ABIO ARCA biopharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Gencaro
Chronic Heart Failure
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Phase 3
Phase 3
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Phase 3 trial to be initiated in 2021 subject to financing.
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AB201
COVID-19
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Phase 2
Phase 2
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Phase 2 trial to be initiated 4Q 2020.
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Latest News
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- ARCA anticipates filing an IND for AB201 for COVID-19 in September 2020 and initiating Phase 2B clinical testing as early as Q4 2020
WESTMINSTER, CO / ACCESSWIRE / August 12, 2020 / ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced it has completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19. With this feedback, ARCA anticipates submitting its IND application in September 2020 in preparation for initiating a Phase 2B clinical trial as early as the fourth quarter of this year.
A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA's guidance for clinical trials for the sponsor's new drug candidate. The FDA has created CTAP as a special emergency program for possible coronavirus therapies which is designed to use every available method to move new treatments to patients as quickly as possible, while evaluating safety and effectiveness.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "Receiving the FDA's guidance is an important step in developing and executing our clinical development program for AB201. With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19. AB201's differentiated mechanism of action may also allow for use in combination with other COVID-19 therapeutics and provide a potential treatment for those patients who cannot take vaccines or for whom vaccines are not effective."
About AB201 (rNAPc2)
AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19. AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. AB201 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including as an anti-thrombotic agent in the setting of acute myocardial infarction (MI), where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19 and other RNA virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted atrial fibrillation (AF) prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19 or any other RNA virus associated disease, future treatment options for patients with COVID-19, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]SOURCE: ARCA biopharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/601279/ARCA-Biopharma-Announces-Completion-of-FDA-Pre-IND-Consultation-Under-Coronavirus-Treatment-Acceleration-Program-for-AB201-as-a-Potential-Treatment-for-Severe-COVID-19
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- AB201 being developed as a potential treatment for COVID-19 and other RNA virus associated diseases
- ARCA anticipates filing an IND for AB201 in Q3 2020 and initiating Phase 2 clinical testing in Q4 2020
WESTMINSTER, Colo., Aug. 05, 2020 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the second quarter of 2020 and provided a corporate update.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "As the SARS-CoV-2 pandemic has progressed, serious complications relating to over-activation of the coagulation and immune systems have increasingly been observed in patients hospitalized with severe disease. Based on previous and emerging work on mechanisms of virus pathogenesis, we believe this evidence implicates involvement of tissue factor pathways, of which AB201 is a potent and long-acting inhibitor, providing a strong rationale to evaluate AB201 as a potential therapeutic for COVID-19. With this rationale along with significant safety data from prior human clinical trials, we look forward to initiating Phase 2 clinical development later this year."
Pipeline Update
AB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
- Initiated planning for development of AB201 as a potential treatment for patients with severe COVID-19.
- Clinical collaboration established with the Colorado Prevention Center, the University of Colorado's Academic Research Organization.
- The Company anticipates filing an Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19 with the U.S. Food and Drug Administration (FDA) in third quarter of this year.
- Pending FDA concurrence, ARCA estimates initiating Phase 2 clinical testing of AB201 in the fourth quarter of this year.
GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).
- Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. ARCA estimates that enrollment in PRECISION-AF could start in 2021; however, this estimate is subject to change due to the uncertainties of the ongoing COVID-19 pandemic and the availability of patients for non-COVID-19 related clinical trials. Any future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.
- The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients.
Second Quarter 2020 Summary Financial Results
Cash and cash equivalents were $11.0 million as of June 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents, together with net proceeds of $24.1 million raised in July from sales of its common stock, will be sufficient to fund its operations, at its current cost structure, plus projected costs for the AB201 clinical development program, through the end of the fourth quarter of 2021.Research and development (R&D) expense for the three months ended June 30, 2020 was $0.4 million compared to $0.4 million for the corresponding period of 2019, a decrease of approximately $68,000. R&D expense for the six months ended June 30, 2020 was $0.7 million compared to $1.1 million for the corresponding period of 2019, a decrease of approximately $0.4 million.
R&D personnel costs decreased approximately $0.1 million for the three months ended June 30, 2020, as compared to the corresponding period of 2019. R&D personnel costs decreased approximately $0.3 million for the six months ended June 30, 2020, as compared to the corresponding period of 2019. The remaining decrease is primarily a result of lower outside services and consulting costs.
General and administrative (G&A) expenses were $0.9 million and $1.1 million for the three months ended June 30, 2020 and 2019, respectively. The $0.1 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020. G&A expenses were $1.9 million and $2.2 million for the six months ended June 30, 2020 and 2019, respectively. The $0.3 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020.
Total operating expenses for the three months ended June 30, 2020 were $1.3 million compared to $1.5 million for the corresponding period in 2019. Total operating expenses for the six months ended June 30, 2020 were $2.7 million compared to $3.3 million for the corresponding period in 2019.
Net loss for the three months ended June 30, 2020 was $1.3 million, or $0.73 per basic and diluted share, compared to $1.4 million, or $1.14 per basic and diluted share, for the corresponding period in 2019. Net loss for the six months ended June 30, 2020 was $2.6 million, or $1.55 per basic and diluted share, compared to $3.1 million, or $2.87 per basic and diluted share, for the corresponding period in 2019.
