Citius Pharmaceuticals, Inc. · NASDAQ:CTXR
Citius Pharmaceuticals — Investor Presentation (April 2020)
39 slides from Citius Pharmaceuticals's investor presentation, Apr 29, 2020
Slide 1: Citius Pharmaceuticals Corporate Presentation Summer 2020
Citius Pharmaceuticals, Inc. Corporate Presentation Summer 2020 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
Olympic Motto: “ Citius , Altius, Fortius ” (Faster, Higher, Stronger) Late Stage Lead Asset Large Market Need Expert Team to Execute Mid - way through Phase 3; Favorable review received from Futility Analysis by Independent Review Board Market estimated to be >$1.8 B worldwide; current SOC is dange
Slide 4: Key Management & Advisors
Key Management & Advisors We believe we have the team needed to manage all aspects of a successful startup pharmaceutical company, including commercial preparation and strategic partnerships LEADERSHIP SCIENTIFIC ADVISORS Leonard Mazur, Director and Chairman of the Board Myron Holubiak, President &
Slide 5: Unique Pipeline in Progressive Stages
Program Market (Worldwide) Preclinical Phase I Phase II Phase III Mino - Lok® Treat CVC Infections > $1.5B CITI - 002 (Halo - Lido) Rx Therapy for Hemorrhoids > $2B CITI - 101 (Mino - Wrap) Prevent Infections Associated with Breast Implants ~ $400M Option CITI - 401 NoveCite Cells Treat ARDS Multi -
Slide 6: NoveCite: ARDS in COVID-19
6 NASDAQ: CTXR SARS - CoV - 2 NoveCite : ARDS in COVID - 19
Slide 7: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) 7 NASDAQ: CTXR ARDS Lung Normal a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS impairs the lungs’ ability to exchange oxygen for carbon dioxide includes shortness of breath, rapid breathing, and blui
Slide 8: NoveCite Planned Program
• Next generation mesenchymal stem cell therapy (MSCs) for ARDS • ARDS caused by COVID - 19 • ARDS by all other causes • Several MSC suppliers use adult - derived stem cells (bone marrow, adipose tissue or placenta) • NoveCite MSC (NC - MSC) Advantages/Differences • Clonally derived [single source i
Slide 9: ARDS cases and market potential
9 • Over 250,000 non - COVID - 19 ARDS cases in the United States In 2020 • Multiple etiology: viruses, trauma, aspiration, etc. • COVID - 19 pandemic adds significantly to base number • 31%* of hospitalized COVID - 19 patients develop acute respiratory distress syndrome (ARDS) • ARDS close to 50% m
Slide 10: Rationale for MSCs in ARDS
10 Rationale for MSCs in ARDS Michael Matthay , MD Professor, Medicine UCSF EDUCATION & TRAINING Harvard University A.B. 1969 English University of Pennsylvania M.D. 1973 School of Medicine U. of Colorado Medical Center Internship & Residency 1976 Internal Medicine UCSF Fellowship 1978 Pulmonary Div
Slide 11: What Makes Novellus Cells (NC-MSCs) Different?
11 What Makes Novellus Cells (NC - MSCs) Different? Feature • Single source induced pluripotent stem cell (iPSC) master cell bank vs. cells from multiple donors • Rapid production of MSCs (expansion directly from master cell bank) • Higher expansion capability ( no need to re - harvest donor cells)
Slide 12: NoveCite Cells (NC-MSCs) Production
iPSCs Day 0 Induction medium Day 4 MSC medium Day 6 Passage Day 9 Passage Day 13 Passage Day 19 Passage Day 26 Passage Day 29 Passage NC - MSCs • mRNAs reprogramming process is fast, efficient, and footprint free • Extensively characterized iPSCs act as perpetual master cell bank NC - MSC Production
Slide 13: NoveCite MSCs vs. Donor-Derived MSCs
13 NASDAQ: CTXR Growth Curve Telomere Length Greater expansion potential streamlines manufacturing NoveCite MSCs vs. Donor - Derived MSCs NC - MSCs can be expanded for >70 population doublings Restored telomeres lead to greater expansion potential
Slide 14: Estimated Timeline to the Clinic
14 NASDAQ: CTXR Submit FDA meeting request … = PIND submitted April 24 FDA Meeting granted response ………… = expected within week of request Pre - IND meeting ....................... = expected within 30 business days of request CMC process with CMO ......................................... Initial IN
Slide 15: NoveCite advisors
15 • Michael A. Matthay, MD Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Intensive Care Unit at UCSF. He received his AB from Harvard University and his MD from
Slide 16: Novellus Company Highlights
16 Overview Team Patented Technology • Experienced in drug development, start - ups and exits • Technology inventors continue to lead the research effort • 70 granted patents for: – RiboLog™ non - immunogenic mRNA – RiboSlice™ gene editing and NoveSlice™ gene editing protein – RiboCell™ cell reprogr
Slide 17: Summary of NoveCite Opportunity
