ORAI1

Therapeutic treatment with Auxora shown to hasten the recovery of kidney function and improve survival in a rat model of acute kidney injury (AKI) Preclinical results are consistent with clinical observations made with Auxora, supporting the KOURAGE trial in patients with severe AKI that will start enrolling in 2Q 2024 LA JOLLA, Calif., March 13, 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, last evening presented data from preclinical studies of Auxora™ in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. David Basile, Ph.D., Professor of Anatomy, Cell Biology and Physiology at Indiana University, gave an oral and poster presentation entitled "The Store-Operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-Induced Acute Kidney Injury in Rats." "At AKI & CRRT, Prof. Basile discussed the most recent preclinical study of Auxora in an acute kidney injury model that used a treatment regimen of three daily doses of drug started six hours after ischemic injury, which resembles the dosing in our clinical protocol. The positive results from this study build on prior preclinical data and indicate that inhibiting Orai1 activity in an AKI model improves kidney function," said Kenneth Stauderman, Ph.D., Founder and Chief Scientific Officer of CalciMedica. "In rats with ischemic kidney injury akin to Stage 2 AKI, Auxora was shown to provide nearly complete recovery of kidney function, as evidenced by improved glomerular filtration rate (GFR) at 72 hours after injury, while placebo-treated animals showed little improvement in GFR. In rats with kidney injury akin to Stage 3 AKI, the rats treated with placebo died while those on Auxora survived and showed modest recovery of GFR. We are excited as these studies support clinical observations of Auxora that suggest the drug may be beneficial for AKI patients." AKI is a serious acute critical illness and denotes a sudden reduction in kidney function, or the organ's ability to clean and filter the blood, that results from a complication of critical illness. These animal model studies support observations from CalciMedica's clinical trials, particularly CARDEA, the Company's Phase 2 trial in patients with severe and critical COVID-19 pneumonia, where AKI was a relatively common co-morbidity or a common sequela of the disease. Compared to placebo-treated patients, Auxora-treated patients in CARDEA had lower levels of key biomarkers associated with kidney injury, lower incidence of treatment-emergent AKI and reduced mortality in those patients with decreased kidney function at the time of treatment. Additionally, previous preclinical studies conducted by CalciMedica and others suggest that Orai1 activity contributes to the activation and infiltration of pro-inflammatory Th17 cells in the kidney, which is associated with the development of AKI. CalciMedica has also shown that the active ingredient in Auxora, zegocractin, inhibits release of IL-17, which is a key pro-inflammatory cytokine from Th17 cells. "As we initiate KOURAGE, our Phase 2 trial of Auxora in severe AKI patients with associated acute hypoxemic respiratory failure, we are encouraged to have additional supporting data showing that Auxora has beneficial activity in animal models of AKI," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "Patients randomized in KOURAGE will have Stage 2 and Stage 3 AKI, so the results from Prof. Basile's recent preclinical study, most notably the survival benefit, are particularly meaningful. Severe AKI in the presence of respiratory failure has a mortality of approximately 50% and we are heartened to see that Auxora has the potential for a positive impact on patients with this devastating disease." Data Presented at the AKI & CRRT Conference The data presented at AKI & CRRT was from a series of studies referred to as Study 1 and Study 2. In Study 1, AKI was induced in a rat model through ischemia reperfusion injury (I/R), a transient ligation of the renal artery, while control animals underwent sham-surgery. Within 30 minutes of injury, the animals were treated with a single intravenous infusion of either 16 mg/kg of Auxora or placebo over a period of 4 hours. GFR, an important indicator of kidney function, was evaluated at 24 hours post-injury. Study 2 evaluated recovery of kidney function following I/R similar to Study 1 but varying in intensity to mimic different severity of disease. In Study 2, GFR was measured 2-4 hours after injury but before