The Company will need to raise additional capital, and/or complete a partnership or other possible strategic transaction, to fund future operations and develop AB201 and Gencaro or any other product candidates.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of ARCA's financial resources to support its operations through the end of the fourth quarter of 2021, potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, AB201's potential to treat COVID-19 or CAC, future treatment options for patients with COVID-19, or AF, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
ARCA BIOPHARMA, INC. BALANCE SHEET DATA (in thousands) (unaudited) June 30, 2020 December 31, 2019 Cash and cash equivalents $11,041 $8,363 Working capital $10,245 $7,554 Total assets $11,633 $8,536 Total stockholders' equity $10,305 $7,610 ARCA BIOPHARMA, INC. STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 (in thousands, except share and per share amounts) Costs and expenses: Research and development $ 372 $ 440 $ 737 $ 1,102 General and administrative 938 1,068 1,913 2,187 Total costs and expenses 1,310 1,508 2,650 3,289 Loss from operations (1,310 ) (1,508 ) (2,650 ) (3,289 ) Interest and other income 2 48 26 86 Interest expense (3 ) (3 ) (7 ) (6 ) Loss before income taxes (1,311 ) (1,463 ) (2,631 ) (3,209 ) Income tax benefit 9 27 9 109 Net loss $ (1,302 ) $ (1,436 ) $ (2,622 ) $ (3,100 ) Net loss per share: Basic and diluted $ (0.73 ) $ (1.14 ) $ (1.55 ) $ (2.87 ) Weighted average shares outstanding: Basic and diluted 1,793,900 1,263,768 1,693,985 1,080,885 
- AB201 being developed as a potential treatment for COVID-19 and other RNA virus associated diseases
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- Integrin A5 may be a new target for intervening in the cell infectious process
- Findings may lead to the development of precision therapeutic approaches to prevent SARS-CoV-2-cell entry while preserving the functional activity of ACE2
WESTMINSTER and AURORA, Colo., July 07, 2020 (GLOBE NEWSWIRE) -- The University of Colorado Anschutz Medical Campus and ARCA biopharma, Inc. (NASDAQ:ABIO) today announced that the paper entitled "Dynamic Regulation of SARS-CoV-2 Binding and Cell Entry Mechanisms in Remodeled Human Ventricular Myocardium" (Bristow MR, et al. https://doi.org/10.1016/j.jacbts.2020.06.007 was published in JACC: Basic to Translational Science (JBTS), a member of the Journal of the American College of Cardiology (JACC) family of journals. The paper provides new information on mechanisms involved in host cell binding and entry of the SARS-CoV-2 in the human heart. Investigators affiliated with the Bristow Laboratory at CU Anschutz Medical Campus, Cardiovascular Institute at the University of Colorado School of Medicine and ARCA biopharma determined how known and potential mechanisms responsible for COVID-19 infection in the intact heart are altered by prior heart muscle disease, and to what extent they are changed when damaged heart muscle improves through a process called reverse remodeling.
COVID-19 infection occurs when SARS-CoV-2 infects host cells by binding to receptor sites on cell surface membranes, then merging its viral membrane with host cell surface and intracellular membranes to facilitate internalization, and finally taking control over host cell RNA synthesis to replicate virus. When heart muscle is damaged, enlarges and weakens (a process termed "remodeling"), various myocardial cell constituents change their expression, including some that may participate in CoV-2 host cell binding and internalization. Foremost of those that have been previously identified is angiotensin converting enzyme-2 (ACE2), which based on work performed in the Bristow Laboratory, was first reported to be increased ("upregulated") at the protein and enzyme activity levels in explanted remodeled human hearts in 2003 (Zisman LS et al, Circulation 108:1709-12). Shortly thereafter, ACE2 was reported by others to be the receptor for SARS-CoV binding to host cells (Li W et al, Nature 426:450-4, 2003), and recently, ACE2 was identified as the receptor for SARS-CoV-2 cell binding (Hoffman et al, Cell 181:1-10, 2020). However, it was not known if ACE2 upregulation in remodeled explanted hearts was due to heart failure medications that can affect ACE2 expression or was only found in late stage heart failure and remodeling present in hearts obtained from cardiac transplant recipients. Moreover, mechanisms or constituents other than ACE2 that could participate in CoV2 host cell binding and internalization had not been previously investigated in remodeled human left ventricles (LVs).
In the JBTS reported study, 46 patients with mild-moderate heart failure and remodeling from nonischemic dilated cardiomyopathy and nonfailing, non-remodeled controls had RNA extracted from interventricular septum endomyocardial biopsies. From the extracted RNA, genes known to participate in CoV-2 host cell binding and cell entry or who were possible candidates for these processes had mRNA expression measured by two independent platforms. The 46 dilated cardiomyopathy patients were then treated for 12 months with beta-blocking agents to produce reverse remodeling, measured by improvement in left ventricular ejection fraction (LVEF), which occurred in 65 percent of the patients. Gene expression in patients with reverse remodeling was then compared to the 35 percent of patients whose LVEFs/remodeling did not change. Importantly, the dilated cardiomyopathy patients were being treated with inhibitors of the renin-angiotensin system prior to baseline measurements and throughout the study, eliminating the possibility that such therapy could have affected ACE2 expression.
