Zegocractin

Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and CM5480 IND submission both anticipated in mid-2027 FDA aligned that the primary endpoint for the Phase 2b trial in acute pancreatitis will measure whether Auxora can reduce new-onset severe respiratory failure LA JOLLA, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- 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 inflammatory, immunologic, and cardiopulmonary diseases, today reported financial results for the second quarter ended June 30, 2026 and provided clinical and corporate updates. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “The recent financing supports a pulmonary hypertension strategy, including a Phase 1b proof-of-concept trial using Auxora and the continued development of CM5480 as an oral therapy for chronic use,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “Preclinical models suggest CRAC channel inhibitors may provide a differentiated approach in pulmonary hypertension by targeting multiple disease drivers, including right ventricular dysfunction, which is the principal driver of mortality and not directly targeted by existing therapies. In acute pancreatitis, FDA alignment on the Phase 2b trial endpoints and patient enrichment strategy provides a clear framework for the next stage of development in a disease with no approved therapies. With Auxora PAH data and the CM5480 IND submission both anticipated in mid-2027, we expect multiple meaningful catalysts over the next 12 months.” Recent Program Highlights: Pulmonary Hypertension (PH) Program Update Private placement financing to advance PH strategy: On June 24, 2026, CalciMedica announced a private placement of up to approximately $49 million in gross proceeds, including approximately $15 million in upfront gross proceeds. The proceeds are expected to support the advancement of Auxora and CM5480 as part of the Company’s pulmonary hypertension strategy. Auxora Phase 1b proof-of-concept trial in PAH planned: CalciMedica plans to evaluate Auxora in a Phase 1b trial in patients with pulmonary arterial hypertension to generate initial clinical evidence regarding the effects of CRAC channel inhibition on pulmonary vascular and right ventricular function. Data are anticipated in mid-2027. CM5480 preclinical and IND-enabling studies advancing: Studies are ongoing to further characterize the pharmacology, pharmacokinetics, and safety pro CM5480, CalciMedica’s oral CRAC channel inhibitor candidate for chronic use in PH. Preclinical data suggest CM5480 may be differentiated by directly protecting right ventricular function, a key driver of outcomes in PH that is not directly targeted by existing therapies. An IND submission is anticipated in mid-2027. Acute Pancreatitis (AP) Program Update FDA alignment on Phase 2b trial design: On July 29, 2026, following a Type C Focused Meeting, CalciMedica announced that FDA aligned with the Company’s Phase 2b trial design for Auxora in AP. The primary endpoint will measure whether Auxora can reduce the development of new-onset severe respiratory failure. Key secondary endpoints will include multi-organ failure and the time until patients are medically ready for discharge. The trial will also evaluate whether elevated lactate dehydrogenase (LDH) can identify patients at higher risk of developing severe disease. AP is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S. 1 Mechanistic Data from the Phase 2 CARDEA Trial Publication in the Journal of Clinical Investigation: On July 28, 2026, the Journal of Clinical Investigation published a study titled " The CRAC Channel Inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell Circuits in Viral Pneumonia ". The publication combines findings from an exploratory mechanistic study conducted alongside the Phase 2 CARDEA trial in severe COVID-19 pneumonia with laboratory studies of human immune cells. Together the results provide additional evidence that Auxora modulates key inflammatory pathways involved in lung injury, strengthening the scientific rationale for CRAC channel inhibition in inflammatory lung diseases. Financial Results for the Second Quarter Ended June 30, 2026: Cash Position: Cash and cash equivalents were $18.6 million as of June 30, 2026. The Company expects its cash and cash equivalents to fund its current operating plan into the second half of 2027. R&D Expenses: Research and development expenses were $2.1 million for the three months ended June 30, 2026, compared to $4.1 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, research and development expenses were $5.6 million, compared to $8.3 million for the six months ended June 30, 2025. The decrease of $2.7 million was primarily due to a decrease in preclinical and clinical trial related activities, consultants and personnel, and chemistry, manufacturing and controls activities. G&A Expenses: General and administrative expenses were $1.9 million for the three months ended June 30, 2026, compared to $2.6 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, general and administrative expenses were $4.0 million, compared to $4.8 million for the six months ended June 30, 2025. The decrease of $0.8 million was primarily due to a decrease in personnel and consultant costs. Other Income/Expense: Total other expense was $3.6 million for the three months ended June 30, 2026, compared to total other income of $0.7 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, total other income was $6.9 million, compared to $2.1 million for the six months ended June 30, 2025. The increase of $4.8 million primarily reflected an increase in income from changes in the fair value of the Company’s financial instruments. Net Income/Loss: Net loss was $7.7 million, or $0.45 per basic and diluted share, for the three months ended June 30, 2026, compared to a net loss of $6.0 million, or $0.40 per basic and diluted share, for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was $2.