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Akouos (AKUS)

Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

Company profile

AKUS stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

15 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) 76.03M 76.03M 76.03M 76.03M 76.03M 76.03M
Cash burn (monthly) (no burn) 4.81M 7M 7.99M 5.66M 6.06M
Cash used (since last report) n/a 14.72M 21.42M 24.46M 17.31M 18.55M
Cash remaining n/a 61.31M 54.61M 51.57M 58.71M 57.48M
Runway (months of cash) n/a 12.7 7.8 6.5 10.4 9.5

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
23 Jun 22 Ramasastry Saira Stock Option Common Stock Grant Acquire A No No 4.21 16,000 67.36K 16,000
23 Jun 22 Parmar Kush Stock Option Common Stock Grant Acquire A No No 4.21 16,000 67.36K 16,000
23 Jun 22 Sato Vicki L Stock Option Common Stock Grant Acquire A No No 4.21 16,000 67.36K 16,000
23 Jun 22 Christopher M Smith Stock Option Common Stock Grant Acquire A No No 4.21 16,000 67.36K 16,000
23 Jun 22 Tzianabos Arthur Stock Option Common Stock Grant Acquire A No No 4.21 16,000 67.36K 16,000
13F holders Current Prev Q Change
Total holders 69 75 -8.0%
Opened positions 16 7 +128.6%
Closed positions 22 9 +144.4%
Increased positions 9 17 -47.1%
Reduced positions 20 20
13F shares Current Prev Q Change
Total value 345.92M 336.82M +2.7%
Total shares 46.9M 43.78M +7.1%
Total puts 0 0
Total calls 309.8K 263K +17.8%
Total put/call ratio
Largest owners Shares Value Change
FMR 4.59M $21.55M -0.0%
NEA Management 4.3M $20.16M 0.0%
New Enterprise Associates 16 4.29M $96.62M 0.0%
5AM Venture Management 4.14M $19.4M 0.0%
FHI Federated Hermes 3.38M $15.86M +28.2%
5AM Ventures V 3.15M $60.92M 0.0%
VR Adviser 2.67M $12.51M NEW
Venrock Healthcare Capital Partners II 2.39M $8.13M NEW
EcoR1 Capital 1.98M $9.27M 0.0%
Pivotal bioVenture Partners Fund I 1.79M $15.25M 0.0%
Largest transactions Shares Bought/sold Change
VR Adviser 2.67M +2.67M NEW
Venrock Healthcare Capital Partners II 2.39M +2.39M NEW
Ra Capital Management 0 -2.28M EXIT
BLK Blackrock 782.71K -1.19M -60.4%
Marshall Wace 820.93K +820.93K NEW
FHI Federated Hermes 3.38M +743.21K +28.2%
Millennium Management 915.85K +478.21K +109.3%
Laurion Capital Management 456K +456K NEW
STT State Street 78.37K -332.97K -80.9%
MS Morgan Stanley 59.07K -210.27K -78.1%

