Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (March 2019)
26 slides from Cormedix's investor presentation, March 2019
Slide 1: Harnessing Taurolidine Technology
HarnessingTaurolidine Technology Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance March 2019 CORMEDIX
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. Th
Slide 3: Financial Summary
FINANCIAL SUMMARY Founded January 2006 Exchange: Ticker NYSE American: CRMD Headquarters Berkeley Heights, NJ Employees (U.S.) 21 Common Stock O/S 105.3 Million Pref/CS Equivalents 18.3 Million Warrants Outstanding 16.6 Million $6.4 Million ($13.9 Million pro Cash at September 30, 2018 forma with de
Slide 4: 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 5: Corporate Highlights
CORPORATE HIGHLIGHTS NEUTROLIN SIGNIFICANT MARKET OPPORTUNITY Non-antibiotic antimicrobial solution designed to prevent costly and Current estimates of annual need for catheter lock solutions in the dangerous bloodstream infections associated with the use of U.S. for hemodialysis alone are 30 to 40
Slide 6: CorMedix Management Team
CORMEDIX MANAGEMENT TEAM Khoso Baluch CEO Robert Cook CFO Paul Chew, MD Chief Medical Officer Jack Armstrong EVP Technical Operations Elizabeth Masson EVP & Head Of Clinical Operations Antony Pfaffle, MD Chief Scientific Officer John Ortiz VP Regulatory Affairs & Quality Assurance CORMEDIX 6
Slide 7: Current CorMedix Pipeline
CURRENT CORMEDIX PIPELINE DRUG PIPELINE Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Hemodialysis Stopped for Efficacy at Interim Review: FDA Discussions Ongoing Neutrolin® U.S. Oncology ICU / CCU CMDX-001 Pediatric Neuroblastoma* * Orphan Disease Opportunity MEDICAL DEVI
Slide 8: Summary and Near-Term Milestones
SUMMARY AND NEAR-TERM MILESTONES Q2 2018 Q3 2018 Q4 2018 Q1 2019 Neutrolin® U.S. Phase 3 Trial Stopped for Efficacy at Interim Review: FDA Discussions Ongoing Completed in vivo proof-of- Taurolidine concept data for various medical device applications Platform Medical Device & Neuroblastoma - U.S./E
Slide 9: Hemodialysis Is Life-Saving
HEMODIALYSIS IS LIFE-SAVING CRBSI is Life-Threatening CORMEDIX 9
Slide 10: Neutrolin: Key Benefits
KEY BENEFITS OF NEUTROLIN® NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI Prevents and reduces bloodstream infection. Bacteria and fungi, Antibiotic- NEUTROLIN® resistant strains, No reported resistance in Proprietary Formulation a clinical setting Taurolidine – 1.35% (anti-infective, ant
Slide 11: LOCK-IT-100 Preventing CRBSI in Dialysis Patients
LOCK-IT 100 PREVENTING CRBSI IN DIALYSIS PATIENTS DESIGN OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINTS Phase 3, multicenter, double- Demonstrate the efficacy and Time to occurrence of CRBSI Catheter patency blind, randomized (1:1), active safety of Neutrolin® as a control (heparin) catheter lock so
Slide 12: Topline Results of LOCK-IT-100 Study
TOPLINE RESULTS OF LOCK-IT 100 STUDY Interim Analysis Full Study Total CRBSIs 28 41 Total Subjects 653 795 Neutrolin Reduced CRBSIs by: 72% 71% Neutrolin (control) Event Rates* 0.136 (0.491) 0.133 (0.465) p-value 0.0034 0.0006 0.6 0.6 0.5 -72% 0.5 -71% 0.4 0.4 0.3 0.3 c c 0.2 0.2 0.1 0.1 0 0 Neutrol
Slide 13: Secondary Endpoints: No Significant Differences
SECONDARY ENDPOINTS: NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN NEUTROLIN & CONTROL ARMS Catheter Removal: p=0.42 v Neutrolin Control Arm Event Rate* 3.48 3.23 Subjects 236 out of 397 224 out of 398 Loss of Catheter Patency: p=0.10 v Neutrolin Control Arm Event Rate* 1.01 0.74 Subjects 64 out
Slide 14: Europe: Neutrolin Clinically Validated in Real World Study
Europe: NEUTROLIN CLINICALLY VALIDATED IN REAL WORLD STUDY Neutrolin Usage Monitoring Program (NUMP) Neutrolin Significantly Reduced Open-label, post-market observational study Infection and Thrombosis RATE PER 1000 CATHETER DAYS PRIMARY GOAL Benchmark Data Neutrolin Monitor safety and efficacy of C
Slide 15: 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 250,000 catheter-related bloodstream infections 01 (CRB
Slide 16: What Are Biofilms and Why Do They Cause Chronic Inflammation?
