Anti- Infective Solutions. Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance

Transcription

1 Anti- Infective Solutions Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance

2 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 forwardlooking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. The forward looking statements in this presentation include statements about our business, including commercialization plans and potential markets for our products and product candidates, clinical trials, potential indications for our product candidates, development timelines, regulatory timelines and future events that have not yet occurred. Pharmaceutical and medical device development inherently involves significant risks and uncertainties, including the risks outlined in Risk Factors in our Annual Report on Form 10-K filed with the Securities and Exchange Commission and in Risk Factors in our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Our actual results may differ materially from our expectations due to these risks and uncertainties, including, but not limited to, our dependence on the success of our lead product candidate Neutrolin, and factors relating to commercialization and regulatory approval thereof; unpredictability of the size of the markets for, and market acceptance of Neutrolin; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin in the U.S.; our need for and ability to raise sufficient capital; our ability to identify and enter into strategic transactions; intellectual property protection; retaining our stock s listing on the NYSE MKT; research and development activities; competition; industry environment, and other matters. Any forward-looking statements included in this presentation are based on information available to us on the date of this presentation. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. 2

3 CorMedix: Protecting Chronic Care Patients From Infection Large and growing unmet medical need increasing number of catheterization in patients in hemodialysis, oncology, and intensive care units coupled with a growing anti-microbial resistance. Neutrolin is an anti-microbial solution, lead product candidate in Phase 3 clinical development (U.S.) for central venous catheter infection reduction. CE Mark already granted in Europe and other territories. Neutrolin Granted FDA Fast Track and Qualified Infectious Disease Product (QIDP) designation to allow for expedited approval process. 3

4 Neutrolin : Non- antibiotic Anti- Infective to Prevent CRBSI Neutrolin Proprietary formulation: ü Taurolidine (anti-infective, anti-inflammatory) ü Heparin (anti-coagulant; current standard of care) ü Citrate (buffer) Reduces Risk of Bloodstream Infection Prevents Microbial Colonization and Biofilm Formation Inside Catheter Neutrolin Untreated Blood Vessel Mechanism of Action: Prevent crosslinking of peptides at the bacterial and fungal cell walls as well as adhesion to the lumen of the catheter and blood vessel luminal wall Taurolidine can neutralize endotoxins, exotoxins and lipopolysaccharides released by bacteria Source: Caruso F, Darnowski JW, Opazo C, Goldberg A, Kishore N, et al. (2010) Ta u ro lid in e Antiadhesive Properties on Interaction with E. co li; Its Transformation in Biological Environment and Interaction with Bacteria Cell Wall. PLoSONE 5(1): e8927. doi: /journal.pone Catheter-Related Blood Stream Infections (CRBSI) 4

5 Neutrolin : Non- antibiotic Anti- Infective to Prevent CRBSI Lack of Microbial Resistance: Adaptation of microorganisms to taurolidine has not yet emerged as a factor in the pathogenesis of CRBSI Bacterial resistance has not been reported, as taurolidine s mode of action resembles a anti-infectant rather than an antibiotic Spectrum of Coverage: Gram positive microorganisms: Coagulase-negative Staphylococcus species and Staphylococcus aureus Gram negative microorganisms: Klebsiella pneumoniae, Escherichia coli and pseudomonas aeruginosa Clinically relevant fungi: Candida albicans and aspergillus fumigatus 5

6 More ESRD Patients = Greater CRBSI Risk Increased Burden to Healthcare System ESRD Patients 800, , , , , , ,000 ESRD Prevalence (U.S.) 1 4.6% CAGR Catheter-Related Blood Stream Infections (CRBSI) ~ 55k CRBSI related to ESRD per year ~ 20% of ESRD patients remain on catheters >1st yr ~ 62 million catheter hemodialysis days per yr ~ 1-2 hospital admissions for ESRD patients per year due to infections/catheter related issues 100, USRDS Annual Data Report Volume 2 - ESRD in th e Un ited Sta tes; Source: Company 10- K ESRD: End stage renal disease 6

7 Focused on Execution of U.S. Clinical Strategy Approval Pathway: Designated an investigational new drug by FDA Granted FDA Fast Track Qualified Infectious Disease Product (QIDP) 10.5 years Potential Market Exclusivity Phase 3 LOCK-IT Program (Catheter LOCK Solution Investigational Trial) Ongoing: LOCK-IT 100: Currently enrolling hemodialysis patients Expected Milestones: Year-end 2017: Complete patient enrollment H2 2018: Report top-line data Planned: LOCK-IT 200: Oncology patients with central venous catheters Planned Post-market Phase 4 studies: ICU/CCU patients 7

8 LOCK- IT 100: Preventing CRBSI in Dialysis Patients Study Design Phase 3, multicenter, double-blind, randomized (1:1), active control (heparin) 632 hemodialysis patients on a catheter for end stage renal disease Currently enrolling Primary Endpoint Time to occurrence of CRBSI in patients using Neutrolin vs. heparin as a catheter lock solution Key Secondary Endpoints Catheter patency Catheter removal 8

