Welcome to our dedicated page for CALCIMEDICA news (Ticker: CALC), a resource for investors and traders seeking the latest updates and insights on CALCIMEDICA stock.
Overview
CalciMedica Inc (CALC) is a clinical‐stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapies that target calcium release-activated calcium (CRAC) channels. By focusing on CRAC channel inhibition, the company aims to modulate the immune response and protect against tissue injury in life-threatening inflammatory and immunologic diseases. Core therapeutic areas include autoimmune disorders, organ transplant rejection, acute pancreatitis with systemic inflammatory response syndrome (SIRS), acute kidney injury (AKI) with associated respiratory failure, and pediatric conditions linked to asparaginase-induced pancreatic toxicity.
Innovative Technology and Therapeutic Focus
At the heart of CalciMedica’s approach is its proprietary technology targeting CRAC channels. These channels play a critical role in cellular calcium influx and immune cell activation, which are central to the pathogenesis of numerous inflammatory and immunologic diseases. By selectively inhibiting CRAC channels, CalciMedica’s lead product candidate, Auxora™, is designed to attenuate overactive immune responses while simultaneously offering organ tissue protection. This dual mechanism of action underlines the potential of their therapies to treat conditions with high unmet medical need for which no approved therapies exist.
Clinical Programs and Pipeline
CalciMedica’s pipeline is robust, encompassing multiple clinical trials addressing severe acute illnesses:
- Acute Pancreatitis (AP) with SIRS: The Phase 2b CARPO trial evaluates the efficacy of Auxora in improving clinical outcomes in AP patients. The trial is international, randomized, and placebo-controlled, ensuring rigorous assessment of dose-response and safety.
- Acute Kidney Injury (AKI) with Respiratory Failure: The Phase 2 KOURAGE trial examines Auxora in patients with Stage 2 and Stage 3 AKI accompanied by acute hypoxemic respiratory failure. Enrollment criteria are designed to select patients experiencing severe inflammation, addressing a critical area with no current approved therapy.
- Pediatric Asparaginase-Induced Pancreatic Toxicity (AIPT): An investigator-sponsored Phase 1/2 trial investigates Auxora’s potential in pediatric patients undergoing treatment for acute lymphoblastic leukemia, where asparaginase therapy can lead to debilitating pancreatic toxicity.
Market Position and Competitive Landscape
Within the dynamic biopharmaceutical landscape, CalciMedica differentiates itself through its focused approach on CRAC channel inhibition—a mechanism that directly addresses underlying inflammatory pathways rather than merely treating symptoms. The company has garnered attention from leading life science investors and secured strategic financing arrangements, highlighting confidence in its science and clinical promise. Its rigorous clinical trials and adherence to robust regulatory standards position it as a notable player in treating diseases with significant unmet needs.
Expertise, Safety, and Future Readiness
CalciMedica’s commitment to advancing therapies through well-designed clinical trials reinforces its expertise and credibility. Clinical data have consistently demonstrated a well-tolerated safety profile for Auxora™, with meaningful improvements in critical endpoints such as time to solid food tolerance in AP and reduction in severe organ failure in trial participants. Detailed and transparent reporting reinforces the company’s authoritativeness in its field while ensuring that the scientific community and investors receive balanced, factual information regarding its progress. The company’s strategy underlines its focus on solving complex inflammatory conditions through targeted and innovative approaches, reflecting deep industry insights and technical precision.
Summary
In summary, CalciMedica Inc is firmly positioned at the intersection of cutting-edge science and clinical need. Through its unique CRAC channel inhibition strategy, the company is addressing severe inflammatory and immunologic diseases with no current approved therapeutic options. With a clearly articulated clinical pipeline, robust scientific rationale, and considerable industry expertise, CalciMedica provides a comprehensive model of innovation and excellence in biopharmaceutical research and development.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies for inflammatory and immunologic conditions, has announced its participation in the upcoming Jones Healthcare and Technology Innovation Conference.
The company's CEO, Rachel Leheny, Ph.D., will deliver a presentation on Wednesday, April 9, 2025, at 11:00 a.m. PT. Interested parties can access the live webcast through CalciMedica's IR website in the 'Upcoming Events' section. The presentation recording will remain available on the company's website for a 90-day period.
CalciMedica (CALC) has reported its financial results for 2024 and provided key clinical updates. The company continues enrollment in its Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) and respiratory failure, with data expected around end of 2025. A notable post-hoc analysis showed a 62.7% relative reduction in mortality at day 30 in AKI patients treated with Auxora versus placebo.
Financial highlights include cash position of $18.7 million as of December 31, 2024, plus $9.7 million from recent debt financing, expected to fund operations into mid-2026. The company reported reduced R&D expenses of $14.5 million (down from $15.9 million in 2023) and G&A expenses of $9.7 million (down from $22.2 million in 2023). Net loss decreased to $13.7 million from $34.4 million in 2023.