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.0 million, or $0.76 per basic and diluted share, for the six months ended June 30, 2025. About Pulmonary Hypertension Pulmonary hypertension (PH) encompasses a diverse group of diseases, including pulmonary arterial hypertension (PAH). Across PH groups, progressive right ventricular dysfunction is a shared consequence and a key determinant of survival. Approved therapies act primarily on the pulmonary vasculature and do not directly target the failing right ventricle. Orai1, the pore-forming subunit of the CRAC channel, is upregulated in diseased pulmonary vasculature and cardiac tissue, where persistent CRAC channel signaling has been linked to proliferation, inflammation, vasoconstriction, fibrosis, and remodeling. In preclinical PH models, CRAC channel inhibition has been observed to improve the structure and function of the pulmonary vasculature and both ventricles. 2 , 3 CalciMedica's planned Phase 1b proof-of-concept trial will evaluate Auxora in patients with PAH and is intended to generate initial clinical evidence supporting CRAC channel inhibition in PH. Findings from the trial are also expected to inform the continued development of CM5480, the Company’s oral CRAC channel inhibitor for chronic dosing. About Acute Pancreatitis Acute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and approximately 300,000 hospitalizations annually in the U.S. 4 Respiratory failure is a major driver of mortality and intensive care utilization among patients with severe disease. CalciMedica’s planned Phase 2b trial will evaluate new-onset severe respiratory failure as the primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. The trial will also assess elevated lactate dehydrogenase as a potential enrichment marker to identify patients at increased risk of severe disease. Initiation of the trial is subject to additional financing. About Auxora Auxora™ (zegocractin) is CalciMedica’s proprietary intravenous CRAC channel inhibitor and most advanced pipeline candidate. It is designed to reduce inflammation by inhibiting CRAC channel-driven cytokine release in immune cells and to limit excessive calcium entry that may contribute to organ injury. Auxora has been studied in more than 350 patients across conditions involving endothelial injury and respiratory failure: Acute pancreatitis: In the Phase 2b CARPO trial, Auxora produced a dose-dependent reduction in median time to solid food tolerance among hyper-inflamed patients. The medium and high dose groups also experienced a 100% reduction in new-onset severe respiratory failure compared with placebo. Pulmonary arterial hypertension: CalciMedica plans to conduct a Phase 1b proof-of-concept trial, with data anticipated in mid-2027. COVID-19 pneumonia: In the Phase 2 CARDEA trial, Auxora reduced 30-day all-cause mortality by 56% compared with placebo. Acute kidney injury with respiratory failure: Auxora was evaluated in the Phase 2 KOURAGE trial, in which enrollment was paused in January 2026 following a mortality imbalance. No drug-related toxicity was identified. FDA subsequently reviewed a protocol amendment and interim safety data without comments or questions, allowing clinical development of Auxora to proceed. CalciMedica does not plan to restart KOURAGE at this time. About CM5480 CM5480 is CalciMedica’s proprietary oral CRAC channel inhibitor designed for chronic dosing. By inhibiting Orai1-containing CRAC channels, it is intended to regulate abnormal calcium entry linked to vasoconstriction, pulmonary vascular remodeling, and right ventricular dysfunction. In preclinical pulmonary hypertension models, CM5480 and other CRAC channel inhibitors have improved hemodynamics and reduced pulmonary vascular and right ventricular remodeling, both as monotherapy and in combination with vasodilators. In a rodent pulmonary artery banding model, which isolates cardiac effects from changes in the pulmonary vasculature, CM5480 also demonstrated evidence of direct protective activity in the right ventricle. These findings support the potential of CM5480 as a differentiated therapy targeting key drivers of disease progression. CalciMedica is advancing CM5480 for pulmonary hypertension, including PAH and PH-HFpEF, and anticipates submitting an IND in mid-2027. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes two distinct CRAC channel inhibitor compounds: zegocractin, which is formulated for intravenous administration as Auxora™, and CM5480, which is designed for chronic oral dosing. Auxora has been evaluated in more than 350 patients and is being developed for pulmonary arterial hypertension and acute pancreatitis, including a planned Phase 1b proof-of-concept trial in PAH and a planned Phase 2b trial in acute pancreatitis. CM5480 is being developed for pulmonary hypertension, with an IND submission anticipated in mid-2027. For more information, please visit Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica’s business strategy and clinical development plans for Auxora™ and CM5480; the planned design, initiation, conduct, timing, and completion of a Phase 2b trial of Auxora in AP, including that initiation of the trial is subject to additional financing; CalciMedica's interpretation of its discussions with FDA, including the potential use of LDH as an enrichment marker; the potential safety, efficacy, clinical utility, and regulatory development path for Auxora in AP; CalciMedica’s plans to evaluate Auxora in a Phase 1b proof-of-concept trial in PAH, including the anticipated timing of data from that trial; CalciMedica’s plans regarding the KOURAGE trial, including its current intention not to restart the trial; the development of CM5480 as a potential oral therapy for pulmonary hypertension, including the anticipated timing of an IND submission; the potential benefits and differentiated therapeutic pro Auxora, CM5480, and CRAC channel inhibition, including their potential effects on pulmonary vascular remodeling, right ventricular dysfunction, inflammation, endothelial injury, and other disease-related pathways; CalciMedica’s interpretations of clinical, preclinical, mechanistic, and biomarker data; the expected use of proceeds from CalciMedica’s private placement; CalciMedica’s expected cash runway into the second half of 2027; and the potential of CalciMedica's proprietary technology to provide therapeutic benefit in inflammatory, immunologic, and cardiopulmonary 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; CalciMedica’s ability to obtain and maintain regulatory approval for Auxora and CM5480; 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 and CM5480; 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, 2026, being filed with the 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 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. Investor Relations Contact Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com CALCIMEDICA, INC. Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts) (Unaudited) June 30, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents $ 18,617 $ 11,520 Short-term investments — 1,496 Prepaid clinical trial expenses 228 201 Other prepaid expenses and current assets 575 259 Assets held for sale 43 54 Total current assets 19,463 13,530 Property and equipment, net 36 50 Other assets 4 11 Total assets $ 19,503 $ 13,591 Liabilities and Stockholders’ Equity (Deficit) Current liabilities Accounts payable $ 2,073 $ 1,161 Accrued clinical trial costs 193 1,081 Accrued expenses 1,224 290 Current portion, promissory note — 1,250 Total current liabilities 3,490 3,782 Long-term liabilities Promissory note 9,200 8,450 Warrant liability 1,300 8,000 Total liabilities 13,990 20,232 Commitments and contingencies (Note 8) Stockholders’ equity (deficit) Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; no shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively — — Common stock, $0.0001 par value; 500,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 30,736,401 and 15,437,410, issued and outstanding at June 30, 2026 and December 31, 2025, respectively 6 4 Additional paid-in capital 197,510 182,681 Accumulated deficit (192,002) (189,326) Accumulated other comprehensive loss (1) — Total stockholders’ equity (deficit) 5,513 (6,641) Total liabilities and stockholders’ equity (deficit) $ 19,503 $ 13,591 CALCIMEDICA, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 2,102 $ 4,052 $ 5,587 $ 8,276 General and administrative 1,910 2,569 4,036 4,842 Total operating expenses 4,012 6,621 9,623 13,118 Loss from operations (4,012) (6,621) (9,623) (13,118) Other income (expense): Change in fair value of financial instruments (3,600) 500 7,200 2,200 Interest expense (325) (324) (644) (771) Interest income 54 220 160 422 Other income 231 269 231 269 Total other (expense) income (3,640) 665 6,947 2,120 Net loss $ (7,652) $ (5,956) $ (2,676) $ (10,998) Net loss per share - basic and diluted $ (0.45) $ (0.40) $ (0.16) $ (0.76) Weighted-average number of shares outstanding used in computing net loss per share—basic and diluted 17,100,457 14,995,404 16,464,841 14,560,900 __________________________________ 1 Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology . 2022;162(2):621-644. 2 Saint-Martin Willer A, Ruffenach G, Masson B, et al. Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction. JCI Insight . 2025. doi:10.1172/jci.insight.191780. 3 Bartoli F, Bailey MA, Rode B, et al. Orai1 channel inhibition preserves left ventricular systolic function and normal Ca2+ handling after pressure overload. Circulation . 2020;141(3):199-216. 4 Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology . 2022;162(2):621-644.

