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Avidity Biosciences (RNA)

Avidity Biosciences, Inc. is driven to change lives with a new class of therapies called Antibody Oligonucleotide Conjugates (AOCs) that are designed to overcome current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. Avidity's proprietary AOC platform combines the tissue selectivity of monoclonal antibodies and the precision of oligonucleotide therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. Avidity's lead product candidate, AOC 1001, is designed to treat myotonic dystrophy type 1, and its other muscle programs are focused on the treatment of Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy, Pompe disease and muscle atrophy. In addition to its muscle franchise, Avidity has research efforts focused on immune, cardiac and other cell types.

Company profile

Ticker
RNA
Exchange
CEO
Sarah Boyce
Employees
Incorporated
Location
Fiscal year end
Former names
Avidity Biosciences LLC, Avidity NanoMedicines LLC
SEC CIK
IRS number
461336960

RNA stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

9 Aug 22
1 Oct 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
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) 125.36M 125.36M 125.36M 125.36M 125.36M 125.36M
Cash burn (monthly) 4.8M 12.61M 15.43M 12.38M 11.85M 9.34M
Cash used (since last report) 14.69M 38.57M 47.21M 37.88M 36.24M 28.58M
Cash remaining 110.67M 86.78M 78.15M 87.48M 89.11M 96.78M
Runway (months of cash) 23.0 6.9 5.1 7.1 7.5 10.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
25 Aug 22 Boyce Sarah Common Stock Sell Dispose S No Yes 23.069 14,855 342.69K 0
25 Aug 22 Boyce Sarah Common Stock Option exercise Acquire M No Yes 1.24 14,855 18.42K 14,855
25 Aug 22 Boyce Sarah Stock Option Common Stock Option exercise Dispose M No Yes 1.24 14,855 18.42K 1,147,015
24 Aug 22 Boyce Sarah Common Stock Sell Dispose S No Yes 22.7971 35,045 798.92K 0
24 Aug 22 Boyce Sarah Common Stock Option exercise Acquire M No Yes 1.24 35,045 43.46K 35,045
24 Aug 22 Boyce Sarah Stock Option Common Stock Option exercise Dispose M No Yes 1.24 35,045 43.46K 1,161,870
16 Aug 22 Levin Arthur A Common Stock Sell Dispose S No Yes 22.0798 3,499 77.26K 1,330
16 Aug 22 Levin Arthur A Common Stock Option exercise Acquire M No Yes 1.24 3,499 4.34K 4,829
16 Aug 22 Levin Arthur A Stock Option Common Stock Option exercise Dispose M No Yes 1.24 3,499 4.34K 128,423
15 Aug 22 Boyce Sarah Common Stock Sell Dispose S No Yes 22.47 100 2.25K 0
93.5% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 113 102 +10.8%
Opened positions 18 14 +28.6%
Closed positions 7 19 -63.2%
Increased positions 44 34 +29.4%
Reduced positions 19 27 -29.6%
13F shares Current Prev Q Change
Total value 812.61M 1.14B -28.7%
Total shares 54.45M 53.37M +2.0%
Total puts 0 0
Total calls 230K 139.2K +65.2%
Total put/call ratio
Largest owners Shares Value Change
TROW T. Rowe Price 7.88M $114.54M -1.3%
RTW Investments 4.8M $69.67M 0.0%
BLK Blackrock 3.93M $57.13M +20.4%
FMR 3.81M $55.35M -0.0%
EcoR1 Capital 2.76M $40.1M 0.0%
FHI Federated Hermes 2.47M $35.95M 0.0%
Vanguard 2.42M $35.19M +5.4%
LLY Lilly(Eli) & Co 2.32M $55.13M 0.0%
Cowen And 2.26M $32.9M NEW
Ra Capital Management 2.17M $31.49M 0.0%
Largest transactions Shares Bought/sold Change
Aaron Wealth Advisors 215.75K -3.77M -94.6%
Cowen And 2.26M +2.26M NEW
BLK Blackrock 3.93M +665.65K +20.4%
Artisan Partners Limited Partnership 393.34K +393.34K NEW
STT State Street 1.84M +195.81K +11.9%
Balyasny Asset Management 186.7K +186.7K NEW
Dimensional Fund Advisors 510.27K +137.52K +36.9%
Walleye Capital 272.31K +132.67K +95.0%
Alliancebernstein 272.29K +130.28K +91.7%
Vanguard 2.42M +123.76K +5.4%

