Category: Press Release

Approximately Six Million Patients in Europe Estimated to Have Atrial Fibrillation

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Geographic Expansion of Trial Intended to Support European Regulatory Submissions, European Partnering Discussions and Enrollment

Westminster, CO, October 6, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to the development of genetically-targeted therapies for cardiovascular diseases, today announced the randomization of the first European patients in the GENETIC-AF Phase 2B/3 clinical trial.  GENETIC-AF, which has been enrolling patients in the United States and Canada, is evaluating Gencaro^TM as a potential treatment for atrial fibrillation (AF).  Last week, ARCA hosted a GENETIC-AF European Investigator Meeting which brought together European physicians and research coordinators for study-specific training and information sharing.  It is estimated that approximately six million patients in Europe have atrial fibrillation.

ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for AF in the GENETIC-AF Phase 2B/3 clinical trial.  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 therapy for the prevention of atrial fibrillation.

“We are excited to expand the GENETIC-AF trial to European investigative sites that have expressed interest in participating in the on-going trial,” said Michael R. Bristow, President and Chief Executive Officer.  “We expect that the additional investigative sites in certain European countries will support the latter part of Phase 2B, and potentially the Phase 3 stage, of the trial.  We believe inclusion of European investigative sites may also support potential European regulatory submissions and on-going business development activity.”

Based on the current enrollment rate, the Company expects to randomize at least 150 patients into the trial by the end of 2016. The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct an interim efficacy, safety and futility analysis of data from at least 150 patients with evaluable data. The Company expects the outcome of this interim analysis in the second quarter of 2017.

About ARCA biopharma

 ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation.  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 prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information, please visit www.arcabio.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities, the potential for any European regulatory submissions for Gencaro, the potential outcome of the GENETIC-AF Phase 2B interim analysis, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings.  The Company disclaims any intent or obligation to update these forward-looking statements.

 Investor & Media Contact:

Derek Cole

720.940.2163

derek.cole@arcabio.com

###

Westminster, CO, October 4, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it will present a corporate overview at the Dawson James Securities Second Annual Growth Stock Conference.

Date:                                         Thursday, October 20, 2016

Time:                                         1:15 p.m. (Eastern Time)

Presenter:                               Thomas Keuer, Chief Operating Officer

Webcast/Presentation:    The live webcast and accompanying slides will be available at http://wsw.com/webcast/dawson2/abio and https://arcabio.com/investors/investor-presentations/ , respectively.

Replay Information:          A replay is expected to be available approximately two hours after the presentation on October 20, 2016, and will remain available for 90 days.  The replay can be accessed at http://wsw.com/webcast/dawson2/abio.

About ARCA biopharma

 ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation.  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 prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information, please visit www.arcabio.com.

 Safe Harbor Statement

This press release and the anticipated presentation contain “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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities, the potential outcome of the GENETIC-AF Phase 2B interim analysis, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings.  The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:

Derek Cole

720.940.2163

derek.cole@arcabiopharma.com

###

Outcome of GENETIC-AF Clinical Trial Interim Efficacy Analysis Anticipated

in the Second Quarter of 2017

GENETIC-AF Evaluating Gencaro as Potentially First Genetically-Targeted

Treatment for Atrial Fibrillation

Westminster, CO, August 9, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended June 30, 2016, and provided a business update.

“We believe that our precision medicine approach to drug development, tailoring medical treatment to the genetic characteristics of patient subpopulations, can enable more effective therapies, improve patient outcomes and reduce healthcare costs,” commented Dr. Michael Bristow, ARCA’s President and CEO.  “Our on-going GENETIC-AF Phase 2B/3 clinical trial is evaluating Gencaro^TM as potentially the first genetically-targeted treatment for atrial fibrillation.  We believe enrollment is on track for having a sufficient number of patients by the end of this year for the DSMB Phase 2B interim efficacy analysis, the outcome of which we expect in the second quarter of 2017.  With our experienced team, strong balance sheet, supportive collaborations with Medtronic and LabCorp, and high quality investors, we feel ARCA is well positioned as a late stage cardiovascular company dedicated to serving patients with these chronic diseases.”

