CalciMedica Q1 2024 Financial Results and Clinical & Corporate Updates

In a significant milestone for CalciMedica Inc., a clinical-stage biopharmaceutical company, the firm has reported noteworthy progress and financial outcomes for the first quarter ending March 31, 2024. CalciMedica is dedicated to developing innovative calcium release-activated calcium (CRAC) channel inhibition therapies to treat acute and chronic inflammatory and immunologic diseases.

The company has recently completed patient enrollment for its Phase 2b CARPO trial, which investigates the efficacy of Auxora™ in treating acute pancreatitis (AP). The trial, which reached its target enrollment of 216 patients, is set to reveal topline data in the second quarter of 2024. This randomized, double-blind, placebo-controlled study marks a pivotal point in CalciMedica's advancements.

In addition to the CARPO trial, CalciMedica is making headway with its Phase 2 KOURAGE trial, aimed at assessing Auxora in severe acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). This trial, for which the company received FDA clearance in February 2024, is expected to commence patient enrollment later this quarter. The data from KOURAGE is anticipated in 2025.

CalciMedica's progress extends beyond clinical trials. At the Digestive Disease Week (DDW) 2024, Dr. Richard Waldon from Cedars-Sinai Medical Center will present an abstract showcasing human proteomics data that support the potential benefits of Auxora in treating AP. This presentation underscores Auxora's promising therapeutic potential.

Furthermore, at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) held in March 2024, Dr. David Basile from Indiana University shared preclinical data indicating Auxora's capability to expedite recovery and improve survival in rat models of AKI. These findings emphasize the potential of Auxora to inhibit Orai1 channels, which play a vital role in the immune response and kidney function.

Another significant initiative is the CRSPA study, which addresses asparaginase-induced pancreatic toxicity (AIPT). This study has been expanded to additional sites, and the Phase 2 dose has been established, targeting a total enrollment of 24 patients. Data from this trial is expected in 2025.

Financially, CalciMedica is on a strong footing. The company completed a private placement of securities in January 2024, securing up to approximately $54 million in gross proceeds. This includes an upfront investment of $20.4 million and potential additional funding of approximately $33.1 million from accompanying warrants. As of March 31, 2024, CalciMedica reported $25.7 million in cash, cash equivalents, and short-term investments. This financial position is expected to support operations into the second half of 2025.

For the three months ending March 31, 2024, CalciMedica reported a total loss from operations of approximately $5.8 million. However, this was mitigated by a $5.6 million gain from the fair value adjustment to warrant liability and interest income of $0.3 million, resulting in a net income of $0.1 million, or $0.01 per share.

CalciMedica's proprietary technology, focused on CRAC channel inhibition, aims to modulate immune responses and protect against tissue cell injury. The company's lead product candidate, Auxora™, has shown consistent positive results in multiple clinical efficacy trials.

Moving forward, CalciMedica remains committed to advancing its clinical programs and achieving several key milestones. With a robust financial position and ongoing trials, the company is poised to make significant strides in addressing life-threatening inflammatory and immunologic diseases.