Argot Partners Kevin Murphy [email protected] (212) 600-1902 About CalciMedica SOURCE CalciMedica, Inc. LA JOLLA, Calif., April 1, 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 Jo ...

Financial Condition - As of December 31, 2024, the company had an accumulated deficit of $159.8 million and reported a net loss of $13.7 million for the year [290]. - The company had $18.7 million in cash, cash equivalents, and short-term investments as of December 31, 2024, which is insufficient to fund product candidates through regulatory approval [293]. - The company expects to incur increasing levels of operating losses over the next several years, impacting stockholders' equity and working capital [290]. - The company has federal net operating loss (NOL) carryforwards of approximately $296.8 million, with $102.2 million generated prior to 2018 set to expire in 2026 unless utilized [442]. - The company has federal and state research and development credit carryforwards totaling $13.3 million and $3.1 million, respectively, with federal credits beginning to expire in 2027 [442]. Funding and Capital Requirements - The company will need to raise substantial additional funding to complete the development and commercialization of its product candidates [292]. - The company entered into a Loan and Security Agreement on February 28, 2025, for an initial growth capital loan of $10 million, with additional funding contingent on achieving certain clinical milestones [302]. - The company has primarily financed its operations through private placements and public offerings since its inception in October 2006 [292]. - The company anticipates that any acquisitions or strategic collaborations may increase capital requirements and could dilute stockholders [300]. - The company may need to increase expenditures for development and commercialization activities, which could require obtaining additional capital that may not be available on acceptable terms [424]. Clinical Development and Trials - The company has conducted several clinical trials for its lead product candidate, Auxora, including ongoing Phase 2 trials and plans for a Phase 3 trial [289]. - The company is highly dependent on the success of its lead product candidate, Auxora, which is currently in multiple clinical trials, including a Phase 1/2 trial and a Phase 2 trial initiated in July 2024 [311]. - Auxora recently completed a Phase 2b clinical trial, but the company has not yet advanced any product candidates into late-stage or pivotal trials [311]. - The company has not completed any late-stage or pivotal clinical trials or submitted a new drug application (NDA) to the FDA, which poses a risk to its ability to generate revenue [312]. - Clinical development is described as lengthy, expensive, and uncertain, with only a small percentage of programs entering clinical development receiving marketing approval [316]. Regulatory Challenges - The regulatory pathway for Auxora may be complex and time-consuming due to the novelty of the CRAC channel inhibition science and the lack of relevant experience with the indications being pursued [310]. - The FDA may grant accelerated approval for product candidates designed to treat serious conditions, contingent on the agreement to conduct additional post-approval studies [349]. - Regulatory approval processes are expensive and can take many years, with no guarantee of approval despite significant investment in clinical development [352]. - The FDA requires approval for any proposed product names, and failure to secure such approval may adversely affect the company's business [359]. - The company faces significant liability risks if found to have improperly promoted off-label uses of approved products [367]. Market and Competitive Landscape - The company faces substantial competition in the biotechnology and pharmaceutical industries, which may hinder its ability to develop and commercialize product candidates effectively [414]. - Competitors may obtain FDA or other regulatory approvals more rapidly, potentially establishing a strong market position before the company can enter the market [419]. - The company must prioritize specific treatment developments due to limited resources, which may lead to missed opportunities with potentially more commercially viable candidates [371]. - The competitive landscape includes larger companies with more resources and experience, as well as smaller firms and academic institutions, increasing the challenge for the company [418]. - The company is highly dependent on third-party payors for coverage and reimbursement, which are critical for product acceptance and profitability [390]. Intellectual Property and Compliance - The ability to obtain and maintain intellectual property protection is crucial for the commercialization of products, with uncertainties surrounding patent rights [459]. - The patent application process is complex and costly, with risks of failing to secure necessary protections for proprietary technologies [462]. - The company may face challenges in protecting its intellectual property rights globally due to prohibitively expensive patent filing and enforcement processes [478]. - The company may encounter claims challenging the inventorship or ownership of its patents, which could lead to litigation and potential loss of valuable intellectual property rights [482]. - The company may struggle to obtain necessary rights to product components and processes through acquisitions and in-licenses, impacting its development pipeline [483]. Operational Risks - The company relies on third parties for research and clinical trials, and any failure by these parties to meet obligations could delay development programs and increase costs [375]. - Manufacturing and supply of product candidates are dependent on third parties, with potential risks of limited supply or quality issues that could impair development efforts [384]. - The company has limited manufacturing arrangements, relying on a single source supplier in China for certain components, which increases risks related to geopolitical and regulatory changes [384]. - The company is increasingly dependent on information technology systems, which may be vulnerable to security breaches and disruptions, potentially affecting sensitive information and business operations [436]. - Cyber incidents have increased in frequency and sophistication, posing risks to the company's sensitive information and operational integrity [437]. Healthcare Regulations and Reimbursement - The company anticipates that obtaining reimbursement for its product candidates may be particularly difficult due to higher prices associated with branded therapeutics [396]. - The company expects pricing pressures due to trends in managed healthcare and legislative changes, which may hinder successful commercialization of new products [398]. - The European Union's reimbursement status for product candidates varies by member state, with ongoing efforts for transparency in pharmaceutical payments [452]. - Compliance with healthcare laws is critical, as violations could result in substantial penalties, including exclusion from government-funded programs [453]. - The Affordable Care Act has significantly impacted the U.S. pharmaceutical industry, with ongoing amendments and challenges that may affect the company's financial condition [446].