treatment, and treatment with 16 mg/kg of Auxora or placebo was administered at 6, 24 and 48 hours post-injury, with GFR again evaluated at 72 hours. Results from Study 1 showed that at 24 hours post-injury, GFR was significantly higher in rats treated with Auxora 30 minutes after injury versus placebo (61%, p<0.05). Additionally, animals treated with Auxora showed a reduction in Th17 cells in the kidney of approximately 50% as compared to those treated with placebo. In Study 2, in a group of animals with initial GFR reductions of approximately 50%, similar to Stage 2 AKI, GFR at 72 hours was significantly greater in Auxora-treated animals as compared to placebo-treated animals (0.81±0.03 vs. 0.47±0.04 ml/min/100g respectively; p<0.001). In a group of animals with GFR reductions ≥66%, similar to Stage 3 AKI, placebo-treated rats experienced 100% mortality by 72 hours while Auxora-treated rats had no mortality at 72 hours and were stable, showing modest recovery of kidney function. These results indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI. 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 critical illness such as sepsis, pneumonia and acute pancreatitis, and other causes such as trauma, surgery and burns. There are approximately 3.7 million patients 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 KOURAGE KOURAGE is a randomized, double-blind, placebo-controlled study that will evaluate 150 patients with Stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or intermittent mandatory ventilation (IMV). Patients will be stratified by classification of stage of AKI as well as the use of IMV. Patients will receive either a four-hour infusion of Auxora or placebo at 1.25 mL/kg as a first dose, after which they will receive Auxora or placebo at 1.0 mL/kg at hours 24, 48, 72 and 96. The primary endpoint of the trial will be evaluation of patients through day 30 to determine days alive, ventilator-free and dialysis-free. Secondary endpoints will include a composite of: all-cause mortality, decrease in estimated glomerular filtration rate (eGFR), and the incidence of dialysis over a period of 90 days, also known as MAKE-90 (Major Adverse Kidney Events at 90 days). 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 immune system cells, endothelium cells and pancreatic acinar 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 . 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, expected patient enrollment thereof and the expected timing for the release of data from those trials, 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, and its Phase 2 dose-ranging pharmacodynamic study in critical COVID-19 patients; the potential benefits of Auxora for the treatment of AKI, AP and AIPT; the potential of Auxora for the treatment of other acute indications including acute respiratory distress syndrome; the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases; pre-clinical and clinical studies of Auxora supporting the rationale for and design for the KOURAGE trial and the estimated patient population in the United States for AKI. 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 . 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 Company Codes: NASDAQ-NMS:CALC

An essential protein that acts as a gatekeeper for calcium entering cells promotes the growth of oral cancer and generates pain, according to a new study. Targeting this protein -- the ORAI1 calcium channel -- could provide a new approach to treating oral cancer, which causes persistent pain that worsens as it progresses. An essential protein that acts as a gatekeeper for calcium entering cells promotes the growth of oral cancer and generates pain, according to a new study published in Science Signaling led by researchers at NYU College of Dentistry. Targeting this protein -- the ORAI1 calcium channel -- could provide a new approach to treating oral cancer, which causes persistent pain that worsens as it progresses. "Our results show that the ORAI1 channel fuels the growth of oral cancer tumors and produces an abundance of molecules that, once secreted, interact with neurons resulting in an increased sensitivity to pain," said Ga-Yeon Son, a postdoctoral fellow in the Department of Molecular Pathobiology at NYU College of Dentistry and the study's first author. The keepers of the gates of heaven ORAI calcium channels -- named after the three sisters in Greek mythology who guarded the gates of heaven at Mount