Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (January 2025)
27 slides from Citius Pharmaceuticals's investor presentation, January 2025
Slide 1: Citius Pharmaceuticals Corporate Overview
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Overview JANUARY 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 • Led by management team with successful pharma/biotech track record • $26.5 million invested by founders Diversified Portfolio • LYMPHIR (denileukin diftitox-cxdl) • NOW APPRO
Slide 4: Proven Management Team with Successful Track Record
CLICK TO EDIT MASTER MANAGEMENT TITLEPROVEN TEAM WITH STYLE TRACK RECORD LEONARD MAZUR MYRON HOLUBIAK JAIME BARTUSHAK DR. MYRON CZUCZMAN CHAIRMAN VICE CHAIRMAN EVP, CFO & CBO EVP, CHIEF MEDICAL CEO & CO-FOUNDER & CO-FOUNDER OFFICER GARY TALARICO KELLY CREIGHTON CATHERINE KESSLER NIK BURLEW EVP, OPER
Slide 5: 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 • Majority-owned (~90%) publicly-traded subsidiary of Citius Pharma • NASDAQ listed August 2024 • LYMPHIR approved by the FDA
Slide 6: What Is Cutaneous T-Cell Lymphoma (CTCL)?
CLICK WHATTO EDIT MASTERT-CELL IS CUTANEOUS TITLE LYMPHOMA 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 Hodgkin lymphoma (NHL)* the blood, lymph nodes, and internal orga
Slide 7: Differentiated Mechanism of Action (MOA)
CLICK TO EDIT MASTER DIFFERENTIATED TITLE STYLE MECHANISM OF ACTION (MOA) LYMPHIR targets the IL-2 receptor, working both as a targeted therapy against malignant T-cells AND as an immunotherapy against Tregs Malignant T-cells and Tregs share a common marker: the IL-2 receptor IL-2 receptor offers a
Slide 8: LYMPHIR: Approved August 2024
CLICK TO EDIT LYMPHIR: MASTERAUGUST APPROVED TITLE STYLE 2024 Commercialization anticipated 1H 2025 • Added to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, supporting adoption and reimbursement NASDAQ: CTXR 8
Slide 9: Clinical Data Makes Efficacy Apparent
CLICK TO EDIT CLINICAL DATAMASTER TITLE STYLE MAKES EFFICACY APPARENT OBJECTIVE RESPONSE RATE1 RAPID RESPONSE TIME DURABLE RESPONSE 36% 1.4 months 6.5 months 9% achieved complete response Median number of months to Median months of controlled 27% achieved partial response response among patients who
Slide 10: Safety: Well-Tolerated
CLICK TOWELL-TOLERATED SAFETY: EDIT MASTER TITLE STYLE Overall, LYMPHIR was well-tolerated with the use of pre-medications, close patient monitoring, and prompt initiation of supportive measures and drug management • No evidence of cumulative toxicity • Most patients experienced low grade 1/2 treatm
Slide 11: Competitive Landscape
CLICK TO EDIT LANDSCAPE COMPETITIVE MASTER TITLE STYLE Generic Name Denileukin diftitox (E7777) Brentuximab vedotin Mogamulizumab Romidepsin Monoclonal antibody against CC chemokine IL-2-diphtheria fusion protein binds to IL-2 receptors, is Antibody-drug conjugate that binds to CD30 receptor type 4
Slide 12: Opportunities for Growth
CLICK TO EDIT MASTER OPPORTUNITIES TITLE STYLE FOR GROWTH Upside opportunity in immuno-oncology Expanded indication potential in PTCL Two investigator-initiated I/O trials are underway to Denileukin diftitox is already approved for the evaluate LYMPHIR for potential use as an immuno- treatment of Pe
Slide 13: 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 13
Slide 14: 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 15: 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 15
Slide 16: 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 17: 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 18: 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 19: 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 20: 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 21: 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 22: 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 23: 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 24: Halo-Lido
CLICK TO EDIT MASTER TITLE STYLE HALO-LIDO Halobetasol/Lidocaine NASDAQ: CTXR 24
Slide 25: 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 26: Summary
CLICK TO EDIT MASTER TITLE STYLE SUMMARY NASDAQ: CTXR 26
Slide 27: 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 • Pipeline of additional late-stage assets • Attractive investor entry points • CTXR market cap as of 1/9/2025: ~$30
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