Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (February 2019)
50 slides from Citius Pharmaceuticals's investor presentation, Feb 19, 2019
Slide 1: Citius Pharmaceuticals Corporate Presentation Winter 2019
Citius Pharmaceuticals, Inc. Corporate Presentation Winter 2019
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) € Low Risk/ High Reward Strategy • Low development risk … focused on 505(b)2 regulatory pathway products, • avoids unnecessary duplication of studies already performed on previously approved drugs • resul
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. This is a very serious problem with a clear unmet medical need. We estimate the market to be >$1 billion worldwide. € Pha
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 with low development risk € Develop products for unique, attractive indications (unmet need/few competitors) € Ensure intellectual property protection for 10 years € Focus on th
Slide 6: Citius Lead Product: Mino-Lok
Citius Lead Product 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 Bio lm 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 or fungemia 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: Vascular injury following dialysis catheter placement
15 (a) Vascular injury following dialysis catheter placement. Initial chest X - ray after reported uneventful place of a tunneled rig ht internal jugular dialysis line in a 67 - year - old female with end - stage renal disease. (b) After initial attempts to access catheter demonstrated t hat fluid w
Slide 16: Locking a Central Venous Line with Mino-Lok
16 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
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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: Mino-Lok Phase 3 Study Design
19 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 20: Mino-Lok Phase 3 End Points
Mino - Lok Phase 3 End Points Primary End Points: • 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 symptoms of the in
Slide 21: Mino-Lok Development Plan (as of 02/2019)
21 Mino - Lok® Development Plan (as of 02/2019) 2014 2015 2016 2017 2018 2019 2020 2021 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 Q1 Q2 Q3 Phase 2 Clinical Study Chemistry and Manufacturing Control (CMC) Development Registration Manufacturing Phase 3 Clinica
Slide 22: Intellectual Property
22 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 been issued and will add protection through 2036. Creators Description of Patent All U.S. and Foreign Paten
Slide 23: Regulatory Protection: QIDP and Fast Track
23 Regulatory Protection Qualified Infectious Disease Product (QIDP) € Eligibility for Fast Track Status, enables frequent communication and collaboration with FDA; € Priority Review, reduces the NDA review time from 12 to 6 months; and, € Market Exclusivity, grants an additional 5 years of market e
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) € Treats catheter - related blood stream infections (CRBSIs). € Penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anti - clotting properties. € Preserves central venous access in patie
Slide 26: Mino-Wrap
Mino - Wrap CITI - 101 Minocycline/Rifampin (M/R) Gelatin Film Bioabsorbable Extended Release Antimicrobial Wrap for the Prevention of Breast Tissue Expander Infections
Slide 27: Background on Mastectomies
Background on Mastectomies € Breast cancer is the most frequent cancer in women worldwide and is increasing particularly in developing countries where the majority of cases are diagnosed in late stages (WHO). € Mastectomies have increased 36% from 2005 to 2013 in the US (AHRQ). € The incidence of po
Slide 28: Background: Rate of Infection Post-Mastectomy
Background: Rate of Infection Post - Mastectomy € As a comparison, the rate of infection following breast augmentation is approximately 2%, while it is as high as 24% for breast reconstructive procedures. Estimated mean is 10%. € Once the TE becomes infected, the patient is hospitalized and the impl
Slide 29: Mino-Wrap: Thesis
Mino - Wrap: Thesis € To decrease the high rate of TE infections, Mino - Wrap is a malleable, bioabsorbable, antimicrobial wrap that is placed in the surgical pocket as a solid film. It slowly liquefies in situ for a specified period of time providing extended protection against infection from the m
Slide 30: Mino-Wrap Pre-Clinical Development Summary
Mino - Wrap Pre - Clinical Development Summary Four Aspects Have Been Evaluated Preclinically 1. Physical changes over time and durability • Assessed if wrap could retain physical presence in a simulated TE pocket environment • evaluated in patient drain fluid samples following mastectomy and observ
Slide 31: Mino-Wrap Pre-Clinical Development Summary (cont'd)
Mino - Wrap Pre - Clinical Development Summary (cont’d) 3. Mammalian cellular cytotoxicity The human fibroblast cell line, HEK - 293T, used for toxicity testing. Gelatin films without antimicrobials, untreated cells and medium were used as controls. 4. Sterilization and stability. Gamma irradiation
Slide 32: Conclusion
Conclusion The in vitro preclinical experiments reveal that Mino - Wrap delivers minocycline and rifampin to the silicone surface in an active form • Remains intact at least for 1 week after being submerged in a collagenase - saline solution at 37 ⁰ C, • Is safe and not cytotoxic towards human fibro
Slide 33: Regulatory Pathway Options
Regulatory Pathway Options • 510K • Premarket submission demonstrating Mino - Wrap is at least as safe and effective as another legally marketed device that is not subject to premarket approval. • K142611 - TYRX™ Absorbable Antibacterial Envelope is a fully absorbable antibacterial envelope for card
Slide 34: Intellectual Property
Intellectual Property 34 • US Patent filed April 17, 2014 • US Patent Issued Dec. 26, 2017 • If CDER, then apply for Orphan Drug Designation (+7 years) , QIDP (+5 years) Priority Review and Fast Track
Slide 35: Halobetasol/Lidocaine Halo-Lido CITI-002
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment Halo - Lido CITI - 002
Slide 36: CITI-002 (halobetasol + lidocaine)
36 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 37: Phase 2a Trial Results - Hydrocortisone/Lidocaine (CITI-001)
37 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 38: Phase 2a Trial Results - Positive Directional Improvement
38 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 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: Financial Summary: Current Cap Table
Financial Summary Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 18,520,360 56.0 % Warrants 12,871,623 38.9 % Options 1,601,034 4.8 % Unit Purchase Options 100 , 667 0. 3 % Fully Diluted Shares Outstanding 33,093,684 100% Principal Insider and Former Insider Shareholders (1)
Slide 41: Management Team
Management Team Executives, Directors, & Board Members
Slide 42: Citius Management Team (Leadership)
42 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 43: Citius Management Team
43 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 44: Citius Management Team
44 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 45: Citius Board of Directors
45 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 46: Citius Board of Directors
46 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 47: Citius Scientific Advisory Board
47 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 48: Citius Scientific Advisory Board
48 Citius Scientific Advisory Board Jesse Selber , M.D. Dr. Jesse C. Selber, M.D., MPH, FACS is the Director of Clinical Research and an Associate Professor in the Department of Plastic Surgery at the University of Texas MD Anderson Cancer Center in Houston, Texas. A microvascular reconstructive sur
Slide 49: Corporate Profile
49 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 50: A Guide to the 505(b)(2) Regulatory Pathway
A Guide to the 505(b)(2) Regulatory Pathway • The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many applicants. The pathway was created by the Hatch - Waxman Amendments of 1984,
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