Accessibility StatementSkip Navigation Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing treatments Cardiac benefit supports the mechanistic rationale for CRAC channel inhibition in acute kidney injury (AKI), being evaluated in the Phase 2 KOURAGE trial with data expected in 1H 2026 LA JOLLA, Calif., Nov. 12, 2025/PRNewswire/ -- CalciMedica Inc. ("Calci ...

Core Insights - CalciMedica's Auxora has shown significant potential in reducing IL-17-related inflammation and improving kidney function in a rat model of acute kidney injury (AKI) [1][3][6] - The company is currently evaluating Auxora in the Phase 2 KOURAGE trial for severe AKI with respiratory failure, reinforcing its therapeutic potential [1][4] Study Findings - In a study involving rat models of ischemia/reperfusion-induced AKI, Auxora (16 mg/kg) was administered intravenously, leading to a significant increase in glomerular filtration rate (GFR) and a reduction in renal injury [2][6] - Three-day dosing of Auxora resulted in a 64% reduction in Th-17 cells in the kidney and a 59% reduction in the lung, along with a 69% decrease in IL-6-producing CD4 cells [6] Mechanistic Support - The study provided strong mechanistic support for Auxora as a treatment for severe AKI with acute hypoxemic respiratory failure (AHRF), highlighting the correlation between elevated IL-17 levels and adverse kidney events [3][4] - Down-regulation of IL-17 may be crucial in mitigating multi-organ failure, which is common in critically ill patients with severe AKI [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases, with a proprietary technology aimed at modulating immune responses [5][7] - The company has conducted multiple efficacy clinical trials for Auxora, which has been well-tolerated in over 350 critically ill patients [7]

LA JOLLA, Calif., Sept. 2, 2025 /PRNewswire/ -- 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 announced that Rachel Leheny, Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8, 2025, at 3:30 p.m. ET.A li ...

Financial Performance - The company reported a net loss of $11.0 million for the six months ended June 30, 2025, with total operating expenses of $13.1 million[153]. - Net loss for Q2 2025 was $5.96 million, representing a 51% increase compared to a net loss of $3.95 million in Q2 2024[169]. - Total operating expenses for the first half of 2025 were $13.12 million, an increase of 7% from $12.30 million in the same period of 2024[173]. - Research and development expenses for the first half of 2025 rose by 17% to $8.28 million, up from $7.10 million in the first half of 2024, largely due to a $1.02 million increase in preclinical and clinical trial-related activities[173]. - Other income for Q2 2025 was $0.67 million, a significant decrease of 74% from $2.58 million in Q2 2024, primarily due to a decrease in fair value adjustments[172]. - Cash used in operating activities was $11.5 million for the six months ended June 30, 2025, primarily due to the net loss and changes in operating assets and liabilities[194]. Cash and Funding - As of June 30, 2025, the company had an accumulated deficit of $170.8 million and $18.0 million in cash, cash equivalents, and short-term investments[153]. - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after transaction costs[149]. - An underwritten public offering in November 2024 generated gross proceeds of $10.2 million from the sale of 2,720,000 shares at $3.75 per share[150]. - The company expects to finance future cash requirements through existing cash, equity offerings, and debt financing, with a total principal amount of up to $32.5 million available under a Loan Agreement[189]. - Cash provided by financing activities for the six months ended June 30, 2025, was $10.6 million, primarily from debt financing[197]. - The company has entered into a Loan Agreement for growth capital loans of up to $32.5 million, with $10 million funded on the closing date[152]. Research and Development - The company has conducted multiple Phase 2 clinical trials for its lead product candidate, Auxora, demonstrating a reduction in organ damage and recovery time in treated patients[145]. - A Phase 2 trial for Auxora in acute kidney injury with associated acute hypoxemic respiratory failure is currently ongoing, with data expected in early 2026[145]. - The company anticipates research and development expenses to continue increasing as product candidates advance into later stages of clinical development[164]. - The company has paused IND enabling preclinical work on certain compounds to focus resources on clinical programs, pending additional funding[146]. - The company incurs substantial expenses related to clinical trials, with costs estimated based on the number of services provided but not yet invoiced, included in accrued liabilities and R&D expenses[203]. - The company has not experienced material differences between accrued costs and actual costs incurred since inception, indicating effective cost estimation practices[204]. Administrative Expenses - General and administrative expenses for Q2 2025 increased by 8% to $2.6 million from $2.4 million in Q2 2024, mainly driven by a $0.6 million increase in personnel costs[171]. - Personnel costs in general and administrative expenses for the first half of 2025 increased by 57% to $2.68 million from $1.71 million in the same period of 2024[174]. Regulatory and Compliance - The company has filed a shelf registration statement allowing for the offering of up to $100.0 million in various securities, including common stock and warrants[147]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until December 31, 2025[209]. - The company qualifies as a smaller reporting company, with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[210]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[210]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[213]. - No recently adopted accounting pronouncements were reported, indicating stability in accounting practices[211].