Financial Performance - CalciMedica reported a net loss of $13.7 million for the year ended December 31, 2024, a significant improvement from a net loss of $34.4 million in 2023[11]. - Total operating expenses decreased to $24,204 million in 2024 from $38,075 million in 2023, a reduction of approximately 36.4%[18]. - Net loss improved to $13,700 million in 2024 compared to a net loss of $34,357 million in 2023, representing a reduction of about 60.1%[18]. - Net loss per share decreased to $1.22 in 2024 from $7.66 in 2023, indicating a significant improvement in per-share performance[18]. - Overall, the financial performance indicates a positive trend with significant reductions in losses and operating expenses year-over-year[18]. Expenses - Research and development expenses decreased to $14.5 million in 2024 from $15.9 million in 2023, primarily due to a reduction in personnel expenses related to a merger[11]. - General and administrative expenses were $9.7 million in 2024, down from $22.2 million in 2023, reflecting a decrease in personnel expenses driven by one-time charges from the merger[11]. - Research and development expenses were $14,478 million in 2024, down from $15,859 million in 2023, reflecting a decrease of about 8.7%[18]. - General and administrative expenses significantly decreased to $9,726 million in 2024 from $22,216 million in 2023, a decline of approximately 56.3%[18]. - The company reported a loss from operations of $24,204 million in 2024, down from $38,075 million in 2023, a decrease of about 36.4%[18]. Assets and Funding - Cash, cash equivalents, and short-term investments totaled $18.7 million as of December 31, 2024, expected to fund operations into mid-2026[11]. - The total assets increased to $19.8 million as of December 31, 2024, compared to $12.2 million in 2023[16]. - The company secured a credit facility of up to $32.5 million to support its operations, with an initial tranche of $10 million already funded[10]. Clinical Trials and Development - Enrollment is ongoing in the Phase 2 KOURAGE trial, targeting 150 patients with severe acute kidney injury and associated respiratory failure, with data expected by the end of 2025[4]. - A post-hoc analysis from the Phase 2 CARDEA trial indicated a 62.7% relative reduction in mortality at day 30 for patients treated with Auxora compared to placebo[3]. - CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA in mid-2025, aiming to initiate a Phase 3 program in acute pancreatitis by the end of 2025[8]. Leadership Changes - The company appointed Stephen Bardin as Chief Financial Officer in November 2024, enhancing its leadership team[9]. Other Income - Total other income rose to $10,504 million in 2024, up from $3,718 million in 2023, marking an increase of about 182.5%[18]. - Change in fair value of financial instruments increased to $9,490 million in 2024 from $3,168 million in 2023, a growth of approximately 199.2%[18]. Shareholder Information - Weighted-average number of shares outstanding increased to 11,245,915 in 2024 from 4,486,258 in 2023, reflecting an increase of approximately 150.1%[18].

