CalciMedica Reports Second Quarter 2026 Financial Results and Provides Clinical & Corporate Updates (Form 8-K)

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

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., August 11, 2026 - 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

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Acute Pancreatitis (AP) Program Update

Mechanistic Data from the Phase 2 CARDEA Trial

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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.

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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™ (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.

Auxora has been studied in more than 350 patients across conditions involving endothelial injury and respiratory failure:

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About CM5480

CM5480 is CalciMedica's proprietary oral CRAC channel inhibitor designed for chronic dosing. By inhibiting Orai1-containing CRAC channels, it is intended to regulate abnormal calcium entry linked to vasoconstriction, pulmonary vascular remodeling, and right ventricular dysfunction.

In preclinical pulmonary hypertension models, CM5480 and other CRAC channel inhibitors have improved hemodynamics and reduced pulmonary vascular and right ventricular remodeling, both as monotherapy and in combination with vasodilators. In a rodent pulmonary artery banding model, which isolates cardiac effects from changes in the pulmonary vasculature, CM5480 also demonstrated evidence of direct protective activity in the right ventricle.

These findings support the potential of CM5480 as a differentiated therapy targeting key drivers of disease progression. CalciMedica is advancing CM5480 for pulmonary hypertension, including PAH and PH-HFpEF, and anticipates submitting an IND in mid-2027.

About CalciMedica

CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes two distinct CRAC channel inhibitor compounds: zegocractin, which is formulated for intravenous administration as Auxora™, and CM5480, which is designed for chronic oral dosing. Auxora has been evaluated in more than 350 patients and is being developed for pulmonary arterial hypertension and acute pancreatitis, including a planned Phase 1b proof-of-concept trial in PAH and a planned Phase 2b trial in acute pancreatitis. CM5480 is being developed for pulmonary hypertension, with an IND submission anticipated in mid-2027. For more information, please visit www.calcimedica.com.