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ABIO 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, GencaroTM(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.

Company profile

Ticker
ABIO
Exchange
CEO
Michael Bristow
Employees
Incorporated
Location
Fiscal year end
Former names
HYSEQ INC, NUVELO INC
SEC CIK
IRS number
363855489

ABIO stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 May 21
27 Jul 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
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Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 66.93M 66.93M 66.93M 66.93M 66.93M 66.93M
Cash burn (monthly) (positive/no burn) (positive/no burn) 1.37M 1.04M 1.74M 938.67K
Cash used (since last report) n/a n/a 5.31M 4.06M 6.77M 3.65M
Cash remaining n/a n/a 61.62M 62.88M 60.17M 63.29M
Runway (months of cash) n/a n/a 45.1 60.2 34.5 67.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
12 May 21 Robert E Conway Common Stock Buy Aquire P No No 3.1947 10,000 31.95K 50,000
5 May 21 Robert E Conway Common Stock Buy Aquire P No No 3.2345 10,000 32.35K 40,000
12 Jan 21 Daniel J Mitchell Stock Option Common Stock Grant Aquire A No No 4.31 12,000 51.72K 12,000
12 Jan 21 Robert E Conway Stock Option Common Stock Grant Aquire A No No 4.31 12,000 51.72K 12,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

6.1% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 17 20 -15.0%
Opened positions 4 10 -60.0%
Closed positions 7 5 +40.0%
Increased positions 6 4 +50.0%
Reduced positions 3 0 NEW
13F shares
Current Prev Q Change
Total value 3.2M 3.29M -2.9%
Total shares 876.82K 821.34K +6.8%
Total puts 33.7K 12.5K +169.6%
Total calls 54.6K 0 NEW
Total put/call ratio 0.6 Infinity NaN%
Largest owners
Shares Value Change
BLK Blackrock 287.26K $1.05M 0.0%
Vanguard 137.5K $502K +56.9%
Susquehanna International 106.6K $389K +230.6%
Gsa Capital Partners 93.24K $340K +102.3%
Geode Capital Management 79.15K $288K +141.7%
MS Morgan Stanley 40.74K $149K +952.5%
Tekla Capital Management 32.46K $118K 0.0%
Citadel Advisors 19.2K $70K NEW
NTRS Northern Trust 17.52K $64K -0.0%
PDT Partners 17.3K $63K NEW
Largest transactions
Shares Bought/sold Change
Renaissance Technologies 0 -205.5K EXIT
Susquehanna International 106.6K +74.36K +230.6%
Vanguard 137.5K +49.88K +56.9%
Gsa Capital Partners 93.24K +47.14K +102.3%
Geode Capital Management 79.15K +46.4K +141.7%
MS Morgan Stanley 40.74K +36.87K +952.5%
GS Goldman Sachs 0 -30.3K EXIT
Citadel Advisors 19.2K +19.2K NEW
PDT Partners 17.3K +17.3K NEW
Tower Research Capital 15.66K +15.66K NEW

