CalciMedica — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and short-term investments totaled $13.8 million as of September 30, 2026, down from $13.0 million (combined cash and short-term investments of $11.5M + $1.5M) at December 31, 2025.
• Research and development expenses were $2.3 million for the three months ended September 30, 2026, a decrease from $3.9 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $7.9 million compared to $12.1 million in 2025.
• General and administrative expenses were $2.4 million for the three months ended September 30, 2026, an increase from $1.8 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $6.5 million compared to $6.6 million in 2025.
• Total other income was $3.1 million for the three months ended September 30, 2026, compared to total other expense of $2.2 million in the same period in 2025; for the nine months ended September 30, 2026, total other income was $10.0 million compared to total other expense of $0.1 million in 2025.
• Net loss was $1.7 million ($0.24 per share) for the three months ended September 30, 2026, compared to a net loss of $7.8 million ($2.59 per share) in the same period in 2025; for the nine months ended September 30, 2026, net loss was $4.4 million ($0.96 per share) compared to $18.8 million ($6.61 per share) in 2025.
• Total liabilities decreased to $10.1 million as of September 30, 2026, from $20.2 million as of December 31, 2025, driven by a reduction in warrant liability from $8.0 million to $0.3 million.
• Stockholders' equity turned positive to $4.2 million as of September 30, 2026, compared to a deficit of $6.6 million as of December 31, 2025.

Guidance and Future Outlook:

• Cash and investments are expected to fund the current operating plan into the second half of 2027.
• Data from the Auxora Phase 1b proof-of-concept trial in pulmonary hypertension and the CM5480 IND submission are both anticipated in mid-2027.
• Details regarding the Phase 1b trial design and target patient population are expected to be disclosed by year-end 2026.
• The initiation of the Phase 2b trial for Auxora in acute pancreatitis is subject to additional financing.
• Management expects multiple meaningful catalysts over the next 12 months.

Business Segments and Product Lines:

• Pulmonary Hypertension (PH): CalciMedica plans to evaluate Auxora in a Phase 1b trial to generate initial clinical evidence on CRAC channel inhibition effects on cardiac and pulmonary function. CM5480, an oral CRAC channel inhibitor candidate, is advancing through preclinical and IND-enabling studies to characterize pharmacology, pharmacokinetics, and safety.
• Acute Pancreatitis (AP): FDA aligned with the Phase 2b trial design for Auxora in July, which will test enrollment based on elevated lactate dehydrogenase (LDH) levels to select for severe outcomes assessed via severe respiratory failure as the primary endpoint.
• Auxora: Evaluated in over 350 patients across conditions including acute pancreatitis (CARPO trial showed dose-dependent reduction in time to solid food tolerance and 100% reduction in new-onset severe respiratory failure in medium/high dose groups), pulmonary hypertension, and COVID-19 pneumonia (CARDEA trial showed 56% reduction in 30-day all-cause mortality).
• CM5480: Designed for chronic oral dosing in PH; preclinical data suggests it may directly protect right ventricular function, a key driver of PH outcomes not targeted by existing therapies.
• KOURAGE Trial: Enrollment was paused in January 2026 following a mortality imbalance in the Phase 2 trial for acute kidney injury with respiratory failure; no drug-related toxicity was identified, and the FDA reviewed the protocol amendment without comments. CalciMedica does not plan to restart the trial.

Market and Competitive Landscape:

• Acute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S.
• Pulmonary hypertension involves progressive right ventricular dysfunction, a key determinant of survival not directly targeted by approved therapies which act primarily on the pulmonary vasculature.
• Preclinical models suggest CRAC channel inhibitors may provide a differentiated approach in PH by targeting multiple disease drivers including right ventricular dysfunction.

Risks and Challenges:

• Initiation of the Phase 2b AP trial is subject to additional financing.
• No assurance that CalciMedica will maintain compliance with Nasdaq listing requirements.
• Results from clinical trials or preclinical studies may not be indicative of future results.
• Potential safety and other complications from Auxora and CM5480.
• Risks related to the impact of fluctuations in global financial markets, ability to execute plans, regulatory approval uncertainty, and market acceptance.

Management Commentary and Tone:

• CEO Rachel Leheny, Ph.D., stated the company continues to advance its pulmonary hypertension strategy with data anticipated in mid-2027.
• Management highlighted FDA alignment on the AP trial design as providing a clear framework for the next stage of development in a disease with no approved therapies.
• The tone indicates confidence in the differentiated therapeutic profile of CRAC channel inhibitors targeting right ventricular dysfunction and inflammation.

Other Key Points:

• A 1-for-5 reverse stock split was announced in August, reducing issued and outstanding shares from approximately 34.5 million to 6.9 million, effective August 31, 2026.
• The reverse stock split brought CalciMedica into compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
• The increase in other income for the nine months ended September 30, 2026, primarily reflected an increase in income from changes in the fair value of the Company's financial instruments.
• The decrease in R&D expenses was primarily due to a decrease in nonclinical and clinical trial activities, consultants, and chemistry, manufacturing, and controls activities, offset by an increase in personnel costs.