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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) 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).
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.