Financial report summary

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Risks
  • We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We are early in our development efforts and only have one product candidate in clinical development. All of our other development programs are in the preclinical or discovery stage. If we are unable to successfully develop, obtain regulatory approval and ultimately commercialize product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Interim, topline and preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our approach to the discovery and development of product candidates based on our AOC platform is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our AOC platform obsolete.
  • Preclinical and clinical development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Our product candidates may not have favorable results in clinical trials, if any, or receive regulatory approval on a timely basis, if at all.
  • Any difficulties or delays in the commencement or completion, or termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
  • Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
  • As an organization, we have never completed any clinical trials or submitted a BLA for regulatory approval and may be unable to do so for any of our product candidates.
  • Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Receipt of breakthrough therapy designation or fast track designation by the FDA for one or more of our product candidates may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • We may conduct certain of our clinical trials for our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain regulatory approval for or commercialize our product candidates may be delayed.
  • We rely on third parties for the manufacture of our product candidates for preclinical and clinical development. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We are dependent on the Lilly Agreement for the discovery, development and commercialization of AOCs directed against certain targets in immunology and other select indications. Under certain circumstances, Lilly may unilaterally terminate the agreement for convenience, which could materially and adversely affect our business.
  • We may seek to enter into additional collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.
  • Even if we receive regulatory approval for any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
  • Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • The commercial success of our product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors and others in the medical community.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • We face significant competition, and if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected.
  • If the market opportunities for our products are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • We may encounter difficulties in managing our growth and expanding our operations successfully.
  • We are subject to various federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and may affect the prices we may set.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
  • We and any of our current and potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • The COVID-19 pandemic and other epidemic diseases could adversely impact our business, including our preclinical studies, planned clinical trials and financial condition.
  • Our business could be affected by litigation, government investigations and enforcement actions.
  • Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.
  • If we are unable to obtain and maintain patent protection for our therapeutic programs and other proprietary technologies we develop, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our therapeutic programs and other proprietary technologies we may develop may be adversely affected.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering our therapeutic programs and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • If we do not obtain patent term extension for our product candidate, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be successful in obtaining necessary rights to any product candidate we may develop through acquisitions and in-licenses.
  • We may be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Intellectual property rights do not necessarily address all potential threats.
  • We partially depend on intellectual property licensed from third parties, and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We, our collaborators and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs and our failure to comply with them could subject us to potentially significant fines or penalties and otherwise harm our business.
  • Our use of open source software could impose limitations on our ability to commercialize our product candidates.
  • The trading price of the shares of our common stock has been, and is likely to continue to be, highly volatile, and purchasers of our common stock could incur substantial losses.
  • An active, liquid and orderly market for our common stock may not be maintained.
  • Our executive officers, directors and principal stockholders, if they choose to act together, will continue to have the ability to significantly influence all matters submitted to stockholders for approval.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or current or potential future collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We could face criminal liability and other serious consequences for violations, which could harm our business.
  • Changes in tax laws may impact our future financial position and results of operations.
  • We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • We could be subject to securities class action litigation.
Management Discussion
  • ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
  • This quarterly report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategies and plans, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, the impact of COVID-19 on our business, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
  • We are a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates, or AOCs. Our proprietary AOC platform is designed to combine the specificity of monoclonal antibodies, or mAbs, with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics. We are initially focused on muscle diseases to demonstrate the capabilities of our AOCs, and we expect to have three muscle programs in clinical development by the end of 2022. Our lead product candidate, AOC 1001, is designed to treat myotonic dystrophy type 1, or DM1, a rare monogenic muscle disease. AOC 1001 is currently in clinical testing with the ongoing Phase 1/2 MARINA trial, a trial designed to evaluate the safety and tolerability of single and multiple ascending doses of AOC 1001 administered intravenously in adults with DM1. The Part A single dose cohort of MARINA is fully enrolled, and dosing is complete. In Part A, there were no serious adverse events observed and any adverse events were mild to moderate. We are continuing to enroll patients in the Part B multidose cohort. In the fourth quarter of 2022, we plan to conduct a preliminary assessment of safety, tolerability and key biomarkers in approximately half of the trial participants from the MARINA study. In July, we announced the initiation of the Phase 2 MARINA open-label extension study, or MARINA-OLE. The MARINA-OLE is a two-year study that will continue to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AOC 1001 in patients that previously enrolled in the Phase 1/2 MARINA trial. The U.S. Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, have granted Orphan Designation for AOC 1001. The FDA has also granted Fast Track Designation to AOC 1001 for the treatment of DM1.  

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