CalciMedica(CALC)
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CalciMedica(CALC) - 2025 Q3 - Quarterly Report
2025-11-12 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to s Commission File Number 001-39538 CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdi ...
CalciMedica(CALC) - 2025 Q3 - Quarterly Results
2025-11-12 12:15
Exhibit 99.1 LA JOLLA, Calif., November 12, 2025 – 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 Auxor ...
CalciMedica Reports Third Quarter 2025 Financial Results and Provides Clinical & Corporate Updates
Prnewswire· 2025-11-12 12:01
Core Insights - CalciMedica is advancing its clinical programs, particularly the Phase 2 KOURAGE trial for Auxora in acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026 [1][5] - Positive discussions with the FDA regarding a pivotal trial in acute pancreatitis (AP) are ongoing, with final trial design anticipated in the first half of 2026 [1][2] - The company's cash position is projected to support operations into the second half of 2026 [1][8] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with Stage 2 or Stage 3 AKI with respiratory failure, with results expected in 1H 2026 [5] - Recent animal model data presented at ASN Kidney Week 2025 supports the efficacy of Auxora in improving kidney function and reducing renal injury [5][7] - Collaboration with Telperian aims to utilize AI-driven analytics to enhance the design of the pivotal trial in AP [2][6] Financial Results - As of September 30, 2025, CalciMedica reported cash, cash equivalents, and short-term investments totaling $14.1 million [8] - Research and development expenses for Q3 2025 were $3.9 million, up from $3.6 million in Q3 2024, primarily due to increased clinical trial activities [9] - General and administrative expenses decreased to $1.8 million in Q3 2025 from $2.2 million in Q3 2024 [10] - The net loss for Q3 2025 was $7.8 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.50 per share, in Q3 2024 [12]
CalciMedica Announces Publication in JCI Insight of Preclinical Data Supporting CRAC Channel Inhibitor as a Potential Therapy for Pulmonary Arterial Hypertension
Prnewswire· 2025-11-12 12:00
Accessibility StatementSkip Navigation Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing treatments Cardiac benefit supports the mechanistic rationale for CRAC channel inhibition in acute kidney injury (AKI), being evaluated in the Phase 2 KOURAGE trial with data expected in 1H 2026 LA JOLLA, Calif., Nov. 12, 2025/PRNewswire/ -- CalciMedica Inc. ("Calci ...
CalciMedica Presents Data from Preclinical Study of Auxora™ in an Animal Model of AKI at ASN Kidney Week 2025
Prnewswire· 2025-11-10 12:00
Core Insights - CalciMedica's Auxora has shown significant potential in reducing IL-17-related inflammation and improving kidney function in a rat model of acute kidney injury (AKI) [1][3][6] - The company is currently evaluating Auxora in the Phase 2 KOURAGE trial for severe AKI with respiratory failure, reinforcing its therapeutic potential [1][4] Study Findings - In a study involving rat models of ischemia/reperfusion-induced AKI, Auxora (16 mg/kg) was administered intravenously, leading to a significant increase in glomerular filtration rate (GFR) and a reduction in renal injury [2][6] - Three-day dosing of Auxora resulted in a 64% reduction in Th-17 cells in the kidney and a 59% reduction in the lung, along with a 69% decrease in IL-6-producing CD4 cells [6] Mechanistic Support - The study provided strong mechanistic support for Auxora as a treatment for severe AKI with acute hypoxemic respiratory failure (AHRF), highlighting the correlation between elevated IL-17 levels and adverse kidney events [3][4] - Down-regulation of IL-17 may be crucial in mitigating multi-organ failure, which is common in critically ill patients with severe AKI [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases, with a proprietary technology aimed at modulating immune responses [5][7] - The company has conducted multiple efficacy clinical trials for Auxora, which has been well-tolerated in over 350 critically ill patients [7]
CalciMedica to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Prnewswire· 2025-09-02 11:00
LA JOLLA, Calif., Sept. 2, 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 announced that Rachel Leheny, Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8, 2025, at 3:30 p.m. ET.A li ...
CalciMedica(CALC) - 2025 Q2 - Quarterly Report
2025-08-12 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to s Commission File Number 001-39538 CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdiction ...
CalciMedica(CALC) - 2025 Q2 - Quarterly Results
2025-08-12 11:30
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., August 12, 2025 – 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 imm ...
CalciMedica Reports Second Quarter 2025 Financial Results and Provides Clinical & Corporate Updates
Prnewswire· 2025-08-12 11:00
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 biopharmaceutica ...
CalciMedica to Participate in the H.C. Wainwright 4th Annual Kidney Virtual Conference
Prnewswire· 2025-07-08 11:00
LA JOLLA, Calif., July 8, 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 announced that Rachel Leheny, Ph.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025, at 2:0 ...