Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (November 2017)
47 slides from Citius Pharmaceuticals's investor presentation, Nov 7, 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 important, high potential, later stage drugs that address unmet medical needs x Lead product used in serious infections is entering phase 3 x Proven drugs that have very low develo
Slide 4: Strong, Unique Pipeline in Progressive Stages
4 Strong, 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, has been granted QIDP, Fast Track, and is in Phase 3. There is no approved competition nor any on the horizon. We
Slide 5: Development Strategy
5 Development Strategy Platform Objectives ✓ Identify later stage drug candidates that can be developed within a 3 - 4 year time horizon using a 505(b)2 regulatory pathway ✓ Acquire the most relevant and advanced technologies to provide superior product characteristics and intellectual property prot
Slide 6: Mino-Lok: Antibiotic Lock Therapy for CRBSI
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. Contaminated Catheter Hub Hematogenous Skin Insertion
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
Slide 10: The Problem: CRBSI; The Solution: Mino-Lok
10 The Problem : Catheter - Related Blood Stream Infection (CRBSI) The Solution : Mino - Lok TM to Clear 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 that are used annually in the
Slide 11: CRBSI Rates by Setting
11 CRBSI Rates by Setting Despite recent advances, CRBSIs remain a significant issue for hospitals. 0 0.5 1 1.5 2 2.5 2006-2008 2009 2010 Pooled mean annual CRBSI rate per 1,000 central line days Year CRBSI 1 Rate by Care Setting Critical care: Medical/surgical (non-teaching) Critical care: Medical/
Slide 12: The Market is Large and Receptive to a New Solution
12 The Market is Large and Receptive to a New Solution Annual Incidence of CRBSI Treatments (flushes/locks) 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 Catheter
Slide 13: 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 14: Current Standard of Care: Remove & Replace
14 Current Standard of Care Remove & Replace The current standard - of - care for treating CRBSI is to remove the infected CVC and replace with a fresh, new catheter while treating the patient for their blood stream infection with systemic antibiotic(s). The removal and replacement of the CVC is a r
Slide 15: CVC Insertion Complications
15 CVC Insertion Complications Complications of central vein catheterization include infection, thrombosis, occlusion, and, in particular, mechanical complications which usually occur during insertion and are closely related to the anatomic location of the central veins. • Infectious complications a
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: Successful Salvage of Central Venous Catheters
Successful Salvage of Central Venous Catheters in the Setting of Catheter Related or Central Line Associated Bloodstream Infections Using Catheter Lock Consisting of Minocycline, EDTA and 26% Ethanol Sred song te caret DSA cers
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 ler RESULTS ——SSeeesin
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: Phase 3 Study Design (Endpoints)
22 Mino - Lok™ Phase 3 Study Design (Endpoints) Primary Endpoint : Proportion of ITT Patients who have Overall Success at TOC week 8 …(Overall Success is defined as a subject who does NOT demonstrate ANY of the following): • All - cause mortality at Week 8; • Catheter removal for any infection - rel
Slide 23: Mino-Lok Development Plan
23 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 24: Intellectual Property
24 Intellectual Property Mino - Lok TM is supported by a robust intellectual property portfolio that provides protection until June 7, 2024 (we have received a QIDP designation providing 5 years market exclusivity, and 3 years of Hatch - Waxman market exclusivity from the time of NDA approval…e xten
Slide 25: Regulatory Protection
25 Regulatory Protection Qualified Infectious Disease Product (QIDP) • Fast Track Status, enables frequent communication and collaboration with FDA • Priority Review, reduces the NDA review time from 12 to 6 months • Market Exclusivity, grants an additional 5 years of market exclusivity at NDA, comb
Slide 26: Competitive Landscape
26 Competitive Landscape Company/Source Product/Components Status Features/Weaknesses CorMedix (NJ, USA) Neutrolin ® taurolidine , citrate, heparin Phase III trial in Prevention in HD Available in Europe (CE Mark) Prevention only Anti - infective being used in prophylaxis Great Lakes (US) B - Lock T
Slide 27: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
27 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 Will be indicated as adjunctive therap
Slide 28: Hydro-Lido: Prescription topical for hemorrhoid treatment
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 • At any time, up to 5% of the U.S. population suffers from hemorrhoids, but there are no FDA - approved prescription products on the market • B
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), Hydr0 - Lido (3% hydrocortisone + 5% lidocaine) showed directional improvement over its comp
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 and Cap Table
32 Financial Summary Cap Table a s of October 31, 2017 Shares % of Fully Diluted Basic Shares Outstanding 8,345,844 66.0% Warrants 3,346,941 26.4% Options 961,701 7.6% Fully Diluted Shares Outstanding 12,654,485 100.00% Principal Shareholders Leonard Mazur (40.0%) Myron Holubiak (6.2%) Reinier Beeuw
Slide 33: Management Team
Management Team Executives, Directors, & Board Members
Slide 34: Citius Management Team (Leadership)
3 4 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 instrumenta
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:
Slide 42: Phase 2 Patient Detail Appendix
Phase 2 Patient Detail Appendix 1
Slide 43: Phase II Clinical Trial Outcomes: Catheter Salvage
43 Patient Organism Bacteremia prior to ALT (Days) Blood CFU/ml prior to ALT Blood CFU/ml Conclusion of ALT Catheter Salvaged 1 E.coli 2 201 - 500 negative yes 2 AHS* 3 >1000 negative yes 3 E. coli 6 501 - 1000 negative yes 4 Coag . neg. Staph. 9 51 - 100 negative yes 5 E. coli 5 11 negative yes 6 E
Slide 44: Interim Pilot Trial Outcomes: Catheter Salvage
44 Interim Pilot Trial Outcomes: Catheter Salvage with Mino - Lok Therapy Patient Organism Bacteremia prior to ALT (Days) Blood CFU/ml prior to ALT Blood CFU/ml Conclusion of ALT Catheter Salvaged 16 Ps. aeruginosa 3 11 negative yes 17 Coag . Neg. Staph . 3 201 - 500 <10 (lab contaminant) yes 18 E.
Slide 45: CRBSI Diagnosis and CVC R&R Complications Appendix
CRBSI Diagnosis and CVC R&R Complications Appendix 2
Slide 46: Diagnosis of CRBSI
X Diagnosis of CRBSI Febrile patient with indweling CVC arin CVC aco yds tain smitrcusboodaaer Chek forsocesfinkcton ok Cand ptpbelven "h Loalignandsmptons Noloalignand gmt fomdnocteriance—~ fomdater sce iiiterprpintetnapy — Chekoodareeits +] pic achngeand __teprointe ciwecve aap, Osten eso Tr ‘pant
Slide 47: CVC Mechanical Insertion Complications Rates
47 CVC Mechanical Insertion Complications Rates by Sites of Venous Access Sites Mechanical complications, total (%) Arterial puncture (%) Hematoma (%) Pneumothorax (%) Internal jugular vein 6.3 - 11.8 6.3 - 9.4 <0.1 - 2.2 <0.2 Internal jugular vein, ultrasound guided 4 1.4 - 1.7 <0.1 - 2.2 <0.1 Subc
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