Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (December 2017)
41 slides from Citius Pharmaceuticals's investor presentation, Dec 1, 2017
Slide 1: Citius Pharmaceuticals Corporate Presentation Winter 2017
Citius Pharmaceuticals, Inc. Corporate Presentation Winter 2017 NASDAQ: CTXR
Slide 2: Disclaimer
2 Disclaimer This presentation has been prepared by Citius Pharmaceuticals, Inc. (the “Company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the Co
Slide 3: Investment Opportunity
3 Investment Opportunity Olympic Motto: “ Citius , Altius, Fortius ” (Faster, Higher, Stronger) x Pipeline portfolio of later stage drugs that address unmet medical needs • Lead product used in serious infections is entering phase 3 • Very low development risk …505(b)2 regulatory pathway • Quick mar
Slide 4: Unique Pipeline in Progressive Stages
4 Unique Pipeline in Progressive Stages x Phase 3: Mino - Lok™ • Lead product (Mino - Lok) is a unique antibiotic lock therapy that salvages central lines in bacteremic patients. We estimate the market to be >$1 billion worldwide. x Phase 2: Hydro - Lido • Gastrointestinal product has Phase 2a compl
Slide 5: Development Strategy
5 Development Strategy Platform Objectives ✓ Identify drug candidates that can be developed within a 3 - 4 year time horizon ✓ Acquire technologies with superior product characteristics ✓ Ensure intellectual property protection for 10 years ✓ Focus on therapeutic areas that are highly influenced by
Slide 6: Antibiotic Lock Therapy for CRBSI: Mino-Lok
Antibiotic Lock Therapy for Catheter Related Bloodstream Infection (CRBSI) Mino - Lok™
Slide 7: Central Venous Catheters
7 Central Venous Catheters Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis Central Venous Catheter PICC Hemodialysis CTXR
Slide 8: Pathogenesis of CRBSI
8 Pathogenesis of CRBSI Safdar N, Maki DG. The pathogenesis of catheter - related bloodstream infection with noncuffed short - term central venous catheters. Int Care Med . 2004;30:62 - 67. CTXR Endogenous: Skin flora Extrinsic: HCW hands; Contaminated field Endogenous: Skin flora Extrinsic: HCW han
Slide 9: Biofilm Formation Protects Colonies
9 Biofilm Formation Protects Colonies • Pathogens attach to the surface of the lumen in a central venous catheter and form colonies. • Colonies grow and exude a fibrous glycocalyx that protects the organisms from antibiotics, even when shown to be sensitive in vitro CTXR Micrograph of Biofilm in Cen
Slide 10: Biofilm Visualizations Post-Removal
Biofilm Visualizations Post - Removal CTXR 10 Glycocalyx under Microscope CVC Dissections Post - Removal
Slide 11: The Problem: Removing and Replacing the Catheter in CRBSI
11 The Problem : Removing and Replacing the Catheter in CRBSI The Solution : Mino - Lok TM to Disinfect and Salvage the Catheter • Central venous catheters (CVCs) are life - saving vascular access ports for patients requiring long term intravenous therapy. • Of the 7,000,000 CVCs used annually in US
Slide 12: The Market is Large and Receptive to a New Solution
12 The Market is Large and Receptive to a New Solution Factors Short Term CVC Long Term CVC Number of Catheters 3 million 4 million Average Duration (days) 12 100 Catheter Days 36 million 400 million Infection Rate 2/1000 days 1/1000 days Catheters Infected 72,000 400,000 Sources: Ann Intern Med 200
Slide 13: Long-term CVC or port related bacteremia or fungemia
Long - term central venous catheter (CVC) – or port (P) – related bacteremia or fungemia Complicated Uncomplicated Tunnel infection, port abscess Septic thrombosis, endocarditis, osteomyelitis Coagulase - negative staphylococcus Staphylococcus aureus Enterococcus Gram - negative bacilli Candida spp.
