RankAlpha logo
Back to Rankings

CALC

CalciMedicaF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
8
Stored
Transcripts
0
Recent loaded
Latest report
2026-08-11
Investor release

Document history

Earnings documents stored for CALC.

8 shown
Investor releaseQuarter not tagged2026-08-11

CalciMedica stock gains 6% as pulmonary hypertension progress offsets Q2 earnings miss

InvestorsHub
CalciMedica, Inc. (NASDAQ:CALC) shares rose 6.22% in pre-market trading on Tuesday despite the clinical-stage biopharmaceutical company reporting a wider-than-expected second-quarter loss, as investors focused on progress across its pulmonary hypertension programme and regulatory pipeline. CalciMedica reported a quarterly loss of $0.45 per share, compared with the analyst estimate for a loss of $0.26 per share. Net loss for the three months ended June 30, 2026 was $7.7 million, widening from $6.0 million in the same period last year. Investor attention instead appeared to centre on CalciMedica’s clinical development plans and recently completed financing. The company secured a private placement of up to approximately $49 million, including $15 million in upfront gross proceeds, to help advance its pulmonary hypertension strategy. “The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. The company expects Phase 1b proof-of-concept data for Auxora in pulmonary arterial hypertension in mid-2027. An investigational new drug submission for CM5480 is also anticipated around the same time. These milestones give investors clearer upcoming clinical catalysts as CalciMedica expands its development efforts in pulmonary hypertension. CalciMedica also reported alignment with the U.S. Food and Drug Administration on the design of a Phase 2b trial evaluating Auxora in acute pancreatitis. The planned study’s primary endpoint will assess whether Auxora can reduce the development of new-onset severe respiratory failure. For a clinical-stage biotechnology company without commercial revenue, progress toward defined regulatory and clinical milestones remains particularly important to the investment case. CalciMedica ended June with $18.6 million in cash and cash equivalents, which the company expects will fund operations into the second half of 2027. Operating expenses moved lower during the quarter. Research and development spending declined to $2.1 million from $4.1 million a year earlier, primarily reflecting reduced preclinical and clinical trial activity. General and administrative expenses decreased to $1.9 million from $2.6 million. For the six months ended June 30…Read full document

CalciMedica, Inc. (NASDAQ:CALC) shares rose 6.22% in pre-market trading on Tuesday despite the clinical-stage biopharmaceutical company reporting a wider-than-expected second-quarter loss, as investors focused on progress across its pulmonary hypertension programme and regulatory pipeline. CalciMedica reported a quarterly loss of $0.45 per share, compared with the analyst estimate for a loss of $0.26 per share. Net loss for the three months ended June 30, 2026 was $7.7 million, widening from $6.0 million in the same period last year. Investor attention instead appeared to centre on CalciMedica’s clinical development plans and recently completed financing. The company secured a private placement of up to approximately $49 million, including $15 million in upfront gross proceeds, to help advance its pulmonary hypertension strategy. “The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. The company expects Phase 1b proof-of-concept data for Auxora in pulmonary arterial hypertension in mid-2027. An investigational new drug submission for CM5480 is also anticipated around the same time. These milestones give investors clearer upcoming clinical catalysts as CalciMedica expands its development efforts in pulmonary hypertension. CalciMedica also reported alignment with the U.S. Food and Drug Administration on the design of a Phase 2b trial evaluating Auxora in acute pancreatitis. The planned study’s primary endpoint will assess whether Auxora can reduce the development of new-onset severe respiratory failure. For a clinical-stage biotechnology company without commercial revenue, progress toward defined regulatory and clinical milestones remains particularly important to the investment case. CalciMedica ended June with $18.6 million in cash and cash equivalents, which the company expects will fund operations into the second half of 2027. Operating expenses moved lower during the quarter. Research and development spending declined to $2.1 million from $4.1 million a year earlier, primarily reflecting reduced preclinical and clinical trial activity. General and administrative expenses decreased to $1.9 million from $2.6 million. For the six months ended June 30, CalciMedica reported a net loss of $2.7 million, or $0.16 per share, compared with a loss of $11.0 million, or $0.76 per share, in the first half of 2025. For investors, the immediate earnings miss is being weighed against a strengthened financing position and a more defined clinical roadmap. Attention now shifts toward execution of the pulmonary hypertension programme, the Auxora Phase 2b programme in acute pancreatitis and the clinical and regulatory milestones expected in 2027. CalciMedica stock price

Investor releaseQuarter not tagged2026-08-11

CalciMedica Reports Second Quarter 2026 Financial Results and Provides Clinical & Corporate Updates

GlobeNewswire
Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and CM5480 IND submission both anticipated in mid-2027 FDA aligned that the primary endpoint for the Phase 2b trial in acute pancreatitis will measure whether Auxora can reduce new-onset severe respiratory failure LA JOLLA, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- 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 inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the second quarter ended June 30, 2026 and provided clinical and corporate updates. “The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Preclinical models suggest CRAC channel inhibitors may provide a differentiated approach in pulmonary hypertension by targeting multiple disease drivers, including right ventricular dysfunction, which is the principal driver of mortality and not directly targeted by existing therapies. In acute pancreatitis, FDA alignment on the Phase 2b trial endpoints and patient enrichment strategy provides a clear framework for the next stage of development in a disease with no approved therapies. With Auxora PAH data and the CM5480 IND submission both anticipated in mid-2027, we expect multiple meaningful catalysts over the next 12 months.” Recent Program Highlights: Pulmonary Hypertension (PH) Program Update Private placement financing to advance PH strategy: On June 24, 2026, CalciMedica announced a private placement of up to approximately $49 million in gross proceeds, including approximately $15 million in upfront gross proceeds. The proceeds are expected to support the advancement of Auxora and CM5480 as part of the Company’s pulmonary hypertension strategy. Auxora Phase 1b proof-of-concept trial in PAH planned: CalciMedica plans to evaluate Auxora in a Phase 1b trial in patients with pulmonary arterial hypertension to generate initial clinical evidence regarding the effe…Read full document

Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and CM5480 IND submission both anticipated in mid-2027 FDA aligned that the primary endpoint for the Phase 2b trial in acute pancreatitis will measure whether Auxora can reduce new-onset severe respiratory failure LA JOLLA, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- 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 inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the second quarter ended June 30, 2026 and provided clinical and corporate updates. “The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Preclinical models suggest CRAC channel inhibitors may provide a differentiated approach in pulmonary hypertension by targeting multiple disease drivers, including right ventricular dysfunction, which is the principal driver of mortality and not directly targeted by existing therapies. In acute pancreatitis, FDA alignment on the Phase 2b trial endpoints and patient enrichment strategy provides a clear framework for the next stage of development in a disease with no approved therapies. With Auxora PAH data and the CM5480 IND submission both anticipated in mid-2027, we expect multiple meaningful catalysts over the next 12 months.” Recent Program Highlights: Pulmonary Hypertension (PH) Program Update Private placement financing to advance PH strategy: On June 24, 2026, CalciMedica announced a private placement of up to approximately $49 million in gross proceeds, including approximately $15 million in upfront gross proceeds. The proceeds are expected to support the advancement of Auxora and CM5480 as part of the Company’s pulmonary hypertension strategy. Auxora Phase 1b proof-of-concept trial in PAH planned: CalciMedica plans to evaluate Auxora in a Phase 1b trial in patients with pulmonary arterial hypertension to generate initial clinical evidence regarding the effects of CRAC channel inhibition on pulmonary vascular and right ventricular function. Data are anticipated in mid-2027. CM5480 preclinical and IND-enabling studies advancing: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety profile of CM5480, CalciMedica’s oral CRAC channel inhibitor candidate for chronic use in PH. Preclinical data suggest CM5480 may be differentiated by directly protecting right ventricular function, a key driver of outcomes in PH that is not directly targeted by existing therapies. An IND submission is anticipated in mid-2027. Acute Pancreatitis (AP) Program Update FDA alignment on Phase 2b trial design: On July 29, 2026, following a Type C Focused Meeting, CalciMedica announced that FDA aligned with the Company’s Phase 2b trial design for Auxora in AP. The primary endpoint will measure whether Auxora can reduce the development of new-onset severe respiratory failure. Key secondary endpoints will include multi-organ failure and the time until patients are medically ready for discharge. The trial will also evaluate whether elevated lactate dehydrogenase (LDH) can identify patients at higher risk of developing severe disease. AP is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S.1 Mechanistic Data from the Phase 2 CARDEA Trial Publication in the Journal of Clinical Investigation: On July 28, 2026, the Journal of Clinical Investigation published a study titled "The CRAC Channel Inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell Circuits in Viral Pneumonia". The publication combines findings from an exploratory mechanistic study conducted alongside the Phase 2 CARDEA trial in severe COVID-19 pneumonia with laboratory studies of human immune cells. Together the results provide additional evidence that Auxora modulates key inflammatory pathways involved in lung injury, strengthening the scientific rationale for CRAC channel inhibition in inflammatory lung diseases. Financial Results for the Second Quarter Ended June 30, 2026: Cash Position: Cash and cash equivalents were $18.6 million as of June 30, 2026. The Company expects its cash and cash equivalents to fund its current operating plan into the second half of 2027. R&D Expenses: Research and development expenses were $2.1 million for the three months ended June 30, 2026, compared to $4.1 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, research and development expenses were $5.6 million, compared to $8.3 million for the six months ended June 30, 2025. The decrease of $2.7 million was primarily due to a decrease in preclinical and clinical trial related activities, consultants and personnel, and chemistry, manufacturing and controls activities. G&A Expenses: General and administrative expenses were $1.9 million for the three months ended June 30, 2026, compared to $2.6 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, general and administrative expenses were $4.0 million, compared to $4.8 million for the six months ended June 30, 2025. The decrease of $0.8 million was primarily due to a decrease in personnel and consultant costs. Other Income/Expense: Total other expense was $3.6 million for the three months ended June 30, 2026, compared to total other income of $0.7 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, total other income was $6.9 million, compared to $2.1 million for the six months ended June 30, 2025. The increase of $4.8 million primarily reflected an increase in income from changes in the fair value of the Company’s financial instruments.Net Income/Loss: Net loss was $7.7 million, or $0.45 per basic and diluted share, for the three months ended June 30, 2026, compared to a net loss of $6.0 million, or $0.40 per basic and diluted share, for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was $2.