Citius Pharmaceuticals, Inc. · NASDAQ:CTXR

Citius Pharmaceuticals — Investor Presentation (July 2021)

29 slides from Citius Pharmaceuticals's investor presentation, Jul 7, 2021

  1. Slide 1: Citius Pharmaceuticals Corporate Overview July 2021

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) CORPORATE OVERVIEW JULY 2021

  2. Slide 2: Forward-Looking Statements

    NASDAQ: CTXR CLICK TO EDIT MASTER 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, promise or repres

  3. Slide 3: Overview

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 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 produ

  4. Slide 4: Investment Highlights

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 4 INVESTMENT HIGHLIGHTS • Extensive pharma operational and financial track record • Experienced “Blue Ribbon” Board of Directors • Scientific Advisory Board of leading KOL’s in infectious disease, pulmonology (ARDS), and breast surgery • Multi - billion

  5. Slide 5: Three Pillars of Our Strategy

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE F ASTER TO M ARKET Invest in assets with differentiated upside potential Advance assets with a unique commercial advantage Create long - term sustainable value for shareholders 5 THREE PILLARS OF OUR STRATEGY N EW C HEMICAL E NTITY B ENEFITS F INANCIAL S

  6. Slide 6: Four Active Pipeline Programs

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE PROGRAM INVESTIGATIONAL INDICATION ESTIMATED MARKET (WW) PRECLINICAL PHASE I PHASE II PHASE III ANTICIPATED MILESTONES MINO - LOK ® T REAT CVC I NFECTIONS > $1.8B HALO - LIDO (CITI - 002) R X T HERAPY FOR H EMORRHOIDS > $2B MINO - WRAP (CITI - 101) P REV

  7. Slide 7: Lead Product Candidate: Mino-Lok

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LEAD PRODUCT CANDIDATE: MINO - LOK ® 7 First and Only antibiotic lock therapy under investigation to sterilize and salvage infected Central Venous Catheters (CVCs) CRBSI/CLABSI infections annually in the U.S.** ~500,000 Central Venus Catheters (CVCs) use

  8. Slide 8: Mino-Lok Penetrates Biofilm

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 8 MINO - LOK ® PENETRATES BIOFILM Biofilm formation protects pathogen colonies from traditional antibiotic lock therapies

  9. Slide 9: Current Standard of Care Is a Poor Option

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 9 CURRENT STANDARD OF CARE IS A POOR OPTION • Limited availability of other vascular sites • Does not address need to maintain infusion therapy • Potential for complications: infectious, thrombotic and mechanical • 57% - 67% patients experience adverse p

  10. Slide 10: Potential Gold Standard in CLABSI Treatment

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE POTENTIAL GOLD STANDARD IN CLABSI TREATMENT x Limited duration IV therapy x Limits disruption of infusion therapy x Ease of Administration • Locking a catheter is a well known SOP • Procedure can be performed by any healthcare provider x Not flushed into

  11. Slide 11: Mino-Lok Phase 2b Trial Results

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MINO - LOK ® PHASE 2B TRIAL RESULTS 11 *1 polymicrobial patient had Gr+ and Gr – organism cultured; ** 6 patients had >1 complication; ***all 3 CVCs were removed within 1 month. Effective in salvaging CVCs in all patients treated with Mino - Lok ® Patien

  12. Slide 12: Mino-Lok Phase 3 Pivotal Trial Underway

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Active Arm (n=72) Mino - Lok® Solution Control Arm (n=72) Antibiotic Lock Patients with CRBSI (n~144) R Multi - center, randomized, open label, blinded assessor, active control superiority study Anticipated median time of 21 days vs. 38 days to achieve s

  13. Slide 13: Mino-Lok Development Plan

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 2019 2020 2021 2022 Pivotal Phase 3 ALT Study PRE - CLINICAL & CLINICAL DEVELOPMENT REGULATORY PRODUCT & CMC FDA filings** NDA submission *As of 7/2021, best estimate subject to impact of COVID - 19 pandemic on operations ** in vitro disc study…catheter

  14. Slide 14: IP Protection Through 2036

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE IP PROTECTION THROUGH 2036 Mino - Lok TM 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 throu

  15. Slide 15: Regulatory Protections

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE REGULATORY PROTECTIONS 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

  16. Slide 16: Competitive Landscape

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE COMPETITIVE LANDSCAPE Company Product Status Limitation NDA accepted by the FDA in August 2020 CRL received from FDA in March 2021 Available in Europe (CE Mark) Prevention only Anti - infective only being used in prophylaxis • No company has US regulator

