CALC News & Events

CalciMedica announced that the FDA has reviewed a protocol amendment and interim safety data for CalciMedica's Phase 2 KOURAGE trial in patients with Stage 2 or Stage 3 acute kidney injury, or AKI, with associated acute hypoxemic respiratory failure, or AHRF. Following the applicable review period, the Company has received no comments from the FDA on the submission, meaning that CalciMedica may continue to dose patients with Auxora in the study. In March 2026, CalciMedica submitted an amendment to the KOURAGE trial to address design issues, which included refinements to patient inclusion criteria and changes to stratification methodology. The FDA has confirmed that the Clinical Pharmacology team of the Division of Cardiology and Nephrology has no comments regarding this submission. As the KOURAGE trial was never placed on clinical hold, and the decision to pause enrollment was made solely at the discretion of the Company, the FDA is not obligated to respond to the IND amendment. Following more than 60 days of review, the information contained in the amendment has resulted in no comments or questions from the FDA and no clinical hold communication. CalciMedica expects feedback from the FDA on the design of a potential pivotal program evaluating Auxora in acute pancreatitis in the Q3.

CalciMedica announced it has entered into a definitive securities purchase agreement with leading healthcare investors for a private placement for up to approximately $49M in gross proceeds. The financing includes participation from new and existing investors, including members of CalciMedica's Board of Directors and management team. In the private placement, the Company will sell an aggregate of 18,673,429 units, with each unit comprised of (i) one share of its common stock or one pre-funded warrant to purchase shares of common stock at an exercise price of $0.0001 per share, (ii) a right to receive one Series A warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock at an exercise price of $0.8033 per share, and (iii) a right to receive one Series B warrant to purchase shares of its common stock or pre-funded warrants to purchase shares of its common stock at an exercise price of $1.00 per share. The private placement is comprised of (i) upfront gross proceeds of approximately $15 million, representing a purchase price of $0.8033 for each unit or $0.8032 for each unit including a pre-funded warrant sold in lieu of common stock, (ii) Series A warrants with the potential for up to an additional $15 million in gross proceeds if exercised in full, and (iii) Series B warrants with the potential for up to approximately an additional $19 million in gross proceeds if exercised in full. Both Series A warrants and Series B warrants are issuable subject to stockholder approval in accordance with Nasdaq listing rules. The purchase price for each unit for the members of CalciMedica's Board of Directors and management team will be priced at or above the Nasdaq Consolidated Closing Bid Price as of June 23. Guggenheim Securities is acting as sole placement agent in connection with the private placement financing.

CalciMedica files $125M mixed securities shelf