Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (September 2017)
22 slides from Cormedix's investor presentation, September 2017
Slide 1: Anti-Infective Solutions
Anti-Infective Solutions Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance September 2017 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward- looking statements. T
Slide 3: Mission Statement
Mission Statement To harness our taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases First commercial product candidate: Neutrolin® A novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infectio
Slide 4: Corporate Overview
Corporate Overview Founded January 2006 Exchange: Ticker NYSE American: CRMD Headquarters Bedminster, NJ Employees 15 Shares Outstanding 61.7 Million Warrants Outstanding 23.6 Million Cash (at June 30, 2017) $18.8 Million Debt $0 Recent Share Price $0.43 Recent Market Cap $26.5 million 4
Slide 5: Current Taurolidine-Based Pipeline
Current Taurolidine-Based Pipeline Drug Pipeline: Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Hemodialysis Currently Enrolling Neutrolin® Oncology U.S. ICU / CCU CMDX-001 Pediatric Neuroblastoma* * Orphan Disease Opportunity Medical Device Pipeline: In Vitro In Vivo Prod
Slide 6: Summary and Near-Term Milestones
Summary and Near-Term Milestones • Lead U.S. product candidate Neutrolin® in Phase 3 clinical development • Q4 2017: Interim review • Q2 2018: Complete patient enrollment • 2H 2018: Report top-line data • Unlocking additional value by leveraging taurolidine platform • Q4 2017: in vivo proof-of-conce
Slide 7: Medical Opportunity
Medical Opportunity Despite improvements and initiatives to control infection, biofilm develops very quickly and can lead to life-threatening complications, costing the U.S. healthcare system billions of dollars annually Significant Unmet Need Untreated 24 hours Heparin 7 months Neutrolin® 5 mon. •
Slide 8: Neutrolin®: Non-antibiotic Anti-Infective to Prevent CRBSI
Neutrolin®: Non-antibiotic Anti-Infective to Prevent CRBSI Proprietary formulation: ü Taurolidine (anti-infective, anti-inflammatory) Neutrolin® ü Heparin (anti-coagulant; current standard of care) ü Citrate (pH buffer) Key Benefits: Neutrolin Prevents and reduces bloodstream infection • Bacteria an
Slide 9: Neutrolin®: Non-antibiotic Anti-Infective to Prevent CRBSI
Neutrolin®: Non-antibiotic Anti-Infective to Prevent CRBSI Lack of Microbial Resistance: Spectrum of Coverage: • Adaptation of microorganisms to taurolidine • Gram positive microorganisms: has not yet emerged as a factor in the § Coagulase-negative Staphylococcus pathogenesis of CRBSI species and St
Slide 10: Focused on Execution of Phase 3 U.S. Clinical Strategy
Focused on Execution of Phase 3 U.S. Clinical Strategy Approval Pathway: Designated an investigational new drug by FDA 10.5 years • Granted FDA Fast Track Potential Market • Qualified Infectious Disease Product (QIDP) Exclusivity Phase 3 “LOCK-IT” Program (Catheter LOCK Solution Investigational Tria
Slide 11: LOCK-IT 100: Preventing CRBSI in Dialysis Patients
LOCK-IT 100: Preventing CRBSI in Dialysis Patients Current Study Phase 3, multicenter, double-blind, randomized (1:1), active control (heparin) • Minimum 632 patients on hemodialysis for end stage renal disease (ESRD) Design • Approximately 70 clinical centers in the U.S. Demonstrate the efficacy an
Slide 12: Neutrolin Clinically Validated in Real World Study
Neutrolin Clinically Validated in Real World Study Neutrolin Usage Monitoring Program (NUMP) Neutrolin Significantly Reduces Open-label, post-market observational study Infection and Thrombosis Rate per 1000 catheter days 4.00 • Primary outcome: monitor safety and efficacy of CE Marked 3.50 Neutroli
