CALC

EX-99.1

2 ck0001534133-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

CalciMedica Reports First Quarter 2026 Financial Results and Provides Clinical & Corporate Updates

FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026

Preclinical and IND-enabling studies advancing for CM5480, an oral CRAC channel inhibitor candidate, with IND submission in pulmonary hypertension expected in 2027

LA JOLLA, Calif., May 12, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious acute and chronic inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the first quarter ended March 31, 2026 and provided clinical and corporate updates.

"We continue to work closely with the FDA as we finalize the design of our pivotal program for Auxora in AP and explore potential future development in AKI, both serious illnesses with high unmet need that are not adequately addressed by current standard of care," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "As we progress in these discussions and continue to advance our oral CRAC channel inhibitor, CM5480, in preclinical and IND-enabling studies for pulmonary hypertension, we are encouraged by preclinical data recently published in Human Immunology, which offers a strong endorsement of the mechanistic rationale for selective CRAC channel inhibition in inflammatory and immune-mediated diseases."

Recent Program Highlights:

Acute Pancreatitis (AP) Program Update

• Continued positive FDA engagement on pivotal program in AP: CalciMedica continues to engage constructively with the U.S. Food and Drug Administration (FDA) regarding the design of a potential pivotal program evaluating Auxora in AP, with FDA feedback on program design expected in the second quarter of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, a serious inflammatory disease with approximately 300K hospitalizations annually in the U.S. alone.

• Phase 2b CARPO trial results published in eClinicalMedicine: In February 2026, a manuscript authored by CalciMedica and collaborators titled "Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial" was published in eClinicalMedicine, a journal in The Lancet Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO

1

trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora was well-tolerated and demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant 100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge.

• Preclinical data published in Human Immunology: In April 2026, a manuscript authored by CalciMedica collaborators titled “Single-cell Transcriptomics Reveals Targeted Modulation of Inflammatory Repertoire by SOCE Blockers” was published in Human Immunology. The publication describes preclinical data showing that in normal human peripheral blood mononuclear cells (PBMCs) in a T-cell activation model, store-operated calcium entry (SOCE) blockers such as Auxora inhibit the expression of pro-inflammatory and cytotoxic genes within regulatory T cells, while crucially preserving tolerance-associated anti-inflammatory pathways. This selective modulation provides further mechanistic support for the continued evaluation of Auxora in acute and chronic inflammatory and immunologic illnesses such as AP and acute kidney injury. The data also suggest potential implications for targeted immune modulation in transplantation settings.

Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update

• FDA feedback expected regarding potential future development in AKI: Following comprehensive internal and external safety reviews after the Company paused enrollment in the Phase 2 KOURAGE trial of Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF, no evidence of drug-related toxicity was identified. The Company expects fee

8-K

0001534133false00015341332025-11-122025-11-12

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

Date of Report (Date of earliest event reported): March 3, 2026

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 obligation 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, par value $0.0001 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 2.02. Results of Operations and Financial Condition.

On March 3, 2026, CalciMedica, Inc. issued a press release announcing its financial results for the years ended December 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), 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 “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number

Description

99.1

Press Release dated March 3, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CalciMedica, Inc.

Date:

March 3, 2026

By:

/s/ A. Rachel Leheny, Ph. D.

Name: Title:

A. Rachel Leheny, Ph. D. Chief Executive Officer

8-K

false000153413300015341332025-11-122025-11-12

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

Date of Report (Date of earliest event reported): November 12, 2025

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 obligation 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, par value $0.0001 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 2.02. Results of Operations and Financial Condition.

On November 12, 2025 CalciMedica, Inc. issued a press release announcing its financial results for the fiscal quarter ended September 30, 2025. A copy of the press release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), 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 “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number

Description

99.1

Press Release dated November 12, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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

CalciMedica, Inc.

Date:

November 12, 2025

By:

/s/ A. Rachel Leheny, Ph. D.

Name: Title:

A. Rachel Leheny, Ph. D. Chief Executive Officer