PART I Item 1. Business ARCA biopharma is a clinical-stage company developing Gencaro for cardiovascular diseases and evaluating strategic options for its pipeline assets - ARCA is a clinical-stage biopharmaceutical company applying a precision medicine approach to develop targeted therapies for cardiovascular diseases7174 - The lead product candidate is Gencaro™ (bucindolol hydrochloride) for the treatment of atrial fibrillation (AF) in patients with chronic heart failure (HF) who have a specific genotype associated with heightened efficacy89175176 - In April 2022, the Board of Directors established a Special Committee to evaluate strategic options, including mergers, asset sales, or other alternatives to maximize stockholder value713175185 - rNAPc2 (AB201) is a protein therapeutic in clinical development for COVID-19, but the company currently does not plan additional clinical development without a commercial or government partner1112180182 - The company's strategy includes advancing Gencaro's Phase 3 development, partnering rNAPc2, and building a cardiovascular pipeline, all dependent on securing additional funding or strategic transactions13 Research and Development Expenses (2021-2022) | Year Ended December 31 | R&D Expense (in millions) | |:-----------------------|:--------------------------| | 2022 | $4.7 | | 2021 | $13.8 | - Research and development expenses decreased by $9.1 million in 2022 compared to 2021, primarily due to the completion of enrollment in the rNAPc2 (AB201) Phase 2b clinical trial in Q4 2021 and a workforce reduction30188189 Item 1A. Risk Factors The company faces significant risks from strategic transactions, product development, capital needs, Nasdaq listing, and intellectual property - There is no guarantee that any strategic transaction will increase stockholder value, and such transactions may involve risks like equity dilution, substantial debt, or business disruptions565758 - Failure to successfully develop, obtain FDA approval for, and commercialize Gencaro or rNAPc2 in a timely manner could lead to the discontinuation of business operations6061 - The company expects a Phase 3 PRECISION-AF clinical trial for Gencaro will require substantially more capital, and there is no guarantee of securing such additional financing on acceptable terms6768201 - Maintaining Nasdaq Capital Market listing requirements is crucial; failure to do so could result in delisting, adversely affecting the ability to raise funds and stock price77 - The company's financial statements were prepared assuming it will continue as a going concern, but management concluded that substantial doubt exists due to the need for additional capital and uncertainties in securing funding78228229 - The company relies on third parties for clinical trials, diagnostic services, and manufacturing, which reduces direct control over timing, conduct, and expenses, posing risks to development and commercialization82838790 - The company's intellectual property rights may not prevent competitors from developing similar products, and patent litigation is a substantial risk in the biopharmaceutical industry149152 Item 1B. Unresolved Staff Comments This item indicates that there are no unresolved staff comments from the SEC Item 2. Properties The company's headquarters in Westminster, Colorado, consists of approximately 8,200 square feet of office space, with portions leased and subleased under varying terms - Headquarters: Approximately 8,200 square feet of office space in Westminster, Colorado166 - Lease terms: 5,200 sq ft leased until March 2024 (option to renew for 36 months); 3,000 sq ft subleased until October 2023 (no renewal option)166 Item 3. Legal Proceedings The company has no material legal proceedings to report Item 4. Mine Safety Disclosures The company is not subject to mine safety disclosures PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities ARCA biopharma's common stock trades on The Nasdaq Capital Market under 'ABIO', with no dividends paid or anticipated, as earnings are retained for growth - Common stock trades on The Nasdaq Capital Market under the symbol 'ABIO'168 Common Stock Information (as of Feb 22, 2023) | Metric | Value | |:-----------------------|:-------------| | Stockholders of Record | ~18 | | Last Sale Price | $2.12/share | - The company has not paid and does not anticipate paying cash dividends, retaining earnings for future growth170160 Item 6. Reserved This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations ARCA biopharma, a clinical-stage company, is developing Gencaro and evaluating strategic options for rNAPc2, with 2022 financial results showing decreased R&D expenses and a need for additional financing for future trials - ARCA is a clinical-stage biopharmaceutical company focused on precision medicine for cardiovascular diseases, with Gencaro as its lead product candidate for atrial fibrillation in heart failure patients174175176 - The company is evaluating strategic options and seeking partners for rNAPc2 (AB201) for COVID-19, as further development requires additional financing175180182185 Key Financial Results (Years Ended Dec 31, in thousands) | Metric | 2022 | 2021 | |:-----------------------------|:------------|:------------| | Research and Development | $4,749 | $13,832 | | General and Administrative | $5,847 | $5,503 | | Interest and Other Income | $675 | $13 | | Other Loss | ($5) | — | | Net Loss | ($9,926) | ($19,322) | - R&D expenses decreased by $9.1 million in 2022, primarily due to the completion of the rNAPc2 Phase 2b clinical trial and a 67% workforce reduction188189 - G&A expenses increased by $0.3 million in 2022, mainly due to higher professional fees, consulting costs, and one-time termination benefits191 - Cash and cash equivalents as of December 31, 2022, were $42.4 million, a decrease of $10.9 million from 2021, expected to fund operations through mid-2024, but additional financing is needed for a Phase 3 Gencaro trial194201 Overview ARCA biopharma is a clinical-stage company developing Gencaro for cardiovascular diseases, evaluating strategic options, and seeking partners for rNAPc2, with current cash projected to fund operations through mid-2024, but additional financing is required for a Phase
ARCA biopharma(ABIO) - 2022 Q4 - Annual Report