  17. Slide 17: Market Opportunity

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Regulatory Environment Reimbursement Commercial With modest penetration at conservative pricing >$500M peak year US sales achievable with a worldwide opportunity of $1.8B DISARM Act pending • create a DRG carveout for QIDP products • Allow for full reimb

  18. Slide 18: Mino-Lok Summary

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 18 MINO - LOK ® SUMMARY Potential market - leading antibiotic lock therapy to salvage the CVC in patients with CRBSI/CLABSI Patented solution • Breaks down biofilm barriers • Provides anti - clotting properties to maintain CVC patency • Worldwide license

  19. Slide 19: Expanding Portfolio: Engineered Stem Cell Therapy

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 19 EXPANDING PORTFOLIO: ENGINEERED STEM CELL THERAPY Privately - held pre - clinical stage biotechnology company with patented non - immunogenic mRNA technology for gene editing Majority - owned subsidiary of Citius Developing next generation mesenchymal

  20. Slide 20: Differentiated Stem Cell Platform

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE SINGLE DONOR / CLONAL • Genetically identical i - MSCs Œ derived from mutation - free iPSCs • One homogeneous, validated source for all future cells • NO repeat harvesting from multiple donors; NO repeat donor testing SCALABLE MFG • Rapid production from

  21. Slide 21: i-MSC Accession Cell Bank

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE i - MSC Œ A CCESSION C ELL B ANK 4 W EEKS FROM I PSC TO I - MSC Œ C ELL C ULTURE One homogeneous, validated source for all future cells Patented synthetic, non - immunogenic mRNA high efficiency cell reprogramming S INGLE DONOR IRB QUALIFIED “A NGEL C EL

  22. Slide 22: Interim Results of i-MSC Study in Sheep Model of ARDS

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE P/F ratio Pulmonary Lymph Flow Pulmonary Lymph Protein Loss Norepinephrine Requirement Improved Oxygenation Reduced Lung Vascular Injury Less Systemic Shock Animals receiving i - MSC s Πdemonstrated stronger therapeutic effects v. control INTERIM RESULT

  23. Slide 23: NC i-MSC Development Plan

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 2020 2021 2022 2023 POC sheep studies Preclinical Toxicology studies Phase 1/2 Phase 3 In vitro studies Pre - IND FDA consultations End of Ph2 Mtg IND Submission Pre - NDA FDA Mtg NDA Submission Product development & testing i - MSC ΠMCB Chemical & Manu

  24. Slide 24: Diversified Pipeline with Near Term Catalysts

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 24 DIVERSIFIED PIPELINE WITH NEAR TERM CATALYSTS Q2 2021 • Mino - Lok ® DMC recommends proceeding with trial as planned Q3 2021 • Dosing to commence in NC i - MSC Œ pilot study Q4 2021 • Halo - Lido (CITI - 002) IND filing • Halo - Lido (CITI - 002) Phas

  25. Slide 25: Management Team with Proven Track Record

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 25 MANAGEMENT TEAM WITH PROVEN TRACK RECORD LEONARD MAZUR EXECUTIVE CHAIRMAN, DIRECTOR MYRON HOLUBIAK PRESIDENT & CEO, DIRECTOR JAMIE BARTUSHAK EVP, CFO GARY TALARICO EVP, OPERATIONS DR. MYRON CZUCZMAN EVP, CHIEF MEDICAL OFFICER DR. ALAN LADER VP, CLINIC

  26. Slide 26: Scientific Advisory Board of Leading KOLs

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE CELL THERAPY ADVISORS Michael A. Matthay, MD University of California at San Francisco (UCSF) Lorraine B. Ware, MD Vanderbilt University Mitchell M. Levy, MD Brown University, Rhode Island Hospital Perenlei Enkhbaatar MD, PhD, FAHA University of Texas Jo

  27. Slide 27: Financial Summary

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE FINANCIAL SUMMARY * 27 CURRENT CAP ITALIZATION SHA R ES % OF FULLY DILUTED BASIC SHARES OUTSTANDING 145,979,429 76.5 % WARRANTS 40,234,172 21.1 % OPTIONS 4,655,166 2.4 % FULLY DILUTED SHARES OUTSTANDING 190,868,767 100% ( 1 ) Beneficial stock ownership a

  28. Slide 28: Citius: Why Invest? Why Now?

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 28 CITIUS: WHY INVEST? WHY NOW? Diversified pipeline of potential first - in - class products addressing recognized unmet medical needs Attractive diversified multi - billion dollar opportunities in adjunctive cancer care, infectious disease and gastroin

  29. Slide 29: Citius Pharmaceuticals Contact

    NASDAQ: CTXR 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 iallen@citiuspharma.com

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