Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (December 2018)
40 slides from Citius Pharmaceuticals's investor presentation, Dec 12, 2018
Slide 1: Citius Pharmaceuticals, Inc. Corporate Presentation Winter 2018
Citius Pharmaceuticals, Inc. Corporate Presentation Winter 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 Company or any dire
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 clinical trials (phase 3) • Low development risk … planned 505(b)2 regulatory
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. € Prep for Phase 2b: CITI - 002 (Halo - Lido) • Early version (with h
Slide 5: Citius Development Strategy
5 Citius Development Strategy Objectives € Identify drug candidates that can be developed within a 3 - 4 year time horizon with low development risk. € Develop products for unique, attractive indications (unmet need/few competitors) € Ensure intellectual property protection for 10 years € Focus on t
Slide 6: Mino-Lok: Antibiotic Lock Therapy for Salvaging Catheters
Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections 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: Biofilm Visualizations Post-Removal
Biofilm Visualizations Post - Removal 10 Glycocalyx under Microscope CVC Dissections Post - Removal
Slide 11: The Problem: Removing and Replacing an Infected Catheter is Risky and Costly
11 The Problem : Removing and Replacing an Infected Catheter in CRBSI is Risky and Costly 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 7,000,00
Slide 12: Long-term CVC or Port Related Bacteremia Treatment
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
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% ( 1,2 ). 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 tra
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 Phase 3 Outcome Measures
Mino - Lok Phase 3 Outcome Measures Primary Outcome Measures : • Proportion of subjects deemed successfully treated at the end of the study period [ Time Frame: 8 weeks ] • Success is defined as any subject who demonstrates eradication of the pathogen, stabilization or improvement in signs and sympt
Slide 22: Mino-Lok Development Plan (as of 12/2018)
22 Mino - Lok® Development Plan (as of 12/2018) 2014 2015 2016 2017 2018 2019 2020 Q1 Q2 Q3 Q4 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 Registration Manufacturing Phase 3 Clinical Study FDA EO
Slide 23: Intellectual Property
23 Intellectual Property Mino - Lok TM is supported by a robust intellectual property portfolio Composition of Matter patent that 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.
Slide 24: Regulatory Protection
24 Regulatory Protection Qualified Infectious Disease Product (QIDP) x Eligibility for 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 e
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® (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 27: Halobetasol/Lidocaine Topical for Symptomatic Hemorrhoid Treatment CITI-002
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment CITI - 002
Slide 28: CITI-002 (halobetasol + lidocaine)
28 CITI - 002 ( halobetasol + lidocaine) Citius’ product candidate 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
Slide 29: Phase 2a Trial Results - Hydrocortisone/Lidocaine (CITI-001)
29 Phase 2a Trial Results - Hydrocortisone/Lidocaine (CITI - 001) 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
Slide 30: Phase 2a Trial Results - Positive Directional Improvement
30 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 31: Financial Summary: Current Cap Table
3 1 Financial Summary Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 1 7,798,791 48.9 % Warrants 15,193,241 45.9 % Options 1,606,034 4.9 % Unit Purchase Options 100 , 667 0. 3 % Fully Diluted Shares Outstanding 33,098,733 100% Principal Insider and Former Insider Shareholders
Slide 32: Management Team
Management Team Executives, Directors, & Board Members
Slide 33: Citius Management Team (Leadership)
33 Citius Management Team (Leadership) Leonard Mazur, Director and Chairman of the Board Mr . Mazur is a highly accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building and creating value and returns for the investors . He has been instrument
Slide 34: Citius Management Team
34 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 35: Citius Management Team
35 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 36: Citius Board of Directors
36 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 37: Citius Board of Directors
37 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 38: Citius Scientific Advisory Board
38 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 39: Summary
39 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 40: Corporate Profile
40 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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