Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (December 2022)
30 slides from Citius Pharmaceuticals's investor presentation, December 2022
Slide 1: Corporate Overview Winter 2022/2023
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Overview WINTER 2022/2023 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: I/ONTAK - purified reformulation of IL-2 diphtheria toxin fusion protein for CTCL • Phase 3: Mino-Lok® - potential to be first and only FDA-approved product to salvage infected CVCs
Slide 4: 2022 Milestones & 2023 Anticipated Catalysts
CLICK TO EDIT MASTER 2022 MILESTONES TITLE & 2023 STYLE ANTICIPATED CATALYSTS 2022 2023 MILESTONES ANTICIPATED CATALYTS • Reported results of I/ONTAK • I/ONTAK PDUFA: July 28, 2023 Phase 3 trial • Complete Mino-Lok Phase 3 trial • Submitted I/ONTAK BLA • As of 12/15/22: • 72 of 92 failure events to
Slide 5: I/ONTAK (E7777) BLA Filed
CLICK TO EDIT MASTER TITLE STYLE I/ONTAK (E7777) BLA Filed NASDAQ: CTXR 5
Slide 6: I/ONTAK Overview
CLICK TO OVERVIEW I/ONTAK EDIT MASTER TITLE STYLE Reformulated oncology asset with an attractive near-term revenue opportunity • Improved formulation of previously-approved drug (ONTAK) for treatment of cutaneous T-cell lymphoma (CTCL) • Orphan indication with market est. $300-$400+M | market dynami
Slide 7: 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 8: I/ONTAK Mechanism of Action (MOA)
CLICK TO MECHANISM I/ONTAK EDIT MASTEROF TITLE STYLE(MOA) ACTION Directly targets both malignant T-cells and immunosuppressive Tregs via binding to the IL-2 receptor on these cells Targets Malignant Cells Eliminates Immunosuppressive Tregs • Binds to IL-2 receptor to kill tumor cells directly • Crea
Slide 9: Origins of ONTAK
CLICK TO OF ORIGINS EDIT MASTER TITLE STYLE ONTAK • ONTAK was FDA-approved and commercially available in the U.S. between 1999 – 2014 • E7777 (I/ONTAK) was developed by Eisai in 2011 as a purified and more bioactive formulation in response to FDA guidance • Eisai voluntary removed ONTAK from the mar
Slide 10: I/ONTAK Licensing and FDA Pathway
CLICK TO LICENSING I/ONTAK EDIT MASTER TITLE AND FDASTYLE PATHWAY • Citius acquired the exclusive license to Eisai’s E7777 (I/ONTAK) in September 2021 • Phase 3 clinical trial completed December 2021; data was consistent with the prior formulation and no new safety signals were identified • Citius s
Slide 11: Overview of Phase 3 Clinical Trial (Study 302)
CLICK TO EDIT OVERVIEW OF MASTER PHASE 3 TITLE STYLE CLINICAL TRIAL (STUDY 302) • Pivotal, multicenter, open-label, single-arm study of I/ONTAK in subjects with persistent or recurrent CTCL • All subjects were diagnosed with Mycosis Fungoides or Sézary Syndrome, with tumors assessed as positive for
Slide 12: Study 302: Phase 3 Clinical Trial Results
CLICK STUDYTO EDIT 302: MASTER PHASE TITLE STYLE 3 CLINICAL TRIAL RESULTS • Primary Endpoint: Objective Response Rate = complete response + partial response • I/ONTAK (E7777) demonstrated meaningful benefits for trial patients who had previously been treated • 9µg I/ONTAK (E7777) efficacy results ar
Slide 13: Study 302: Meaningful Response in CTCL Patients
CLICK STUDYTO EDIT 302: MASTER TITLE MEANINGFUL STYLE IN CTCL PATIENTS RESPONSE More than half of responders in the trial had at least six months of improved or controlled disease REDUCED SKIN BURDEN RAPID RESPONSE TIME DURABLE RESPONSE 84.4% 1.4 6.5 months months Reduction in skin tumor Median numb
Slide 14: Study 302: No New Safety Signals
CLICK STUDYTO EDIT 302: NOMASTER TITLE SIGNALS NEW SAFETY STYLE Overall, I/ONTAK 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
Slide 15: Promising Opportunities for Additional Indications
CLICK TO EDIT PROMISING MASTER TITLE STYLE OPPORTUNITIES FOR ADDITIONAL INDICATIONS • Potential expanded indication to include PTCL • Eisai’s E7777 is already approved for the treatment of Peripheral T-Cell Lymphoma (PTCL) in Japan (Remitoro®) • Would require clinical trial in U.S. designed as a sin
Slide 16: 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 • I/ONTAK’s (E7777) differentiated mechanism of action reinforces rationale fo
Slide 17: Market Opportunity
CLICK MARKETTO OPPORTUNITY EDIT MASTER TITLE STYLE • Estimated U.S. market size for I/ONTAK in CTCL is $300-$400+ million • Key growth drivers expected to increase overall market size and facilitate market penetration • Evolving treatment paradigm with incremental therapeutic option for pre-treated
Slide 18: Mino-Lok Phase 3
CLICK TO EDIT MASTER TITLE STYLE MINO-LOK® Phase 3 NASDAQ: CTXR 18
Slide 19: 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 CRBSI/CLABSI infections (CVCs) used annually in annually in
Slide 20: 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 mechanica
Slide 21: 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 22: 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 23: Mino-Lok Phase 3 Pivotal Trial
CLICK TO EDIT MINO-LOK MASTER ® PHASE TITLE STYLE 3 PIVOTAL TRIAL Multi-center, randomized, open label, blinded assessor, active control superiority study Patients with Active Arm CRBSI Mino-Lok® Solution Anticipated median time of Randomized 21 days vs. 38 days trial completion at to achieve 92 cat
Slide 24: 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 25: Halo-Lido Phase 2b
CLICK TO EDIT MASTER TITLE STYLE HALO-LIDO Phase 2b Halobetasol/Lidocaine NASDAQ: CTXR 25
Slide 26: Halo-Lido At-a-Glance
CLICK TO EDIT HALO-LIDO MASTER TITLE STYLE AT-A-GLANCE 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 super potent steroid Halobetasol 10+ MILLION propionate (HBP), maintained Lidocai
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 I/ONTAK target PDUFA 7/28/23 I/ONTAK BLA Mino-Lok® standalone submission Phase 3 trial oncology Halo-Lido completion company Halo-Lido Phase Phase 2b trial anticipated anticipated 2b tri
Slide 29: Financial Summary
CLICK TO EDIT FINANCIAL MASTER TITLE STYLE SUMMARY Bandwidth to Execute PRINCIPAL INSIDER SHAREHOLDERS (1) • $42M cash & equivalents as of 9/30/22 LEONARD MAZUR 11.8% • Runway through December 2023 MYRON HOLUBIAK 2.9% • $26.5M invested by insiders % OF FULLY CURRENT CAPITALIZATION SHARES DILUTED BAS
Slide 30: Contact
CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact Ilanit Allen ir@citiuspharma.com NASDAQ: CTXR
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