• 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



    Primary Logo

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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



    Primary Logo

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  1. WESTMINSTER, Colo., Dec. 09, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), today announced that its 2020 Annual Meeting of Stockholders, scheduled for Thursday, December 10, 2020 at 9:00 a.m. MT, now will be held at the company's offices located at 10170 Church Ranch Way, Suite 100, Westminster, CO 80021, approximately one-quarter mile from the previously noticed location. The meeting location change is due to the COVID-19 related unavailability of the previously noticed meeting location.

    Due to the COVID-19 pandemic, seating capacity will be limited to comply with guidelines promulgated by relevant public health authorities. Social distancing will be observed at all times during the meeting and each attendee will be required…

    WESTMINSTER, Colo., Dec. 09, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), today announced that its 2020 Annual Meeting of Stockholders, scheduled for Thursday, December 10, 2020 at 9:00 a.m. MT, now will be held at the company's offices located at 10170 Church Ranch Way, Suite 100, Westminster, CO 80021, approximately one-quarter mile from the previously noticed location. The meeting location change is due to the COVID-19 related unavailability of the previously noticed meeting location.

    Due to the COVID-19 pandemic, seating capacity will be limited to comply with guidelines promulgated by relevant public health authorities. Social distancing will be observed at all times during the meeting and each attendee will be required to wear a protective face covering. Should more participants want to join the meeting than available seating capacity, those participants will be provided the opportunity participate in the meeting via remote means.

    Further information regarding the annual meeting matters is available in the company's Notice of 2020 Annual Meeting and Proxy Statement filed on October 28, 2020, which is available by clicking on "SEC Filings" under the "Investors" tab on the company's website.

    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 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 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 AB201, the expected features and characteristics of AB201, AB201's potential to treat COVID-19, or any other RNA virus associated disease, and future treatment options 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 AB201 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



    Primary Logo

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    • Development addresses need for treatments for patients hospitalized with COVID-19 whether vaccines are available or not
    • AB201 is the only novel compound being developed for COVID Associated Coagulopathy
    • Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December
    • Topline trial data anticipated Q2 2021

    WESTMINSTER, Colo., Nov. 23, 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 U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19. The Company intends to…

    • Development addresses need for treatments for patients hospitalized with COVID-19 whether vaccines are available or not

    • AB201 is the only novel compound being developed for COVID Associated Coagulopathy
    • Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December
    • Topline trial data anticipated Q2 2021

    WESTMINSTER, Colo., Nov. 23, 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 U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19. The Company intends to initiate a Phase 2b clinical trial (ASPEN-COVID-19) of AB201 in approximately 100 patients hospitalized with COVID-19 in December 2020, with topline trial data anticipated in the second quarter of 2021.

    According to the FDA's Fast Track Guidance document, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

    "Fast Track designation for the AB201 development program is an important acknowledgement of the critical need for treatments for hospitalized COVID-19 patients, whether effective vaccines are approved and available or not," 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 AB201's combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19 and look forward to beginning the ASPEN-COVID-19 trial to evaluate AB201's potential efficacy in this patient population."

    Fast Track drug development designation is included in the FDA Modernization Act of 1997 (FDAMA) as a formal process to enhance interactions with the FDA during drug development. A drug development program with Fast Track designation would be eligible for consideration for some or all of the following programs for expediting development and review: scheduled meetings to seek FDA input into development plans, priority review of the New Drug Application (NDA), the option of submitting portions of an NDA prior to submission of the complete application and potential accelerated approval. ARCA believes that AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation.

    About AB201

    AB201 is a small recombinant protein being developed as a potential treatment for RNA virus-associated diseases, initially focusing on COVID-19. AB201 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 AB201 a combination of anticoagulant, anti-inflammatory and antiviral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways. AB201 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 AB201 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 AB201 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 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 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 AB201, the expected features and characteristics of AB201, AB201's potential to treat COVID-19, CAC or any other RNA virus associated disease, whether AB201 is the only anticoagulant class new chemical entity in development for COVID-19 that has a Fast Track designation and future treatment options 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 AB201 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 



    Primary Logo

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    • Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID19 anticipated in fourth quarter

    • Topline data from trial anticipated Q2 2021

    WESTMINSTER, Colo., Nov. 02, 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 reported financial results for the third quarter of 2020 and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority…

    • Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID19 anticipated in fourth quarter



    • Topline data from trial anticipated Q2 2021

    WESTMINSTER, Colo., Nov. 02, 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 reported financial results for the third quarter of 2020 and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority. AB201'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 are working rapidly towards initiating the Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID-19."

    Pipeline Update

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

    • Advancing development of AB201 as a potential treatment for patients hospitalized with COVID-19



    • U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19



    • ARCA estimates initiating Phase 2b clinical testing of AB201 in fourth quarter of this year

    Gencaro™ (bucindolol hydrochloride) is 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 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. 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. Future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.

    Third Quarter 2020 Summary Financial Results

    Cash and cash equivalents were $51.1 million as of September 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022, including the projected costs for the AB201 Phase 2b clinical trial.

    Research and development (R&D) expense for the three months ended September 30, 2020 was $1.1 million compared to $0.3 million for the corresponding period of 2019, an increase of $0.7 million. R&D expense for the nine months ended September 30, 2020 was $1.8 million compared to $1.4 million for the corresponding period of 2019, an increase of approximately $0.3 million.

    Clinical expense increased approximately $0.3 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. Manufacturing process development costs increased approximately $0.2 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. The increase in costs were related to initial costs for the AB201 clinical trial, which the Company plans to initiate in the fourth quarter of 2020. The remaining increase is primarily a result of higher outside services and consulting costs.

    General and administrative (G&A) expenses were $0.9 million for both the three months ended September 30, 2020 and 2019. G&A expenses were $2.9 million and $3.1 million for the nine months ended September 30, 2020 and 2019, respectively. The $0.2 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 September 30, 2020 were $1.9 million compared to $1.2 million for the corresponding period in 2019. Total operating expenses for the nine months ended September 30, 2020 were $4.6 million compared to $4.5 million for the corresponding period in 2019.

    Net loss for the three months ended September 30, 2020 was $2.0 million, or $0.33 per basic and diluted share, compared to $1.2 million, or $0.76 per basic and diluted share, for the corresponding period in 2019.   Net loss for the nine months ended September 30, 2020 was $4.6 million, or $1.46 per basic and diluted share, compared to $4.3 million, or $3.46 per basic and diluted share, for the corresponding period 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 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 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 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, 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 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 Cole

    720.940.2163

    (Tables follow)



    ARCA BIOPHARMA, INC.

