Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Benzinga Global Small Cap Conference 2021
37 slides from Citius Pharmaceuticals's conference presentation, May 13, 2021
Slide 1: Citius Pharmaceuticals, Inc. Corporate Presentation
Citius Pharmaceuticals, Inc. Corporate Presentation Summer 2021 NASDAQ: CTXR
Slide 2: Disclaimer
Disclaimer 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 representation by the Company or any direct
Slide 3: Company Overview
Company Overview Olympic Motto: “Citius, Altius, Fortius” (Faster, Higher, Stronger) Four Active Lead Mino-Lok in late Phase 3; favorable review received for Futility Programs with a Analysis by Data Monitoring Committee (12/2019); favorable review Late Stage Lead for safety and efficacy analysis in
Slide 4: Management Team with Proven Track Record
MANAGEMENT TEAM WITH PROVEN TRACK RECORD LEONARD MAZUR MYRON HOLUBIAK JAMIE BARTUSHAK EXECUTIVE CHAIRMAN, DIRECTOR PRESIDENT & CEO, DIRECTOR EVP, CFO HUDSON STRATEGIC COMMUNICATIONS GROUP DR. MYRON CZUCZMAN DR. ALAN LADER GARY TALARICO ILANIT ALLEN EVP, CHIEF MEDICAL OFFICER VP, CLINICAL OPERATIONS
Slide 5: Management
Management Leonard Mazur, Director and Executive Chairman • Founder/co-founder of: Genesis, Triax, Akrimax, and others Myron Holubiak, Director, CEO and President • Former President of Roche Laboratories, Inc. Jaime Bartushak, EVP, Chief Financial Officer • Over 20 years experience in corporate fina
Slide 6: Four Active Pipeline Programs
FOUR ACTIVE PIPELINE PROGRAMS INVESTIGATIONAL ESTIMATED ANTICIPATED PROGRAM PRECLINICAL PHASE I PHASE II PHASE III INDICATION MARKET (WW) MILESTONES MINO-LOK® TREAT CVC • DMC review > $1.8B INFECTIONS • NDA HALO-LIDO RX THERAPY FOR (CITI-002) > $2B • IND HEMORRHOIDS • Phase 2b PREVENT MINO-WRAP INFE
Slide 7: Mino-Lok
Mino-Lok® LEAD PRODUCT Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections
Slide 8: The Problem: CVCs are a Lifeline for Cancer Patients
THE PROBLEM: CVCs are a Lifeline for Cancer Patients BUT Infection Rates + Poor SOC Leads to Death & Morbidity Infections are Common & Dangerous SOC is a Poor Option for Patients & Hospitals Of the 7,000,000 CVCs used annually in US, up to 472,000 Current SOC is to remove and replace (R&R) the CVC,
Slide 9: CVC Remove and Replace (R&R) Complications
CVC Remove and Replace (R&R) Complications R&R procedures are invasive and discomforting to patient R&R Procedures are costly and usually require additional hospital stay. Complications include infection, thrombosis, occlusion, and mechanical complications. • Infectious complications are reported to
Slide 10: Locking a Central Venous Line with Mino-Lok
Locking a Central Venous Line with Mino-Lok® Locking a Catheter is a Standard Operating Procedure 1. Using Mino-Lok does not require any novel methodologies. 2. Any RN or LPN or Technician can perform the procedure. 3. There is no change in normal workflow and does not require exceptional training.
