Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (March 2025)
24 slides from Citius Pharmaceuticals's investor presentation, March 2025
Slide 1: Citius Pharmaceuticals Corporate Overview March 2025
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Overview MARCH 2025 NASDAQ: CTXR
Slide 2: Forward-Looking Statements
CLICK TO EDIT MASTER TITLE FORWARD-LOOKING STYLE STATEMENTS 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: Investment Highlights
CLICK TO EDITHIGHLIGHTS INVESTMENT MASTER TITLE STYLE Biopharmaceutical company with multiple advanced development programs Diversified Portfolio • LYMPHIR (denileukin diftitox-cxdl) • NOW APPROVED for the treatment of cutaneous T-cell lymphoma (CTCL) • Mino-Lok® • Only treatment designed to salvage
Slide 4: Citius Oncology, Inc. (NASDAQ: CTOR)
CLICK CITIUSTO EDIT MASTER ONCOLOGY, INC.TITLE STYLECTOR) (NASDAQ: Biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies • Lead product, LYMPHIR , FDA approved August 2024 • Orphan Indication: treatment of adult patients with relapsed or refractor
Slide 5: Citius Is Preparing to Launch LYMPHIR in 1H 2025
CLICK TO EDIT MASTER TITLE STYLE CITIUS IS PREPARING TO LAUNCH LYMPHIR IN 1H 2025 Commercial launch readiness nearing completion through disciplined financial strategy Citius has invested ~$90 Significant pre-commercial Additional pre-commercial million in LYMPHIR to date activities have been activi
Slide 6: Opportunities for Growth Beyond CTCL
CLICK TO EDIT MASTER OPPORTUNITIES TITLE STYLE FOR GROWTH BEYOND CTCL • University of Pittsburgh: an investigator-initiated trial is underway to evaluate LYMPHIR for potential use as an immuno-oncology therapy in combination with KEYTRUDA® in patients with recurrent or metastatic solid tumors (NCT05
Slide 7: University of Pittsburgh Interim Study Data
CLICK TO EDIT UNIVERSITY OFMASTER TITLE INTERIM PITTSBURGH STYLE STUDY DATA • 27% Objective Response Rate (ORR) • 33% Clinical Benefit Rate (CBR) • Median Progression Free Survival (PFS) of 57 weeks • Chemotherapy-free immunomodulatory regimen well-tolerated with no documented serious immune- relate
Slide 8: Competitive Landscape
CLICK TO EDIT LANDSCAPE COMPETITIVE MASTER TITLE STYLE Today’s CTCL treatments are non-curative • Current systemic therapies often have a limited duration of response and/or are discontinued early due to adverse events • Prescribing is based on patient needs and not on a sequential pathway Antibody
Slide 9: LYMPHIR Holds Potential to Deliver Significant Value
CLICK TO EDIT LYMPHIR HOLDSMASTER TITLETO POTENTIAL STYLE DELIVER SIGNIFICANT VALUE LYMPHIR is poised for successful launch with potential upside opportunities beyond CTCL • LYMPHIR is an approved therapy in a rare indication with no curative therapies • Estimated $400M+ addressable U.S. market with
Slide 10: Mino-Lok: Phase 3 Trial Completed, Positive Topline Data
CLICK TO EDIT MASTER TITLE STYLE MINO-LOK Phase 3 Trial Completed: Positive Topline Data NASDAQ: CTXR 10
Slide 11: Mino-Lok Overview
CLICK TO EDIT MINO-LOK MASTER TITLE STYLE OVERVIEW A novel antibiotic lock solution designed to salvage catheters in patients with catheter-related bloodstream infections Mino-Lok addresses the complications, discomfort and cost of catheter removal and replacement No drugs currently approved to salv
Slide 12: Central Venous Catheters
CLICK TO EDIT CENTRAL MASTER VENOUS TITLE STYLE CATHETERS Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis Central Venous Catheter PICC Hemodialysis NASDAQ: CTXR 12
