Citius Pharmaceuticals, Inc. · NASDAQ:CTXR

Citius Pharmaceuticals — Investor Presentation (June 2023)

29 slides from Citius Pharmaceuticals's investor presentation, Jun 29, 2023

  1. Slide 1: Citius Pharmaceuticals Corporate Update June 2023

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Update JUNE 2023

  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: Investment Highlights

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 3 INVESTMENT HIGHLIGHTS Diversified Pipeline: Building a Biotech Platform • BLA Filed: LYMPHIR Ρ - purified reformulation of IL - 2 diphtheria toxin fusion protein for CTCL 1 • Phase 3: Mino - Lok ® - potential to be first and only FDA - approved product

  4. Slide 4: Management Team with Proven Track Record

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 4 MANAGEMENT TEAM WITH PROVEN TRACK RECORD LEONARD MAZUR CHAIRMAN, CEO & CO - FOUNDER JAIME BARTUSHAK EVP, CFO & CBO DR. MYRON CZUCZMAN EVP, CHIEF MEDICAL OFFICER MYRON HOLUBIAK VICE CHAIRMAN & CO - FOUNDER DR. ALAN LADER SVP , CLINICAL OPERATIONS JAY WA

  5. Slide 5: 2023 Milestones & Anticipated Catalysts

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 2023 MILESTONES & ANTICIPATED CATALYSTS • LYMPHIR Œ FDA target decision date (PDUFA): July 28, 2023 • Anticipated Mino - Lok Phase 3 trial completion • 85 of 92 required events achieved • Topline results of Halo - Lido Phase 2b trial • Enrollment complet

  6. Slide 6: Mino-Lok Phase 3

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MINO - LOK ® Phase 3 6

  7. Slide 7: Late-Stage Product Candidate: Mino-Lok

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 7 LATE - STAGE PRODUCT CANDIDATE: MINO - LOK ® 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 (C

  8. Slide 8: Current Standard of Care Is a Poor Option

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 8 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% of patients experience adver

  9. Slide 9: 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 in

  10. Slide 10: Mino-Lok Phase 2b Trial Results

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 10 MINO - LOK ® PHASE 2B TRIAL RESULTS *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

  11. Slide 11: Mino-Lok Phase 3 Pivotal Trial Underway

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Multi - center, randomized, open label, blinded assessor, active control superiority study • Primary Endpoint: Comparison of Time to Catheter Failure Event (TOC = 6 weeks) • Interim Analyses: DMC recommended proceeding with trial without modification fol

  12. Slide 12: IP & Regulatory Protections

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE IP & 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) • Exped

  13. Slide 13: LYMPHIR (I/ONTAK, E7777) BLA Filed

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LYMPHIR Π(I/ONTAK, E7777) BLA Filed 13

  14. Slide 14: LYMPHIR Licensing and FDA Pathway

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LYMPHIR Œ LICENSING AND FDA PATHWAY Q3 2021: Citius Acquired the Exclusive License to Eisai’s E7777 in all Markets Except Japan and Parts of Asia from Dr. Reddy’s Q4 2021: E7777 Phase 3 Clinical Trial Completed (December) Q3 2021 Q3 2023 Q4 2021 Q3 2022

  15. Slide 15: What Is Cutaneous T-Cell Lymphoma (CTCL)?

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE WHAT IS CUTANEOUS T - CELL LYMPHOMA (CTCL)? Plaque Stage Tumor Stage Considered to be incurable, CTCL is a general term for T - cell lymphoma that involve the skin, but may also involve the blood, lymph nodes, and internal organs CTCL accounts for approx

  16. Slide 16: Why LYMPHIR?

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE WHY LYMPHIR Π? Reformulated oncology asset with an attractive near - term revenue opportunity 16 Improved formulation of previously FDA - approved drug (ONTAK); marketed 1999 - 2014 Developed for the treatment of cutaneous T - cell lymphoma (CTCL) Marke