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.0 million, or $0.76 per basic and diluted share, for the six months ended June 30, 2025. About Pulmonary HypertensionPulmonary hypertension (PH) encompasses a diverse group of diseases, including pulmonary arterial hypertension (PAH). Across PH groups, progressive right ventricular dysfunction is a shared consequence and a key determinant of survival. Approved therapies act primarily on the pulmonary vasculature and do not directly target the failing right ventricle. Orai1, the pore-forming subunit of the CRAC channel, is upregulated in diseased pulmonary vasculature and cardiac tissue, where persistent CRAC channel signaling has been linked to proliferation, inflammation, vasoconstriction, fibrosis, and remodeling. In preclinical PH models, CRAC channel inhibition has been observed to improve the structure and function of the pulmonary vasculature and both ventricles.2, 3 CalciMedica's planned Phase 1b proof-of-concept trial will evaluate Auxora in patients with PAH and is intended to generate initial clinical evidence supporting CRAC channel inhibition in PH. Findings from the trial are also expected to inform the continued development of CM5480, the Company’s oral CRAC channel inhibitor for chronic dosing. About Acute PancreatitisAcute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S.4 Respiratory failure is a major driver of mortality and intensive care utilization among patients with severe disease. CalciMedica’s planned Phase 2b trial will evaluate new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. The trial will also assess elevated lactate dehydrogenase as a potential enrichment marker to identify patients at increased risk of severe disease. Initiation of the trial is subject to additional financing. About AuxoraAuxora™ (zegocractin) is CalciMedica’s proprietary intravenous CRAC channel inhibitor and most advanced pipeline candidate. It is designed to reduce inflammation by inhibiting CRAC channel-driven cytokine release in immune cells and to limit excessive calcium entry that may contribute to organ injury. Auxora has been studied in more than 350 patients across conditions involving endothelial injury and respiratory failure: Acute pancreatitis: In the Phase 2b CARPO trial, Auxora produced a dose-dependent reduction in median time to solid food tolerance among hyper-inflamed patients. The medium and high dose groups also experienced a 100% reduction in new-onset severe respiratory failure compared with placebo. Pulmonary arterial hypertension: CalciMedica plans to conduct a Phase 1b proof-of-concept trial, with data anticipated in mid-2027. COVID-19 pneumonia: In the Phase 2 CARDEA trial, Auxora reduced 30-day all-cause mortality by 56% compared with placebo. Acute kidney injury with respiratory failure: Auxora was evaluated in the Phase 2 KOURAGE trial, in which enrollment was paused in January 2026 following a mortality imbalance. No drug-related toxicity was identified. FDA subsequently reviewed a protocol amendment and interim safety data without comments or questions, allowing clinical development of Auxora to proceed. CalciMedica does not plan to restart KOURAGE at this time. About CM5480CM5480 is CalciMedica’s proprietary oral CRAC channel inhibitor designed for chronic dosing. By inhibiting Orai1-containing CRAC channels, it is intended to regulate abnormal calcium entry linked to vasoconstriction, pulmonary vascular remodeling, and right ventricular dysfunction. In preclinical pulmonary hypertension models, CM5480 and other CRAC channel inhibitors have improved hemodynamics and reduced pulmonary vascular and right ventricular remodeling, both as monotherapy and in combination with vasodilators. In a rodent pulmonary artery banding model, which isolates cardiac effects from changes in the pulmonary vasculature, CM5480 also demonstrated evidence of direct protective activity in the right ventricle. These findings support the potential of CM5480 as a differentiated therapy targeting key drivers of disease progression. CalciMedica is advancing CM5480 for pulmonary hypertension, including PAH and PH-HFpEF, and anticipates submitting an IND in mid-2027. About CalciMedicaCalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes two distinct CRAC channel inhibitor compounds: zegocractin, which is formulated for intravenous administration as Auxora™, and CM5480, which is designed for chronic oral dosing. Auxora has been evaluated in more than 350 patients and is being developed for pulmonary arterial hypertension and acute pancreatitis, including a planned Phase 1b proof-of-concept trial in PAH and a planned Phase 2b trial in acute pancreatitis. CM5480 is being developed for pulmonary hypertension, with an IND submission anticipated in mid-2027. For more information, please visit www.calcimedica.com. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica’s business strategy and clinical development plans for Auxora™ and CM5480; the planned design, initiation, conduct, timing, and completion of a Phase 2b trial of Auxora in AP, including that initiation of the trial is subject to additional financing; CalciMedica's interpretation of its discussions with FDA, including the potential use of LDH as an enrichment marker; the potential safety, efficacy, clinical utility, and regulatory development path for Auxora in AP; CalciMedica’s plans to evaluate Auxora in a Phase 1b proof-of-concept trial in PAH, including the anticipated timing of data from that trial; CalciMedica’s plans regarding the KOURAGE trial, including its current intention not to restart the trial; the development of CM5480 as a potential oral therapy for pulmonary hypertension, including the anticipated timing of an IND submission; the potential benefits and differentiated therapeutic profile of Auxora, CM5480, and CRAC channel inhibition, including their potential effects on pulmonary vascular remodeling, right ventricular dysfunction, inflammation, endothelial injury, and other disease-related pathways; CalciMedica’s interpretations of clinical, preclinical, mechanistic, and biomarker data; the expected use of proceeds from CalciMedica’s private placement; CalciMedica’s expected cash runway into the second half of 2027; and the potential of CalciMedica's proprietary technology to provide therapeutic benefit in inflammatory, immunologic, and cardiopulmonary 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; CalciMedica’s ability to obtain and maintain regulatory approval for Auxora and CM5480; 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 and CM5480; 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 June 30, 2026, being filed with the SEC later today, 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. Investor Relations ContactJoyce Allaire LifeSci Advisors, LLC [email protected] __________________________________1 Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2022;162(2):621-644.2 Saint-Martin Willer A, Ruffenach G, Masson B, et al. Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction. JCI Insight. 2025. doi:10.1172/jci.insight.191780.3 Bartoli F, Bailey MA, Rode B, et al. Orai1 channel inhibition preserves left ventricular systolic function and normal Ca2+ handling after pressure overload. Circulation. 2020;141(3):199-216.4 Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2022;162(2):621-644.

