Cara Therapeutics(US:CARA)2021-05-11 03:37Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities totaled $228.3 million as of March 31, 2021, down from $251.5 million at December 31, 2020, primarily due to cash used in operating activities of $23.7 million [26] - Net loss for Q1 2021 was $23.3 million or $0.47 per share, compared to a net loss of $28.9 million or $0.62 per share for the same period in 2020 [27] - Total revenue for Q1 2021 was $1.9 million, a decrease from $8.1 million in Q1 2020, with revenue related to a milestone payment from Maruishi Pharmaceutical [27] Business Line Data and Key Metrics Changes - Research and development expenses were $19.1 million for Q1 2021, down from $33.5 million in the same period of 2020, mainly due to decreased clinical trial costs [28] - General and administrative expenses increased to $6.4 million in Q1 2021 from $4.6 million in Q1 2020, attributed to higher stock compensation and payroll costs [28] Market Data and Key Metrics Changes - The European Medicines Agency accepted the Marketing Authorization Application for difelikefalin Injection for chronic kidney disease-related pruritus, with a decision expected in Q2 2022 [11] Company Strategy and Development Direction - The company is focused on the U.S. launch of KORSUVA Injection in the second half of 2021, supported by a commercial license agreement with Vifor Pharma [8][9] - Plans to initiate Phase 3 programs for Oral KORSUVA in mild to moderate atopic dermatitis and pre-dialysis CKD patients by year-end [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date of August 23, 2021, for KORSUVA Injection, with no current issues regarding site inspections [32] - The company aims to leverage existing data from hemodialysis patients to support the approval of Oral KORSUVA in pre-dialysis CKD patients [49] Other Important Information - The company expects its existing cash and equivalents to fund operations into 2023 without considering potential milestone payments or product revenue [29] - The company is implementing measures to minimize disruptions to clinical studies due to the COVID-19 pandemic [19] Q&A Session Summary Question: Any CMC site inspection issues regarding KORSUVA Injection? - Management indicated no current issues with site inspections and remains on track for the PDUFA date [32] Question: Insights on the oral CKD trial and Stage 5 patient population? - Management noted that Stage 5 patients have similar prevalence rates of pruritus as hemodialysis patients, indicating a strong potential for Oral KORSUVA [32] Question: How does the company view the potential for KORSUVA Injection compared to Parsabiv? - Management believes KORSUVA Injection has a better positioning as a first-in-class medication for hemodialysis patients, with significant unmet needs [40] Question: What is the expected placebo response rate in the PBC trial? - Management expects a more controlled placebo response in PBC patients due to the consistency of pruritus in this population [54] Question: Will Stage 4 patients be included in the Phase 3 program? - Management is in discussions with the FDA to include Stage 4 patients alongside Stage 5 in the Phase 3 program [58] Question: How will the commercialization strategy differ between Oral KORSUVA and KORSUVA Injection? - Management indicated that capturing pre-dialysis patients earlier in the treatment cycle would enhance the commercialization strategy [50]