エドガーで原本を確認する
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 27, 2025 |
CalciMedica, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-39538 |
45-2120079 |
||
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
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 27, 2025 CalciMedica, Inc. issued a press release announcing its financial results for the fiscal year ended December 31, 2024. 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 |
|
|
|
|
|
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 27, 2025 |
By: |
/s/ A. Rachel Leheny, Ph. D. |
|
|
Name: Title: |
A. Rachel Leheny, Ph. D. |
Exhibit 99.1
CalciMedica Reports 2024 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
Post-hoc analysis of subset of patients with AKI in the Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia showed a 62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated with Auxora versus placebo
Cash position expected to fund operations into mid-2026
LA JOLLA, CA, Mar. 27, 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 year ended December 31, 2024 and provided clinical and corporate updates.
“Enrollment in our Phase 2 KOURAGE trial is on track to deliver data around the end of 2025,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Looking ahead to the KOURAGE readout, we are further encouraged by the promising readthrough from the data recently presented at the 30th International AKI & CRRT Conference, which show a 62.7% relative reduction in mortality in CARDEA patients with both kidney failure and respiratory failure, mirroring KOURAGE’s patient population. With the proceeds from our recent credit facility with Avenue Capital, we have ample runway to get through our KOURAGE data readout based on our current enrollment projections and engage with the FDA on the design of a Phase 3 program in acute pancreatitis with SIRS in the next few months.”
Recent Clinical & Corporate Highlights:
Clinical Updates & Anticipated Milestones
Acute Kidney Injury (AKI) Program Update
1
Acute Pancreatitis (AP) Program Update
Asparaginase-induced Pancreatic Toxicity (AIPT) Program Update
Corporate Updates
2
Other Business Highlights:
2024 Financial Results:
3
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 around the end of 2025 and continuing to support the ongoing investigator-initiated Phase 1/2 trial (called CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with an update 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, CalciMedica's expected cash runway; CalciMedica’s planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; plans for an end-of-Phase 2 meeting with the FDA for CARPO 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 certain 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 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 Annual Report on Form 10-K for the year ended December 31, 2024, 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.
4
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
CALCIMEDICA, INC.
Consolidated Balance Sheets
(in thousands, except par value and share amounts)
|
|
December 31, |
|
|
December 31, |
|
||
|
|
|
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
7,935 |
|
|
$ |
5,530 |
|
Short-term investments |
|
|
10,734 |
|
|
|
5,708 |
|
Prepaid clinical trial expenses |
|
|
748 |
|
|
|
71 |
|
Other prepaid expenses and current assets |
|
|
248 |
|
|
|
296 |
|
Total current assets |
|
|
19,665 |
|
|
|
11,605 |
|
Property and equipment, net |
|
|
119 |
|
|
|
167 |
|
Other assets |
|
|
10 |
|
|
|
413 |
|
Total assets |
|
$ |
19,794 |
|
|
$ |
12,185 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
1,998 |
|
|
$ |
1,419 |
|
Accrued clinical trial costs |
|
|
820 |
|
|
|
1,141 |
|
Accrued expenses |
|
|
866 |
|
|
|
1,468 |
|
Total current liabilities |
|
|
3,684 |
|
|
|
4,028 |
|
Long-term liabilities |
|
|
|
|
|
|
||
Warrant liability |
|
|
1,700 |
|
|
|
— |
|
Total liabilities |
|
|
5,384 |
|
|
|
4,028 |
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
||
Stockholders’ equity |
|
|
|
|
|
|
||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 500,000,000 shares authorized at December 31, 2024 and December 31, 2023; 13,481,917 and 5,754,505 issued and outstanding at December 31, 2024 and December 31, 2023, respectively |
|
|
4 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
174,166 |
|
|
|
154,218 |
|
Accumulated deficit |
|
|
(159,764 |
) |
|
|
(146,064 |
) |
Accumulated other comprehensive income |
|
|
4 |
|
|
|
2 |
|
Total stockholders’ equity |
|
|
14,410 |
|
|
|
8,157 |
|
Total liabilities and stockholders’ equity |
|
$ |
19,794 |
|
|
$ |
12,185 |
|
5
CALCIMEDICA, INC.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
|
|
Year Ended December 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
14,478 |
|
|
$ |
15,859 |
|
General and administrative |
|
|
9,726 |
|
|
|
22,216 |
|
Total operating expenses |
|
|
24,204 |
|
|
|
38,075 |
|
Loss from operations |
|
|
(24,204 |
) |
|
|
(38,075 |
) |
Other income |
|
|
|
|
|
|
||
Change in fair value of financial instruments |
|
|
9,490 |
|
|
|
3,168 |
|
Other income |
|
|
1,014 |
|
|
|
550 |
|
Total other income |
|
|
10,504 |
|
|
|
3,718 |
|
Net loss |
|
$ |
(13,700 |
) |
|
$ |
(34,357 |
) |
Net loss per share - basic and diluted |
|
$ |
(1.22 |
) |
|
$ |
(7.66 |
) |
Weighted-average number of shares outstanding used in |
|
|
11,245,915 |
|
|
|
4,486,258 |
|
6