FDA aligned on new-onset severe respiratory failure as the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints FDA aligned on a strategy to evaluate elevated lactate dehydrogenase (LDH) as a potential enrichment marker for identifying patients at increased risk of new-onset severe respiratory failure LA JOLLA, Calif., July 29, 2026 /PRNewswire/ -- CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today announced that, following a Type C Focused Meeting, the U.S. Food and Drug Administration (FDA) and the Company have aligned on Phase 2b trial endpoints and a patient population enrichment strategy for its planned registration program evaluating Auxora™ in acute pancreatitis (AP). Auxora is designed to inhibit CRAC channels, which regulate calcium entry into endothelial cells and drive the vascular injury and inflammation seen across acute inflammatory diseases.¹,² In AP, this endothelial injury is believed to contribute to new-onset severe respiratory failure, a major driver of mortality and morbidity in the disease and the endpoint on which FDA and CalciMedica aligned for the Phase 2b trial. In the completed CARPO trial in patients with AP, patients treated with medium and high doses of Auxora experienced a 100% reduction in new-onset severe respiratory failure.3 These findings are consistent with Auxora's observed clinical effects on respiratory compromised patients. "Acute pancreatitis is a serious disease with no approved therapies, and this alignment with FDA is an important step toward what would be the first U.S. pivotal program evaluating a therapeutic candidate for AP," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "Alignment on a biomarker-based enrichment approach using LDH to potentially identify patients at greater risk of severe disease gives us a clear path to a Phase 2b trial designed to inform a well-powered Phase 3 program." "There hasn't been a validated and practical way to identify which patients with AP are most likely to progress to severe, life-threatening disease," said Timothy B. Gardner, M.D., Director of Pancreatic Disorders at Dartmouth–Hitchcock Medical Center and senior author of the American College of Gastroenterology's acute pancreatitis clinical guidelines. "Respiratory failure is the primary driver of prolonged hospital stays and mortality in this disease, yet no therapy has been approved for AP, and the field has not established a clinical trial endpoint framework to evaluate treatments. CalciMedica's program will help define that framework directly with FDA, and it reflects how AP actually presents in the clinic." FDA aligned on new-onset severe respiratory failure as the Phase 2b trial's primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. FDA and CalciMedica also aligned on the Phase 2b trial's role in confirming patient selection criteria and informing the endpoint for the Phase 3 program. The parties agreed to discuss additional Phase 3 program design features at future meetings. Based on its discussions with FDA, the Company believes that new-onset severe respiratory failure could be an important component of the Phase 3 registrational endpoint strategy. The Phase 2b trial will also prospectively assess whether elevated LDH, a recognized marker of tissue injury and disease severity and a component of the Ranson criteria for AP severity, identifies patients at greater risk of developing severe disease. This approach is supported by an exploratory analysis of the completed CARPO trial, in which elevated LDH was associated with a higher incidence of new-onset severe respiratory failure. The Company believes LDH may offer a rapid and readily available assessment of risk because, in CARPO, higher LDH was associated with higher levels of IL-6, a known correlate of severe outcomes in AP patients. Among the patients with both baseline LDH and IL-6 measurements, those with LDH above 240 U/L (n=30) had a median IL-6 of 134 pg/mL, compared with 49 pg/mL among those with LDH below 240 U/L (n=24) (p=0.004). CalciMedica plans to evaluate the relationship between LDH and events of new-onset severe respiratory failure in the Phase 2b trial to establish that LDH may be used as an enrichment criterion for the Phase 3 program. CalciMedica continues to advance preparations for the Phase 2b trial, including engaging with a contract research organization and holding discussions with potential clinical sites. About Acute Pancreatitis Acute pancreatitis is a serious inflammatory disease with no FDA-approved therapies and accounts for approximately 300,000 hospitalizations annually in the U.S.5 Mortality in AP follows a bimodal pattern: early deaths are driven primarily by respiratory failure, while later deaths typically follow infected pancreatic necrosis that progresses to septic shock and, ultimately, respiratory failure. Respiratory failure is therefore both a leading cause of death in AP and a major driver of intensive care resource use, including prolonged mechanical ventilation and hospitalization. No therapy has been approved for AP in the United States, and no clinical trial endpoint framework for the disease has been established through a completed U.S. registration program. CalciMedica's planned Phase 2b trial is designed to prospectively evaluate new-onset severe respiratory failure as a primary endpoint in AP, with multi-organ failure and time to medically indicated discharge as key secondary endpoints. This endpoint framework was developed in consultation with FDA in the absence of an established regulatory precedent for AP. About Auxora Auxora™ (zegocractin) is CalciMedica's proprietary intravenous CRAC channel inhibitor and most advanced