CalciMedica (Nasdaq: CALC) has secured a credit facility of up to $32.5 million from Avenue Venture Opportunities Fund II. The agreement includes an initial $10 million tranche funded at closing, with additional tranches of up to $22.5 million available subject to certain milestones.
The 3.5-year credit facility has no minimum cash requirement or financial covenants. The initial funding extends CalciMedica's cash runway into mid-2026, supporting their product pipeline development, including the anticipated data from their Phase 2 KOURAGE trial of Auxora in patients with acute kidney injury and hypoxemia throughout 2025.
The extended runway will also support anticipated FDA discussions regarding the design of a Phase 3 program in acute pancreatitis. Auxora is the company's lead pipeline candidate targeting acute inflammatory and immunologic diseases.
CalciMedica (CALC) presented new data from a post-hoc analysis of their Phase 2 CARDEA trial studying Auxora™ in severe COVID-19 pneumonia patients with Acute Kidney Injury (AKI). The analysis revealed:
- A 62.7% relative reduction in mortality at day 30 (sustained through day 60) in AKI patients treated with Auxora versus placebo
- Only 17.4% (4/23) Auxora-treated patients died compared to 46.7% (7/15) on placebo
- An absolute mortality reduction of 29.3% in the AKI subset
The study included 38 patients with AKI (defined as eGFR ≤ 60 ml/min/1.73 m²) and moderate/severe respiratory failure. Preclinical studies showed CRAC channel inhibition reduced Th17 cells in rat kidneys, protected podocyte cells, and improved GFR recovery. The company is currently conducting a Phase 2 trial of Auxora in Stage 2/3 AKI patients with acute hypoxemic respiratory failure, with results expected in 2025.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies for inflammatory and immunologic illnesses, has announced an upcoming plenary presentation at the 30th International AKI & CRRT Conference in San Diego.
The company's Chief Medical Officer, Dr. Sudarshan Hebbar, will present on 'The Role of ORAI-1 in AKI' during the 'Bench to Bedside: Translating Discoveries to Clinical Care' session on March 3, 2025, at 10:35 AM PT.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies for inflammatory and immunologic illnesses, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference.
The company's CEO, Rachel Leheny, Ph.D., will deliver a presentation on Wednesday, February 12, 2025, at 8:00 a.m. ET. Interested parties can access a live webcast of the presentation through CalciMedica's IR website under the 'Upcoming Events' section. The presentation recording will remain available on the company's website for 90 days following the event.
CalciMedica (Nasdaq: CALC) announced the appointment of Dr. Alan Glicklich to its Board of Directors, effective January 15, 2025. Dr. Glicklich, currently Chief Medical Officer of Nuvig Therapeutics, brings over 20 years of biotechnology industry experience. He will contribute to CalciMedica's development of Auxora, their CRAC channel inhibition therapy, as it progresses toward Phase 3 trials in acute pancreatitis and awaits data from the KOURAGE trial in acute kidney injury.
Dr. Glicklich's experience includes leadership roles at Chinook Therapeutics, Bird Rock Bio, and Arena Pharmaceuticals, where he successfully led clinical development programs. At Nuvig Therapeutics, he is currently preparing multiple Phase 2 trials for inflammatory autoimmune diseases. His appointment strengthens CalciMedica's expertise in inflammatory and immunologic disease spaces.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing CRAC channel inhibition therapies for inflammatory and immunologic illnesses, announced its participation in the Piper Sandler 36th Annual Healthcare Conference. CEO Rachel Leheny, Ph.D., will present on December 4, 2024, at 9:10 a.m. ET. The presentation will be available via live webcast on CalciMedica's IR website, with a replay accessible for 90 days following the event.
CalciMedica (Nasdaq: CALC) announced two upcoming presentations of its Phase 2b CARPO trial results for Auxora™ in Acute Pancreatitis. The first is a plenary presentation by Prof. Robert Sutton at the American Pancreatic Association (APA) 2024 Annual Meeting in Maui on December 10, focusing on how Auxora reduces severe organ failure in patients with acute pancreatitis and SIRS.
The second is a poster presentation at the Emergencies in Medicine (EIM) 2024 Meeting in Maui, highlighting the randomized, double-blind, placebo-controlled dose-ranging study. Both presentations will be available on CalciMedica's IR website after the sessions.
CalciMedica (Nasdaq: CALC) reported Q3 2024 financial results and clinical updates. The company announced positive data from its Phase 2b CARPO trial of Auxora™ in acute pancreatitis, showing a 100% relative risk reduction in new-onset severe respiratory failure. Enrollment continues in Phase 2 KOURAGE trial for acute kidney injury and CRSPA trial for asparaginase-induced pancreatic toxicity, with data expected in 2025. Following a public offering of 2,720,000 shares at $3.75 per share in October, the company's cash position of $23.7 million is expected to fund operations into first half of 2026. Q3 2024 net loss was $5.6 million ($0.50 per share).
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