CalciMedica, Inc.
For the period ended Aug 11, 2026. Filed Aug 11, 2026.
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Aug 11, 2026 · Filed Aug 11, 2026
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Contents
EX-99.1 · Recent Program Highlights:
Recent Program Highlights:
Pulmonary Hypertension (PH) Program Update
Private placement financing to advance PH strategy: On June 24, 2026, CalciMedica announced a private placement of up to approximately $49 million in gross proceeds, including approximately $15 million in upfront gross proceeds. The proceeds are expected to support the advancement of Auxora and CM5480 as part of the Company’s pulmonary hypertension strategy.
Auxora Phase 1b proof-of-concept trial in PAH planned: CalciMedica plans to evaluate Auxora in a Phase 1b trial in patients with pulmonary arterial hypertension to generate initial clinical evidence regarding the effects of CRAC channel inhibition on pulmonary vascular and right ventricular function. Data are anticipated in mid-2027.
CM5480 preclinical and IND-enabling studies advancing: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety profile of CM5480, CalciMedica’s oral CRAC channel inhibitor candidate for chronic use in PH. Preclinical data suggest CM5480 may be differentiated by directly protecting right ventricular function, a key driver of outcomes in PH that is not directly targeted by existing therapies. An IND submission is anticipated in mid-2027.
Acute Pancreatitis (AP) Program Update
FDA alignment on Phase 2b trial design: On July 29, 2026, following a Type C Focused Meeting, CalciMedica announced that FDA aligned with the Company’s Phase 2b trial design for Auxora in AP. The primary endpoint will measure whether Auxora can reduce the development of new‑onset severe respiratory failure. Key secondary endpoints will include multi-organ failure and the time until patients are medically ready for discharge. The trial will also evaluate whether elevated lactate dehydrogenase (LDH) can identify patients at higher risk of developing severe disease. AP is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S.1
Mechanistic Data from the Phase 2 CARDEA Trial
Publication in the Journal of Clinical Investigation: On July 28, 2026, the Journal of Clinical Investigation published a study titled "The CRAC Channel Inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell Circuits in Viral Pneumonia". The publication combines findings from an exploratory mechanistic study conducted alongside the Phase 2 CARDEA trial in severe COVID-19 pneumonia with laboratory studies of human immune cells. Together the results provide additional evidence that Auxora modulates key inflammatory pathways involved in lung injury, strengthening the scientific rationale for CRAC channel inhibition in inflammatory lung diseases.
1 Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2022;162(2):621-644.
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