LA JOLLA, Calif., August 11, 2026
CalciMedica, Inc. reported its second-quarter 2026 financial results and provided updates across its clinical development programs, including plans to advance Auxora (zegocractin) and CM5480 in pulmonary hypertension (PH) and further develop Auxora in acute pancreatitis. The company recently completed a private placement of up to approximately $49 million in gross proceeds, including approximately $15 million in upfront proceeds, to support its pulmonary hypertension strategy. CalciMedica expects to conduct a Phase 1b proof-of-concept trial of Auxora in pulmonary arterial hypertension (PAH), with data anticipated in mid-2027, while preclinical and IND-enabling studies for the oral CRAC channel inhibitor CM5480 are progressing toward an anticipated IND submission in mid-2027. In acute pancreatitis, the company also reported that the U.S. Food and Drug Administration (FDA) aligned with the proposed Phase 2b trial design, including a primary endpoint focused on new-onset severe respiratory failure.
Pulmonary Hypertension Program Gains Financial and Clinical Support
CalciMedica is positioning its CRAC channel inhibition platform as a potential differentiated approach to pulmonary hypertension by targeting mechanisms involved in pulmonary vascular disease, inflammation and right ventricular dysfunction. The company plans to evaluate Auxora in a Phase 1b PAH trial to generate initial clinical evidence regarding its effects on pulmonary vascular and right ventricular function. Data are expected in mid-2027. CalciMedica is also advancing CM5480, an oral CRAC channel inhibitor intended for chronic treatment, through preclinical pharmacology, pharmacokinetic and safety studies. According to the company, preclinical models suggest that CRAC channel inhibition may directly protect right ventricular function, an important driver of outcomes in PH that is not directly addressed by many existing therapies. The recent financing is expected to provide resources for advancing both programs.
FDA Aligns With Auxora Phase 2b Acute Pancreatitis Strategy
CalciMedica reported that the FDA has aligned with the company’s proposed Phase 2b trial design for Auxora in acute pancreatitis following a July 2026 Type C Focused Meeting. The primary endpoint is planned to evaluate whether Auxora can reduce the development of new-onset severe respiratory failure, while key secondary endpoints will assess multi-organ failure and time until patients are medically ready for discharge. The study will also investigate whether elevated lactate dehydrogenase (LDH) can identify patients at greater risk of developing severe disease and potentially enrich the trial population. Acute pancreatitis affects a substantial number of hospitalized patients in the United States and currently has no FDA-approved therapies. However, initiation of the planned Phase 2b study remains subject to additional financing.
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Auxora and CM5480 Supported by Expanding CRAC Channel Development
Auxora is CalciMedica’s most advanced intravenous CRAC channel inhibitor and has been evaluated in more than 350 patients across multiple clinical programs involving inflammatory disease, endothelial injury and respiratory failure. In the Phase 2 CARPO trial in acute pancreatitis, the company previously reported dose-dependent reductions in time to solid food tolerance among hyper-inflamed patients, while the medium- and high-dose groups showed no new-onset severe respiratory failure compared with placebo. Auxora has also been studied in COVID-19 pneumonia and acute kidney injury with respiratory failure. Meanwhile, CM5480 is being developed as an oral, chronic-use CRAC channel inhibitor for pulmonary hypertension, with CalciMedica targeting an IND submission in mid-2027. The company believes its CRAC inhibition platform could address multiple disease mechanisms, including abnormal calcium signaling, inflammation, pulmonary vascular remodeling and right ventricular dysfunction.
CalciMedica Reports Q2 Financial Results and Upcoming Catalysts
As of June 30, 2026, CalciMedica reported $18.6 million in cash and cash equivalents, which the company expects to support its current operating plan into the second half of 2027. Second-quarter research and development expenses decreased to $2.1 million, compared with $4.1 million in the prior-year period, while general and administrative expenses declined to $1.9 million from $2.6 million. The company reported a second-quarter net loss of $7.7 million, or $0.45 per share, compared with a $6.0 million net loss in the second quarter of 2025. Key upcoming catalysts include Auxora Phase 1b PAH proof-of-concept data and a CM5480 IND submission anticipated in mid-2027, alongside continued development of Auxora in acute pancreatitis. While the FDA alignment provides a clearer regulatory path for the pancreatitis program, clinical efficacy and future financing remain important factors for the company’s development strategy.
Source:CalciMedica press release
