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 second quarter of 2020 and provided a
corporate update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “As the SARS-CoV-2 pandemic has
progressed, serious complications relating to over-activation of
the coagulation and immune systems have increasingly been observed
in patients hospitalized with severe disease. Based on previous and
emerging work on mechanisms of virus pathogenesis, we believe this
evidence implicates involvement of tissue factor pathways, of which
AB201 is a potent and long-acting inhibitor, providing a strong
rationale to evaluate AB201 as a potential therapeutic for
COVID-19. With this rationale along with significant safety
data from prior human clinical trials, we look forward to
initiating Phase 2 clinical development later this year.”
Pipeline Update
AB201 (rNAPc2) – a small
recombinant protein being developed as a potential treatment for
RNA virus associated disease, initially focusing on COVID-19.
- Initiated planning for development of AB201 as a potential
treatment for patients with severe COVID-19.
- Clinical collaboration established with the Colorado Prevention
Center, the University of Colorado's Academic Research
Organization.
- The Company anticipates filing an Investigational New Drug
(IND) application for AB201 as a potential treatment for COVID-19
with the U.S. Food and Drug Administration (FDA) in third quarter
of this year.
- Pending FDA concurrence, ARCA estimates initiating Phase 2
clinical testing of AB201 in the fourth quarter of this year.
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).
- Initiation of the PRECISION-AF Phase 3 clinical trial is on
hold due to the ongoing COVID-19 pandemic and prioritizing the
development of AB201. ARCA estimates that enrollment in
PRECISION-AF could start in 2021; however, this estimate is subject
to change due to the uncertainties of the ongoing COVID-19 pandemic
and the availability of patients for non-COVID-19 related clinical
trials. Any future development of Gencaro, including
initiating any Phase 3 clinical trial, is dependent on obtaining
additional financing.
- The FDA has 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.
Second Quarter 2020 Summary Financial
ResultsCash and cash equivalents were
$11.0 million as of June 30, 2020, compared to $8.4 million as of
December 31, 2019. ARCA believes that its current cash and cash
equivalents, together with net proceeds of $24.1 million raised in
July from sales of its common stock, will be sufficient to fund its
operations, at its current cost structure, plus projected costs for
the AB201 clinical development program, through the end of the
fourth quarter of 2021.
Research and development (R&D)
expense for the three months ended June 30, 2020 was
$0.4 million compared to $0.4 million for the corresponding
period of 2019, a decrease of approximately $68,000. R&D
expense for the six months ended June 30, 2020 was $0.7 million
compared to $1.1 million for the corresponding period of 2019, a
decrease of approximately $0.4 million.
R&D personnel costs decreased approximately
$0.1 million for the three months ended June 30, 2020, as
compared to the corresponding period of 2019. R&D personnel
costs decreased approximately $0.3 million for the six months ended
June 30, 2020, as compared to the corresponding period of 2019. The
remaining decrease is primarily a result of lower outside services
and consulting costs.
General and administrative (G&A)
expenses were $0.9 million and $1.1 million for the three
months ended June 30, 2020 and 2019, respectively. The $0.1 million
decrease was primarily a result of lower personnel costs and lower
outside services and consulting costs in 2020. G&A expenses
were $1.9 million and $2.2 million for the six months ended June
30, 2020 and 2019, respectively. The $0.3 million decrease was
primarily a result of lower personnel costs and lower outside
services and consulting costs in 2020.
Total operating expenses for
the three months ended June 30, 2020 were $1.3 million compared to
$1.5 million for the corresponding period in 2019. Total
operating expenses for the six months ended June 30, 2020 were $2.7
million compared to $3.3 million for the corresponding period in
2019.
Net loss for the three months
ended June 30, 2020 was $1.3 million, or $0.73 per basic and
diluted share, compared to $1.4 million, or $1.14 per basic and
diluted share, for the corresponding period in 2019. Net loss
for the six months ended June 30, 2020 was $2.6 million, or $1.55
per basic and diluted share, compared to $3.1 million, or $2.87 per
basic and diluted share, for the corresponding period in 2019.
The Company will need to raise additional
capital, and/or complete a partnership or other possible strategic
transaction, to fund future operations and develop AB201 and
Gencaro or any other product candidates.
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA is developing AB201 as a potential
treatment for diseases caused by RNA viruses, initially focusing on
COVID-19. ARCA is also developing GencaroTM (bucindolol
hydrochloride), an investigational, pharmacologically unique
beta-blocker and mild vasodilator, as a potential treatment for
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 more
information, please visit www.arcabio.com or follow the Company on
LinkedIn.
Safe Harbor StatementThis 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 fourth quarter of
2021, potential future development plans for AB201 and Gencaro, the
expected features and characteristics of AB201 and Gencaro,
including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat atrial fibrillation, AB201’s potential to treat COVID-19 or
CAC, future treatment options for patients with COVID-19, or 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 AB201 or
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
A photo accompanying this announcement is
available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
ARCA BIOPHARMA, INC. |
|
BALANCE SHEET DATA |
(in thousands) |
(unaudited) |
|
June 30, 2020 |
December 31, 2019 |
Cash and cash equivalents |
$11,041 |
$8,363 |
Working capital |
$10,245 |
$7,554 |
Total assets |
$11,633 |
$8,536 |
Total stockholders’ equity |
$10,305 |
$7,610 |
ARCA BIOPHARMA, INC. |
|
STATEMENTS OF OPERATIONS |
|
(unaudited) |
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
372 |
|
|
$ |
440 |
|
|
$ |
737 |
|
|
$ |
1,102 |
|
General and administrative |
|
938 |
|
|
|
1,068 |
|
|
|
1,913 |
|
|
|
2,187 |
|
Total costs and expenses |
|
1,310 |
|
|
|
1,508 |
|
|
|
2,650 |
|
|
|
3,289 |
|
Loss from operations |
|
(1,310 |
) |
|
|
(1,508 |
) |
|
|
(2,650 |
) |
|
|
(3,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
2 |
|
|
|
48 |
|
|
|
26 |
|
|
|
86 |
|
Interest expense |
|
(3 |
) |
|
|
(3 |
) |
|
|
(7 |
) |
|
|
(6 |
) |
Loss before income taxes |
|
(1,311 |
) |
|
|
(1,463 |
) |
|
|
(2,631 |
) |
|
|
(3,209 |
) |
Income tax benefit |
|
9 |
|
|
|
27 |
|
|
|
9 |
|
|
|
109 |
|
Net loss |
$ |
(1,302 |
) |
|
$ |
(1,436 |
) |
|
$ |
(2,622 |
) |
|
$ |
(3,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.73 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.55 |
) |
|
$ |
(2.87 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
1,793,900 |
|
|
|
1,263,768 |
|
|
|
1,693,985 |
|
|
|
1,080,885 |
|
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Aug 2024 to Sep 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Sep 2023 to Sep 2024