CalciMedica reported third-quarter 2026 results and updates on its drug-development programs, including plans to test Auxora in pulmonary hypertension and advance an oral candidate, CM5480. The company expects initial data from the Auxora study and an investigational new drug application for CM5480 around mid-2027.
The clinical-stage biotech had $13.8 million in cash, cash equivalents and short-term investments at Sept. 30, which it expects to fund its current operating plan into the second half of 2027.
Pipeline and clinical plans
- Pulmonary hypertension: CalciMedica plans a Phase 1b proof-of-concept trial of Auxora to assess the effects of CRAC channel inhibition on heart and lung function. It expects to provide details on the trial and targeted patient group by year-end, with data anticipated in mid-2027.
- CM5480: The company is continuing preclinical and other studies of this oral CRAC channel inhibitor, intended for chronic use in pulmonary hypertension. It expects to submit an investigational new drug application in mid-2027. CalciMedica says preclinical work suggests the drug may protect right-ventricular function, but that benefit has not yet been established in patients.
- Acute pancreatitis: The FDA has aligned with CalciMedica’s proposed Phase 2b trial design for Auxora. The study will test whether selecting patients with elevated lactate dehydrogenase levels identifies people more likely to experience severe outcomes; severe respiratory failure will be the primary endpoint. The company describes this as a step in defining the next stage of development for a disease with no FDA-approved therapies.
- CalciMedica’s CEO said the company expects multiple meaningful development milestones over the next 12 months.
Finances and corporate update
- Research and development expenses were $2.3 million in the third quarter, down from $3.9 million a year earlier. For the first nine months of 2026, they were $7.9 million, compared with $12.1 million in the same period of 2025. The nine-month decrease was mainly tied to lower nonclinical and clinical-trial activity, consulting and manufacturing-related costs, partly offset by higher personnel costs.
- General and administrative expenses rose to $2.4 million in the third quarter from $1.8 million a year earlier. For the first nine months, they were $6.5 million, roughly in line with $6.6 million a year earlier.
- A 1-for-5 reverse stock split took effect for trading on Aug. 31. It reduced the number of issued and outstanding shares from about 34.5 million to about 6.9 million and brought the company into compliance with Nasdaq’s minimum bid-price requirement.
The disclosed cash runway is tied to CalciMedica’s current operating plan. The update gives expected timing for key pulmonary-hypertension milestones, while the proposed acute-pancreatitis trial approach is intended to identify a more severe patient group and measure severe respiratory failure.