Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (June 2023)
29 slides from Citius Pharmaceuticals's investor presentation, June 2023
Slide 1: Citius Pharmaceuticals Corporate Update June 2023
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Update JUNE 2023 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 1 Diversified Pipeline: Building a Biotech Platform • BLA Filed: LYMPHIR™ - purified reformulation of IL-2 diphtheria toxin fusion protein for CTCL1 • Phase 3: Mino-Lok® - potential to be first and only FDA-approved product to salvage infected CV
Slide 4: Proven Management Team with Track Record
CLICK TO EDIT MASTER MANAGEMENT TITLEPROVEN TEAM WITH STYLE TRACK RECORD LEONARD MAZUR MYRON HOLUBIAK JAIME BARTUSHAK DR. MYRON CZUCZMAN GARY TALARICO CHAIRMAN, CEO & CO-FOUNDER VICE CHAIRMAN & CO-FOUNDER EVP, CFO & CBO EVP, CHIEF MEDICAL OFFICER EVP, OPERATIONS KELLY CREIGHTON CATHERINE KESSLER NIK
Slide 5: 2023 Milestones & Anticipated Catalysts
CLICK TO EDIT MASTER 2023 MILESTONES TITLE STYLECATALYSTS & ANTICIPATED • LYMPHIR™ 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 completed April 2023 • Pos
Slide 6: Mino-Lok Phase 3
CLICK TO EDIT MASTER TITLE STYLE MINO-LOK® Phase 3 NASDAQ: CTXR 6
Slide 7: Late-Stage Candidate: Mino-Lok
CLICK TO EDIT LATE-STAGE MASTERCANDIDATE: PRODUCT TITLE STYLE MINO-LOK ® First and Only antibiotic lock therapy under investigation to sterilize and salvage infected Central Venous Catheters (CVCs) 7 Million ~500,000 Central Venus Catheters (CVCs) CRBSI/CLABSI infections used annually in the U.S.* a
Slide 8: Current Standard of Care Is a Poor Option
CLICK TO EDIT CURRENT MASTER STANDARD OFTITLE CARESTYLE IS A POOR OPTION Multiple challenges to removing and replacing infected CVCs • Limited availability of other vascular sites • Does not address need to maintain infusion therapy • Potential for complications • infectious, thrombotic and mechanic
Slide 9: Potential Gold Standard in CLABSI Treatment
CLICK TO EDIT POTENTIAL MASTER GOLD TITLE STYLE STANDARD IN CLABSI TREATMENT Mino-Lok® addresses the complications, discomfort and cost of CVC removal and replacement ✓ Limited duration IV therapy 5-7 DAYS ✓ Limits disruption of infusion therapy ✓ Ease of Administration • Locking a catheter is a wel
Slide 10: Mino-Lok Phase 2b Trial Results
CLICK TO EDIT MINO-LOK MASTER ® PHASE TITLERESULTS 2B TRIAL STYLE Mino-Lok® demonstrated a strong safety and efficacy signal Mino-Lok Arm Control Arm Parameter 100% Effective in salvaging CVCs in all N % N % patients treated with Mino-Lok® Patients 30 100% 60 100% Cancer Type 100% Patients treated w
Slide 11: Mino-Lok Phase 3 Pivotal Trial Underway
CLICK TO EDIT MINO-LOK MASTER ® PHASE TITLE STYLE 3 PIVOTAL TRIAL UNDERWAY Multi-center, randomized, open label, blinded assessor, active control superiority study Patients with ACTIVE ARM: Mino-Lok® Solution Trial Completion catheter-related upon blood stream 92 catheter failure infections (CRBSI)
Slide 12: 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 13: LYMPHIR (I/ONTAK, E7777) BLA Filed
CLICK TO EDIT MASTER TITLE STYLE LYMPHIR™ (I/ONTAK, E7777) BLA Filed NASDAQ: CTXR 13
Slide 14: LYMPHIR Licensing and FDA Pathway
CLICK TO EDIT LYMPHIR™ MASTER AND LICENSING TITLEFDA STYLE PATHWAY • September 2021 Citius acquired the exclusive license to Eisai’s E7777 (LYMPHIR™) • December 2021 Phase 3 clinical trial completed • September 2022 Citius submitted a BLA for E7777 (LYMPHIR™) • July 2023 FDA target decision date (PD
Slide 15: 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 16: Why LYMPHIR?
