CalciMedica Announces Presentation of Data from a Preclinical Study of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference

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CalciMedica Inc. announces positive preclinical data for Auxora in treating acute kidney injury (AKI) in rats, showing improved kidney function. The study indicates that Auxora can enhance glomerular filtration rate, suggesting potential therapeutic benefits for AKI.

Preclinical data show that therapeutic treatment with Auxora in a rat model of AKI improves kidney function as measured by glomerular filtration rate

LA JOLLA, Calif., Feb. 28, 2024 /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 diseases, today announced that data from its most recent preclinical study of Auxora™ (zegocractin) in acute kidney injury (AKI) will be presented in a poster and oral presentation at the 29^th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) being held March 12-15, 2024 in San Diego, CA.

The data will highlight the promising therapeutic benefits of Auxora in a rat model of AKI and suggest that Auxora can hasten recovery of renal function. The study was conducted to evaluate whether the selective CRAC channel inhibitor Auxora would improve glomerular filtration rate (GFR), an important indicator of kidney function, when given therapeutically in a rat model of AKI induced by ischemia reperfusion injury, a timed ligation of the renal artery.

Presentation Title: The Store-operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-induced Acute Kidney Injury in Rats

Presenter: David P. Basile, Ph.D., Indiana University

Session Date and Time: Tuesday, March 12, 5:30-7:30 p.m.

Session Title: Oral Session 2: Translational Research

About AKI
Acute kidney injury (AKI) denotes a sudden reduction in kidney function, or the organ's ability to clean and filter the blood, as measured by increased serum creatinine (a cellular waste product) or decreased urine volume. AKI can result as a complication of other serious illnesses such as sepsis, respiratory infections and failure, acute pancreatitis, trauma, surgery and burns. There are approximately 3.7 million hospitalized with AKI in the United States each year. The majority have Stage 1 AKI and recover with supportive care alone. However, approximately 1.1 million of these patients advance to stage 2 and stage 3 AKI, over half of whom have associated acute hypoxemic respiratory failure (AHRF). The risk of serious morbidities and mortality is significant for advanced stage 2 and stage 3 AKI patients. There are currently no approved therapies for AKI.

About Auxora™
CalciMedica's lead clinical compound, Auxora™, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with acute inflammatory and immunologic illnesses. CRAC channels are found on many cell types, including pancreatic acinar cells, endothelium cells and immune system cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes. Auxora is currently being evaluated in: (i) a Phase 2b trial for acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS), called CARPO, (ii) an investigator-sponsored Phase 1/2 trial called CRSPA being conducted in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase, (iii) a Phase 2 dose-ranging pharmacodynamic study in critical COVID-19 patients, and (iv) a Phase 2 trial in AKI with associated AHRF, called KOURAGE expected to initiate in the first half of 2024. There are currently no approved therapies to treat either AP, AIPT or AKI. In previous trials, patients responded well to Auxora regardless of severity or cause of disease. CalciMedica is also exploring the potential of Auxora treatment for other acute indications including acute respiratory distress syndrome.

About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora™, a proprietary, intravenous-formulated CRAC channel inhibitor, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica is currently conducting a Phase 2b trial for a planned 216 patients (called CARPO – NCT04681066) for AP with SIRS, with topline data expected in the first half of 2024, as well as supporting the ongoing Phase 1/2 CRSPA AIPT study (called CRSPA – NCT04195347), with additional data expected by 2H 2024. CalciMedica plans to initiate its Phase 2 KOURAGE study in AKI in 1H 2024. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com.

Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica's planned and ongoing clinical trials and the timing, design and expected patient enrollment thereof, including its planned Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF, its ongoing Phase 2b trial of Auxora for AP with accompanying SIRS, its ongoing Phase 1/2 trial of Auxora in pediatric patients with AIPT; the potential benefits of Auxora for the treatment of AKI, AP and AIPT; the estimated patient population in the United States for AKI; the expected timing for release of data in CalciMedica's ongoing clinical trials; and plans to present results from CalciMedica's pre-clinical studies in a rat model of AKI induced by ischemia reperfusion injury at the 29th International AKI & Continuous Renal Replacement Therapy Conference. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings.

CalciMedica Contact:

Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902

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SOURCE CalciMedica, Inc.

FAQ

What does the preclinical data for Auxora in AKI show?

The preclinical data demonstrate that therapeutic treatment with Auxora in a rat model of AKI improves kidney function, as measured by glomerular filtration rate.

Where will the data from the recent preclinical study of Auxora be presented?

The data will be presented in a poster and oral presentation at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA.

Who is the presenter of the study on Auxora for AKI?

The study will be presented by David P. Basile, Ph.D. from Indiana University.

When is the session scheduled for the presentation of the study on Auxora?

The session is scheduled for Tuesday, March 12, from 5:30-7:30 p.m.

What is the focus of the study on Auxora for AKI?

The study evaluates whether the CRAC channel inhibitor Auxora can improve glomerular filtration rate in a rat model of AKI induced by ischemia reperfusion injury.