Form 8-K - Current report
04 March 2025 - 11:05PM
Edgar (US Regulatory)
NASDAQ false 0001534133 0001534133 2025-03-04 2025-03-04
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
March 4, 2025
Date of Report (Date of earliest event reported)
CalciMedica, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-39538 |
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45-2120079 |
| (State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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505 Coast Boulevard South, Suite 307
La Jolla, California |
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92037 |
| (Address of principal executive offices) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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| Title of each class |
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Trading
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Name of each exchange
on which registered |
| Common Stock, $0.0001, par value per share |
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CALC |
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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 March 4, 2025, CalciMedica, Inc. (the “Company”) issued a press release announcing data based on a post-hoc analysis from the previously completed Phase 2 CARDEA trial of Auxora patients with severe COVID-19 pneumonia. 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 March 4, 2025, the Company announced new data from a post-hoc analysis of the previously completed CARDEA trial, the Company’s Phase 2 trial evaluating Auxora for the treatment of severe COVID-19 pneumonia. The study included a subset of 38 patients who enrolled with Acute Kidney Injury (“AKI”), defined as an estimated glomerular filtration rate (“eGFR”) ≤ 60 ml/min/1.73 m², in addition to moderate or severe respiratory failure, which was an inclusion criterion. Within this subset, patients treated with Auxora showed a 62.7% relative reduction versus placebo in mortality at day 30 which persisted through day 60. Seven out of 15 (46.7%) of patients on placebo died by day 30 and day 60 as compared to 4 out of 23 (17.4%) of patients on Auxora. Auxora exhibited an absolute reduction in mortality of 29.3% in this subset.
This reduction in mortality in the patient subset with AKI exceeded that of the entire study population. In the entire study population (n = 261), a 56.3% (p = 0.017) relative reduction versus placebo in mortality at day 30 was observed, with an absolute reduction of 9.9% versus placebo.
The Company summarized previously disclosed data supporting the role of CRAC channel inhibition as a potential therapeutic mechanism in AKI, including:
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In preclinical biomarker studies, rats with AKI following ischemic reperfusion injury had decreased Th17 cells in their kidneys when receiving a CRAC inhibitor versus control, highlighting immunomodulatory effects. |
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In in-vitro experiments, CRAC channel inhibition ameliorated injury to podocyte cells (kidney cells involved in filtration) caused by high glucose or angiotensin II, highlighting tissue-protective effects. |
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In preclinical outcome studies, glomerular filtration rates recovered more quickly and mortality was reduced in rats with severe or moderately severe AKI that received Auxora versus placebo. |
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In clinical trial biomarker studies, CARDEA patients who received Auxora versus placebo had changes in cardiorenal biomarkers—increases in angiopoietin-1 and decreases in angiopoietin-2 and D-dimers—which have been linked to the prevention of endothelial damage in prior studies and were correlated with improved outcomes in CARDEA. |
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At doses used experimentally and clinically, Auxora potentially provides a therapeutic window to treat acute critical illnesses without increasing risk of infection. |
1
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 business strategy; results of post-hoc analyses from the previously completed Phase 2 CARDEA trial of Auxora and the Company’s ongoing and planned clinical trials and the timing and design, thereof, and the expected timing for the release of data from those trials; the potential benefits of Auxora for the treatment of AKI; and the potential of the Company’s proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases. 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, including preliminary results, 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 impact of government laws and regulations; and the Company’s 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 under the caption “Risk Factors” and elsewhere in the Company’s most recent filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and any 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.
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.
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CalciMedica, Inc. |
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| Date: March 4, 2025 |
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By: |
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/s/ A. Rachel Leheny, Ph.D. |
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Name: |
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A. Rachel Leheny, Ph.D. |
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Chief Executive Officer |
Exhibit 99.1
CalciMedica Presents AKI Data from a Post-Hoc Analysis of the
Phase 2 CARDEA trial of Auxora™ in Severe COVID-19 Pneumonia at the 30th International
AKI & CRRT Conference
62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated
with Auxora versus placebo in subset of patients in CARDEA with AKI
LA JOLLA, Calif., Mar. 4, 2025 – CalciMedica Inc.