Core Insights - CalciMedica is conducting a Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) and expects data by the end of 2025 [1][4] - 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 [1][4] - The company has sufficient cash to fund operations into mid-2026, with a cash position of $18.7 million as of December 31, 2024 [10] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with severe AKI and acute hypoxemic respiratory failure [4] - The CARDEA trial analysis included 38 patients with AKI and respiratory failure, showing a 29.3% absolute reduction in mortality at day 30 [4] - An end-of-Phase 2 meeting with the FDA is planned for mid-2025 to discuss a Phase 3 program for acute pancreatitis with systemic inflammatory response syndrome (SIRS) [4] Financial Performance - Research and development expenses decreased to $14.5 million in 2024 from $15.9 million in 2023, primarily due to reduced personnel expenses [10] - General and administrative expenses significantly decreased to $9.7 million in 2024 from $22.2 million in 2023, also due to reduced personnel costs [10] - The net loss for 2024 was $13.7 million, a reduction from a net loss of $34.4 million in 2023 [10][15] Corporate Developments - The company secured a credit facility of up to $32.5 million from Avenue Capital Group, providing financial support for ongoing operations [7] - Leadership was strengthened with the appointment of Stephen Bardin as Chief Financial Officer in November 2024 [9] - Alan Glicklich, M.D., was appointed to the Board of Directors in January 2025, bringing over 20 years of biotechnology experience [9]

Core Insights - CalciMedica Inc. has secured a credit facility of up to $32.5 million from Avenue Venture Opportunities Fund II, L.P. to support its product pipeline development [1][2] - The initial tranche of $10 million is fully funded at close, with additional tranches of up to $22.5 million contingent on achieving certain milestones [2] - The funding is expected to extend CalciMedica's cash runway into mid-2026, allowing the company to prepare for critical milestones in 2025, including data from its Phase 2 KOURAGE trial [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases [5] - The company's lead product candidate, Auxora™, has shown positive clinical results in multiple trials, including a Phase 2b trial for acute pancreatitis and ongoing trials for acute kidney injury and pediatric patients with asparaginase-induced pancreatic toxicity [5] - CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, California [5] Funding Details - The credit agreement has a term of 3.5 years and includes no minimum cash requirement or other financial covenants [2] - The funding will enable CalciMedica to maintain operations and support ongoing clinical trials, including anticipated discussions with the FDA regarding a Phase 3 program in acute pancreatitis [3][6] - Avenue Capital Group, managing approximately $12.1 billion in assets, aims to provide creative financing solutions to high-growth, venture capital-backed companies [4]

Core Insights - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases [1][2] - The company will present at the 30th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference, highlighting the role of ORAI-1 in acute kidney injury (AKI) [1][2] 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 conditions without approved therapies [2] - The lead product candidate, Auxora™, has shown positive clinical results in multiple completed efficacy trials [2] - Ongoing clinical trials include a Phase 2b trial for acute pancreatitis (CARPO), a Phase 2 trial for COVID pneumonia (CARDEA), and a Phase 2 trial for acute kidney injury with respiratory failure (KOURAGE) [2] - The company also supports a Phase 1/2 trial in pediatric patients with asparaginase-induced pancreatic toxicity (CRSPA) [2] - CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, California [2]