Investor releaseQuarter not tagged2026-05-12

CalciMedica Reports First Quarter 2026 Financial Results and Provides Clinical & Corporate Updates

PR Newswire
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…Read full document

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 Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora was well-tolerated and demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant 100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge. Preclinical data published in Human Immunology: In April 2026, a manuscript authored by CalciMedica collaborators titled "Single-cell Transcriptomics Reveals Targeted Modulation of Inflammatory Repertoire by SOCE Blockers" was published in Human Immunology. The publication describes preclinical data showing that in normal human peripheral blood mononuclear cells (PBMCs) in a T-cell activation model, store-operated calcium entry (SOCE) blockers such as Auxora inhibit the expression of pro-inflammatory and cytotoxic genes within regulatory T cells, while crucially preserving tolerance-associated anti-inflammatory pathways. This selective modulation provides further mechanistic support for the continued evaluation of Auxora in acute and chronic inflammatory and immunologic illnesses such as AP and acute kidney injury. The data also suggest potential implications for targeted immune modulation in transplantation settings. Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update FDA feedback expected regarding potential future development in AKI: Following comprehensive internal and external safety reviews after the Company paused enrollment in the Phase 2 KOURAGE trial of Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF, no evidence of drug-related toxicity was identified. The Company expects feedback from the FDA regarding potential future development of Auxora in AKI in the second quarter of 2026. Pulmonary Hypertension (PH) Program Update Preclinical activities to advance CM5480 in PH underway: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety profile of CM5480, CalciMedica's proprietary oral CRAC channel inhibitor candidate with the potential to be a first-in-class, differentiated therapy targeting pulmonary vascular and right ventricular remodeling, key drivers of disease progression in PH, including pulmonary arterial hypertension. An IND submission for CM5480 is anticipated in 2027. Financial Results for the First Quarter Ended March 31, 2026: Cash Position: Cash and cash equivalents were $8.2 million as of March 31, 2026. The Company expects its cash position to be sufficient to fund its current operating plan into the fourth quarter of 2026. R&D Expenses: Research and development expenses were $3.5 million for the three months ended March 31, 2026, compared to $4.2 million for the three months ended March 31, 2025. The decrease of $0.7 million was primarily due to a decrease in preclinical and clinical trial related activities, and a decrease in chemistry, manufacturing and controls activities. G&A Expenses: General and administrative expenses were $2.1 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily due to a decrease in personnel costs. Other Income: Other income was $10.6 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025. The increase of $9.1 million was primarily due to the fair value adjustments to our promissory note and common stock warrants. Net Income/Loss: Net income was $5.0 million, or $0.31 per basic share and $0.30 per diluted share, for the three months ended March 31, 2026, compared to a net loss of $5.0 million, or $0.36 per basic and diluted share, for the three months ended March 31, 2025. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory, immunologic, and cardiopulmonary 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 serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate Auxora™ has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. The Company initiated a Phase 2 trial (KOURAGE; NCT06374797) evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF); in January 2026, CalciMedica paused enrollment in the trial following a recommendation from the Independent Data Monitoring Committee and, as a next step, plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential oral therapy for pulmonary hypertension (PH), supported by preclinical data demonstrating effects on pulmonary vascular and right ventricular remodeling. For more information, please visit www.calcimedica.com. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, and the expected timing for updates; statements regarding the anticipated timing of filing an IND; statements regarding the safety and efficacy of its product candidates; statements regarding FDA's constructive engagement on a pivotal program for Auxora in AP and expectations for FDA feedback on program design in the second quarter of 2026; statements regarding the potential of Auxora's clinical data to support a first U.S. pivotal program in AP; statements regarding the positive safety review of the unblinded KOURAGE dataset and discussions with the FDA in the second quarter of 2026 regarding the future development of Auxora in AKI; statements regarding expected cash runway; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases such as AP, AKI and PH, including in transplantation settings. 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, 2026, being filed with the Securities and Exchange Commission (SEC) later today, 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 Information Kevin Murphy [email protected] (212) 600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-first-quarter-2026-financial-results-and-provides-clinical--corporate-updates-302768889.html

Investor releaseQuarter not tagged2026-03-03

CalciMedica Reports 2025 Financial Results and Provides Clinical Updates

PR Newswire
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.…Read full document