    BALANCE SHEET DATA

    (in thousands)

    (unaudited)

     September 30, 2020  December 31, 2019 
    Cash and cash equivalents$51,095  $8,363 
    Working capital$50,409  $7,554 
    Total assets$51,982  $8,536 
    Total stockholders' equity$50,455  $7,610 
            



    ARCA BIOPHARMA, INC.

    STATEMENTS OF OPERATIONS

    (unaudited)

     Three Months Ended  Nine Months Ended 
     September 30,  September 30, 
     2020  2019  2020  2019 
                
                
     (in thousands, except share and per share amounts) 
    Costs and expenses:               
    Research and development$1,051  $347  $1,788  $1,449 
    General and administrative 939   900   2,852   3,087 
    Total costs and expenses 1,990   1,247   4,640   4,536 
    Loss from operations (1,990)  (1,247)  (4,640)  (4,536)
                    
    Interest and other income 1   50   27   136 
    Interest expense (2)  (1)  (9)  (7)
    Loss before income taxes (1,991)  (1,198)  (4,622)  (4,407)
    Income tax benefit    42   9   151 
    Net loss$(1,991) $(1,156) $(4,613) $(4,256)
                    
    Net loss per share:               
    Basic and diluted$(0.33) $(0.76) $(1.46) $(3.46)
    Weighted average shares outstanding:               
    Basic and diluted 6,044,315   1,521,259   3,154,680   1,229,289 
                    

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

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    • Initiation of Phase 2b clinical trial anticipated in Q4 2020
    • Trial to enroll approximately 100 patients hospitalized with COVID-19
    • Topline data anticipated Q2 2021

    WESTMINSTER, Colo., Oct. 07, 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 the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in…

    • Initiation of Phase 2b clinical trial anticipated in Q4 2020
    • Trial to enroll approximately 100 patients hospitalized with COVID-19
    • Topline data anticipated Q2 2021

    WESTMINSTER, Colo., Oct. 07, 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 the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results. The Company anticipates topline data from the trial in the second quarter of 2021.

    The planned Phase 2b trial is anticipated to be a randomized comparison of two dose regimens of AB201 versus heparin prescribed per local standard of care. 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. AB201 is a potent tissue factor inhibitor anticoagulant with anti-inflammatory and antiviral properties. The primary endpoint of the trial will be change in D-dimer level from baseline to Day 8. 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.   If Phase 2b indicates a favorable effect on D-dimer levels, following FDA review of the data and identification of the proposed Phase 3 AB201 dose, the Company anticipates that clinical investigative sites will begin enrolling in the planned Phase 3 clinical trial. The primary endpoint of Phase 3 will be clinical recovery as measured by the Adaptive COVID-19 Treatment Trial (ACTT-1) ordinal scale, with secondary endpoints that include D-dimer levels and the number of thrombotic events. Phase 3 will be event driven, with an estimated requirement of 450 patients. The Phase 2b and Phase 3 trials are described in a common protocol and use identical entry criteria and the same heparin regimen control.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator, commented, "The ASPEN-COVID-19 trial will use the coagulopathy biomarker D-dimer to identify an optimal dose from AB201 regimens that are both within the therapeutic range as determined from Phase 2 trials investigating cardiovascular thrombosis prophylaxis. If successful, we anticipate using this dose in a planned Phase 3 trial to evaluate potential improvement in clinical outcomes. We believe that the combination of anticoagulant, anti-inflammatory and antiviral effects of AB201 may favorably impact clinical recovery of patients hospitalized with COVID-19."

    The trial is being managed in collaboration with the Colorado Prevention Center (CPC), the University of Colorado's Academic Research Organization with extensive experience in managing vascular and anticoagulation clinical trials.

    Marc Bonaca, MD, Executive Director of CPC, commented: "The ASPEN-COVID-19 trial will enable us to step beyond the question of intensity of anticoagulation and ask the question of whether specifically targeting tissue factor, a key step in the extrinsic pathway of anticoagulation and a key part of viral pathogenesis, improves outcomes in COVID-19. Dosing and safety are critical, and the Phase 2 trial will enable selection of a dose for safety, coagulopathy, and anti-viral parameters for use in a planned Phase 3 clinical trial. This selected dose will be deployed in the proposed Phase 3 pivotal outcomes study with the hope of translation to the clinical setting. We believe this therapy holds promise to improve outcomes in the current pandemic and given the positive findings in an Ebola animal model, has the potential for broader application in other severe viral infections characterized by coagulopathy."

    About AB201

    AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated diseases, initially focusing on COVID-19.   AB201 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 AB201 a combination of anti-coagulant, immuno-modulatory and anti-viral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways.   AB201 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 AB201 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 AB201 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 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 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 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 any other RNA virus associated disease, future treatment options for patients with 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 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 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., Oct. 05, 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 the promotion of Debra Marshall, MD, FACC to Chief Medical Officer, and Sharon Perry, RAC, to Vice President, Regulatory Affairs and Quality.

    Dr. Marshall joined ARCA in 2016 as Senior Vice President, Medical Affairs. She has spent more than 20 years dedicated to cardiovascular drug development. Prior to joining ARCA, she served as an Executive Medical Director in the Cardiovascular Therapeutic Area at Amgen, Senior Medical Director in Cardio-Metabolism at Genentech, Global Senior Medical Director…

    WESTMINSTER, Colo., Oct. 05, 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 the promotion of Debra Marshall, MD, FACC to Chief Medical Officer, and Sharon Perry, RAC, to Vice President, Regulatory Affairs and Quality.

    Dr. Marshall joined ARCA in 2016 as Senior Vice President, Medical Affairs. She has spent more than 20 years dedicated to cardiovascular drug development. Prior to joining ARCA, she served as an Executive Medical Director in the Cardiovascular Therapeutic Area at Amgen, Senior Medical Director in Cardio-Metabolism at Genentech, Global Senior Medical Director for the CV/Acute Care team at Lilly and Associate Medical Director for CV Medical Affairs at Novartis Pharmaceutical Corporation. Dr. Marshall has been involved development and approval of medicines for Heart Failure, Hypertension, Acute Coronary Syndromes and Dyslipidemias. Dr. Marshall holds a B.S. in Chemistry and an M.D. from the University of California, Los Angeles. She completed an internship in Internal Medicine at the University of Pennsylvania, Philadelphia and a Cardiology fellowship at the Oregon Health Sciences University in Portland, Oregon. Dr. Marshall has been an NIH and AHA grant recipient and has authored numerous scientific and clinical publications. She earned board certifications in Internal Medicine, Cardiovascular Diseases, Interventional Cardiology and Nuclear Cardiology.