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 proprietary technology aims to inhibit CRAC channels to modulate immune responses and protect against tissue cell injury, potentially providing therapeutic benefits for life-threatening inflammatory and immunologic diseases without approved therapies [3] Product Development - CalciMedica's lead product candidate, Auxora™, has shown positive and consistent clinical results in multiple completed efficacy clinical trials [3] - The company has announced data for a Phase 2b trial (CARPO – NCT04681066) in patients with acute pancreatitis (AP) and systemic inflammatory response syndrome (SIRS) [3] - A Phase 2 trial (CARDEA – NCT04345614) has been completed in patients with COVID pneumonia [3] - Currently, a Phase 2 trial (KOURAGE – NCT06374797) is being conducted in patients with acute kidney disease (AKI) and associated acute hypoxemic respiratory failure (AHRF), with data expected in 2025 [3] - The company is also supporting an ongoing Phase 1/2 trial (CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT), with data also expected in 2025 [3] Upcoming Events - Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica, will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on CalciMedica's IR website, with a replay archived for 90 days [2]

Core Insights - CalciMedica Inc. has appointed Dr. Alan Glicklich to its Board of Directors, effective January 15, 2025, bringing over 20 years of biotechnology experience [1][2] Company Overview - CalciMedica 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 diseases [4] - The company's lead product candidate, Auxora™, has shown positive clinical results in multiple trials, targeting conditions such as acute pancreatitis and acute kidney injury [4] Leadership and Expertise - Dr. Glicklich's previous roles include Chief Medical Officer at Nuvig Therapeutics, Chinook Therapeutics, and Bird Rock Bio, where he led various clinical development initiatives [2][3] - His expertise includes designing successful Phase 3 studies and managing clinical operations across multiple therapeutic areas [2][3] Clinical Development - CalciMedica is progressing Auxora towards a Phase 3 trial in acute pancreatitis and is awaiting data from the KOURAGE trial in acute kidney injury [2] - The company has completed a Phase 2 trial in patients with COVID pneumonia and is conducting ongoing trials in pediatric patients with asparaginase-induced pancreatic toxicity [4]

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 diseases [3] - The company's lead product candidate, Auxora™, has shown positive clinical results in multiple completed efficacy trials [3] - CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, California [3] Clinical Trials and Product Development - CalciMedica has announced topline data for a Phase 2b trial (CARPO – NCT04681066) in patients with acute pancreatitis and systemic inflammatory response syndrome [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 disease and associated acute hypoxemic respiratory failure [3] - The company is also supporting an ongoing Phase 1/2 trial (CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity [3] Upcoming Events - Rachel Leheny, Ph.D., CEO of CalciMedica, will present at the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, at 9:10 a.m. ET [1] - A live webcast of the presentation will be available on CalciMedica's investor relations website, with a replay archived for 90 days [2]

Core Insights - CalciMedica Inc. announced the acceptance of abstracts for presentations at two upcoming medical conferences, focusing on the Phase 2b CARPO trial of its lead product candidate Auxora™ for treating acute pancreatitis [1][2] Group 1: Presentation Details - The plenary presentation at the American Pancreatic Association (APA) 2024 Annual Meeting will be titled "Auxora Decreases the Development of Severe Organ Failure in Patients with Acute Pancreatitis and SIRS" and will be delivered by Prof. Robert Sutton [2] - The poster presentation at the Emergencies in Medicine (EIM) 2024 Meeting will cover a randomized, double-blind, placebo-controlled dose-ranging study of Auxora in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome (SIRS) [2] Group 2: Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases [3] - The company’s lead product candidate, Auxora™, has shown positive clinical results in multiple completed efficacy trials, including a Phase 2b trial (CARPO) for acute pancreatitis and a Phase 2 trial (CARDEA) for COVID pneumonia [3] - CalciMedica is also conducting ongoing trials for acute kidney disease and pediatric patients with asparaginase-induced pancreatic toxicity, with data expected in 2025 [3]