CalciMedica(CALC)

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CalciMedica(CALC) - 2024 Q3 - Quarterly Results
2024-11-13 12:15
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].
CalciMedica Reports Third Quarter 2024 Financial Results and Provides Clinical & Corporate Updates
Prnewswire· 2024-11-13 12:00
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]
CalciMedica Strengthens Leadership Team with Appointment of Stephen Bardin as Chief Financial Officer
Prnewswire· 2024-11-07 12:00
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]
CalciMedica Announces Pricing of Public Offering of Common Stock
Prnewswire· 2024-10-31 02:11
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].
CalciMedica Announces Proposed Public Offering of Common Stock
Prnewswire· 2024-10-30 20:50
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].
CalciMedica Announces Upcoming Late-Breaker Plenary Presentation at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting
Prnewswire· 2024-10-16 12:00
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]
CalciMedica to Present at the H.C. Wainwright 26th Annual Global Investment Conference
Prnewswire· 2024-09-03 12:00
Core Insights - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases [3] Company Overview - CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury [3] - The company aims to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies [3] - CalciMedica's lead product candidate, Auxora™, has shown positive and consistent clinical results in multiple completed efficacy clinical trials [3] Clinical Trials - The company has announced topline data for a Phase 2b trial (CARPO – NCT04681066) in patients with acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS) [3] - A Phase 2 trial (CARDEA – NCT04345614) in patients with COVID pneumonia has been completed [3] - Currently, CalciMedica is conducting a Phase 2 trial (KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxic respiratory failure (AHRF), with data expected in 2025 [3] - The company is also supporting an ongoing Phase 1/2 trial (CRSPA – NCT04195347) in patients with acute inflammatory pulmonary thrombosis (AIPT), with data also expected in 2025 [3] Upcoming Events - Rachel Leheny, Ph.D., CEO of CalciMedica, will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024 [1]
CalciMedica(CALC) - 2024 Q2 - Quarterly Report
2024-08-12 20:30
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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39538 CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdiction o ...
CalciMedica(CALC) - 2024 Q2 - Quarterly Results
2024-08-12 20:15
Exhibit 99.1 CalciMedica Reports Second Quarter 2024 Financial Results and Provides Clinical & Corporate Updates Positive topline data announced from CARPO, Phase 2b trial of Auxora™ in acute pancreatitis (AP); additional data to be presented at a medical meeting later this year First patient enrolled in KOURAGE, Phase 2 trial of Auxora™ in severe acute kidney injury (AKI), with data expected in 2025 LA JOLLA, Calif., August 12, 2024 – CalciMedica Inc. ("CalciMedica or the Company") (Nasdaq: CALC), a clinic ...
CalciMedica Reports Second Quarter 2024 Financial Results and Provides Clinical & Corporate Updates
Prnewswire· 2024-08-12 20:10
Positive topline data announced from CARPO, Phase 2b trial of Auxora™ in acute pancreatitis (AP); additional data to be presented at a medical meeting later this year First patient enrolled in KOURAGE, Phase 2 trial of Auxora™ in severe acute kidney injury (AKI), with data expected in 2025 LA JOLLA, Calif., Aug. 12, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica or the Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRA ...