ABIO ARCA biopharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Gencaro
Chronic Heart Failure
|
Phase 3
Phase 3
|
Phase 3 trial to be initiated 4Q 2020 subject to financing.
|
Latest News
-
View Full Article Hide Full Article
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 [email protected], 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
[email protected]
-
View Full Article Hide Full Article
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 [email protected], 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
[email protected] -
ARCA biopharma Announces AB201 Development Program for Treatment of COVID-19 Associated CoagulopathyView Full Article Hide Full Article
- 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
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
-
View Full Article Hide Full Article
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
[email protected] -
View Full Article Hide Full Article
- 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
[email protected]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
- U.S. FDA Special Protocol Assessment agreement for PRECISION-AF, a single pivotal Phase 3 clinical trial of genetically targeted Gencaro