Financial Position - Cash position as of June 30, 2025, was $18.0 million, expected to fund operations into mid-2026[7] - Total assets as of June 30, 2025, were $19.1 million, a decrease from $19.8 million at the end of 2024[16] Expenses - Research and development expenses for Q2 2025 were $4.1 million, a slight decrease from $4.2 million in Q2 2024[7] - General and administrative expenses increased to $2.6 million in Q2 2025 from $2.4 million in Q2 2024[9] - Total operating expenses for Q2 2025 were $6.6 million, compared to $6.5 million in Q2 2024[18] Net Loss - Net loss for Q2 2025 was $6.0 million, or $0.40 per share, compared to a net loss of $4.0 million, or $0.36 per share, in Q2 2024[10] - Other income for Q2 2025 was $0.7 million, down from $2.6 million in Q2 2024, primarily due to decreased fair value adjustments[10] Clinical Trials and Development - Enrollment ongoing in Phase 2 KOURAGE trial with a target of 150 patients, data expected in early 2026[4] - Initial meeting with the FDA regarding Auxora for acute pancreatitis was productive, with alignment on a pivotal trial anticipated by the end of 2025[3] - Publication in the American Journal of Nephrology in June 2025 supports the development of Auxora for AKI treatment[4]

Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) with respiratory failure; data expected in early 2026 Productive initial meeting with the FDA on Auxora in acute pancreatitis (AP); conversations continue, with alignment on a pivotal trial anticipated around the end of 2025 Cash position expected to fund operations into mid-2026 LA JOLLA, Calif., Aug. 12, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutica ...

LA JOLLA, Calif., July 8, 2025 /PRNewswire/ -- 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 announced that Rachel Leheny, Ph.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025, at 2:0 ...

Core Insights - CalciMedica Inc. announced the publication of preclinical data and a post-hoc analysis of its lead candidate Auxora™ for treating acute kidney injury (AKI) with respiratory failure, highlighting its potential as a transformative treatment [1][3][5] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases [5][6] - The company’s lead product candidate, Auxora™, has shown positive clinical results in multiple trials and has been well-tolerated in over 350 critically ill patients [5] Clinical Trial Details - The KOURAGE trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Auxora in patients with severe AKI and respiratory failure, aiming to enroll approximately 150 patients [4] - The primary endpoint of the KOURAGE trial is the number of days alive without the need for a ventilator or dialysis, with secondary endpoints including all-cause mortality and decline in estimated glomerular filtration rate (eGFR) [4] Preclinical and Clinical Evidence - Preclinical models demonstrated that Auxora significantly increased glomerular filtration rate (GFR) and prevented mortality in AKI models [3] - A post-hoc analysis from the CARDEA trial indicated a 62.7% relative reduction and a 29.3% absolute reduction in mortality for patients treated with Auxora compared to placebo [3] Market Context - Approximately 3.7 million patients are hospitalized with AKI in the U.S. annually, with a high mortality risk of around 50% for those with severe AKI and respiratory failure [3]