Slide 13: Catheter Lock Solutions - U.S. Market Potential is Significant
Catheter Lock Solutions - U.S. Market Potential is Significant; Driven by Catheter Days Estimated Vials per Total Neutrolin® Patients Catheter Catheter Day Units Days Hemodialysis 660,000 63mm 0.5 31mm Oncology/TPN 7,740,000 90mm 3 270mm ICU 5,700,000 29mm 5 143mm 444mm Catheter Population and Oppor
Slide 14: Expanding the Taurolidine Franchise
Expanding the Taurolidine Franchise Sutures Protects surgical sites from infection Medical Neuroblastoma Synergy with Vincristine Increased Efficacy Device Topical Lower Toxicity Opportunities Hydrogels Burns and Wounds Drug Diabetic Foot Ulcers Biofilm Prevention Opportunities Meshes Advanced Osteo
Slide 15: Investigational Taurolidine-Based Therapy for Neuroblastoma
Investigational Taurolidine-Based Therapy for Neuroblastoma Incidence Rate (U.S.)* Unmet Rare Disease - occurs in 1/100,000 children Medical (usually under 5 years of age) Need Feasibility • Encouraging IC50 data against neuroblastoma cell lines with nanoparticles of taurolidine Synergy with vincris
Slide 16: Investigational Taurolidine Antibacterial Synthetic Absorbable Sutures
Investigational Taurolidine Antibacterial Synthetic Absorbable Sutures Unmet Incidence Rate (WW)* 300K-500K SSI’s predicted to occur annually Medical Approximately 40 million procedures Each year with antimicrobial sutures Need Antibacterial sutures Feasibility inhibit surgical site • Prototypes dem
Slide 17: Investigational Non–Woven Mesh for Hernia Repair
Investigational Non–Woven Mesh for Hernia Repair Incidence Rate* Unmet Total hernia surgeries per year Medical ~400k failures requiring surgical intervention and repair Need Feasibility No marketed resorbable • Mesh prototypes demonstrate highly effective antimicrobial activity antimicrobial synthet
Slide 18: Investigational Hydrogels for Burns, Diabetic Foot Ulcers, and Wounds
Investigational Hydrogels for Burns, Diabetic Foot Ulcers, and Wounds Incidence Rate (WW) Unmet Wounds (surgical, traumatic, chronic), Medical lacerations, and diabetic foot ulcers (lifetime incidence up to 25% of diabetes population**) Need Feasibility No Current antimicrobial • Hydrogel prototypes
Slide 19: Planned Milestones for Medical Device Pipeline
Planned Milestones for Medical Device Pipeline 4Q 2017: • Complete Proof-of-Concept animal modeling for antimicrobial sutures, nonwoven meshes, and topical hydrogels Development Strategy: • Continue to advance medical device programs through animal proof-of-concept • Prepare data for potential 510(k
Slide 20: Projected markets for medical devices
Projected markets for medical devices Market Size – Forecasted, 2018 Product Category Indications U.S. Europe Worldwide Sutures $1.7B $550M $3.9B All Burns/DFU/ Hydrogels $1.02B $220M $1.9B Osteoarthritis Hernia repair/Burns/ Mesh $1.0B $250M $2.0B Wounds/Reconstructive Surgery 1. Sutures: Reference
Slide 21: Summary and Near-Term Milestones
Summary and Near-Term Milestones • Lead U.S. product candidate Neutrolin® in Phase 3 clinical development • Q4 2017: Interim review • Q2 2018: Complete patient enrollment • 2H 2018: Report top-line data • Additional pivotal and post-market studies to expand Neutrolin use • Unlocking additional value
Slide 22: Thank You
1430 Route 206 NYSE American: CRMD Suite 200 Bedminster, NJ 07921 Thank @CorMedixInc 908.517.9500 You Investor & Media Contacts Tiberend Strategic Advisors, Inc. Josh Drumm, Ph.D. [email protected]; 212-375-2664 Janine McCargo [email protected]; 646-604-5150 22