Citius Pharmaceuticals, Inc.
Corporate Presentation
Summer 2020
NASDAQ: CTXR
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 director, employee, agent, or adviser of the Company. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. The information contained in this presentation and the comments and remarks of the representatives of the Company made during any presentation to which this presentation relates are integrally related and, as such, are intended to be delivered and understood together. Information provided in this presentation speaks only as of the date hereof. The Company assumes no obligation to update any statement after the date of this presentation as a result of new information, subsequent events or any other circumstances.
This presentation also includes express and implied forward-looking statements regarding the current expectations, estimates, opinions and beliefs of the Company that are not historical facts. Such forward-looking statements may be identified by words such as "believes", "expects", "endeavors", "anticipates", "intends", "plans", "estimates", "projects", "should", "objective" and variations of such words and similar words. The accuracy of such statements is dependent upon future events, and involves known and unknown risks, uncertainties and other factors beyond
the Company's control that may cause actual results to differ materially from what is presented herein. Investors are strongly encouraged to
carefully review the Company's SEC filings for a listing of the risks that could cause actual results to differ from these forward looking statements. These forward-looking statements speak only as of the date of this presentation and should not be construed as statements of facts.
NASDAQ: CTXR | 2 |
Company Overview
Late Stage Lead Asset
Mid-way through Phase 3; Favorable review received from Futility Analysis by Independent Review Board
Large Market Need
Market estimated to be >$1.8 B worldwide; current SOC is dangerous and costly
Expert Team to Execute
Management Commitment
Management has history of >$1B in pharma M&A;
Scientific Advisors are key KOL's in infectious disease
Management / Founders have invested $26.5 million into the company
Olympic Motto: "Citius, Altius, Fortius" (Faster, Higher, Stronger)
NASDAQ: CTXR | 3 |
Key Management & Advisors
LEADERSHIP | SCIENTIFIC ADVISORS |
Leonard Mazur, Director and Chairman of the Board
- Has launched many leading brands in their respective categories
- Founder/co-founderof: Genesis, Triax, Akrimax, and others
- Previous executive positions: Medicis Pharma, ICN Pharma, and Knoll Pharma (division of BASF), Cooper Laboratories
Myron Holubiak, President & CEO and Director
- Former President of Roche Laboratories, where he transformed it into a leading antibiotic and biotech company
- Former Chairman of Bioscrip, Inc., a national home infusion services provider
Jaime Bartushak, CFO
- 20 years corporate finance, M&A, and strategic planning
Gary Talarico, EVP, Operations
- Has led commercial activities for many corporate expansions and start-ups, including Reliant Pharma and Ventiv Health
- Directs all commercial disciplines at Citius
Issam Raad, M.D.
- Chair of MD Anderson Cancer Center's Dept. of Infectious Diseases
- Author of the underlying patents for Mino-Lok®
- Dr. Raad's innovations have been endorsed at the highest level (Category 1A) by the Center for Disease Control (CDC)
Mark Rupp, M.D.
- Professor and Chief of the Division of Infectious Diseases in the Dept. of Internal Medicine at the U. of Nebraska Medical Center
- Past-Presidentof SHEA and Past-President of ASM Division L
- Has served as consultant to FDA, CDC, NIH, and VA
Leonard A. Mermel, D.O.
- Technical Expert Panel Member of Medicare Patient Safety Monitoring System, US Dept. of Health & Human Services
- Has co-authored US guidelines dealing with prevention and management of intravascular catheter infections
We believe we have the team needed to manage all aspects of a successful startup pharmaceutical company, including commercial preparation and strategic partnerships
NASDAQ: CTXR | 4 |
Unique Pipeline in Progressive Stages
Program | Market | Preclinical | Phase I | Phase II | Phase III | ||
(Worldwide) | |||||||
Mino-Lok® | > $1.5B | Next milestone: Interim Efficacy Analysis (results in 2H 2020) | |||||
Treat CVC Infections | |||||||
CITI-002 (Halo-Lido) | Next milestone: | Phase 2B Initiated | |||||
Rx Therapy for | > $2B | ||||||
(expected | 2H 2020) | ||||||
Hemorrhoids | |||||||
CITI-101 (Mino-Wrap) | |||||||
Prevent Infections | ~ $400M | Pre-IND meeting | |||||
w/FDA by YE2020 | |||||||
Associated with | |||||||
Breast Implants | |||||||
Option | Pre-IND | ||||||
CITI-401 | |||||||
Multi-billion | submitted | ||||||
(iMSC) | |||||||
2Q2020 | |||||||
Treat ARDS | |||||||
NASDAQ: CTXR | 5 |
NoveCite: ARDS in COVID-19
SARS-CoV-2
NASDAQ: CTXR | 6 |
Acute Respiratory Distress Syndrome (ARDS)
Normal | ARDS Lung | ARDS |
Symptoms
Treatments
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 bluish skin coloration; for those who survive, a decreased quality of life is common
none
Clinical Management
supportive care, through the use of ventilator, as well as fluid management, and in some instances, extracorporeal membrane oxygenation
NASDAQ: CTXR | 7 |
NoveCite Planned Program
- Next generation mesenchymal stem cell therapy for ARDS
- ARDS caused by COVID-19
• ARDS by all other causes | XXX |
- Several MSC suppliers use adult-derived stem cells (bone marrow, adipose tissue or placenta); NoveCite MSCs are induced mesenchymal stem cells: iMSCs
- NoveCite iMSC Advantages/Differences
- Clonally derived [single source induced pluripotent stem cell (iPSC) master cell bank]
- Single-sourcevs. adult derived cells from multiple donors
- Higher expression of immunomodulatory proteins
- Higher expansion capability
- Accelerated development track
- Ultra-fasttrack regulatory pathway (Coronavirus Treatment Acceleration Program)
- Anticipated to be in the clinic this year
- NoveCite, a subsidiary of Citius, Inc.
