ABIO ARCA biopharma Inc.

3.28
+0.05  (+2%)
Previous Close 3.23
Open 3.2
52 Week Low 2.92
52 Week High 22
Market Cap $47,265,269
Shares 14,410,143
Float 14,381,919
Enterprise Value $-19,994,239
Volume 152,578
Av. Daily Volume 446,118
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Upcoming Catalysts

Drug Stage Catalyst Date
rNAPc2 (AB201)
COVID-19
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Gencaro
Chronic Heart Failure
Phase 3
Phase 3
Phase 3 trial initiation on hold - dependent on obtaining additional financing.

Latest News

    • Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 anticipated in the third quarter of 2021

    WESTMINSTER, Colo., May 11, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported first quarter 2021 financial results and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are continuing to advance the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, actively enrolling patients at 7 clinical trial sites in the United States…

    • Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 anticipated in the third quarter of 2021

    WESTMINSTER, Colo., May 11, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported first quarter 2021 financial results and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are continuing to advance the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, actively enrolling patients at 7 clinical trial sites in the United States. We look forward to sharing the trial results early in the third quarter of this year. We believe rNAPc2's combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. As a therapeutic aimed at a host response to a disease syndrome, we believe rNAPc2 has therapeutic potential for future viral outbreaks beyond the current pandemic, even after safe and effective vaccines for SARS-CoV-2 are successfully deployed."

    Pipeline Update

    rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

    • Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 initiated in December 2020.
    • Currently enrolling patients in ASPEN-COVID-19 at 7 clinical trial sites in the United States.
    • Phase 2b topline data anticipated early in the third quarter of 2021.
    • U.S. Food and Drug Administration (FDA) designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.

    Gencaro™ (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).

    • In February 2021, ARCA was issued a new patent by the United States Patent and Trademark Office (USPTO) for use of Gencaro in treating AF in patients with HF. The Company believes this patent would provide effective patent coverage in the United States into 2039. ARCA has filed similar patent applications in other countries.
    • The Company continues to evaluate 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.

    First Quarter 2021 Summary Financial Results

    Cash and cash equivalents were $66.9 million as of March 31, 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 $2.9 million for the quarter ended March 31, 2021, compared to $0.4 million for the corresponding period in 2020. The $2.5 million increase in R&D expenses in the first 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 $1.2 million for the quarter ended March 31, 2021, compared to $1.0 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 2021 are expected to be consistent with those in 2020 as the Company maintains administrative activities to support its ongoing operations.

    Total operating expenses for the quarter ended March 31, 2021 were $4.1 million compared to $1.3 million for the first quarter of 2020.

    Net loss for the quarter ended March 31, 2021 was $4.1 million, or $0.33 per basic and diluted share, compared to $1.3 million, or $0.83 per basic and diluted share for the first quarter of 2020.

    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 U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing Gencaro™ (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 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 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 Cole

    720.940.2163

    (Tables follow)

     
    ARCA BIOPHARMA, INC.



    BALANCE SHEET DATA

    (in thousands)

    (unaudited)
     
       
     March 31, 2021December 31, 2020
    Cash and cash equivalents$66,933$49,071
    Working capital$65,850$46,469
    Total assets$69,183$50,429
    Total stockholders' equity$65,909$46,521



    ARCA BIOPHARMA, INC.



    STATEMENTS OF OPERATIONS



    (unaudited)
     
     Three Months Ended 
     March 31, 
     2021  2020 
       
     (in thousands, except share

    and per share amounts)
     
    Costs and expenses:       
    Research and development$2,876  $365 
    General and administrative 1,226   975 
    Total costs and expenses 4,102   1,340 
    Loss from operations (4,102)  (1,340)
            
    Interest and other income 2   24 
    Interest expense    (4)
    Net loss$(4,100) $(1,320)
            
    Net loss per share:       
    Basic and diluted$(0.33) $(0.83)
    Weighted average shares outstanding:       
    Basic and diluted 12,356,928   1,594,070 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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  1. WESTMINSTER, Colo., May 05, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that Christopher Graybill, Ph.D., has joined ARCA as Vice President, Clinical Development.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are delighted to welcome Christopher to ARCA as Vice President of Clinical Development. His over 14 years of experience in the biotechnology and medical device industries, supporting global clinical strategy, clinical trial planning and conduct, and other aspects of product development including in the cardiovascular space, will…

    WESTMINSTER, Colo., May 05, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that Christopher Graybill, Ph.D., has joined ARCA as Vice President, Clinical Development.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are delighted to welcome Christopher to ARCA as Vice President of Clinical Development. His over 14 years of experience in the biotechnology and medical device industries, supporting global clinical strategy, clinical trial planning and conduct, and other aspects of product development including in the cardiovascular space, will be a tremendous asset as we continue to advance the development of rNAPc2 and Gencaro."

