CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY

Advancing CRAC channel inhibition.

Developing investigational treatments for pulmonary hypertension and acute pancreatitis: intravenous Auxora for hospital-based use and oral CM5480, designed for chronic treatment.

View our pipeline View corporate presentation

AuxoraIV · clinical-stage

CM5480Oral · preclinical / IND-enabling

FIG. 1 — CRAC CHANNEL BIOLOGYORAI1 / STIM1

01 / 05

Resting state

Calcium stores are maintained and Orai1 remains closed.

Read the five stages

01Scientific rationale

Targeting persistent CRAC channel signaling in disease.

CRAC channel signaling is mediated by Orai1 channels activated by STIM1, a calcium sensor in the endoplasmic reticulum. In disease, sustained Orai1-mediated calcium influx can create a pathologic signal associated with inflammation, tissue injury, microvascular dysfunction, and vascular and ventricular remodeling.

Normal signaling

STIM1 senses calcium depletion within the endoplasmic reticulum and activates Orai1, enabling tightly regulated calcium entry.

Disease overactivation

Persistent receptor signaling and cellular stress can drive sustained Orai1-mediated calcium influx, creating a pathologic calcium signal.

CRAC channel inhibition

CalciMedica's compounds are designed to inhibit persistent CRAC channel activity and reduce disease-associated calcium signaling.

02Therapeutic focus

One pathway. Two distinct treatment settings.

CalciMedica is advancing CRAC channel inhibition in pulmonary hypertension and acute pancreatitis, spanning hospital-based intravenous treatment with Auxora and chronic oral treatment with CM5480.

Cardiopulmonary disease

Pulmonary Hypertension

No approved therapies directly target the RVKey therapeutic gap

Pulmonary hypertension places a sustained load on the right ventricle. CalciMedica is investigating CRAC channel inhibition to address pulmonary vascular disease and preserve right-ventricular function.

Initial development programs: PAH + CpcPH-HFpEF
Auxora PAH IND submission anticipated 2H 2026; Phase 1b data anticipated mid-2027
CM5480 IND submission in pulmonary hypertension anticipated mid-2027

Explore Pulmonary Hypertension

Acute critical illness

Acute Pancreatitis

No approved drug therapyCurrent treatment remains supportive

Acute pancreatitis accounted for approximately 255,000 U.S. hospital admissions in 2021 and can progress to respiratory failure, multi-organ failure, and pancreatic necrosis.

CARPO Phase 2b completed in 216 patients
New-onset severe respiratory failure was 0% in the medium- and high-dose Auxora groups versus 8.5% with placebo
FDA alignment on the design of a planned Phase 2b study using new-onset severe respiratory failure as the primary endpoint

Explore Acute Pancreatitis

03Pipeline

A focused pipeline of two differentiated CRAC channel inhibitors.

Auxora is an intravenous clinical-stage CRAC channel inhibitor for hospital-based use. CM5480 is a next-generation oral CRAC channel inhibitor in preclinical and IND-enabling development for chronic treatment.

Program progressFuture stage

Pulmonary Hypertension

AuxoraIV

Pulmonary Arterial Hypertension

Preclinical / IND-enablingPhase 1Phase 2Phase 3

IND submission anticipated 2H 2026 · Phase 1b data anticipated mid-2027

Phase 1b trial not yet initiated.

CM5480Oral

Pulmonary Arterial Hypertension

Preclinical / IND-enablingPhase 1Phase 2Phase 3

Preclinical and IND-enabling studies ongoing · IND submission anticipated mid-2027

CM5480Oral

CpcPH-HFpEF

Preclinical / IND-enablingPhase 1Phase 2Phase 3

Preclinical and IND-enabling studies ongoing · IND submission anticipated mid-2027

Acute Critical Illness

AuxoraIV

Acute Pancreatitis

Preclinical / IND-enablingPhase 1Phase 2Phase 3

CARPO Phase 2b completed · FDA-aligned design for a planned Phase 2b study · initiation subject to additional funding

Development status as of October 2026. Milestone dates are anticipated.

View full pipeline

04Evidence to date

Evidence across pulmonary hypertension and acute pancreatitis.

CARPO results and study context Pulmonary hypertension evidence and sources

Pulmonary hypertension · preclinical

Pulmonary vasculature + RV

In the MCT rat PAH model, CM5480 reduced pulmonary vascular resistance and remodeling, improved cardiac output, and reduced right-ventricular remodeling.

Pulmonary hypertension · preclinical

Direct right-ventricular effects

In a pulmonary artery banding model that isolates right-ventricular pressure overload from pulmonary vascular disease, CM5480 improved right-ventricular function and reduced hypertrophy and fibrosis, supporting direct cardiac effects independent of pulmonary vascular effects.

Acute pancreatitis · Phase 2b

Prevented new severe respiratory failure

New-onset severe respiratory failure was 0% in the medium- and high-dose Auxora groups versus 8.5% with placebo in CARPO.

Acute pancreatitis · Phase 2b

Win ratio 1.64

An exploratory hierarchical analysis across key clinical outcomes favored high-dose Auxora, with a win ratio of 1.64 (95% CI 1.03–2.61; p=0.037).

05Newsroom

Latest news.

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September 8, 2026

Press release

CalciMedica to Participate in the H.C. Wainwright 28th Annual Global Investment Conference

Press release

August 27, 2026

Press release

CalciMedica Announces One-for-Five Reverse Stock Split

Press release

August 11, 2026

Press release

CalciMedica Reports Second Quarter 2026 Financial Results and Provides Clinical & Corporate Updates

Press release