CALC

KOURAGE Trial Update: CalciMedica is currently enrolling patients in the Phase 2 KOURAGE trial for Auxora™ targeting acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026.

FDA Discussions on Acute Pancreatitis: The company has had positive discussions with the FDA regarding the design of a pivotal trial for acute pancreatitis, which is anticipated to be finalized in the first half of 2026.

Financial Position: As of September 30, 2025, CalciMedica reported a cash position of $14.1 million, expected to fund operations into the second half of 2026, despite a net loss of $7.8 million for the third quarter.

Collaboration with Telperian: CalciMedica announced a collaboration with Telperian to utilize AI-driven analytics for optimizing the design of its pivotal trial in acute pancreatitis, leveraging insights from previous Auxora trials.

CRAC Channel Inhibitor for PAH: Preclinical data suggests that CM5480, a CRAC channel inhibitor, may serve as a first-in-class therapy for pulmonary arterial hypertension (PAH), showing efficacy both as a standalone treatment and in combination with existing therapies.

Mechanism and Benefits: The study demonstrated that CM5480 significantly reduced pulmonary neomuscularization, right ventricular systolic pressure, and right ventricular hypertrophy in animal models, indicating its potential to improve cardiac function and pulmonary vascular remodeling.

Combination Therapy Efficacy: Combining CM5480 with standard PAH treatments like ambrisentan or sildenafil yielded greater therapeutic benefits than using these therapies alone, highlighting the importance of targeting multiple pathways in PAH treatment.

Implications for Acute Kidney Injury: The findings also suggest that CRAC channel inhibition could improve right ventricular dysfunction in patients with sepsis, which is a leading cause of acute kidney injury, with ongoing trials expected to provide further insights by 2026.

Auxora's Efficacy in AKI Treatment: Treatment with Auxora significantly reduced IL-17-related inflammation in kidney and lung, improved glomerular filtration rate (GFR), and decreased renal injury in a rat model of acute kidney injury (AKI).

Phase 2 KOURAGE Trial: The findings support Auxora's potential as a treatment for severe AKI with respiratory failure, currently being evaluated in the Phase 2 KOURAGE trial.

Mechanistic Insights: The study demonstrated a significant reduction in Th-17 cells and IL-6-producing CD4 cells in both kidney and lung, reinforcing the mechanistic rationale for using Auxora in critically ill patients.

CalciMedica's Focus: CalciMedica is dedicated to developing novel therapies targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases, with Auxora being their lead product candidate.