“During 2018, we made significant clinical and corporate advancements with our late-stage pruritus programs, including the initiation of both Phase 3 pivotal trials with KORSUVA Injection for chronic kidney disease-associated pruritus, or CKD-aP, in hemodialysis patients,” said CEO Derek Chalmers.
In 2019, Cara Therapeutics expects significant clinical readouts from both pivotal Phase 3 trials of Korsuva injection, and from Phase 2 trial of oral Korsuva in pre-dialysis patients with chronic kidney disease-associated pruritus (itching).
R&D expenses for the fourth quarter of 2018 increased to $22.8 million from $11.6 million in the same period of 2017 due to a net increase in costs associated with clinical trials, as well as increases in stock compensation expense and payroll and related costs.
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable securities of as of December 31, 2018 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into 2021, without giving effect to any potential milestone payments under existing collaborations.
Companies like Cara Therapeutics, GW Pharmaceuticals (GWPH) and Zynerba Pharmaceuticals (ZYNE) are focused on developing and testing new CBD-based drugs. On February 26, Zynerba won the patent for its CBD gel, which is used to treat Fragile X syndrome.
GW Pharma, which reported quarterly results for the three months ended Dec 31, 2018 recently, filed a marketing authorization application with the European Medicines Agency (EMA) for its frontline cannabinoid drug Epidiolex and expects the Committee for Medicinal Products for Human Use (CHMP) recommendation in Q2 2019.
CARA shares have rallied 34% so far this year and 21% in the past 12 months.
Listen to Cara Therapeutics’ previous quarters’ earnings calls