CalciMedica, Inc.

CalciMedica, Inc. is a clinical-stage biopharmaceutical company developing therapies for serious inflammatory and immunologic diseases driven by calcium signaling and direct cellular injury. Its core scientific focus is inhibition of calcium release-activated calcium, or CRAC, channels, which the company believes could create a new class of therapeutics. The lead program is Auxora, an intravenously formulated small-molecule CRAC channel inhibitor containing zegocractin, which has been studied in acute critical care settings such as acute pancreatitis, severe COVID-19 pneumonia, pediatric asparaginase-induced pancreatic toxicity, and acute kidney injury with acute hypoxemic respiratory failure. The company is still in development mode, has no approved products, and is working toward a potential pivotal program in acute pancreatitis while relying on external capital and contract manufacturers.

3.58

3.58

— CalciMedica, Inc.
%
Lead clinical asset: Auxora100% Auxora is the company's lead IV small-molecule CRAC channel inhibitor being developed for acute inflammatory and tissue-injury settings.
CRAC channel inhibitor platform0% The platform includes discovery and development of therapies that modulate CRAC channel signaling across multiple indications.
Clinical development programs0% This includes Phase 2 and planned pivotal clinical work in acute pancreatitis and other critical care indications.
Preclinical and translational research0% Earlier-stage work supporting new indications and mechanism validation for CRAC inhibition.

CalciMedica does not yet have commercial customers because it has no approved products or product sales...

  • Clinical trial sites and investigatorsprimary

    Hospitals and research centers that run Auxora trials and generate the clinical data needed for regulatory advancement.

  • Regulatory agenciesprimary

    The FDA and other regulators that review trial design, safety, and efficacy before any commercialization can occur.

  • Potential hospital buyersemerging

    If approved, hospitals and health systems would buy Auxora for acute care use in serious inflammatory conditions.

  • Pharmaceutical collaboratorssecondary

    Potential partners that may provide funding, development support, or commercialization capabilities.

CalciMedica is headquartered in La Jolla, California, and its operations are centered in the United States...

  • •Headquartered in La Jolla, California, United States
  • •Primary regulatory and corporate activity is U.S.-based
  • •Clinical development is centered on U.S. trial and FDA interactions
  • •Manufacturing is outsourced to third-party CMOs rather than owned plants
  • •Global supply-chain and geopolitical disruptions can affect trial execution

The company’s near-term strategy is to advance Auxora in acute pancreatitis and finalize the design of a potential...

01
Finalize pivotal program design for acute pancreatitisshort-term

A clear FDA-aligned pivotal path is necessary to move Auxora from Phase 2 evidence toward potential approval.

02
Secure additional financingshort-term

The company states current cash is insufficient to fund development through approval, making capital access essential.

03
Expand development through partnershipsmedium-term

Collaborations could provide non-dilutive funding, development expertise, and future commercialization support.

CalciMedica faces the classic risks of a clinical-stage biotech: it has no product revenue, a limited operating...

critical

Clinical development failure for Auxora

The company’s value is concentrated in a single lead asset that must prove safety and efficacy in pivotal studies.

Scope
Lead program in acute pancreatitis and other critical care indications
Materiality
high
critical

Going-concern and financing risk

Management disclosed that current cash may not fund operations for the next year and that substantial additional capital is required.

Scope
All R&D and corporate operations
Materiality
high
high

Regulatory risk

The FDA may require additional data, different endpoints, or larger trials before approval can be pursued.

Scope
Pivotal program design and approval pathway
Materiality
high
high

Third-party manufacturing and trial execution risk

The company relies on CMOs and external research organizations rather than owning manufacturing or trial infrastructure.

Scope
Drug supply, clinical materials, and study operations
Materiality
medium
medium

Competitive risk

Other companies may develop more effective, safer, or faster-to-market treatments for the same indications.

Scope
Acute pancreatitis and critical care markets
Materiality
medium
Research and development cost accruals
Can materially shift quarterly operating loss and liabilities
Going-concern assessment
Affects investor assessment of liquidity and solvency
Stock-based compensation
Impacts reported losses and dilution analysis
Financing and debt/equity issuance accounting
Affects cash flow, dilution, and financing-related expenses

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