Core Insights - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for treating acute and chronic inflammatory and immunologic diseases [1][4] - The company will host a symposium titled "Auxora for the Treatment of AKI" at the 43rd Vicenza Course AKI-CRRT-EBPT and Critical Care Nephrology meeting from June 24-26 in Vicenza, Italy [1] Presentation Details - The symposium will feature several oral presentations, including an overview of CRAC channels by Dr. Sudarshan Hebbar, scheduled for June 24, 1:45-2:00 p.m. CEST [2] - Another presentation will discuss the role of IL-17 in the pathophysiology of acute kidney injury (AKI) by Dr. Javier Neyra, set for June 24, 2:00-2:20 p.m. CEST [2] - Dr. Lakhmir Chawla will present on the KOURAGE trial (NCT06374797) on June 24, 2:20-2:35 p.m. CEST [3] Company Overview - CalciMedica's proprietary technology aims to inhibit CRAC channels to modulate immune responses and protect against tissue cell injury, potentially addressing life-threatening inflammatory and immunologic diseases without approved therapies [4] - The lead product candidate, Auxora™, has shown positive clinical results in multiple trials and has been well-tolerated in over 350 critically ill patients [4] - The company is conducting several clinical trials, including a Phase 2b trial (CARPO – NCT04681066) for acute pancreatitis and a Phase 2 trial (CARDEA – NCT04345614) for COVID pneumonia, as well as the ongoing KOURAGE trial for AKI with associated acute hypoxemic respiratory failure [4]

Financial Performance - The company reported a net loss of $5.0 million for the three months ended March 31, 2025, with total operating expenses of $6.5 million and interest expense of $0.4 million[144]. - Net loss for the three months ended March 31, 2025, was $5.0 million, a significant increase of 3978% compared to a net income of $130,000 in the same period of 2024[158]. - Other income decreased by 75% to $1.5 million for the three months ended March 31, 2025, compared to $5.9 million in 2024[161]. - Cash used in operating activities for the three months ended March 31, 2025, was $4.9 million, primarily due to cash outlays for operations[179]. - Cash used in investing activities for the three months ended March 31, 2025, was $1.2 million, primarily from the purchase of short-term investments[181]. - The company has experienced significant operating losses since inception, except for the three-month period ending March 31, 2024[144]. Cash and Investments - As of March 31, 2025, the company had an accumulated deficit of $164.8 million and $24.6 million in cash, cash equivalents, and short-term investments[144]. - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025[162]. - Cash provided by financing activities for the three months ended March 31, 2025, was $10.8 million, comprised of debt financing of $9.8 million and $1.0 million from the ATM[182]. - The Company expects cash requirements for its lease obligation to be approximately $95,000 over the next nine months[183]. Funding and Capital - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after deducting transaction costs[140]. - An underwritten public offering in November 2024 generated gross proceeds of $10.2 million from the sale of 2,720,000 shares at a price of $3.75 per share[141]. - A loan agreement was established for growth capital loans totaling up to $32.5 million, with $10 million funded on the closing date[143]. - The Company entered into a Loan Agreement for an initial $10.0 million of gross proceeds on February 28, 2025[163]. - The company filed a Shelf Registration Statement in August 2023 for the offering of up to $100.0 million in various securities[170]. Research and Development - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and regulatory approvals[149]. - Research and development expenses increased by 43% to $4.2 million for the three months ended March 31, 2025, compared to $2.9 million for the same period in 2024[158]. - Research and development expenses included a 271% increase in chemistry, manufacturing, and controls costs related to Phase 2 clinical trials of Auxora[159]. - The company is conducting a Phase 2 trial for Auxora in acute kidney injury with data expected around the end of 2025[136]. - The company has not generated any product revenue and does not expect to do so until successful development and regulatory approval of its product candidates[146]. - The company expects to need substantial additional capital to fund product candidates through regulatory approval and commercialization[164]. Operational Adjustments - The company has paused IND enabling preclinical work on several product candidates to focus resources on clinical programs, pending additional funding[137]. - General and administrative expenses decreased by 19% to $2.3 million for the three months ended March 31, 2025, down from $2.8 million in 2024[160].