Olympus -- play an important role controlling how much calcium enters cells. "These calcium channels can be a source of good or bad for cells," said Rodrigo Lacruz, professor of molecular pathobiology at NYU College of Dentistry and the study's senior author. "Calcium entering cells is necessary for many good things, but too much calcium for a long time has the opposite effect." Calcium channels have been linked to various cancers, especially cancer progression, but few studies have looked at the role of ORAI1 in cancer and pain. "Calcium influx through ORAI1 channels has been well known to contribute to the regulation of gene expression by activating gene transcription factors in the cells. Notably, our investigation extends its function in regulating gene expression to altering oral cancer pain," said Son. Less ORAI1, less cancer growth and pain The researchers first analyzed tissue samples from human oral cancer tumors and healthy tongues. They found that the ORAI1 gene, which contains instructions for creating the ORAI1 calcium channel, was heavily overexpressed in the tumors but not in healthy tissue. They then examined human oral cancer cells and found that activating the ORAI1 calcium channel (but not other calcium channels) caused a large influx of calcium into cancer cells. This influx resulted in the increase of a calcium-dependent enzyme called matrix metalloprotease 1 (MMP1) that is secreted outside of cancer cells. MMP1 is abundant in multiple types of cancer, including oral cancer, where its overexpression is associated with metastasis and poor prognosis. Removing the ORAI1 gene from oral cancer cells changed the course of the disease in animal studies. When mice were inoculated with cancer cells lacking the ORAI1 gene, tumors grew more slowly and were less painful. "These findings demonstrate an important role for ORAI1 in oral cancer progression and pain, but what is the mechanism? We wondered if MMP1 could be the messenger relaying pain," said Lacruz. In collaboration with NYU Pain Research Center scientists Rajesh Khanna and Yi Ye, the team looked at the levels of MMP1 expressed in the fluid surrounding oral cancer cells and saw that cells lacking the ORAI1 gene secreted less MMP1 into the surrounding fluid. They combined the fluid with neurons from the trigeminal ganglia, a collection of nerves in the face that transmit pain in oral cancer. The fluid from cancer cells without the ORAI1 gene did not elicit a strong response from the neurons, but the MMP1-rich fluid from cells with ORAI1 evoked an increase in action potentials, the necessary signal for pain transmission. "This gives us evidence that an abundance of MMP1 may generate increased sensitivity to pain," said Lacruz. The researchers also ran experiments with abnormal but non-cancerous cells. When they overexpressed the ORAI1 gene in these non-invasive cells, they became invasive, raising the possibility that ORAI1 could play a role in cells switching from non-cancerous to cancerous cells. Future research: blocking ORAI Several FDA-approved drugs block the ORAI1 calcium channel, but they have not yet been tested in oral cancer. In future studies, the researchers will see whether nanoparticles can be loaded with an ORAI-blocking drug and precisely delivered into the tongues of animal models to stop oral cancer progression and pain. "In light of the ongoing opioid crisis, our study paves the way for validating novel pain treatments in oral cancer," said Rajesh Khanna, director of the NYU Pain Research Center, professor of molecular pathobiology at NYU Dentistry, and a co-author of the study. "Ultimately, our hope is that targeting the ORAI1 channel in oral cancer can prevent or delay the progression from oral epithelial dysplasia to oral cancer tumors and concurrently alleviate the pain burden experienced by oral cancer patients," added Son. Additional study authors include Nguyen Huu Tu, Maria Daniela Santi, Santiago Loya Lopez, and Guilherme H. Souza Bomfim of NYU College of Dentistry; Manikandan Vinu, Ariya Chaloemtoem, Rama Alhariri, and Youssef Idaghdour of NYU Abu Dhabi; and Fang Zhou of NYU Langone Health. The research was supported by the National Institute of Dental and Craniofacial Research (DE027981, DE027679, R01DE029493), National Institutes of Health HEAL Initiative (R01DE032501), National Institute of Neurological Disorders and Stroke (NS098772, NS120663), and National Institute on Drug Abuse (DA042852).

