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]

Financial Performance - The company reported a net loss of $9.4 million for the nine months ended September 30, 2024, with total operating expenses of $18.0 million [78]. - As of September 30, 2024, the company had an accumulated deficit of $155.5 million and $14.6 million in cash, cash equivalents, and short-term investments [78]. - Net loss for Q3 2024 was $5.6 million, a 22% increase from $4.6 million in Q3 2023 [84]. - The net loss for the nine months ended September 30, 2024 was $9.4 million, a significant improvement from a net loss of $30.2 million for the same period in 2023 [94]. - Cash used in operating activities for the nine months ended September 30, 2024 was $16.2 million, compared to $22.1 million for the same period in 2023 [96]. - Other income for the nine months ended September 30, 2024 was $8.5 million, an increase of $5.0 million compared to $3.5 million for the same period in 2023 [91]. - Total operating expenses for the nine months ended September 30, 2024, were $18.0 million, a decrease of 47% from $33.8 million in the same period of 2023 [88]. Research and Development - The lead product candidate, Auxora, demonstrated a 100% reduction in new onset severe respiratory failure in a Phase 2b trial compared to placebo [76]. - In the CARPO trial, Auxora showed a statistically significant dose response in median time to solid food tolerance and a 64.2% reduction in new onset persistent respiratory failure [76]. - The company plans to initiate a Phase 3 program for Auxora in acute pancreatitis in 2025 following discussions with the FDA [76]. - The KOURAGE trial will evaluate 150 patients with severe acute kidney injury and acute hypoxemic respiratory failure, with results expected in 2025 [77]. - Research and development expenses for Q3 2024 were $3.5 million, an increase of 28% from $2.8 million in Q3 2023 [84]. - Research and development expenses for the nine months ended September 30, 2024, were $10.6 million, a decrease of 19% from $13.1 million in the same period of 2023 [88]. - The company expects research and development expenses to increase as it continues to develop product candidates and seek regulatory approvals [78]. - The company expects research and development expenses to continue increasing as product candidates advance into later stages of clinical development [84]. General and Administrative Expenses - General and administrative expenses for Q3 2024 were $2.2 million, a 6% increase from $2.1 million in Q3 2023 [82]. - General and administrative expenses for the nine months ended September 30, 2024, were $7.4 million, a significant decrease of 64% from $20.7 million in the same period of 2023 [90]. - The company anticipates general and administrative expenses to rise over the next several years to support ongoing research and development and operational activities [82]. Capital and Funding - The company closed the 2024 Follow-On offering of 2,720,000 shares at $3.75 per share, generating gross proceeds of $10.2 million [93]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $19.1 million, primarily from the 2024 Private Placement [98]. - The company expects its current cash and investments, including proceeds from the 2024 Follow-On, to fund operations through certain clinical milestones into the first half of 2026 [93]. - The company will need to raise substantial additional capital to complete the development and commercialization of its product candidates [94]. Legal and Compliance - The company is involved in various legal proceedings, but currently believes there is no pending litigation that could materially adversely affect its financial condition [112]. - There were no changes in the internal control over financial reporting during the quarter ended September 30, 2024, that materially affected the company's financial reporting [109]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies [103]. - The market value of the company's stock held by non-affiliates is less than $700 million, and its annual revenue is below $100 million, qualifying it as a smaller reporting company [103]. Operational Costs - The company incurs substantial expenses related to clinical trials, with costs estimated based on patient enrollment and contracted amounts, ensuring that accrued expenses are adjusted as actual costs become known [101]. - The company has a lease obligation for office and laboratory space in La Jolla, California, with a monthly rent expense of approximately $10,000, totaling an expected cash requirement of about $30,000 over the next three months [99]. - The company has not experienced any material differences between accrued costs and actual costs incurred since its inception, indicating effective cost estimation practices [101]. Accounting and Valuation - The company utilizes the Black-Scholes model for valuing common warrants, with various scenarios considered to arrive at the final valuation [102]. - The company has adopted recent accounting pronouncements, with potential impacts on its financial condition and results of operations assessed [105]. - The company has entered into contracts with third-party service providers for clinical trials and other services, which are generally terminable upon notice, minimizing non-cancelable obligations [99].

Financial Position - As of September 30, 2024, CalciMedica, Inc. reported cash, cash equivalents, and short-term investments totaling $14.6 million[2]. Financial Reporting - The financial estimates are preliminary and unaudited, subject to change upon completion of the financial statement closing procedures[3]. - The independent registered public accounting firm has not audited or reviewed the preliminary results, providing no assurance on them[4]. - CalciMedica plans to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, on or about November 14, 2024[4]. Public Offering - On October 30, 2024, CalciMedica announced a proposed underwritten public offering of its common stock[5]. - During the proposed public offering, CalciMedica suspended offerings under the existing Sales Agreement, which remains in effect[6]. - The company will not make any sales of common stock under the Sales Agreement until a new prospectus supplement is filed with the SEC[6]. Forward-Looking Statements - Forward-looking statements regarding the public offering and other expectations are subject to various risks and uncertainties[9]. - Actual results may differ materially from forward-looking statements due to factors affecting CalciMedica's business[10]. - The company assumes no obligation to update forward-looking statements except as required by law[11].