Slide 14: Current Standard of Care: Remove & Replace
14 Current Standard of Care Remove & Replace: Risky, Discomforting, and Costly CTXR
Slide 15: CVC Insertion Complications
15 CVC Insertion Complications Complications include infection, thrombosis, occlusion, and mechanical complications. x Infectious complications are reported to occur in 5% to 26% of patients; x Mechanical complications in 5% to 19%; and, x Thrombotic complications in 2% to 26% ( 4,5 ). Mechanical co
Slide 16: Locking a Central Venous Line with Mino-Lok
16 Locking a Central Venous Line with Mino - Lok™ Mino - Lok TM Instructions for Use 1. Aspirate the contents of the catheter lumen using the known catheter volume as a guide for the exact amount of fluid to withdraw; lumen volume is usually 0.8 to 1.0 ml. 2. Flush each lumen of the catheter with no
Slide 17: 17 CTXR
17 CTXR
Slide 18: Phase 2b Trial Results
18 Phase 2b Trial Results Parameter Mino - Lok Arm N ( % ) Control Arm N ( % ) Patients 30 (100%) 60 (100%) Cancer Type - Hematologic 20 (67) 48 (80) - Solid tumor 10 (33) 12 (20) ICU Admission 4 (13) 4 (7) Mech. Ventilator 3 (10) 0 (0) Bacteremia - Gram+ 17 (57)* 32 (53) - Gram - 14 (47)* 28 (47) N
Slide 19: International Experience with Minocycline, EDTA and Ethanol Lock
International Experience with Minocycline, EDTA and Ethanol Lock for Salvaging of Central Catheters in the Setting of Central Line Associated Bloodstream Infections ‘MD Anderson PATIENTS AND METHODS coNcLUsIONs
Slide 20: Ex-US Pilot Trial Results
20 Ex - US Pilot Trial Results Parameter Mino - Lok Arm N (%) Control Arm N (%) Patients 20 (100%) 24 (100%) Lebanon (American University of Beirut) 9 (45) 10 (42) Brazil (Albert Einstein, Sao Paolo) 9 (45) 10 (42) Japan (St. Lukes International, Tokyo) 2 (45) 4 (17) Cancer Type - Hematologic 17/18
Slide 21: Mino-Lok Phase 3 Study Design
21 Active Arm (n=350) Mino - Lok™ Solution + CVC Salvage + SOC IV Antibiotics for All organisms Control Arm (n=350) Antibiotic Lock + SOC IV Antibiotics for All Organisms [including S.aureus (incl. MRSA ), Gram - , Candida] Patients with CRBSI/CLABSI (n=700) R Mino - Lok™ Phase 3 Study Design Multi
Slide 22: Mino-Lok Development Plan (as of 11/2017)
22 Mino - Lok™ Development Plan (as of 11/2017) 2013 2014 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 2 Clinical Study CMC and Packaging Development Registration Manufacturing Phase 3 Clinical Study FDA EOP2 Meeting FDA CMC Meeting FDA Interim Mt
Slide 23: Intellectual Property
23 Intellectual Property Mino - Lok TM is supported by a robust intellectual property portfolio that provides protection until June 7, 2024. Additionally, life cycle management with an improved stability product will add several more years of protection (possibly through 2036). Creators Description
Slide 24: Regulatory Protection
24 Regulatory Protection Qualified Infectious Disease Product (QIDP) x Fast Track Status, enables frequent communication and collaboration with FDA; x Priority Review, reduces the NDA review time from 12 to 6 months; and, x Market Exclusivity, grants an additional 5 years of market exclusivity at ND
Slide 25: Competitive Landscape
25 Competitive Landscape Company/Source Product/Components Status Features/Weaknesses CorMedix Neutrolin ® taurolidine, citrate, heparin Phase III trial in Prevention in HD; Available in Europe (CE Mark) Prevention only Anti - infective only being used in prophylaxis No company has United States reg
Slide 26: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
26 Mino - Lok TM (minocycline/disodium EDTA/ethyl alcohol) x Treats catheter - related blood stream infections (CRBSIs). x Penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anti - clotting properties. x Preserves central venous access in pat
Slide 27: Mino-Lok the Ideal Antibiotic Lock Solution for Treatment of CRBSI
Mino - Lok the Ideal Antibiotic Lock Solution for the Treatment of CRBSI “A decision regarding the use of antimicrobial lock solution should be driven by its broad spectrum antimicrobial activity against organisms embedded in biofilm, ease of administration, short dwell time, minimal interactions wi
Slide 28: Hydro-Lido
