CALC

FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026 Preclinical and IND-enabling studies advancing for CM5480, an oral CRAC channel inhibitor candidate, with IND submission in pulmonary hypertension expected in 2027 LA JOLLA, Calif., May 12, 2026 /PRNewswire/ -- 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 acute and chronic inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the first quarter ended March 31, 2026 and provided clinical and corporate updates. "We continue to work closely with the FDA as we finalize the design of our pivotal program for Auxora in AP and explore potential future development in AKI, both serious illnesses with high unmet need that are not adequately addressed by current standard of care," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "As we progress in these discussions and continue to advance our oral CRAC channel inhibitor, CM5480, in preclinical and IND-enabling studies for pulmonary hypertension, we are encouraged by preclinical data recently published in Human Immunology, which offers a strong endorsement of the mechanistic rationale for selective CRAC channel inhibition in inflammatory and immune-mediated diseases." Recent Program Highlights: Acute Pancreatitis (AP) Program Update Continued positive FDA engagement on pivotal program in AP: CalciMedica continues to engage constructively with the U.S. Food and Drug Administration (FDA) regarding the design of a potential pivotal program evaluating Auxora in AP, with FDA feedback on program design expected in the second quarter of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, a serious inflammatory disease with approximately 300K hospitalizations annually in the U.S. alone. Phase 2b CARPO trial results published in eClinicalMedicine: In February 2026, a manuscript authored by CalciMedica and collaborators titled "Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial" was published in eClinicalMedicine, a journal in The Lancet Discov...

Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™ Design of pivotal program in acute pancreatitis (AP) expected in 1H 2026 JCI Insight publication of preclinical data demonstrates CM5480 as a potential differentiated therapy in pulmonary arterial hypertension (PAH); IND submission anticipated in 2027 LA JOLLA, Calif., March 3, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the year ended December 31, 2025 and provided clinical and corporate updates. "First and foremost, in acute kidney injury, we and our external advisors have reviewed the unblinded KOURAGE data and have found no evidence of a drug-related toxicity. We look forward to discussions with the FDA about potential future clinical studies in AKI. We are also advancing Auxora towards the pivotal program in acute pancreatitis following constructive FDA engagement and the peer-reviewed publication of our Phase 2b CARPO results. The Company plans to finalize the design for this program in the first half of this year," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Concurrently, we continue to advance our second CRAC channel inhibitor, CM5480, in pulmonary arterial hypertension, following the recent publication of preclinical data which demonstrate its potential in cardiopulmonary disease." Recent Program Highlights: Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update Phase 2 KOURAGE trial safety review: In January 2026, CalciMedica announced the discontinuation of the Phase 2 KOURAGE trial evaluating Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF. The decision followed a recommendation from the trial's Independent Data Monitoring Committee (IDMC) regarding a safety concern relating to a mortality imbalance that warranted reevaluation of the study design. The IDMC did not identify evidence of drug-related toxicity, and the Company's comprehensive review, performed in conjunction with external experts, reached the same conclusion....

Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) with respiratory failure; data expected in 1H 2026 Positive discussions with FDA on pivotal trial in acute pancreatitis (AP); final trial design expected in 1H 2026 Cash position expected to fund operations into 2H 2026 LA JOLLA, Calif., Nov. 12, 2025 /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 reported financial results for the third quarter ended September 30, 2025 and provided clinical and corporate updates. "Enrollment continues in our Phase 2 KOURAGE trial evaluating Auxora in patients with AKI with respiratory failure, and we look forward to sharing data in the first half of 2026. As we approach this milestone, we are encouraged by AKI animal model data recently shared at ASN and results in PAH animal models published in JCI Insight, both of which provide further mechanistic rationale for CRAC channel inhibition as a promising approach for treating AKI," said Rachel Leheny, Ph.D., CEO of CalciMedica. "Additionally, discussions with the FDA have been positive regarding our program in AP. We expect our recently announced collaboration with Telperian and its AI-driven analytics platform will enable us to leverage insights from completed Auxora trials to optimize the design of our pivotal trial in AP, which we expect to finalize in the first half of 2026." Recent Clinical & Corporate Highlights: Clinical Updates & Anticipated Milestones Acute Kidney Injury (AKI) with Respiratory Failure Program Update Enrollment ongoing in Phase 2 KOURAGE trial: Enrollment is ongoing in KOURAGE, CalciMedica's randomized, double-blind, placebo-controlled Phase 2 trial of Auxora™ in patients with Stage 2 or Stage 3 AKI with respiratory failure. The Company plans to enroll 150 patients in KOURAGE, with data expected in the first half of 2026. Poster presentation at the American Society of Nephrology (ASN) Kidney Week 2025: In November 2025, CalciMedica and collaborators from Indiana University School of Medicine, including David P. Basile, Ph.D., Professor of Anatomy, Cell Biology and Physiology, presented a poster titled "Store-Operated Calcium-Chann...

Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) with respiratory failure; data expected in early 2026 Productive initial meeting with the FDA on Auxora in acute pancreatitis (AP); conversations continue, with alignment on a pivotal trial anticipated around the end of 2025 Cash position expected to fund operations into mid-2026 LA JOLLA, Calif., Aug. 12, 2025 /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 reported financial results for the second quarter ended June 30, 2025 and provided clinical and corporate updates. "We have continued to spotlight the growing body of evidence supporting the development of Auxora for the treatment of AKI with respiratory failure, including publications in two peer-reviewed journals, multiple presentations at medical meetings, and a symposium at the 43rd Vicenza Course AKI-CRRT-EBPT and Critical Care Nephrology meeting. We look forward to the readout of our Phase 2 KOURAGE trial expected in early 2026," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Additionally, we are encouraged by our initial meeting with the FDA regarding our program in AP. The meeting was constructive, and we are eager to continue our discussions with the agency, with the objective of reaching alignment on a pivotal trial around the end of 2025." Recent Clinical & Corporate Highlights: Clinical Updates & Anticipated Milestones Acute Kidney Injury (AKI) with Respiratory Failure Program Update Enrollment ongoing in Phase 2 KOURAGE trial: Enrollment is ongoing in KOURAGE, the Company's randomized, double-blind, placebo-controlled Phase 2 trial of Auxora™ in patients with Stage 2 or Stage 3 AKI with associated respiratory failure. CalciMedica plans to enroll 150 patients in KOURAGE, with data expected in early 2026. Publication in the American Journal of Nephrology (AJN): In June 2025, CalciMedica announced a publication in AJN, titled, "Inhibition of Calcium Release-Activated Calcium (CRAC) Channels to Treat Acute Kidney Injury: Design and Rationale of the KOURAGE Study." The manuscript describes the preclinical and clinical evidence supporting Auxora as a poten...

Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) and respiratory failure; data expected around the end of 2025 Presentations at three recent medical meetings, including a post-hoc analysis of subset of patients with AKI in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia, which showed a 62.7% relative reduction in mortality for Auxora versus placebo Cash position expected to fund operations into mid-2026 LA JOLLA, Calif., May 14, 2025 /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 reported financial results for the first quarter ended March 31, 2025 and provided clinical and corporate updates. "We continue to execute across our pipeline and have taken steps to ensure that we are well-positioned ahead of multiple expected milestones in 2025," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Our cash runway extends into mid-2026, which will allow us to deliver the readout of our Phase 2 KOURAGE trial in AKI with respiratory failure expected around the end of this year, as well as to discuss our Phase 3 program in acute pancreatitis with SIRS with the FDA. Our lead compound, Auxora, has the potential to transform treatment in both indications, which have no approved therapies and affect hundreds of thousands of critically ill patients per year in the United States and many more worldwide." Recent Clinical & Corporate Highlights: Clinical Updates & Anticipated Milestones Acute Kidney Injury (AKI) Program Update Enrollment ongoing in Phase 2 KOURAGE trial: Enrollment is ongoing in KOURAGE, the Company's randomized, double-blind, placebo-controlled Phase 2 trial of Auxora™ in patients with Stage 2 or Stage 3 AKI with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to enroll 150 patients, with data expected around the end of 2025. Post-hoc analysis of patients with AKI from the Phase 2 CARDEA trial in severe COVID-19 pneumonia: In March 2025, Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered a plenary presentation at the 30th International Acute Kidney Injury and Continuous Renal Replacement Therapy (AKI & CRR...

Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) and respiratory failure; data expected around the end of 2025 Post-hoc analysis of subset of patients with AKI in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia showed a 62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated with Auxora versus placebo Cash position expected to fund operations into mid-2026 LA JOLLA, Calif., March 27, 2025 /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 reported financial results for the year ended December 31, 2024 and provided clinical and corporate updates. "Enrollment in our Phase 2 KOURAGE trial is on track to deliver data around the end of 2025," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Looking ahead to the KOURAGE readout, we are further encouraged by the promising readthrough from the data recently presented at the 30th International AKI & CRRT Conference, which show a 62.7% relative reduction in mortality in CARDEA patients with both kidney failure and respiratory failure, mirroring KOURAGE's patient population. With the proceeds from our recent credit facility with Avenue Capital, we have ample runway to get through our KOURAGE data readout based on our current enrollment projections and engage with the FDA on the design of a Phase 3 program in acute pancreatitis with SIRS in the next few months." Recent Clinical & Corporate Highlights: Clinical Updates & Anticipated Milestones Acute Kidney Injury (AKI) Program Update Enrollment ongoing in Phase 2 KOURAGE trial: Enrollment is ongoing in KOURAGE, the Company's randomized, double-blind, placebo-controlled Phase 2 trial of Auxora™ in patients with severe AKI with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to enroll 150 patients with stage 2 and stage 3 AKI who have AHRF and are receiving oxygen either by non-invasive mechanical ventilation, high-flow nasal cannula, or invasive mechanical ventilation. Data are expected around the end of 2025. Post-hoc analysis of patients with AKI from the Phase 2 CARDEA trial in severe COVID-19...