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CalciMedica, Inc. (Nasdaq: CALC) is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel small molecule drugs for treating autoimmune disorders, organ transplant rejection, and other immune diseases. The company's primary focus is on developing therapies for life-threatening inflammatory diseases with a high unmet need. Utilizing its proprietary technology, CalciMedica targets the inhibition of calcium release-activated calcium (CRAC) channels. This approach is designed to modulate the immune response and protect against tissue cell injury, offering therapeutic benefits for diseases with no approved therapies.
CalciMedica's lead product candidate, Auxora™, is an intravenous-formulated CRAC channel inhibitor that has shown promising results in multiple clinical trials. The company is currently conducting several significant studies:
- CARPO Trial: A Phase 2b international, randomized, double-blind, placebo-controlled, dose-ranging trial aimed at establishing Auxora's efficacy in treating acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS). The trial has successfully enrolled 216 patients, with topline data expected in the second quarter of 2024.
- CRSPA Study: An investigator-sponsored Phase 1/2 trial focusing on pediatric patients with acute lymphoblastic leukemia (ALL) experiencing asparaginase-induced pancreatic toxicity (AIPT). This study aims to define an optimal pediatric dose for Auxora and is expected to provide additional data by the second half of 2024.
- KOURAGE Trial: A Phase 2 trial targeting patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF). This randomized, double-blind, placebo-controlled study plans to evaluate 150 patients, with data anticipated in 2025.
CalciMedica has also secured substantial funding through a securities purchase agreement, raising up to $55 million in gross proceeds. This financing will support ongoing and planned clinical trials, bringing the company closer to achieving its goal of providing effective treatments for critically ill patients.
Recent achievements include the presentation of positive Phase 1/2 CRSPA study results at the 65th Annual American Society of Hematology Meeting and the clearance of an Investigational New Drug (IND) application by the FDA for the KOURAGE trial. Additionally, the company has engaged in a private placement financing, ensuring continued financial health and the ability to pursue pivotal clinical trials.
Founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, CalciMedica is headquartered in La Jolla, CA. For more information, visit www.calcimedica.com.
CalciMedica (Nasdaq: CALC) has announced the pricing of an underwritten public offering of 2,720,000 shares of common stock at $3.75 per share. The company expects to raise gross proceeds of $10,200,000 before deducting underwriting costs and expenses. CalciMedica has granted underwriters a 30-day option to purchase up to an additional 408,000 shares at the public offering price. The offering is expected to close around November 1, 2024. Jones is serving as the sole book-running manager for this offering, which is being conducted under a shelf registration statement previously declared effective by the SEC.
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing CRAC channel inhibition therapies, has announced a proposed underwritten public offering of common stock. The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of the offered shares. Jones will serve as the sole book-running manager. The offering is being made through a shelf registration statement on Form S-3 previously filed with the SEC. The completion, size, and terms of the offering are subject to market conditions.
CalciMedica (CALC) announced positive Phase 2b CARPO trial results for Auxora™ in acute pancreatitis (AP) patients with SIRS. The trial showed a 100% reduction in new-onset severe respiratory failure (p=0.0027) and 64.2% reduction in persistent respiratory failure (p=0.0476) for combined high/medium doses versus low dose/placebo. The high dose (2.0 mg/kg) demonstrated a significant stratified win ratio of 1.640 (p=0.0372) compared to placebo. Additional benefits included reduced necrotizing pancreatitis and shorter hospital stays. The drug was well-tolerated with no drug-related serious adverse events in the high-dose group.
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.
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