pipeline candidate. Auxora is designed to act through a dual mechanism: in immune cells, it modulates the immune response by inhibiting CRAC channel activation that drives cytokine release and inflammation; in organ tissue cells, it limits excess calcium entry that can cause tissue injury and cell death. In a Phase 2 trial in COVID-19 pneumonia, Auxora treatment was associated with reduced levels of D-dimer and other biomarkers of endothelial activation, an effect that correlated with improved oxygenation and clinical status.4 Auxora has been evaluated in multiple completed and ongoing clinical trials involving more than 350 patients across indications characterized by endothelial damage and respiratory failure: In acute pancreatitis (AP), Auxora was evaluated in the completed Phase 2b CARPO trial, which met its primary objective by demonstrating a dose-dependent reduction in median time to solid food tolerance in a prespecified subgroup of hyper-inflamed patients. Medium and high doses of Auxora also showed a 100% reduction in new-onset severe respiratory failure compared with placebo. In COVID-19 pneumonia, Auxora was evaluated in the completed Phase 2 CARDEA trial, which enrolled patients with moderate-to-severe respiratory failure and demonstrated a statistically significant 56% reduction in all-cause mortality at 30 days compared with placebo. In acute kidney injury (AKI) with respiratory failure, Auxora was evaluated in the Phase 2 KOURAGE trial. In January 2026, enrollment was paused following a recommendation from the trial's Independent Monitoring Committee regarding a safety concern relating to a mortality imbalance that warranted reevaluation of the trial design. The IDMC did not identify evidence of drug-related toxicity, and the Company's comprehensive review, performed in conjunction with external experts, reached the same conclusion. FDA subsequently reviewed a protocol amendment and interim safety data and notified the Company that it had no comments on the submission, allowing dosing to resume under the amended protocol. CalciMedica is evaluating the future development of Auxora in AKI, with no current plans to resume dosing in the KOURAGE trial. CalciMedica also plans to evaluate Auxora in a Phase 1b proof-of-concept trial in patients with pulmonary arterial hypertension (PAH), with data anticipated in mid-2027. The trial is supported by proceeds from a private placement financing completed in June 2026. About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases. The Company's pipeline includes Auxora™ (zegocractin), its intravenous CRAC channel inhibitor, and CM5480, its proprietary, selective oral CRAC channel inhibitor candidate. Auxora has been evaluated in more than 350 patients across completed and ongoing clinical trials and is planned to be evaluated in a Phase 1b proof-of-concept trial in patients with pulmonary arterial hypertension (PAH). CM5480 is being developed as a potential oral therapy for chronic inflammatory diseases such as pulmonary hypertension (PH), with an IND submission expected in mid-2027. Together, the programs are intended to establish CRAC channel inhibition as a differentiated therapeutic approach targeting both pulmonary vascular remodeling and right ventricular dysfunction in PH. For more information, please visit . References Gandhirajan RK, et al. Blockade of NOX2 and STIM1 signaling limits lipopolysaccharide-induced vascular inflammation. J Clin Invest. 2013;123(2):887-902. Kosuru R, et al. Rap1A controls store-operated calcium entry and lung inflammation via Orai1 regulation. Arterioscler Thromb Vasc Biol. 2024;44:2271-2287. Sutton R, Garg PK, Miller J, et al. Zegocractin for acute pancreatitis with systemic inflammatory response syndrome: a randomized, controlled, dose-ranging, phase 2b trial. eClinicalMedicine. 2026;93:103757. Hou PC, et al. Reduction in D-dimer levels after treatment with Auxora in patients with severe COVID-19 pneumonia. Thrombosis Update. 2025;20:100217. Peery AF, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States. Gastroenterology. 2022;162(2):621-644. Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica's clinical development plans for Auxora™ in AP; the design, conduct, timing, and completion of the planned Phase 2b and Phase 3 studies; CalciMedica's interpretation of its discussions with FDA, including the potential use of LDH as an enrichment marker; the potential for future focused meetings with FDA to address additional Phase 3 program design features; the potential safety, efficacy, clinical utility, and regulatory development path for Auxora in AP; CalciMedica's plans to evaluate Auxora in a Phase 1b proof-of-concept trial in PAH, including the anticipated timing of data from that trial; CalciMedica's evaluation of the future development of Auxora in acute kidney injury; the development of CM5480 as a potential oral therapy for pulmonary hypertension, including the anticipated timing of IND submission; and the potential of CalciMedica's proprietary technology to provide therapeutic benefit in inflammatory, immunologic, and cardiopulmonary 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; CalciMedica's ability to obtain and maintain regulatory approval for Auxora and CM5480; 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 and CM5480; 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, filed with the SEC on May 12, 2026, 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 . 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 Investor Relations Contact Joyce Allaire LifeSci Advisors, LLC [email protected] SOURCE CalciMedica, Inc. 21% more press release views with Request a Demo