CalciMedica, Inc.

What they do

CalciMedica is developing two CRAC channel inhibitors: Auxora (zegocractin, formerly CM4620), an intravenous small molecule evaluated in Phase 2 trials in acute pancreatitis, severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity and acute kidney injury, and CM5480, an oral small molecule in preclinical development for chronic pulmonary hypertension. The company has no approved products and reports no product revenue, funding operations through equity issuances. Its lead near-term activity is preparation of a Phase 2b trial of Auxora in acute pancreatitis and a Phase 1b proof-of-concept trial in pulmonary arterial hypertension.

Revenue drivers

• Auxora (intravenous CRAC channel inhibitor) — Lead clinical candidate with no approved indication and no revenue; Phase 2b planning in acute pancreatitis is subject to obtaining additional financing, and a Phase 1b PAH study is planned with data expected mid-2027.
• CM5480 (oral CRAC channel inhibitor) — Preclinical candidate for chronic pulmonary hypertension; IND submission anticipated in mid-2027, so it generates no revenue and requires continued R&D spending.
• Equity financing proceeds — The company's primary source of funds is equity issuance, including a June 24, 2026 private placement of up to approximately $49 million in gross proceeds with approximately $15 million upfront.

Recent performance

CalciMedica reported a net loss of $29.6 million for fiscal 2025, compared with a net loss of $13.7 million for 2024. Operating cash use was $21.2 million in 2025 and $21.1 million in 2024. As of June 30, 2026, the company reported total assets of $19.5 million, total liabilities of $14.0 million, shareholder equity of $5.5 million and cash and equivalents of $18.6 million. In January 2026, enrollment in the KOURAGE Phase 2 trial of Auxora in acute kidney injury and acute hypoxemic respiratory failure was paused after an IDMC recommendation due to a mortality imbalance; the company later submitted a protocol amendment and stated the FDA issued no clinical hold communication.

Strategy

The company said the June 2026 private placement proceeds are expected to support its pulmonary hypertension strategy, including a planned Auxora Phase 1b proof-of-concept trial in PAH and continued development of CM5480 as an oral chronic therapy. Following a July 2026 Type C meeting, it aligned with the FDA on a Phase 2b acute pancreatitis trial using new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints and LDH as a potential enrichment marker. Initiation of the Phase 2b trial is subject to obtaining additional financing. Management expects Auxora PAH data and the CM5480 IND submission both in mid-2027.

Risks

• No approved products or revenue — CalciMedica has no product revenue and depends on external financing, with operating cash use of $21.2 million in 2025 against $18.6 million of cash and equivalents at June 30, 2026.
• Clinical safety and trial design risk — Enrollment in the KOURAGE Phase 2 trial in AKI and AHRF was paused in January 2026 after an IDMC recommendation citing a mortality imbalance, requiring protocol revisions to patient inclusion criteria and stratification.
• Financing-dependent trial initiation — The company states that initiation of the Auxora Phase 2b acute pancreatitis trial is subject to its ability to obtain additional financing.
• Early-stage pipeline concentration — The pipeline consists of Auxora, which has completed only Phase 2 trials in several indications, and CM5480, which remains preclinical with an IND submission not anticipated until mid-2027.

Outlook

Management expects multiple catalysts over the next 12 months, including Auxora Phase 1b proof-of-concept data in PAH and an IND submission for CM5480, both anticipated in mid-2027. The company is advancing preparations for the Auxora Phase 2b trial in acute pancreatitis, including engaging a contract research organization and holding discussions with potential clinical sites, subject to additional financing. It also plans continued selective research into CRAC channel inhibition in other inflammatory, immunologic and cardiopulmonary indications.