CalciMedica, Inc. (CALC)·Q2 2025 Earnings Summary

Executive Summary

• Q2 delivered expected clinical execution but a modest EPS miss versus consensus; GAAP net loss was $6.0M (-$0.40 per share) vs. Q2 2024 net loss of $4.0M (-$0.36), with the delta primarily driven by lower non-cash fair value gains and higher G&A . Against S&P Global consensus, EPS of -$0.40 came in below -$0.35*, while revenue remained non-material in line with a $0.0* estimate .
• Clinical catalysts advanced: enrollment in the Phase 2 KOURAGE trial (AKI with respiratory failure) continues; timing was updated from “around end of 2025” to “early 2026,” extending the catalyst window modestly .
• Acute pancreatitis (AP) path forward clarified: initial FDA meeting held; the company anticipates alignment on a pivotal U.S. trial design around end of 2025, marking tangible regulatory progress .
• Liquidity sufficient into mid-2026, reducing near-term financing overhang; quarter-end cash and investments were $18.0M and runway guided “into the middle of 2026” .

What Went Well and What Went Wrong

• What Went Well

  • KOURAGE execution and scientific validation: Enrollment ongoing; AJN and Thrombosis Update publications plus a Vicenza symposium reinforced the mechanistic and clinical rationale for Auxora in AKI with respiratory failure .
  • FDA engagement on AP: A constructive initial FDA meeting occurred; management expects alignment on a pivotal trial design around end of 2025, a key step toward first-ever U.S. pivotal study in AP .
  • Balance sheet visibility: Cash/investments of $18.0M and runway into mid-2026 help bridge to AKI Phase 2 readout and AP pivotal alignment milestones . Quote: “We look forward to the readout of our Phase 2 KOURAGE trial expected in early 2026… [and] alignment on a pivotal trial around the end of 2025.” – CEO Rachel Leheny .

• What Went Wrong

  • EPS miss: Q2 GAAP EPS of -$0.40 was below S&P Global consensus of -$0.35*, driven by lower non-cash fair value gains and increased G&A y/y .
  • Timing slippage for KOURAGE: Data timing moved from “around the end of 2025” (Q1 view) to “early 2026,” modestly pushing out the core AKI catalyst .
  • Operating leverage remains limited pre-revenue: Net loss increased y/y to $6.0M as non-cash other income normalized vs. prior periods; revenue remains non-material at this stage .

Financial Results

Results vs prior periods (oldest → newest)

Q2 2025 vs Estimates (S&P Global)

Liquidity and shares (oldest → newest)

Notes: Consensus values marked with * are Values retrieved from S&P Global.

Segment breakdown / KPIs: The company is pre-commercial; no revenue segments. Key KPIs remain operating expenses, cash runway, and clinical enrollment/milestone timing .

Guidance Changes

No quantitative revenue/EPS/OpEx guidance was provided; guidance is primarily clinical and runway-related .

Earnings Call Themes & Trends

(Using prior two quarters’ communications; no transcript available for a Q2 call)

Management Commentary

• “We look forward to the readout of our Phase 2 KOURAGE trial expected in early 2026… Additionally, we are encouraged by our initial meeting with the FDA regarding our program in AP… with the objective of reaching alignment on a pivotal trial around the end of 2025.” – Rachel Leheny, Ph.D., CEO .
• On scientific rationale strengthening: publications in AJN and Thrombosis Update and multiple medical presentations bolster Auxora’s profile in AKI and AP .
• Runway: “Cash, cash equivalents, and short-term investments were $18.0 million… sufficient to fund… into the middle of 2026.” .

Q&A Highlights

• No Q2 2025 earnings call transcript was available in our document set; we found no transcript to extract Q&A themes. The company’s updates were conveyed via the 8-K/press release and additional press communications .

Estimates Context

• EPS: Q2 actual -$0.40 missed S&P Global consensus -$0.35*; the miss largely reflects lower non-cash fair value gains and modestly higher G&A y/y, per the release .
• Revenue: No product revenue reported; in line with S&P Global consensus of $0.0* .
• Estimate detail: EPS estimates count = 4*; revenue estimates count = 4*.
  Notes: Consensus values marked with * are Values retrieved from S&P Global.

Key Takeaways for Investors

• KOURAGE timing nudged to early 2026; investors should recalibrate catalyst timelines accordingly while noting enhanced scientific validation during Q2 (AJN/Thrombosis Update/Vicenza) .
• AP program de-risked on regulatory path: initial FDA meeting completed; alignment on pivotal design expected around end 2025, a key inflection for this second indication .
• Liquidity into mid-2026 reduces near-term financing risk; Avenue Capital facility remains an incremental option should milestones be met .
• Q2 EPS miss vs consensus was driven by noisy non-cash items normalizing y/y and higher G&A; core R&D spend is consistent with trial execution .
• Near-term stock drivers: any updates on KOURAGE enrollment pace, AP FDA feedback, and additional peer-reviewed data or conference presentations that further validate Auxora’s mechanism and clinical utility .
• Medium-term thesis: A positive KOURAGE readout combined with an agreed AP pivotal design could establish a multi-indication pipeline with first-mover potential in AP and a high-need AKI segment; timing risk remains the primary overhang alongside funding for later-stage development .

Appendices

Additional Q2 2025 Financial Detail (from condensed statements)

Clinical/Regulatory Milestones Referenced

• KOURAGE (AKI with respiratory failure) Phase 2: Enrollment ongoing; data now expected early 2026 .
• AP (with SIRS): Initial FDA meeting completed; anticipate alignment on pivotal design around end 2025 .
• Publications and scientific presentations: AJN design/rationale paper; Thrombosis Update biomarker analysis; Vicenza symposium; ASN presentation .

Citations:

• Q2 2025 8-K and Exhibit 99.1 press release:
• Q2 2025 company press release distribution:
• Q1 2025 8-K/press release:
• FY 2024 press release for context:
• AJN publication press release:
• Vicenza symposium press release:

Notes: Consensus values marked with * are Values retrieved from S&P Global.