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. Imbalances in the patients' severity of disease at baseline may have contributed to the observed safety concern. Next steps in AKI: The Company plans to discuss the KOURAGE data and potential future development in AKI with the FDA in the second quarter of 2026. The trial remains ongoing for patient follow-up. Acute Pancreatitis (AP) Program Update Positive FDA engagement on pivotal program in AP: CalciMedica continues constructive discussions with the U.S. Food and Drug Administration (FDA) regarding the pivotal program for Auxora in AP and expects to finalize the program design in the first half of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, an illness with approximately 300K hospitalizations annually in the U.S. 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 Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant 100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge. Auxora was generally well tolerated, with a trend of decreasing treatment-emergent serious adverse event (TESAE) rates with increasing doses of drug. Additionally, there were no drug-related TESAEs or deaths in patients receiving the high dose of Auxora. Pulmonary Arterial Hypertension (PAH) Program Update Publication in JCI Insight highlighting CM5480 in a pulmonary arterial hypertension (PAH) model: In November 2025, a manuscript authored by CalciMedica and collaborators titled "Combination of Orai1 Inhibitor CM5480 with Specific Therapy Mitigates Pulmonary Hypertension and Its Cardiac Dysfunction" was published in JCI Insight. The publication describes preclinical data supporting CalciMedica's proprietary CRAC channel inhibitor candidate, CM5480, as a potential first-in-class, differentiated therapy for the treatment of PAH. In an animal model of PAH, CM5480 restored or improved multiple disease-affected pathways and functions—including heart contraction and cardiac output, gene expression profiles, DNA repair, and metabolism. Treatment with CM5480 also significantly reduced right ventricular dysfunction (RVD) both as a monotherapy and in combination with existing PAH therapies. Preclinical activities to advance CM5480 in PAH underway: Ongoing studies are being conducted to further characterize CM5480's pharmacology, pharmacokinetics, and safety profile to support IND (investigational new drug)-enabling development in PAH. An IND submission is currently anticipated in 2027. Financial Results for the Year Ended December 31, 2025: Cash Position: Cash, cash equivalents, and short-term investments were $13.0 million as of December 31, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into the fourth quarter of 2026. R&D Expenses: Research and development expenses were $15.2 million for the year ended December 31, 2025, compared to $14.5 million for the year ended December 31, 2024. The increase of $0.7 million was primarily due to an increase in preclinical and clinical trial related activities offset by a decrease in chemistry, manufacturing, and control activities and personnel costs. G&A Expenses: General and administrative expenses were $7.9 million for the year ended December 31, 2025, compared to $9.7 million for the year ended December 31, 2024. The decrease of $1.8 million was primarily due to a decrease in consultants and other costs and professional services offset by an increase in personnel costs driven by stock-based compensation. Other Income (Expense): Other expenses were $6.4 million for the year ended December 31, 2025, compared to other income of $10.5 million for the year ended December 31, 2024. The increase of $16.9 million of expense was primarily due to the non-cash fair value adjustments to the Company's financial instruments, an increase in interest expense associated with the Company's promissory note, and a decrease in interest income offset by miscellaneous income. Net Loss: Net loss was $29.6 million, or $1.97 per basic and diluted share, for the year ended December 31, 2025, compared to $13.7 million, or $1.22 per basic and diluted share, for the year ended December 31, 2024. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (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 serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate Auxora™ has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. The Company initiated a Phase 2 trial (KOURAGE; NCT06374797) evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF); in January 2026, the trial was discontinued following a recommendation from the Independent Data Monitoring Committee, and the Company plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential therapy for pulmonary arterial hypertension (PAH), supported by preclinical data demonstrating effects on pulmonary vascular remodeling and right ventricular function. For more information, please visit www.calcimedica.com. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, and the expected timing for updates; statements regarding the anticipated timing of filing an IND; statements regarding the safety and efficacy of its product candidates; statements regarding FDA's positive engagement on a pivotal program for Auxora in AP and a final pivotal program design in the first half of 2026; statements regarding the analysis of the unblinded KOURAGE dataset, including timing of discussions with the FDA and whether such analysis will inform future trial parameters; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in PAH and other acute and chronic inflammatory and immunologic diseases such as AKI, AP, and AIPT. 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 Annual Report on Form 10-K for the year ended December 31, 2025, being filed with the Securities and Exchange Commission (SEC) later today, 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 Information Kevin Murphy [email protected] (212) 600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-2025-financial-results-and-provides-clinical-updates-302701714.html

Investor releaseQuarter not tagged2025-11-12

CalciMedica Reports Third Quarter 2025 Financial Results and Provides Clinical & Corporate Updates

PR Newswire
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…Read full document

