CalciMedica stops Phase 2 AKI trial for Auxora

CalciMedica, Inc. has discontinued its Phase 2 KOURAGE clinical trial of Auxora in patients with Stage 2 or Stage 3 acute kidney injury with associated acute hypoxemic respiratory failure.

Accepted by SEC EDGAR 01/28/2026 - 07:06 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

CalciMedica, Inc. has discontinued its Phase 2 KOURAGE clinical trial of Auxora in patients with Stage 2 or Stage 3 acute kidney injury with associated acute hypoxemic respiratory failure. The move follows a safety-related recommendation from the trial’s Independent Data Monitoring Committee, which believes the study design and patient enrollment criteria should be reevaluated.

The company states there were no deaths assessed as related to Auxora or placebo, and no serious adverse events triggered expedited U.S. Food and Drug Administration reporting. CalciMedica will conduct a comprehensive review of the unblinded data to understand how baseline characteristics, disease severity and concomitant therapies influenced outcomes and to determine how future clinical evaluation of Auxora in AKI may proceed. The FDA has been notified, and investigators will follow all enrolled patients for 90 days.

Insights

Biotech clinical development analyst

Stopping the Phase 2 KOURAGE trial is a setback for Auxora’s AKI program.

CalciMedica has halted its Phase 2 KOURAGE study of Auxora in acute kidney injury with hypoxemic respiratory failure after the Independent Data Monitoring Committee identified a safety concern that warrants reevaluating the study design and enrollment criteria. This removes an active mid-stage trial from the development path.

The company emphasizes that no deaths were assessed as related to study drug and no serious adverse events met expedited U.S. Food and Drug Administration reporting criteria. However, the decision to discontinue based on an IDMC safety concern suggests the existing protocol may not be suitable for continued testing in this population.

CalciMedica plans a comprehensive review of unblinded data to examine baseline characteristics, disease severity, concomitant therapies and other factors, with the goal of informing any future Auxora trials in acute kidney injury. The company has notified the FDA and will complete 90-day follow-up for all enrolled patients, meaning further insight will depend on this planned analysis and subsequent regulatory and clinical decisions.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

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NASDAQ false 0001534133 0001534133 2026-01-28 2026-01-28

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

January 28, 2026

Date of Report (Date of earliest event reported)

CalciMedica, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39538		45-2120079
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

505 Coast Boulevard South, Suite 307 La Jolla, California		92037
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 952-5500

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001, par value per share		CALC		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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 Auxora^TM 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press release dated January 28, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				CalciMedica, Inc.
Date: January 28, 2026				By:		/s/ A. Rachel Leheny, Ph.D.
				Name:		A. Rachel Leheny, Ph.D.
				Title:		Chief Executive Officer