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CalciMedica, Inc. develops calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. The clinical-stage biopharmaceutical company’s lead product candidate, Auxora, is an intravenous small-molecule CRAC channel inhibitor based on zegocractin and is being studied across severe inflammatory conditions involving tissue cell injury.
Company news commonly covers financial results, clinical and preclinical updates, regulatory discussions, publications, and corporate developments. Recurring program topics include Auxora data in acute pancreatitis with systemic inflammatory response syndrome, severe COVID-19 pneumonia, and acute kidney injury, as well as preclinical work on CM5480 in pulmonary arterial hypertension.
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).
CalciMedica (Nasdaq: CALC), a clinical-stage biopharmaceutical company, announced the appointment of Stephen Bardin as Chief Financial Officer, succeeding Daniel Geffken, Interim CFO, upon the filing of the third quarter financial statements. Bardin, who previously served as CFO of atai Life Sciences, brings extensive expertise in capital raising, corporate development, and strategic finance. He has already contributed to CalciMedica's successful public financing and will play a key role in advancing their clinical-stage pipeline, including the CARPO Phase 2b trial in acute pancreatitis and the upcoming KOURAGE Phase 2 trial in acute kidney injury. Bardin's background includes significant roles at BridgeBio Pharma and Myovant Sciences, and he holds an M.B.A. from Stanford and a B.S.E. from Duke University.
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.