Second Quarter 2016 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $31.4 million as of June 30, 2016, compared to $38.8 million as of December 31, 2015.  The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through at least the end of 2017.  ARCA had approximately 9.1 million outstanding shares of common stock as of June 30, 2016.

Research and development (R&D) expense for the three months ended June 30, 2016 was $2.9 million compared to $1.7 million for the corresponding period of 2015, an increase of approximately $1.2 million.  R&D expense for the six months ended June 30, 2016 was $5.5 million compared to $3.5 million for the corresponding period of 2015, an increase of approximately $2.1 million.  The increase in R&D expense in the three and six month periods ended June 30, 2016 is due, primarily, to the increased clinical expense of the GENETIC-AF clinical trial.  The Company expects R&D expense in 2016 to be higher than 2015 as it activates new clinical sites and enrolls additional patients in the GENETIC-AF clinical trial.

General and administrative (G&A) expense for the three months ended June 30, 2016 was $1.0 million compared to $1.0 million for the corresponding period in 2015.  G&A expense was $2.1 million for the six months ended June 30, 2016 as compared to $2.0 million for the corresponding period in 2015, an increase of $93,000.  The increase in G&A expense is due, primarily, to increased franchise taxes.  The Company expects G&A expense in 2016 will be higher than in 2015 as the Company increases administrative activities to support the GENETIC-AF clinical trial.

Total operating expense for the three months ended June 30, 2016 was $3.9 million compared to $2.7 million for the corresponding period in 2015.  Total operating expense for the six months ended June 30, 2016 was $7.6 million compared to $5.5 million for the corresponding period in 2015.

Net loss was $3.9 million, or $0.43 per share, for the second quarter of 2016, compared to $2.7 million, or $0.69 per share, for the second quarter of 2015.  For the first half of 2016, net loss was $7.5 million, or $0.83 per share, compared to $5.5 million, or $1.57 per share, for the first half of 2015.

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in approximately 620 patients.  Eligible patients will have heart failure with reduced left ventricular ejection fraction (HFREF), a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that the Company believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/atrial flutter (AFL) or all-cause mortality.  The combined Phase 2B/Phase 3 trial is designed for 90 percent power at a p-value of less than 0.01 significance level to detect a 25 percent reduction in the primary endpoint for patients in the Gencaro arm compared to patients in the Toprol-XL arm.  The trial is currently enrolling patients in the United States and Canada.

The GENETIC-AF Data and Safety Monitoring Board (DSMB) will conduct a pre-specified interim analysis of study endpoints for efficacy, safety and futility to recommend whether or not the trial should proceed to Phase 3.  The DSMB will make its recommendation based on a predictive probability analysis of certain trial data after at least 150 patients have evaluable endpoint data.  An enrolled patient has evaluable endpoint data either when they experience their first endpoint event, or after they complete the 24-week follow up period.  The DSMB interim analysis will focus on analyses of the AF/AFL endpoints in the trial using both clinical-based intermittent monitoring and device-based continuous monitoring techniques.  Should the DSMB interim analysis indicate that the data are consistent with pre-trial statistical assumptions and the potential for achieving statistical significance for the Phase 3 endpoint, the DSMB may recommend that the study continue to Phase 3.  The DSMB may also recommend that the study be halted.  Based on the current enrollment rate, the Company expects to enroll at least 150 patients in the trial by the end of 2016.  The Company expects the outcome of the interim analysis in the second quarter of 2017.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development.  The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation.  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 prevention treatment.  ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information, please visit www.arcabiopharma.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings.  The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:

Derek Cole

720.940.2163

derek.cole@arcabiopharma.com

###

(Tables Follow)

ARCA BIOPHARMA, INC.

BALANCE SHEET DATA

(in thousands)

June 30, 2016           December 31, 2015

ARCA BIOPHARMA, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

Westminster, CO, May 11, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended March 31, 2016, and provided a business update.