CLICK TO EDIT MASTER TITLE STYLE WHY LYMPHIR™? Reformulated oncology asset with an attractive near-term revenue opportunity Developed for the treatment of Improved formulation of previously FDA-approved cutaneous T-cell lymphoma (CTCL) drug (ONTAK); marketed 1999-2014 Orphan indication with market M
Slide 17: Differentiated Mechanism of Action
CLICK TO EDIT MASTER DIFFERENTIATED TITLE STYLE 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 Immunosuppressive Tregs • Re
Slide 18: Competitive Landscape
CLICK TO EDIT LANDSCAPE COMPETITIVE MASTER TITLE STYLE • Since CTCL treatments are non-curative and often have a limited duration of response and/or are discontinued early, patients are put on multiple alternate therapies • LYMPHIR™’s differentiated MOA reinforces rationale for inclusion among the c
Slide 19: Market Opportunity
CLICK MARKETTO OPPORTUNITY EDIT MASTER TITLE STYLE • 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 pre-treated pat
Slide 20: LYMPHIR Phase 3 Trial (Study 302): Completed
CLICK TO EDIT LYMPHIR™ MASTER PHASE TITLE 3 TRIAL STYLE302): COMPLETED (STUDY Pivotal, multicenter, open-label, single-arm study of LYMPHIR™ in subjects with persistent or recurrent CTCL All subjects were LEAD-IN STUDY Doses ranged from 6 to 15 µg/kg/day diagnosed with Mycosis Fungoides n=21 9 μg/kg
Slide 21: Study 302: Clinical Trial Results
CLICK STUDYTO EDIT 302: MASTER PHASE TITLE STYLE 3 CLINICAL TRIAL RESULTS LYMPHIR™ demonstrated meaningful benefits for trial patients who had previously been treated 36.2% ORR (Objective Response Rate ) 1,2 95% CI (25%, 48.7%) Nearly half of patients on the trial experienced a complete 49% response
Slide 22: Meaningful Response in CTCL Patients
CLICK TO EDIT RESPONSE MEANINGFUL MASTER TITLE STYLE IN CTCL PATIENTS More than half of responders in the trial had at least six months of improved or controlled disease REDUCED SKIN BURDEN Reduction in skin tumor burden among evaluable patients, with 84.4% ≥ 80% maximum reduction in skin tumor in ~
Slide 23: No New Safety Signals
CLICK NO NEWTO SAFETY EDIT MASTER TITLE STYLE SIGNALS 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 24: Opportunities for Growth
CLICK TO EDIT MASTER OPPORTUNITIES TITLE STYLE FOR GROWTH • Eisai’s E7777 is already approved for the treatment of Peripheral T-Cell PTCL expanded Lymphoma (PTCL) in Japan (Remitoro®) indication potential • Would require clinical trial in U.S. designed as a single-arm pivotal study • Two investigato
Slide 25: Halo-Lido Phase 2b
CLICK TO EDIT MASTER TITLE STYLE HALO-LIDO Phase 2b Halobetasol/Lidocaine NASDAQ: CTXR 25
Slide 26: Halo-Lido: Phase 2b Trial Overview
CLICK TO EDIT HALO-LIDO: MASTER PHASE TITLE OVERVIEW 2B TRIAL STYLE Potentially the first FDA-approved prescription product to treat hemorrhoids in the US • Based on the results of Phase 2 trial in 240 patients, CTXR elected to use highly potent steroid Halobetasol propionate (HBP), maintained Lidoc
Slide 27: Summary
CLICK TO EDIT MASTER TITLE STYLE SUMMARY NASDAQ: CTXR 27
Slide 28: Why Invest Now?
CLICK TO EDIT WHY WHY INVEST? MASTER TITLE STYLE NOW? Multiple value-creating catalysts on the horizon Spinoff of LYMPHIR™ PDUFA 7/28/23 LYMPHIR™ BLA Mino-Lok® standalone submission Phase 3 trial oncology Halo-Lido completion company Halo-Lido Phase Phase 2b trial anticipated anticipated 2b trial in
Slide 29: Financial Summary
CLICK TO EDIT FINANCIAL MASTER TITLE STYLE SUMMARY Bandwidth to Execute PRINCIPAL INSIDER SHAREHOLDERS (1) • $29M cash & equivalents as of 3/31/23 LEONARD MAZUR 11.4% • Runway through May 2024 MYRON HOLUBIAK 2.7% • $26.5M invested by insiders % OF FULLY CURRENT CAPITALIZATION(2) SHARES DILUTED BASIC
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