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CalciMedica, Inc.

CALC
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Business Summary

CalciMedica, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for serious illnesses driven by inflammatory and immunologic processes and direct cellular damage . The company's product candidates target calcium release-activated calcium ("CRAC") channels, representing a new class of therapeutics . Dysregulated CRAC channel signaling has been implicated in a range of acute and chronic diseases characterized by immune activation, inflammation, and cellular injury . The company seeks to leverage its CRAC channel inhibitor platform to develop therapies for indications where these pathways are clinically relevant .

The core business model of CalciMedica, Inc. is centered on the discovery and development of CRAC channel inhibitors, with a strategy to advance therapies for acute critical illnesses with high unmet medical need, while selectively expanding its platform into chronic inflammatory and immunologic diseases . The company generates revenue through equity offerings, debt financings, and potentially grants, collaborations, or licenses, as it has never generated any revenue from product sales . Primary customer segments, once products are commercialized, would include physicians, patients, hospitals, and healthcare payors .

CalciMedica's lead product candidate is Auxora, a potent and selective, intravenously formulated small-molecule CRAC channel inhibitor containing the active compound zegocractin . Auxora has been evaluated in multiple Phase 2 clinical trials across acute critical care settings, including acute pancreatitis ("AP"), severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity ("AIPT"), and acute kidney injury ("AKI") with associated acute hypoxemic respiratory failure ("AHRF") . The company is continuing development activities in AP and expects to finalize the pivotal program design in the first half of 2026 . In January 2026, the KOURAGE Phase 2 clinical trial evaluating Auxora in patients with AKI and AHRF was discontinued due to a safety concern relating to a mortality imbalance .

Another product candidate in the pipeline is CM5480, a CRAC channel inhibitor being advanced for the treatment of pulmonary arterial hypertension ("PAH") . Preclinical data support the potential application of CRAC channel inhibition in both chronic and acute inflammatory and immunologic diseases, including PAH, chronic pancreatitis, rheumatoid arthritis, ulcerative colitis, allergic asthma, and traumatic brain injury . Submission of an Investigational New Drug application ("IND") for CM5480 is currently anticipated in 2027 .

For the fiscal year ended December 31, 2025, CalciMedica, Inc. reported a net loss of $29.6 million . As of December 31, 2025, the company had an accumulated deficit of $189.3 million and $13.0 million in cash, cash equivalents, and short-term investments . The filing does not provide specific figures for total revenue, gross profit, gross margin percentage, operating income, operating margin, basic and diluted EPS, total debt, or net debt for the reported fiscal period.

The company's operational developments include the discontinuation of the KOURAGE Phase 2 clinical trial in January 2026 due to a safety concern related to a mortality imbalance, although the Independent Data Monitoring Committee did not identify evidence of drug-related toxicity . The company plans to discuss the KOURAGE data and potential future development in AKI with the FDA in the second quarter of 2026 . In October 2024, the company presented late-breaking data from the CARPO Phase 2b trial in AP, which met its primary objective by demonstrating a statistically significant dose response in median time to solid food tolerance in a prespecified subgroup of patients with hyper-inflamed AP .

Business Outlook

CalciMedica, Inc. expects to finalize the design for a potential pivotal program in Acute Pancreatitis (AP) in the first half of 2026 and, subject to funding, be in a position to initiate that program later in 2026 . The company plans to discuss the KOURAGE data and potential future development in Acute Kidney Injury (AKI) with the FDA in the second quarter of 2026 . The filing does not provide specific revenue, margin, or EPS guidance for the upcoming period.

A major growth vector for CalciMedica is the advancement of Auxora toward potential pivotal development in AP, a serious inflammatory condition with no approved disease-modifying therapies . Based on results from completed Phase 2a and Phase 2b clinical trials, the company believes a future pivotal program may focus on patients at highest risk for severe disease and organ failure . The consistency of treatment effects observed across multiple clinically meaningful endpoints supports the use of a hierarchical composite endpoint incorporating mortality, respiratory failure, and recovery measures, such as time to medically indicated discharge . Auxora has received Fast Track designation from the FDA and orphan drug designation in the European Union from the EMA for the treatment of AP .

Another growth vector is the advancement of CM5480 for Pulmonary Arterial Hypertension (PAH) . CM5480 is a small-molecule CRAC channel inhibitor, and the company is currently conducting IND-enabling activities, with submission of an IND application currently anticipated in 2027 . Preclinical studies have shown that inhibition of Orai1-mediated CRAC channel activity was associated with improvements in pulmonary hemodynamics, attenuation of pulmonary vascular remodeling, and preservation of right ventricular structure and function in animal models of PAH .

Operationally, the company expects to continue selective research activities to further evaluate CRAC channel inhibition across other inflammatory and immunologic indications, depending on financing . The company believes its completed respiratory failure studies provide clinically relevant insights into the role of CRAC channel inhibition in acute respiratory failure and may inform future development strategies . The company also plans to generate additional clinical experience with Auxora in pediatric AIPT through an ongoing investigator-initiated Phase 1/2 clinical trial, with an update expected in 2026 .

The company's planned capital allocation includes continued investment in research and development activities, with eight of its 16 full-time employees primarily engaged in these activities as of December 31, 2025 . The company will need substantial additional funding to complete the development and any commercialization of its product candidates, as its existing resources are believed to be sufficient to fund current operations through certain clinical milestones into the fourth quarter of 2026 . The company intends to finance its cash needs through equity offerings, debt financings, or other capital sources, including potentially grants, collaborations, or licenses .

Management has explicitly flagged several structural headwinds and execution risks to the growth plan. The company has a history of net losses and anticipates incurring significant losses in the future, never having generated revenue from product sales . The need for additional capital raises substantial doubt about its ability to continue as a going concern, and if unable to raise capital when needed, the company may be forced to delay, reduce, or eliminate development programs . The terms of the Loan Agreement with Avenue Venture Opportunities Fund, which provided an initial growth capital loan of $10,000,000 funded on March 3, 2025 , place restrictions on operating and financial flexibility .

Risk Factors

CalciMedica, Inc. faces substantial risks, including its limited operating history, a history of net losses, and the need for significant additional funding, which raises substantial doubt about its ability to continue as a going concern . The company's ability to use its federal net operating loss carryforwards of approximately $315.4 million may be limited by ownership changes under Sections 382 and 383 of the Internal Revenue Code . The terms of its Loan Agreement with Avenue Venture Opportunities Fund restrict operating and financial flexibility, and any new debt could further limit this flexibility . The company's proprietary CRAC channel inhibition science is novel and unproven, exposing it to unforeseen risks and making it difficult to predict development time and cost . Clinical development is lengthy, expensive, and uncertain, with preclinical and early clinical trial results not always predictive of future outcomes . The discontinuation of the KOURAGE Phase 2 trial due to a mortality imbalance highlights the risk of unexpected safety concerns . The company relies on third parties for most research, preclinical studies, and clinical trials, and for manufacturing and supply, increasing the risk of delays, increased costs, or quality issues, especially with a single source supplier in China for one component of Auxora . International trade policies, including tariffs and sanctions like the BIOSECURE Act, may adversely affect the business, particularly given foreign suppliers . The market price of the company's stock has been and may continue to be volatile due to various factors, including clinical trial results and competitive developments .

