Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program
Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and CM5480 IND submission both anticipated in mid-2027
FDA aligned that the primary endpoint for the Phase 2b trial in acute pancreatitis will measure whether Auxora can reduce new-onset severe respiratory failure
LA JOLLA, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium $(CRAC)$ channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the second quarter ended June 30, 2026 and provided clinical and corporate updates.
"The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Preclinical models suggest CRAC channel inhibitors may provide a differentiated approach in pulmonary hypertension by targeting multiple disease drivers, including right ventricular dysfunction, which is the principal driver of mortality and not directly targeted by existing therapies. In acute pancreatitis, FDA alignment on the Phase 2b trial endpoints and patient enrichment strategy provides a clear framework for the next stage of development in a disease with no approved therapies. With Auxora PAH data and the CM5480 IND submission both anticipated in mid-2027, we expect multiple meaningful catalysts over the next 12 months."
Recent Program Highlights:
Pulmonary Hypertension $(PH)$ Program Update
-- Private placement financing to advance PH strategy: On June 24, 2026,
CalciMedica announced a private placement of up to approximately
$49 million in gross proceeds, including approximately $15 million in
upfront gross proceeds. The proceeds are expected to support the
advancement of Auxora and CM5480 as part of the Company's pulmonary
hypertension strategy.
-- Auxora Phase 1b proof-of-concept trial in PAH planned: CalciMedica plans
to evaluate Auxora in a Phase 1b trial in patients with pulmonary
arterial hypertension to generate initial clinical evidence regarding the
effects of CRAC channel inhibition on pulmonary vascular and right
ventricular function. Data are anticipated in mid-2027.
-- CM5480 preclinical and IND-enabling studies advancing: Studies are
ongoing to further characterize the pharmacology, pharmacokinetics, and
safety profile of CM5480, CalciMedica's oral CRAC channel inhibitor
candidate for chronic use in PH. Preclinical data suggest CM5480 may be
differentiated by directly protecting right ventricular function, a key
driver of outcomes in PH that is not directly targeted by existing
therapies. An IND submission is anticipated in mid-2027.
Acute Pancreatitis (AP) Program Update
-- FDA alignment on Phase 2b trial design: On July 29, 2026, following a
Type C Focused Meeting, CalciMedica announced that FDA aligned with the
Company's Phase 2b trial design for Auxora in AP. The primary endpoint
will measure whether Auxora can reduce the development of new-onset
severe respiratory failure. Key secondary endpoints will include
multi-organ failure and the time until patients are medically ready for
discharge. The trial will also evaluate whether elevated lactate
dehydrogenase (LDH) can identify patients at higher risk of developing
severe disease. AP is a serious inflammatory disease with no FDA-approved
therapies and approximately 300,000 hospitalizations annually in the
U.S.1
Mechanistic Data from the Phase 2 CARDEA Trial
-- Publication in the Journal of Clinical Investigation: On July 28, 2026,
the Journal of Clinical Investigation published a study titled "The CRAC
Channel Inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell
Circuits in Viral Pneumonia". The publication combines findings from an
exploratory mechanistic study conducted alongside the Phase 2 CARDEA
trial in severe COVID-19 pneumonia with laboratory studies of human
immune cells. Together the results provide additional evidence that
Auxora modulates key inflammatory pathways involved in lung injury,
strengthening the scientific rationale for CRAC channel inhibition in
inflammatory lung diseases.
Financial Results for the Second Quarter Ended June 30, 2026:
Cash Position: Cash and cash equivalents were $18.6 million as of June 30, 2026. The Company expects its cash and cash equivalents to fund its current operating plan into the second half of 2027.
R&D Expenses: Research and development expenses were $2.1 million for the three months ended June 30, 2026, compared to $4.1 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, research and development expenses were $5.6 million, compared to $8.3 million for the six months ended June 30, 2025. The decrease of $2.7 million was primarily due to a decrease in preclinical and clinical trial related activities, consultants and personnel, and chemistry, manufacturing and controls activities.
G&A Expenses: General and administrative expenses were $1.9 million for the three months ended June 30, 2026, compared to $2.6 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, general and administrative expenses were $4.0 million, compared to $4.8 million for the six months ended June 30, 2025. The decrease of $0.8 million was primarily due to a decrease in personnel and consultant costs.
Other Income/Expense: Total other expense was $3.6 million for the three months ended June 30, 2026, compared to total other income of $0.7 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, total other income was $6.9 million, compared to $2.1 million for the six months ended June 30, 2025. The increase of $4.8 million primarily reflected an increase in income from changes in the fair value of the Company's financial instruments.
Net Income/Loss: Net loss was $7.7 million, or $0.45 per basic and diluted share, for the three months ended June 30, 2026, compared to a net loss of $6.0 million, or $0.40 per basic and diluted share, for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was $2.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.0 million, or $0.76 per basic and diluted share, for the six months ended June 30, 2025.
About Pulmonary Hypertension
Pulmonary hypertension (PH) encompasses a diverse group of diseases, including pulmonary arterial hypertension (PAH). Across PH groups, progressive right ventricular dysfunction is a shared consequence and a key determinant of survival. Approved therapies act primarily on the pulmonary vasculature and do not directly target the failing right ventricle.
Orai1, the pore-forming subunit of the CRAC channel, is upregulated in diseased pulmonary vasculature and cardiac tissue, where persistent CRAC channel signaling has been linked to proliferation, inflammation, vasoconstriction, fibrosis, and remodeling. In preclinical PH models, CRAC channel inhibition has been observed to improve the structure and function of the pulmonary vasculature and both ventricles.(2) (,) (3)
CalciMedica's planned Phase 1b proof-of-concept trial will evaluate Auxora in patients with PAH and is intended to generate initial clinical evidence supporting CRAC channel inhibition in PH. Findings from the trial are also expected to inform the continued development of CM5480, the Company's oral CRAC channel inhibitor for chronic dosing.
About Acute Pancreatitis
Acute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S.(4) Respiratory failure is a major driver of mortality and intensive care utilization among patients with severe disease.
CalciMedica's planned Phase 2b trial will evaluate new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. The trial will also assess elevated lactate dehydrogenase as a potential enrichment marker to identify patients at increased risk of severe disease. Initiation of the trial is subject to additional financing.
About Auxora
Auxora$(TM)$ (zegocractin) is CalciMedica's proprietary intravenous CRAC channel inhibitor and most advanced pipeline candidate. It is designed to reduce inflammation by inhibiting CRAC channel-driven cytokine release in immune cells and to limit excessive calcium entry that may contribute to organ injury.