“We are grateful for the continuing support of the physicians, clinical investigators and patients participating in the GENETIC-AF trial evaluating Gencaro^TM as potentially the first genetically-targeted treatment for atrial fibrillation,” commented Dr. Michael Bristow, ARCA’s President and CEO. “Last month we reached the halfway mark in enrollment to have a sufficient number of patients for the DSMB Phase 2B interim efficacy analysis, the outcome of which we expect in the second quarter of 2017. This analysis will provide the foundation for the decision whether or not to proceed to the Phase 3 portion of the GENETIC-AF trial. This is an important step for the Gencaro development program, which, if successful, may address an unmet medical need for new atrial fibrillation treatments that have fewer side effects than currently available therapies and are more effective in heart failure patients with reduced ejection fraction.”

First Quarter 2016 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $35.9 million as of March 31, 2016, compared to $38.8 million as of December 31, 2015. The Company believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through at least the end of 2017. ARCA had approximately 9.1 million outstanding shares of common stock as of March 31, 2016.

Research and development (R&D) expense for the three months ended March 31, 2016 was $2.6 million compared to $1.7 million for the corresponding period of 2015. The increase in R&D expense is due, primarily, to the increased clinical expense of our GENETIC-AF clinical trial. The Company expects R&D expense in 2016 to be higher than 2015 as it activates new clinical sites and enrolls additional patients in the GENETIC-AF clinical trial.

General and administrative (G&A) expense for the three months ended March 31, 2016 was $1.1 million compared to $1.0 million for the corresponding period in 2015.  The increase in G&A expense is due, primarily, to increased franchise taxes and outside services. The Company expects G&A expense in 2016 will be higher than in 2015 as the Company increases administrative activities to support the GENETIC-AF clinical trial.

Total operating expense for the three months ended March 31, 2016 was $3.7 million compared to $2.7 million for the corresponding period in 2015.

Net loss was $3.6 million, or $0.40 per share, for the first quarter of 2016, compared to $2.7 million, or $0.91 per share, for the first quarter of 2015.

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in approximately 620 patients. Eligible patients will have heart failure with reduced left ventricular ejection fraction (HFREF), a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that the Company believes responds most favorably to Gencaro.  The primary endpoint of the study is time to first event of symptomatic AF/atrial flutter (AFL) or all-cause mortality.  The combined Phase 2B/Phase 3 trial is designed for 90 percent power at a p-value of less than 0.01 significance level to detect a 25 percent reduction in the primary endpoint for patients in the Gencaro arm compared to patients in the Toprol-XL arm.  The trial is currently enrolling patients in the United States and Canada.

Based on the current enrollment rate, the Company expects to enroll at least 150 patients in the trial by the end of 2016. The GENETIC-AF Data and Safety Monitoring Board (DSMB) will conduct a pre-specified interim analysis of study endpoints for efficacy, safety and futility to recommend whether or not the trial should proceed to Phase 3. The DSMB will make its recommendation based on a predictive probability analysis of certain trial data after at least 150 patients have evaluable endpoint data. An enrolled patient has evaluable endpoint data either when they experience their first endpoint event, or after they complete the 24-week follow up period.  The DSMB interim analysis will focus on analyses of the AF/AFL endpoints in the trial using both clinical-based intermittent monitoring and device-based continuous monitoring techniques. Should the DSMB interim analysis indicate that the data are consistent with pre-trial statistical assumptions and the potential for achieving statistical significance for the Phase 3 endpoint, the DSMB may recommend that the study continue to Phase 3. The DSMB may also recommend that the study be halted.  The Company expects the outcome of the interim analysis in the second quarter of 2017.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. 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 prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information please visit www.arcabiopharma.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabiopharma.com

###

(Tables Follow)

ARCA BIOPHARMA, INC.
BALANCE SHEET DATA
(in thousands)

ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)

ARCA BIOPHARMA ANNOUNCES 75TH PATIENT ENROLLED IN GENETIC-AF
PHASE 2B/3 CLINICAL TRIAL

GENETIC-AF Evaluating Gencaro as Potentially First Genetically-Targeted Treatment for Atrial Fibrillation

