Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (September 2023)
28 slides from Citius Pharmaceuticals's investor presentation, Sep 11, 2023
Slide 1: Citius Pharmaceuticals Corporate Update September 2023
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Update SEPTEMBER 2023
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
Slide 3: Investment Highlights
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 3 INVESTMENT HIGHLIGHTS Diversified Pipeline: Building a Biotech Platform • LYMPHIR Ρ : purified reformulation of IL - 2 diphtheria toxin fusion protein for CTCL 1 (P3 completed) • Mino - Lok ® : potential to be first and only FDA - approved product to s
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
Slide 5: Milestones & Recent Developments
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MILESTONES & RECENT DEVELOPMENTS 5 2021 2023 2022 2024 Early 2024: resubmission planned • July 28: CRL • Citius addressing enhanced product testing required by FDA • No clinical data issues related to safety or efficacy • Citius planning for resubmission
Slide 6: Mino-Lok
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MINO - LOK Phase 3 6
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 (CVC
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 • Infusion therapy interrupted • Potential for complications • infectious, thrombotic and mechanical • 57% - 67% of patients experience adverse physical and psycho
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 s tandard operating procedure x Not flushed into the venous system x Lowers r
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 Patients t
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
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
Slide 13: LYMPHIR (I/ONTAK, E7777)
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LYMPHIR (I/ONTAK, E7777) 13
Slide 14: LYMPHIR Licensing and FDA Pathway
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LYMPHIR 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 Q3
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
Slide 16: Why LYMPHIR?
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE WHY LYMPHIR? Near - term revenue opportunity for a reformulated oncology asset with a unique MOA targeting an underserved clinical condition 16 Improved formulation of previously FDA - approved drug (ONTAK); marketed 1999 - 2014 Developed for the treatme
Slide 17: Differentiated Mechanism of Action (MOA)
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR’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 Immunosuppress
Slide 18: Competitive Landscape
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MOA Marketed By Brand CD30 antigen directed CCR4 targeted HDAC inhibitor COMPETITIVE LANDSCAPE LYMPHIR ( E7777 ) (denileukin diftitox) Differentiated MOA targets IL - 2 receptor Potential to be additive to market • Since CTCL treatments are non - curativ
Slide 19: Market Opportunity
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MARKET OPPORTUNITY • Estimated U.S. market size for LYMPHIR 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 for
Slide 20: LYMPHIR Phase 3 Trial (Study 302): Completed
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 20 LYMPHIR PHASE 3 TRIAL (STUDY 302): COMPLETED Pivotal, multicenter, open - label, single - arm study of LYMPHIR in subjects with persistent or recurrent CTCL LEAD - IN STUDY n=21 MAIN STUDY n=71 Stage I - IV CTCL All subjects were diagnosed with Mycosi
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
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 48 . 4 % subjects with ≥ 50 % reduction in skin tumor burden . Complete clearing of s
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 6% CAPILLARY LEAK SYNDROME 23 • No evidence of cumulative toxicity • Most patients experienced low g rade 1/2 treatment emergent adverse events (TEAEs) Overall, LYMPHIR was well -
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
Slide 25: Halo-Lido
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE HALO - LIDO Halobetasol/Lidocaine 25
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
Slide 27: Summary
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE SUMMARY 27
Slide 28: Why Invest? Why Now?
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE WHY INVEST? WHY NOW? 28 • Diversified late - stage pipeline with near term catalysts • Healthy Financial Platform with cash runway through August 2024 • $33.3 M cash as of 6/30/23 • $26.5 M invested by founders % OF FULLY DILUTED SHA R ES CURRENT CAP ITA
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