    Ms. Perry joined ARCA in 2008 as Senior Manager, Quality. She has more than 30 years of pharmaceutical industry experience as a Regulatory and Quality professional. Prior to joining ARCA, she was Quality Assurance Manager at Colorado Histoprep, Quality Assurance Specialist at Gilead Sciences, Chemist at Paragon Analytics, Manager of Quality for PR Pharmaceuticals and Quality Assurance Coordinator at Pfizer. Ms. Perry's expertise includes Quality Department and Quality Management Systems development and implementation, global Good Clinical, Laboratory and Manufacturing Practices (GXP), FDA pre-approval and Good Manufacturing Practices (GMP)/Good Clinical Practice (GCP) inspections, New Drug Applications (NDA), Investigational New Drug (IND) applications and Clinical Trial Applications, and Fast Track Designation and Orphan Drug Designation applications.

    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 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 atrial fibrillation (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 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 any other RNA virus associated disease, future treatment options for patients with 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 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 Cole

    720.940.2163

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  3. WESTMINSTER, Colo., Sept. 21, 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 it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented…

    WESTMINSTER, Colo., Sept. 21, 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 it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "This IND submission is a key milestone in the clinical development of AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19, as well as other RNA virus associated diseases."

    About AB201 (rNAPc2)

    AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19.   AB201 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 AB210 a combination of anti-coagulant, immuno-modulation and anti-viral properties, and therefore the potential to be effective in addressing the pathologies caused by viral infections from multiple aspects.   AB201 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 AB201 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 AB201 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 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 atrial fibrillation (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 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 any other RNA virus associated disease, future treatment options for patients with 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 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 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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    • ARCA anticipates filing an IND for AB201 for COVID-19 in September 2020 and initiating Phase 2B clinical testing as early as Q4 2020

    WESTMINSTER, CO / ACCESSWIRE / August 12, 2020 / ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19. With this feedback, ARCA anticipates submitting its IND…

    • ARCA anticipates filing an IND for AB201 for COVID-19 in September 2020 and initiating Phase 2B clinical testing as early as Q4 2020

    WESTMINSTER, CO / ACCESSWIRE / August 12, 2020 / ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19. With this feedback, ARCA anticipates submitting its IND application in September 2020 in preparation for initiating a Phase 2B clinical trial as early as the fourth quarter of this year.

    A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA's guidance for clinical trials for the sponsor's new drug candidate. The FDA has created CTAP as a special emergency program for possible coronavirus therapies which is designed to use every available method to move new treatments to patients as quickly as possible, while evaluating safety and effectiveness.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "Receiving the FDA's guidance is an important step in developing and executing our clinical development program for AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19. AB201's differentiated mechanism of action may also allow for use in combination with other COVID-19 therapeutics and provide a potential treatment for those patients who cannot take vaccines or for whom vaccines are not effective."

    About AB201 (rNAPc2)
    AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19. AB201 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. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including as an anti-thrombotic agent in the setting of acute myocardial infarction (MI), 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, 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 AB201 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 AB201 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 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 atrial fibrillation (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 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 any other RNA virus associated disease, future treatment options for patients with 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 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 Cole
    720.940.2163

    SOURCE: ARCA biopharma, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/601279/ARCA-Biopharma-Announces-Completion-of-FDA-Pre-IND-Consultation-Under-Coronavirus-Treatment-Acceleration-Program-for-AB201-as-a-Potential-Treatment-for-Severe-COVID-19

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    • AB201 being developed as a potential treatment for COVID-19 and other RNA virus associated diseases
    • ARCA anticipates filing an IND for AB201 in Q3 2020 and initiating Phase 2 clinical testing in Q4 2020

    WESTMINSTER, Colo., Aug. 05, 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 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…

    • AB201 being developed as a potential treatment for COVID-19 and other RNA virus associated diseases

    • ARCA anticipates filing an IND for AB201 in Q3 2020 and initiating Phase 2 clinical testing in Q4 2020

    WESTMINSTER, Colo., Aug. 05, 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 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 Results



    Cash 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 biopharma

    ARCA 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 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 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 Cole

    720.940.2163



    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 

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    • Integrin A5 may be a new target for intervening in the cell infectious process
    • Findings may lead to the development of precision therapeutic approaches to prevent SARS-CoV-2-cell entry while preserving the functional activity of ACE2

    WESTMINSTER and AURORA, Colo., July 07, 2020 (GLOBE NEWSWIRE) -- The University of Colorado Anschutz Medical Campus and ARCA biopharma, Inc. (NASDAQ:ABIO) today announced that the paper entitled "Dynamic Regulation of SARS-CoV-2 Binding and Cell Entry Mechanisms in Remodeled Human Ventricular Myocardium" (Bristow MR, et al. https://doi.org/10.1016/j.jacbts.2020.06.007 was published in JACC: Basic to Translational Science (JBTS), a member of the Journal of the American College of Cardiology (JACC) family of journals…

    • Integrin A5 may be a new target for intervening in the cell infectious process
    • Findings may lead to the development of precision therapeutic approaches to prevent SARS-CoV-2-cell entry while preserving the functional activity of ACE2

    WESTMINSTER and AURORA, Colo., July 07, 2020 (GLOBE NEWSWIRE) -- The University of Colorado Anschutz Medical Campus and ARCA biopharma, Inc. (NASDAQ:ABIO) today announced that the paper entitled "Dynamic Regulation of SARS-CoV-2 Binding and Cell Entry Mechanisms in Remodeled Human Ventricular Myocardium" (Bristow MR, et al. https://doi.org/10.1016/j.jacbts.2020.06.007 was published in JACC: Basic to Translational Science (JBTS), a member of the Journal of the American College of Cardiology (JACC) family of journals. The paper provides new information on mechanisms involved in host cell binding and entry of the SARS-CoV-2 in the human heart. Investigators affiliated with the Bristow Laboratory at CU Anschutz Medical Campus, Cardiovascular Institute at the University of Colorado School of Medicine and ARCA biopharma determined how known and potential mechanisms responsible for COVID-19 infection in the intact heart are altered by prior heart muscle disease, and to what extent they are changed when damaged heart muscle improves through a process called reverse remodeling.

