CalciMedica reports 2025 results and KOURAGE trial discontinuation

CalciMedica (NASDAQ:CALC) reported its full-year 2025 financial results on Tuesday, outlining a path forward for its lead candidate, Auxora™, despite the recent discontinuation of its primary kidney injury study.

The La Jolla-based biopharmaceutical company reported a net loss of $29.6 million, or $1.97 per share, for 2025.

This represents a significant widening from the $13.7 million loss ($1.22 per share) recorded in 2024, driven largely by elevated clinical and development costs.

As of December 31, 2025, the company held $13 million in cash and equivalents, a reserve management expects will fund operations into the fourth quarter of 2026.

The financial update follows a setback for the company’s Phase 2 KOURAGE trial, which was evaluating Auxora in patients with acute kidney injury (AKI).

The trial was discontinued following a recommendation from the Independent Data Monitoring Committee (IDMC) due to a mortality imbalance.

However, CalciMedica noted that subsequent reviews found no evidence of drug-related toxicity, providing some regulatory breathing room as the firm prepares for formal discussions with the FDA in the second quarter of 2026.

With the AKI program under review, CalciMedica is shifting its primary focus toward its acute pancreatitis (AP) program.

The company aims to finalize the design of a pivotal study for AP in the first half of 2026, seeking to capitalize on earlier data that suggested Auxora could mitigate the systemic inflammatory response often seen in severe cases of the disease.

The company also highlighted progress in its earlier-stage pipeline.

Recent preclinical data for CM5480, a treatment being developed for pulmonary arterial hypertension (PAH), were published in early 2026.

CalciMedica currently anticipates filing an Investigational New Drug (IND) application for the PAH candidate in 2027.