Prescription strength topical for symptomatic hemorrhoid treatment Hydro - Lido
Slide 29: Hydro-Lido (hydrocortisone + lidocaine)
29 Hydro - Lido (hydrocortisone + lidocaine) Citius’ product is expected to be the first FDA - approved prescription product to treat hemorrhoids in the US OTC Products are the Mainstay for Treatment of Grade I and II • Up to 5% of the U.S. population suffers from hemorrhoids, but there are no FDA -
Slide 30: Phase 2a Trial Results - Positive Directional Improvement
30 Phase 2a Trial Results - Positive Directional Improvement In a randomized, double blind study of topical formulations of vehicle and various strengths of components (cream, hydrocortisone, and lidocaine), Hydro - Lido showed directional improvement over its components and vehicle*. This study mea
Slide 31: Phase 2a Trial Results - Faster Relief at Day 2
31 Phase 2a Trial Results - Positive Directional Improvement Faster Relief at Day 2 * Pruritus Hydro - Lido achieved 88.9% relief at Day 2 compared to any of its components Pain and Discomfort Hydro - Lido achieved 85.7% relief of pain and discomfort at Day 2 compared to any of its components 88.90%
Slide 32: Financial Summary
32 Financial Summary Cap Table a s of November 30, 2017 Shares % of Fully Diluted Basic Shares Outstanding 8,423,390 66.4% Warrants 3,305,106 26.0% Options 961,701 7.6% Fully Diluted Shares Outstanding 12,690,197 100.00% Principal Shareholders Leonard Mazur (40.0%) Myron Holubiak (6.2%) Reinier Beeu
Slide 33: Management Team
Management Team Executives, Directors, & Board Members
Slide 34: Citius Management Team (Leadership)
34 Citius Management Team (Leadership) Leonard Mazur, Director and Chairman of the Board Mr . Mazur is highly accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building and creating value and returns for the investors . He has been instrumental
Slide 35: Citius Management Team
35 Citius Management Team Jaime Bartushak, CFO Mr . Bartushak is an experienced finance professional for early stage pharmaceutical companies, and has over 20 years of corporate finance, business development, restructuring, and strategic planning experience . Most recently in 2014 , Mr . Bartushak h
Slide 36: Citius Management Team
36 Citius Management Team Alan Lader, Ph . D . , VP, Clinical Operations Dr . Lader has over 25 years of experience in medical research . Prior to joining Citius, Dr . Lader was the Director of Clinical Operations for Ischemix , Inc . Dr . Lader was an Instructor in Medicine at Harvard Medical Schoo
Slide 37: Citius Board of Directors
37 Citius Board of Directors Dr. William Kane, Director Dr. Kane has served as a Clinical Professor at Duke University Medical Center since 2003. From 2006 to 2009, he served as the Chief Executive Officer of RadarFind Corporation, and from 2002 to 2003, he served as the Interim Chief Medical Office
Slide 38: Citius Board of Directors
38 Citius Board of Directors Suren Dutia, Director Mr. Dutia is a seasoned executive in the healthcare and medical device space. Mr. Dutia has served as Senior Fellow of the Ewing Mario Kauffman Foundation since March 2011 and as Senior Fellow of Skandalaris Center for Entrepreneurial Studies at Was
Slide 39: Citius Scientific Advisory Board
39 Citius Scientific Advisory Board Dr. Issam Raad , M.D. Dr. Issam Raad , M.D. is Chair of MD Anderson Cancer Center’s Department of Infectious Diseases and the Endowed Distinguished Professor of Medicine. Dr. Raad is the author of the underlying patents for Mino - Lok. Dr. Raad’s innovations in pr
Slide 40: Summary
40 Summary x Addressing attractive diversified multi - billion dollar opportunities – Adjunctive Cancer Care/Infectious Disease, Gastrointestinal Disease x Portfolio addressing recognized unmet medical needs with cost - saving or cost - effective solutions with low risk development pathways x Multip
Slide 41: Corporate Profile
41 Corporate Profile Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 908 - 967 - 6767 www.citiuspharma.com IRTH Communications Robert Haag, Managing Director 866 - 976 - 4784 CTXR@irthcommunications.com Media and Investor Relations: CTXR
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