Calcimedica, Inc. · NASDAQ:CALC
Calcimedica — Investor Presentation (June 2023)
29 slides from Calcimedica's investor presentation, Jun 15, 2023
Slide 1: Developing First-in-Class Therapies for Acute Inflammatory Diseases with High Unmet Need
Exhibit 99.1 CalciMedica Developing First-in-Class Therapies for Acute Inflammatory Diseases with High Unmet Need June 2023
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: CalciMedica is Building a Leading Company Dedicated to Treating Life-threatening Diseases
CalciMedica is Building a Leading Company Dedicated to Treating Life- threatening Proprietary technology targeting CRAC channel inhibition to develop Differentiated first-in-class therapies for life-threatening inflammatory diseases with high Technology unmet need Compelling Auxora has been studied
Slide 4: Differentiated Pipeline Addressing Significant Unmet Patient Needs
Differentiated Pipeline Addressing Significant Unmet Patient Needs 4 Confidential
Slide 5: Market Opportunity for Auxora Across Acute Inflammatory Diseases
Market Opportunity for Auxora Across Acute Inflammatory Diseases AP with SIRS AIPT AKI Stages 2 & 3 1.1M 100K 300 Patients Patients Patients • No approved therapies • No approved therapies • No approved therapies • SOC primarily supportive care • Ultra-orphan pediatric indication • SOC primarily sup
Slide 6: Auxora's MOA Addresses Multiple Acute Inflammatory Diseases
Auxora’s MOA Addresses Multiple Acute Inflammatory Diseases
Slide 7: Overactivation of CRAC Channels: Immune System Activation and Tissue Cell Injury
Overactivation of CRAC Channels: Immune System Activation and Tissue Cell Injury 7 Confidential
Slide 8: Proprietary IV Formulation Provides Rapid Onset of Action Without Long-Term Risk of Immune-Suppression
Final Concontration of Zegocractin in Blood Assay (nM) Proprietary IV Formulation Provides Rapid Onset of Action Without Long- Term Risk of Immune-Suppression Auxora IV Formulation: Ideal Characteristics for Acute Care Setting Relationship of Pharmacodynamic Readout with Assay Concentration of Zegoc
Slide 9: Auxora Has Demonstrated Biological Activity and Favorable Safety Profile in Phase 2 Trials
Auxora Has Demonstrated Biological Activity and Favorable Safety Profile in Two Ongoing and Four Completed Phase 2 Trials Population Trial Size Results Pancreas Asparaginase-Associated N=9 • Trial ongoing, preliminary results show rapid resolution of pain and food tolerance Pancreatitis N=216 • Tria
Slide 10: Auxora for Acute Pancreatitis
Auxora for Acute Pancreatitis
Slide 11: Significant Unmet Need in Treatment of Acute Pancreatitis
Significant Unmet Need in Treatment of Acute Pancreatitis U.S. Hospitalizations per Year From Acute Pancreatitis: ~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 constr
Slide 12: Potential to Offer Significant Clinical Benefits to Patients with Predicted Severe AP
Potential to Offer Significant Clinical Benefits to Patients with Predicted Severe AP 1. Fluid resuscitation Current standard of care is 2. Enteral nutrition for food tolerance 3. Antibiotics for infection limited to supportive therapy 4. Minimally invasive therapy for local complications Patient Jo
Slide 13: Acute Pancreatitis Phase 2a Clinical Trial
Acute Pancreatitis Phase 2a Clinical Trial Safety, tolerability, and efficacy trial for various doses of Auxora compared to standard of care 13 Confidential
Slide 14: 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 100 SOC patients (n=7) 6.0 days 93% 90 Auxora-treated patients (n=14) 3.7 days 80 70 O
Slide 15: CARPO Phase 2b Clinical Trial in Acute Pancreatitis Ongoing with Data Expected 1H 2024
CARPO Phase 2b Clinical Trial in Acute Pancreatitis Ongoing with Data Expected 1H 2024 15 Confidential
Slide 16: Potential to Offer Significant Clinical Benefits to Children with Asparaginase-Induced Pancreatic Toxicity
Potential to Offer Significant Clinical Benefits to Children with Asparaginase- Induced Pancreatic Toxicity 3,000+ 7-10% 50%+ children with acute of ALL patients develop of patients with AIPT lymphoblastic leukemia asparaginase-induced develop pseudocyst or (ALL) treated with pancreatic toxicity (AI
Slide 17: Proof-of-Concept Ongoing in AIPT
Proof-of-Concept Ongoing in AIPT Pediatric Patients Receiving Auxora Had Rapid Resolution of Pain and Food Tolerance • CRSPA Phase 1/2 Trial in Pediatric Asparaginase-Induced Pancreatic Toxicity (AIPT) – Investigator-initiated, open-label trial being conducted at St. Jude Children’s Research Hospita
Slide 18: Auxora for Acute Kidney Injury
Auxora for Acute Kidney Injury
Slide 19: Early Treatment with Auxora Could Offer Significant Benefits to AKI Patients
Early Treatment with Auxora Could Offer Significant Benefits to AKI Patients and Prevent Disease Progression 1. Fluid Resuscitation / Diuretics Current standard of care is 2. Nutrition limited to supportive therapy 3. Correction of underlying cause Disease Progression without Early Intervention Post
Slide 20: Improved GFR and Decreased Inflammatory Cell Infiltrates Within 24 Hours in AKI Model
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 7
Slide 21: Phase 2 CARDEA Trial Showed 40% Reduction in Reported Acute Kidney Injury in COVID Pneumonia Patients
Phase 2 CARDEA Trial Showed 40% Reduction in Reported Acute Kidney Injury in COVID Pneumonia Patients Ang-2/Tie2 results in endothelial inflammation Ang-1/Tie2 signaling maintains vascular integrity with resulting endothelial cell activation and increased endothelial permeability Angiopoietin-1 Leve
Slide 22: Auxora for Acute Respiratory Distress Syndrome
Auxora for Acute Respiratory Distress Syndrome
Slide 23: Clinical Evidence in COVID-19 Pneumonia and Ventilated Patients Demonstrate Promising Data in Respiratory Failure
Clinical Evidence in Phase 2 COVID-19 Pneumonia and Ventilated Patients Demonstrate Promising Data in Respiratory Failure CARDEA Phase 2 Trial Complete • 56% reduction in mortality at Day 30 (p=0.023) Severe and Critical COVID-19 • 33% reduction ventilation (p=0.18) Pneumonia Patients • Three-day sh
Slide 24: CARDEA Phase 2 Trial Auxora in Severe COVID-19 Pneumonia
CARDEA Phase 2 Trial Auxora in Severe COVID-19 Pneumonia 24 Confidential
Slide 25: CARDEA Phase 2 Positive Results on Key Endpoints
CARDEA Phase 2 Positive Results on Key Endpoints Reduction in Mortality and Ventilator Use in COVID-19 Pneumonia Patients 25 Confidential
Slide 26: Platform Applications for CRAC Channel Inhibition
Platform Applications for CRAC Channel Inhibition
Slide 27: Preclinical Results Supporting Other Indications
Preclinical Results Supporting Other 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) (Submitted for publication) In vivo efficacy of zegocractin in a
Slide 28: Anticipated Milestones
CalciMedica Anticipated Milestones
Slide 29: Existing Cash Provides Runway through 2H24 With Key Clinical Readouts by 1H24
Existing Cash Provides Runway through 2H24 With Key Clinical Readouts by 1H24 Acute P Phas hase e 2b D 2b Dat ata E a Ex xpec pectted ed iin 2H n 1H23 24 Acute Pancreatitis Pancreatitis P Phas hase 3 e 2/3 I Initni iat tiat ion E ion x in X pecX ted i XXn 2024 Asparaginase- Initial First Cohort Data