- Holds option for exclusive worldwide license from Novellus, Inc. to treat ARDS
NASDAQ: CTXR | 8 |
NoveCite Market - COVID and Beyond
- Over 250,000 non-COVID-19 ARDS cases in the United States in 2020
- Multiple etiology: viruses, trauma, aspiration, etc.
- COVID-19pandemic adds significantly to base number
- 31%* of hospitalized COVID-19 patients develop acute respiratory distress syndrome (ARDS)
- ARDS close to 50% mortality rate
- No effective drug treatment (only mechanical ventilation)
- COVID-19mortality on ventilators reported to be ~80%
- Several earlier generation (adult-derived) cell therapies in clinical trials, regulatory pathway appears to be established
- Multi-billiondollar market potential worldwide
Estimate ARDS Cases in U.S. 2020
(excluding COVID-19 impact)
270,000 | |||
266,000 | |||
265,000 | |||
258000 | |||
260,000 | |||
255,000 | |||
250,000 | |||
250,000 | |||
245,000 | |||
240,000 | |||
2020 | 2021 | 2022 |
Sources: DawsonJames
- Source: "Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study",Fei Zhou, MD et al,VOLUME 395, ISSUE 10229, P1054-1062, MARCH 28, 2020,Published:March 11, 2020,https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30566-3/fulltext
NASDAQ: CTXR | 9 |
Rationale for MSCs in ARDS
- Home in on lungs (also first pass effect)
- Counter cytokine storm and IL-10
- Produce potent anti-inflammatory properties
- Restore endothelial and epithelial barrier integrity
- Enhance clearance of fluid from the lungs
- May also exhibit antimicrobial properties
- Decrease the death of some of the endogenous cells in the lungs
Michael Matthay, MD
Professor, Medicine
UCSF
EDUCATION & TRAINING
Harvard | A.B. | 1969 | English |
University | |||
University of | M.D. | 1973 | School of Medicine |
Pennsylvania | |||
U. of | Internship | 1976 | Internal Medicine |
Colorado | & | ||
Medical | Residency | ||
Center | |||
UCSF | Fellowship | 1978 | Pulmonary Division |
UCSF | Fellowship | 1979 | Cardiovascular |
Research | |||
Institute |
- Active by both cell contact dependent and independent mechanisms
Source: The Acute Respiratory Distress Syndrome, Lorraine B. Ware, M.D., & Michael A. Matthay, M.D., May 4, 2000, N Engl J Med 2000; 342:1334-1349
10
What Makes NoveCite Cells, iMSCs, Different?
