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ABIO ARCA biopharma

ARCA biopharma, Inc. is a biopharmaceutical company, which develops genetically targeted therapies for heart failure and other cardiovascular diseases. The company engages in cardiovascular pathophysiology, molecular genetics and clinical development. Its product candidate, Gencaro is a pharmacologic beta-blocker and mild vasodilator, which is developed for the treatment of chronic heart failure and other indications. The company was founded by Michael R. Bristow and Christopher David Ozeroff in 1992 and is headquartered in Westminster, CO.

Company profile

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

ABIO stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

18 Mar 21
13 Apr 21
31 Dec 21
Quarter (USD)
Dec 20 Sep 20 Jun 20 Mar 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
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
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) 49.07M 49.07M 49.07M 49.07M 49.07M 49.07M
Cash burn (monthly) 674.67K (positive/no burn) 1.71M 814K 998.33K 643.75K
Cash used (since last report) 2.32M n/a 5.87M 2.8M 3.43M 2.21M
Cash remaining 46.75M n/a 43.2M 46.27M 45.64M 46.86M
Runway (months of cash) 69.3 n/a 25.3 56.8 45.7 72.8

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
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
12 Jan 21 Grais Linda S Stock Option Common Stock Grant Aquire A No No 4.31 12,000 51.72K 12,000
12 Jan 21 Anders D Hove Stock Option Common Stock Grant Aquire A No No 4.31 12,000 51.72K 12,000
12 Jan 21 Raymond L. Woosley 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.

5.7% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 20 15 +33.3%
Opened positions 10 8 +25.0%
Closed positions 5 1 +400.0%
Increased positions 4 3 +33.3%
Reduced positions 0 2 EXIT
13F shares
Current Prev Q Change
Total value 3.29M 1.82M +80.9%
Total shares 821.34K 412.19K +99.3%
Total puts 12.5K 0 NEW
Total calls 0 0
Total put/call ratio Infinity
Largest owners
Shares Value Change
BLK Blackrock 287.26K $1.15M 0.0%
Renaissance Technologies 205.5K $824K +436.4%
Vanguard 87.62K $351K +527.1%
Gsa Capital Partners 46.1K $185K NEW
Geode Capital Management 32.75K $131K NEW
Tekla Capital Management 32.46K $130K 0.0%
Susquehanna International 32.25K $129K NEW
GS Goldman Sachs 30.3K $121K NEW
VIRT Virtu Financial 24.64K $99K NEW
NTRS Northern Trust 17.53K $70K NEW
Largest transactions
Shares Bought/sold Change
Renaissance Technologies 205.5K +167.19K +436.4%
Vanguard 87.62K +73.65K +527.1%
Gsa Capital Partners 46.1K +46.1K NEW
Geode Capital Management 32.75K +32.75K NEW
Susquehanna International 32.25K +32.25K NEW
GS Goldman Sachs 30.3K +30.3K NEW
VIRT Virtu Financial 24.64K +24.64K NEW
Schonfeld Strategic Advisors 0 -18.2K EXIT
NTRS Northern Trust 17.53K +17.53K NEW
Jump Financial 12K +12K 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.
  • 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.
  • 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.
  • 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.
Management Discussion
  • Research and development, or R&D, expense is comprised primarily of personnel costs, clinical development, manufacturing process development, and regulatory activities and costs. Our R&D expense continues to be almost entirely generated by our activities relating to the development of Gencaro.
  • Our research and development expenses were $5.0 million for the year ended December 31, 2020 as compared to $1.8 million for 2019. The $3.2 million increase in research and development expenses in 2020 as compared to 2019 was primarily related to the initiation of our rNAPc2 (AB201) clinical trial in the second half of 2020.
  • Clinical expense increased approximately $1.7 million for the year ended December 31, 2020. The increase was related to the initiation of our rNAPc2 (AB201) clinical trial in the second half of 2020.  
Content analysis
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Legalese
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