Slide 13: Biofilm Formation Protects Colonies
CLICK TO FORMATION BIOFILM EDIT MASTERPROTECTS TITLE STYLE 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 NAS
Slide 14: Clinical Need: Catheter Is a Lifeline
CLICK TO EDIT CLINICAL NEED:MASTER TITLE CATHETER STYLE IS A LIFELINE Catheter access is essential to patient care Significance in a clinical setting CVCs are crucial for severely ill Infections in CVCs can lead patients to provide medication, pain to life-threatening management, and nutritional sup
Slide 15: Current Standard of Care Is a Poor Option
CLICK TO EDIT CURRENT MASTER STANDARD OFTITLE CARESTYLE IS A POOR OPTION Catheter removal and replacement (R&R) presents multiple challenges Infusion therapy interrupted Limited availability of other vascular sites Delayed treatment Delayed treatment Especially for unstable patients or those with se
Slide 16: Market Potential: $1B+ in US and $2B+ Globally
CLICK MARKETTO POTENTIAL: EDIT MASTER TITLE $1B+ INSTYLE US AND $2B+ GLOBALLY High incidence of catheter-related infections support need for effective treatment options 7 million Central Venus 4 million Catheters (CVCs) used annually in the U.S.* Long-term CVCs (>1 month) in the ~500,000 U.S.* CRBSI
Slide 17: Potential to Change Standard of Care
CLICK TO EDIT POTENTIAL TOMASTER CHANGETITLE STYLE OF CARE STANDARD Mino-Lok addresses the complications, discomfort and cost of CVC removal and replacement salvage existing catheters Limited duration IV Limits disruption of therapy designed to infusion therapy eradicate bacterial allowing continued
Slide 18: Mino-Lok Phase 3 Pivotal Trial Completed
CLICK TO EDIT MINO-LOK MASTER PHASE TITLE STYLE 3 PIVOTAL TRIAL COMPLETED Multi-center, randomized, open label, blinded assessor, active control superiority study 241 Patients with ACTIVE ARM: Mino-Lok solution + systemic antibiotic catheter-related bloodstream infections were randomized CONTROL ARM
Slide 19: Mino-Lok Phase 3 Topline Trial Results
CLICK TO EDIT MINO-LOK MASTER PHASE TITLE 3 TRIAL STYLE RESULTS TOPLINE Mino-Lok significantly outperforms hospital-specific anti-infective lock solutions • Kaplan Meier Analysis demonstrated clear separation between Mino-Lok and control arms, illustrating Mino- Lok’s superiority in extending time t
Slide 20: IP & Regulatory Protections
CLICK TO EDIT MASTER IP & REGULATORY TITLE STYLE PROTECTIONS Robust intellectual property portfolio with protection through 2036 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
Slide 21: Halo-Lido: Halobetasol/Lidocaine
CLICK TO EDIT MASTER TITLE STYLE HALO-LIDO Halobetasol/Lidocaine NASDAQ: CTXR 21
Slide 22: Halo-Lido Overview
CLICK TO EDIT HALO-LIDO MASTER TITLE STYLE OVERVIEW • 10+ Million patients report symptoms of hemorrhoidal disease; 1/3 seek physician treatment1 • A cream formulation containing halobetasol propionate (highly potent steroid) and Lidocaine HCl Potentially the first • Phase 2b enrollment completed FD
Slide 23: Summary
CLICK TO EDIT MASTER TITLE STYLE SUMMARY NASDAQ: CTXR 23
Slide 24: Why Invest Now?
CLICK TO EDIT WHY WHY INVEST? MASTER TITLE STYLE NOW? Diversified late-stage biopharmaceutical company with commercialization anticipated in 1H 2025 • LYMPHIR poised to launch 1H 2025 • $400+M est. addressable market with multiple opportunities for growth • First new systemic CTCL therapy since 2018
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