Slide 11: Phase 2b Trial Results
Phase 2b Trial Results Parameter Mino-Lok Arm Control Arm N (%) N (%) Patients 30 (100%) 60 (100%) Cancer Type - Hematologic 20 (67) 48 (80) - Solid tumor 10 (33) 12 (20) ICU Admission 4 (13) 4 (7) Mech. Ventilator 3 (10) 0 (0) Bacteremia - Gram+ 17 (57)* 32 (53) - Gram - 14 (47)* 28 (47) Neutropeni
Slide 12: Mino-Lok Phase 3 Pivotal Trial Design
Mino-Lok® Phase 3 Pivotal Trial Design Multi-center, randomized, open label, blinded assessor, active control superiority study (80% powered) Adjunct in CLABSI/CRBSI Active Arm (n=72) Mino-Lok® Solution Patients with CRBSI/CLABSI R (n~ 144) Control Arm (n=72) Antibiotic Lock Anticipated median time
Slide 13: Mino-Lok Development Plan
Mino-Lok® Development Plan (estimated as of 2/2021*) 2015 2016 2017 2018 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase Pivotal Phase 3 ALT Study 2 First Patient In Interim Data Interim Data DMC Chemistry and Manufacturing Futility Analysis E
Slide 14: Market Opportunity
Market Opportunity Pursue Directly >4 million Partnerable CLABSI’s per year* United States Worldwide Ex-US With modest penetration at conservative pricing, we believe that >$500M peak year U.S. sales is achievable. Regulatory Updates Reimbursement Pricing DISARM Act is pending in the Senate, Company
Slide 15: Intellectual Property
Intellectual Property Mino-LokTM is supported by a robust intellectual property portfolio Composition of Matter patent that provides protection until June 7, 2024. Formulation Patent has been issued and will add protection through 2036. All U.S. and Foreign Patent Creators Description of Patent Appl
Slide 16: Regulatory Protection
Regulatory Protection Qualified Infectious Disease Product (US) • Eligibility for Fast Track Status, enables frequent communication and collaboration with FDA; • Priority Review, reduces the NDA review time from 12 to 6 months; and, • Market Exclusivity, grants an additional 5 years of market exclus
Slide 17: Competitive Landscape
Competitive Landscape There are no products being developed for treatment of infected central venous lines. Company/Source Product/Components Status Features/Weaknesses CorMedix DefenCathTM (Neutrolin®) NDA accepted by the FDA in Prevention only taurolidine, citrate, heparin August 2020 Anti-infecti
Slide 18: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
Mino-Lok® (minocycline/disodium EDTA/ethyl alcohol) Treats catheter-related blood stream infections (CRBSIs). Penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anti-clotting properties. Salvages central venous access in patients highly depen
Slide 19: NoveCite induced Mesenchymal Stem Cells (i-MSCs)
NoveCite induced Mesenchymal Stem Cells (“i-MSCs”)
Slide 20: Citius, Novellus and NoveCite Biotherapeutics
Citius Pharmaceuticals, Inc. Novellus Therapeutics • late-stage specialty pharmaceutical • pre-clinical stage biotechnology company company • patented non-immunogenic mRNA technology • critical care products (anti-infectives and • gene editing, mutation-free & footprint- cancer care) free cell repro
Slide 21: NoveCite i-MSC Compelling Unique Advantages
NoveCite i-MSC Compelling Unique Advantages • Novellus mRNA cell reprogramming efficiently creates i-PSC cells (i-PSCs are an ideal building-block for cell-based therapies) • Clonal i-PSC master cell bank is created – consistent cell source - no batch-to-batch variation and footprint-free (no viral
Slide 22: NoveCite i-MSCs: ARDS in COVID-19
NoveCite i-MSCs: ARDS in COVID-19 Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2
Slide 23: Acute Respiratory Distress Syndrome (ARDS)
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) Normal ARDS Lung ARDS a type of respiratory failure characterized by rapid onset of widespread inflammation and fluid accumulation in the lungs. ARDS impairs the lungs’ ability to exchange oxygen for carbon dioxide Symptoms includes shortness of breath, rap
Slide 24: i-MSC Advantages: Levels of Immunomodulator Secretion