  17. Slide 17: Differentiated Mechanism of Action

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR Œ ’s differentiated mechanism of action supports two therapeutic effects Targets Malignant Cells • Binds to IL - 2 receptors to deliver diphtheria toxin, killing tumor cells directly Eliminates Immunosuppr

  18. Slide 18: Competitive Landscape

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Brand Marketed By MOA CD30 antigen directed CCR4 targeted HDAC inhibitor COMPETITIVE LANDSCAPE LYMPHIR Ρ ( E7777 ) (denileukin diftitox) Differentiated MOA targets IL - 2 receptor Potential to be additive to market • Since CTCL treatments are non - curat

  19. Slide 19: Market Opportunity

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MARKET OPPORTUNITY • Estimated U.S. market size for LYMPHIR Ρ in CTCL is $300 - $400+ million • Key growth drivers expected to increase overall market size and facilitate market penetration • Evolving treatment paradigm; incremental therapeutic option fo

  20. Slide 20: LYMPHIR Phase 3 Trial (Study 302): Completed

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 20 LYMPHIR ΠPHASE 3 TRIAL (STUDY 302): COMPLETED Pivotal, multicenter, open - label, single - arm study of LYMPHIR Πin subjects with persistent or recurrent CTCL LEAD - IN STUDY n=21 MAIN STUDY n=71 Stage I - IV CTCL All subjects were diagnosed with My

  21. Slide 21: Study 302: Phase 3 Clinical Trial Results

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE STUDY 302: PHASE 3 CLINICAL TRIAL RESULTS 1 . Primary Efficacy Analysis Set includes 69 Stage I - III CTCL subjects from the Lead - In Study and the Main Study who received a dose of 9 ug/kg/day of study drug . Two subjects were considered by the Indepen

  22. Slide 22: Meaningful Response in CTCL Patients

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MEANINGFUL RESPONSE IN CTCL PATIENTS 1 . In the Primary Efficacy Analysis set, 84 . 4 % ( 54 / 64 ) of skin evaluable subjects had a decrease in skin tumor burden, with almost one - third of these subjects ( 32 . 8 % , 21 / 64 ) having a ≥ 80 % maximum d

  23. Slide 23: No New Safety Signals

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE NO NEW SAFETY SIGNALS Low rate of Grade ≥3 capillary leak syndrome at 9µg 5.8% CAPILLARY LEAK SYNDROME 0.0% No Grade ≥3 loss in visual acuity observed during the trial VISUAL IMPAIRMENT 4.3% Limited infusion site reaction INFUSION REACTION 23 • No eviden

  24. Slide 24: Opportunities for Growth

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE OPPORTUNITIES FOR GROWTH 24 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. KYMRIAH® is a registered trademark of Novartis AG, Basel, Switzerland PTCL expanded indication potential

  25. Slide 25: Halo-Lido Phase 2b

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE HALO - LIDO Phase 2b Halobetasol/Lidocaine 25

  26. Slide 26: Halo-Lido: Phase 2b Trial Overview

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE • Based on the results of Phase 2 trial in 240 patients, CTXR elected to use highly potent steroid Halobetasol propionate (HBP), maintained Lidocaine HCl (LH) and developed 10 prototype formulations • A cream formulation containing novel excipient select

  27. Slide 27: Summary

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE SUMMARY 27

  28. Slide 28: Why Invest? Why Now?

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE WHY INVEST? WHY NOW? Multiple value - creating catalysts on the horizon 28 H ALO - L IDO Rx therapy for hemorrhoids M INO - L OK Salvage CVCs M INO - W RAP Prevent Infections associated with breast Implants post - mastectomy NC i - MSC Treat ARDS with i

  29. Slide 29: Financial Summary

    NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 29 FINANCIAL SUMMARY CURRENT CAP ITALIZATION (2) SHA R ES % OF FULLY DILUTED BASIC SHARES OUTSTANDING 158,857,798 72.3% WARRANTS 51,563,999 23.5% OPTIONS 9,400,171 4.3 % FULLY DILUTED SHARES OUTSTANDING 219,821,968 100% As of 3/31/23 unless otherwise not

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