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-Channel Inhibitor Auxora Improves Kidney Function Following Ischemia-Induced AKI in Rats" at ASN Kidney Week 2025. In the study, treatment with Auxora versus placebo significantly reduced Th17 cells in both the kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of AKI. The findings, particularly the new observations of IL-17 reductions in the lung, provide strong mechanistic support for Auxora as a potential treatment for severe AKI with respiratory failure. The inclusion and exclusion criteria of CalciMedica's Phase 2 KOURAGE study are expected to enrich for patients with elevated IL-17 levels, which have been shown to correlate with mortality and major adverse kidney events in severe AKI. Acute Pancreatitis (AP) Program Update Positive discussions with the U.S. Food and Drug Administration (FDA) on pivotal trial in AP: CalciMedica has had constructive engagement with the FDA regarding the design of a pivotal trial in AP. The Company expects to finalize the pivotal trial design in the first half of 2026. This study is anticipated to be the first pivotal trial in the U.S. for a therapeutic in AP. Announced collaboration with Telperian to leverage AI insights to support the design of pivotal trial design in AP: In October 2025, CalciMedica and Telperian announced a collaboration to integrate Telperian's advanced AI platform into analyses of data from completed Auxora clinical trials. Insights from this work are expected to help inform the finalization of the design of CalciMedica's pivotal trial in AP and support ongoing regulatory discussions with the FDA. Preclinical Program Updates Publication in JCIInsight: In November 2025, a manuscript authored by CalciMedica and collaborators titled "Combination of Orai1 Inhibitor CM5480 with Specific Therapy Mitigates Pulmonary Hypertension and Its Cardiac Dysfunction" was published in JCI Insight. The publication describes preclinical data supporting CalciMedica's proprietary CRAC channel inhibitor candidate, CM5480, as a potential first-in-class, differentiated therapy for the treatment of pulmonary arterial hypertension (PAH). In an animal model of PAH, CM5480 restored or improved multiple disease-affected pathways and functions—including heart contraction and cardiac output, gene expression profiles, DNA repair, and metabolism. Treatment with CM5480 also significantly reduced right ventricular dysfunction (RVD) both as a monotherapy and in combination with existing PAH therapies. Beyond PAH, these findings suggest that CRAC channel inhibition may directly improve RVD, which occurs in approximately half of patients with sepsis, the leading cause of AKI. This potential effect provides additional mechanistic support for Auxora as a potential treatment for AKI with respiratory failure. Financial Results for the Third Quarter Ended September 30, 2025: Cash Position: Cash, cash equivalents, and short-term investments were $14.1 million as of September 30, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into the second half of 2026. R&D Expenses: Research and development expenses were $3.9 million for the three months ended September 30, 2025, compared to $3.6 million for the three months ended September 30, 2024. The increase of $0.3 million was primarily due to an increase in clinical trial and preclinical activities offset by a decrease in consultants and other costs. G&A Expenses: General and administrative expenses were $1.8 million for the three months ended September 30, 2025, compared to $2.2 million for the three months ended September 30, 2024. The decrease of $0.4 million was primarily due to a decrease in professional services and consultants and other costs. Other Income (Expense): Other expenses were $2.2 million for the three months ended September 30, 2025, compared to other income of $0.1 million for the three months ended September 30, 2024. The increase of $2.3 million in expenses was primarily due to a non-cash increase in fair value adjustments to the Company's financial instruments. Net Loss: Net loss was $7.8 million, or $0.52 per basic and diluted share, for the three months ended September 30, 2025, compared to $5.6 million, or $0.50 per basic and diluted share, for the three months ended September 30, 2024. About CalciMedica CalciMedica 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 in the first half of 2026. For more information, please visit www.calcimedica.com. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to CalciMedica's expected cash runway; 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 in the first half of 2026; the positive nature of discussions with the FDA concerning design of a pivotal trial in AP and expectation of a final trial design in first half of 2026; the potential benefits of CalciMedica's collaboration with Telperian, including with respect to the design of CalciMedica's pivotal trial in AP; CalciMedica's belief that Auxora reduces Th17 cells in both the kidney and lung, increases glomerular filtration rate, and decreases renal injury; the potential regarding preclinical animal studies of Auxora; the potential of CM5480 to provide therapeutic benefits in PAH; 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 September 30, 2025, being filed with the Securities and Exchange Commission (SEC) later today, 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 Information Kevin Murphy [email protected] (212) 600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-third-quarter-2025-financial-results-and-provides-clinical--corporate-updates-302612229.html

Investor releaseQuarter not tagged2025-08-12

CalciMedica Reports Second Quarter 2025 Financial Results and Provides Clinical & Corporate Updates

PR Newswire
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…Read full document

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 potential treatment for AKI with respiratory failure, as well as the rationale for the patient selection and endpoint selection for the Company's Phase 2 KOURAGE trial. "Auxora for the Treatment of AKI" Symposium: In June 2025, the Company presented a symposium titled "Auxora for the Treatment of AKI" at the 43rd Vicenza Course AKI-CRRT-EBPT and Critical Care Nephrology meeting. The symposium featured oral presentations delivered by Sudarshan Hebbar, M.D., CMO of CalciMedica; Javier Neyra, M.D., Associate Professor of Medicine and Associate Director of the Nephrology Research & Training Center at University of Alabama at Birmingham; and Lakhmir Chawla, M.D., Clinical Professor of Medicine at University of California San Diego, CMO at ExThera Medical, and Chair of the KOURAGE Steering Committee. Webcasts of the presentations are available on the "Medical Events and Presentations" section of CalciMedica's IR website. Publication in the Thrombosis Update: In July 2025, a manuscript authored by CalciMedica and collaborators, titled, "Reduction in D-dimer Levels After Treatment with Auxora in Patients with Severe Covid-19 Pneumonia," was published in the Thrombosis Update. The manuscript highlights a biomarker analysis from patients treated with Auxora in the Company's previously completed Phase 2 CARDEA trial in severe COVID-19 pneumonia. In the analysis, Auxora was found to significantly decrease D-dimer levels and other biomarkers of systemic inflammation, with these decreases correlating with positive outcomes in patients. These findings showing Auxora's anti-inflammatory effects and endothelial stabilization support its continued development for the treatment of acute illnesses with a strong inflammatory component, such as AKI and AP. Oral presentation and panel discussion at the American Society of Nephrology (ASN) 3rd Acute Kidney Injury: From Bench to Bedside Conference: In May 2025, Dr. Hebbar delivered an oral presentation titled "Experiences with AKI Clinical Trial Design" and participated in a panel discussion at the ASN 3rd Acute Kidney Injury: From Bench to Bedside Conference. Acute Pancreatitis (AP) Program Update Conducted initial meeting with the U.S. Food and Drug Administration (FDA) on next steps in AP program: The Company conducted a productive initial meeting with the FDA to present the findings from the Phase 2b CARPO trial and discuss the design of a pivotal trial in AP. Additional meetings with the FDA are anticipated in the second half of 2025, with alignment on trial design anticipated around the end of the year. This will be the first pivotal trial in the U.S. for a therapeutic in AP. Poster presentation at Digestive Disease Week (DDW) 2025: In May 2025, Kenneth A. Stauderman, Ph.D., co-Founder and CSO of CalciMedica, presented a poster titled "Patients with Acute Pancreatitis (AP) and Accompanying Systemic Inflammatory Response Syndrome (SIRS) Have a Larger Volume of Distribution Compared to Healthy Volunteers" at DDW 2025. Financial Results for the Second Quarter Ended June 30, 2025: Cash Position: Cash, cash equivalents, and short-term investments were $18.0 million as of June 30, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into the middle of 2026. R&D Expenses: Research and development expenses were $4.1 million for the three months ended June 30, 2025, compared to $4.2 million for the three months ended June 30, 2024. The decrease of $0.1 million was primarily due to a decrease in CMC costs offset by an increase in clinical activities relating to Auxora. G&A Expenses: General and administrative expenses were $2.6 million for the three months ended June 30, 2025, compared to $2.4 million for the three months ended June 30, 2024. The increase of $0.2 million was primarily due to an increase in personnel costs partially offset by a decrease in professional services. Other Income: Other income was $0.7 million for the three months ended June 30, 2025, compared to $2.6 million for the three months ended June 30, 2024. The decrease of $1.9 million was primarily due to a decrease in fair value adjustments to the Company's financial instruments. Net Loss: Net loss was $6.0 million, or $0.40 per basic and diluted share, for the three months ended June 30, 2025, compared to $4.0 million, or $0.36 per basic and diluted share, for the three months ended June 30, 2024. About CalciMedica CalciMedica 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 in early 2026. For more information, please visit www.calcimedica.com. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to CalciMedica's expected cash runway; 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 in early 2026; the productive nature of discussions with the FDA concerning design of a pivotal trial in AP and the alignment with the FDA on a pivotal trial around the end of 2025; 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 June 30, 2025, being filed with the Securities and Exchange Commission (SEC) later today, 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 Information Kevin Murphy [email protected] (212) 600-1902 View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-second-quarter-2025-financial-results-and-provides-clinical--corporate-updates-302526849.html SOURCE CalciMedica, Inc.

