Loading...
Docoh

Stoke Therapeutics (STOK)

Stoke Therapeutics, is a biotechnology company dedicated to addressing the underlying cause of severe diseases by up-regulating protein expression with RNA-based medicines. Using the company's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach Stoke is developing antisense oligonucleotides (ASOs) to selectively restore protein levels. The company's first compound, STK-001 is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Dravet syndrome is one of many diseases caused by a haploinsufficiency, in which a loss of ~50% of normal protein levels leads to disease. The company is pursuing treatment for a second haploinsufficient disease, autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Stoke's initial focus is haploinsufficiencies and diseases of the central nervous system and the eye, although proof of concept has been demonstrated in other organs, tissues, and systems, supporting the company's belief in the broad potential for its proprietary approach. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts.

Company profile

STOK stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

8 Aug 22
4 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 Dec 19
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) 68.32M 68.32M 68.32M 68.32M 68.32M 68.32M
Cash burn (monthly) 5.45M 8.41M 8.41M 8.1M 6.64M 1.53M
Cash used (since last report) 17.17M 26.5M 26.49M 25.52M 20.92M 4.82M
Cash remaining 51.15M 41.83M 41.83M 42.81M 47.41M 63.5M
Runway (months of cash) 9.4 5.0 5.0 5.3 7.1 41.5

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
7 Jun 22 Tzianabos Arthur Director Stock Option Common Stock Grant Acquire A No No 12.96 21,000 272.16K 21,000
7 Jun 22 Smith Julie Director Stock Option Common Stock Grant Acquire A No No 12.96 21,000 272.16K 21,000
7 Jun 22 Levin Arthur A Director Stock Option Common Stock Grant Acquire A No No 12.96 21,000 272.16K 21,000
7 Jun 22 Menzel Garry E Director Stock Option Common Stock Grant Acquire A No No 12.96 21,000 272.16K 21,000
7 Jun 22 Burstein Jennifer Director Stock Option Common Stock Grant Acquire A No No 12.96 21,000 272.16K 21,000
13F holders Current Prev Q Change
Total holders 94 100 -6.0%
Opened positions 10 22 -54.5%
Closed positions 16 15 +6.7%
Increased positions 41 36 +13.9%
Reduced positions 20 27 -25.9%
13F shares Current Prev Q Change
Total value 791.18M 902.03M -12.3%
Total shares 44.74M 43.07M +3.9%
Total puts 0 0
Total calls 35K 160K -78.1%
Total put/call ratio
Largest owners Shares Value Change
Skorpios Trust 14.44M $190.8M 0.0%
RTW Investments 3.65M $48.24M +0.2%
FMR 2.96M $39.17M +6.8%
MS Morgan Stanley 2.62M $34.56M +2.5%
Vanguard 2M $26.35M +2.9%
Redmile 1.99M $26.33M -1.5%
Cowen Financial Products 1.87M $34.81M 0.0%
BLK Blackrock 1.7M $22.49M +19.7%
Cowen And 1.51M $19.94M +6.3%
Wellington Management 1.26M $16.62M +5.9%
Largest transactions Shares Bought/sold Change
BMO Bank of Montreal 1.01M +1.01M NEW
STT State Street 382.11K -571.92K -59.9%
Millennium Management 949.66K +521.66K +121.9%
DB Deutsche Bank AG - Registered Shares 788.38K +516.5K +190.0%
Gilder Gagnon Howe & Co 58.31K -506.21K -89.7%
Healthcare Of Ontario Pension Plan Trust Fund 911.1K -425.4K -31.8%
BLK Blackrock 1.7M +279.94K +19.7%
Granahan Investment Management 198.62K +198.62K NEW
FMR 2.96M +189.41K +6.8%
SG Americas Securities 0 -182.59K EXIT

