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

TL;DR

<b>Dyne Therapeutics, Inc. has filed its 2023 10-K report detailing its fiscal year-end operations and financial standing.</b>

AI Summary

Dyne Therapeutics, Inc. (DYN) filed a Annual Report (10-K) with the SEC on March 5, 2024. Dyne Therapeutics, Inc. filed its 2023 Form 10-K on March 5, 2024, reporting on its fiscal year ending December 31, 2023. The company's principal business address is 1560 TRAPELO ROAD, WALTHAM, MA 02451. Dyne Therapeutics operates within the Pharmaceutical Preparations industry (SIC 2834). The filing covers a period of 496 days, indicating a potential change in reporting period. Key financial data points such as cash, debt, and equity are detailed within the report, though specific values are not immediately extracted here.

Why It Matters

For investors and stakeholders tracking Dyne Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Dyne Therapeutics' financial health, operational activities, 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 disclosures within the 10-K are essential for understanding the company's asset base, liabilities, equity, and cash flows, enabling informed investment decisions and risk assessment.

Risk Assessment

Risk Level: medium — Dyne Therapeutics, Inc. shows moderate risk based on this filing. The filing is a standard 10-K, which is a comprehensive annual report. While it contains significant financial and operational details, it does not immediately highlight any extreme positive or negative developments that would classify the risk as low or high without further in-depth analysis of the content.

Analyst Insight

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

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 20240305 — Filing Date (Filed as of date)
• 496 — Reporting Period Days (Indicates the length of the reporting period)
• 001-39509 — SEC File Number (SEC file number for Dyne Therapeutics, Inc.)

Key Players & Entities

• Dyne Therapeutics, Inc. (company) — Filer name
• 20231231 (date) — Conformed period of report
• 20240305 (date) — Filed as of date
• 1560 TRAPELO ROAD (address) — Business address street 1
• WALTHAM (location) — Business address city
• MA (location) — Business address state
• 02451 (postal_code) — Business address zip
• 2834 (industry_code) — Standard Industrial Classification

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-05: 10-K Filing Date — Date Dyne Therapeutics, Inc. filed its annual report.

Key Financial Figures

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

Filing Documents

• dyn-20231231.htm (10-K) — 2590KB
• dyn-ex21_1.htm (EX-21.1) — 5KB
• dyn-ex23_1.htm (EX-23.1) — 4KB
• dyn-ex31_1.htm (EX-31.1) — 11KB
• dyn-ex31_2.htm (EX-31.2) — 11KB
• dyn-ex32_1.htm (EX-32.1) — 6KB
• dyn-ex32_2.htm (EX-32.2) — 5KB
• dyn-ex97.htm (EX-97) — 25KB
• img108075666_0.jpg (GRAPHIC) — 185KB
• img108075666_1.jpg (GRAPHIC) — 15KB
• img108075666_2.jpg (GRAPHIC) — 60KB
• img108075666_3.jpg (GRAPHIC) — 325KB
• img108075666_4.jpg (GRAPHIC) — 312KB
• img108075666_5.jpg (GRAPHIC) — 264KB
• img108075666_6.jpg (GRAPHIC) — 241KB
• 0000950170-24-025402.txt (&nbsp;) — 12132KB
• dyn-20231231.xsd (EX-101.SCH) — 1188KB
• dyn-20231231_htm.xml (XML) — 1283KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 48 Item 1B. Unresolved Staff Comments 114 Item 1C. Cybersecurity 114 Item 2.

Properties

Properties 116 Item 3.

Legal Proceedings

Legal Proceedings 116 Item 4. Mine Safety Disclosures 116 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 117 Item 6. [Reserved] 117 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 118 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 129 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 129 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 129 Item 9A.

Controls and Procedures

Controls and Procedures 129 Item 9B. Other Information 130 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 130 PART III Item 10. Directors, Executive Officers and Corporate Governance 131 Item 11.

Executive Compensation

Executive Compensation 131 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 131 Item 13. Certain Relationships and Related Transactions, and Director Independence 131 Item 14. Principal Accounting Fees and Services 131 PART IV Item 15. Exhibits and Financial Statement Schedules 132 Item 16 Form 10-K Summary 134 i Cautionary Note Regarding Forward-Looking Statements and Industry Data This Annual Report on Form 10-K, or this Annual Report, contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements other than statements of historical fact, contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue" "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would," or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this Annual Report include, among other things, statements about: the initiation, timing, progress and results of our research and development programs, preclinical studies and clinical trials; the anticipated timing of the submission and clearance of investigational new drug applications, or INDs, and comparable foreign applications for any product candidates we may develop; our estimates regarding expenses, future revenue, capital requirements, need for additional financing and the period over which we believe our cash, cash equivalents and marketable securities will be s

B usiness

Item 1. B usiness. Overview We are a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE platform to overcome the current limitations of muscle tissue delivery and advance modern oligonucleotide therapeutics for muscle diseases. Our proprietary FORCE platform therapeutics consist of an oligonucleotide payload that we rationally design to target the genetic basis of the disease we are seeking to treat, a clinically validated linker and an antigen-binding fragment, or Fab, that we attach to the payload using the linker. With our FORCE platform, we have the flexibility to deploy different types of oligonucleotide payloads with specific mechanisms of action that modify target functions. We leverage this modularity to focus on muscle diseases with high unmet need, with etiologic targets and with clear translational potential from preclinical disease models to well-defined clinical development and regulatory pathways. Using our FORCE platform, we are assembling a broad portfolio of muscle disease therapeutics, including our programs in myotonic dystrophy type 1, or DM1, Duchenne muscular dystrophy, or DMD, and facioscapulohumeral dystrophy, or FSHD. In addition, we plan to expand our portfolio through development efforts focused on rare skeletal muscle diseases, as well as cardiac and metabolic muscle diseases, including some with larger patient populations, and diseases involving the central nervous system, or CNS. We have identified product candidates for each of our DM1, DMD and FSHD programs that are in varying stages of preclinical and clinical development. The following table summarizes our portfolio: Our product candidate DYNE-101 is being evaluated in ACHIEVE, an ongoing Phase 1/2 global clinical trial in patients with DM1. ACHIEVE, which is designed to be a registrational trial, consists of a 24-week multiple ascendin

View Full Filing

View this 10-K filing on SEC EDGAR