Investor releaseQuarter not tagged2025-05-14

CalciMedica Reports First Quarter 2025 Financial Results and Provides Clinical & Corporate Updates

PR Newswire
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 &…Read full document

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 & CRRT) Conference. The presentation outlined the multi-faceted role of CRAC channels in AKI pathophysiology as well as new data based on a post-hoc analysis from the previously completed CARDEA trial, which included 38 patients who were enrolled with AKI in addition to respiratory failure. Within this subset, patients treated with Auxora showed a 62.7% relative reduction and 29.3% absolute reduction versus placebo in mortality at day 30, which persisted through day 60. 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. Oral presentation and panel discussion at the American Society of Nephrology (ASN) 3rd Acute Kidney Injury: From Bench to Bedside Conference: In May 2025, Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered an oral presentation titled "Experiences with AKI Clinical Trial Design" and participated in a panel discussion at the ASN 3rd Acute Kidney Injury: From Bench to Bedside Conference. Acute Pancreatitis (AP) Program Update End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) planned: CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA around the middle of 2025 and expects to be in a position to initiate a Phase 3 program in AP and accompanying systemic inflammatory response syndrome (SIRS) around the end of 2025 pending additional funding. Poster presentation at Digestive Disease Week (DDW) 2025: In May 2025, Kenneth A. Stauderman, Ph.D., co-Founder and Chief Scientific Officer of CalciMedica, presented a poster titled "Patients with Acute Pancreatitis (AP) and Accompanying Systemic Inflammatory Response Syndrome (SIRS) Have a Larger Volume of Distribution Compared to Healthy Volunteers" at DDW 2025. Corporate Updates Key addition to Board of Directors: In January 2025, CalciMedica announced the appointment of Alan Glicklich, M.D., to the Company's Board of Directors. Dr. Glicklich has more than 20 years of experience in the biotechnology industry and currently serves as Chief Medical Officer of Nuvig Therapeutics. Previously, he was Chief Medical Officer of Chinook Therapeutics. Other Business Highlights: On March 5, 2025, CalciMedica announced a credit facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing up to $32.5 million. The credit agreement, which has a term of 3.5 years, includes an initial tranche of $10 million fully funded at close and additional tranches of up to $22.5 million available to the Company subject to certain milestones. Financial Results for the Three Months Ended March 31, 2025: Cash Position: Cash, cash equivalents, and short-term investments were $24.6 million as of March 31, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into mid-2026. R&D Expenses: Research and development expenses were $4.2 million for the three months ended March 31, 2025, compared to $2.9 million for the three months ended March 31, 2024. The increase of $1.3 million was primarily due to activities involving the Phase 2 KOURAGE clinical trial. G&A Expenses: General and administrative expenses were $2.3 million for the three months ended March 31, 2025, compared to $2.8 million for the three months ended March 31, 2024. The decrease of $0.5 million was primarily due to a decrease in consultants and transaction costs associated with the private placement for the three months ended March 31, 2024. Other Income: Other income was $1.5 million for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024. The decrease of $4.4 million was primarily due to a decrease in non-cash gain related to the fair value adjustments to the Company's financial instruments. Net Loss: Net loss was $5.0 million for the quarter ended March 31, 2025 compared to net income of $0.1 million for the quarter ended March 31, 2024. 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 acute hypoxemic respiratory failure (AHRF) with data expected around the end of 2025. For more information, please visit https://calcimedica.com/. Forward-Looking StatementsThis communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's expectation of multiple milestones in 2025; 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 those trials, including its Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF and its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; and plans for an end-of-Phase 2 meeting with the FDA for CARPO around the middle of 2025 and to be in a position to initiate a pivotal trial in AP around the end of 2025; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases; and the potential of additional proceeds from the credit facility with Avenue Capital Group if required milestones are achieved. 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, being filed with the Securities and Exchange Commission (SEC) later today, 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 [email protected](212) 600-1902       View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-first-quarter-2025-financial-results-and-provides-clinical--corporate-updates-302454622.html SOURCE CalciMedica, Inc.

