Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (August 2018)
38 slides from Citius Pharmaceuticals's investor presentation, Aug 1, 2018
Slide 1: Citius Pharmaceuticals, Inc. Corporate Presentation Summer 2018
Citius Pharmaceuticals, Inc. Corporate Presentation Summer 2018 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) € Pipeline portfolio of later stage drugs that address unmet medical needs • Lead product used in serious infections is now in the clinic (phase 3) • Very low development risk …505(b)2 regulatory pathway
Slide 4: Unique Pipeline in Progressive Stages
4 Unique Pipeline in Progressive Stages € 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. € Phase 2: CITI - 002 (Halo - Lido) • Gastrointestinal product has Ph
Slide 5: Citius Development Strategy Objectives
5 Citius Development Strategy 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 sm
Slide 6: Mino-Lok Antibiotic Lock Therapy for CRBSI
Minocycline/EDTA/Ethanol 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
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. Endogenous: Skin flora Extrinsic: HCW hands; Contaminated field Endogenous: Skin flora Extrinsic: HCW hands Fr
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 Micrograph of Biofilm in Central V
Slide 10: The Problem: Removing and Replacing the Catheter in CRBSI
10 The Problem : Removing and Replacing the Catheter in CRBSI The Solution : Mino - Lok ® to Sterilize 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 11: The Market is Large and Receptive to a New Solution
11 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 12: 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 13: Current Standard of Care Remove & Replace: Risky, Discomforting, and Costly
13 Current Standard of Care Remove & Replace: Risky, Discomforting, and Costly
Slide 14: CVC Insertion Complications
14 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 15: Locking a Central Venous Line with Mino-Lok
15 Locking a Central Venous Line with Mino - Lok® Locking a Catheter is a Standard Operating Procedure 1. Using Mino - Lok® does not require any novel methodologies. 2. Any RN or LPN or Technician can perform the procedure. 3. There is no change in normal workflow and does not require exceptional tr
Slide 16: M.D. Anderson Cancer Center study
M.D. Anderson Cancer Center, Dept of Infectious Diseases, Infection Contol& Employee Health 9 hata nanan a mc Sg ESE MO, Mary Jordan, MD, Zanaib Al Hamal, MD, Ying thee 3b 19 andy 2014, we rote 20 pater wih {CABSICROSIn a gronpetre, cpa abe srgeatiso ity Eth rw fcr 8 Mtn nce Cer OE son in faction dy
Slide 17: Phase 2b Trial Results
17 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 18: International Experience with Minocycline, EDTA and Ethanol Lock
International Experience wi jocycline, EDTA and Ethanol Lock for Salvaging of Central “sora Catheters in the Setting of Central Line Associated Bloodstream Infections MDAnderson ee st MO*Nebuyesh Mor, MO Ying an, ms aay nay, NCL Cee
Slide 19: Ex-US Pilot Trial Results
19 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 20: Mino-Lok Phase 3 Study Design
20 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 21: Mino-Lok Development Plan (as of 08/2018)
21 Mino - Lok® Development Plan (as of 08/2018) 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 Chemistry and Manufacturing Control (CMC) Development Clinical Trial Material Manufacturing Phase 3 Clinical Study FDA EOP2 Mee
Slide 22: Intellectual Property
22 Intellectual Property Mino - Lok® is supported by a robust intellectual property portfolio Composition of Matter patent provides protection until June 7, 2024. Formulation Patent has received Notice of Allowance and will add protection through 2036. Creators Description of Patent All U.S. and For
Slide 23: Regulatory Protection
23 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 24: Competitive Landscape
24 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 25: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
25 Mino - Lok® (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 patie
Slide 26: CITI-002 Halobetasol/Lidocaine for Symptomatic Hemorrhoid Treatment
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment CITI - 002
Slide 27: CITI-002 (halobetasol + lidocaine)
27 CITI - 002 ( halobetasol + 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 - app
Slide 28: Phase 2a Trial Results - Positive Directional Improvement
28 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), CITI - 001 showed directional improvement over its components and vehicle*. This study measu
Slide 29: Phase 2a Trial Results - Faster Relief at Day 2
29 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 30: Financial Summary Current Cap Table
30 Financial Summary Current Cap Table Shares % of Fully Diluted Basic Shares Outstanding 10,677,222 66.25% Warrants 4,479,494 27.79% Options 861,039 5.34% Unit Purchase Options 100,000 0.62% Fully Diluted Shares Outstanding 16,117,755 100% Principal Insider and Former Insider Shareholders (1) (101
Slide 31: Management Team
Management Team Executives, Directors, & Board Members
Slide 32: Citius Management Team (Leadership)
32 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 33: Citius Management Team
33 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 34: Citius Management Team
34 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 35: Citius Board of Directors
35 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 36: Citius Board of Directors
36 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 37: Summary
37 Summary € Addressing attractive diversified multi - billion dollar opportunities – Adjunctive Cancer Care/Infectious Disease, Gastrointestinal Disease € Portfolio addressing recognized unmet medical needs with cost - saving or cost - effective solutions with low risk development pathways € Multip
Slide 38: Corporate Profile
38 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:
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