Item 7.01 Regulation FD Disclosure.
On January 28, 2026, CalciMedica, Inc. (the “Company”) issued a press release announcing the discontinuation of its Phase 2 KOURAGE clinical trial evaluating AuxoraTM in patients with Stage 2 or Stage 3 acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure (“AHRF”). The decision follows a recommendation from the trial’s Independent Data Monitoring Committee (“IDMC”) (the “Trial Discontinuation”). A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 7.01 of this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any filing we make with the U.S. Securities and Exchange Commission (“SEC”), whether before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
On January 28, 2026, the Company announced the Trial Discontinuation. During a prescheduled interim data review, the IDMC identified a safety concern that, in its view, warrants reevaluation of the study design, particularly with respect to patient enrollment criteria. There were no deaths in the trial that were assessed by investigators or the Company as being related to study drug (either Auxora or placebo). In addition, no serious adverse events met the criteria for expedited reporting to the U.S. Food and Drug Administration (“FDA”). Based on the IDMC’s recommendation, the Company has discontinued the trial and plans to perform a comprehensive review of the unblinded clinical data. The Company will assess the impact of baseline characteristics, disease severity, concomitant therapies, and other factors on patient outcomes. These analyses are expected to inform how future clinical evaluation of Auxora in AKI may proceed. The Company has notified the FDA about the Trial Discontinuation and will work with investigators to ensure all patients currently enrolled in the trial complete the full 90-day follow-up.
Cautionary Statement Regarding Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements which include, but are not limited to, statements related to the Company’s planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for updates; statements regarding the safety and efficacy of its product candidates; statements regarding the planned analysis of the unblinded KOURAGE dataset, including the timing of such analysis and whether such analysis will inform future trial parameters; and the potential of the Company’s proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases such as AKI and AP. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including, but not limited to, risks and uncertainties related to: the impact of fluctuations in global financial markets on the Company’s business and the actions it may take in response thereto; the Company’s ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of the Company generally; the Company’s ability to protect its intellectual property position; the impact of government laws and regulations; and the Company’s financial position and need for additional capital. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 12, 2025, and elsewhere in the Company’s subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time. The forward-looking statements included in this Current Report on Form 8-K are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