9 Neutrolin Clinically Validated in Real World Study Neutrolin Usage Monitoring Program (NUMP) Open Label Study Post-market observational study conducted in Germany Complication (per 1000 catheter days) Historical Benchmark Neutrolin % Reduction Infection % Thrombosis 2.5 2, % n=202 patients, representing 36,083 hemodialysis catheter days Positive results consistent with prior clinical studies Data accumulated from NUMP registry add support to planned U.S. NDA filing Sources: CDC Guidelines for the Prevention of Intravascular Catheter Related Infections; O`Grady et al., 2011; Morris P, Knechtle SJ. Kidney Transplantation - Principles and Practice. Saunders, Print.; Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter- related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis.. 9

10 Multiple Factors Expected to Drive Neutrolin Adoption Increasing Focus on CRBSI Prevention Hospital- Acquired Infections Not Reimbursed Increased Antibiotic Resistance 1/5 of ESRD patients that acquire an infection die Publishing Infection Rates by Hospital and Dialysis Clinic The Joint Commission emphasizing the importance of reducing central line infections CMS ceased payment for HAIs based on Medicare modernization act CMS initiated 30 day risk standardized re- admission measure penalizing hospitals Federal Engagement in Antimicrobial Resistance is exemplified by: - White House Forum on Antibiotic Stewardship - CDC initiated Hospital Antibiotic Stewardship Programs such as Antibiotic Resistance Solutions Initiative ü ü Neutrolin Prevents Microbial Colonization and Biofilm Formation Inside Catheter Reduces Risk of Bloodstream Infection USRDS Annual Data Report Volume 2 - ESRD in the United States; /do wnload /vol2_04_ Vascu lar Acce ss_15.pdf Source: Company 10- K 10

11 Novel Taurolidine- based Cancer Therapy Data & Mechanism Of Action Known to inhibit a variety of human cancer cell growth in vitro 1 Significantly enhances activity of cytotoxic drugs against neuroblastoma 1,2 May 2016: Exclusive research licenses to NanoProteagen s NanoPro technology Delivering combination therapy: CRMD- 005 plus vincristine (marketed as Oncovin ) Currently testing feasibility, with option to obtain exclusive worldwide license Initial target: pediatric neuroblastoma (Orphan Disease; ~650 cases per year in the U.S. 3 ) September 2016: Agreement with Pediatric Oncology Experimental Therapeutics Investigators Consortium (POETIC) Develop and evaluate novel taurolidine- based therapies for rare orphan pediatric tumors Memorial Sloan Kettering Cancer Center (MSK), Weill Cornell Medical Center, Alberta Children s Hospital, and other top tier cancer centers of excellence 1. Ta u ro lid in e specifically inhibits growth of neuroblastoma cell lines in vitro 2. Taurolidine cooperates with antineoplastic drugs in neuroblastoma cells Pediatric Neuroblastoma emedicine. overview 11

12 U.S. Market Potential is Significant; Driven by Catheter Days (estimates) Neutrolin Patients Catheter Days Vials per Catheter Day Total Units Hemodialysis 660,000 63mm mm Neutrolin 2.0 Cartridges/Vials per Catheter Day Oncology/TPN 7,740,000 90mm 3 270mm ICU 5,700,000 29mm 5 143mm 444mm Catheter Population and Opportunity are Significant Source: Hemodialysis: USRDS 2015 Annual Data Report: 2015 USRDS Annual Data Report Volume ESRD in the United States and CorMed ix estimates Oncology: American Cancer Society. Cancer Facts and Statistics. Accessed on April 1, 2015 and CorMedix estimates Intensive Care Units: Society of Critical Care Medicine. Critical Care Statistics. Accessed on April 10, 2015 and CorMedix estimates 12

13 Unlocking Additional Value for Taurolidine Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Neutrolin Neutrolin 2.0 CRMD-005 / Vincristine Combo Nanoparticle Leveraging the Taurolidine Platform Neutrolin Europe Hemodialysis Oncology ICU / CCU Pediatric Neuroblastoma* Taurolidine-Incorporated Sutures Wound closures Injectable and topical gels Surgical mesh Catheter lock solution * Orphan Disease Opportunity 13

14 CorMedix Summary and Value Proposition U.S. FDA Fast- track designation with Phase 3 hemodialysis trial underway Proven clinical utility in EU post- market observational study Granted QIDP Designation up to 10.5 years potential market exclusivity in U.S. Additional pivotal and post- market studies planned to expand Neutrolin use Additional value may be unlocked through leveraging the platform Taurolidine use in medical device applications and oncology Three research collaborations in place and multiple discussions ongoing Neutrolin currently available in EU and Middle East (CE Marked) 14

15 Thank You NYSE MKT: Investor & Media Contact Tiberend Strategic Advisors, Inc Route 206 Suite 200 Bedminster, NJ (ph) Josh Drumm, Ph.D Janine McCargo