CALC 8-K
CalciMedica, Inc. (CALC)
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
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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:
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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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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 May 14, 2025 CalciMedica, Inc. issued a press release announcing its financial results for the fiscal quarter ended March 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
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Exhibit Number |
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Description |
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99.1 |
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104 |
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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.
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CalciMedica, Inc. |
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Date: |
May 14, 2025 |
By: |
/s/ A. Rachel Leheny, Ph. D. |
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Name: Title: |
A. Rachel Leheny, Ph. D. |
Exhibit 99.1
CalciMedica Reports First Quarter 2025 Financial Results and Provides Clinical & Corporate Updates
Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) and respiratory failure; data expected around the end of 2025
Presentations at three recent medical meetings, including a post-hoc analysis of subset of patients with AKI in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia, which showed a 62.7% relative reduction in mortality for Auxora versus placebo
Cash position expected to fund operations into mid-2026
LA JOLLA, Calif., May 14, 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 reported financial results for the first quarter ended March 31, 2025 and provided clinical and corporate updates.
“We continue to execute across our pipeline and have taken steps to ensure that we are well-positioned ahead of multiple expected milestones in 2025,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Our cash runway extends into mid-2026, which will allow us to deliver the readout of our Phase 2 KOURAGE trial in AKI with respiratory failure expected around the end of this year, as well as to discuss our Phase 3 program in acute pancreatitis with SIRS with the FDA. Our lead compound, Auxora, has the potential to transform treatment in both indications, which have no approved therapies and affect hundreds of thousands of critically ill patients per year in the United States and many more worldwide.”
Recent Clinical & Corporate Highlights:
Clinical Updates & Anticipated Milestones
Acute Kidney Injury (AKI) Program Update
1
Acute Pancreatitis (AP) Program Update
Corporate Updates
Other Business Highlights:
Financial Results for the Three Months Ended March 31, 2025:
2
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 and been well-tolerated in over 350 critically ill patients dosed. 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) and for 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 around the end of 2025. For more information, please visit www.calcimedica.com.
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, CalciMedica's expected cash runway; CalciMedica's expectation of multiple milestones in 2025; CalciMedica’s planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for updates and the release of data from those trials, including its Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF and its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; and plans for an end-of-Phase 2 meeting with the FDA for CARPO around the middle of 2025 and to be in a position to initiate a pivotal trial in AP around the end of 2025; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases; and the potential of additional proceeds from the credit facility with Avenue Capital Group if required milestones are achieved. 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 regarding these matters may not materialize. Actual outcomes and results may differ materially
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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 CalciMedica's business and the actions it may take in response thereto; CalciMedica'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 CalciMedica generally; CalciMedica's ability to protect its intellectual property position; the impact of government laws and regulations; and CalciMedica’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 CalciMedica's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, being filed with the Securities and Exchange Commission (SEC) later today, 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
(212) 600-1902
4
CALCIMEDICA, INC.
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
(Unaudited)
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March 31, |
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December 31, |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
12,556 |
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$ |
7,935 |
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Short-term investments |
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12,069 |
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10,734 |
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Prepaid clinical trial expenses |
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396 |
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748 |
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Other prepaid expenses and current assets |
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197 |
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248 |
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Total current assets |
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25,218 |
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19,665 |
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Property and equipment, net |
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118 |
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119 |
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Other assets |
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11 |
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10 |
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Total assets |
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$ |
25,347 |
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$ |
19,794 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
2,016 |
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$ |
1,998 |
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Accrued clinical trial costs |
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1,230 |
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820 |
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Accrued expenses |
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1,213 |
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866 |
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Total current liabilities |
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4,459 |
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3,684 |
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Long-term liabilities |
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Promissory note |
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8,600 |
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— |
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Warrant liability |
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1,400 |
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1,700 |
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Total liabilities |
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14,459 |
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5,384 |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2025 and December 31, 2024, respectively; no shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively |
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— |
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— |
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Common stock, $0.0001 par value; 500,000,000 shares authorized at March 31, 2025 and December 31, 2024, respectively; 13,971,990 and 13,481,917, issued and outstanding at March 31, 2025 and December 31, 2024, respectively |
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4 |
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4 |
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Additional paid-in capital |
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175,691 |
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174,166 |
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Accumulated deficit |
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(164,806 |
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(159,764 |
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Accumulated other comprehensive (loss) income |
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(1 |
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4 |
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Total stockholders’ equity |
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10,888 |
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14,410 |
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Total liabilities and stockholders’ equity |
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$ |
25,347 |
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$ |
19,794 |
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5
CALCIMEDICA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
4,224 |
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$ |
2,944 |
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General and administrative |
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2,273 |
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2,823 |
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Total operating expenses |
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6,497 |
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5,767 |
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Loss from operations |
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(6,497 |
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(5,767 |
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Other income (expense) |
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Change in fair value of financial instruments |
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1,700 |
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5,590 |
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Interest income |
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202 |
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307 |
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Interest expense |
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(447 |
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— |
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Total other income |
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1,455 |
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5,897 |
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Net (loss) income |
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$ |
(5,042 |
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$ |
130 |
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Earnings per share |
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Basic |
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$ |
(0.36 |
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$ |
0.01 |
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Diluted |
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$ |
(0.36 |
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$ |
0.01 |
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Shares used in computing earnings per share |
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Basic |
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14,121,569 |
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9,754,517 |
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Diluted |
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14,121,569 |
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10,047,415 |
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6