(“CalciMedica” or the “Company”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and
immunologic illnesses, today announced that Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered a plenary presentation at the 30th International Acute Kidney Injury and
Continuous Renal Replacement Therapy Conference (AKI & CRRT) on March 3, 2025 in San Diego, CA. The presentation outlined the role of CRAC channels in acute kidney injury (AKI) pathophysiology and included new data highlighting the
potential of CalciMedica’s lead product candidate, Auxora™, in AKI. CalciMedica is currently conducting a Phase 2 trial of Auxora in patients with Stage 2 or Stage 3 AKI and acute
hypoxemic respiratory failure, which is expected to read out in 2025.
The new data presented were based on a
post-hoc analysis from the previously completed Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia. The study included 38 patients who enrolled with AKI,
defined as an estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m², in addition to moderate or severe respiratory failure, which was an inclusion criterion. Within this subset:
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• |
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Patients treated with Auxora showed a 62.7% relative reduction versus placebo in mortality at day 30 which
persisted through day 60. |
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7 out of 15 (46.7%) patients on placebo died by day 30 and day 60 as compared to 4 out of 23 (17.4%) patients on
Auxora. |
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Auxora exhibited an absolute reduction in mortality of 29.3%. |
This reduction in mortality in the patient subset with AKI exceeded that of the entire study population. In the entire population (n = 261), a 56.3% (p =
0.017) relative reduction versus placebo in mortality at day 30 was observed, with an absolute reduction of 9.9% versus placebo.
In his presentation,
Dr. Hebbar also summarized previously disclosed data supporting the role of CRAC channel inhibition as a potential therapeutic mechanism in AKI. Key data include:
| |
• |
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In preclinical biomarker studies, rats with AKI following ischemic reperfusion injury had decreased Th17 cells in
their kidneys when receiving a CRAC inhibitor versus control, highlighting immunomodulatory effects. |
| |
• |
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In in-vitro experiments, CRAC channel inhibition ameliorated injury to
podocyte cells (kidney cells involved in filtration) caused by high glucose or angiotensin II, highlighting tissue-protective effects. |
1
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• |
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In preclinical outcome studies, GFRs recovered more quickly and mortality was reduced in rats with severe or
moderately severe AKI that received Auxora versus placebo. |
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• |
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In clinical trial biomarker studies, CARDEA patients who received Auxora versus placebo had changes in
cardiorenal biomarkers—increases in angiopoietin-1 and decreases in angiopoietin-2 and D-dimers—which have been linked
to the prevention of endothelial damage in prior studies and were correlated with improved outcomes in CARDEA. |
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• |
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At doses used experimentally and clinically, Auxora potentially provides a therapeutic window to treat acute
critical illnesses without increasing risk of infection. |
“As illustrated by these data, the biological rationale for CRAC channel
inhibition as a potential therapeutic mechanism for AKI is compelling,” said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. “The post-hoc analysis from CARDEA is especially relevant
given that the 62.7% relative reduction in mortality was observed in patients with both kidney failure and respiratory failure, which mirrors the intended patient population for our ongoing Phase 2 KOURAGE study.”
The presentation is now available on the Medical Events & Presentations section of CalciMedica’s IR website at
https://ir.calcimedica.com/news-events/medical-events-publications.
About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic
diseases. CalciMedica’s proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening
inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica’s lead product candidate Auxora™ has demonstrated positive and
consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic
inflammatory response syndrome (SIRS). The Company has also completed a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE
–NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA
– NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute
for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.
Forward-Looking Statements
This communication contains
forward-looking statements which include, but are not limited to, results of post-hoc analyses from the previously completed Phase 2 CARDEA trial of Auxora and CalciMedica’s ongoing and planned
clinical trials and the timing and design thereof, and the expected timing for the release of data from those trials, including its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its ongoing Phase 2 KOURAGE trial of
Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; and the potential of CalciMedica’s proprietary technology to provide therapeutic benefits in life-threatening inflammatory and
immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica’s expectations and beliefs
2
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. 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 CalciMedica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on November 13, 2024,
and elsewhere in CalciMedica’s subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with
the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica’s web page
at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update
them after this date, except as required by law.
Contact Information
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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