ARCA biopharma, Inc. Stock Price, News & Analysis

ARCA biopharma, Inc. (Nasdaq: ABIO) announced a Phase 2b clinical trial for AB201, targeting COVID-19, expected to begin in Q4 2020. The FDA has approved the IND application for AB201, which combines anticoagulant, anti-inflammatory, and antiviral properties. Financially, ARCA reported cash of $51.1 million as of September 30, 2020, allowing operation funding through 2022. However, the net loss increased to $2.0 million for Q3 2020, with a per-share loss of $0.33. The development of Gencaro is on hold due to COVID-19, dependent on future financing.

ARCA biopharma (Nasdaq: ABIO) received FDA approval for its IND application of AB201 as a potential treatment for COVID-19 patients. The company plans to initiate a Phase 2b/3 clinical trial, known as ASPEN-COVID-19, enrolling approximately 100 patients in Q4 2020, with topline results expected in Q2 2021. This trial will assess the efficacy of AB201, a tissue factor inhibitor, in improving clinical outcomes, focusing on changes in the D-dimer biomarker. If successful, a Phase 3 trial will follow, seeking to evaluate broader impacts on patient recovery.

ARCA biopharma (Nasdaq: ABIO) has announced key management promotions, elevating Debra Marshall, MD, FACC to Chief Medical Officer and Sharon Perry, RAC to Vice President of Regulatory Affairs and Quality. Dr. Marshall, with over 20 years in cardiovascular drug development, previously held senior roles at Amgen and Genentech. Ms. Perry, with more than 30 years in the industry, has extensive experience in regulatory and quality compliance. The company focuses on genetically targeted therapies for cardiovascular diseases, with ongoing developments for AB201 and Gencaro, both showing promise in their respective areas.

ARCA biopharma, Inc. (NASDAQ:ABIO) has successfully completed a pre-IND consultation with the FDA regarding AB201 as a potential COVID-19 treatment. The FDA's feedback set the stage for ARCA to file an IND application in September 2020 and initiate Phase 2B trials in Q4 2020. AB201, which has previously shown efficacy in over 700 patients, targets tissue factor to combat inflammatory responses in viral infections. The company aims to offer therapeutic options for patients unable to benefit from vaccines.

ARCA biopharma (NASDAQ:ABIO) has completed a pre-Investigational New Drug (IND) consultation with the FDA regarding its therapeutic candidate AB201 for severe COVID-19. The company is poised to file an IND application by September 2020 and initiate a Phase 2B clinical trial as early as Q4 2020. The FDA's guidance affirms ARCA's clinical development strategy, with prior data showing AB201's potential effectiveness in treating RNA virus-associated diseases, including COVID-19, based on its mechanism of action as an anti-inflammatory and anticoagulant agent.

ARCA biopharma (ABIO) reported Q2 2020 financial results and updates on its clinical programs. The company is developing AB201 for COVID-19, anticipating an IND filing in Q3 2020 and Phase 2 initiation in Q4 2020. As of June 30, 2020, cash and equivalents stood at $11 million. R&D expenses were stable at $0.4 million, while G&A expenses decreased to $0.9 million. The net loss narrowed to $1.3 million, or $0.73 per share. The company may seek additional capital to support its clinical programs, including AB201 and Gencaro, due to ongoing financial needs.

ARCA biopharma, Inc. (Nasdaq: ABIO) has closed a registered direct offering, selling 348,000 shares at $9.00 each and pre-funded warrants at $8.999 per warrant, yielding approximately $6.1 million in gross proceeds. This is a reduction from the previously announced $9.4 million. Funds will primarily support the clinical trial of AB201 and general corporate purposes. The shares were issued under an SEC-approved shelf registration statement. JonesTrading acted as the exclusive placement agent for this offering.

ARCA biopharma, Inc. (Nasdaq: ABIO) announced a registered direct offering of 348,000 shares at $9.00 each and pre-funded warrants for 694,222 shares at $8.999 each, totaling approximately $9.4 million in gross proceeds. The offering is expected to close on June 3, 2020, subject to customary conditions. Proceeds will fund the clinical trial of AB201 and general corporate purposes. The shares are offered under a shelf registration statement effective since May 20, 2020. JonesTrading Institutional Services LLC is the exclusive placement agent.

ARCA biopharma, Inc. (NASDAQ: ABIO) announced a Special Protocol Assessment agreement from the U.S. FDA for its Phase 3 clinical trial, PRECISION-AF, targeting genetically selected heart failure patients. The trial aims to evaluate Gencaro in preventing atrial fibrillation, addressing a significant unmet medical need. The study is set to initiate in Q4 2020 if financing is secured. Financially, ARCA reported Q1 2020 results, with a net loss of $1.3 million and cash reserves of $6.7 million.