At baseline, ACE2 myocardial mRNA expression was markedly upregulated in the dilated cardiomyopathy patients, by nearly two-fold. With reverse remodeling, ACE2 gene expression normalized, and was unchanged in those with no remodeling improvement. The behavior of ACE2 as well as the degree of baseline expression was highly correlated with that of the natriuretic peptide B gene, whose processed protein product BNP is considered the gold standard biomarker for heart failure and remodeling. These data indicate that the increased expression of ACE2 begins much earlier than in end stage heart failure, that it is directly related to the remodeling process and not to the administration of heart failure therapy, and that by virtue of its potential for increasing the amount of virus internalization into host cells including cardiac myocytes, it is a likely a contributor to the increased adverse outcomes of patients with underlying heart disease who have COVID-19 infection.
ACE2 is a "protective" or counter-regulatory enzyme that catalyzes the conversion of angiotensin-II to angiotensin-(1-7), a peptide that mitigates abnormal cell growth, blood vessel constriction and thrombosis (blood clots) mediated by angiotensin-II, which is known to be elevated in COVID-19 patients with clinically significant disease. However, the increased expression of ACE2 in the remodeled heart means that its beneficial effects may also predispose to increased cell infection by CoV-2. Based on these observations, the paper concludes that an optimal ACE2 targeted treatment for COVID-19 would consist of an agent that blocks CoV-2 binding without diminishing or perhaps even increasing ACE2 enzyme activity.
The study also examined the expression of multiple proteases that facilitate cell entry through virus-host cell membrane fusion, and found that none previously shown to be involved in CoV or CoV-2 membrane coalescence were altered, and that 11 additional expressed proteases were not upregulated in remodeling. In contrast, the study found that integrin A5 subunit (ITGA5), which binds to ACE2 and can mediate host cell internalization of viruses, was upregulated in remodeled heart and normalized its expression on reverse remodeling similar to ACE2. The study concluded that the ITGA5 protein gene product or the a5b1 heterodimer is a candidate for facilitating CoV-2 binding and entry in myocardial cells. Thus, in remodeled, intact human hearts one (ACE2) and possibly two (ITGA5) myocardial cell components are altered to favor enhanced infection by CoV-2, which may explain COVID-19 increased adverse outcomes in patients with underlying heart muscle disorders.
Michael Bristow MD, PhD, Director of Pharmacogenomics at the Cardiovascular Institute, and ARCA's President and Chief Executive Officer commented, "These findings add to the evidence that increased ACE2 expression contributes to the increased adverse outcomes risk observed for COVID-19 in patients with underlying myocardial disease. In addition, we detected a possible additional route of CoV-2 binding and host cell internalization that is upregulated in remodeled human ventricles, involving integrin A5. This information sets the stage for the development of diagnostic approaches to and therapeutic manipulation of ACE2 for preventing CoV-2-host cell internalization while preserving functional activity, and may identify a new target for intervening in the cell infectious process."
About the University of Colorado School of Medicine Cardiovascular Institute
The University of Colorado School of Medicine Cardiovascular Institute (CU-CVI) was co-founded in 1998 by Dr. Bristow and Leslie Leinwand, PhD with the mission of integrating cardiovascular research, treatment, and discovery through a collaboration of the Anschutz Medical and Boulder campuses. The CU-CVI is now Co-directed by Dr. Leinwand and Peter Buttrick, MD, Division Head of Cardiology and Senior Associate Dean for Academic Affairs at the CU School of Medicine, who is a co-author on the JBTS paper.The scientific goals of the Institute are to understand the genetic basis and specific molecular mechanisms responsible for heart muscle disease and heart failure and to produce new diagnostic techniques and treatments for patients. By integrating the effort of those committed to curing heart muscle disease and heart failure, the collaborative nature of the Institute encourages the sharing of findings and data, which ultimately translate into improved treatments and therapies of patients. www.ucdenver.edu/academics/colleges/medicalschool/institutes/CardiovascularInstitute.
In work sponsored by the American Heart Association the research team that worked on the current study is now investigating the effects of CoV-2 on host cell entry and internalization mechanisms in the intact heart of patients with COVID-19 cardiac involvement.
About the University of Colorado Anschutz Medical Campus
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, together we deliver life-changing treatments, patient care, professional training, and conduct world-renowned research. For more information, visit www.cuanschutz.edu.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted and other precision therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 (rNAPc2) as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of ARCA's financial resources to support its operations through the end of the third quarter of 2020, potential future development plans for AB201 and Gencaro, the expected features and characteristics of AB201 or Gencaro, including the potential for AB201 to treat COVID-19/CAC, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of AB201 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.CU Anschutz and School of Medicine Media Contacts:
Julia Milzer (CU Anschutz), E: [email protected] C: 303.725.0733
Chanthy Na (School of Medicine), E: [email protected]ARCA biopharma 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
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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] -
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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]