)
|
Years Ended December 31, |
|
|
2019 |
|
2018 |
|
|
|
|
|
|
|
(in
thousands, except share |
|
and per
share amounts) |
Costs and expenses: |
|
|
|
|
|
|
Research and development |
$ |
1,833 |
|
$ |
4,239 |
|
General and administrative |
|
3,981 |
|
|
3,879 |
|
Total costs and expenses |
|
5,814 |
|
|
8,118 |
|
Loss from operations |
|
(5,814 |
) |
|
(8,118 |
) |
|
|
|
|
|
|
|
Interest
and other income |
|
172 |
|
|
162 |
|
Interest
expense |
|
(7 |
) |
|
(8 |
) |
Loss before income taxes |
|
(5,649 |
) |
|
(7,964 |
) |
Income
tax benefit |
|
167 |
|
|
31 |
|
Net loss |
$ |
(5,482 |
) |
$ |
(7,933 |
) |
|
|
|
|
|
|
|
Change in
unrealized loss on marketable securities |
|
— |
|
|
2 |
|
Comprehensive loss |
$ |
(5,482 |
) |
$ |
(7,931 |
) |
|
|
|
|
|
|
|
Net loss
per share: |
|
|
|
|
|
|
Basic and diluted |
$ |
(4.15 |
) |
$ |
(10.31 |
) |
Weighted
average shares outstanding: |
|
|
|
|
|
|
Basic and diluted |
|
1,321,234 |
|
|
769,392 |
|
|
|
|
|
|
|
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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