Cara Therapeutics : Costs Associated with Exit/Disposal Form 8 K
June 19, 2024 at 03:22 pm IST
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Item 2.05.
Costs Associated with Exit or Disposal Activities.
On June 14, 2024, the Board of Directors of Cara Therapeutics, Inc. (the "Company") approved a streamlined operating plan exploring strategic alternatives focused on maximizing shareholder value after the Company announced its decision to discontinue the clinical program in notalgia paresthetica ("NP") following 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 on June 12, 2024. In connection with the streamlined operating plan, the Board of Directors also approved a reduction in the Company's workforce by approximately 70%, which the Company expects to substantially complete by June 30, 2024. The Company anticipates recognizing approximately $2.6 million in total charges in connection with the reduction in force, which costs are expected to be substantially recognized in the second and third quarter of 2024. These charges will consist primarily of one-time cash charges for termination benefits. The charges the Company expects to incur in connection with this reduction in workforce are subject to a number of assumptions, risks and uncertainties, and actual results may materially differ. The Company may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, these actions.
Forward-Looking Statements
Statements contained in this report regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the Company's streamlined operating plan, the expected costs of the reduction in force and the timing of recognition of such charges. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include the risks inherent in the clinical and regulatory development of pharmaceutical products, and the risks described more fully in Cara Therapeutics' filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this report speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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Cara Therapeutics, Inc. is a development-stage biopharmaceutical company. The Company is focused on treatment paradigm to improve the lives of patients suffering from chronic pruritus. It is 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 (NP), a common, underdiagnosed neuropathy affecting the upper back. It is conducting Phase II/III Clinical Program in NP. The program is comprised of two studies - KOURAGE 1 and KOURAGE 2, which are double-blind, placebo-controlled, eight-week studies with patients allowed to roll-over into open-label 52-week extensions. It has developed an IV formulation of difelikefalin, for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide.