CalciMedica Reports First Quarter 2026 Financial Results and Provides Clinical & Corporate Updates
Rhea-AI Summary
CalciMedica (Nasdaq: CALC) reported Q1 2026 results and pipeline updates. Cash was $8.2 million, expected to fund operations into 4Q 2026. Q1 net income was $5.0 million versus a $5.0 million loss a year ago, driven by higher other income.
CalciMedica expects FDA feedback in 2Q 2026 on the pivotal Auxora program in acute pancreatitis and potential future development in acute kidney injury. Phase 2b CARPO results in AP showed dose-dependent improvements in several clinical endpoints. Preclinical and IND-enabling work for oral CRAC inhibitor CM5480 in pulmonary hypertension continues, with an IND submission anticipated in 2027.
Positive
- Q1 2026 net income of $5.0 million versus $5.0 million loss in Q1 2025
- Other income increased to $10.6 million from $1.5 million, mainly fair value adjustments
- R&D expenses decreased to $3.5 million from $4.2 million year-over-year
- G&A expenses decreased to $2.1 million from $2.3 million year-over-year
- Cash of $8.2 million expected to fund the operating plan into Q4 2026
- FDA feedback on pivotal Auxora acute pancreatitis program expected in Q2 2026
- Phase 2b CARPO trial of Auxora showed dose-dependent improvements and reduced severe respiratory failure
- Safety reviews in AKI with AHRF found no evidence of drug-related toxicity after enrollment pause
- Preclinical advancement of CM5480 in pulmonary hypertension with IND submission anticipated in 2027
Negative
- Cash runway only expected to extend into the fourth quarter of 2026
- Pivotal Auxora program in acute pancreatitis still pending FDA feedback on design
- Future development path for Auxora in AKI depends on upcoming FDA feedback
- Q1 2026 profitability driven largely by non-operating fair value adjustments in other income
News Market Reaction – CALC
In the May 12 session, CALC gained 6.63%, reflecting a notable positive market reaction. Argus tracked a peak move of +17.8% during that session. Argus tracked a trough of -2.6% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. Trading volume was above average at 2.0x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 03 | Full-year 2025 earnings | Negative | +14.4% | Reported larger net loss and KOURAGE discontinuation alongside cash runway update. |
| Nov 12 | Q3 2025 earnings | Neutral | +4.0% | Provided Q3 results, cash runway, KOURAGE enrollment, and AP pivotal planning. |
| Aug 12 | Q2 2025 earnings | Negative | -10.1% | Higher quarterly net loss with continued KOURAGE enrollment and AP FDA dialogue. |
| May 14 | Q1 2025 earnings | Positive | -0.9% | Showed strong AKI mortality reduction signal and extended cash runway into mid-2026. |
| Mar 27 | 2024 earnings | Positive | +4.0% | Reported reduced 2024 net loss and funding into mid-2026 with AKI program updates. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings updates often pair financial runway with pipeline milestones; share reactions have been mixed, with both rallies and selloffs, suggesting news isn’t the sole driver of price moves.
Over the last year, CalciMedica’s earnings releases have consistently combined funding runway updates with progress on Auxora in acute pancreatitis and AKI plus CM5480 in pulmonary hypertension. Prior earnings on Mar 3, 2026 highlighted a larger $29.6M net loss and KOURAGE discontinuation yet saw a positive reaction. Earlier 2025 updates showed declining cash balances but continued FDA engagement. Today’s Q1 2026 report continues this pattern with new clinical publications and a shift to quarterly profitability.
Key Terms
crac channel inhibitor medical
phase 2b medical
systemic inflammatory response syndrome medical
stratified win ratio medical
store-operated calcium entry medical
peripheral blood mononuclear cells medical
acute hypoxemic respiratory failure medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
"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
- Continued positive FDA engagement on pivotal program in AP: CalciMedica continues to engage constructively with the
U.S. Food and Drug Administration (FDA) regarding the design of a potential pivotal program evaluating Auxora in AP, with FDA feedback on program design expected in the second quarter of 2026. This would represent the first U.S. pivotal program evaluating a therapeutic candidate for AP, a serious inflammatory disease with approximately 300K hospitalizations annually in the U.S. alone. - Phase 2b CARPO trial results published in eClinicalMedicine: In February 2026, a manuscript authored by CalciMedica and collaborators titled "Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial" was published in eClinicalMedicine, a journal in The Lancet Discovery Science suite. The publication details previously announced topline results from 214 patients enrolled in the Phase 2b CARPO trial of Auxora in AP with systemic inflammatory response syndrome (SIRS). In hyper-inflamed patients, Auxora demonstrated clinically meaningful, dose-dependent reductions in median time to solid food tolerance. Across the overall study population, Auxora was well-tolerated and demonstrated dose-dependent improvements in multiple clinically relevant endpoints, including reductions in organ failure, necrotizing pancreatitis, and time to medically indicated discharge. Notably, medium- and high-dose Auxora arms achieved a statistically significant
100% reduction in new-onset severe respiratory failure compared to placebo (p < 0.05), and the high-dose Auxora arm achieved a statistically significant stratified win ratio of 1.640 (p < 0.05), which represents a hierarchical composite of mortality, new-onset severe respiratory failure, new-onset necrotizing pancreatitis, and time to medically indicated discharge. - Preclinical data published in Human Immunology: In April 2026, a manuscript authored by CalciMedica collaborators titled "Single-cell Transcriptomics Reveals Targeted Modulation of Inflammatory Repertoire by SOCE Blockers" was published in Human Immunology. The publication describes preclinical data showing that in normal human peripheral blood mononuclear cells (PBMCs) in a T-cell activation model, store-operated calcium entry (SOCE) blockers such as Auxora inhibit the expression of pro-inflammatory and cytotoxic genes within regulatory T cells, while crucially preserving tolerance-associated anti-inflammatory pathways. This selective modulation provides further mechanistic support for the continued evaluation of Auxora in acute and chronic inflammatory and immunologic illnesses such as AP and acute kidney injury. The data also suggest potential implications for targeted immune modulation in transplantation settings.
Acute Kidney Injury (AKI) with Acute Hypoxemic Respiratory Failure (AHRF) Program Update
- FDA feedback expected regarding potential future development in AKI: Following comprehensive internal and external safety reviews after the Company paused enrollment in the Phase 2 KOURAGE trial of Auxora in patients with Stage 2 or Stage 3 AKI with associated AHRF, no evidence of drug-related toxicity was identified. The Company expects feedback from the FDA regarding potential future development of Auxora in AKI in the second quarter of 2026.
Pulmonary Hypertension (PH) Program Update
- Preclinical activities to advance CM5480 in PH underway: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety profile of CM5480, CalciMedica's proprietary oral CRAC channel inhibitor candidate with the potential to be a first-in-class, differentiated therapy targeting pulmonary vascular and right ventricular remodeling, key drivers of disease progression in PH, including pulmonary arterial hypertension. An IND submission for CM5480 is anticipated in 2027.
Financial Results for the First Quarter Ended March 31, 2026:
Cash Position: Cash and cash equivalents were
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Other Income: Other income was
Net Income/Loss: Net income was
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
Contact Information
Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
CALCIMEDICA, INC. Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts) (Unaudited)
| ||||||||
March 31, | December 31, | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 8,164 | $ | 11,520 | ||||
Short-term investments | — | 1,496 | ||||||
Prepaid clinical trial expenses | 215 | 201 | ||||||
Other prepaid expenses and current assets | 122 | 259 | ||||||
Assets held for sale | 54 | 54 | ||||||
Total current assets | 8,555 | 13,530 | ||||||
Property and equipment, net | 43 | 50 | ||||||
Other assets | 11 | 11 | ||||||
Total assets | $ | 8,609 | $ | 13,591 | ||||
Liabilities and Stockholders' Deficit | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,675 | $ | 1,161 | ||||
Accrued clinical trial costs | 466 | 1,081 | ||||||
Accrued expenses | 672 | 290 | ||||||
Current portion, promissory note | 2,500 | 1,250 | ||||||
Total current liabilities | 5,313 | 3,782 | ||||||
Long-term liabilities | ||||||||
Promissory note | 4,200 | 8,450 | ||||||
Warrant liability | 200 | 8,000 | ||||||
Total liabilities | 9,713 | 20,232 | ||||||
Commitments and contingencies (Note 8) | ||||||||
Stockholders' deficit | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 4 | 4 | ||||||
Additional paid-in capital | 183,242 | 182,681 | ||||||
Accumulated deficit | (184,350) | (189,326) | ||||||
Total stockholders' deficit | (1,104) | (6,641) | ||||||
Total liabilities and stockholders' deficit | $ | 8,609 | $ | 13,591 | ||||
CALCIMEDICA, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited)
| ||||||||
Three Months Ended March 31, | ||||||||
2026 | 2025 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 3,485 | $ | 4,224 | ||||
General and administrative | 2,126 | 2,273 | ||||||
Total operating expenses | 5,611 | 6,497 | ||||||
Loss from operations | (5,611) | (6,497) | ||||||
Other income: | ||||||||
Change in fair value of financial instruments | 10,800 | 1,700 | ||||||
Interest expense | (319) | (447) | ||||||
Interest income | 106 | 202 | ||||||
Total other income | 10,587 | 1,455 | ||||||
Net income (loss) | $ | 4,976 | $ | (5,042) | ||||
Earnings (loss) per share | ||||||||
Basic | $ | 0.31 | $ | (0.36) | ||||
Diluted | $ | 0.30 | $ | (0.36) | ||||
Shares used in computing earnings (loss) per share | ||||||||
Basic | 15,822,163 | 14,121,569 | ||||||
Diluted | 16,328,947 | 14,121,569 | ||||||
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SOURCE CalciMedica, Inc.