ABIO ARCA biopharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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rNAPc2 (AB201) - (ASPEN)
COVID-19
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Phase 2b
Phase 2b
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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 initiation delayed due to COVID-19.
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Latest News
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WESTMINSTER, Colo., Nov. 09, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that Tom Keuer, Chief Operating Officer, will present at the Q4 Virtual Investor Summit being held November 16-17, 2021.
ARCA is scheduled to present on Wednesday, November 17, 2021 at 4:15 PM ET. Management will be available for one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay at: https://us06web.zoom.us/webinar/register/WN_f2a6CQ14RLSGAC5STDNKrg.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2b clinical testing. ARCA is also developing Gencaro™ (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]
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- On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for COVID-19
- DSMC interim analysis of safety and efficacy data from ASPEN-COVID-19 completed with recommendation to continue trial to completion with no modifications
- Topline data anticipated in first quarter of 2022
- Cash and cash equivalents of $58.3 million at September 30, 2021, sufficient to fund operations through 2022
WESTMINSTER, Colo., Nov. 02, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported third quarter 2021 financial results and provided a corporate update.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "The continuing pandemic and the emergence of multiple variants that have led to a resurgence of infections and hospitalizations, highlight the need for additional safe and effective therapeutic tools to treat patients that develop severe COVID-19. With rNAPc2's combination of anticoagulant, anti-inflammatory and potential antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. Our international Phase 2b clinical trial is nearing completion and we look forward to sharing its results in the first quarter."
Pipeline Update
rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.
- On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, enrolling patients at investigative sites in United States, Argentina and Brazil.
- Clinical trial Data and Safety Monitoring Committee (DSMC) completed a pre-specified interim analysis and, based on the DSMC's review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the clinical trial design.
- Phase 2b topline data anticipated in first quarter of 2022.
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).
- ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Third Quarter 2021 Summary Financial Results
Cash and cash equivalents were $58.3 million as of September 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.
Research and development (R&D) expenses were $3.4 million for the quarter ended September 30, 2021, compared to $1.1 million for the corresponding period in 2020. The $2.3 million increase in R&D expenses in the third quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020 as the Company continues the rNAPc2 Phase 2b clinical trial.
General and administrative (G&A) expenses were $1.3 million for the quarter ended September 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.4 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the last quarter of 2021 are expected to be consistent with the third quarter of 2021 as the Company maintains administrative activities to support its ongoing operations.
Total operating expenses for the quarter ended September 30, 2021 were $4.7 million compared to $2.0 million for the third quarter of 2020.
Net loss for the quarter ended September 30, 2021 was $4.7 million, or $0.33 per basic and diluted share, compared to $2.0 million, or $0.33 per basic and diluted share for the third quarter of 2020.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for COVID-19 and potentially other viral diseases. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for rNAPc2 and Gencaro, the expected features and characteristics of rNAPc2 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, rNAPc2's potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, the potential for Gencaro to be the first genetically targeted AF prevention treatment and the ability of ARCA's financial resources to support its operations through 2022. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected](Tables follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)September 30, 2021 December 31, 2020 Cash and cash equivalents $58,313 $49,071 Working capital $56,484 $46,469 Total assets $60,192 $50,429 Total stockholders' equity $56,600 $46,521 ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 (in thousands, except share and per share amounts) Costs and expenses: Research and development $ 3,438 $ 1,051 $ 9,891 $ 1,788 General and administrative 1,278 939 3,764 2,852 Total costs and expenses 4,716 1,990 13,655 4,640 Loss from operations (4,716 ) (1,990 ) (13,655 ) (4,640 ) Interest and other income 4 1 9 27 Interest expense — (2 ) — (9 ) Loss before income taxes (4,712 ) (1,991 ) (13,646 ) (4,622 ) Income tax benefit — — — 9 Net loss $ (4,712 ) $ (1,991 ) $ (13,646 ) $ (4,613 ) Net loss per share: Basic and diluted $ (0.33 ) $ (0.33 ) $ (0.99 ) $ (1.46 ) Weighted average shares outstanding: Basic and diluted 14,410,143 6,044,315 13,733,259 3,154,680 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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- Enrollment completion anticipated by year end 2021
- Topline data anticipated in first quarter of 2022
WESTMINSTER, Colo., Oct. 28, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today provided an update on the ASPEN-COVID-19 Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with severe COVID-19. The Company announced that the Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis and, based on the DSMC's review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the trial design. The rNAPc2 development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The Company now anticipates completion of target enrollment of 160 patients by year end 2021 and reporting of topline data in the first quarter of 2022.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "Clearing the final interim analysis with no recommended changes in the Phase 2b clinical trial design is an important step in a clinical trial and in the development of rNAPc2 for prevention of COVID-19-associated coagulopathy. We are focused on finishing the clinical trial, which we estimate will complete enrollment by year end. We look forward to sharing the top-line trial results in the first quarter of next year and reviewing the findings with the FDA."
