CalciMedica Announces Publication in the American Journal of Nephrology Discussing Design and Rationale of Phase 2 KOURAGE Trial of Auxora™ in AKI with Respiratory Failure

Publication includes previously announced preclinical data of Auxora™ in acute kidney injury (AKI) models as well as a post-hoc analysis of patients in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia who had AKI with respiratory failure at enrollment , /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced a publication in the American Journal of Nephrology (AJN) highlighting the design and rationale of the Company's Phase 2 KOURAGE trial of lead candidate Auxora™ in acute kidney injury (AKI) with respiratory failure. The manuscript, entitled, "Inhibition of Calcium Release-Activated Calcium (CRAC) Channels to Treat Acute Kidney Injury: Design and Rationale of the KOURAGE Study," was co-authored by Lakhmir Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, and Chair of the KOURAGE Steering Committee; Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica; Glenn Chertow, M.D., Norman S. Coplon/ Satellite Healthcare Professor of Medicine, Professor of Epidemiology and Population Health and Health Policy at Stanford Medicine, and Member of the KOURAGE Steering Committee; and other CalciMedica collaborators. "Approximately 3.7 million patients are hospitalized with AKI in the U.S. each year. Patients with severe AKI who have associated respiratory failure have a high risk of mortality, estimated to be approximately 50%. Despite the prevalence and the serious consequences of the disease, current standard of care remains limited to supportive therapy," said Dr. Chawla. "Preclinical models and prior clinical trials of Auxora show that by inhibiting CRAC channels, Auxora has promising anti-inflammatory and protective effects, indicating that it could be a potentially transformative treatment for AKI patients with respiratory failure." The manuscript describes the preclinical and clinical evidence supporting Auxora as a development candidate in AKI with respiratory failure, as well as the rationale for the patient selection and endpoint selection for CalciMedica's KOURAGE trial. In ischemia/reperfusion (I/R) models of AKI in rats, Auxora was found to significantly increase glomerular filtration rate (GFR) and to prevent mortality in Auxora-treated animals versus placebo-treated controls. In the CARDEA trial of patients with severe and critical COVID pneumonia, a post-hoc analysis of a subgroup of 38 patients with AKI at the time of enrollment showed a 62.7% relative reduction and 29.3% absolute reduction in mortality for Auxora versus placebo. Specifically, 7 out of 15 (46.7%) patients on placebo died by day 30 and day 60, as compared to 4 out of 23 (17.4%) patients on Auxora. Patients in KOURAGE will similarly have AKI with respiratory failure and the primary endpoint for the trial is days alive not on a ventilator and not on dialysis. About KOURAGEKOURAGE is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Auxora in patients with severe acute kidney injury (AKI) with respiratory failure. The study is expected to enroll approximately 150 patients with Stage 2 and 3 AKI who have respiratory failure, and patients are randomized to receive 5 daily doses of Auxora or placebo. The study will assess patients up to day 30 following the final dosing to evaluate the number of days alive without the need for a ventilator or dialysis. The study's secondary endpoints include a composite measure of all-cause mortality, decline in estimated glomerular filtration rate (eGFR) and the occurrence of dialysis over a 90-day period, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). Data from KOURAGE are expected around the end of 2025. About CalciMedicaCalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora™ has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials and been well-tolerated in over 350 critically ill patients dosed. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) and for a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated respiratory failure, with data expected around the end of 2025. For more information, please visit www.calcimedica.com. Forward-Looking StatementsThis communication contains forward-looking statements which include, but are not limited to CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for updates and the release of data from its Phase 2 KOURAGE trial of Auxora in AKI with associated respiratory failure around the end of 2025; the number of the treatable patients with AKI; the potential benefits of Auxora for the treatment of AKI and AP; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope, progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; the impact of government laws and regulations; and CalciMedica's financial position and need for additional capital. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 14, 2025, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law. Contact InformationArgot Partners[email protected](212) 600-1902 SOURCE CalciMedica, Inc. 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CalciMedica Announces Publication in the American Journal of Nephrology Discussing Design and Rationale of Phase 2 KOURAGE Trial of Auxora™ in AKI with Respiratory Failure

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