Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (September 2021)
38 slides from Citius Pharmaceuticals's investor presentation, September 2021
Slide 1: Citius Pharmaceuticals Corporate Overview Autumn 2021
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) CORPORATE OVERVIEW AUTUMN 2021 NASDAQ: CTXR
Slide 2: Forward-Looking Statements
CLICK TO EDIT MASTER STATEMENTS FORWARD-LOOKING TITLE STYLE 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, promi
Slide 3: Overview
CLICK TO EDIT MASTER TITLE STYLE OVERVIEW Citius is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti- infectives in adjunct cancer care, stem cell therapy and unique prescription products Olympic
Slide 4: Investment Highlights
CLICK TO EDITHIGHLIGHTS INVESTMENT MASTER TITLE STYLE • Diversified Pipeline with Five Active Programs • E7777 “I/ONTAK’: purified reformulation of IL-2 diphtheria toxin fusion protein immunotoxin for CTCL • Mino-Lok® (Phase 3): potential to be first and only FDA-approved product to salvage infected
Slide 5: Three Pillars of Our Strategy
CLICK THREETO EDIT MASTER PILLARS OF OURTITLE STYLE STRATEGY NEW CHEMICAL ENTITY FASTER TO MARKET FINANCIAL STEWARDSHIP BENEFITS Advance therapies with unique Invest in assets with Create long-term sustainable commercial advantages differentiated upside potential value for shareholders NASDAQ: CTXR
Slide 6: Recent Developments
CLICK RECENTTODEVELOPMENTS EDIT MASTER TITLE STYLE • Secured exclusive worldwide* license of Eisai’s late-stage cancer immunotherapy “I/ONTAK” (E7777) • Completed characterization and expansion of NoveCite’s i-MSC accession cell bank (ACB) at Waisman Biomanufacturing at the University of Wisconsin-
Slide 7: Five Active Programs
CLICK TO EDIT FIVE ACTIVE MASTERPROGRAMS PIPELINE TITLE STYLE Unlocking Potential. Faster. ESTIMATED INVESTIGATIONAL ANTICIPATED PROGRAM MARKET PRECLINICAL PHASE I PHASE II PHASE III INDICATION MILESTONES (WW) I/ONTAK IL-2R CANCER >$300M BLA 2022 (E7777) IMMUNOTHERAPY MINO-LOK® TREAT CVC > $1.8B NDA
Slide 8: Late-Stage Oncology Asset Added to Pipeline
CLICK TO EDIT LATE-STAGE MASTER TITLE ONCOLOGY ASSETSTYLE ADDED TO PIPELINE • $40 million upfront cash payment to Dr. Reddy’s (DRL) funded with existing capital • Development and commercial • Secured exclusive worldwide* license milestone payments to DRL and Eisai of Eisai’s cancer immunotherapy E77
Slide 9: I/ONTAK (E7777) Transaction Rationale
CLICK TO(E7777) I/ONTAK EDIT MASTER TITLE STYLE TRANSACTION RATIONALE I/ONTAK (E7777) is a novel oncology asset with an attractive near-term revenue opportunity and substantially de-risked path to support commercial success IMPROVED Enhanced formulation of ONTAK®, previously FDA-approved and markete
Slide 10: Multiple Shots on Goal
CLICK TO EDIT MULTIPLE SHOTSMASTER TITLE STYLE ON GOAL Near-term opportunity in CTCL with significant upside potential in PTCL and I/O CTCL PTCL Immuno-Oncology (I/O) ADDRESSABLE • Monotherapy in relapsed / • Monotherapy in relapsed / • Combination with Checkpoint refractory CTCL refractory (R/R) sy
Slide 11: What Is Cutaneous T-Cell Lymphoma (CTCL)?