Core Insights - CalciMedica Inc. reported positive data from the Phase 2b CARPO trial of Auxora™ in acute pancreatitis, indicating a potential for initiating a Phase 3 program in 2025 [1][4][3] - The company is actively enrolling patients in the Phase 2 KOURAGE trial for acute kidney injury and the Phase 2 CRSPA trial for asparaginase-induced pancreatic toxicity, with data expected in 2025 [1][5][6] - Following a public offering, CalciMedica's cash position is projected to support operations into the first half of 2026 [1][7] Clinical Updates - The CARPO trial demonstrated a 100% relative risk reduction in new-onset severe respiratory failure (p = 0.0027) and a 64.2% reduction in new-onset persistent respiratory failure (p = 0.0476) for high and medium dose Auxora patients compared to low dose and placebo [3] - A statistically significant win ratio of 1.640 (p = 0.0372) was observed for high dose Auxora patients, along with clinically meaningful reductions in new-onset necrotizing pancreatitis and time to medically indicated discharge [3] Financial Results - As of September 30, 2024, CalciMedica had approximately $14.6 million in cash, cash equivalents, and short-term investments, which is expected to increase to about $23.7 million post-offering [7] - The company reported a total loss from operations of approximately $5.7 million for the three months ended September 30, 2024, and $18.0 million for the nine months ended September 30, 2024 [8][13] - The net loss for the same periods was approximately $5.6 million and $9.4 million, translating to a net loss per share of $0.50 and $0.88, respectively [8][13]

Core Insights - CalciMedica, Inc. has appointed Stephen Bardin as Chief Financial Officer, succeeding Daniel Geffken, who will depart after the third quarter financial statements are filed [1][2] - Bardin has extensive experience in capital raising and corporate development, having previously served as CFO at atai Life Sciences and BridgeBio Pharma, where he helped raise over $2 billion [2][3] - The company is focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases, with promising clinical data from recent trials [3] Company Developments - CalciMedica's lead product candidate, Auxora™, has shown positive results in multiple clinical trials, including a Phase 2b trial in acute pancreatitis and a Phase 2 trial in COVID pneumonia [3] - The company is currently conducting a Phase 2 trial (KOURAGE) in acute kidney injury, with data expected in 2025, and is also supporting a Phase 1/2 trial in asparaginase-induced pancreatic toxicity [3] - The recent appointment of Bardin is expected to enhance the company's strategic direction and financial operations as it advances its clinical-stage pipeline [2][3]

Core Viewpoint - CalciMedica, Inc. has announced a public offering of 2,720,000 shares at $3.75 per share, aiming to raise approximately $10.2 million before expenses [1]. Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases [5]. - The company's lead product candidate, Auxora™, has shown positive results in multiple clinical trials, including a Phase 2b trial for acute pancreatitis and a Phase 2 trial for COVID pneumonia [5]. - CalciMedica is currently conducting a Phase 2 trial for acute kidney injury and supporting an ongoing Phase 1/2 trial for acute inflammatory pulmonary thrombosis, with data expected in 2025 [5]. Offering Details - The public offering consists of 2,720,000 shares priced at $3.75 each, with gross proceeds expected to be $10,200,000 [1]. - The underwriters have a 30-day option to purchase an additional 408,000 shares at the same price [1]. - The offering is expected to close around November 1, 2024, pending customary closing conditions [1]. Regulatory Information - The offering is made under a shelf registration statement filed with the SEC, which was declared effective on August 18, 2023 [3]. - A preliminary prospectus supplement was filed on October 30, 2024, with a final prospectus supplement to be made available on the SEC's website [3].

Core Viewpoint - CalciMedica, Inc. has initiated an underwritten public offering of its common stock to support its clinical-stage biopharmaceutical development focused on CRAC channel inhibition therapies for inflammatory and immunologic diseases [1][2]. Company Overview - CalciMedica is a clinical-stage biopharmaceutical company that develops novel therapies targeting CRAC channels to modulate immune responses and protect against tissue cell injury [6]. - The company’s lead product candidate, Auxora™, has shown positive results in multiple clinical trials, including a Phase 2b trial for patients with acute pancreatitis and systemic inflammatory response syndrome (SIRS) [6]. - CalciMedica is conducting ongoing trials, including a Phase 2 trial for acute kidney injury (AKI) with data expected in 2025 [6]. Offering Details - The public offering will consist entirely of shares sold by the company, with a potential 30-day option for the underwriter to purchase an additional 15% of the shares [2]. - The offering is made under a shelf registration statement previously filed with the SEC, which was declared effective in August 2023 [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 illnesses [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 Presentations - A late-breaking abstract for a plenary presentation by Prof. Robert Sutton from the University of Liverpool has been accepted for the ACG 2024 Annual Scientific Meeting, scheduled for October 28-30 in Philadelphia [1] - The presentation will focus on the CARPO clinical trial, which studies acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS) [1][2] - CalciMedica is currently conducting several clinical trials, including a Phase 2b trial (CARPO) for AP with SIRS, a Phase 2 trial (KOURAGE) for acute kidney injury (AKI) with associated acute hypoxic respiratory failure (AHRF), and a Phase 1/2 trial (CRSPA) for acute intestinal pseudo-obstruction (AIPT) [3]