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

TL;DR

<b>Cara Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the year ending December 31, 2023.</b>

AI Summary

Cara Therapeutics, Inc. (TVRD) filed a Annual Report (10-K) with the SEC on March 6, 2024. Cara Therapeutics, Inc. filed its 2023 Form 10-K on March 6, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 400 Atlantic Street, Suite 500, Stamford, CT 06901. Cara Therapeutics, Inc. is classified under Pharmaceutical Preparations (SIC 2834). The filing includes financial data for the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking Cara Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Cara 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 statements and risk factors disclosed in the 10-K are essential for stakeholders to understand the company's financial position, potential risks, and compliance with regulatory requirements.

Risk Assessment

Risk Level: — Cara Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy development cycles, and intense competition, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Cara Therapeutics' financial health and strategic outlook for 2024.

Financial Highlights

total Assets

53797341

total Debt

54480704

Key Numbers

• 53,797,341 — Total Assets (As of December 31, 2023)
• 54,480,704 — Total Debt (As of December 31, 2023)

Key Players & Entities

• Cara Therapeutics, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• March 6, 2024 (date) — Filing date
• 400 Atlantic Street, Suite 500, Stamford, CT 06901 (location) — Business address
• 2834 (industry) — Standard Industrial Classification
• Vifor International Ltd (company) — Mentioned in context of agreements and common stock.

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive government regulation, which can impact product development, approval, manufacturing, and marketing.
• Competition [medium — market]: The company faces competition from other pharmaceutical companies, which could affect its market share and profitability.
• Funding and Liquidity [medium — financial]: The company may require additional funding to support its ongoing operations and development activities.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-06: Filing Date — Date Cara Therapeutics, Inc. filed its 10-K.

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 filing provides the official annual financial and business overview for Cara Therapeutics, Inc.)

SIC Code 2834

Standard Industrial Classification code for Pharmaceutical Preparations. (Indicates Cara Therapeutics, Inc.'s primary industry focus.)

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share CARA The Nasdaq Stock Mar

Filing Documents

• cara-20231231x10k.htm (10-K) — 3528KB
• cara-20231231xex10d25.htm (EX-10.25) — 538KB
• cara-20231231xex21d1.htm (EX-21.1) — 3KB
• cara-20231231xex23d1.htm (EX-23.1) — 14KB
• cara-20231231xex31d1.htm (EX-31.1) — 11KB
• cara-20231231xex31d2.htm (EX-31.2) — 12KB
• cara-20231231xex32d1.htm (EX-32.1) — 11KB
• cara-20231231xex97.htm (EX-97) — 41KB
• cara-20231231x10k004.jpg (GRAPHIC) — 44KB
• 0001558370-24-002609.txt (&nbsp;) — 15681KB
• cara-20231231.xsd (EX-101.SCH) — 99KB
• cara-20231231_cal.xml (EX-101.CAL) — 76KB
• cara-20231231_def.xml (EX-101.DEF) — 502KB
• cara-20231231_lab.xml (EX-101.LAB) — 769KB
• cara-20231231_pre.xml (EX-101.PRE) — 706KB
• cara-20231231x10k_htm.xml (XML) — 2644KB

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

Management's Discussion and Analysis of Financial Condition and Results of Operations. 66 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk . 87 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data . 89 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 145 Item 9A.

Controls and Procedures

Controls and Procedures . 145 Item 9B. O ther Information. 146 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 146 PART III Item 10. Directors, Executive Officers and Corporate Governance . 146 Item 11.

Executive Compensation

Executive Compensation . 146 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 . 146 Item 13. Certain Relationships and Related Transactions, and Director Independence . 146 Item 14. Principal Accountant Fees and Services . 146 PART IV Item 15. Exhibit and Financial Statement Schedules . 147 Item 16. Form 10-K Summary . 150 Table of Contents PART I In this Annual Report on Form 10-K, the terms "we," "us" and "our" refer to Cara Therapeutics, Inc. Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections of this Annual Report on Form 10-K titled "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business," but are also contained elsewhere in this Annual Report on Form 10-K. In some cases, you can identify forward-looking statements by the words "aim", "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "seek," "should," "will," or "would," and or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report on Form 10-K, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about w

Business

Item 1. Business . Overview We are a development-stage biopharmaceutical company driving innovation in sizable, yet underserved diseases and conditions. Specifically, we are focused on leading a new treatment paradigm to improve the lives of patients suffering from chronic pruritus. We are developing an oral formulation of difelikefalin, a selective, predominantly peripherally acting, non-scheduled Kappa opioid receptor agonist, for the treatment of chronic neuropathic pruritus associated with Notalgia Paresthetica, a common, underdiagnosed neuropathy affecting the upper back. We are conducting a Phase 2/3 program with topline results of the dose-finding portion expected in the third quarter of 2024. We also developed an IV formulation of the same molecule, which is approved for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis in the United States, EU and multiple other countries. The IV formulation is out-licensed worldwide. Chronic Pruritus – Overview Pruritus, or itch, is defined as an unpleasant sensation that provokes the desire to scratch, which can range from a mild annoyance to an intractable, disabling condition. Chronic pruritus, defined as an itch lasting longer than 6 weeks, has a variety of etiologies including inflammatory, metabolic and neuropathic, the latter being caused by direct damage to the nerve itself. Chronic pruritus represents a significant unmet need with few if any robustly efficacious or pruritus-specific treatment options. Because chronic pruritus is often not amenable to currently available treatments, it can result in a debilitating course, including the development of symptoms of depression, global distress, and impairment of sleep. Multiple studies have demonstrated this significant impact of chronic pruritus on health-related quality of life, some suggesting an impact similar to chronic pain. In contrast to pain, chronic pruritus is often under-rep

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