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Share Name | Share Symbol | Market | Type |
---|---|---|---|
ARCA Biopharma Inc | NASDAQ:ABIO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.025 | -0.76% | 3.26 | 3.21 | 3.61 | 3.39 | 3.2087 | 3.22 | 23,535 | 05:00:00 |
Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We continue to be encouraged with the opportunities we see in our development pipeline compounds, rNAPc2 and Gencaro. With the ASPEN-COVID-19 Phase 2b trial of rNAPc2 expanding to South America, we look forward to completing the trial and we anticipate sharing the results in the fourth quarter. Given the rate of global vaccination and the continued emergence of variants, along with rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. For Gencaro, we believe that, if approved, it may be a safe and effective therapy for the treatment of higher ejection fraction heart failure patients with atrial fibrillation and look forward to evaluating it in the planned PRECISION-AF Phase 3 clinical study.”
Pipeline Update
rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
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).
Corporate
Second Quarter 2021 Summary Financial Results
Cash and cash equivalents were $63.2 million as of June 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.
Research and development (R&D) expenses were $3.6 million for the quarter ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. The $3.2 million increase in R&D expenses in the second quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020, as the Company continues the rNAPc2 Phase 2b clinical trial.
General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.3 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the second half of 2021 are expected to be consistent with the first half of 2021 as the Company maintains administrative activities to support its ongoing operations.
Total operating expenses for the quarter ended June 30, 2021 were $4.8 million compared to $1.3 million for the second quarter of 2020.
Net loss for the quarter ended June 30, 2021 was $4.8 million, or $0.34 per basic and diluted share, compared to $1.3 million, or $0.73 per basic and diluted share for the second quarter of 2020.
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 rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. 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 potential future development plans for rNAPc2 and Gencaro, the expected features and characteristics of rNAPc2 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, rNAPc2’s potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, the potential for Gencaro to be the first genetically targeted AF prevention treatment and the ability of ARCA’s financial resources to support its operations through 2022. 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 rNAPc2 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, 2020, 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
(Tables follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA (in thousands) (unaudited)
June 30, 2021 | December 31, 2020 | ||
Cash and cash equivalents | $63,197 | $49,071 | |
Working capital | $61,098 | $46,469 | |
Total assets | $65,338 | $50,429 | |
Total stockholders’ equity | $61,208 | $46,521 |
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS(unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
Costs and expenses: | |||||||||||||||
Research and development | $ | 3,577 | $ | 372 | $ | 6,453 | $ | 737 | |||||||
General and administrative | 1,260 | 938 | 2,486 | 1,913 | |||||||||||
Total costs and expenses | 4,837 | 1,310 | 8,939 | 2,650 | |||||||||||
Loss from operations | (4,837 | ) | (1,310 | ) | (8,939 | ) | (2,650 | ) | |||||||
Interest and other income | 3 | 2 | 5 | 26 | |||||||||||
Interest expense | — | (3 | ) | — | (7 | ) | |||||||||
Loss before income taxes | (4,834 | ) | (1,311 | ) | (8,934 | ) | (2,631 | ) | |||||||
Income tax benefit | — | 9 | — | 9 | |||||||||||
Net loss | $ | (4,834 | ) | $ | (1,302 | ) | $ | (8,934 | ) | $ | (2,622 | ) | |||
Net loss per share: | |||||||||||||||
Basic and diluted | $ | (0.34 | ) | $ | (0.73 | ) | $ | (0.67 | ) | $ | (1.55 | ) | |||
Weighted average shares outstanding: | |||||||||||||||
Basic and diluted | 14,410,143 | 1,793,900 | 13,389,207 | 1,693,985 |
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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