CalciMedica (NASDAQ: CALC) swings to Q1 profit as expenses decline
Rhea-AI Filing Summary
CalciMedica reported a profitable first quarter of 2026 and highlighted progress across its pipeline. Net income was $5.0 million for the quarter ended March 31, 2026, or $0.31 per basic share and $0.30 per diluted share, compared with a $5.0 million net loss a year earlier. Other income rose to $10.6 million, mainly from fair value adjustments to a promissory note and common stock warrants, while research and development and general and administrative expenses both declined year over year.
Cash and cash equivalents were $8.2 million as of March 31, 2026, and the company expects this to fund its current operating plan into the fourth quarter of 2026. CalciMedica expects FDA feedback in the second quarter of 2026 on the design of a potential pivotal Auxora program in acute pancreatitis and on potential future development in acute kidney injury, and it is advancing its oral CRAC inhibitor CM5480 toward an anticipated IND submission in pulmonary hypertension in 2027.
Positive
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Insights
Q1 profit driven by non-cash fair value gains while pipeline milestones approach.
CalciMedica moved from a net loss of $5.0M in Q1 2025 to net income of $5.0M in Q1 2026. This swing is largely due to a $10.8M positive change in the fair value of financial instruments, not higher product revenue, so the quality of earnings is heavily non-operational.
Operating expenses declined modestly, with research and development at $3.5M and general and administrative at $2.1M, reflecting tighter spending as the company advances Auxora and CM5480. Cash of $8.2M is expected to fund the current plan into the fourth quarter of 2026, suggesting additional capital may be needed beyond that horizon.
Upcoming FDA feedback in Q2 2026 on a potential pivotal Auxora program in acute pancreatitis and on future development in acute kidney injury, together with a targeted 2027 IND for CM5480 in pulmonary hypertension, are key clinical and regulatory milestones. Subsequent company filings may provide more detail on trial designs, regulatory interactions, and future funding plans.
8-K Event Classification
Key Figures
Key Terms
acute pancreatitis medical
CRAC channel inhibition medical
store-operated calcium entry medical
warrant liability financial
change in fair value of financial instruments financial
acute hypoxemic respiratory failure medical
Earnings Snapshot
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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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)) |
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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 12, 2026, CalciMedica, Inc. issued a press release announcing its financial results for the fiscal quarter ended March 31, 2026. 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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Description |
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99.1 |
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Press Release dated May 12, 2026 |
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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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May 12, 2026 |
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 2026 Financial Results and Provides Clinical & Corporate Updates
FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026
Preclinical and IND-enabling studies advancing for CM5480, an oral CRAC channel inhibitor candidate, with IND submission in pulmonary hypertension expected in 2027
LA JOLLA, Calif., May 12, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious acute and chronic inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the first quarter ended March 31, 2026 and provided clinical and corporate updates.
"We continue to work closely with the FDA as we finalize the design of our pivotal program for Auxora in AP and explore potential future development in AKI, both serious illnesses with high unmet need that are not adequately addressed by current standard of care," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "As we progress in these discussions and continue to advance our oral CRAC channel inhibitor, CM5480, in preclinical and IND-enabling studies for pulmonary hypertension, we are encouraged by preclinical data recently published in Human Immunology, which offers a strong endorsement of the mechanistic rationale for selective CRAC channel inhibition in inflammatory and immune-mediated diseases."
Recent Program Highlights:
Acute Pancreatitis (AP) Program Update
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Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update
Pulmonary Hypertension (PH) Program Update
Financial Results for the First Quarter Ended March 31, 2026:
Cash Position: Cash and cash equivalents were $8.2 million as of March 31, 2026. 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 $3.5 million for the three months ended March 31, 2026, compared to $4.2 million for the three months ended March 31, 2025. The decrease of $0.7 million was primarily due to a decrease in preclinical and clinical trial related activities, and a decrease in chemistry, manufacturing and controls activities.
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G&A Expenses: General and administrative expenses were $2.1 million for the three months ended March 31, 2026, compared to $2.3 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily due to a decrease in personnel costs.