CLICK TOCUTANEOUS WHAT IS EDIT MASTER TITLELYMPHOMA T-CELL STYLE (CTCL)? Considered to be incurable, CTCL is a CTCL accounts for general term for T-cell lymphoma that approximately 4% of all non- involve the skin, but may also involve the Hodgkin lymphoma (NHL) blood, lymph nodes, and internal organ
Slide 12: I/ONTAK Pivotal Trial in CTCL Nearing Completion
CLICK TOPIVOTAL I/ONTAK EDIT MASTER TRIAL TITLE STYLE IN CTCL NEARING COMPLETION PIVOTAL TRIAL DESIGN Global, multicenter, open Inclusion Criteria: label single arm pivotal - CTCL (MF or SS) clinical trial for the treatment - CD25+ of patients with persistent or - Stage IA-IVA recurrent CTCL - At le
Slide 13: I/ONTAK (E7777): Unique MOA
CLICK TO(E7777): I/ONTAK EDIT MASTER UNIQUETITLE MOA STYLE I/ONTAK expected to be an important option, especially when existing targeted therapies are poorly tolerated or have limited efficacy CCR4 HDAC targeted1 inhibitor2 I/ONTAK (E7777) (denileukin diftitox) CD30 antigen HDAC directed3 targets IL
Slide 14: Pivotal Trial Preliminary Results
CLICK TO EDITPIVOTAL PRELIMINARY MASTERTRIAL TITLERESULTS STYLE No new safety signals identified with I/ONTAK compared to ONTAK PHASE 3 PIVOTAL 21 days SINGLE ARM DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 TRIAL N=70 CYCLE DOSING: 9mcg/kg/day IV CYCLE ORR* ORR* in ITT population in “efficacy-evaluable” populatio
Slide 15: Multi-Layered Protection Through IP and Exclusivity
CLICK TO EDIT MASTER MULTI-LAYERED TITLE STYLE PROTECTION THROUGH IP AND EXCLUSIVITY Proprietary Manufacturing Orphan Drug Designation Process granted for CTCL and PTCL trade secret (eligible for 7 years of marketing exclusivity) BLA Exclusivity Patents Pending limits competition for I/O use as comb
Slide 16: Attractive Near-Term Opportunity in CTCL
CLICK TO EDIT ATTRACTIVE MASTER TITLE NEAR-TERM STYLE OPPORTUNITY IN CTCL PATIENTS LIVING WITH PATIENTS WITH ADVANCED, ADDRESSABLE U.S. CTCL IN THE U.S.1 RELAPSED OR MARKET 1 REFRACTORY CTCL 30-40K 10K $300+ EST. 3,000 NEW CASES PER YEAR 2 THAT REQUIRE SYSTEMIC THERAPY 1 MILLION PHASE 3 TRIAL TOPLIN
Slide 17: I/ONTAK Anticipated Milestones (12-18 Months)
CLICK TO EDITI/ONTAK ANTICIPATED MASTERMILESTONES TITLE STYLE(12-18 MONTHS) 2021 1H 2022 2H 2022 Complete Pivotal trial for Readout of top line Pivotal Submit BLA for CTCL CTCL indication by end of trial results indication year Support start of investigator Initiate program planning to initiated stu
Slide 18: Late-Stage Candidate: Mino-Lok
CLICK TOPRODUCT LATE-STAGE EDIT MASTER TITLE STYLE CANDIDATE: MINO-LOK ® First and Only antibiotic lock therapy under investigation to sterilize and salvage infected Central Venous Catheters (CVCs) 7 Million ~500,000 CRBSI/CLABSI infections Central Venus Catheters annually in the U.S.** (CVCs) used
Slide 19: Mino-Lok Penetrates Biofilm
CLICK TO EDIT MINO-LOK MASTER TITLE ® PENETRATES STYLE BIOFILM Biofilm prevents penetration of pathogen colonies by most traditional antibiotics Attachment Colonization Growth Biofilm Formation NASDAQ: CTXR 19
Slide 20: Current Standard of Care Is a Poor Option
