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LA JOLLA, Calif. - CalciMedica Inc. (NASDAQ:CALC), a clinical-stage biotech company with a market capitalization of $23 million and shares trading near 52-week lows, announced the publication of a manuscript in the American Journal of Nephrology outlining the design and rationale of its Phase 2 KOURAGE trial of Auxora in acute kidney injury (AKI) with respiratory failure. According to InvestingPro analysis, the stock appears fairly valued based on current Fair Value estimates.
The manuscript includes preclinical data showing Auxora significantly increased glomerular filtration rate in rat models of AKI. It also presents a post-hoc analysis from the company’s CARDEA trial, which showed a 62.7% relative reduction in mortality among COVID-19 patients with AKI who received Auxora compared to placebo. InvestingPro data reveals the company maintains a strong liquidity position with a current ratio of 5.66, though it’s currently experiencing significant cash burn.
The KOURAGE trial is a randomized, double-blind, placebo-controlled study expected to enroll approximately 150 patients with Stage 2 and 3 AKI who have respiratory failure. Participants will receive either five daily doses of Auxora or placebo, with the primary endpoint being days alive without ventilator or dialysis support.
"Approximately 3.7 million patients are hospitalized with AKI in the U.S. each year. Patients with severe AKI who have associated respiratory failure have a high risk of mortality, estimated to be approximately 50%," said Lakhmir Chawla, Chair of the KOURAGE Steering Committee, according to the press release.
Auxora is a calcium release-activated calcium (CRAC) channel inhibitor designed to modulate immune response and protect against tissue cell injury. The drug has been administered to over 350 critically ill patients in previous trials.
CalciMedica expects data from the KOURAGE trial around the end of 2025. The company is developing CRAC channel inhibition therapies for inflammatory and immunologic diseases.
The information in this article is based on a press release statement from CalciMedica.
In other recent news, CalciMedica announced its financial results for the fourth quarter and full year of 2024, reporting earnings per share of ($0.33) for the fourth quarter and ($1.22) for the full year. These figures were below H.C. Wainwright’s estimates but exceeded consensus expectations. The company has a pro-forma cash balance of approximately $28.4 million, supported by recent debt financing, which management believes will fund operations into mid-2026. Additionally, CalciMedica has made strides in the development of its lead clinical candidate, Auxora, with plans for an End of Phase 2 meeting with the FDA and a Phase 3 study in acute pancreatitis by the end of 2025.
In other developments, CalciMedica is actively enrolling participants in the Phase 2 KOURAGE trial for acute kidney injury, with results expected by the end of 2025. The company also reported promising results from a post-hoc analysis of the CARDEA trial, which showed a significant reduction in mortality for severe COVID-19 pneumonia patients treated with Auxora. Meanwhile, CalciMedica has appointed Baker Tilly as its new accounting firm following a merger with Moss Adams, a decision approved by the Board of Directors’ Audit Committee. H.C. Wainwright has maintained its Buy rating and $16 price target for CalciMedica, citing these recent developments as reasons for continued confidence in the company.
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