Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (January 2020)
37 slides from Citius Pharmaceuticals's investor presentation, Jan 22, 2020
Slide 1: Citius Pharmaceuticals, Inc. Corporate Presentation Winter 2020
Citius Pharmaceuticals, Inc. Corporate Presentation Winter 2020 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
Olympic Motto: “ Citius , Altius, Fortius ” (Faster, Higher, Stronger) Late Stage Lead Asset Large Market Need Expert Team to Execute Mid - way through Phase 3; Favorable review received from Futility Analysis by Independent Review Board Market estimated to be ~$1.5B worldwide; current SOC is danger
Slide 4: Key Management & Advisors
Key Management & Advisors We believe we have the team needed to execute on commercial preparation, IDSA guidelines, and strategic partnerships MANAGEMENT SCIENTIFIC ADVISORS Leonard Mazur, Director and Chairman of the Board Myron Holubiak, President & CEO and Director Jaime Bartushak, CFO • 20 years
Slide 5: 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 Next milestone: Phase 2B Initiated (Q3 2020) Pre -
Slide 6: Lead Product: Mino-Lok
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 NASDAQ: CTXR
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: The Problem: CVCs are a Lifeline for Cancer Patients
THE PROBLEM: CVC’s 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 infe
Slide 11: Long-term CVC or port related bacteremia treatment guidelines
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 12: CVC Remove and Replace (R&R) Complications
12 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 13: Locking a Central Venous Line with Mino-Lok
13 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 14: Phase 2b Trial Results
14 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 15: 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) Performed at 40% for Futility and 75% for Superiority Adjunct in CLABSI/CRBSI 15 Mi
Slide 16: Mino-Lok Time-To-Catheter Failure Trial Design
Mino - Lok® Time - To - Catheter Failure Trial Design 0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 60 Catheter Survival (%) Time (days) Kaplan - Meier Model ALT MLT 21 vs. 38 Day Difference in Median Number of Catheter Failures NASDAQ: CTXR 16
Slide 17: Phase 3 Futility Analysis Complete
17 Independent Data Monitoring Committee has recommended to continue the Phase 3 trial with no amendments Mino - Lok® is Fast Tracked & Priority Reviewed. Test for Superior Efficacy is Estimated to Occur Q2 2020. Phase 3 Futility Analysis Complete (Dec. 2019) NASDAQ: CTXR
Slide 18: Mino-Lok Development Plan
Mino - Lok® Development Plan (estimated as of Jan. 2020) 2014 2015 2016 2017 2018 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 2 Chemistry and Manufacturing Control (CMC) Development Registration Manufacturing and Stability Phase 3 ALT Study h FDA EOP2 Meeting FDA CMC Meeting 2019 Q1
Slide 19: Regulatory Pathway: QIDP and Fast Track
• 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 w
Slide 20: Market Opportunity
Market Opportunity 20 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 products. This wo
Slide 21: Intellectual Property
21 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 22: Competitive Landscape
22 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 23: Mino-Lok summary
23 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 24: 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 25: 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 26: Background on Tissue Expanders
Background on Tissue Expanders A Tissue Expander (TE) serves as a temporary implant that is placed below the pectoralis muscle within the mastectomy space. Once a sufficiently large soft tissue envelope has been created, the TE is replaced by a permanent breast implant (two - stage approach). 26 NAS
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 Jan. 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 Dev
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 * 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% 54.50
Slide 33: Current Status
Current Status 33 • Hydro/Lido Trial Results • Use more potent steroid, Halobetasol propionate (HBP), and maintain Lidocaine HCl (LH) • Formulation screen examined a gel and cream • Ongoing stability tests for new formula (cream and gel) • Completed Vasoconstriction Assay (VCA) study to determine op
Slide 34: Halo/Lido Development Plan
Halo/Lido Development Plan (estimated as of Jan. 2020) 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
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
Financial Summary (as of 01.20.2020) Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 31,348,299 54.6 % Warrants 23,246,172 40.4 % Options 2,751,838 4.8 % Unit Purchase Options 100 , 667 0. 2 % Fully Diluted Shares Outstanding 57,446,976 100% Principal Insider and Former Inside
Slide 37: Corporate Profile
37 Corporate Profile Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 908 - 967 - 6677 www.citiuspharma.com IRTH Communications Robert Haag, Managing Director 866 - 976 - 4784 CTXR@irthcommunications.com Media and Investor Relations: NASDAQ: CTXR
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