CLICK TO EDIT CURRENT MASTER STANDARD OFTITLE CARESTYLE IS A POOR OPTION Removing & replacing infected CVCs has multiple limitations • Limited availability of other vascular sites • Does not address need to maintain infusion therapy • Potential for complications: infectious, thrombotic and mechanica
Slide 21: Potential Gold Standard CLABSI Treatment
CLICK TO EDIT POTENTIAL GOLDMASTER TITLE IN STANDARD STYLE CLABSI TREATMENT Mino-Lok® addresses the complications, discomfort and cost of CVC removal and replacement ✓ Limited duration IV therapy 5-7 DAYS ✓ Limits disruption of infusion therapy ✓ Ease of Administration • Locking a catheter is a well
Slide 22: Mino-Lok Phase 2b Trial Results
CLICK®TO MINO-LOK EDIT 2B PHASE MASTER TITLE STYLE Mino-Lok® demonstrated a strong safety and efficacy signal TRIAL RESULTS Mino-Lok Arm Control Arm Parameter N % N % Patients 30 100% 60 100% 100% Effective in salvaging CVCs in all Cancer Type patients treated with Mino-Lok® - Hematologic 20 67% 48
Slide 23: Mino-Lok Phase 3 Pivotal Trial Underway
CLICK TO EDIT MINO-LOK MASTER ® PHASE TITLE TRIAL 3 PIVOTAL STYLEUNDERWAY Multi-center, randomized, open label, blinded assessor, active control superiority study Active Arm (n=72) Mino-Lok® Solution Anticipated median Patients with time of CRBSI R 21 days vs. 38 days (n~144) to achieve Control Arm
Slide 24: Mino-Lok Development Plan
CLICK TO EDIT MINO-LOK MASTER TITLE ® DEVELOPMENT STYLE PLAN* Completing Phase 3 pivotal superiority trial 2019 2020 2021 2022 Pivotal Phase 3 ALT Study PRE-CLINICAL & CLINICAL DEVELOPMENT Interim Futility Interim Safety / Interim Analysis Efficacy Analysis Analysis FDA Review NDA FDA filings** Meet
Slide 25: IP Protection Through 2036
CLICK TO EDIT MASTER IP PROTECTION TITLE THROUGH 2036STYLE Mino-Lok® is supported by a robust intellectual property portfolio • Composition of Matter and Method of Use patents that provide protection until June 2024 • Formulation patent has been issued and will add protection through 2036 Creators D
Slide 26: Regulatory Protections
CLICK TO EDITPROTECTIONS REGULATORY MASTER TITLE STYLE Qualified Infectious Disease Product (US) • Priority Review reduces NDA review time from 12 to 6 months • Additional 5 years of market exclusivity upon approval, combined with Hatch-Waxman Fast Track Designation (US) • Expedites review of drugs
Slide 27: Market Opportunity
CLICK MARKETTOOPPORTUNITY EDIT MASTER TITLE STYLE With modest penetration at conservative pricing >$500M peak year US sales achievable with a worldwide opportunity of $1.8B United States Ex-US 4+ million PURSUE DIRECTLY CLABSI’s per year* PARTNER Regulatory Environment Reimbursement Commercial DISAR
Slide 28: Mino-Lok Summary
CLICK TO EDIT MINO-LOK MASTER TITLE STYLE ® SUMMARY Potential market-leading antibiotic lock therapy to salvage the CVC in patients with CRBSI/CLABSI • Breaks down biofilm • First and only • Phase 2b trial: • Effective at barriers therapy under 100% effective in penetrating biofilm Key Advantages Ma
Slide 29: Expanding Portfolio: Engineered Stem Cell Therapy