International expansion of CARPO, a Phase 2b clinical trial of Auxora in acute pancreatitis (AP) patients with accompanying systemic inflammatory response syndrome (SIRS), in India Expansion of team with key leadership appointments in regulatory and clinical development Filing of an investigational new drug (IND) application for Auxora in acute kidney injury (AKI) expected by year-end 2023 LA JOLLA, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (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 reported financial results for the second quarter ended June 30, 2023. “Following the completion of our reverse merger in March 2023, CalciMedica has taken critical steps to accelerate clinical activities with our lead compound, Auxora,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. “We undertook the international expansion of our Phase 2b CARPO study in acute pancreatitis with systemic inflammatory response syndrome and enrolled our first patient in India. Also, our collaborators at St. Jude Children’s Research Hospital are expanding our Phase 1/2 CRSPA study in asparaginase-induced pancreatic toxicity to additional sites. Further, we expect to IND application for Auxora in acute kidney injury by year-end.” Dr. Leheny continued, “On the corporate side, we appointed a new Chief Regulatory Officer, Raven Jaeger, M.S., as well as a Senior Vice President of Clinical Development, Andrew Cunningham, M.D., MRCPI. Raven and Andrew have proved to be wonderful additions to our team and are providing leadership in the execution of our clinical and regulatory plans. Finally, due to the diligent work of our entire team, we were able to relist our common stock on the Nasdaq Capital Market in June, and we are pleased to be trading on that exchange.” Clinical and Pre-Clinical Updates and Anticipated Milestones: In April 2023, CalciMedica initiated the international expansion of CARPO, a Phase 2b clinical trial of its lead candidate, Auxora, in AP patients with accompanying SIRS, in India and began enrolling patients there during the third quarter of 2023. CARPO enrollment is expected to be complete by the first quarter of 2024, with topline data available in the first half of 2024. In May 2023, the Independent Data Monitoring Committee for CARPO met to review data from the first 90 patients enrolled in the trial and determined that the trial should continue without modifications. Collaborators at St. Jude Children’s Research Hospital are expanding the Phase 1/2 CRSPA trial of Auxora in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT), which has been a single-center study to date. Patient enrollment from additional sites is expected to begin in the fourth quarter of 2023. CalciMedica expects to IND application for Auxora in AKI by year-end 2023. If allowed, CalciMedica will then be in a position to initiate clinical trials in this indication in the first half of 2024, pending additional funding. In May 2023, preclinical data from studies in animal models of recurrent acute pancreatitis (RAP) and early chronic pancreatitis (CP) conducted at University of Szeged were published in The Journal of Clinical Investigation Insight. The data showed that inhibiting Orai1-mediated store-operated Ca2+ entry with a selective CRAC channel inhibitor prevented the progression of RAP and early CP into established CP, thus supporting the initiation of clinical studies assessing Orai1 inhibition in patients with RAP and early CP. Financial Results for the Three and Six Months Ended June 30, 2023: Cash, Cash Equivalents and Marketable Securities: As of June 30, 2023, CalciMedica had $19.1 million in cash and cash equivalents, which the Company expects to be sufficient to fund operations for at least the next twelve months. Total Operating Expenses: Total operating expenses were $6.6 million for the three months ended June 30, 2023. Total operating expenses were $28.9 million for the six months ended June 30, 2023, which included $16.2 million of one-time charges related to accelerated vesting and severance for employees of Graybug Vision, Inc. at the time of the reverse merger with Graybug. The majority of costs stemming from the reverse merger have been expensed including the payment of accrued transaction expenses in the second quarter. Net Loss: Net loss was $6.3 million, or $1.11 per share (basic and diluted), and $25.6 million, or $7.86 per share (basic and diluted), for the three and six months ended June 30, 2023, respectively. Corporate Updates In May 2023, CalciMedica announced the appointments of Raven Jaeger, M.S. as Chief Regulatory Officer and Andrew Cunningham, M.D., MRCPI as Senior Vice President of Clinical Development. In June 2023, CalciMedica’s common stock was relisted on the Nasdaq Capital Market. CalciMedica trades on the Nasdaq Capital Market under the ticker symbol “CALC”. 