Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (December 2017)
24 slides from Cormedix's investor presentation, December 2017
Slide 1: Anti-Infective Solutions
Anti-Infective Solutions Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance December 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 Berkeley Heights, NJ Employees 15 Common Stock O/S 62.0 Million Pref/CS Equivalents 6.0 Million Warrants Outstanding 23.2 Million Cash (at June 30, 2017) $18.8 Million Debt $0 Recent Share Price $0.60 Recent Ma
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: CorMedix Strategy – Build on 3 Core Drivers
CorMedix Strategy – Build on 3 Core Drivers Create value for shareholders and employees Foundation Partnerships Leverage • Ensure favorable financing • Bring closure to the • Leverage taurolidine • Quickly complete the Europe legal cases technology via the registration studies for • Neutrolin: For t
Slide 7: 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 - Efficacy • Q2 2018: Complete patient enrollment • 2H 2018: Report top-line data • Unlocking additional value by leveraging taurolidine platform • Q4 2017: in vivo pr
Slide 8: 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 9: 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 10: 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 11: 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 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: Strategy for Ex-U.S. Commercialization of Neutrolin®
Strategy for Ex-U.S. Commercialization of Neutrolin® • Partnership model – Country or Regional • Territories that recognize CE Mark • Ideal commercial partners • Proven capabilities and infrastructure • Established presence with Neutrolin customer base • Germany • United Arab Emirates • France • Qat
Slide 15: 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 16: Anti-tumor Properties Reported in Literature
Anti-tumor Properties Reported in Literature • Broadly active against many diverse tumor types • Enhances oxidative stress (ROS) selectively in tumor cells • Can be attenuated with glutathione; taurolidine may interfere with glutathione-s-transferase 1 • Induces apoptosis, necroptosis and autophagy;
Slide 17: Investigational Taurolidine-Based Therapy for Neuroblastoma
Investigational Taurolidine-Based Therapy for Neuroblastoma New cases per year (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 vinc
Slide 18: 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 19: 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 20: 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 21: 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 Next Steps - Timelines • H1, 2018 – Prepare data for potential 510(k) and CE Mark • H2, 2018 – Submission(s) beginning in 2018 for 510
Slide 22: 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 23: 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 - Efficacy • Q2 2018: Complete patient enrollment • 2H 2018: Report top-line data • Unlocking additional value by leveraging taurolidine platform • Q4 2017: in vivo pr
Slide 24: Thank You
400 Connell Drive, 5th Floor NYSE American: CRMD Suite 5000 Berkeley Heights, NJ 07922 Thank @CorMedixInc 908.517.9500 You Investor & Media Contacts Tiberend Strategic Advisors, Inc. Josh Drumm, Ph.D. jdrumm@tiberend.com; 212-375-2664 Janine McCargo jmccargo@tiberend.com; 646-604-5150 30