i-MSC Advantages: Levels of Immunomodulator Secretion i-MSCs secrete higher levels of many immunomodulatory proteins Novellus iMSCs Example: Example: Example: VEGF-A = 10,800 pg/ml MMP-1 MMP-1 == 6,500 6,500 pg/ml pg/ml Commercial BM-MSCs MMP-1 = 330 pg/ml VEGF-A = 3,000 pg/ml MMP-1 = 330 pg/ml *Dat
Slide 25: ARDS Sheep Study
XITIUS PHARMA ARDS Sheep Study
Slide 26: Interim Results: Beneficial Effect of i-MSCs in Sheep Model of ARDS
Interim Results: Very Strong Beneficial Effect of i-MSCs in Sheep Model of ARDS P/F ratio Norepinephrine Requirement Improved Oxygenation Less systemic shock Pulmonary Lymph Flow Pulmonary Lymph Protein Loss Reduced Lung Vascular Injury Overview of findings: In this ovine model of severe ARDS the an
Slide 27: Our Solution – NoveCite i-MSCs
Our Solution – NoveCite i-MSCs Description: • Allogeneic (“off-the-shelf”) i-PSC-derived induced Mesenchymal Stem Cells • High potency i-MSCs – in vitro data showing exponentially higher secretion of immunomodulatory proteins vs. BM-derived MSCs • Footprint-free i-PSCs created using patented non-imm
Slide 28: Clinical Development Plan
CLINICAL DEVELOPMENT PLAN (ESTIMATED AS OF 2/2021*) 2020 2021 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre-Clinical Pre-Clinical (tox) Phase 3 POC (Sheep) studies Phase 1/2 And Clinical Studies Clinical Study In vitro studies E of Ph2 Pre-NDA NDA Regulatory FDA Pre-IND Consultations
Slide 29: Mino-Wrap
Mino-Wrap CITI-101 Minocycline/Rifampin (M/R) Gelatin Film Bioabsorbable Extended Release Antimicrobial Wrap for the Prevention of Breast Tissue Expander Infections
Slide 30: Background: Rate of Infection Post-Mastectomy
Background: Rate of Infection Post-Mastectomy • The rate of infection following mastectomy with tissue expander (TE) is 2.4 to 24%. Estimated mean is 12-14%*. • Once the implant becomes infected, the patient is usually hospitalized requiring approximate 2 weeks of IV and/or oral antimicrobials; and
Slide 31: Mino-Wrap: Thesis
Mino-Wrap: Thesis • The highest risk for TE-related infections occurs at the time of surgery and as long as drains remain in place (about two weeks post-operatively) and there are portals for microbial colonization. • Mino-Wrap is a malleable, bioabsorbable, antimicrobial wrap that is placed over th
Slide 32: Halo-Lido
Halo-Lido CITI-002 Halobetasol/Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment
Slide 33: CITI-002 (halobetasol + lidocaine)
CITI-002 (halobetasol + lidocaine) Citius’ product candidate would be the first FDA-approved prescription product to treat hemorrhoids in the US OTC Products are the Mainstay for Treatment of Grade I and II Existing Rx Treatments: “Grandfathered Products” • Up to 5% of the U.S. population suffers fr
Slide 34: Current Status
Current Status • Based on the results of phase 2 trial in 240 patients, CTXR elected to use super potent steroid Halobetasol propionate (HBP), maintained Lidocaine HCl (LH) and developed 10 prototype formulations • Two formulations selected for Vasoconstriction Assay (VCA) studies • A cream formulat
Slide 35: Financial Summary
FINANCIAL SUMMARY (AS OF 03/31/21) % OF FULLY CURRENT CAPITALIZATION SHARES Bandwidth to Execute DILUTED • $103.7M in cash as of 3/31/21 BASIC SHARES OUTSTANDING 134,701,219 70.6% • 1H 2021 R&D expense of $7.7M WARRANTS 51,569,059 27.0% • Runway into 2023 OPTIONS 4,615,171 2.4% • $26.5M invested by
Slide 36: Citius: why invest? Why now?
Citius: why invest? Why now? Portfolio addressing recognized unmet medical needs with cost-saving or cost- 01 effective solutions with potential first-in-class products Attractive diversified multi-billion dollar opportunities – Adjunctive Cancer 02 Care/Infectious Disease and Gastrointestinal Disea
Slide 37: Citius Pharmaceuticals, Inc. Contact
Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact: Ilanit Allen– V.P., Corporate Communications & Investor Relations (908) 967-6677 x113 iallen@citiuspharma.com NASDAQ: CTXR 37
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