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, lung 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 AP with accompanying SIRS, called CARPO, (ii) an investigator-sponsored Phase 1/2 trial called CRSPA being conducted in pediatric patients with AIPT as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase, and (iii) a Phase 2 dose-ranging pharmacodynamic study in critical COVID-19 patients. There are currently no approved therapies to treat either AP or AIPT. 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 kidney injury and acute respiratory distress syndrome. About CARPO CARPO is an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish efficacy in AP with accompanying SIRS. It is expected to enroll 216 patients. AP can be a life-threatening condition where the pancreas becomes inflamed, sometimes leading to pancreatic cell death or necrosis, systemic inflammation, organ failure and death. There are an estimated 275,000 hospitalizations for AP annually in the United States, of which approximately 40% present with SIRS, which can compromise the function of other tissues or organs, especially the lungs. Organ failure is responsible for much of the mortality seen in AP. There is currently no approved therapy for AP. Details of the CARPO trial are available on clinicaltrials.gov (NCT04681066). About CRSPA CRSPA is an investigator-sponsored Phase 1/2 trial being conducted in pediatric acute lymphoblastic leukemia (ALL) patients with AIPT, which is acute pancreatitis toxicity caused by the administration of asparaginase and for which there is no approved therapy. Treatment with asparaginase triggers the development of AIPT in 7-10% of these patients, with approximately half developing pancreatic necrosis and/or pseudocysts. CalciMedica believes that the CRSPA trial has defined an optimal pediatric dose for Auxora in this setting and the trial is currently being expanded to additional sites. Details of the CRSPA trial are available on clinicaltrials.gov (NCT04195347). 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 designed 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. Auxora is in development for AP with SIRS and AIPT. 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 . Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica’s expected cash runway; CalciMedica’s business strategy; the design and potential benefits of Auxora; CalciMedica’s plans and expected timing for developing its product candidates and potential benefits of its product candidates; CalciMedica’s ongoing and planned clinical trials; the development and outcomes of CARPO and CRSPA trial programs, including the milestones, data announcements, expected enrollment and any other potential results related thereto. 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 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 March 31, 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 . 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 Selected Financial Information Condensed Consolidated Balance Sheets (In thousands, except par value and share amounts) June 30, 2023 December 31, 2022 (unaudited) Assets Current assets Cash and cash equivalents $ 19,084 $ 1,476 Prepaid expenses and other current assets 961 254 Total current assets 20,045 1,730 Property and equipment, net 199 147 Right-of-use asset, net — 48 Other assets 1 1,424 Total assets $ 20,245 $ 3,349 Liabilities and Stockholders’ Equity (Deficit) Current liabilities Accounts payable $ 1,743 $ 2,866 Accrued clinical trial costs $ 1,207 $ 1,143 Accrued other 1,074 572 Other current liabilities — 199 Total current liabilities 4,024 4,780 Long-term liabilities Warrant liability — 2,645 Convertible promissory notes — 5,157 Total liabilities 4,024 12,582 Commitments and contingencies (Note 8) Preferred stock — 62,071 Stockholders’ equity (deficit) Common stock 1 3 Additional paid-in capital 153,519 40,400 Accumulated deficit (137,299 ) (111,707 ) Total stockholders’ equity (deficit) 16,221 (71,304 ) Total liabilities and stockholders’ equity $ 20,245 $ 3,349 Selected Financial Information Condensed Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 3,814 $ 2,259 $ 10,305 $ 5,184 General and administrative 2,769 1,330 18,618 2,616 Total operating expenses 6,583 3,589 28,923 7,800 Loss from operations (6,583 ) (3,589 ) (28,923 ) (7,800 ) Other income (expense) Other income (expense), net 279 (29 ) 163 (29 ) Change in fair value of financial instruments — 588 3,168 1,169 Total other income (expense), net 279 559 3,331 1,140 Net loss and comprehensive loss $ (6,304 ) $ (3,030 ) $ (25,592 ) $ (6,660 ) Net loss per share—basic and diluted $ (1.11 ) $ (36.55 ) $ (7.86 ) $ (82.42 ) Weighted-average number of shares outstanding used in computing net loss per share—basic and diluted 5,661,933 82,923 3,255,868 80,812