Core Insights - CalciMedica is advancing its clinical programs, particularly the Phase 2 KOURAGE trial for Auxora in acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026 [1][5] - Positive discussions with the FDA regarding a pivotal trial in acute pancreatitis (AP) are ongoing, with final trial design anticipated in the first half of 2026 [1][2] - The company's cash position is projected to support operations into the second half of 2026 [1][8] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with Stage 2 or Stage 3 AKI with respiratory failure, with results expected in 1H 2026 [5] - Recent animal model data presented at ASN Kidney Week 2025 supports the efficacy of Auxora in improving kidney function and reducing renal injury [5][7] - Collaboration with Telperian aims to utilize AI-driven analytics to enhance the design of the pivotal trial in AP [2][6] Financial Results - As of September 30, 2025, CalciMedica reported cash, cash equivalents, and short-term investments totaling $14.1 million [8] - Research and development expenses for Q3 2025 were $3.9 million, up from $3.6 million in Q3 2024, primarily due to increased clinical trial activities [9] - General and administrative expenses decreased to $1.8 million in Q3 2025 from $2.2 million in Q3 2024 [10] - The net loss for Q3 2025 was $7.8 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.50 per share, in Q3 2024 [12]

Accessibility StatementSkip Navigation Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing treatments Cardiac benefit supports the mechanistic rationale for CRAC channel inhibition in acute kidney injury (AKI), being evaluated in the Phase 2 KOURAGE trial with data expected in 1H 2026 LA JOLLA, Calif., Nov. 12, 2025/PRNewswire/ -- CalciMedica Inc. ("Calci ...

Core Insights - CalciMedica's Auxora has shown significant potential in reducing IL-17-related inflammation and improving kidney function in a rat model of acute kidney injury (AKI) [1][3][6] - The company is currently evaluating Auxora in the Phase 2 KOURAGE trial for severe AKI with respiratory failure, reinforcing its therapeutic potential [1][4] Study Findings - In a study involving rat models of ischemia/reperfusion-induced AKI, Auxora (16 mg/kg) was administered intravenously, leading to a significant increase in glomerular filtration rate (GFR) and a reduction in renal injury [2][6] - Three-day dosing of Auxora resulted in a 64% reduction in Th-17 cells in the kidney and a 59% reduction in the lung, along with a 69% decrease in IL-6-producing CD4 cells [6] Mechanistic Support - The study provided strong mechanistic support for Auxora as a treatment for severe AKI with acute hypoxemic respiratory failure (AHRF), highlighting the correlation between elevated IL-17 levels and adverse kidney events [3][4] - Down-regulation of IL-17 may be crucial in mitigating multi-organ failure, which is common in critically ill patients with severe AKI [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases, with a proprietary technology aimed at modulating immune responses [5][7] - The company has conducted multiple efficacy clinical trials for Auxora, which has been well-tolerated in over 350 critically ill patients [7]