WHAT ARE BIOFILMS AND WHY DO THEY CAUSE CHRONIC INFLAMMATION AND TISSUE DAMAGE? A B C D A. Planktonic bacteria can be cleared by antibodies, phagocytosis, and are susceptible to antibiotics. B. Adherent bacterial cells form biofilms preferentially on inert surfaces or devitalized tissue, and these s
Slide 17: Biofilms Are Highly Tolerant to Antibiotics
BIOFILMS ARE HIGHLY TOLERANT TO ANTIBIOTICS Tobramycin vs. planktonic or biofilm Pseudomonas control biofilm dead Tobramycin rapidly kills planktonic Pseudomonas aeruginosa (●) very effectively, but is not effective against biofilm (●) planktonic Walters et al, Contributions of antibiotic penetratio
Slide 18: Neutrolin: Non-antibiotic Anti-infective
NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI NO MICROBIAL RESISTANCE SHOWN BROAD SPECTRUM OF COVERAGE Adaptation of microorganisms to taurolidine has Gram Positive Microorganisms not yet emerged as a factor in the pathogenesis Coagulase-negative Staphylococcus species and of CRBSI Staph
Slide 19: A New Superbug
A NEW SUPERBUG Hard to Detect But Easy to Cause Bloodstream Infections Source: CDC,https://www.cdc.gov/fungal/candida-auris/c-auris-drug-resistant.html CORMEDIX 19
Slide 20: CDC Risk Factor Analysis for C. auris
CDC RISK FACTOR ANALYSIS FOR C. AURIS Bloodstream, wound and ear infections CDC RISK FACTOR Broad-spectrum Recent surgery Diabetes ANALYSIS: antibiotic use Endotracheal tubes, Antifungal Recent Nursing Home feeding tubes, Central No Age Preferences use stay Catheters Infections by C. auris CORMEDIX
Slide 21: Cumulative Cases of C. auris in the US 2017-2018
CUMULATIVE CASES OF C. AURIS IN THE US 2017-2018 September 2017 November 2018 For 2017 (https://www.cdc.gov/fungal/candida-auris/c-auris-drug-resistant.html) For 2018 (https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html) CORMEDIX 21
Slide 22: CDC Guidelines Upgraded in 2011 to Recommend Antimicrobial Locks
CDC GUIDELINES UPGRADED IN 2011 TO RECOMMEND USE OF ANTIMICROBIAL LOCKS Although antimicrobial locks are associated with a significant reduction in CRBSI, their use was limited because of: CDC Recommendation Use prophylactic antimicrobial lock • Potential for side effects solution in patients with l
Slide 23: FDA Recognizes Potential of Neutrolin
FDA RECOGNIZES POTENTIAL OF NEUTROLIN APPROVAL PATHWAY Designated an investigational new drug by FDA (Catheter LOCK Solution Investigational Trial) 10.5 YEARS Granted New Chemical Entity (NCE) Status 5 years exclusivity Potential Market Exclusivity Granted Qualified Infectious Disease Product (QIDP)
Slide 24: FDA Meeting on LOCK-IT-100
FDA MEETING ON LOCK-IT-100 • Agreed CRMD can request LPAD Pathway • FDA reviewed preliminary analyses of database up to Interim Analysis (654 subjects) • FDA requested analyses of full dataset (795 subjects) whose topline results disclosed Jan 30th, 2019 • Detailed analyses of full dataset to be com
Slide 25: LOCK-IT-100 Current Status
LOCK-IT 100 CURRENT STATUS Successful Interim Analysis for Convincing Efficacy in July 2018 DSMB Recommended Study Stop Unblinded Data: Impressive Treatment Effect that was Highly Statistically Significant Cleared to Request Approval under LPAD Pathway Discussions Commenced with FDA for NDA Submissi
Slide 26: Thank You
NYSE American: CRMD @CorMedixInc @Investor & Media Contacts THANK LifeSci Advisors, LLC Dan Ferry [email protected] YOU 617-535-7746 400 Connell Drive Suite 5000 Berkeley Heights, NJ 908.517.9500 CORMEDIX