    COVID-19 infection occurs when SARS-CoV-2 infects host cells by binding to receptor sites on cell surface membranes, then merging its viral membrane with host cell surface and intracellular membranes to facilitate internalization, and finally taking control over host cell RNA synthesis to replicate virus. When heart muscle is damaged, enlarges and weakens (a process termed "remodeling"), various myocardial cell constituents change their expression, including some that may participate in CoV-2 host cell binding and internalization. Foremost of those that have been previously identified is angiotensin converting enzyme-2 (ACE2), which based on work performed in the Bristow Laboratory, was first reported to be increased ("upregulated") at the protein and enzyme activity levels in explanted remodeled human hearts in 2003 (Zisman LS et al, Circulation 108:1709-12). Shortly thereafter, ACE2 was reported by others to be the receptor for SARS-CoV binding to host cells (Li W et al, Nature 426:450-4, 2003), and recently, ACE2 was identified as the receptor for SARS-CoV-2 cell binding (Hoffman et al, Cell 181:1-10, 2020). However, it was not known if ACE2 upregulation in remodeled explanted hearts was due to heart failure medications that can affect ACE2 expression or was only found in late stage heart failure and remodeling present in hearts obtained from cardiac transplant recipients. Moreover, mechanisms or constituents other than ACE2 that could participate in CoV2 host cell binding and internalization had not been previously investigated in remodeled human left ventricles (LVs).

    In the JBTS reported study, 46 patients with mild-moderate heart failure and remodeling from nonischemic dilated cardiomyopathy and nonfailing, non-remodeled controls had RNA extracted from interventricular septum endomyocardial biopsies. From the extracted RNA, genes known to participate in CoV-2 host cell binding and cell entry or who were possible candidates for these processes had mRNA expression measured by two independent platforms. The 46 dilated cardiomyopathy patients were then treated for 12 months with beta-blocking agents to produce reverse remodeling, measured by improvement in left ventricular ejection fraction (LVEF), which occurred in 65 percent of the patients. Gene expression in patients with reverse remodeling was then compared to the 35 percent of patients whose LVEFs/remodeling did not change. Importantly, the dilated cardiomyopathy patients were being treated with inhibitors of the renin-angiotensin system prior to baseline measurements and throughout the study, eliminating the possibility that such therapy could have affected ACE2 expression.

    At baseline, ACE2 myocardial mRNA expression was markedly upregulated in the dilated cardiomyopathy patients, by nearly two-fold. With reverse remodeling, ACE2 gene expression normalized, and was unchanged in those with no remodeling improvement. The behavior of ACE2 as well as the degree of baseline expression was highly correlated with that of the natriuretic peptide B gene, whose processed protein product BNP is considered the gold standard biomarker for heart failure and remodeling. These data indicate that the increased expression of ACE2 begins much earlier than in end stage heart failure, that it is directly related to the remodeling process and not to the administration of heart failure therapy, and that by virtue of its potential for increasing the amount of virus internalization into host cells including cardiac myocytes, it is a likely a contributor to the increased adverse outcomes of patients with underlying heart disease who have COVID-19 infection.

    ACE2 is a "protective" or counter-regulatory enzyme that catalyzes the conversion of angiotensin-II to angiotensin-(1-7), a peptide that mitigates abnormal cell growth, blood vessel constriction and thrombosis (blood clots) mediated by angiotensin-II, which is known to be elevated in COVID-19 patients with clinically significant disease. However, the increased expression of ACE2 in the remodeled heart means that its beneficial effects may also predispose to increased cell infection by CoV-2. Based on these observations, the paper concludes that an optimal ACE2 targeted treatment for COVID-19 would consist of an agent that blocks CoV-2 binding without diminishing or perhaps even increasing ACE2 enzyme activity.

    The study also examined the expression of multiple proteases that facilitate cell entry through virus-host cell membrane fusion, and found that none previously shown to be involved in CoV or CoV-2 membrane coalescence were altered, and that 11 additional expressed proteases were not upregulated in remodeling. In contrast, the study found that integrin A5 subunit (ITGA5), which binds to ACE2 and can mediate host cell internalization of viruses, was upregulated in remodeled heart and normalized its expression on reverse remodeling similar to ACE2. The study concluded that the ITGA5 protein gene product or the a5b1 heterodimer is a candidate for facilitating CoV-2 binding and entry in myocardial cells. Thus, in remodeled, intact human hearts one (ACE2) and possibly two (ITGA5) myocardial cell components are altered to favor enhanced infection by CoV-2, which may explain COVID-19 increased adverse outcomes in patients with underlying heart muscle disorders.

    Michael Bristow MD, PhD, Director of Pharmacogenomics at the Cardiovascular Institute, and ARCA's President and Chief Executive Officer commented, "These findings add to the evidence that increased ACE2 expression contributes to the increased adverse outcomes risk observed for COVID-19 in patients with underlying myocardial disease. In addition, we detected a possible additional route of CoV-2 binding and host cell internalization that is upregulated in remodeled human ventricles, involving integrin A5. This information sets the stage for the development of diagnostic approaches to and therapeutic manipulation of ACE2 for preventing CoV-2-host cell internalization while preserving functional activity, and may identify a new target for intervening in the cell infectious process."

    About the University of Colorado School of Medicine Cardiovascular Institute

    The University of Colorado School of Medicine Cardiovascular Institute (CU-CVI) was co-founded in 1998 by Dr. Bristow and Leslie Leinwand, PhD with the mission of integrating cardiovascular research, treatment, and discovery through a collaboration of the Anschutz Medical and Boulder campuses. The CU-CVI is now Co-directed by Dr. Leinwand and Peter Buttrick, MD, Division Head of Cardiology and Senior Associate Dean for Academic Affairs at the CU School of Medicine, who is a co-author on the JBTS paper.

    The scientific goals of the Institute are to understand the genetic basis and specific molecular mechanisms responsible for heart muscle disease and heart failure and to produce new diagnostic techniques and treatments for patients. By integrating the effort of those committed to curing heart muscle disease and heart failure, the collaborative nature of the Institute encourages the sharing of findings and data, which ultimately translate into improved treatments and therapies of patients. www.ucdenver.edu/academics/colleges/medicalschool/institutes/CardiovascularInstitute.

    In work sponsored by the American Heart Association the research team that worked on the current study is now investigating the effects of CoV-2 on host cell entry and internalization mechanisms in the intact heart of patients with COVID-19 cardiac involvement.

    About the University of Colorado Anschutz Medical Campus

    The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, together we deliver life-changing treatments, patient care, professional training, and conduct world-renowned research. For more information, visit www.cuanschutz.edu.

    About ARCA biopharma

    ARCA biopharma is dedicated to developing genetically targeted and other precision therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 (rNAPc2) 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 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 AB201 and Gencaro, the expected features and characteristics of AB201 or Gencaro, including the potential for AB201 to treat COVID-19/CAC, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, 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 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.