    Prior to joining ARCA, Dr. Graybill served in multiple clinical development roles at Terumo BCT, from 2015 to 2021, including Senior Manager of Global Clinical Affairs, Manager of Clinical Research, and Manager of Scientific/Clinical Medical Writing. Prior to that, he worked at DaVita Clinical Research, PRA International, Myogen, Inc., and Gilead Sciences. Dr. Graybill has authored numerous scientific and clinical publications. He earned a B.S. in Biochemistry from Susquehanna University and a Ph.D. in Biochemistry and Molecular Pharmacology from the Graduate School of Biomedical Sciences at the University of Massachusetts.

    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 U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing Gencaro™ (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 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, 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 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 Cole

    720.940.2163

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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  2. WESTMINSTER, Colo., May 03, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced C. Jeff Dekker as its Chief Financial Officer, effective May 10, 2021, following Brian Selby's planned departure after 14 years of service with the Company.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer commented: "We are delighted to welcome Jeff to ARCA as our Chief Financial Officer. Jeff brings over 25 years of biotech industry and finance experience. I am confident he will be a strong CFO for ARCA. We believe his broad experience and capabilities in all aspects of finance…

    WESTMINSTER, Colo., May 03, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced C. Jeff Dekker as its Chief Financial Officer, effective May 10, 2021, following Brian Selby's planned departure after 14 years of service with the Company.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer commented: "We are delighted to welcome Jeff to ARCA as our Chief Financial Officer. Jeff brings over 25 years of biotech industry and finance experience. I am confident he will be a strong CFO for ARCA. We believe his broad experience and capabilities in all aspects of finance, his fundamental understanding of our business and the industry, and his strong leadership, uniquely enable Jeff to help us continue to drive our clinical development and corporate strategies."

    Dr. Bristow commented further, "Over his 14 years of service, Brian has made invaluable contributions to ARCA. His partnership and guidance directing our financial and accounting organization provided a stable foundation to help advance our clinical development programs. While we will miss his leadership, collaboration and insight, we wish him well in his future endeavors."

    Prior to joining ARCA, Mr. Dekker served in multiple roles of increasing responsibility at GlobeImmune, Inc. from 2006 to 2021, including President, Vice President of Finance, and Senior Director, Finance and Controller. Before joining GlobeImmune, Mr. Dekker held leadership positions in finance and accounting at private software companies since 1993, including posts ranging from Corporate Controller to Vice President at Webroot Software Inc., Requisite Technology Inc. and NxTrend Technology Inc. Earlier in his career, Mr. Dekker worked at ITT Rayonier Port Angeles Pulp Division and at KPMG in Los Angeles. He earned a B.S. in accounting from Utah State University and is a certified public accountant.

    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 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 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, 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 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 Cole

    720.940.2163

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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    • Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 anticipated in the third quarter of 2021
    • New patent issued by USPTO for use of Gencaro in treating atrial fibrillation in heart failure patients with ejection fractions greater than 40%

    WESTMINSTER, Colo., March 18, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2020 financial results and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are currently actively enrolling patients in a Phase 2b clinical trial evaluating…

    • Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 anticipated in the third quarter of 2021
    • New patent issued by USPTO for use of Gencaro in treating atrial fibrillation in heart failure patients with ejection fractions greater than 40%

    WESTMINSTER, Colo., March 18, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2020 financial results and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are currently actively enrolling patients in a Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 who are at high risk for thrombotic complications, as indicated by elevated D-dimer levels, which are elevated in nearly 70% of hospitalized COVID-19 patients and are associated with adverse clinical outcomes. We believe rNAPc2's combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. We look forward to sharing the trial results in the third quarter of this year. As a therapeutic aimed at a host response to a disease syndrome, we believe rNAPc2 has therapeutic potential for future viral outbreaks beyond the current pandemic, even after safe and effective vaccines for SARS-CoV-2 are successfully deployed."

    Pipeline Update

    rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

    • Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 initiated in December 2020.
    • Phase 2b topline data anticipated in the third quarter of 2021.
    • U.S. Food and Drug Administration (FDA) designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.

    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).

    • In February 2021, ARCA was issued a new patent by the United States Patent and Trademark Office (USPTO) for use of Gencaro in treating AF in the HF population that ARCA plans to enroll in Phase 3 development, a population that includes more than half of all HF patients in the United States and Europe and has few approved or effective drug therapies. The Company believes this patent would provide effective patent coverage in the United States into 2039. ARCA has filed similar patent applications in other countries.
    • 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. We continue to evaluate the feasibility and potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial.

    Full Year 2020 Summary Financial Results

    Cash and cash equivalents were $49.1 million as of December 31, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents, together with the $23.3 million of net proceeds raised through February 2021 from sales of the common stock under the Company's "at-the-market" offering, will be sufficient to fund its operations through 2022.

    Research and development (R&D) expenses were $5.0 million for the year ended December 31, 2020, compared to $1.8 million for 2019. The $3.2 million increase in R&D expenses in 2020 as compared to 2019 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 $4.8 million for the year ended December 31, 2020, compared to $4.0 million for 2019, an increase of approximately $0.8 million. The increase in expenses during 2020 was comprised primarily of increased legal and professional costs, insurance costs and higher personnel costs in 2020, as compared to 2019. G&A expenses in 2021 are expected to be consistent with those in 2020 as the Company maintains administrative activities to support our ongoing operations.

