Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (August 2020)
36 slides from Citius Pharmaceuticals's investor presentation, Aug 26, 2020
Slide 1: Citius Pharmaceuticals, Inc. Corporate Presentation Fall 2020
Citius Pharmaceuticals, Inc. Corporate Presentation Fall 2020 NASDAQ: CTXR
Slide 2: Disclaimer
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 direct
Slide 3: Company Overview
Olympic Motto: “ Citius , Altius, Fortius ” (Faster, Higher, Stronger) Late Stage Lead Asset Large Market Needs Expert Team to Execute Mino - Lok mid - way through Phase 3; Favorable review received for Futility Analysis by Independent Review Board; superior efficacy interim scheduled late September
Slide 4: Management
4 Management Leonard Mazur, Director and Executive Chairman • Founder/co - founder of: Genesis, Triax , Akrimax , and others Myron Holubiak, Director, CEO and President • Former President of Roche Laboratories, Inc. Jaime Bartushak, EVP, Chief Financial Officer • Over 20 years experience in corporat
Slide 5: Key Scientific/Medical Advisors (ID and CA)
Key Scientific/Medical Advisors (ID and CA) Isaam Raad , M.D • Chair of MD Anderson Cancer Center’s Dept. of Infectious Diseases • Author of the underlying patents for Mino - Lok® • Dr. Raad’s innovations have been endorsed at the highest level (Category 1A) by the Center for Disease Control (CDC) M
Slide 6: Key Cellular Therapy Advisors
6 Key Cellular Therapy Advisors Michael A. Matthay, MD • Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF) • Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. • Research focused on the p
Slide 7: Unique Pipeline in Progressive Stages
Program Market (Worldwide) Preclinical Phase I Phase II Phase III Mino - Lok® Treat CVC Infections > $1.5B CITI - 002 (Halo - Lido) Rx Therapy for Hemorrhoids > $2B CITI - 101 (Mino - Wrap) Prevent Infections Associated with Breast Implants ~ $400M Option CITI - 401 ( i MSC ) Treat ARDS Multi - bill
Slide 8: NoveCite: ARDS in COVID-19
8 NASDAQ: CTXR SARS - CoV - 2 NoveCite : ARDS in COVID - 19
Slide 9: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) 9 NASDAQ: CTXR ARDS Lung Normal a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS impairs the lungs’ ability to exchange oxygen for carbon dioxide includes shortness of breath, rapid breathing, and blui
Slide 10: MSC Mechanisms of Action in the Lungs
10 MSC Mechanisms of Action in the Lungs NASDAQ: CTXR
Slide 11: NoveCite Planned Program: iMSCs
• NoveCite i MSCs are induced Pluripotent Stem Cell (iPSC) - derived mesenchymal stem cells NOT donor - derived • Donor - derived MSCs are sourced from individual donors (bone marrow, adipose tissue, placenta, umbilical tissue, etc.) and have significant limitations • i MCS are the next generation m
Slide 12: What Makes NoveCite Cells, iMSCs, Different?
12 What Makes NoveCite Cells, i MSCs , Different? Feature • Single source induced pluripotent stem cell (iPSC) master cell bank vs. cells from multiple donors • Rapid production of i MSCs (expansion directly from master cell bank) • Higher expansion capability ( no need to re - harvest donor cells)
Slide 13: Summary of NoveCite Opportunity
13 NASDAQ: CTXR Element Comments Market Opportunity ARDS is a significant unmet medical need, now made larger and more urgent with COVID - 19 MSCs Well accepted as safe therapies for ARDS Novellus Technology mRNA platform (synthetic, non - immunogenic) creates superior i PSC & i MSC characteristics
Slide 14: Lead Product: Mino-Lok
LEAD PRODUCT Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections Mino - Lok®
Slide 15: The Problem: CVCs are a Lifeline for Cancer Patients
THE PROBLEM: CVCs are a Lifeline for Cancer Patients BUT Infection Rates + Poor SOC Leads to Death & Morbidity Infections are Common & Dangerous Of the 7,000,000 CVCs used annually in US, up to 472,000 become infected leading to serious, life threatening infections called CRBSI/CLABSI. 1 These infec
Slide 16: CVC Remove and Replace (R&R) Complications
16 CVC Remove and Replace (R&R) Complications R&R procedures are invasive and discomforting to patient R&R Procedures are costly and usually require additional hospital stay. Complications include infection, thrombosis, occlusion, and mechanical complications. x Infectious complications are reported
Slide 17: Locking a Central Venous Line with Mino-Lok
17 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 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 Pivotal Trial Design
Active Arm (n=72) Mino - Lok® Solution Control Arm (n=72) Antibiotic Lock Patients with CRBSI/CLABSI (n~ 144) R Multi - center, randomized, open label, blinded assessor, active control superiority study (80% powered) Futility Performed at 35 - 40 Events and 60 - 70 Events for Superior Efficacy Adjun
Slide 20: Mino-Lok Development Plan
Mino - Lok® Development Plan (estimated as of 08/2020) 2015 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pivotal Phase 3 ALT Study 2019 Q1 Q2 Q3 Q4 2020 Q1 Q2 Q3 Q4 2021 Q1 Q2 Q3 Q4 Interim Data Superior Efficacy First Patient In Interim Data Futility Analysis NASDAQ: CTXR 20 FDA I
Slide 21: Market Opportunity
Market Opportunity 21 NASDAQ: CTXR Worldwide Ex - US United States Regulatory Updates Reimbursement Pricing With modest penetration at conservative pricing, we believe that >$500M peak year U.S. sales is achievable. DISARM Act is pending in the Senate, which would create a DRG carveout for QIDP prod
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 Pate
Slide 23: Qualified Infectious Disease Product (QIDP)
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 exclusivity at NDA, combined wit
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. • Salvages central venous access in patien
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: 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 implant becomes infected, the patient is usually hospitalized requiring approximate 2 weeks of IV and/or oral antimicrobials;
Slide 28: 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 29: Mino-Wrap Development Plan
29 Mino - Wrap Development Plan (estimated as of 08/2020) 2019 2020 2021 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre - Clinical Studies* Chemistry and Manufacturing Control (CMC) Development Phase 3 Study Concept Planning and Risk Analysis Product Devel
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 would 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 - ap
Slide 32: Current Status
Current Status NASDAQ: CTXR 32 • Based on the results of phase 2 trial in 240 patients, CTXR elected to use super potent steroid Halobetasol propionate (HBP), maintained Lidocaine HCl (LH) and developed 10 prototype formulations • Two formulations selected for Vasoconstriction Assay (VCA) studies •
Slide 33: Halo/Lido Development Plan
Halo/Lido Development Plan (estimated as of 08/2020) NASDAQ: CTXR 33 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 Phase 2a Clinical Study Product and Formulation Development Phase 2b Clinical Study Pre - Clinical Studies FDA Type C meeting IND
Slide 34: Citius Corporate Summary
34 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 35: Financial Summary
Financial Summary (as of 08/10/20) Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 55,475,822 65.1 % Warrants 26,926,646 31.6 % Options 2,765,171 3.3 % Unit Purchase Options 100 , 667 0. 1 % Fully Diluted Shares Outstanding 85,268,306 100% Stock Price Current Price $ 1.15 52 W
Slide 36: Citius Pharmaceuticals, Inc. Contact
36 Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact : Andrew Scott – V.P., Corporate Development (908) 967 - 6677 x105 ascott@citiuspharma.com NASDAQ: CTXR
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