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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to s Commission File Number 001-39538 CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdiction ...

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., August 12, 2025 – 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 imm ...

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].

Financial Performance - CalciMedica reported a net loss of $5.9 million for the first quarter of 2025, compared to a net income of $0.1 million for the same period in 2024[15]. - Total operating expenses for the first quarter of 2025 were $6.5 million, compared to $5.8 million for the same period in 2024[21]. - General and administrative expenses decreased to $2.3 million for the first quarter of 2025, down from $2.8 million in the same period of 2024[15]. Research and Development - Research and development expenses increased to $4.2 million for the three months ended March 31, 2025, up from $2.9 million in the same period of 2024, primarily due to activities related to the Phase 2 KOURAGE clinical trial[11][12]. - The Phase 2 KOURAGE trial is ongoing, with an expected enrollment of 150 patients and data anticipated around the end of 2025[4]. - CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA around mid-2025 and aims to initiate a Phase 3 program in acute pancreatitis by the end of 2025[10]. - A post-hoc analysis from the Phase 2 CARDEA trial indicated a 62.7% relative reduction in mortality for patients treated with Auxora compared to placebo[5]. Financial Position - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025, which is expected to fund operations into mid-2026[11]. - Total assets increased to $25.3 million as of March 31, 2025, compared to $19.8 million as of December 31, 2024[19]. - The company announced a credit facility providing up to $32.5 million, with an initial tranche of $10 million fully funded at close[8].

Company Overview - CalciMedica Inc. is 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 [3] - The company's lead product candidate, Auxora™, has shown positive and consistent clinical results in multiple completed efficacy clinical trials [3] Clinical Trials and Developments - CalciMedica has announced data for a Phase 2b trial (CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) [3] - The company completed a Phase 2 trial (CARDEA – NCT04345614) in patients with COVID pneumonia [3] - Currently, CalciMedica is conducting a Phase 2 trial (KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), with data expected around the end of 2025 [3] - The company is also supporting an ongoing investigator-initiated Phase 1/2 trial (CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT), with an update expected in the second half of 2025 [3] Upcoming Events - Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica, will present at the Jones Healthcare and Technology Innovation Conference on April 9, 2025, at 11:00 a.m. PT [1] - A live webcast of the presentation will be available on CalciMedica's IR website, with a replay archived for 90 days [2]