17 NASDAQ: CTXR Element Comments Market Opportunity ARDS is a significant unmet medical need, now made larger and more urgent with COVID - 19 MSCs Well accepted as safe therapies for ARDS Novellus Technology mRNA platform (synthetic, non - immunogenic) creates superior iPSC & NC - MSC characteristic
Slide 18: Lead Product Mino-Lok
LEAD PRODUCT Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections Mino - Lok®
Slide 19: 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 Of the 7,000,000 CVCs used annually in US, up to 472,000 become infected leading to serious, life threatening infections called CRBSI/CLABSI. 1 These infec
Slide 20: CVC Remove and Replace (R&R) Complications
20 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. x Infectious complications are reported
Slide 21: Locking a Central Venous Line with Mino-Lok
21 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 tra
Slide 22: Phase 2b Trial Results
22 Phase 2b Trial Results Parameter Mino - Lok Arm N ( % ) Control Arm 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) N
Slide 23: Mino-Lok Phase 3 Pivotal Trial Design
Active Arm (n=72) Mino - Lok® Solution Control Arm (n=72) Antibiotic Lock Patients with CRBSI/CLABSI (n~ 144) R Multi - center, randomized, open label, blinded assessor, active control superiority study (80% powered) Futility Performed at 35 - 40 Events and 60 - 70 Events for Superior Efficacy Adjun
Slide 24: Mino-Lok Development Plan
Mino - Lok® Development Plan (estimated as of April 2020) 2014 2015 2016 2017 2018 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 3 ALT Study 2019 Q1 Q2 Q3 Q4 First Patient In 2020 Q1 Q2 Q3 Q4 2021 Q1 Q2 Q3 Q4 Interim Data Futility Analysis Interim Data Superior Efficacy NASDAQ: CTXR 24
Slide 25: Market Opportunity
Market Opportunity 25 NASDAQ: CTXR Worldwide Ex - US United States Regulatory Updates Reimbursement Pricing With modest penetration at conservative pricing, we believe that >$500M peak year U.S. sales is achievable. DISARM Act is pending in the Senate, which would create a DRG carveout for QIDP prod
Slide 26: Intellectual Property
26 Intellectual Property Mino - Lok TM 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. Creators Description of Patent All U.S. and Foreign Pate
Slide 27: Competitive Landscape
27 Competitive Landscape Company/Source Product/Components Status Features/Weaknesses CorMedix Neutrolin ® taurolidine, citrate, heparin Phase III trial in Prevention in HD; Available in Europe (CE Mark) Prevention only Anti - infective only being used in prophylaxis No company has United States reg
Slide 28: Mino-Lok (minocycline/disodium EDTA/ethyl alcohol)
28 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 patien
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;
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
Slide 32: Mino-Wrap Development Plan
32 Mino - Wrap Development Plan (estimated as of April 2020) 2019 2020 2021 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre - Clinical Studies* Chemistry and Manufacturing Control (CMC) Development Phase 3 Study Concept Planning and Risk Analysis Product De
Slide 33: Halo-Lido CITI-002
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment Halo - Lido CITI - 002
Slide 34: Halobetasol + Lidocaine for Hemorrhoids
34 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 • Up to 5% of the U.S. population suffers from hemorrhoids, but there are no FDA - ap
Slide 35: Current Status
Current Status NASDAQ: CTXR 35 • 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 •
Slide 36: Halo/Lido Development Plan
Halo/Lido Development Plan (estimated as of April, 2020) NASDAQ: CTXR 36 2015 2016 2017 2018 2019 2020 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 2a Clinical Study Product and Formulation Development Phase 2b Clinical Study Pre - Clinical Studies FDA Type C meeting
Slide 37: Citius Corporate Summary
37 CITIUS Corporate Summary • Addressing attractive diversified multi - billion dollar opportunities – Adjunctive Cancer Care/Infectious Disease and Gastrointestinal Disease • Portfolio addressing recognized unmet medical needs with cost - saving or cost - effective solutions with low risk developme
Slide 38: Financial Summary
Financial Summary (as of 4/14/2020) Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 38,078,062 59.1 % Warrants 23,501,091 36.5 % Options 2,751,838 4.3 % Unit Purchase Options 100 , 667 0. 1 % Fully Diluted Shares Outstanding 64,431,658 100% Stock Price Current Price $ 0.65 52
Slide 39: Citius Pharmaceuticals contact details
39 Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact : Andrew Scott – V.P., Corporate Development (908) 967 - 6677 x105 ascott@citiuspharma.com NASDAQ: CTXR
Citius Pharmaceuticals — Investor Presentation (April 2020) on 6ix