Financial report summary

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Risks
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses during all fiscal periods since our inception, have no products approved for commercial sale, and we expect to incur substantial losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We are heavily dependent on the success of our product candidates, AK-OTOF and AK-antiVEGF.
  • We will need substantial additional capital to execute our business plan. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • The COVID-19 pandemic may affect our ability to initiate and complete nonclinical studies, delay our ongoing manufacturing activities, delay the initiation of our planned clinical trial or future clinical trials, disrupt regulatory activities, or have other adverse effects on our business and operations. In addition, this pandemic has adversely impacted economies worldwide and could impact the financial markets, both of which could result in adverse effects on our business and operations.
  • Risks Related to the Development of our Product Candidates
  • We are very early in our development efforts. Our business is dependent on our ability to advance AK-OTOF, AK-antiVEGF, and our other current and future product candidates through nonclinical studies and clinical trials, obtain marketing approval, and ultimately commercialize them. If we are unable to complete clinical development, obtain regulatory approval for, or commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We may encounter substantial delays in commencement or completion of our clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, which could prevent us from commercializing our current and future product candidates on a timely basis, if at all.
  • If we experience delays or difficulties in participant enrollment for clinical trials, our research and development efforts and the receipt of necessary regulatory approvals could be significantly delayed or prevented.
  • Genetic medicine is an emerging field of drug development that poses many risks. We have only limited prior experience in genetic medicine research and no prior experience in genetic medicine clinical development. Our lack of experience and the limited patient populations for our genetic medicine programs may limit our ability to be successful or may delay our development efforts.
  • Our AAV genetic medicine product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all.
  • Our product candidates or the process for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
  • The outcome of nonclinical studies and earlier-stage clinical trials may not be predictive of future results or the success of later-stage clinical trials.
  • Interim top-line and preliminary results from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures, which could result in material changes in the final data.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of our product candidates.
  • Risks Related to Manufacturing
  • The manufacture of genetic medicine products is complex and difficult and is subject to a number of scientific and technical risks, some of which are common to the manufacture of drugs and biologics and others of which are unique to the manufacture of gene therapies. We could experience manufacturing problems that result in delays in our development or commercialization of product candidates.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We depend on third-party suppliers for materials used in the manufacture of our product candidates, and the loss of these third-party suppliers or their inability to supply us with adequate materials could harm our business.
  • Risks Related to Our Dependence on Third Parties
  • We and our third-party manufacturers are subject to significant regulation with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • We expect to rely on third parties to conduct, supervise and monitor our clinical trials, and if these third parties perform in an unsatisfactory manner, it may harm our business.
  • Risks Related to Commercialization
  • We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
  • Even if any product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, patient advocacy groups, third-party payors, and others in the medical community necessary for commercial success.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing, and distribution agreements with third parties, we may not be successful in commercializing our product candidates if and when they are approved.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain adequate intellectual property protection and regulatory exclusivity for our products and technology, or if the scope of the intellectual property protection and regulatory exclusivity obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to ultimately successfully commercialize our products and technology may be adversely affected.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we do not obtain patent term extension for our product candidates, our business may be harmed.
  • 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.
  • We may not be successful in obtaining necessary rights to our product candidates through acquisitions and in-licenses.
  • If we fail to comply with our obligations under our existing license agreements, or under any future intellectual property licenses, or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged. We may not be able to protect our trade secrets in court.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
  • Intellectual property litigation or other proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be subject to claims asserting 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.
  • Changes in patent law in the United States or worldwide could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • Even if we complete the necessary nonclinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us from obtaining approvals for the commercialization of any product candidates we develop. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, product candidates we develop, and our ability to generate revenue will be materially impaired.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent any product candidates we develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • Regulatory requirements governing genetic medicine products are periodically updated and may continue to change in the future.
  • We have received a rare pediatric disease designation for AK-OTOF and may seek a rare pediatric disease designation for one or more of our other product candidates. However, a BLA for one or more of our product candidates may not meet the eligibility criteria for a priority review voucher upon approval.
  • We have received orphan drug designations for AK-OTOF but we may not be able to obtain orphan drug exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent FDA or EMA from approving other competing products.
  • AK-OTOF and our other product candidates will be a biologic-device combination involving a novel delivery approach, which may result in additional regulatory and other risks.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
  • Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our medicines, when and if any of them are approved.
  • Our relationships with healthcare providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
  • Recently enacted and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • The commercial success of our products depends on the availability and sufficiency of third-party payor coverage and reimbursement.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.
  • Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Risks Related to Employee Matters, Managing Growth, and General Business Operations
  • Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and potentially implement sales, marketing, and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our operations might be affected by the occurrence of a natural disaster or other catastrophic event.
  • Our internal computer systems, or those used by our CROs, third-party manufacturers, or other contractors or consultants, may fail or suffer security breaches.
  • Risks Related to Ownership of Our Common Stock
  • An active trading market for our common stock may not continue to develop or be sustained.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
  • Our executive officers, directors, and their affiliates, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval.
  • We have broad discretion in the use of our cash, cash equivalents and marketable securities and may not use them effectively.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
  • Future sales of shares of our common stock, including by us, employees, and significant stockholders, could negatively affect our stock price.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted and will continue to be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • Our certificate of incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers, and employees.
Management Discussion
  • Research and development expenses were $14.3 million for the three months ended June 30, 2022, compared to $17.1 million for the three months ended June 30, 2021. The decrease of $6.0 million in direct costs related to our AK OTOF program was due to timing of manufacturing activities for existing third-party manufacturers (including Catalent Maryland, Inc.), in addition to the substantial completion of activities with one of our third-party manufacturers, Lonza Houston, Inc. The increase of $2.1 million in direct costs related to our AK-antiVEGF program was primarily due to increased manufacturing costs. The decrease of $0.5 million in research and development expenses for our other early-stage programs was primarily due to decreased spend related to the research of these programs.

Content analysis

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Positive
Negative
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Constraining
Legalese
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Readability
H.S. junior Avg
New words: AK, beneficiary, capping, Catalent, length, Maryland, omicron, outpace, penalizing, pilot, prioritized, SNHL, variant
Removed: Arabia, favored, historically, nationwide, Saudi

Patents

Utility
Aav-mediated Delivery of Therapeutic Antibodies to the Inner Ear
25 Aug 22
Provided herein are methods that include introducing into an inner ear of a mammal a therapeutically effective amount of an adeno-associated virus (AAV) vector that includes a nucleotide sequence encoding (a) a polypeptide including an antibody heavy chain variable domain operably linked to a signal peptide and a polypeptide including an antibody light chain variable domain operably linked to a signal peptide; (b) a polypeptide including an antigen-binding antibody fragment operably linked to a signal peptide; or (c) a soluble vascular endothelial growth factor receptor operably linked to a signal peptide.
Utility
Compositions and Methods for Treating Non-age-associated Hearing Impairment In a Human Subject
10 Feb 22
Provided herein are compositions that include at least two different nucleic acid vectors, where each of the at least two different vectors includes a coding sequence that encodes a different portion of an otoferlin protein, and the use of these compositions to treat hearing loss in a subject.
Utility
a Method for Treating an Auditory Neuropathy Spectrum Disorder
6 Jan 22
The present invention provides a method for treating an auditory neuropathy spectrum disorder in a subject comprising transferring the gene of DFNB59 via an adeno-associated virus (AAV) vector to the subject.
Utility
Aav-mediated Delivery of Therapeutic Antibodies to the Inner Ear
25 Nov 21
Provided herein are methods that include introducing into an inner ear of a mammal a therapeutically effective amount of an adeno-associated virus (AAV) vector that includes a nucleotide sequence encoding (a) a polypeptide including an antibody heavy chain variable domain operably linked to a signal peptide and a polypeptide including an antibody light chain variable domain operably linked to a signal peptide; (b) a polypeptide including an antigen-binding antibody fragment operably linked to a signal peptide; or (c) a soluble vascular endothelial growth factor receptor operably linked to a signal peptide.
Utility
Compositions and Methods for Treating Non-age-associated Hearing Impairment In a Human Subject
25 Nov 21
Provided herein are compositions that include at least two different nucleic acid vectors, where each of the at least two different vectors includes a coding sequence that encodes a different portion of an otoferlin protein, and the use of these compositions to treat hearing loss in a subject.