    CU Anschutz and School of Medicine Media Contacts:

    Julia Milzer (CU Anschutz),  E:  C: 303.725.0733

    Chanthy Na (School of Medicine), E:

    ARCA biopharma 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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  4. WESTMINSTER, Colo., June 03, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the closing of its previously announced registered direct offering with certain institutional and accredited investors of 348,000 shares of ARCA's common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 325,500 shares of common stock at a purchase price of $8.999 per warrant. The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, were approximately $6.1 million. The gross proceeds represent a mutually agreed reduction…

    WESTMINSTER, Colo., June 03, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the closing of its previously announced registered direct offering with certain institutional and accredited investors of 348,000 shares of ARCA's common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 325,500 shares of common stock at a purchase price of $8.999 per warrant. The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, were approximately $6.1 million. The gross proceeds represent a mutually agreed reduction in the gross proceeds of the offering from the initial $9.4 million previously announced on June 1, 2020.

    JonesTrading Institutional Services LLC acted as the exclusive placement agent for the offering.

    ARCA anticipates that the net proceeds from this offering will be used to initiate its clinical trial of AB201 and for working capital and general corporate purposes.

    The shares of common stock were offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238067), which was declared effective by the Securities and Exchange Commission (SEC) on May 20, 2020. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing , or at the SEC's website at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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 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 ARCA 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 expected gross and net proceeds from the offering, the planned use of proceeds from the offering, potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 or Gencaro, including the potential for AB201 to treat COVID-19, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, 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: uncertainties related to market conditions; 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; statements related to the intended use of net proceeds from the registered direct offering; 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

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  5. WESTMINSTER, Colo., June 01, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors to purchase, in a registered direct offering, 348,000 shares of ARCA's common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 694,222 shares of common stock at a purchase price of $8.999 per warrant. The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, are expected to be approximately $9.4 million…

    WESTMINSTER, Colo., June 01, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors to purchase, in a registered direct offering, 348,000 shares of ARCA's common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 694,222 shares of common stock at a purchase price of $8.999 per warrant. The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, are expected to be approximately $9.4 million. Subject to customary closing conditions, the transaction is expected to close on Wednesday, June 3, 2020.

    JonesTrading Institutional Services LLC is acting as the exclusive placement agent for the offering.

    ARCA anticipates that the net proceeds from this offering will be used to initiate its clinical trial of AB201 and for working capital and general corporate purposes.

    The shares of common stock are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238067), which was declared effective by the Securities and Exchange Commission (SEC) on May 20, 2020. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained, when available, from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing , or at the SEC's website at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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 AB201 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 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 ARCA 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 expected gross and net proceeds from the offering, the planned use of proceeds from the offering, the expected completion of the offering, potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 or Gencaro, including the potential for AB201 to treat COVID-19, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, 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: uncertainties related to market conditions and satisfaction of customary closing conditions related to the offering; 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; statements related to the intended use of net proceeds from the registered direct offering; 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

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    • AB201 (rNAPc2) is being developed as a potential treatment for COVID Associated Coagulopathy, a condition characterized by abnormal blood clotting in patients with COVID-19
    • Previous safety data in more than 700 patients through Phase 2 may enable more rapid development
    • ARCA anticipates filing an IND in the third quarter of 2020 and initiating late-stage clinical testing in the second half of this year
    • Prior rNAPc2 results treating Ebola and Marburg viral infections in non-human primate trials support development as treatment for RNA virus associated disease
    • AB201 (rNAPc2) is a potent inhibitor of tissue factor, a key driver of the viral infection process and associated inflammatory response, including virus-associated coagulopathy

    WESTMINSTER…

    • AB201 (rNAPc2) is being developed as a potential treatment for COVID Associated Coagulopathy, a condition characterized by abnormal blood clotting in patients with COVID-19
    • Previous safety data in more than 700 patients through Phase 2 may enable more rapid development
    • ARCA anticipates filing an IND in the third quarter of 2020 and initiating late-stage clinical testing in the second half of this year
    • Prior rNAPc2 results treating Ebola and Marburg viral infections in non-human primate trials support development as treatment for RNA virus associated disease
    • AB201 (rNAPc2) is a potent inhibitor of tissue factor, a key driver of the viral infection process and associated inflammatory response, including virus-associated coagulopathy

    WESTMINSTER, Colo., May 28, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) today announced a new development program to evaluate AB201 (rNAPc2), a potent, selective inhibitor of tissue factor (TF), as a potential treatment for COVID-19 associated coagulopathy (CAC) and the related inflammatory response. CAC is one of the most serious adverse effects seen in COVID-19 patients. AB201 has previously undergone clinical testing through Phase 2 in more than 700 patients for other indications, generating substantial safety data, which the Company believes may enable more rapid development. ARCA anticipates filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the third quarter and initiating late-stage clinical testing in the second half of this year.

    TF is the protein responsible for initiating the primary or extrinsic coagulation pathway. TF has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. AB201 (rNAPc2), a single-chain, 85 amino acid, recombinant protein, has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including as an anti-thrombotic agent in the setting of acute myocardial infarction (MI), 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 coagulopathic disorders in which the blood's ability to coagulate (form clots) is impaired by consumption of clotting factors (disseminated intravascular coagulation, DIC). For example, filovirus infections such as Ebola and other hemorrhagic fevers are characterized by dysregulated activation of the TF pathway, resulting in abnormal systemic coagulation and related inflammation, leading to organ failure and mortality. Recent mechanistic discoveries, as well as data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. Collectively, the Company believes these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19, the disease caused by SARS CoV-2 virus.

    COVID-19 disease is associated with a significant incidence of coagulation-related adverse events, including stroke, MI (i.e., heart attack), pulmonary emboli, and disseminated intravascular coagulation (DIC), a condition in which small blood clots develop throughout the bloodstream. A commonly used biomarker for assessing coagulation activation is a D-dimer test, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes. In Ebola or Marburg NHP models, AB201 inhibited the DIC process, as measured by lowered D-dimer levels, which the Company believes provides further support for its therapeutic potential for CAC. The Company believes the efficacy of AB201 against COVID-19 disease may not be affected by potential mutations of the SARS CoV-2 virus, would be additive with therapeutics inhibiting virus-cell binding or viral RNA polymerase, and could be effective against other coagulopathy-associated viruses.

    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, "Our research, combined with the accumulating evidence on the clinical importance of large and small vessel thromboses in the COVID-19 infected patients, points to a potentially important role for the tissue factor pathway in viral infection, inflammatory response and the development of coagulopathy. With its properties in modulating the TF pathway and the evidence from its prior development, rNAPc2 has the potential to be a uniquely beneficial therapy for patients with COVID-19."

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator, commented, "During this global health crisis, we believe it is important to rapidly and collaboratively evaluate multiple technologies to address COVID-19 and the associated pathologic host responses. The combination of anticoagulation, anti-inflammatory effects and antiviral activity have the potential to make AB201 a unique therapeutic to treat patients afflicted with COVID-19 while vaccine development is underway and for patients for whom a vaccine is not effective. We believe this therapeutic approach may also have potential to address future outbreaks of diseases related to other RNA viruses."

