Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (September 2019)
41 slides from Citius Pharmaceuticals's investor presentation, Sep 19, 2019
Slide 1: Citius Pharmaceuticals Corporate Presentation Fall 2019
Citius Pharmaceuticals, Inc. Corporate Presentation Fall 2019 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) • Low Risk/ High Reward Strategy • Low development risk … focused on 505(b)2 regulatory pathway products, aimed to • avoid unnecessary duplication of studies already performed on previously approved drugs
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 Lead Product Mino-Lok
Citius Lead Product Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections Mino - Lok®
Slide 6: Central Venous Catheters
6 Central Venous Catheters Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis Central Venous Catheter PICC Hemodialysis CTXR
Slide 7: Pathogenesis of CRBSI
7 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 8: Biofilm Formation Protects Colonies
8 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 Cent
Slide 9: Catheter-Biofilm Visualizations Post-Removal
Catheter - Biofilm Visualizations Post - Removal CTXR 9 Glycocalyx under Microscope CVC Dissections Post - Removal
Slide 10: The Problem: Removing and Replacing an Infected Catheter is Risky and Costly
10 The Problem : Removing and Replacing (R&R) an Infected Catheter in CRBSI is Risky and Costly The Solution : Mino - Lok® to Sterilize and Salvage the Catheter vs. R&R • Central venous catheters (CVCs) are life - saving vascular access ports for patients requiring long term intravenous therapy. • O
Slide 11: CVC Insertion Complications
11 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 12: Locking a Central Venous Line with Mino-Lok
12 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 13: Phase 2b Trial Results
13 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 14: Mino-Lok Phase 3 Pivotal Trial Design
14 Active Arm (n=72) Mino - Lok® Solution Control Arm (n=72) Antibiotic Lock Patients with CRBSI/CLABSI (n~ 144) R Mino - Lok® Phase 3 Pivotal Trial Design Multi - center, randomized, open label, blinded assessor, active control superiority study (80% powered) Primary End Point: Comparison of “Time
Slide 15: Mino-Lok Phase 3 End Point Measures
Mino - Lok Phase 3 End Point Measures A significance in the time to catheter failure between the two arms after randomization and TOC (Week 6) in the intent - to - treat (ITT) population (Kaplan - Meier Analysis). • A catheter failure event is ANY of the following: • All - cause mortality at TOC (We
Slide 16: Mino-Lok Development Plan
16 Mino - Lok® Development Plan (as of 08/2019) 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 Phase 2 Clinical Study Chemistry and Manufacturing Control (CMC) Development Registration Manufacturing and Stability Phase 3 ALT Study FDA EOP2 Meeting FDA CMC Meetin
Slide 17: Intellectual Property
17 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 Pate
Slide 18: Regulatory Protection
18 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
Slide 19: Competitive Landscape
19 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 20: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
20 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. • Salvages central venous access in patien
Slide 21: 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 22: 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 (1). • The incidence of post
Slide 23: Rates of Mastectomy and Breast Reconstructive Surgery 2009-2014
Rates of Mastectomy and Breast Reconstructive Surgery 2009 - 2014 CTXR 23 • 62 percent increase in the population rate of breast reconstruction for mastectomy from 2009 to 2014. • 67 percent increase in the ratio of breast reconstructions to mastectomies between 2009 and 2014. • The trend in the rat
Slide 24: Background: Rate of Infection Post-Mastectomy
Background: Rate of Infection Post - Mastectomy • The rate of infection following mastectomy with tissue expander (TE) is 2.4 to 24%. Estimated mean is 12 - 14 %*. • Once the TE becomes infected, the patient is hospitalized and aggressive and lengthy course of antibiotics is used to attempt salvage
Slide 25: Mino-Wrap: Thesis
Mino - Wrap: Thesis • The highest risk for TE - related infections occurs at the time of surgery and as long as drains remain in place (about two weeks post - operatively) and there are portals for microbial colonization. • Mino - Wrap is a malleable, bioabsorbable, antimicrobial wrap that is placed
Slide 26: 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 27: 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 28: Next Steps
Next Steps • Meeting with CDRH Has Been Completed. • Proof of Concept on Final Design • In vitro dissolving and elution experiments • In vivo animal experiments tissue distribution • CMC and Manufacturing Scale Up • Pre - clinical PK and Toxicology (IND enabling) • Pre - IND Meeting Request CTXR 28
Slide 29: Intellectual Property
Intellectual Property CTXR 29 • 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 30: Halo-Lido (CITI-002)
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment Halo - Lido CITI - 002
Slide 31: CITI-002 (halobetasol + lidocaine)
31 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 32: Phase 2a Trial – Positive Directional Improvement
Phase 2a Trial – Positive Directional Improvement • Faster Relief at Day 2 * CTXR 32 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 33: Current Status
Current Status CTXR 33 • Hydro/Lido Trial Results • Use more potent steroid, Halobetasol propionate (HBP), and maintain Lidocaine HCl (LH) • Formulation screen provided a gel and cream with HBP and LH • Ongoing stability tests for new formula F6 (cream) and F7 (gel) • Manufactured scale - up in 2019
Slide 34: Halo/Lido Development Plan
Halo/Lido Development Plan CTXR 34 Phase 2a Clinical Study Product and Formulation Development Phase 2b Clinical Study Pre - Clinical Studies FDA Type C meeting IND Prep VCA 2015 2016 2017 2018 2019 2020 Q1 Q2 Q3 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2021 Q1 Q2 Q3 Q4
Slide 35: Citius Corporate Summary
35 CITIUS Corporate Summary • Addressing attractive diversified multi - billion dollar opportunities – Adjunctive Cancer Care/Infectious Disease and Gastrointestinal Disease • Portfolio addressing recognized unmet medical needs with cost - saving or cost - effective solutions with low risk developme
Slide 36: Financial Summary: Current Cap Table
Financial Summary Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 22,075,781 54.6 % Warrants 16,490,794 40.8 % Options 1,771,039 4.4 % Unit Purchase Options 100 , 667 0. 2 % Fully Diluted Shares Outstanding 40,438,281 100% Principal Insider and Former Insider Shareholders (1)
Slide 37: Management Team
Management Team Executives, Directors, & Board Members
Slide 38: Citius Management Team (Leadership)
38 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 39: Citius Scientific Advisory Board: Dr. Issam Raad
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: Citius Scientific Advisory Board: Jesse Selber
40 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 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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