If You Invested in Cara Therapeutics, Inc. (CARA)

Cara Therapeutics, Inc. (CARA) is a biopharmaceutical company whose activities have been focused on pruritus, or chronic itch. According to multiple company disclosures, Cara Therapeutics describes itself as a development-stage or commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.

The company has developed difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor agonist. Cara Therapeutics developed an intravenous (IV) formulation of difelikefalin, which is approved in the United States, the European Union, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The company states that this IV formulation is out-licensed worldwide.

In addition to the IV product, Cara Therapeutics has been developing an oral formulation of difelikefalin for chronic pruritus associated with notalgia paresthetica (NP), which the company describes as a common, underdiagnosed neuropathy affecting the upper back for which there are no FDA-approved therapies. Company communications describe a Phase 2/3 clinical program in NP, referred to as the KOURAGE program, including the KOURAGE 1 and KOURAGE 2 studies evaluating oral difelikefalin for moderate-to-severe pruritus in patients with NP.

Cara Therapeutics has also reported that it has prioritized its late-stage NP clinical program, including a dose-finding portion (KOURAGE 1 Part A) and planned pivotal portions, and that it has taken steps such as a streamlined operating plan focused on cost-containment and cash conservation. The company has discussed exploring strategic alternatives and engaging a financial advisor in connection with that process.

In later disclosures, Cara Therapeutics describes itself as a biopharmaceutical company that has been focused on leading a new treatment paradigm to improve the lives of patients suffering from chronic pruritus. It notes that it developed the IV formulation of difelikefalin, which is approved for the treatment of moderate-to-severe pruritus associated with advanced kidney disease in adults undergoing hemodialysis in the United States, European Union, and multiple other countries, and that this IV formulation is out-licensed worldwide.

In addition to its development activities, Cara Therapeutics has reported collaborative revenue, commercial supply revenue, and other revenue related to KORSUVA (the brand name used for difelikefalin injection in certain markets) and Kapruvia under agreements with partners. The company has disclosed that KORSUVA injection generated net sales and that it records collaborative revenue representing its share of profit from sales of KORSUVA injection. It has also noted royalty and milestone payments related to ex-U.S. sales of KORSUVA/Kapruvia under agreements with partners.

From a capital markets perspective, Cara Therapeutics’ common stock has traded on the Nasdaq Capital Market under the symbol "CARA". The company has implemented reverse stock splits of its outstanding common stock, including a 1-for-12 reverse stock split that became effective on December 30, 2024, after which the stock continued to trade on a reverse stock split-adjusted basis on Nasdaq under the symbol CARA. The company has stated that this reverse stock split was part of its plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

Subsequently, Cara Therapeutics announced that its Board of Directors approved a 1-for-3 reverse stock split of its outstanding shares of common stock in connection with a proposed merger with Tvardi Therapeutics, Inc. The company stated that Cara’s common stock is expected to begin trading on a reverse stock split-adjusted basis under the new name “Tvardi Therapeutics, Inc.” and under the new symbol “TVRD” following the anticipated closing of the merger with Tvardi Therapeutics, Inc. The announcement explains that, at the effective time of this reverse stock split, every three issued and outstanding shares of the company’s common stock will automatically be combined into one issued and outstanding share, with no change in par value per share, and that fractional shares will not be issued.

These disclosures indicate that the ticker symbol CARA historically represents Cara Therapeutics, Inc., a biopharmaceutical company focused on pruritus, the development and commercialization (through partners) of difelikefalin injection for pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis, and the clinical development of an oral formulation of difelikefalin for notalgia paresthetica. The company has also described plans and actions related to strategic alternatives and a proposed merger with Tvardi Therapeutics, Inc., with an anticipated transition to a new company name and ticker symbol in connection with that merger.

Business focus and therapeutic areas

Cara Therapeutics’ disclosures emphasize its focus on chronic pruritus. The company describes its work in:

• Developing and commercializing, through partners, an IV formulation of difelikefalin for moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis.
• Developing an oral formulation of difelikefalin for chronic pruritus associated with notalgia paresthetica, a neuropathic disorder characterized by chronic pruritus of the upper back for which there are no FDA-approved therapies.

The company characterizes difelikefalin as a selective, peripherally acting, non-scheduled kappa opioid receptor agonist, and positions its clinical programs as part of a new treatment paradigm for patients suffering from pruritus.

Clinical development programs

Cara Therapeutics has described a Phase 2/3 clinical program in notalgia paresthetica under the name KOURAGE, consisting of two studies, KOURAGE 1 and KOURAGE 2. Company communications explain that KOURAGE 1 includes a dose-finding Part A and a pivotal portion, and that KOURAGE 2 is also designed as a double-blind, placebo-controlled study. The company has reported enrollment in KOURAGE 1 Part A and has discussed expectations for topline efficacy and safety results from that portion of the program.

In later updates, Cara Therapeutics announced that oral difelikefalin did not demonstrate a meaningful clinical benefit compared to placebo in the dose-finding Part A of the KOURAGE-1 study in notalgia paresthetica, and that, as a result, the company decided to discontinue the clinical program in NP and explore strategic alternatives.

Commercial and partnered activities

Cara Therapeutics has reported that KORSUVA (difelikefalin) injection generated net sales in the United States, and that the company recorded collaborative revenue representing its share of profit from sales of KORSUVA injection to third parties under agreements with a partner. It has also reported commercial supply revenue related to sales of KORSUVA injection to a partner, as well as royalty and milestone payments related to ex-U.S. sales of KORSUVA/Kapruvia under agreements with partners.

The company has discussed reimbursement aspects for KORSUVA injection in the U.S., including the end of a Transitional Drug Add-On Payment Adjustment (TDAPA) period and subsequent reimbursement through a bundled payment system for end stage renal disease.

Corporate and capital structure developments

Cara Therapeutics has disclosed several corporate and capital structure developments, including:

• A 1-for-12 reverse stock split of its outstanding shares of common stock, effective as of December 30, 2024, with trading on a reverse stock split-adjusted basis on the Nasdaq Capital Market under the symbol CARA beginning December 31, 2024. The company stated that this reverse stock split was part of its plan to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
• A subsequent 1-for-3 reverse stock split of its outstanding shares of common stock approved by the Board of Directors in connection with a proposed merger with Tvardi Therapeutics, Inc., with the expectation that, following the anticipated closing of the merger, the combined company would trade under the new name “Tvardi Therapeutics, Inc.” and the new symbol “TVRD”.

The company has also discussed a process of exploring strategic alternatives, including engaging a financial advisor, and has described a streamlined operating plan focused on cost-containment and cash conservation.

Historical context for the CARA ticker

Based on the company’s own announcements, the ticker symbol CARA has historically been associated with Cara Therapeutics, Inc., a biopharmaceutical company focused on pruritus and the development and commercialization (through partners) of difelikefalin-based therapies. Company communications indicate a planned transition in connection with a proposed merger, under which the stock is expected to trade under a new company name and symbol after the anticipated closing of that merger.