    Next Steps:

    • The Company anticipates filing an IND application for AB201 as a potential treatment for COVID-19 with the FDA in the third quarter of this year.
    • In collaboration with the Colorado Prevention Center, the University of Colorado's Academic Research Organization directed by Marc Bonaca, MD, a vascular and anti-coagulation clinical trialist, a Phase 2B/3 clinical trial protocol is being developed for hospitalized COVID-19 patients with elevated D-dimer levels.
    • Pending FDA concurrence and obtaining trial funding, ARCA estimates initiating late-stage clinical testing of AB201 in the second half of 2020.

    Dr. Bonaca commented, "The thrombotic complications of COVID-19 are severe and stem directly from viral activity and vascular inflammation. By targeting tissue factor and the extrinsic pathway, AB201 may offer a unique approach that could simultaneously reduce the severity of the viral infection as well as reduce the risk of its thrombotic complications. The extensive Phase 2 safety experience in other diseases could enable more rapid development via a Phase 2B-Phase 3 adaptive program."

    AB201 is manufactured using a proven process that enables production at commercial scale, should clinical testing provide sufficient evidence of efficacy to seek regulatory approval.

    About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)
    SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS-CoV), both of which caused serious human infections of respiratory system. The disease caused by the SARS-CoV-2 virus has been designated COVID-19. Since this outbreak was first reported in late-2019, the virus has infected over 5.4 million people and has caused over 349,000 reported deaths (as of May 27, 2020). It has been declared a pandemic by the World Health Organization. Currently there is no vaccine or curative drug therapy for COVID-19.

    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 AB201 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 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 ability of ARCA's financial resources to support its operations through the end of the third quarter of 2020, potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 or Gencaro, including the potential for AB201 to treat COVID-19/CAC, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, 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 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 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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  6. New data provide additional evidence of efficacy for Gencaro compared to active control in a pharmacogenetically-defined HF population at risk for AF recurrence

    30% decrease in AF interventions and cardiovascular adverse events (p = 0.008)
    °  

    WESTMINSTER, Colo., May 07, 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 clinical data evaluating Gencaro™ (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF) in patients with heart…

    New data provide additional evidence of efficacy for Gencaro compared to active control in a pharmacogenetically-defined HF population at risk for AF recurrence

    °  26% reduction in total time spent in AF (p < 0.001)
    °  
    30% decrease in AF interventions and cardiovascular adverse events (p = 0.008)
    °  
    55% lower incidence of dose limiting bradycardia (p < 0.001)

    WESTMINSTER, Colo., May 07, 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 clinical data evaluating Gencaro™ (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF) in patients with heart failure (HF) was presented at the 2020 Heart Rhythm Scientific Sessions, the annual scientific conference of the Heart Rhythm Society (HRS). While the in-person meeting was cancelled due to the continued global escalation of COVID-19, HRS has provided author presentations virtually through its online learning platform Heart Rhythm 365 and all abstracts will be published in a supplement to the May edition of the Heart Rhythm Journal.

    The data come from a Phase 2 clinical trial, GENETIC-AF, that enrolled 267 HF patients with a current or recent history of paroxysmal or persistent AF and the ADRB1 Arg389Arg genotype. Patients were randomized to bucindolol or the active comparator, metoprolol succinate, and were followed for approximately 24 weeks.

    "Pharmacogenomic Guided Beta-Blocker Therapy with Bucindolol Reduces Atrial Fibrillation Burden Compared to Metoprolol Succinate: The GENETIC-AF Trial," authored by Jonathon P. Piccini et al, presented data from the device substudy of the GENETIC-AF trial. A total of 69 HF patients underwent continuous heart rhythm monitoring via implanted cardiac devices to evaluate the total time spent in AF during 24 weeks of follow-up, also known as cumulative AF burden. The paper's authors concluded that:

    • Bucindolol decreased cumulative AF burden by 26% (p < 0.001) compared to active control.
    • Treatment effect estimates for cumulative AF burden were consistent with time to first AF event analyses.
    • Cumulative AF burden evaluates more information than time to first event methods, providing greater power to detect clinically meaningful differences between groups with limited sample size.

    "Impact of Pharmacogenetic-guided Bucindolol versus Metoprolol Succinate on the Overall Burden of Clinical Events in Patients with AF and Heart Failure: The GENETIC-AF Trial," authored by Jeff S. Healey et al, presented data on the frequency of AF rhythm interventions (i.e., electrical cardioversions, ablations, and Class 3 antiarrhythmic drug use)  and cardiovascular (CV) adverse events in the GENETIC-AF trial. The paper's authors found that:

    • Bucindolol decreased a composite endpoint of AF interventions and CV adverse events
      by 30% (p = 0.008) compared to active control.
    • Bucindolol decreased AF interventions by 33% (p = 0.009) compared to active control.
    • Significant and numerically greater results were observed (46% and 51%, respectively)
      in a subgroup previously identified by precision therapeutic phenotyping (PTP cohort).
    • Similar significant results were observed (55% and 58%, respectively) for a subgroup of the PTP cohort with baseline LVEF values of 40% to 55%.

    "Bucindolol is Associated with a Lower Incidence of Dose Limiting Bradycardia in Heart Failure Patients with Atrial Fibrillation: The GENETIC-AF Trial," authored by William T. Abraham et al, reviewed drug dosing and safety data for the GENETIC-AF trial. The paper's authors found that:

    • Bucindolol was associated with a 55% (p < 0.001) lower incidence of bradycardia compared to active control.
    • Bradycardia was associated with a 4-fold increase in study drug dose reductions.
    • Differences in study drug dosing were primarily observed in patients with heart rates less than 60 beats per minute, which was much more common in the metoprolol group (p < 0.0001).
    • Fewer bradycardia adverse events in the bucindolol vs. metoprolol groups (5 vs. 20 events, p = 0.003).
    • Bradycardia may limit dosing of conventional beta-blockers in HF patients with AF, which would be expected to compromise effectiveness for reducing HF clinical events.

    The individual presentations can be found on the Scientific Publications page of the ARCA website and at HRS' Heart Rhythm 365.

    Michael Bristow, MD, PhD and CEO of ARCA commented: "Evaluated by the most sensitive and comprehensive measure of atrial fibrillation, continuous heart rhythm monitoring by an implanted device, these data indicate a clear efficacy signal for bucindolol compared to metoprolol succinate. Even more striking is the beneficial effect of bucindolol on downstream AF-related events occurring after an initial AF episode, with fewer clinical interventions to manage heart rhythm seen in the bucindolol group. Finally, the lower incidence of dose-limiting bradycardia with bucindolol provides a clue as to why conventional beta-blockers have not demonstrated efficacy for reducing heart failure events in patients with atrial fibrillation, while bucindolol has."

