A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

Key Inclusion Criteria: * Female and male subjects with an age ≥18 years * Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB) * Subject has at least ONE of the following risk factors for AKI at screening: * History of LVEF \<35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan. * History of previous open chest cavity cardiac surgery with or without CPB * Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug * Age ≥70 years * Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening * Documented history of previous AKI before date of screening independent of the etiology of AKI * Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening * Documented history of albuminuria, defined as UACR \>30 mg/g or \> 30 mg/24 hour in a 24-hour urine collection. * eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation Key Exclusion Criteria: * Estimated glomerular filtration rate (eGFR) is \<30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline * Subject has surgery scheduled to be performed without CPB ("off-pump"…