- Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 expanded to
South America - Topline data anticipated in the fourth quarter of 2021
Dr.
Pipeline Update
rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
- On-going Phase 2b clinical trial (
ASPEN -COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19. ASPEN -COVID-19 expanding toSouth America with regulatory clinical trial commencement authorizations inArgentina andBrazil .- Phase 2b topline data anticipated in the fourth quarter of 2021.
- In July, the Company entered into a patent assignment agreement with the
University Medical Center of Johannes Gutenberg University Mainz ,Germany , under which ARCA received exclusive world-wide patent rights related to the use of rNAPc2 as a potential treatment for COVID-19, and other potential indications.
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).
- Gencaro Phase 2b data on AF burden and rhythm control interventions was published in Circulation: Arrhythmia and Electrophysiology, a journal of the
American Heart Association . In the Phase 2b superiority clinical trial, although the prespecified primary endpoint was not met, compared with metoprolol, Gencaro reduced AF burden, delayed AF progression, increased maintenance of sinus rhythm, and reduced the need for additional rhythm control interventions in patients with HF and the genotype which responds most favorably to Gencaro. - ARCA currently has an agreement with the
U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Corporate
- The Company added to its executive team with the hiring of
Jeff Dekker as Chief Financial Officer andChristopher Graybill as Vice President, Clinical Development.
Second Quarter 2021 Summary Financial Results
Cash and cash equivalents were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Total operating expenses for the quarter ended
Net loss for the quarter ended
About ARCA biopharma
ARCA 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
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 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
Investor & Media Contact:
720.940.2163
derek.cole@arcabio.com
(Tables follow)
BALANCE SHEET DATA
(in thousands)
(unaudited)
Cash and cash equivalents | |||
Working capital | |||
Total assets | |||
Total stockholders’ equity |
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||
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
Dr. Bristow
Dr. Michael Bristow , President and CEO, ARCA biopharma, Inc.
2021 GlobeNewswire, Inc., source