#USA #La Jolla #CalciMedica #Auxora #CM5480

CalciMedica Reports First Quarter Financial Results and Clinical Updates

CalciMedica Inc., a clinical-stage biopharmaceutical firm focused on innovative calcium channel therapies for serious diseases, has released its financial results for the first quarter of 2026, alongside critical updates regarding its ongoing clinical programs. The company aims to address unmet needs in serious conditions through its research and development efforts.

Financial Overview

As of March 31, 2026, CalciMedica reported cash and cash equivalents amounting to $8.2 million. The management anticipates this will sufficiently fund its operational plans until at least the fourth quarter of 2026. Research and development expenses were recorded at $3.5 million, reflecting a decrease from $4.2 million in the previous year, primarily due to reduced clinical trial activities.

General and administrative expenses also showed a slight decrease, amounting to $2.1 million compared to $2.3 million in the same quarter of 2025. Additionally, the company reported other income of $10.6 million for the quarter, significantly rising from $1.5 million in the previous year, largely due to favorable fair value adjustments of financial instruments.

The net income for the quarter stood at $5 million, translating to earnings of $0.31 per basic share. This marks a notable turnaround from a net loss of $5 million experienced in the same period last year.

Clinical Program Updates

Acute Pancreatitis (AP)

CalciMedica continues to engage with the FDA regarding its pivotal program assessing Auxora for the treatment of acute pancreatitis, expecting feedback in the second quarter of 2026. The significance of this trial lies in the fact that it would represent the first pivotal program of its kind in the U.S., catering to a condition responsible for approximately 300,000 hospital admissions annually.

In addition to regulatory discussions, CalciMedica announced the publication of positive results from its Phase 2b CARPO trial in eClinicalMedicine. This study involved 214 patients and showcased that Auxora not only improved time to solid food tolerance but also significantly reduced new-onset severe respiratory failure by 100% in mid- and high-dose arms compared to the placebo group. These results indicate substantial advances in treating AP, especially for patients with systemic inflammatory response syndrome (SIRS).

Acute Kidney Injury (AKI)

The company also anticipates feedback from the FDA regarding the future development of Auxora for acute kidney injury (AKI). Following a comprehensive review of safety data from the paused Phase 2 KOURAGE trial, which assessed Auxora in AKI patients, CalciMedica found no evidence of drug-related toxicity. The discussions with the FDA are expected to pave the way for future steps in the development of Auxora for AKI.

Pulmonary Hypertension (PH)

CalciMedica's oral CRAC channel inhibitor, CM5480, is entering preclinical testing aimed at targeting pulmonary hypertension. The company is working on further pharmacological characterization and plans to file an IND application in 2027. This drug has potential as a first-in-class therapy aimed at addressing both pulmonary vascular and right ventricular remodeling associated with the disease.

Conclusion

CalciMedica remains steadfast in its commitment to innovative therapeutic solutions addressing unmet medical needs in inflammatory and chronic conditions. The company's ongoing dialogue with the FDA, alongside its promising clinical drug candidates, positions it well within the competitive biopharmaceutical landscape. Investors and stakeholders are encouraged to keep abreast of these developments as CalciMedica continues to chart its course toward pioneering healthcare advances.

For further information on CalciMedica and its pipeline, please visit calcimedica.com.