Stoke Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Stoke Therapeutics, Inc. has filed its 2023 10-K annual report, detailing its financial performance and corporate information.</b>

AI Summary

Stoke Therapeutics, Inc. (STOK) filed a Annual Report (10-K) with the SEC on March 25, 2024. Stoke Therapeutics, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at 45 Wiggins Avenue, Bedford, MA 01730. Stoke Therapeutics was formerly known as ASOthera Pharmaceuticals, Inc., with a name change effective October 28, 2014. The filing references the Stoke Therapeutics, Inc. 2019 Equity Incentive Plan. The report details financial information as of December 31, 2023, and for the fiscal year then ended.

Why It Matters

For investors and stakeholders tracking Stoke Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Stoke Therapeutics' financial health, operational status, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed financial statements and disclosures within the 10-K are essential for understanding the company's financial position, including its assets, liabilities, and equity, as well as its revenue and expenses.

Risk Assessment

Risk Level: medium — Stoke Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by the SIC code and the nature of a 10-K filing for a biotech company.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Stoke Therapeutics' current financial standing and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-25 — Filing Date (Filed as of date)
• 0000950170-24-035912 — Accession Number (SEC filing accession number)
• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations)

Key Players & Entities

• Stoke Therapeutics, Inc. (company) — Filer name
• ASOthera Pharmaceuticals, Inc. (company) — Former company name
• 45 Wiggins Avenue, Bedford, MA 01730 (company) — Business address
• 2019 Equity Incentive Plan (company) — Stock plan
• 2023-12-31 (date) — Fiscal year end
• 2024-03-25 (date) — Filing date

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive regulation by government authorities, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors to develop superior products or therapies.
• Funding and Liquidity [high — financial]: As a clinical-stage biotechnology company, Stoke Therapeutics may require significant additional capital to fund its operations and product development, posing liquidity risks.
• Clinical Trial Success [high — operational]: The success of the company's product candidates depends on the outcomes of clinical trials, which are inherently uncertain and can result in delays or failure.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-25: Filing Date — Date the 10-K report was officially submitted to the SEC.

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share STOK Nasdaq Glo

Filing Documents

• stok-20231231.htm (10-K) — 2557KB
• stok-ex3_1.htm (EX-3.1) — 68KB
• stok-ex4_2.htm (EX-4.2) — 40KB
• stok-ex10_12.htm (EX-10.12) — 464KB
• stok-ex23_1.htm (EX-23.1) — 3KB
• stok-ex31_1.htm (EX-31.1) — 15KB
• stok-ex31_2.htm (EX-31.2) — 15KB
• stok-ex32_1.htm (EX-32.1) — 8KB
• stok-ex32_2.htm (EX-32.2) — 8KB
• stok-ex97.htm (EX-97) — 78KB
• img144444814_0.jpg (GRAPHIC) — 131KB
• img144444814_1.jpg (GRAPHIC) — 112KB
• img144444814_2.jpg (GRAPHIC) — 22KB
• img144444814_3.jpg (GRAPHIC) — 89KB
• img144444814_4.jpg (GRAPHIC) — 62KB
• img144444814_5.jpg (GRAPHIC) — 50KB
• img144444814_6.jpg (GRAPHIC) — 28KB
• img144444814_7.jpg (GRAPHIC) — 20KB
• img144444814_8.jpg (GRAPHIC) — 26KB
• img144444814_9.jpg (GRAPHIC) — 21KB
• img144444814_10.jpg (GRAPHIC) — 13KB
• img144444814_11.jpg (GRAPHIC) — 73KB
• img144444814_12.jpg (GRAPHIC) — 55KB
• img144444814_13.jpg (GRAPHIC) — 67KB
• img144444814_14.jpg (GRAPHIC) — 50KB
• img167298193_0.jpg (GRAPHIC) — 37KB
• img167298193_1.jpg (GRAPHIC) — 37KB
• 0000950170-24-035912.txt (&nbsp;) — 11492KB
• stok-20231231.xsd (EX-101.SCH) — 1057KB
• stok-20231231_htm.xml (XML) — 1353KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 36 Item 1B. Unresolved Staff Comments 79 Item 1C. Cybersecurity 79 Item 2.

Properties

Properties 81 Item 3.

Legal Proceedings

Legal Proceedings 81 Item 4. Mine Safety Disclosures 81 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 82 Item 6. [Reserved] 82 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 83 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 96 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 96 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 96 Item 9A.

Controls and Procedures

Controls and Procedures 96 Item 9B. Other Information 97 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 98 PART III Item 10. Directors, Executive Officers and Corporate Governance 99 Item 11.

Executive Compensation

Executive Compensation 99 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 99 Item 13. Certain Relationships and Related Transactions, and Director Independence 99 Item 14. Principal Accountant Fees and Services 99 PART IV Item 15. Exhibits, Financial Statement Schedules 100 Item 16. Form 10-K Summary 102 FORWARD-LOOKI NG STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of present and historical facts contained in this Annual Report on Form 10-K, including, but not limited to, statements regarding the ability of STK-001 to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior or cognition at the indicated dosing levels or at all, the timing and expected progress of clinical trials, our future results of operations and financial position, business strategy, prospective products, planned preclinical studies and clinical or field trials, regulatory approvals, research and development costs, and timing and likelihood of success, as well as plans and objectives of management for future operations, may be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to us. Such statements are subject to a number of kn

Bu siness

Item 1. Bu siness. Overview We are a clinical-stage company dedicated to addressing the underlying causes of severe diseases by upregulating protein expression with RNA-based medicines. Using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, we are developing antisense oligonucleotides ("ASOs") to selectively restore protein levels. Our first compound, STK-001, is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Dravet syndrome is characterized by frequent, prolonged and refractory seizures beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with it. Dravet syndrome is one of many diseases caused by a haploinsufficiency, in which a loss of approximately 50% of normal protein levels leads to disease. We are also pursuing treatment for a second haploinsufficient disease, autosomal dominant optic atrophy ("ADOA"), the most common inherited optic nerve disorder. Our initial focus is on 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 our belief in the broad potential for our proprietary approach. Our executive management team has extensive collective expertise in human genetics and modulation of RNA processes using ASOs, as well as a track record of success in rare disease drug development. Our executive team and co-founders have been previously involved with other companies in the discovery, development and commercialization of many treatments for rare diseases, including Sarepta's Exondys 51 (eteplirsen) and Biogen's SPINRAZA. Our scientific and clinical advisory boards are comprised of leading experts in the fields of human genetics, pre-mRNA splicing and ASOs, and neurodevelopmental and neurodegenerative diseases. Their involv

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View this 10-K filing on SEC EDGAR