Calcimedica, Inc. · NASDAQ:CALC
Calcimedica — Investor Presentation (February 2024)
31 slides from Calcimedica's investor presentation, Feb 13, 2024
Slide 1: Developing Novel Therapies for Acute Inflammatory and Immunologic Diseases
Exhibit 99.1 Developing Novel Therapies for Acute Inflammatory and Immunologic Diseases February 2024 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica’s business strategy and clinical development plans; the design and potential benefits of CalciMedica’s product candidates; CalciMedica’s ongoing an
Slide 3: Investment Highlights
Investment Highlights Notes: CRAC: Calcium release-activated calcium; AP: Acute Pancreatitis; AKI: Acute Kidney Injury 3
Slide 4: Differentiated Pipeline in Acute and Chronic Inflammatory and Immunologic Diseases
Differentiated Pipeline in Acute and Chronic Inflammatory and Immunologic Diseases Phase of Development 1 Program Indication Anticipated Milestones Preclinical Phase 1 Phase 2 Phase 3 Acute Disease (IV) CARPO Phase 2b trial ongoing; Auxora Acute Pancreatitis Data expected in 1H24 Asparaginase-Induce
Slide 5: Overactivation of CRAC Channels: Immune System Activation and Tissue Cell Injury
Overactivation of CRAC Channels: Immune System Activation and Tissue Cell Injury 5
Slide 6: Acute Inflammation: Underlying Cause Across Many Diseases
Acute Inflammation: Underlying Cause Across Many Diseases Acute Pancreatitis ARDS Acute Kidney Injury Old Paradigm Future Paradigm Treatable Trait A Treatable Trait B Auxora has demonstrated positive clinical results in all 3 of these large, underserved patient populations 1) Sources: Reddy, Kiran,
Slide 7: IV Formulation Provides Ideal Benefits for Acute Inflammation
Final Concontration of Zegocractin in Blood Assay (nM) IV Formulation Provides Ideal Benefits for Acute Inflammation Rapid onset of immunomodulatory action reaches peak by the end of 4-hour infusion Relationship of Pharmacodynamic Readout with 1 Assay Concentration of Zegocractin in Human (Mean ± SE
Slide 8: Demonstrated Biological Activity and was well tolerated in Multiple Phase 2 Trials
Demonstrated Biological Activity and was well tolerated in Multiple Phase 2 Trials Population Results Pancreas Asparaginase- Inducted • Trial ongoing, preliminary results show rapid resolution of pain and food Pancreatic Toxicity tolerance Acute Pancreatitis • Trial ongoing With SIRS 1 Acute Pancrea
Slide 9: Large U.S. Market Opportunity in Acute Inflammatory Diseases
Large U.S. Market Opportunity in Acute Inflammatory Diseases 1 AP with SIRS AKI Stages 2 & 3 AIPT 100K 1.1M 300 Patients Patients Patients • No approved therapies • No approved therapies • No approved therapies 2 • SOC primarily supportive care • SOC primarily supportive care • Ultra-orphan pediatri
Slide 10: Auxora for Acute Pancreatitis (AP)
Auxora for Acute Pancreatitis (AP) 10
Slide 11: AP Population: Significant Unmet Need
AP Population: Significant Unmet Need U.S. Hospitalizations per Year from AP: ~275,000 ~40% of patients have SIRS at presentation High risk for moderate to severe disease Patients with SIRS+: ~110,000 Small percentage of patients missed Misdiagnosis, timing constraint, or other Target Patients: ~100
Slide 12: Patient Journey in Severe AP
Patient Journey in Severe AP Disease Progression 48-72 hours 2 Weeks 4 Weeks 6 Weeks Transient organ failure and moderately severe AP 100K US Mortality <5% Patients with SIRS (Predicted Severe 70% Sterile necrosis; Mortality 10% Walled-off Persistent organ failure and severe AP Pancreatitis) pancrea
Slide 13: Potential Clinical Benefits to Patients with Predicted Severe AP
Potential Clinical Benefits to Patients with Predicted Severe AP • Fluid resuscitation Current standard of care is • Enteral nutrition for food tolerance limited to supportive • Antibiotics for infection therapy • Minimally invasive therapy for local complications • Reduction in organ failure Auxora
Slide 14: AP Phase 2a Clinical Trial
AP Phase 2a Clinical Trial Safety, tolerability, and efficacy trial for various doses of Auxora compared to standard of care 14
Slide 15: Positive Phase 2a Results on Potential Pivotal Trial Primary Endpoints
Positive Phase 2a Results on Potential Pivotal Trial Primary Endpoints Rapid Increase in Patients Tolerating Solid Diet >2 Fewer Days Spent in Hospital Potential Pivotal Trial Primary Endpoint Median Hospital Stay SOC patients (n=7) 6.0 days 100 93% Auxora-treated patients (n=14) 3.7 days 90 80 1 On
Slide 16: CARPO Phase 2b Clinical Trial in AP Ongoing with Data Expected 1H 2024
CARPO Phase 2b Clinical Trial in AP Ongoing with Data Expected 1H 2024 Primary End Point Secondary Endpoints Responder analysis planned to validate food tolerance endpoint with FDA 16
Slide 17: Potential Clinical Benefits to Children with AIPT
Potential Clinical Benefits to Children with AIPT 7-10% 50%+ 3,000+ 1 of ALL patients of patients with AIPT children with ALL treated with develop AIPT as a develop pseudocyst result of or pancreatic chemotherapeutic asparaginase necrosis, which can asparaginase in U.S. treatment be life-threatening
Slide 18: Proof-of-Concept Ongoing in AIPT Pediatric Patients
Proof-of-Concept Ongoing in AIPT Pediatric Patients Had Rapid Resolution of Pain and Food Intolerance CRSPA Phase 1/2 Trial in Pediatric AIPT • Investigator-initiated open-label trial being conducted at St. Jude Children’s Research Hospital • Assess the safety in pediatric patients with ALL who have
Slide 19: CRSPA First Cohort Data: Presented at ASH 2023
CRSPA First Cohort Data: Presented at ASH 2023 Total 16 (T16): All AIPT Matched T16 AIPT cohort CRSPA evaluable for efficacy Patients with AIPT 51 16 8 Age: mean (range) 10.3 (2.2-19.4) 9 (2.2-18.4) 8.2 (3.1-17.6) Female (%) 17 (33.3%) 5 (31.3%) 3 (37.5%) Low-risk therapy (%) 9 (17.6%) 1 (6.3%) 2 (2
Slide 20: Auxora for Acute Kidney Injury (AKI)
Auxora for Acute Kidney Injury (AKI) 20
Slide 21: Patient Journey in AKI
Patient Journey in AKI Disease Progression without Early Intervention Post Injury 7 Days 90 Days Acute Chronic End-stage AKI Kidney Disease Kidney Disease Renal Disease ~3.7M AKI hospitalizations annually (U.S.) 71% 17% 12% Stage 2 Stage 1 Stage 3 2 ↑ sCr 2x ↑ sCr 1.5x↑ sCr 3x 1 Auxora Target Market
Slide 22: Potential Clinical Benefits to Patients with AKI
Potential Clinical Benefits to Patients with AKI Current standard of care is • Fluid resuscitation / Diuretics • Nutrition limited to supportive • Correction of underlying cause therapy • Reduced need for dialysis Auxora benefits are • Reduced risk of mortality expected to drive adoption • Greater r
Slide 23: Improved GFR and Decreased Inflammatory Cell Infiltrates Within 24 Hours in AKI Model
1 Improved GFR and Decreased Inflammatory Cell Infiltrates Within 24 Hours in AKI Model A single dose of Auxora or placebo was administered 30 min after bilateral kidney ischemia/reperfusion Mononuclear Cells in Kidney of GFR in Rats After Rats after Ischemia/Reperfusion Kidney Ischemia/Reperfusion
Slide 24: Phase 2 CARDEA Trial: Evidence of Renal Protection
Phase 2 CARDEA Trial: Evidence of Renal Protection Ang-2/Tie2 results in endothelial inflammation with Ang-1/Tie2 signaling maintains vascular integrity increased endothelial permeability Angiopoietin-2 Levels Angiopoietin-1 Levels Decrease Significantly with Auxora Increase Significantly with Auxor
Slide 25: KOURAGE: Acute Kidney Injury with associated AHRF Phase 2 Trial Design
KOURAGE: Acute Kidney Injury with associated AHRF Phase 2 Trial Design 25
Slide 26: Auxora for Acute Respiratory Distress Syndrome (ARDS)
Auxora for Acute Respiratory Distress Syndrome (ARDS) 26
Slide 27: Promising Phase 2 Data from Trials in COVID-19 Pneumonia and Ventilated Patients
Promising Phase 2 Data from Trials in COVID-19 Pneumonia and in Ventilated Patients with Respiratory Failure CARDEA Phase 2 Trial Complete • 56% reduction in mortality at Day 30 (p=0.0165) Severe and Critical COVID-19 • 33% reduction ventilation (p=0.18) Pneumonia Patients • Three-day shorter hospit
Slide 28: Platform Application for CRAC Channel Inhibition
Platform Application for CRAC Channel Inhibition 28
Slide 29: Preclinical Results Supporting Other I&I Indications
Preclinical Results Supporting Other I&I Indications Intended Indication Preclinical Observations Next Steps Formulation In vivo efficacy in a mouse model of CP Chronic Oral using CM5480 Confirm with lead oral candidate Pancreatitis (CP) (Szabo et al, 2023) In vivo efficacy of zegocractin in a Acute
Slide 30: Anticipated Milestones
Anticipated Milestones 30
Slide 31: Anticipated Milestones
Anticipated Milestones CARPO Phase 2b Data Expected in 1H24 AP Phase 3 Initiation Expected in 2025 CRSPA Initial First Cohort Data Released at ASH 2023 AIPT Trial Expansion Underway; Completion Expected 2H24 KOURAGE First Patient Enrolled Expected in 1H24 AKI Data Expected in 2025 Phase 2 Data in Ve