Outcome of Interim Efficacy Analysis of Data from Approximately 150 Patients Anticipated in the Second Quarter of 2017

Westminster, CO, April 18, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the 75th patient has been enrolled in GENETIC-AF, a Phase 2B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation. Seventy-five patients enrolled is the midpoint of the minimum number of patients to be evaluated in the Phase 2B portion of the trial.
Based on the current enrollment rate, the Company expects to enroll at least 150 patients in the trial by the end of 2016. The Company expects the outcome of a pre-specified GENETIC-AF Data Safety Monitoring Board (DSMB) interim efficacy, safety and futility analysis of data from approximately 150 patients in the second quarter of 2017. Based on the outcome of the interim analysis, the DSMB will recommend whether or not the GENETIC-AF trial should proceed to the Phase 3 portion of the trial.

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in approximately 620 patients. Eligible patients will have heart failure with reduced left ventricular ejection fraction (HFREF), have a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and have the beta-1 389 arginine homozygous genotype that the Company believes responds most favorably to Gencaro. The primary endpoint of the study is time to first event of symptomatic AF/atrial flutter (AFL) or all-cause mortality. The combined Phase 2B/Phase 3 trial is designed for 90 percent power at a p-value of less than 0.01 significance level to detect a 25 percent reduction in the primary endpoint for patients in the Gencaro arm compared to patients in the Toprol-XL arm. The trial is currently enrolling patients in the United States and Canada.
The DSMB will conduct a pre-specified interim analysis of study endpoints for efficacy, safety and futility to recommend whether or not the trial should proceed to Phase 3. The DSMB will make its recommendation based on a predictive probability analysis of certain trial data after at
least 150 patients have evaluable endpoint data. An enrolled patient has evaluable endpoint data either when they experience their first endpoint event, or after they complete the 24-week follow up period. The DSMB interim analysis will focus on analyses of the AF/AFL endpoints in the trial using both clinical-based intermittent monitoring and device-based continuous monitoring techniques. Should the DSMB interim analysis indicate that the data are consistent with pre-trial statistical assumptions and the potential for achieving statistical significance for the Phase 3 endpoint, the DSMB may recommend that the study proceed to Phase 3. The DSMB may also halt the study for futility.

Atrial Fibrillation (AF)

Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2016 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the United States in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF increased by 23% among U.S. adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. 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 prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information please visit www.arcabiopharma.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities and related recommendations of the DSMB, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor and Media Contact:

Derek Cole
720.940.2163
derek.cole@arcabiopharma.com

GENETIC-AF Trial Evaluating Gencaro as a Potential Treatment for Atrial Fibrillation

Outcome of Interim Analysis of Phase 2B Efficacy Data Anticipated in the First Half of 2017

Westminster, CO, March 17, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the year ended December 31, 2015, and provided a business update.

“During 2015, we made good progress implementing our corporate strategy based on the belief that a precision medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each patient, can enable more effective therapies, improve patient outcomes and reduce healthcare costs,” commented Dr. Michael Bristow, ARCA’s President and CEO. “In the ongoing GENETIC-AF clinical trial, we are evaluating Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation. We believe we are on track to enroll sufficient patients by year-end for the DSMB to begin the pre-specified interim analysis with the outcome of the analysis anticipated in the first half of 2017.”

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in a combined total of approximately 620 patients. Eligible patients will have heart failure with reduced left ventricular ejection fraction (HFREF), have a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and have the beta-1 389 arginine homozygous genotype that the Company believes responds most favorably to Gencaro. The primary endpoint of the study is time to first event of symptomatic AF/atrial flutter (AFL) or all-cause mortality. The combined Phase 2B/Phase 3 trial is designed for 90 percent power at a p-value of less than 0.01 significance level to detect a 25 percent reduction in the primary endpoint for patients in the Gencaro arm compared to patients in the Toprol-XL arm. The trial is currently enrolling patients in the United States and Canada.

The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct a pre-specified interim analysis of study endpoints for efficacy, safety and futility to recommend whether the trial should proceed to Phase 3. The DSMB will make its recommendation based on a predictive probability analysis of certain trial data after at least 150 patients have evaluable endpoint data.

An enrolled patient has evaluable endpoint data either when they experience their first endpoint event, or after they complete the 24-week follow up period. The DSMB interim analysis will focus on analyses of the AF/AFL endpoints in the trial using both clinical-based intermittent monitoring and device-based continuous monitoring techniques. Should the DSMB interim analysis indicate that the data are consistent with pre-trial statistical assumptions and the potential for achieving statistical significance for the Phase 3 endpoint, the DSMB may recommend that the study proceed to Phase 3. The DSMB may also halt the study for futility. Based on the current enrollment rate, the Company expects to enroll at least 150 patients by the end of 2016. The Company expects the outcome of the DSMB interim analysis and recommendation regarding the potential transition to Phase 3 in the first half of 2017.

In February 2016, the GENETIC-AF protocol was amended to simplify certain operational aspects of the trial. The Company believes these modifications will facilitate site recruitment and enrollment in existing trial sites and potential sites in European countries, where the Company anticipates expanding the study to support both the later portion of Phase 2B, as well as the potential Phase 3 portion of the trial. The Company believes inclusion of European investigative sites may support potential European regulatory submissions and partnering discussions. The Company received no objection from the United States Food and Drug Administration (FDA) or Health Canada on this protocol amendment.

2015 Summary Financial Results

Cash and cash equivalents totaled $38.8 million as of December 31, 2015, compared to $15.4 million as of December 31, 2014. The Company believes that its current cash and cash equivalents will be sufficient to fund its operations, at its projected cost structure, through at least the end of 2017.

Research and development (R&D) expenses for the year ended December 31, 2015 totaled $7.1 million compared to $5.6 million for 2014. The $1.4 million increase in research and development expenses in 2015 as compared to 2014 was primarily due to increased clinical expenses for the GENETIC-AF clinical trial, increased R&D personnel costs and increased manufacturing process development costs. The Company expects R&D expenses in 2016 to be higher than 2015 as it activates new clinical sites and enrolls additional patients in the GENETIC-AF clinical trial.

General and administrative (G&A) expenses for the year ended December 31, 2015 were $4.4 million compared to $4.1 million in 2014. The approximately $325,000 increase in G&A expenses during 2015 was comprised primarily of increased personnel costs, franchise taxes and outside services related to the Company’s reverse stock split, partially offset by decreased non-cash, stock-based compensation expense, insurance and facility costs. The Company expects G&A expenses in 2016 to be consistent with those in 2015 as it maintains administrative activities to support the GENETIC-AF clinical trial.

Total operating expenses for the year ended December 31, 2015 were $11.5 million compared to $9.7 million in 2014. The increase in total operating expenses for 2015 was primarily due to the increase in R&D expense due to the increased clinical expense of the GENETIC-AF clinical trial.

Net loss was $11.4 million, or $1.82 per share, for 2015 compared to $9.7 million, or $3.31 per share, for 2014.

Atrial Fibrillation (AF)

Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2016 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the United States in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF increased by 23% among U.S. adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. 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 prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information please visit www.arcabiopharma.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2015, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:

Derek Cole
720.940.2163
derek.cole@arcabiopharma.com

###

(Tables Follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA(in thousands)

Enrollment for Phase 2B Interim Analysis of Efficacy Data Expected by Year-End 2016

Westminster, CO, January 12, 2016 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today provided an update on GENETIC-AF, the Company’s Phase 2B/3 clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a potential genetically-targeted treatment for the prevention of atrial fibrillation.

Fifty (50) patients have been enrolled in the GENETIC-AF trial. By the end of 2016, the Company anticipates enrollment of a sufficient number of patients for the Data Safety Monitoring Board (DSMB) interim analysis of Phase 2B efficacy data. Allowing for patients to complete their 24-week treatment period, the outcome of the DSMB interim analysis is expected in the first half of 2017.