    Total operating expenses for the year ended December 31, 2020 were $9.8 million compared to $5.8 million in 2019.

    Net loss for the year ended December 31, 2020 was $9.7 million, or $2.07 per basic and diluted share, compared to $5.5 million, or $4.15 per basic and diluted share in 2019.

    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 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 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 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 Cole

    720.940.2163





    ARCA BIOPHARMA, INC.

    BALANCE SHEET DATA

    (in thousands)

    (unaudited)



     December 31, 2020 December 31, 2019
    Cash and cash equivalents$49,071 $8,363
    Working capital$46,469 $7,554
    Total assets$50,429 $8,536
    Total stockholders' equity$46,521 $7,610



    ARCA BIOPHARMA, INC.

    STATEMENTS OF OPERATIONS

    (unaudited)

     Years Ended December 31, 
     2020  2019 
          
     (in thousands, except share and per share amounts) 
    Costs and expenses:       
    Research and development$4,992  $1,833 
    General and administrative 4,774   3,981 
    Total costs and expenses 9,766   5,814 
    Loss from operations (9,766)  (5,814)
            
    Interest and other income 28   172 
    Interest expense (9)  (7)
    Loss before income taxes (9,747)  (5,649)
    Income tax benefit 9   167 
    Net loss$(9,738) $(5,482)
            
    Net loss per share:       
    Basic and diluted$(2.07) $(4.15)
    Weighted average shares outstanding:       
    Basic and diluted 4,710,237   1,321,234 



    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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    • rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccines
    • rNAPc2 is the only novel compound being developed for COVID-19 Associated Coagulopathy
    • Topline trial data anticipated in the second quarter of 2021
    • Data from this development program will also inform potential development in additional RNA virus-associated diseases

    WESTMINSTER, Colo., Dec. 15, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the first patients have been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2…

    • rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccines
    • rNAPc2 is the only novel compound being developed for COVID-19 Associated Coagulopathy
    • Topline trial data anticipated in the second quarter of 2021
    • Data from this development program will also inform potential development in additional RNA virus-associated diseases

    WESTMINSTER, Colo., Dec. 15, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the first patients have been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 (AB201) as a potential treatment for patients hospitalized with COVID-19. The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date. The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021.

    "There is a critical need for safe, efficacious treatments in hospitalized COVID-19 patients, and we believe this need will continue even with potentially effective vaccines available," said Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. "We believe rNAPc2's combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19, and we look forward to completing the ASPEN-COVID-19 trial evaluating rNAPc2's potential efficacy in this patient population."

    ASPEN-COVID-19 Phase 2b is a randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin prescribed per local standard of care in approximately 100 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is safety and change in D-dimer level from baseline to Day 8 relative to standard of care heparin. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.

    Dr. Wolfram Ruf, Scientific Director of the Center for Thrombosis and Hemostasis at the Johannes Gutenberg University Medical Center Mainz, Germany, and Professor at Scripps Research, La Jolla, CA, commented, "The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production. Because rNAPc2 is a potent tissue factor inhibitor, it has anticoagulant with anti-inflammatory and antiviral properties. With its properties in modulating the tissue factor pathway, rNAPc2 has the potential to be a uniquely beneficial therapy for patients hospitalized with COVID-19, and potentially other RNA virus associated diseases as well."

    Dr. Marc Bonaca MD MPH, Executive Director of CPC Clinical Research and the Director of Vascular Research at the University of Colorado School of Medicine, Aurora, Colorado commented, "Coagulopathy has now been well described as a core malignant feature of COVID-19, as well as other severe viral infections, but we are learning that just simply increasing the intensity of anticoagulation using traditional therapies may not be the optimal approach both for efficacy and for bleeding risk. Targeted inhibition of tissue factor, which plays a key role in the complex interplay of coagulation, inflammation, and infection, holds promise to potentially improve outcomes. The ASPEN-COVID-19 study will provide critical data as to the role of rNAPc2 in this setting as well as other viral and inflammatory conditions characterized by tissue factor mediated coagulopathy."

    The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.

    About rNAPc2 (AB201)

    rNAPC2 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, initially focusing on COVID-19.  rNAPC2 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPC2 a combination of anti-coagulant, anti-inflammatory and anti-viral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways.  rNAPC2  has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications.  Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that rNAPC2 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating rNAPC2 as a treatment for COVID-19 and other RNA virus associated diseases.

    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. ARCA is also developing Gencaro™ (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential pharmacogenetic treatment for atrial fibrillation in patients with heart failure. 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 potential future development plans for rNAPc2 (AB201), the expected features and characteristics of rNAPc2, the anticipated development timeline for rNAPc2, rNAPc2's potential to treat COVID-19, or any other RNA virus associated disease, whether rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19 Associated Coagulopathy and the potential future treatment options and needs for patients with COVID-19. 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 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 Cole

    720.940.2163

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740



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