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.
About CalciMedica Inc.
CalciMedica Inc. (Nasdaq: CALC) is a clinical-stage biopharmaceutical company dedicated to advancing the treatment of acute and chronic inflammatory and immunologic diseases through its innovative calcium release-activated calcium (CRAC) channel inhibition technology. Headquartered in La Jolla, California, the company is pioneering therapies that target CRAC channels to modulate immune responses and protect against tissue injury, addressing critical unmet medical needs in life-threatening conditions.
Core Technology and Therapeutic Focus
CalciMedica's proprietary technology revolves around the inhibition of CRAC channels, which are integral to immune cell activation and inflammatory responses. By targeting these channels, the company aims to reduce inflammation, prevent organ damage, and improve clinical outcomes in patients with acute and chronic inflammatory syndromes. The company's lead product candidate, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels. This intravenous formulation has demonstrated promising results in preclinical and clinical trials, showcasing its potential to treat severe inflammatory diseases.
Lead Product Candidate: Auxora™
Auxora™ is being developed to address multiple acute inflammatory conditions, including:
- Acute Pancreatitis (AP): A life-threatening condition characterized by systemic inflammation and organ failure. Auxora™ has shown efficacy in reducing severe organ failure and hospital length of stay in patients with AP and accompanying systemic inflammatory response syndrome (SIRS).
- Acute Kidney Injury (AKI): A critical illness involving sudden kidney function loss, often associated with high mortality rates. Auxora™ is currently being evaluated in the Phase 2 KOURAGE trial for AKI with acute hypoxemic respiratory failure (AHRF).
- Pediatric Pancreatic Toxicity (AIPT): A severe side effect of leukemia treatment in children, for which Auxora™ is being investigated in the ongoing CRSPA trial.
With no approved therapies available for these conditions, Auxora™ represents a significant advancement in addressing these unmet medical needs.
Clinical Development Pipeline
CalciMedica's robust pipeline includes multiple clinical trials:
- CARPO Trial: A Phase 2b trial evaluating Auxora™ for acute pancreatitis with SIRS, which demonstrated positive topline results, including reduced organ failure and improved recovery times.
- KOURAGE Trial: A Phase 2 study targeting severe AKI with AHRF, focusing on ventilator-free and dialysis-free survival as key endpoints.
- CRSPA Trial: An investigator-sponsored Phase 1/2 trial exploring Auxora™ for pediatric patients with asparaginase-induced pancreatic toxicity.
These trials highlight CalciMedica's commitment to advancing therapies for critical illnesses with no current treatment options.
Market Position and Industry Significance
CalciMedica operates at the forefront of immunology and inflammation research, leveraging its expertise in CRAC channel biology to address high-burden diseases. The company’s focus on severe, life-threatening conditions positions it as a key innovator in the biopharmaceutical space. By targeting diseases with no approved therapies, CalciMedica addresses significant gaps in patient care and healthcare systems.
Strategic Vision
Founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, CalciMedica combines cutting-edge science with clinical expertise to develop transformative therapies. The company’s strategic vision includes advancing Auxora™ through pivotal trials, expanding its therapeutic indications, and collaborating with regulatory authorities to bring life-saving treatments to market.
Conclusion
CalciMedica Inc. exemplifies innovation and dedication in the biopharmaceutical industry. With its proprietary CRAC channel inhibition technology, the company is poised to address critical unmet needs in inflammatory and immunologic diseases, offering hope to patients and advancing the field of acute care medicine.
CalciMedica (Nasdaq: CALC) announced a conference call and webcast scheduled for Wednesday, October 30, 2024, at 12 p.m. ET to present the complete data set and win ratio analysis from their Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS). Prof. Robert Sutton from the University of Liverpool, chair of the CARPO trial Steering Committee, will deliver a plenary presentation titled 'A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study of Auxora in Patients with AP and Accompanying SIRS - CARPO' from the American College of Gastroenterology 2024 Annual Scientific Meeting.
CalciMedica Inc. (Nasdaq: CALC) announced the acceptance of a late-breaking abstract for a plenary presentation at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The presentation will be given by Prof. Robert Sutton from the University of Liverpool and Liverpool University Hospitals NHS Foundation Trust on October 30, 2024 at 10:00-10:15 a.m. ET in the Grand Ballroom.
Prof. Sutton is the chair of the Steering Committee for the CARPO acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS) clinical trial. The presentation is part of the Simultaneous Plenary Session 4A and is listed as Abstract #64. The abstract authors include researchers from various institutions, including CalciMedica, Inc.
CalciMedica Inc. (Nasdaq: CALC), a clinical-stage biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's CEO, Rachel Leheny, Ph.D., will deliver a presentation on September 9, 2024, at 7:00 a.m. ET/ 4:00 a.m. PT.
CalciMedica specializes in developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses. Investors and interested parties can access a live webcast of the presentation through the company's IR website. The webcast replay will be available for 90 days following the event.
CalciMedica Inc. (Nasdaq: CALC) reported its Q2 2024 financial results and provided clinical updates. Key highlights include:
1. Positive topline data from the Phase 2b CARPO trial of Auxora™ in acute pancreatitis (AP).
2. First patient enrolled in the Phase 2 KOURAGE trial of Auxora™ in severe acute kidney injury (AKI).
3. Inclusion in the Russell Microcap® Index.
4. Expansion of the CRSPA study in asparaginase-induced pancreatic toxicity (AIPT).
Financial results: $19.1 million in cash and equivalents as of June 30, 2024. Q2 2024 net loss of $4.0 million ($0.36 per share). H1 2024 net loss of $3.8 million ($0.37 per share).
CalciMedica has announced the first patient enrollment in its Phase 2 KOURAGE trial, testing Auxora™ for severe acute kidney injury (AKI) with acute hypoxemic respiratory failure (AHRF). This trial, supported by clinical and pre-clinical evidence, aims to enroll 150 patients. Participants will receive daily doses of Auxora or placebo and will be evaluated up to 30 days post-dosing. The study includes secondary endpoints like all-cause mortality and kidney function decline over 90 days. Previous trials and preclinical models have shown promising results for Auxora. Topline data are expected in 2025.
With AKI causing 3.7 million hospitalizations annually in the U.S., this trial could pave the way for a novel treatment in a field currently to supportive care.
CalciMedica, a clinical-stage biopharmaceutical company specializing in CRAC channel inhibition therapies, announced that CEO Rachel Leheny, Ph.D., will present at two upcoming healthcare investment conferences on July 15, 2024. The events include the H.C. Wainwright 3rd Annual Kidney Virtual Conference at 11:00 AM ET/8:00 AM PT and the JonesTrading Healthcare Seaside Summit at 1:15 PM ET/10:15 AM PT. Live webcasts of these presentations will be available on CalciMedica's Investor Relations website and will be archived for 90 days.
CalciMedica, a biopharmaceutical company specializing in CRAC channel inhibition therapies for inflammatory and immunologic illnesses, announced its inclusion in the Russell Microcap® Index. The inclusion will be effective from July 1, 2024, following the Russell U.S. Indexes annual reconstitution, which ranks the 4,000 largest U.S. stocks by market capitalization. This marks a significant milestone for CalciMedica, highlighting its growth since going public in Q1 2023. Russell indexes are key benchmarks for investment managers and institutional investors, representing $10.5 trillion in assets as of December 2023.
CalciMedica announced positive topline data from its Phase 2b CARPO trial evaluating Auxora™ in treating acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial met its primary objective, showing a statistically significant dose response. Key findings include up to a 43.6% reduction in median time to solid food tolerance, a 61.7% reduction in severe organ failure, and a 100% reduction in hospital stays longer than 21 days. The trial demonstrated Auxora's safety and tolerability, with plans for a Phase 3 trial and an upcoming FDA meeting.
CalciMedica announced it will host a conference call on June 27, 2024, at 8:30 a.m. ET to discuss topline data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS). The clinical-stage biopharmaceutical company focuses on developing CRAC channel inhibition therapies for inflammatory and immunologic illnesses. Interested parties can join the call via a live webcast or dial-in numbers provided on CalciMedica's investor relations website. A webcast replay will be available post-event.
CalciMedica reported a significant quarter ending March 31, 2024, marked by the completion of enrollment for the Phase 2b CARPO trial for Auxora™ in acute pancreatitis (AP), with topline data expected in 2Q 2024.
Additionally, the KOURAGE Phase 2 trial for severe acute kidney injury (AKI) will start patient enrollment in 2Q 2024, with data expected in 2025. A related abstract will be presented at Digestive Disease Week (DDW) 2024.
Financially, the company completed a $54 million private placement, with $20.4 million received upfront and $33.1 million pending from warrant exercises. With $25.7 million in cash and equivalents, operations are funded into the second half of 2025. Total operating losses were $5.8 million for Q1, offset by a $5.6 million gain from warrant liability adjustment, resulting in a $0.1 million net income.