CALCIMEDICA INC Stock Price, News & Analysis

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.

CalciMedica announced positive topline data from its Phase 2b CARPO trial evaluating Auxora™ in treating acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial met its primary objective, showing a statistically significant dose response. Key findings include up to a 43.6% reduction in median time to solid food tolerance, a 61.7% reduction in severe organ failure, and a 100% reduction in hospital stays longer than 21 days. The trial demonstrated Auxora's safety and tolerability, with plans for a Phase 3 trial and an upcoming FDA meeting.

CalciMedica announced it will host a conference call on June 27, 2024, at 8:30 a.m. ET to discuss topline data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS). The clinical-stage biopharmaceutical company focuses on developing CRAC channel inhibition therapies for inflammatory and immunologic illnesses. Interested parties can join the call via a live webcast or dial-in numbers provided on CalciMedica's investor relations website. A webcast replay will be available post-event.

CalciMedica reported a significant quarter ending March 31, 2024, marked by the completion of enrollment for the Phase 2b CARPO trial for Auxora™ in acute pancreatitis (AP), with topline data expected in 2Q 2024.

Additionally, the KOURAGE Phase 2 trial for severe acute kidney injury (AKI) will start patient enrollment in 2Q 2024, with data expected in 2025. A related abstract will be presented at Digestive Disease Week (DDW) 2024.

Financially, the company completed a $54 million private placement, with $20.4 million received upfront and $33.1 million pending from warrant exercises. With $25.7 million in cash and equivalents, operations are funded into the second half of 2025. Total operating losses were $5.8 million for Q1, offset by a $5.6 million gain from warrant liability adjustment, resulting in a $0.1 million net income.

CalciMedica Inc. announces an upcoming presentation at Digestive Disease Week 2024 where collaborators from Cedars-Sinai will present human proteomics data supporting the potential benefits of Auxora™ in severe acute pancreatitis. The presentation will highlight the similarities between the benefits of Auxora and those seen in COVID-19 pneumonia.