About ASPEN-COVID-19
ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in approximately 160 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is associated with adverse clinical outcomes. Heparin is an anti-coagulant commonly given to any patient hospitalized in the United States for COVID-19. Other objectives of Phase 2b are to assess safety, determine the optimal dose regimen of rNAPc2 for a potential Phase 3 clinical trial and evaluate multiple additional clinical endpoints as detailed in the ASPEN-COVID-19 listing on clinicaltrials.gov.The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.
About rNAPc2 (AB201)
rNAPc2 is a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases. rNAPc2 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPc2 a combination of anti-coagulant, anti-inflammatory and potential anti-viral properties, and therefore may be effective in addressing the impact of viral infections from multiple pathways. rNAPc2 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that rNAPc2 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating rNAPc2 as a treatment for COVID-19 and other virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for rNAPc2, the expected features and characteristics of rNAPc2, the anticipated development timeline for rNAPc2, rNAPc2's potential to treat COVID-19, or any other RNA virus associated disease, whether rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19 and the potential future treatment options and needs for patients with COVID-19. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, 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
- Enrollment completion anticipated by year end 2021
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- First international patient enrolled in Brazil
- Trial approximately 75% enrolled
- rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients
- Topline trial data anticipated in the fourth quarter of 2021
WESTMINSTER, Colo., Sept. 16, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the first international patient has been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19. The patient was enrolled in Brazil. ARCA also plans to enroll patients from Argentina and is currently enrolling patients at multiple sites in the United States. The international Phase 2b trial is approximately 75% enrolled as of this date. The Company currently anticipates topline trial data in the fourth quarter of 2021.
"The expansion of ASPEN-COVID-19 to trial sites in South America and the enrollment of the first patient in Brazil add further momentum to rNAPc2's clinical development focused on addressing the critical need for safe, efficacious treatments for hospitalized COVID-19 patients," said Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. "With its combination of anticoagulant, anti-inflammatory and potential antiviral effects, rNAPc2 may favorably impact clinical recovery of patients hospitalized with COVID-19, and thus has the potential to be a uniquely beneficial therapy for these patients, and possibly for other virus associated diseases as well. We look forward to working with the excellent investigators at our trial sites in Argentina and Brazil and, assuming enrollment continues to go well, to sharing the results of this important study in the fourth quarter."
ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in approximately 160 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. Other objectives of Phase 2b are to assess safety and determine the optimal dose regimen of rNAPc2 for Phase 3. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.
The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.
About rNAPc2 (AB201)
rNAPc2 is a small recombinant protein being developed as a potential treatment for RNA virus- associated diseases, initially focusing on COVID-19. rNAPc2 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPc2 a combination of anti-coagulant, anti-inflammatory and potential anti-viral properties, and therefore may be effective in addressing the impact of viral infections from multiple pathways. rNAPc2 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that rNAPc2 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating rNAPc2 as a treatment for COVID-19 and other virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing Gencaro™ (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for rNAPc2, the expected features and characteristics of rNAPc2, the anticipated development timeline for rNAPc2, rNAPc2's potential to treat COVID-19, or any other RNA virus associated disease, whether rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19 Associated Coagulopathy and the potential future treatment options and needs for patients with COVID-19. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, 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
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WESTMINSTER, Colo., Aug. 16, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that Jeff Dekker, Chief Financial Officer, will present at the Q3 Virtual Investor Summit being held August 17-18, 2021.
ARCA is scheduled to present on Wednesday, August 18, 2021 at 1:15 PM ET. Management will be available for one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay at: https://zoom.us/webinar/register/WN_ERJdeAK7QtKvTBMwC5gpcg .
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2b clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]