Trevi Therapeutics Files 2023 10-K

TL;DR

Trevi Therapeutics filed its 2023 10-K, detailing financial activities and operations for the year ending Dec 31, 2023.

AI Summary

Trevi Therapeutics, Inc. filed its 2023 10-K on March 20, 2024, reporting on its fiscal year ending December 31, 2023. The company, operating in pharmaceutical preparations, is based in New Haven, CT. Key financial activities mentioned include an At-The-Market (ATM) sales agreement and a September 2022 offering involving pre-funded warrants.

Why It Matters

This filing provides a comprehensive overview of Trevi Therapeutics' financial health and operational activities for the past fiscal year, crucial for investors and stakeholders to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Trevi Therapeutics is subject to inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 2023-12-31 — Fiscal Year End (The period covered by the 10-K filing.)
• 2024-03-20 — Filing Date (The date the 10-K was officially submitted to the SEC.)

Key Players & Entities

• Trevi Therapeutics, Inc. (company) — Filer of the 10-K
• 2023-12-31 (date) — Fiscal year end
• 2024-03-20 (date) — Filing date
• New Haven, CT (location) — Company headquarters
• 203-304-2499 (phone_number) — Business phone number
• At-The-Market Sales Agreement (financial_instrument) — Mentioned financial activity
• September 2022 Offering (event) — Past financing event
• Pre-funded Warrants (financial_instrument) — Associated with September 2022 offering

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share TRVI The Nasdaq
• $19.9 billion — tus therapeutics is expected to grow to $19.9 billion in 2026. We have a development progra

Filing Documents

• trvi-20231231.htm (10-K) — 2788KB
• trvi-ex4_2.htm (EX-4.2) — 30KB
• trvi-ex23_1.htm (EX-23.1) — 5KB
• trvi-ex31_1.htm (EX-31.1) — 15KB
• trvi-ex31_2.htm (EX-31.2) — 15KB
• trvi-ex32_1.htm (EX-32.1) — 9KB
• trvi-ex32_2.htm (EX-32.2) — 9KB
• trvi-ex97.htm (EX-97) — 23KB
• img23710298_0.jpg (GRAPHIC) — 34KB
• img23710298_1.jpg (GRAPHIC) — 43KB
• 0000950170-24-034167.txt ( ) — 10959KB
• trvi-20231231.xsd (EX-101.SCH) — 1485KB
• trvi-20231231_htm.xml (XML) — 1820KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 34 Item 1B. Unresolved Staff Comments 82 Item 1C Cybersecurity 82 Item 2.

Properties

Properties 82 Item 3.

Legal Proceedings

Legal Proceedings 82 Item 4. Mine Safety Disclosures 83 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 83 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 93 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 93 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 93 Item 9A.

Controls and Procedures

Controls and Procedures 93 Item 9B. Other Information 94 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 94 PART III Item 10. Directors, Executive Officers and Corporate Governance 94 Item 11.

Executive Compensation

Executive Compensation 94 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 94 Item 13. Certain Relationships and Related Transactions, and Director Independence 94 Item 14. Principal Accounting Fees and Services 94 PART IV Item 15. Exhibits, Financial Statement Schedules 94 Item 16 Form 10-K Summary 96 PART I

B usiness

Item 1. B usiness. Overview We are a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis, or IPF, and refractory chronic cough, or RCC. Haduvio is an oral extended-release formulation of nalbuphine. Nalbuphine is a mixed -opioid receptor agonist and -opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the U.S. and Europe. The - and -opioid receptors are known to be critical mediators of cough and itch. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with -opioid agonists because it antagonizes, or blocks, the -opioid receptor. Haduvio's dual mechanism of action targets opioid receptors located in both the central and peripheral nervous systems, each of which plays a role in modulating cough and the sensation of itch. We believe this makes Haduvio a promising potential therapy for the treatment of chronic cough in IPF and RCC. To date, we have dosed over 1,100 patients with different doses of Haduvio, including healthy volunteers, patients with hepatic impairment, and patients with chronic, serious diseases such as uremic pruritus, prurigo nodularis and chronic cough in IPF. Chronic Cough in IPF Program. IPF is a rare, chronic, progressive lung disease, characterized by scarring and thickening of lung tissue leading to an irreversible loss of lung function and reduced life expectancy. Most patients diagnosed with IPF suffer from a dry, non-productive chronic cough that interrupts their daily living and contributes to poor quality of life. Chronic coughing can have a debilitating physical and psychosocial burden, exacerbate concomitant respiratory disease, cause loss of sleep and reduce mobility. Cough may be an independent predictor of disease progression in IPF, and therefore we believe coug

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