CalciMedica, Inc. (CALC)·Q3 2025 Earnings Summary

Executive Summary

• CALC reported Q3 2025 net loss of $7.8M and EPS of $0.52 loss; there is no product revenue. The loss widened year over year on higher non-cash other expense tied to fair-value adjustments, while operating expenses were roughly flat YoY . Versus S&P Global consensus, EPS missed: actual -$0.52 vs -$0.41 consensus (4 estimates), with revenue in line at $0 given no commercial products (consensus $0) ; EPS consensus from S&P Global*.
• Cash, cash equivalents and short-term investments were $14.1M at quarter-end; management reiterated runway into 2H 2026, but 10-Q includes a going-concern warning given funding needs beyond planned milestones .
• Clinical execution: KOURAGE Phase 2 (AKI with respiratory failure) enrollment continues; data now guided to 1H 2026 (slipped from “early 2026” in Q2 and “end of 2025” in Q1). AP pivotal design now expected finalization in 1H 2026 (pushed from “around end of 2025”) .
• Narrative catalysts: preclinical data in PAH (CM5480) published in JCI Insight and ASN AKI poster reinforce CRAC biology and support Auxora’s mechanistic rationale; AI collaboration with Telperian aims to optimize AP pivotal design .

What Went Well and What Went Wrong

What Went Well

• Reinforced scientific rationale: ASN poster showed Auxora reduced Th17 cells in kidney (-64%) and lung (-59%), lowered IL-6-producing CD4 cells (-69%), improved GFR and reduced tubular injury in AKI rat models, supporting the KOURAGE program .
• External validation: JCI Insight publication on CM5480 (Orai1 inhibitor) demonstrated improvements in pulmonary hemodynamics and right ventricular dysfunction in PAH models, bolstering the broader CRAC platform thesis and potential cardio-pulmonary benefits relevant to sepsis-associated AKI .
• Cost discipline: G&A declined YoY (-$0.4M to $1.8M) as professional services and consulting costs fell, partially offsetting higher R&D focus on clinical execution .

What Went Wrong

• EPS miss driven by non-cash items: Other expense swung to -$2.2M vs +$0.1M YoY, primarily from fair value adjustments to financial instruments and higher interest expense on the 2025 debt, contributing to the EPS shortfall .
• Timelines pushed: KOURAGE data guidance moved from “end of 2025” (Q1) to “early 2026” (Q2) to “1H 2026” (Q3); AP pivotal design shifted from “around end of 2025” (Q2) to “1H 2026,” raising execution scrutiny .
• Liquidity overhang: Despite runway to 2H 2026, 10-Q explicitly states substantial doubt about going concern without additional capital; warrant/loan fair-value volatility adds earnings noise and complicates modeling .

Financial Results

Estimate comparison (S&P Global consensus vs actual):

Note: Operating loss QoQ increased primarily due to shift in other income/expense from +$0.67M in Q2 to -$2.19M in Q3 (non-cash fair value adjustments and interest expense) .
*Values retrieved from S&P Global.

No segment reporting; company operates a single segment and has generated no product revenue .

Selected KPIs and balance sheet items:

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Enrollment continues in our Phase 2 KOURAGE trial evaluating Auxora in patients with AKI with respiratory failure, and we look forward to sharing data in the first half of 2026… discussions with the FDA have been positive regarding our program in AP… [Telperian’s] AI-driven analytics platform will enable us to… optimize the design of our pivotal trial in AP” — Rachel Leheny, Ph.D., CEO .
• “These new observations of reductions in IL-17 and IL-6 producing immune cells in animal lungs provide strong mechanistic support for Auxora as a potential treatment of severe AKI with acute hypoxemic respiratory failure.” — Sudarshan Hebbar, M.D., CMO (ASN poster) .
• “Combination therapy with CM5480 provided significantly greater benefits… suggesting Orai1 inhibition as a potential new therapeutic approach for PAH” — JCI Insight authors/CalciMedica commentary .

Q&A Highlights

• No earnings call transcript was available in the document set. Accordingly, there are no public Q&A highlights or clarifications to report for Q3 2025.

Estimates Context

• EPS missed S&P Global consensus: -$0.52 actual vs -$0.41 mean (4 estimates); revenue matched $0 as expected for a clinical-stage company . EPS consensus from S&P Global*.
• Modeling note: management attributes YoY delta to non-cash fair-value adjustments and higher interest expense on the 2025 debt; expect continued volatility in “Other income (expense)” given warrant/liability fair-value accounting .

*Values retrieved from S&P Global.

Key Takeaways for Investors

• EPS miss was driven by non-cash fair-value and interest expense, not by operating spend blowout; OpEx was stable YoY with disciplined G&A, while R&D reflects clinical execution .
• Guidance slippage for KOURAGE (now 1H 2026) and AP pivotal design (now 1H 2026) modestly extends timelines; Telperian AI work could sharpen AP trial design and de-risk endpoints/subgroups .
• Liquidity: $14.1M cash/STI and runway into 2H 2026, but 10-Q includes going-concern language; management expanded ATM capacity in November, indicating openness to opportunistic financing .
• Scientific momentum: ASN AKI and JCI Insight PAH data reinforce CRAC inhibition’s mechanistic basis and potential cardio-pulmonary benefits relevant to AKI with respiratory failure .
• Near-term catalysts: additional regulatory interactions for AP pivotal design; ongoing KOURAGE enrollment updates; financing actions (ATM utilization/tranche draws) .
• Risk alerts: warrant and loan fair-value marks will continue to impact reported EPS; financing risk remains given going-concern disclosure .