    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, Gencaro™ (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 future development plans for Gencaro, the expected features and characteristics of Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future treatment options for patients with AF, the significance of the new additional data from GENETIC-AF contained in these presentations and whether these data may be confirmed in future clinical trials, 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's ability to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or to otherwise continue operations in the future; that 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.

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

    Investor & Media Contact:
    Derek Cole
    720.940.2163

     

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    • U.S. FDA Special Protocol Assessment agreement for PRECISION-AF, a single pivotal Phase 3 clinical trial of genetically targeted Gencaro
    • PRECISION-AF trial to evaluate Gencaro as a potential treatment for prevention of atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies
    • PRECISION-AF clinical trial initiation anticipated fourth quarter

    WESTMINSTER, Colo., May 06, 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 reported financial results for the first quarter of 2020 and provided a corporate update.

    Dr. Michael Bristow, ARCA's President…

    • U.S. FDA Special Protocol Assessment agreement for PRECISION-AF, a single pivotal Phase 3 clinical trial of genetically targeted Gencaro
    • PRECISION-AF trial to evaluate Gencaro as a potential treatment for prevention of atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies
    • PRECISION-AF clinical trial initiation anticipated fourth quarter

    WESTMINSTER, Colo., May 06, 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 reported financial results for the first quarter of 2020 and provided a corporate update.

    Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "During this time of national and global health crisis, ARCA has acted to address uncertainty with a focus on three key areas: protecting the health and well-being of our employees, continuing effective operations to support advancing the development of Gencaro as a potential genetically targeted treatment for heart failure patients with atrial fibrillation, and seeking additional funding, whether through direct financing or on-going partnering discussions. Our planned Phase 3 clinical trial addresses a patient population for which there are currently no FDA approved drug therapies and we believe Gencaro has the potential to help address this substantial unmet medical need."

    Pipeline Update

    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).

    • 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).
    • 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.

    First Quarter 2020 Summary Financial Results

    Cash and cash equivalents were $6.7 million as of March 31, 2020, compared to $8.4 million as of December 31, 2019. 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 three months ended March 31, 2020 were $0.4 million compared to $0.7 million for the corresponding period in 2019, a decrease of approximately $0.3 million. The decrease was primarily due to decreased R&D personnel costs and lower outside services and consulting costs.

    General and administrative (G&A) expenses were $1.0 million for the three months ended March 31, 2020 compared to $1.1 million for the corresponding period in 2019. 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 the three months ended March 31, 2020 were $1.3 million compared to $1.8 million for the corresponding period in 2019.

    Net loss for the three months ended March 31, 2020 was $1.3 million, or $0.83 per basic and diluted share, compared to $1.7 million, or $1.86 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 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, Gencaro™ (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 Cole
    720.940.2163


    ARCA BIOPHARMA, INC.

    BALANCE SHEET DATA
    (in thousands)
    (unaudited)

             
        March 31, 2020   December 31, 2019
    Cash and cash equivalents $ 6,674 $ 8,363
    Working capital $ 6,223 $ 7,554
    Total assets $ 7,461 $ 8,536
    Total stockholders' equity $ 6,306 $ 7,610
             

    ARCA BIOPHARMA, INC.

    STATEMENTS OF OPERATIONS

    (unaudited)

      Three Months Ended  
      March 31,  
      2020     2019  
      (in thousands, except share
    and per share amounts)
     
    Costs and expenses:              
    Research and development $ 365     $ 662  
    General and administrative   975       1,119  
    Total costs and expenses   1,340       1,781  
    Loss from operations   (1,340 )     (1,781 )
                   
    Interest and other income   24       38  
    Interest expense   (4 )     (3 )
    Loss before income taxes   (1,320 )     (1,746 )
    Income tax benefit         82  
    Net loss $ (1,320 )   $ (1,664 )
                   
    Net loss per share:              
    Basic and diluted $ (0.83 )   $ (1.86 )
    Weighted average shares outstanding:              
    Basic and diluted   1,594,070       895,970  
                   

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

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    • U.S. FDA Special Protocol Assessment agreement for a single pivotal Phase 3 clinical trial (PRECISION-AF) of genetically-targeted Gencaro
    • PRECISION-AF clinical trial initiation anticipated fourth quarter of 2020
    • Trial to evaluate Gencaro as a potential treatment for prevention of atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies

    WESTMINSTER, Colo., Feb. 18, 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 reported financial results for the year ended December 31, 2019 and provided a corporate update.

    Dr. Michael Bristow, ARCA's President…

    • U.S. FDA Special Protocol Assessment agreement for a single pivotal Phase 3 clinical trial (PRECISION-AF) of genetically-targeted Gencaro
    • PRECISION-AF clinical trial initiation anticipated fourth quarter of 2020
    • Trial to evaluate Gencaro as a potential treatment for prevention of atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies

    WESTMINSTER, Colo., Feb. 18, 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 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 Cole
    720.940.2163



    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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    • PRECISION-AF pivotal Phase 3 clinical trial initiation anticipated first quarter of 2020
    • Trial to examine atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies

    WESTMINSTER, Colo., Nov. 06, 2019 (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 financial results for the quarter ended September 30, 2019 and provided a corporate update.

    "There are currently no FDA approved drug therapies indicated for treating patients with atrial fibrillation and heart failure with left ventricular ejection fraction values greater than 40%," commented…

    • PRECISION-AF pivotal Phase 3 clinical trial initiation anticipated first quarter of 2020
    • Trial to examine atrial fibrillation in a heart failure population for which there are no FDA indicated drug therapies

    WESTMINSTER, Colo., Nov. 06, 2019 (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 financial results for the quarter ended September 30, 2019 and provided a corporate update.

    "There are currently no FDA approved drug therapies indicated for treating patients with atrial fibrillation and heart failure with left ventricular ejection fraction values greater than 40%," commented Dr. Michael Bristow, ARCA's President and Chief Executive Officer.  "Approximately two-thirds of all heart failure patients have LVEF values greater than 40% and about half of these patients will develop atrial fibrillation. Based on our Phase 2 data, we believe Gencaro has the potential to help address this substantial unmet medical need.  We look forward to further evaluating Gencaro in the planned Phase 3 clinical trial, PRECISION-AF, which we plan to initiate in the first quarter of 2020."