Financial report summary

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Risks
  • If we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of rNAPc2 or Gencaro in a timely manner, we may not be able to continue our business operations.
  • If we encounter difficulties enrolling patients in our clinical trial of rNAPc2, any potential enrollment milestones or potential regulatory approvals could be delayed or otherwise adversely affected.
  • We expect the PRECISION-AF clinical trial will require substantially more capital to complete, and we cannot guarantee when or if we will be able to secure such additional financing.
  • We will need to raise substantial additional funds through public or private equity or debt transactions and/or complete one or more strategic transactions, to continue development of rNAPc2, Gencaro or any of our other product candidates. If we are unable to raise such financing or complete such a transaction, we may not be able to continue operations.
  • Our business could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 global pandemic, in regions where we or third parties on which we rely may have clinical trial sites or other business operations. We anticipate having clinical trial sites in countries that have been directly affected by COVID-19 and depend on third party manufacturing operations for various stages of our supply chain.
  • If we encounter difficulties enrolling patients in any future clinical trials, our future trials could be delayed or otherwise adversely affected.
  • We will rely on contract research organizations to conduct substantial portions of our clinical trials, including any future clinical trial of rNAPc2 or Gencaro, and as a result, we will be unable to directly control the timing, conduct and expense of all aspects of our clinical trials.
  • We expect to depend on existing and future collaborations with third parties for the development of some of our product candidates. If those collaborations are not successful, we may not be able to complete the development of these product candidates.
  • Any future clinical trial for Gencaro will require the use of a third-party diagnostic services provider to administer a genetic test needed to identify the patient receptor genotypes of clinical trial participants, and as a result, we will be unable to directly control the timing, conduct and expense of the genetic test.
  • We will need to establish a collaborative arrangement with a third-party diagnostics services provider to obtain marketing clearance or approval of the companion genetic test. There is no guarantee that the FDA will grant timely clearance or approval of the genetic test, if at all, and failure to obtain such timely clearance or approval would adversely affect our ability to market Gencaro.
  • Regulatory approval is required for the genetic test to be used in our Gencaro clinical trials and to support the commercialization of the test, if approved. Delays or failures in obtaining such regulatory approval, including any required validation analyses may prevent a third-party diagnostics provider from commercializing such genetic test and will adversely affect our business, operating results and prospects.
  • If a third-party diagnostics provider responsible for the genetic test or certain of its third-party suppliers fails to comply with ongoing FDA or other foreign regulatory authority requirements, or if there are unanticipated problems with the genetic test, these products could be subject to restrictions or withdrawal from use in a trial or from the market.
  • Future sales of Gencaro may suffer if its marketplace acceptance is negatively affected by the genetic test.
  • Unless we are able to generate sufficient product revenue, we will continue to incur losses from operations and will not achieve or maintain profitability. We are years away from commercializing a product and generating product revenue.
  • Our product candidates are subject to extensive regulation, which can be costly and time-consuming, and unsuccessful or delayed regulatory approvals could increase our future development costs or impair our future revenue.
  • If our product candidates receive regulatory approval, we would be subject to ongoing regulatory obligations and restrictions, which may result in significant expenses and limit our ability to develop and commercialize other potential products.
  • Reliance on third parties to commercialize rNAPc2, Gencaro or our other product candidates could negatively impact our business. If we are required to establish a direct sales force in the United States and are unable to do so, our business may be harmed.
  • We are dependent on our key personnel.
  • We have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market.
  • Transitioning from a clinical development stage company will require successful completion of a number of steps, many of which are outside of our control and, consequently, we can provide no assurance of our successful and timely transition from a clinical development stage company.
  • If approved by the FDA, rNAPc2 or Gencaro will be entering a competitive marketplace and may not succeed.
  • Future sales of our products may suffer if they are not accepted in the marketplace by physicians, patients and the medical community.
  • Health care reform measures could materially and adversely affect our business.
  • Our competitors may be better positioned in the marketplace and thereby may be more successful than us at developing, manufacturing and marketing approved products.
  • If we fail to identify and license or acquire other products or product candidates, then we may be unable to expand our business, and the acquisition or licensing of other products or product candidates may put a strain on our operations and will likely require us to seek additional financing.
  • We would be subject to applicable regulatory approval requirements of the foreign countries in which we market our products, which are costly and may prevent or delay us from marketing our products in those countries.
  • If our internal control over financial reporting is not considered effective, our business and stock price could be adversely affected.
  • Security breaches, cyber-attacks, or other disruptions or incidents could expose us to liability and affect our business and reputation.
  • If product liability lawsuits are successfully brought against us, then we will incur substantial liabilities and may be required to limit commercialization of rNAPc2, Gencaro or other product candidates.
  • Defending against claims relating to improper handling, storage or disposal of hazardous chemicals, radioactive or biological materials could be time consuming and expensive.
  • The loss of any rights to market key products would significantly impair our operating results.
  • Third parties may own or control patents or patent applications that we may be required to license to commercialize our product candidates or that could result in litigation that would be costly and time consuming.
  • Our intellectual property rights may not preclude competitors from developing competing products and our business may suffer.
  • If the manufacture, use or sale of our products infringe on the intellectual property rights of others, we could face costly litigation, which could cause us to pay substantial damages or licensing fees and limit our ability to sell some or all of our products.
  • Our stock price has been and is expected to be volatile.
  • Future sales or the possibility of future sales of our common stock may depress the market price of our common stock.
  • We do not expect to pay cash dividends, and accordingly, stockholders must rely on stock appreciation for any return on their investment.
  • We have implemented anti-takeover provisions that could discourage, prevent or delay a takeover, even if the acquisition would be beneficial to our stockholders.
Management Discussion
  • ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
  • This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the Private Securities Litigation Reform Act of 1995. Examples of these statements include, but are not limited to, statements regarding the following: potential future development plans for rNAPc2 (AB201) and Gencaro, including the potential for rNAPc2 to treat COVID-19, our ability to secure sufficient financing to support our anticipated clinical trials of rNAPc2 and Gencaro, the likelihood that any Phase 3 clinical trial results for Gencaro will satisfy the requirements of our Special Protocol Assessment agreement, the expected features and characteristics of Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro or AB171, Gencaro’s potential to treat atrial fibrillation, or AF, future vaccines and treatment options for patients with COVID-19, future treatment options for patients with AF, the potential for Gencaro to be the first genetically-targeted AF prevention treatment, statements regarding potential Phase 3 development plans for Gencaro, including the timing and results thereof, the expected features and characteristics of AB171 as a potential genetically-targeted treatment for peripheral arterial disease, or PAD, and for heart failure, or HF, the potential timeline for development of AB171, including any Investigational New Drug, or IND, application submission related thereto, and the ability of ARCA’s financial resources to support its operations through the end of fiscal year 2022, the sufficiency of our current capital to reach certain of our corporate objectives, our ability to obtain additional funding when needed or enter into a strategic or other transaction, including our ability to raise sufficient capital to fund any clinical trials for rNAPc2 and Gencaro and our other operations, the extent to which our issued and pending patents may protect our products and technology, the potential of such product candidates to lead to the development of safe or effective therapies, our ability to enter into collaborations, our ability to maintain listing of our common stock on a national exchange, our future operating expenses, our future losses, our future expenditures, and the sufficiency of our cash resources to maintain operations. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors discussed herein and elsewhere. These and other factors are identified and described in more detail in ARCA’s filings with the U.S. Securities and Exchange Commission, or the SEC, including without limitation our annual report on Form 10-K for the year ended December 31, 2019, and subsequent filings. Forward-looking statements may be identified by words including “will,” “plan,” “anticipate,” “believe,” “intend,” “estimates,” “expect,” “should,” “may,” “potential” and similar expressions. We disclaim any intent or obligation to update these forward-looking statements.
  • The terms “ARCA,” “the Company,” “we,” “us,” “our” and similar terms refer to ARCA biopharma, Inc.
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