Lyra Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Lyra Therapeutics filed its 2023 10-K, detailing its financial status and corporate history.</b>

AI Summary

Lyra Therapeutics, Inc. (LYRA) filed a Annual Report (10-K) with the SEC on March 22, 2024. Lyra Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company's principal executive offices are located at 480 Arsenal Way, Watertown, MA 02472. Lyra Therapeutics was formerly known as 480 Biomedical, Inc., Arsenal Vascular, Inc., and Arsenal Medical, Inc. The filing includes various financial data points and disclosures related to the company's operations and market position. Key dates and events related to stock plans and agreements are noted within the filing.

Why It Matters

For investors and stakeholders tracking Lyra Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Lyra Therapeutics' financial performance and operational status for the fiscal year 2023, crucial for investors assessing the company's health and future prospects. Understanding the company's historical name changes and its current business address is important for accurate identification and context within the biotechnology sector.

Risk Assessment

Risk Level: low — Lyra Therapeutics, Inc. shows low risk based on this filing. The filing is a standard 10-K annual report, which typically contains routine disclosures and does not indicate any immediate, significant risks or positive developments beyond normal business operations.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to form an informed opinion on Lyra Therapeutics' investment potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the 10-K filing)
• 2024-03-22 — Filing Date (Date the 10-K was filed)
• 0000950170-24-035047 — Accession Number (Unique identifier for the filing)
• 3841 — SIC Code (Standard Industrial Classification for Surgical & Medical Instruments & Apparatus)

Key Players & Entities

• Lyra Therapeutics, Inc. (company) — Filer name
• 480 Arsenal Way, Watertown, MA 02472 (location) — Business address
• 480 Biomedical, Inc. (company) — Former company name
• Arsenal Vascular, Inc. (company) — Former company name
• Arsenal Medical, Inc. (company) — Former company name

FAQ

Risk Factors

• General Business Operations [low — operational]: The filing details the company's business, including its history and former names, indicating ongoing operations in the medical device sector.

Key Dates

• 2023-12-31: Fiscal Year End — Defines the reporting period for the 10-K.
• 2024-03-22: Filing Date — Indicates when the annual report was submitted to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This is the primary document type filed, providing essential financial and operational data.)

SIC Code

Standard Industrial Classification code used to classify businesses based on their primary activity. (Helps categorize Lyra Therapeutics within the broader market and industry landscape.)

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share LYRA The Nasdaq

Filing Documents

• lyra-20231231.htm (10-K) — 3417KB
• lyra-ex4_8.htm (EX-4.8) — 38KB
• lyra-ex10_24.htm (EX-10.24) — 94KB
• lyra-ex23_1.htm (EX-23.1) — 4KB
• lyra-ex31_1.htm (EX-31.1) — 16KB
• lyra-ex31_2.htm (EX-31.2) — 16KB
• lyra-ex32_1.htm (EX-32.1) — 9KB
• lyra-ex32_2.htm (EX-32.2) — 9KB
• lyra-ex97_1.htm (EX-97.1) — 42KB
• img223266799_0.jpg (GRAPHIC) — 39KB
• img223266799_1.jpg (GRAPHIC) — 30KB
• img223266799_2.jpg (GRAPHIC) — 25KB
• img223266799_3.jpg (GRAPHIC) — 578KB
• img223266799_4.jpg (GRAPHIC) — 25KB
• img223266799_5.jpg (GRAPHIC) — 25KB
• img223266799_6.jpg (GRAPHIC) — 23KB
• img223266799_7.jpg (GRAPHIC) — 44KB
• img223266799_8.jpg (GRAPHIC) — 46KB
• img223266799_9.jpg (GRAPHIC) — 44KB
• img223266799_10.jpg (GRAPHIC) — 62KB
• 0000950170-24-035047.txt (&nbsp;) — 14089KB
• lyra-20231231.xsd (EX-101.SCH) — 1438KB
• lyra-20231231_htm.xml (XML) — 1959KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 27 Item 1B. Unresolved Staff Comments 81 Item 1C. Cybersecurity 81 Item 2.

Properties

Properties 82 Item 3.

Legal Proceedings

Legal Proceedings 82 Item 4. Mine Safety Disclosures 82 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 83 Item 6. [Reserved] 83 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 84 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 100 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 100 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 100 Item 9A.

Controls and Procedures

Controls and Procedures 101 Item 9B. Other Information 102 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 102 PART III Item 10. Directors, Executive Officers and Corporate Governance 103 Item 11.

Executive Compensation

Executive Compensation 106 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 113 Item 13. Certain Relationships and Related Transactions, and Director Independence 116 Item 14. Principal Accountant Fees and Services 119 PART IV Item 15. Exhibits and Financial Statement Schedules 120 Item 16. Form 10-K Summary 123 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements, including but not limited to statements regarding: our plans to develop and commercialize our product candidates; the timing of our ongoing or planned clinical trials for LYR-210, LYR-220, and any future product candidates; the timing of and our ability to obtain and maintain regulatory approvals for LYR-210, LYR-220, and any future product candidates; the clinical utility of our product candidates; the anticipated demand and market size for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our expectations about the willingness of healthcare professionals to use LYR-210, LYR-220, and any future product candidates; our expectations regarding the development and commercialization of LYR-210 pursuant to the terms of the LianBio License Agreement (as defined below); our ability to continue as a going concern; our intellectual property position; our competitive position and developments and projections relating to our competitors or our industry; our ability to identify, recruit, and retain key personnel; the impact of laws and regulat

Bu siness

Item 1. Bu siness. Overview We are a clinical-stage biotechnology company focused on the development and commercialization of innovative, anti-inflammatory therapies for the localized treatment of patients with chronic rhinosinusitis, or CRS. Our product candidates, LYR-210 and LYR-220, are bioabsorbable nasal inserts designed to be administered in a simple, in-office procedure and intended to deliver six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of CRS with a single administration. The drug embedded within LYR-210 and LYR-220 is mometasone furoate, or MF, which is the active ingredient in various U.S. Food and Drug Administration, or FDA, approved drugs and has a well-established efficacy and safety profile. CRS is an inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and affects approximately 14 million people in the United States. LYR-210 LYR-210 is designed to treat CRS patients who have failed previous medical management. LYR-210 has a smaller dimension and is intended for patients with narrow anatomy, primarily patients who have not undergone ethmoid sinus surgery. A pivotal Phase 3 program of LYR-210, called the ENLIGHTEN program, consists of two pivotal trials and is currently ongoing. LYR-220 Our second pipeline product candidate, LYR-220, is designed for use in CRS patients who continue to require treatment to manage CRS symptoms despite having had ethmoid sinus surgery. LYR-220 employs a larger matrix designed for patients whose nasal cavity is larger including those patients whose nasal cavity is larger after having undergone ethmoid sinus surgery. A Phase 2 clinical trial of LYR-220, called BEACON, has recently concluded and topline data have been presented. Our Technology Our innovative and proprietary drug delivery technology is designed to locally and continuously deliver small molecule drugs to the affected tissue over a

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View this 10-K filing on SEC EDGAR