“We are pleased with the clinical investigator support for the GENETIC-AF trial,” commented Dr. Michael Bristow, ARCA’s President and CEO. “Under the revised trial protocol, which broadened the target patient population, patient enrollment in the trial has increased steadily over the past several months. We expect the DSMB interim analysis of Phase 2B efficacy data, and the potential DSMB recommendation to convert the trial to a pivotal Phase 3 trial, to occur in the first half of 2017.”

There are currently 60 clinical trial sites in the United States and Canada, with 5 additional sites in start-up.

GENETIC-AF Trial Phase 2B Projected Timeline

 Revised protocol distributed to participating clinical trial sites March 2015

 GENETIC-AF Trial Investigators meeting and training May

 First trial sites operating under revised protocol May

 Approximately 65 clinical trial sites in U.S. & Canada Q4

 First 50 patients enrolled in trial January 2016

– Sufficient enrollment for Phase 2B DSMB Interim Efficacy Analysis YE 2016

– DSMB Interim Analysis Decision 1H 2017

The Company’s forecast of the time periods to achieve these milestones is a forward-looking statement and involves risks and uncertainties, and actual results are likely to vary as a result of a number of factors, including the factors discussed in “Risk Factors” in the Company’s periodic

SEC filings.

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in patients with heart failure and left ventricular systolic dysfunction (HFREF patients). The primary endpoint of GENETIC-AF is time to symptomatic AF/atrial flutter (AFL). ARCA is enrolling only HFREF patients with the genetic variant of the cardiac beta-1 adrenergic receptor, which the Company believes responds most favorably to Gencaro, the 389 arginine homozygous genotype (ADRB1 Arg389Arg). GENETIC-AF has an adaptive design, under which the Company initiated the trial as a Phase 2B trial. The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain data from the Phase 2B portion of the trial and recommend, based on a comparison to the pre-trial statistical assumptions, whether the trial should proceed to Phase 3. The Company expects GENETIC-AF will enroll a combined 620 patients over the Phase 2B and Phase 3 portions of the trial.

Atrial Fibrillation (AF)

Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2015 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the United States in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF increased by 23% among U.S. adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. 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 prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information please visit www.arcabiopharma.com.

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 timing for patient enrollment in the GENETIC-AF trial, potential timeline for GENETIC-AF trial activities, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial

fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2014, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:

Derek Cole

720.940.2163

derek.cole@arcabiopharma.com

###

Westminster, CO, November 5, 2015 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that its President and CEO, Michael R. Bristow, M.D., Ph.D., will give two invited presentations at the American Heart Association Scientific Sessions 2015 (http://my.americanheart.org/professional/Sessions/ScientificSessions/Scientific-Sessions_UCM_316900_SubHomePage.jsp)being held November 7-11, 2015 in Orlando, Florida.

The session “Emerging Pharmacological Approaches to Treat Heart Failure” will be held Sunday, November 8, 2015. Dr. Bristow will present “GPCR Polymorphisms driving heart failure therapeutic outcomes” at 8:00am ET.

The session “Phenotyping Heart Failure: Is this the Way Forward?” will be held Sunday, November 8, 2015. Dr. Bristow will present “Phenotyping Heart Failure Helpful New Tool?” at 9:00am ET.

ARCA is currently developing GencaroTM (bucindolol hydrochloride) as a potential treatment for atrial fibrillation in a genotype-defined heart failure population (heart failure patients with reduced left ventricular ejection fraction, HFREF). Earlier this year, the Gencaro development program was designated a Fast Track development program by the U.S. Food and Drug Administration. The Phase 2B/3 GENETIC-AF trial is currently recruiting patients at clinical trial sites in the
United States and Canada.

Atrial Fibrillation (AF)

Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2015 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the United States in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF
increased by 23% among U.S. adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM  (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. 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 prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial.  For more information please visit
www.arcabiopharma.com.

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 timeline for GENETIC-AF trial activities, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the 
potential for Gencaro to be the first genetically-targeted atrial fibrillation 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: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market 
exclusivity provided by the Company’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 SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2014, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:
Derek Cole 720.940.2163
derek.cole@arcabiopharma.com
###