    Pipeline Update

    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 July 2019, the U.S. Food and Drug Administration (FDA) agreed to amend ARCA's Special Protocol Assessment (SPA) agreement for the Phase 3 PRECISION-AF clinical trial to expand the target trial population to include heart failure patients with left ventricular injection fractions (LVEF) > 40% and < 55%.  Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in the first quarter of 2020.

    • In September 2019, Gencaro AF clinical data from the GENETIC-AF Phase 2B trial was presented at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting.  The data indicate Gencaro response appears to 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.

    AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for HF and peripheral arterial disease (PAD).

    • Chemistry, manufacturing and controls (CMC) activities continued in the third quarter.

    • Subject to securing additional financing, Investigational New Drug (IND)-enabling non-clinical studies are anticipated to begin in the first quarter of 2020, and an IND submission is anticipated in the second half of 2020.

    Third Quarter 2019 Summary Financial Results

    Cash and cash equivalents were $9.6 million as of September 30, 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 third quarter of 2020.

    Research and development (R&D) expenses for the three months ended September 30, 2019 were $0.3 million compared to $0.7 million for the corresponding period of 2018.  The decrease in R&D expenses was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2018.  The Company does not anticipate having any material clinical trial expense in 2019, consequently R&D expense in 2019 is expected to be lower than in 2018.

    General and administrative (G&A) expenses were relatively unchanged at $0.9 million for both the three months ended September 30, 2019 and 2018.  The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support its ongoing operations.

    Total operating expenses for the three months ended September 30, 2019 were $1.2 million compared to $1.7 million for the corresponding period of 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 in 2018.

    Net loss was $1.2 million, or $0.76 per share, for the third quarter of 2019 compared to $1.6 million, or $2.06 per share, for the third quarter of 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 Gencaro development program has been granted Fast Track designation by FDA.  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, 2018, 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)
                                                                                                                     

      September 30, 2019 December 31, 2018
    Cash and cash equivalents $9,645 $6,608
    Working capital $8,754 $5,984
    Total assets $9,949 $6,825
    Total stockholders' equity $8,799 $6,032
         


    ARCA BIOPHARMA, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (unaudited)

      Three Months Ended     Nine Months Ended  
      September 30,     September 30,  
      2019     2018     2019     2018  
         
      (in thousands, except share and per share amounts)  
    Costs and expenses:                              
    Research and development $ 347     $ 740     $ 1,449     $ 3,614  
    General and administrative   900       922       3,087       2,977  
    Total costs and expenses   1,247       1,662       4,536       6,591  
    Loss from operations   (1,247 )     (1,662 )     (4,536 )     (6,591 )
                                   
    Interest and other income   50       40       136       124  
    Interest expense   (1 )     (2 )     (7 )     (8 )
    Loss before income taxes   (1,198 )     (1,624 )     (4,407 )     (6,475 )
    Income tax benefit   42       31       151       31  
    Net loss $ (1,156 )   $ (1,593 )   $ (4,256 )   $ (6,444 )
                                   
    Change in unrealized loss on marketable securities                     2  
    Comprehensive loss $ (1,156 )   $ (1,593 )   $ (4,256 )   $ (6,442 )
                                   
    Net loss per share:                              
    Basic and diluted $ (0.76 )   $ (2.06 )   $ (3.46 )   $ (8.39 )
    Weighted average shares outstanding:                              
    Basic and diluted   1,521,259       773,545       1,229,289       767,989  
                                   

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

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  7. WESTMINSTER, Colo., Sept. 12, 2019 (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 Dr. Michael Bristow, President and Chief Executive Officer of ARCA biopharma, will present at the "Excellence in Translational Science Symposium" at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting being held September 13-16 in Philadelphia. The presentation will focus on the development of novel anti-adrenergic therapeutics for atrial fibrillation and heart failure.

    Excellence in Translational Science Symposium: Friday, September 13; 12:00-5:00 p.m. ET

    Session: "Translating…

    WESTMINSTER, Colo., Sept. 12, 2019 (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 Dr. Michael Bristow, President and Chief Executive Officer of ARCA biopharma, will present at the "Excellence in Translational Science Symposium" at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting being held September 13-16 in Philadelphia. The presentation will focus on the development of novel anti-adrenergic therapeutics for atrial fibrillation and heart failure.

    Excellence in Translational Science Symposium: Friday, September 13; 12:00-5:00 p.m. ET

    Session: "Translating Compounds into Clinical Development – Signaling Pathways" Presentation Title: "Novel Anti-Adrenergic Therapeutics".

    Session speakers include: Douglas Sawyer MD, John Burnett MD, Michael Bristow MD, and David Lefer PhD.

    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 Gencaro development program has been granted Fast Track designation by FDA. ARCA is also developing AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for heart failure and peripheral arterial disease (PAD). 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 first 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, 2018, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.

    Investor & Media Contact:
    Derek Cole
    720.940.2163

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  8. WESTMINSTER, Colo., Sept. 11, 2019 (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 Gencaro atrial fibrillation clinical data from the GENETIC-AF Phase 2B trial have been selected for presentation at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting being held September 13-16 in Philadelphia.  William T. Abraham, MD, FACP, FACC, College of Medicine Distinguished Professor, Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, will present the data.

    "Bucindolol response appears to be greater in heart failure patients…

    WESTMINSTER, Colo., Sept. 11, 2019 (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 Gencaro atrial fibrillation clinical data from the GENETIC-AF Phase 2B trial have been selected for presentation at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting being held September 13-16 in Philadelphia.  William T. Abraham, MD, FACP, FACC, College of Medicine Distinguished Professor, Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, will present the data.

    "Bucindolol response appears to be greater in heart failure patients with less severe left ventricular dysfunction, a patient population with few therapeutic options for AF prevention or heart failure," commented Dr. Abraham, "These data provide additional support for pharmacogenetic guided therapy with bucindolol for the prevention of atrial fibrillation in patients with heart failure We look forward to confirming these important findings in the upcoming Phase 3 PRECISION‑AF trial."

    Abstract Number and Title: 1641, "Pharmacogenetic Guided Beta-blocker Therapy with Bucindolol for the Prevention of Atrial Fibrillation/flutter in Heart Failure: Relationship of Left Ventricular Ejection Fraction to Treatment Effect"

    Opening Reception and Poster Reception I: Friday, September 13, 2019; 6:00 – 7:30 p.m. ET
    Poster Reception II: Saturday, September 14, 2019; 6:00 – 7:30p.m. ET

    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 Gencaro development program has been granted Fast Track designation by FDA. ARCA is also developing AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for heart failure and peripheral arterial disease (PAD). 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 first 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, 2018, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.

    Investor & Media Contact:
    Derek Cole
    720.940.2163

     

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