 Conference call today at 4:30 p.m. ET STAMFORD, Conn., Aug. 10, 2020 GLOBE NEWSWIRE -- Cara Therapeutics, Inc. Nasdaq: CARA, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors KORs, today announced financial results and operational highlights for the second quarter ended June 30, 2020.In the second quarter, we continued to advance our clinical development programs for both KORSUVATM Injection and Oral KORSUVA. Following positive top-line data from our KALMTM-2 pivotal Phase 3 trial of KORSUVA Injection for chronic kidney disease-associated pruritus CKD-aP in hemodialysis patients, we remain on track to submit our first New Drug Application NDA to the U.S. Food and Drug Administration FDA in the fourth quarter, said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. We also successfully completed a planned interim statistical analysis of our KARE Phase 2 dose-ranging trial of Oral KORSUVA for moderate-to-severe pruritus in atopic dermatitis AD patients and expect the trial to be fully enrolled by the fourth quarter.Second Quarter and Recent Developments:KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus CKD-aP: HemodialysisIn April 2020, the Company announced positive top-line results from its KALM-2 global pivotal Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP. The trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean Worst Itching Intensity Numeric Rating Scale NRS versus placebo p0.02 at week 12. The trial also met the key secondary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean Worst Itching Intensity NRS versus placebo p0.01 at week 12. KORSUVA Injection was generally well-tolerated through 12 weeks of treatment with a safety profile consistent with prior clinical trials.All safety databases are now closed with more than 1,500 total patient exposures achieved, including more than 700 patients completing at least six months of treatment and more than 400 patients completing one year of treatment.The Company remains on track to submit an NDA for KORSUVA Injection to the FDA in the fourth quarter of 2020.Oral KORSUVA: CKD-aP: Non-HemodialysisIn December 2019, the Company announced positive top-line results from its Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V moderate-to-severe CKD. The Company plans to conduct an End of Phase 2 Meeting with the FDA in the first quarter of 2021. In advance of that meeting, the Company intends to initiate the safety portion of the Phase 3 program in the fourth quarter of 2020.Oral KORSUVA: Atopic Dermatitis ADIn June 2020, the Company announced the completion of an interim conditional power assessment of its ongoing KARE Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in AD patients. The trial is evaluating the safety and efficacy of three tablet strengths 0.25 mg, 0.5 mg and 1.0 mg, twice daily of Oral KORSUVA versus placebo for 12 weeks, followed by a 4-week active extension phase.Based on the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80 or greater on the trials primary endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itching Intensity NRS and key secondary endpoint of the proportion of patients achieving a four point or greater improvement in Worst Itching Intensity NRS score at week 12. The prespecified interim conditional power assessment was conducted after approximately 50 of the originally targeted patient number had completed the designated 12-week treatment period. The Company expects the trial to be fully enrolled in the fourth quarter of 2020 and aims to report top-line results in the first half of 2021, subject to any delays related to the ongoing COVID-19 pandemic.Oral KORSUVA: Chronic Liver Disease-Associated Pruritus CLD-aP: Primary Biliary Cholangitis PBCThe Company is conducting a Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC. The trial is evaluating the safety and efficacy of Oral KORSUVA 1.0 mg tablet, twice daily versus placebo for 16 weeks. The Company continues to screen patients and aims to have top-line data in the first half of 2021, due in part to delays related to the ongoing COVID-19 pandemic.Board of Directors Expansion and AppointmentIn June 2020, the Company expanded its Board of Directors by appointing Susan Shiff, Ph.D., M.B.A., as a new Director. Dr. Shiff currently serves as Senior Vice President and Head of the Center for Observational and Real-World Evidence at Merck, known as MSD outside the United States and Canada.COVID-19 Impacts and Business OperationsDue to the ongoing COVID-19 pandemic and in accordance with the FDAs updated guidance for conducting clinical trials, the Company has implemented numerous clinical and operational measures to prioritize the health and safety of patients, employees and study investigators and minimize potential disruptions to its ongoing clinical studies. Cara is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for its clinical trials.Based on guidelines from the Centers for Disease Control and Prevention and the State of Connecticut, all Cara employees continue to work remotely and business travel has been restricted.Upcoming ActivitiesThe Company expects to make presentations at the following upcoming conferences: 40th Annual Canaccord Genuity Growth Conference, August 11-13, 2020 Cantor Fitzgerald Global Healthcare Conference, September 15-17, 2020 American Society of Nephrology Kidney Week, October 19-25, 2020 Stifel Healthcare Conference, November 17-18, 2020 Jefferies Global Healthcare Conference, November 17-19, 2020 Piper Sandler Health Care Conference, December 1-3, 2020Second Quarter 2020 Financial ResultsNet Loss: Net loss was 25.1 million, or 0.54 per basic and diluted share, for the three months ended June 30, 2020, compared to a net loss of 23.0 million, or 0.58 per basic and diluted share, for the same period of 2019. Revenues: Total revenue was 5.6 million for the three months ended June 30, 2020, compared to 5.2 million during the same period of 2019. Total revenue consisted of: The Company recognized 4.5 million and 5.2 million of license and milestone fees revenue for the three months ended June 30, 2020 and 2019, respectively, related to its license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. VFMCRP. The Company recognized 0.6 million of license and milestone fees revenue for the three months ended June 30, 2020 related to the achievement of a milestone related to its license agreement with Chong Kun Dang Pharmaceutical Corp. The Company recognized 0.5 million of clinical compound revenue from the sales of clinical compound for the three months ended June 30, 2020 to Maruishi Pharmaceutical Company Ltd. and VFMCRP. There were no sales of clinical compound for the three months ended June 30, 2019.Research and Development RD Expenses: RD expenses were 26.1 million for the three months ended June 30, 2020 compared to 24.4 million for the three months ended June 30, 2019. The higher RD expenses in 2020 were primarily due to increases in stock-based compensation expense, payroll and related costs and cost of clinical compound sales, partially offset by a net decrease in clinical trial costs, conferences, and travel and related costs.General and Administrative GA Expenses: GA expenses were 5.4 million for the three months ended June 30, 2020 compared to 5.0 million for the three months ended June 30, 2019. The increase in 2020 was primarily due to increases in consultants costs, legal fees, and insurance costs, partially offset by decreases in stock-based compensation expense.Other Income, Net: Other income, net was 634,000 for the three months ended June 30, 2020 compared to 947,000 for the three months ended June 30, 2019. The decrease in 2020 was due to a decrease in accretion and interest income resulting from a lower yield on our portfolio of investments in the 2020 period.Cash and Cash Equivalents and Marketable Securities Position: At June 30, 2020, cash and cash equivalents and marketable securities totaled 153.0 million compared to 218.2 million at December 31, 2019. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from cash used in operations of 66.0 million, partially offset by proceeds of 0.3 million from the exercise of stock options.Financial GuidanceBased 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 as of June 30, 2020 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into the second half of 2021, without giving effect to any potential milestone payments under existing collaborations. Conference CallCara management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 financial results and provide a business update. 