CLICK TO EDIT EXPANDING MASTER TITLE PORTFOLIO: STYLE STEM CELL THERAPY ENGINEERED + Majority-owned subsidiary of Citius Developing next generation mesenchymal stem cells (NC i-MSCs™) Derived from an iPSC master cell bank Primary focus is ARDS Privately-held pre-clinical stage biotechnology company
Slide 30: Differentiated Stem Cell Platform
CLICK TO EDIT MASTER DIFFERENTIATED TITLEPLATFORM STEM CELL STYLE Next generation allogeneic engineered stem cell platform under development for the treatment of ARDS • Genetically identical i-MSCs™ derived from mutation-free iPSCs SINGLE DONOR / CLONAL • One homogeneous, validated source for all fu
Slide 31: i-MSCs: From One Cell to Trillions
CLICK TO EDIT i-MSCs™: FROM MASTER TITLE ONE CELL TOSTYLE TRILLIONS SINGLE DONOR REPROGRAMMING TO IPSC 4 WEEKS FROM IPSC TO I-MSC™ CELL CULTURE I-MSC™ ACCESSION CELL BANK TO IRB QUALIFIED “FOOTPRINT FREE” CGMP MASTER CELL BANK “ANGEL CELL” (11-14 DAYS) DERMAL FIBROBLAST SYNTHETIC MRNA NO VIRAL VECTO
Slide 32: Interim Results of i-MSC Study in Sheep Model of ARDS
CLICK INTERIM TO EDIT RESULTS OF MASTER TITLE STYLE Improved Oxygenation Less Systemic Shock i-MSC™ STUDY IN SHEEP P/F ratio Norepinephrine Requirement MODEL OF ARDS Animals receiving i-MSCs™ demonstrated stronger therapeutic effects v. control Reduced Pulmonary Lymph FlowLung Vascular InjuryLymph P
Slide 33: NC i-MSC Development Plan
CLICK TO EDIT NC i-MSC™ MASTER TITLE DEVELOPMENT STYLE PLAN* Preparing cGMP NC i-MSC™ Master Cell Bank to support future trials, with IND submission planned for 2022 2020 2021 2022 2023 Preclinical POC sheep Toxicology PRE-CLINICAL & CLINICAL studies studies Phase 1/2 Phase 3 DEVELOPMENT In vitro st
Slide 34: Management Team with Proven Track Record
CLICK TO EDIT MASTER MANAGEMENT TITLE TEAM WITH STYLETRACK RECORD PROVEN LEONARD MAZUR MYRON HOLUBIAK JAIME BARTUSHAK DR. MYRON CZUCZMAN GARY TALARICO EXEC. CHAIRMAN, DIRECTOR PRESIDENT & CEO, DIRECTOR EVP, CFO EVP, CHIEF MEDICAL OFFICER EVP, OPERATIONS JAY WADEKAR DR. ALAN LADER PAUL SOWYRDA JOHN W
Slide 35: Scientific Advisory Board of Leading KOLs
CLICK TO EDIT SCIENTIFIC MASTERBOARD ADVISORY TITLE STYLE OF LEADING KOLS INFECTIOUS DISEASE / CANCER ADVISORS CELL THERAPY ADVISORS Isaam Raad, MD Michael A. Matthay, MD University of Texas MD Anderson Cancer Center University of California at San Francisco (UCSF) Mark Rupp, MD Lorraine B. Ware, MD
Slide 36: Financial Summary
CLICK SUMMARY* FINANCIAL TO EDIT MASTER TITLE STYLE % OF FULLY CURRENT CAPITALIZATION SHARES Bandwidth to Execute DILUTED • $127.6M Financing activities 1H 2021 BASIC SHARES OUTSTANDING 145,979,429 76.5% • $7.7M R&D expense 1H 2021 WARRANTS 40,234,172 21.1% • Runway into 2023 OPTIONS 4,655,166 2.4%
Slide 37: Poised for Growth
CLICK POISEDTO EDIT FOR MASTER TITLE STYLE GROWTH Attractive diversified pipeline in oncology, adjunctive cancer care, infectious disease and gastrointestinal disease HALO-LIDO I/ONTAK (E7777) Rx therapy for hemorrhoids Treat CTCL/PTCL, I/O MINO-LOK NC i-MSC Treat ARDS Treat CVC infections MINO-WRAP
Slide 38: Contact
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact Ilanit Allen ir@citiuspharma.com NASDAQ: CTXR
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