UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
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:
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 August 12, 2024 CalciMedica, Inc. issued a press release announcing its financial results for the fiscal quarter ended June 30, 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
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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: |
August 12, 2024 |
By: |
/s/ A. Rachel Leheny, Ph. D. |
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Name: Title: |
A. Rachel Leheny, Ph. D. |
Exhibit 99.1
CalciMedica Reports Second Quarter 2024 Financial Results and Provides Clinical & Corporate Updates
Positive topline data announced from CARPO, Phase 2b trial of Auxora™ in acute pancreatitis (AP); additional data to be presented at a medical meeting later this year
First patient enrolled in KOURAGE, Phase 2 trial of Auxora™ in severe acute kidney injury (AKI), with data expected in 2025
LA JOLLA, Calif., August 12, 2024 – 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 second quarter ended June 30, 2024.
“CalciMedica continues to progress steadily with the successful execution of multiple milestones across our pipeline. In the second quarter, we completed enrollment in our Phase 2b CARPO trial in patients with AP and subsequently announced positive topline data, which met our primary objective and further support Auxora's potential as an effective treatment for critically ill patients with acute inflammatory disease. We look forward to sharing additional data from this trial later in the year and are also planning to meet with the FDA to discuss the design of a Phase 3 trial,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “In addition, we are excited about KOURAGE, our Phase 2 trial in patients with severe AKI. We are enrolling patients and opening new sites and expect to share topline data from this study in 2025.”
Recent Clinical Updates and Anticipated Milestones:
1
Financial Results for the Three and Six Months Ended June 30, 2024:
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 topline data for a Phase 2b trial (called CARPO – NCT04681066) in patients with AP with SIRS and 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 AKI with associated AHRF with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA – NCT04195347) in patients with AIPT with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and
2
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 2b CARPO trial of Auxora for AP with accompanying SIRS, 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; 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 in 2025; 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 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 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. 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.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
3
CALCIMEDICA, INC.
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
(Unaudited)
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June 30, |
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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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$ |
5,056 |
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$ |
5,530 |
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Short-term investments |
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14,081 |
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5,708 |
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Prepaid expenses and other current assets |
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1,305 |
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367 |
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Total current assets |
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20,442 |
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11,605 |
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Property and equipment, net |
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138 |
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167 |
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Other assets |
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472 |
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413 |
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Total assets |
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$ |
21,052 |
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$ |
12,185 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
2,144 |
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$ |
1,419 |
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Accrued clinical trial costs |
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829 |
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1,141 |
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Accrued expenses |
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941 |
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1,468 |
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Total current liabilities |
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3,914 |
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4,028 |
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Long-term liabilities |
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Warrant liability |
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3,300 |
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— |
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Total liabilities |
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7,214 |
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4,028 |
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Commitments and contingencies (Note 9) |
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Stockholders’ equity |
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Preferred stock, $0.0001 par value; 10,000,000 shares and no shares authorized at June 30, 2024 and December 31, 2023, respectively; no shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
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— |
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— |
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Common stock, $0.0001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023; 10,750,156 and 5,754,505 issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
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3 |
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1 |
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Additional paid-in capital |
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163,732 |
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154,218 |
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Accumulated deficit |
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(149,888 |
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(146,064 |
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Accumulated other comprehensive income (loss) |
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(9 |
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2 |
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Total stockholders’ equity |
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13,838 |
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8,157 |
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Total liabilities and stockholders’ equity |
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$ |
21,052 |
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$ |
12,185 |
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4
CALCIMEDICA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
4,157 |
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$ |
3,814 |
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$ |
7,101 |
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$ |
10,305 |
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General and administrative |
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2,372 |
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2,769 |
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5,195 |
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18,618 |
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Total operating expenses |
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6,529 |
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6,583 |
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12,296 |
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28,923 |
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Loss from operations |
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(6,529 |
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(6,583 |
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(12,296 |
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(28,923 |
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Other income |
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Change in fair value of financial instruments |
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2,300 |
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— |
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7,890 |
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3,168 |
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Other income |
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275 |
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279 |
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582 |
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163 |
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Total other income |
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2,575 |
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279 |
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8,472 |
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3,331 |
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Net loss |
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$ |
(3,954 |
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$ |
(6,304 |
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$ |
(3,824 |
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$ |
(25,592 |
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Net loss per share - basic and diluted |
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$ |
(0.36 |
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$ |
(1.11 |
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$ |
(0.37 |
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$ |
(7.86 |
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Weighted-average number of shares outstanding used in |
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11,129,053 |
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5,661,933 |
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10,441,785 |
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3,255,868 |
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5