Other Income: Other income was $10.6 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025. The increase of $9.1 million was primarily due to the fair value adjustments to our promissory note and common stock warrants.
Net Income/Loss: Net income was $5.0 million, or $0.31 per basic share and $0.30 per diluted share, for the three months ended March 31, 2026, compared to a net loss of $5.0 million, or $0.36 per basic and diluted share, for the three months ended March 31, 2025.
About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory, immunologic, and cardiopulmonary 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, CalciMedica paused enrollment in the trial following a recommendation from the Independent Data Monitoring Committee and, as a next step, plans to discuss potential future development in AKI with the FDA. In addition, CalciMedica is advancing CM5480 as a potential oral therapy for pulmonary hypertension (PH), supported by preclinical data demonstrating effects on pulmonary vascular and right ventricular remodeling. 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, 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 constructive engagement on a pivotal program for Auxora in AP and expectations for FDA feedback on program design in the second quarter of 2026; statements regarding the potential of Auxora's clinical data to support a first U.S. pivotal program in AP; statements regarding the positive safety review of the unblinded KOURAGE dataset and discussions with the FDA in the second quarter of 2026 regarding the future development of Auxora in AKI; statements regarding expected cash runway; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in acute and chronic inflammatory and immunologic diseases such as AP, AKI and PH, including in transplantation settings. 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
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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, 2026, 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
calcimedica@argotpartners.com
(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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$ |
8,164 |
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$ |
11,520 |
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Short-term investments |
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— |
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1,496 |
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Prepaid clinical trial expenses |
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215 |
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201 |
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Other prepaid expenses and current assets |
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122 |
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259 |
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Assets held for sale |
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54 |
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54 |
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Total current assets |
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8,555 |
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13,530 |
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Property and equipment, net |
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43 |
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50 |
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Other assets |
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11 |
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11 |
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Total assets |
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$ |
8,609 |
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$ |
13,591 |
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Liabilities and Stockholders’ Deficit |
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Current liabilities |
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Accounts payable |
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$ |
1,675 |
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$ |
1,161 |
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Accrued clinical trial costs |
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466 |
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1,081 |
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Accrued expenses |
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672 |
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290 |
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Current portion, promissory note |
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2,500 |
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1,250 |
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Total current liabilities |
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5,313 |
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3,782 |
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Long-term liabilities |
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Promissory note |
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4,200 |
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8,450 |
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Warrant liability |
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200 |
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8,000 |
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Total liabilities |
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9,713 |
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20,232 |
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Commitments and contingencies (Note 8) |
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Stockholders’ deficit |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2026 and December 31, 2025, respectively; no shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively |
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— |
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— |
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Common stock, $0.0001 par value; 500,000,000 shares authorized at March 31, 2026 and December 31, 2025, respectively; 15,746,416 and 15,437,410, issued and outstanding at March 31, 2026 and December 31, 2025, respectively |
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4 |
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4 |
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Additional paid-in capital |
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183,242 |
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182,681 |
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Accumulated deficit |
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(184,350 |
) |
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(189,326 |
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Total stockholders’ deficit |
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(1,104 |
) |
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(6,641 |
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Total liabilities and stockholders’ deficit |
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$ |
8,609 |
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$ |
13,591 |
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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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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
3,485 |
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$ |
4,224 |
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General and administrative |
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2,126 |
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2,273 |
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Total operating expenses |
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5,611 |
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6,497 |
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Loss from operations |
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(5,611 |
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(6,497 |
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Other income: |
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Change in fair value of financial instruments |
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10,800 |
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1,700 |
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Interest expense |
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(319 |
) |
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(447 |
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Interest income |
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106 |
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202 |
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Total other income |
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10,587 |
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1,455 |
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Net income (loss) |
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$ |
4,976 |
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$ |
(5,042 |
) |
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Earnings (loss) per share |
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Basic |
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$ |
0.31 |
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$ |
(0.36 |
) |
Diluted |
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$ |
0.30 |
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$ |
(0.36 |
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Shares used in computing earnings (loss) per share |
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Basic |
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15,822,163 |
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14,121,569 |
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Diluted |
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16,328,947 |
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14,121,569 |
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