Investor releaseQuarter not tagged2025-03-27

CalciMedica Reports 2024 Financial Results and Provides Clinical & Corporate Updates

PR Newswire
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…Read full document

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 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 & CRRT) Conference. The presentation outlined the multi-faceted role of CRAC channels in AKI pathophysiology as well as new data based on a post-hoc analysis from the previously completed CARDEA trial, which included 38 patients who were enrolled with AKI in addition to respiratory failure. Within this subset: Patients treated with Auxora showed a 62.7% relative reduction and 29.3% absolute reduction versus placebo in mortality at day 30 which persisted through day 60. 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.      Acute Pancreatitis (AP) Program Update End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) planned: CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA around the middle of 2025 and expects to be in a position to initiate a Phase 3 program in AP and accompanying systemic inflammatory response syndrome (SIRS) around the end of 2025 pending additional funding. Plenary presentation delivered by a collaborator at the American Pancreatic Association (APA) 2024 Annual Meeting: CalciMedica collaborator Prof. Robert Sutton, University of Liverpool and Liverpool University Hospitals NHS Foundation Trust, delivered a plenary presentation titled "Auxora Decreases the Development of Severe Organ Failure in Patients with Acute Pancreatitis and SIRS" at the APA 2024 Annual Meeting.      Asparaginase-induced Pancreatic Toxicity (AIPT) Program Update Enrollment ongoing in Phase 2 portion of CRSPA trial: Enrollment is ongoing in the Phase 2 portion of the Company's CRSPA study in AIPT, with over 50% of the study enrolled. CalciMedica expects to provide an update on this study in the second half of 2025. Corporate Updates Leadership team strengthened with CFO appointment: In November 2024, CalciMedica announced the appointment of Stephen Bardin as Chief Financial Officer and the previously planned departure of Daniel Geffken, Interim Chief Financial Officer. Mr. Bardin has extensive experience in capital raising, corporate development, and strategic finance, and most recently served as Chief Financial Officer of atai Life Sciences. Prior to atai, he was Senior Vice President of Finance and Operations at BridgeBio. Key addition to Board of Directors: In January 2025, the Company announced the appointment of Alan Glicklich, M.D., to the Company's Board of Directors. Dr. Glicklich has more than 20 years of experience in the biotechnology industry and currently serves as Chief Medical Officer of Nuvig Therapeutics. Previously, he was Chief Medical Officer of Chinook Therapeutics. Other Business Highlights:  On March 5, 2025, CalciMedica announced a credit facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing up to $32.5 million. The credit agreement, which has a term of 3.5 years, includes an initial tranche of $10 million fully funded at close and additional tranches of up to $22.5 million available to the Company subject to certain milestones. 2024 Financial Results: Cash Position: Cash, cash equivalents, and short-term investments were $18.7 million as of December 31, 2024, which, combined with the net proceeds of $9.7 million from the Company's recent debt financing announced in March 2025, the Company expects to be sufficient to fund its current operating plan into mid-2026. R&D Expenses: Research and development expenses were $14.5 million for the year ended December 31, 2024, compared to $15.9 million for the year ended December 31, 2023. The decrease of $1.4 million was primarily related to a decrease in personnel expense of $3.3 million, driven by one-time charges as a result of the merger with Graybug Vision ("Merger") for the year ended December 31, 2023. This was partially offset by an increase of $1.3 million in chemistry, manufacturing, and control activities related to the Company's Phase 2 clinical trials of Auxora, costs related to preclinical studies of $0.3 million, and consultants and other costs of $0.3 million. G&A Expenses: General and administrative expenses were $9.7 million for the year ended December 31, 2024, compared to $22.2 million for the year ended December 31, 2023. The decrease of $12.5 million was primarily related to a decrease in personnel expense of $13.0 million, driven by one-time charges as a result of the Merger for the year ended December 31, 2023. Additionally, professional services decreased $0.2 million due to increased costs related to the Merger for the year ended December 31, 2023. These costs were partially offset by an increase of $0.7 million in consultants and other costs. Other Income: Other income for the year ended December 31, 2024, was $10.5 million, compared to $3.7 million for the year ended December 31, 2023. The increase of $6.8 million was due to the fair value adjustments to CalciMedica's warrant liability of $9.5 million as a result of the 2024 Private Placement, compared to fair value adjustments to its warrant liability and convertible promissory notes for the year ended December 31, 2023, and due to an increase of $0.4 million of interest income on the Company's cash equivalents and short-term investments for the year ended December 31, 2024, as compared to the year ended December 31, 2023. Net Loss: Net loss was $13.7 million for the year ended December 31, 2024, compared to a net loss of $34.4 million for the year ended December 31, 2023. 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. 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). The Company has also completed 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 acute hypoxemic respiratory failure (AHRF) with data expected around the end of 2025 and continuing to support the ongoing investigator-initiated Phase 1/2 trial (called CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with an update expected in the second half of 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. 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 expected cash runway; CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its  Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; plans for an end-of-Phase 2 meeting with the FDA  for CARPO and to be in a position to initiate a pivotal trial in AP around the end of 2025;  the potential benefits of Auxora for the treatment of AP,  AKI and AIPT; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases; and the potential of additional proceeds from the credit facility with Avenue Capital Group if certain milestones are achieved. 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 Annual Report on Form 10-K for the year ended December 31, 2024, being filed with the Securities and Exchange Commission (SEC) later today, 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 PartnersSarah Sutton/Kevin [email protected] (212) 600-1902       View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-reports-2024-financial-results-and-provides-clinical--corporate-updates-302412624.html SOURCE CalciMedica, Inc.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook