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
Date of Report (Date of earliest event reported): March 3, 2026 |
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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:
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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Trading |
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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 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
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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: |
March 3, 2026 |
By: |
/s/ A. Rachel Leheny, Ph. D. |
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Name: Title: |
A. Rachel Leheny, Ph. D. |
Exhibit 99.1
CalciMedica Reports 2025 Financial Results and Provides Clinical Updates
Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™
Design of pivotal program in acute pancreatitis (AP) expected in 1H 2026
JCI Insight publication of preclinical data demonstrates CM5480 as a potential differentiated therapy in pulmonary arterial hypertension (PAH); IND submission anticipated in 2027
LA JOLLA, Calif., March 3, 2026 – CalciMedica Inc. (“CalciMedica” or the “Company”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company 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, 2025 and provided clinical and corporate updates.
“First and foremost, in acute kidney injury, we and our external advisors have reviewed the unblinded KOURAGE data and have found no evidence of a drug-related toxicity. We look forward to discussions with the FDA about potential future clinical studies in AKI. We are also advancing Auxora towards the pivotal program in acute pancreatitis following constructive FDA engagement and the peer-reviewed publication of our Phase 2b CARPO results. The Company plans to finalize the design for this program in the first half of this year,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Concurrently, we continue to advance our second CRAC channel inhibitor, CM5480, in pulmonary arterial hypertension, following the recent publication of preclinical data which demonstrate its potential in cardiopulmonary disease.”
Recent Program Highlights:
Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update
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Acute Pancreatitis (AP) Program Update
Pulmonary Arterial Hypertension (PAH) Program Update
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Financial Results for the Year Ended December 31, 2025:
Cash Position: Cash, cash equivalents, and short-term investments were $13.0 million as of December 31, 2025. The Company expects its cash position to be sufficient to fund its current operating plan into the fourth quarter of 2026.
R&D Expenses: Research and development expenses were $15.2 million for the year ended December 31, 2025, compared to $14.5 million for the year ended December 31, 2024. The increase of $0.7 million was primarily due to an increase in preclinical and clinical trial related activities offset by a decrease in chemistry, manufacturing, and control activities and personnel costs.
G&A Expenses: General and administrative expenses were $7.9 million for the year ended December 31, 2025, compared to $9.7 million for the year ended December 31, 2024. The decrease of $1.8 million was primarily due to a decrease in consultants and other costs and professional services offset by an increase in personnel costs driven by stock-based compensation.
Other Income (Expense): Other expenses were $6.4 million for the year ended December 31, 2025, compared to other income of $10.5 million for the year ended December 31, 2024. The increase of $16.9 million of expense was primarily due to the non-cash fair value adjustments to the Company’s financial instruments, an increase in interest expense associated with the Company’s promissory note, and a decrease in interest income offset by miscellaneous income.
Net Loss: Net loss was $29.6 million, or $1.97 per basic and diluted share, for the year ended December 31, 2025, compared to $13.7 million, or $1.22 per basic and diluted share, for the year ended December 31, 2024.
About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (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 serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate Auxora™ has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. The Company initiated a Phase 2 trial (KOURAGE; NCT06374797) evaluating Auxora in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF); in January 2026, the trial was discontinued following a recommendation from the Independent Data Monitoring Committee, and the Company plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential therapy for pulmonary arterial hypertension (PAH), supported by preclinical data demonstrating effects on pulmonary vascular remodeling and right ventricular function. For more information, please visit www.calcimedica.com.
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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, and the expected timing for updates; statements regarding the anticipated timing of filing an IND; statements regarding the safety and efficacy of its product candidates; statements regarding FDA’s positive engagement on a pivotal program for Auxora in AP and a final pivotal program design in the first half of 2026; statements regarding the analysis of the unblinded KOURAGE dataset, including timing of discussions with the FDA and whether such analysis will inform future trial parameters; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in PAH and other acute and chronic inflammatory and immunologic diseases such as AKI, AP, and AIPT. 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, 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
Kevin Murphy
(212) 600-1902
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CALCIMEDICA, INC.
Condensed Consolidated Balance Sheets
(in thousands, except par value and share amounts)
(Audited)
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December 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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$ |
11,520 |
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$ |
7,935 |
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Short-term investments |
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1,496 |
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10,734 |
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Prepaid clinical trial expenses |
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201 |
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748 |
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Other prepaid expenses and current assets |
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259 |
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248 |
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Assets held for sale |
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54 |
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— |
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Total current assets |
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13,530 |
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19,665 |
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Property and equipment, net |
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50 |
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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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$ |
13,591 |
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$ |
19,794 |
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Liabilities and Stockholders’ Equity (Deficit) |
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Current liabilities |
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Accounts payable |
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$ |
1,161 |
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$ |
1,998 |
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Accrued clinical trial costs |
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1,081 |
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820 |
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Accrued expenses |
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290 |
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866 |
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Current portion, promissory note |
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1,250 |
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— |
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Total current liabilities |
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3,782 |
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3,684 |
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Long-term liabilities |
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Promissory note |
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8,450 |
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— |
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Warrant liability |
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8,000 |
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1,700 |
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Total liabilities |
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20,232 |
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5,384 |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity (deficit) |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2025 and December 31, 2024, respectively; no shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively |
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— |
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— |
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Common stock, $0.0001 par value; 500,000,000 shares authorized at December 31, 2025 and December 31, 2024, respectively; 15,437,410 and 13,481,917, issued and outstanding at December 31, 2025 and December 31, 2024, respectively |
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4 |
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4 |
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Additional paid-in capital |
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182,681 |
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174,166 |
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Accumulated deficit |
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(189,326 |
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(159,764 |
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Accumulated other comprehensive income |
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— |
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4 |
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Total stockholders’ equity (deficit) |
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(6,641 |
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14,410 |
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Total liabilities and stockholders’ equity (deficit) |
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$ |
13,591 |
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$ |
19,794 |
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CALCIMEDICA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Audited)
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Year Ended December 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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$ |
15,234 |
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$ |
14,478 |
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General and administrative |
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7,887 |
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9,726 |
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Total operating expenses |
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23,121 |
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24,204 |
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Loss from operations |
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(23,121 |
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(24,204 |
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Other income (expense): |
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Change in fair value of financial instruments |
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(6,000 |
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9,490 |
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Interest expense |
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(1,422 |
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— |
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Interest income |
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713 |
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1,014 |
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Other income |
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268 |
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— |
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Total other income (expense) |
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(6,441 |
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10,504 |
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Net loss |
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$ |
(29,562 |
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$ |
(13,700 |
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Net loss per share - basic and diluted |
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$ |
(1.97 |
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$ |
(1.22 |
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Weighted-average number of shares outstanding used in |
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15,011,321 |
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11,245,915 |
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