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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), 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.
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.
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