Cara Therapeutics Files 8-K

TL;DR

CARA filed an 8-K, looks like standard reporting, no major news yet.

AI Summary

On June 12, 2024, Cara Therapeutics, Inc. filed an 8-K report. The filing primarily concerns Regulation FD Disclosure and Other Events, with no specific financial figures or significant business developments detailed in the provided text. The report confirms the company's identity and filing details.

Why It Matters

This filing indicates routine corporate reporting by Cara Therapeutics, Inc. to the SEC, without revealing new material information in the provided excerpt.

Risk Assessment

Risk Level: low — The provided text is a standard SEC filing header and does not contain information that would indicate a change in risk for the company.

Key Players & Entities

• Cara Therapeutics, Inc. (company) — Registrant
• June 12, 2024 (date) — Date of earliest event reported

FAQ

Key Financial Figures

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

Filing Documents

• tm2416682d3_8k.htm (8-K) — 28KB
• tm2416682d3_ex99-1.htm (EX-99.1) — 10KB
• tm2416682d3_ex99-1img001.jpg (GRAPHIC) — 5KB
• 0001104659-24-070914.txt ( ) — 219KB
• cara-20240612.xsd (EX-101.SCH) — 3KB
• cara-20240612_lab.xml (EX-101.LAB) — 33KB
• cara-20240612_pre.xml (EX-101.PRE) — 22KB
• tm2416682d3_8k_htm.xml (XML) — 4KB

01

Item 7.01. Regulation FD Disclosure. On June 12, 2024, Cara Therapeutics, Inc. (the "Company") issued a press release (the "Press Release") announcing the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica ("NP"). Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company's decision to discontinue the clinical program in NP. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 7.01. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company's filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing.

01

Item 8.01. Other Information. On June 12, 2024, the Company issued the Press Release announcing the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with NP. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company's decision to discontinue the clinical program in NP. The Phase 2/3, two-part, multicenter, randomized, double-blind, placebo-controlled, 8-week study was designed to investigate the use of oral difelikefalin for moderate-to-severe pruritus in adult patients with NP. In Part A, patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day ("BID"), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. Primary Endpoint The primary endpoint was the proportion of patients achieving a 4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release dated June 12, 2024 104 Cover page interactive data file (formatted as Inline XBRL) 2

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CARA THERAPEUTICS, INC. By: /s/ RYAN MAYNARD Ryan Maynard Chief Financial Officer (Principal Financial and Accounting Officer) Date: June 12, 2024 3

View Full Filing

View this 8-K filing on SEC EDGAR