Financial report summary

?
Risks
  • Risks related to product development and regulatory approval
  • We are early in our development efforts. If we are unable to develop, obtain regulatory approval for and commercialize STK-001, STK-002 and our future product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
  • Success in early preclinical studies or clinical trials may not be indicative of results obtained in later preclinical studies and clinical trials, including in our Dravet syndrome program or our ADOA program.
  • If clinical trials of STK-001, STK-002 or any other product candidate that we develop fail to demonstrate safety and efficacy to the satisfaction of FDA or foreign regulatory authorities or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately may be unable to complete, the development and commercialization of such product candidate.
  • Even if we complete the necessary preclinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product candidate and the approval may be for a narrower indication than we seek.
  • Certain of the diseases we seek to treat have low prevalence, and it may be difficult to identify patients with these diseases, which may lead to delays in enrollment for our trials or slower commercial revenue growth if STK-001, STK-002 or our future product candidates are approved.
  • We may not be successful in our efforts to use TANGO to expand our pipeline of product candidates and develop marketable products.
  • Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.
  • STK-001, STK-002 or our future product candidates may cause undesirable and unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences.
  • The ongoing COVID-19 pandemic may, directly or indirectly, adversely affect our business, results of operations and financial condition.
  • A Fast Track Designation by the FDA, even if granted for any of our future product candidates, or any use of the accelerated approval pathway, may not lead to a faster development or regulatory review or approval process, and would not increase the likelihood that our product candidates will receive marketing approval.
  • A Breakthrough Therapy Designation by the FDA for STK-001, STK-002 or our future product candidates may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the product candidate will receive marketing approval.
  • Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, and statutory, regulatory and policy changes.
  • Our operations and relationships with future customers, providers 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 penalties including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Risks related to commercialization and manufacturing
  • The commercial success of our product candidates, including STK-001 and STK-002, will depend upon their degree of market acceptance by providers, patients, patient advocacy groups, third-party payors and the general medical community.
  • We have entered into a collaboration with Acadia Pharmaceuticals and may, in the future, seek to enter into collaborations with other third parties for the discovery, development and commercialization of our product candidates. If our collaborators cease development efforts under our collaboration agreements, or if any of those agreements are terminated, these collaborations may fail to lead to commercial products and we may never receive milestone payments or future royalties under these agreements.
  • The pricing, insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • The CARES Act, and other potential future healthcare reforms may adversely impact pricing, insurance coverage and reimbursement status of newly approved products.
  • If third parties on which we depend to conduct our planned preclinical studies, any future clinical trials, or manufacturing of our product candidates do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with adverse effects on our business, financial condition, results of operations and prospects.
  • The manufacture of drugs is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide supply of STK-001, STK-002 or our future product candidates for clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients, if approved, could be delayed or stopped.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell STK-001, STK-002 and our future product candidates, we may be unable to generate any revenues.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may not be successful in finding strategic collaborators for continuing development of certain of our future product candidates or successfully commercializing or competing in the market for certain indications.
  • Risks related to our financial position
  • We have a history of operating losses, and we may not achieve or sustain profitability. We anticipate that we will continue to incur losses for the foreseeable future. If we fail to obtain additional funding to conduct our planned research and development effort, we could be forced to delay, reduce or eliminate our product development programs or commercial development efforts.
  • We expect that we will need to raise additional funding before we can expect to become profitable from any potential future sales of STK-001, STK-002 or our future product candidates. This additional financing may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Our ability to utilize our net operating loss carryforwards may be subject to limitations.
  • U.S. federal income tax reform and changes in other tax laws could adversely affect us.
  • Risks related to our intellectual property
  • Our success depends in part on our ability to obtain, maintain and protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • Our owned and in-licensed patents and patent applications may not provide sufficient protection of our TANGO platform, our STK-001 and STK-002 product candidates, and our future product candidates or result in any competitive advantage.
  • Our strategy of obtaining rights to key technologies through in-licenses may not be successful.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful and could result in a finding that such patents are unenforceable or invalid.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Our use of open source software could impose limitations on our ability to commercialize our product candidates.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • 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.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in patent law in the United States and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.
  • We are subject to a variety of privacy and data security laws, and our failure to comply with them could harm our business.
  • Risks related to employee matters, managing growth and other risks related to our business
  • We expect to expand our development and regulatory capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We must attract and retain highly skilled employees to succeed.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Unfavorable global economic conditions could adversely affect our business, financial condition, stock price and results of operations.
  • We, or our third party service providers, face risks related to health epidemics and other outbreaks, which could significantly disrupt our operations.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our internal computer and information systems, or those used by our CROs, CMOs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our development programs.
  • A breakdown or breach of our technology systems could subject us to liability or interrupt the operation of our business.
  • Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Risks related to ownership of our common stock
  • The market price of our stock may be volatile, and you could lose all or part of your investment.
  • Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • We may be subject to securities litigation, which is expensive and could divert management attention.

Content analysis

?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. senior Avg
New words: currency, deactivated, LONGWING, primate, tissue
Removed: mg

Patents

Utility
Compositions and Methods for Modulating Splicing and Protein Expression
15 Sep 22
Alternative splicing events can lead to non-productive mRNA transcripts which in turn can lead to aberrant protein expression, and therapeutic agents which can target the alternative splicing events in genes can modulate the expression level of functional proteins in diseased patients and/or inhibit aberrant protein expression.
Utility
Methods and Compositions for Modulating Splicing of Alternative Introns
26 May 22
Provided herein are methods and compositions for modulating expression of a target protein or a target RNA by modulating splicing pre-mRNA and for treating diseases or conditions associated with expression level of the target protein or the target RNA.
Utility
Antisense Oligomers for Treatment of Conditions and Diseases
26 May 22
Alternative splicing events in SCN1A gene can lead to non-productive mRNA transcripts which in turn can lead to aberrant protein expression, and therapeutic agents which can target the alternative splicing events in SCN1A gene can modulate the expression level of functional proteins in Dravet Syndrome patients and/or inhibit aberrant protein expression.
Utility
Methods and Compositions for Modulating Splicing and Translation
28 Apr 22
Alternative splicing events in genes can lead to non-productive or less productive mRNA transcripts, and therapeutic agents which can target the alternative splicing events in genes can modulate the expression level of functional proteins in patients and/or inhibit aberrant protein expression.
Utility
Antisense Oligomers and Uses Thereof
21 Apr 22
Provided herein are methods and compositions for increasing the expression of a protein, and for treating a subject in need thereof, e.g., a subject with deficient protein expression or a subject having a disease described herein.