Management Priorities

Management's message to shareholders emphasizes the company's focus as a clinical-stage biopharmaceutical company on the discovery and development of CRAC channel inhibitors, aiming to advance therapies for acute critical illnesses with high unmet medical need while selectively expanding into chronic inflammatory and immunologic diseases . The company's strategic priorities include advancing Auxora toward potential pivotal development in Acute Pancreatitis, evaluating potential future development of Auxora in Acute Kidney Injury with associated Acute Hypoxemic Respiratory Failure following the discontinuation of the KOURAGE trial, and advancing CM5480 for Pulmonary Arterial Hypertension . Management explicitly states that based on current operating plans, existing resources are believed to be sufficient to fund current operations through certain clinical milestones into the fourth quarter of 2026 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Overview
  5. [5] Item 1, Business — Our Strategy
  6. [6] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
  7. [7] Item 1, Business — Sales and Marketing
  8. [8] Item 1, Business — Overview
  9. [9] Item 1, Business — Overview
  10. [10] Item 1, Business — Overview
  11. [11] Item 1, Business — Overview
  12. [12] Item 1, Business — Overview
  13. [13] Item 1, Business — Overview
  14. [14] Item 1, Business — Overview
  15. [15] Item 1A, Risk Factors — We are a clinical-stage biopharmaceutical company with a limited operating history. We have a history of net losses and anticipate that we will incur significant losses in the future. We have never generated any revenue from product sales and may never be profitable.
  16. [16] Item 1A, Risk Factors — We are a clinical-stage biopharmaceutical company with a limited operating history. We have a history of net losses and anticipate that we will incur significant losses in the future. We have never generated any revenue from product sales and may never be profitable.
  17. [17] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
  18. [18] Item 1, Business — Overview
  19. [19] Item 1, Business — Overview
  20. [20] Item 1, Business — Auxora for the Treatment of Acute Pancreatitis
  21. [21] Item 1, Business — Our Strategy
  22. [22] Item 1, Business — Our Strategy
  23. [23] Item 1, Business — Our Strategy
  24. [24] Item 1, Business — Implications for Pivotal Program Design in AP
  25. [25] Item 1, Business — Implications for Pivotal Program Design in AP
  26. [26] Item 1, Business — Auxora for the Treatment of AP
  27. [27] Item 1, Business — Our Strategy
  28. [28] Item 1, Business — Our Strategy
  29. [29] Item 1, Business — CM5480 for the Treatment of Pulmonary Arterial Hypertension
  30. [30] Item 1, Business — Overview
  31. [31] Item 1, Business — Our Strategy
  32. [32] Item 1, Business — Our Strategy
  33. [33] Item 1, Business — Employees and Human Capital Resources
  34. [34] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
  35. [35] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
  36. [36] Item 1A, Risk Factors — We are a clinical-stage biopharmaceutical company with a limited operating history. We have a history of net losses and anticipate that we will incur significant losses in the future. We have never generated any revenue from product sales and may never be profitable.
  37. [37] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
  38. [38] Item 1A, Risk Factors — We are a clinical-stage biopharmaceutical company with a limited operating history. We have a history of net losses and anticipate that we will incur significant losses in the future. We have never generated any revenue from product sales and may never be profitable.
  39. [39] Item 1A, Risk Factors — Any acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities or subject us to other risks.
  40. [40] Item 1A, Risk Factors — The terms of the Loan Agreement place restrictions on our operating and financial flexibility.
  41. [41] Item 1A, Risk Factors — Summary of risks associated with our business
  42. [42] Item 1A, Risk Factors — Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  43. [43] Item 1A, Risk Factors — Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  44. [44] Item 1A, Risk Factors — The terms of the Loan Agreement place restrictions on our operating and financial flexibility.
  45. [45] Item 1A, Risk Factors — Our proprietary CRAC channel inhibition science is based on novel technologies that are unproven and may not result in approvable or marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval and we may not be successful in our efforts to use and expand our science to build a pipeline of product candidates.
  46. [46] Item 1A, Risk Factors — Clinical development is a lengthy, expensive and uncertain process.
  47. [47] Item 1A, Risk Factors — SAEs, undesirable side effects or other unexpected properties of our product candidates could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates thereby limiting the commercial potential of such product candidate.
  48. [48] Item 1A, Risk Factors — We contract with third parties for the manufacturing and supply of certain goods and services for our product candidates for use in preclinical studies and clinical trials, which supply may become limited or interrupted or may not be of satisfactory quality and quantity.
  49. [49] Item 1A, Risk Factors — International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  50. [50] Item 1A, Risk Factors — The market price of our stock has been and may continue to be volatile, and you could lose all or part of your investment.
  51. [51] Item 1, Business — Our Strategy
  52. [52] Item 1, Business — Our Strategy
  53. [53] Item 1A, Risk Factors — Our need for additional capital raises substantial doubt about our ability to continue as a going concern.

Analysis on 5/20/2026