CalciMedica Q2 2024 Financial Results and Updates

CalciMedica Inc., a biopharmaceutical company dedicated to developing innovative calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases, recently announced several key updates and financial results for the second quarter ending June 30, 2024.

In June 2024, CalciMedica revealed positive topline data from its Phase 2b CARPO trial. This double-blind, placebo-controlled study focused on Auxora™ for treating patients with acute pancreatitis (AP) and systemic inflammatory response syndrome (SIRS). The trial achieved its primary goal, showing a statistically significant dose response in the median time to solid food tolerance among hyper-inflamed AP patients. Additionally, the study found a reduction in severe organ failure across all patients involved. The company plans to present comprehensive data from this trial later in the year and will discuss the results with the FDA to design a pivotal Phase 3 trial, anticipated to begin in 2025.

Another significant milestone for CalciMedica was the enrollment of the first patient in the KOURAGE trial, a Phase 2 study of Auxora™ targeting severe acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). Announced in July 2024, this randomized, double-blind, placebo-controlled trial aims to enroll 150 patients with stage 2 and stage 3 AKI who are receiving oxygen through various methods. The company expects to release topline data from this trial in 2025.

In addition to advancing clinical trials, CalciMedica announced its inclusion in the Russell Microcap® Index, effective from July 1, 2024. This inclusion is part of the annual reconstitution of the Russell U.S. Indexes and represents a significant recognition within the investment community.

CalciMedica's CRSPA study, focusing on asparaginase-induced pancreatic toxicity (AIPT), has also been expanded. This trial's initial cohort determined the recommended Phase 2 dose, and the study now aims to enroll around 24 patients, with data expected in 2025.

From a financial perspective, as of June 30, 2024, CalciMedica reported having approximately $19.1 million in cash, cash equivalents, and short-term investments. This funding is projected to support the company's operations into the second half of 2025. The total loss from operations was $6.5 million for the three months ended June 30, 2024, and $12.3 million for the six months ended the same date. After accounting for a $2.3 million non-cash gain from the fair value adjustment of the warrant liability and $0.3 million of interest income, the net loss for the three months was about $4.0 million, or $0.36 per share. For the six-month period, including a $7.9 million non-cash gain and $0.6 million of interest income, the net loss was $3.8 million, or $0.37 per share.

CalciMedica continues to build on its innovative approaches to treating critical inflammatory and immunologic diseases. The company's lead product candidate, Auxora™, has shown promising and consistent results in multiple clinical trials. Founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, CalciMedica is headquartered in La Jolla, California, and aims to make significant strides in the biopharmaceutical field with its focus on CRAC channel inhibition therapy.