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ARCA biopharma (ABIO)

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.

ABIO stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

2 Aug 22
12 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 46.44M 46.44M 46.44M 46.44M 46.44M 46.44M
Cash burn (monthly) 874K 1.4M 1.07M 1.41M 874K 1.39M
Cash used (since last report) 1.26M 2.01M 1.54M 2.02M 1.26M 2M
Cash remaining 45.18M 44.43M 44.9M 44.41M 45.18M 44.43M
Runway (months of cash) 51.7 31.8 41.8 31.6 51.7 31.9

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
1 Jul 22 Funicular Funds Common Stock Other Acquire J No No 0 2,580,452 0 2,580,452
1 Jul 22 Funicular Funds Common Stock Other Dispose J Yes No 0 2,580,452 0 2,580,452
1 Jul 22 Funicular Funds Put Option Common Stock Other Acquire J No No 2.5 14,500 36.25K 1,450,000
1 Jul 22 Funicular Funds Put Option Common Stock Other Dispose J Yes No 2.5 14,500 36.25K 0
15 Jun 22 Jacob Ma-Weaver Stock Option Common Stock Grant Acquire A No No 2.27 12,000 27.24K 12,000
25 May 22 Funicular Fund Common Stock Buy Acquire P No No 2.3244 64,851 150.74K 2,580,452
24 May 22 Funicular Fund Common Stock Buy Acquire P No No 2.2851 18,110 41.38K 2,515,601
23 May 22 Funicular Fund Common Stock Buy Acquire P No No 2.295 2,301 5.28K 2,497,491
26.6% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 24 20 +20.0%
Opened positions 7 4 +75.0%
Closed positions 3 3
Increased positions 5 4 +25.0%
Reduced positions 6 5 +20.0%
13F shares Current Prev Q Change
Total value 8.52M 2.41M +254.2%
Total shares 3.84M 1.12M +242.8%
Total puts 56.1K 65.4K -14.2%
Total calls 95.3K 78.2K +21.9%
Total put/call ratio 0.6 0.8 -29.6%
Largest owners Shares Value Change
Funicular Fund 1.94M $4.47M NEW
BML Investment Partners 761.86K $1.45M NEW
Vanguard 459.56K $1.06M +13.1%
BLK Blackrock 269.88K $620K -0.7%
Geode Capital Management 96.33K $221K +1.0%
STT State Street 69.94K $161K 0.0%
Citadel Advisors 53.74K $124K +34.5%
Dimensional Fund Advisors 42.5K $98K 0.0%
Tekla Capital Management 32.46K $75K 0.0%
VIRT Virtu Financial 23.87K $55K NEW
Largest transactions Shares Bought/sold Change
Funicular Fund 1.94M +1.94M NEW
BML Investment Partners 761.86K +761.86K NEW
Acadian Asset Management 0 -57.82K EXIT
Vanguard 459.56K +53.28K +13.1%
Susquehanna International 0 -32.07K EXIT
VIRT Virtu Financial 23.87K +23.87K NEW
Bridgeway Capital Management 21.95K +21.95K NEW
Marquette Asset Management 17.32K +17.32K NEW
Millennium Management 11.42K -17.02K -59.8%
Citadel Advisors 53.74K +13.77K +34.5%

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 trials, any potential enrollment milestones or potential regulatory approvals could be delayed or otherwise adversely affected.
  • We may not achieve our projected development goals in the time frames we announce and expect.
  • 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.
  • We have received an SPA agreement from the FDA relating to our planned Phase 3 program for Gencaro. This SPA agreement does not guarantee approval of Gencaro or any other particular outcome from regulatory review.
  • 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.
  • 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 for Gencaro. 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.
  • If a third-party diagnostics provider responsible for the genetic test associated with Gencaro 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.
  • 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.
  • 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.
  • Future sales of our products may suffer if they are not accepted in the marketplace by physicians, patients and the medical community.
  • 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.
  • 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.
  • 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 any 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, 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, and the ability of ARCA’s financial resources to support its operations at the current levels through at least the end of fiscal year 2023, 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, 2021, 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.

Content analysis

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New words: Ladenburg, restructuring, Thalmann, unchanged, workforce
Removed: arrange, diagnosed, duration, financed, invoking, issuable, model, warrant