Put Simply | Feature |
New , Improved Source
Quick to Produce
Scalable
Easy delivery
Potent
Safety profile
- Single source induced pluripotent stem cell (iPSC) master cell bank vs. cells from multiple donors
- Rapid production of induced MSCs (expansion directly from master cell bank)
- Higher expansion capability (no need to re-harvest donor cells)
- Allogeneic ('off-the-shelf') and convenient hospital formulation
- Supplied in 250mL frozen mini-bags
- High-levelsecretion of many immunomodulatory proteins
- History of safety of MSCs in other indications
11
NoveCite Cells (iMSCs) Production
- mRNAs reprogramming process is fast, efficient, and footprint free
- Extensively characterized iPSCs act as perpetual master cell bank
iPSC
Production
Process
Pluripotency Proven by Gold Standard Assay
iMSC
Production
Process
&
Proof of
MSCs
iPSCs | iMSCs | |||
Day 4 | Day 9 | Day 19 | Day 29 | |
MSC medium | Passage | Passage | Passage | |
Day 0 | Day 6 | Day 13 | Day 26 | |
Induction | Passage | Passage | Passage | |
medium | iMSC Differentiation | |||
Novellus iMSCs | Novellus iMSCs | Novellus iMSCs | ||
Novellus iMSCs | +21 days in diff. media | |||
Novellus iMSCs | +25 days in diff. media | Novellus iMSCs +15 days in diff. media | ||
Adipocytes | Osteoblasts | Chondrocytes |
Alizarin Red S stain | ||
Oil Red O stain |
Alcian Blue stain
NoveCite iMSCs vs. Donor-Derived MSCs
Greater expansion potential streamlines manufacturing
iMSCs can be expanded for >70
population doublings
Restored telomeres lead to greater expansion potential
Growth Curve | Telomere Length |
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Summary of NoveCite Opportunity
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 & |
iMSC characteristics and processes | |
NoveCite iMSCs | • Promise of improved efficacy |
Advantages | • Higher level of therapeutic proteins |
• Enhanced expansion for streamlined manufacturing | |
• Streamlined manufacturing, clonal cells, near-unlimited supply | |
Thesis: NoveCite iMSCs are functionally superior than donor-derived MSCs
and have a more efficient manufacturing process
NASDAQ: CTXR | 14 |
Mino-Lok®
LEAD PRODUCT
Minocycline/EDTA/Ethanol
Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections
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 infections are associated with 12-25% mortality and morbidity.2
Hospitals are penalized for reporting high infection rates, not to mention, incur an attributable cost of $46,000 to $65,000 per episode
SOC is a Poor Option for Patients & Hospitals
Current SOC is to remove and replace (R&R) the CVC, while treating with systemic antibiotics
Catheter R&R causes physical and psychological symptoms in 57% to 67% of patients.3
R&R is difficult for many patients, due to unavailability of other accessible vascular sites and the need to maintain infusion therapy
Cost for just the R&R procedure is ~$10,000
Mino-Lok is the first - and only - therapy under investigation that can be used to sterilize and salvage the infected CVC
avoiding the complications, discomfort and costs of removal and replacement.
Sources:
- Shah H., Bosch W., Hellinger W. C., Thompson K. M. (2013). Intravascular catheter-related bloodstream infection. Neurohospitalist 3, 144-151. doi: 10.1177/1941874413476043.
- Antoňáková Němčíková A, Bednárovská E. Catheter-related bloodstream infections: do we know all of it? Klin Onkol. 2017;30(6):405-411. doi: 10.14735/amko2017405.
- Chaftari, AM et al,. Unnecessary Removal of CVCs in Cancer Patients with CRBSI: Impact on Symptom Burden. Poster presentation at ID Week 2017, Infectious Diseases Society of America (IDSA)Oct 04 - 08, 2017
NASDAQ: CTXR | 16 |
Pathogenesis of CLABSI
Contaminated | |
catheter hub | |
Endogenous | |
Skin insertion | Skin flora |
Endogenous | Extrinsic |
HCW hands | |
Skin flora | |
Extrinsic
HCW hands
Contaminated disinfectant
Fibrin sheath, | Skin | ||
thrombus | Hematogenous | ||
3 | |||
Vein | from distant | ||
Infection | |||
(<10%) |
Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Int Care Med. 2004;30:62-67.
The CRBSI Challenge: Organisms Protected from Antibiotics
- 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
Symbol: CTXR
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 occur in 5% to 26% of patients;
- Mechanical complications in 5% to 19%; and,
- Thrombotic complications in 2% to 26%.1,2
Mechanical complications associated with the insertion of CVCs include arterial puncture, hematoma, hemothorax, pneumothorax, arterial-venous fistula, venous air embolism, nerve injury, thoracic duct injury (left side only), intraluminal dissection, and puncture of the aorta.3
Catheter removal and reinsertion causes physical and psychological symptoms in 57% to 67% of patients, respectively.4
Sources (NCBI: Annals of Translational Medicine):
- McGee DC, Gould MK.. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123-33.
- Merrer J, De Jonghe B, Golliot F, et al. Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial. JAMA 2001;286:700-7.
- Polderman KH, Girbes AJ.. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med 2002;28:1-17.
- Chaftari, AM et al,. Unnecessary Removal of CVCs in Cancer Patients with CRBSI: Impact on Symptom Burden. Poster presentation at ID Week 2017, Infectious Diseases Society of America (IDSA)Oct 04 - 08, 2017
NASDAQ: CTXR | 19 |
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.
4. The patient does not experience any sensations similar to the threading of a central line through a vein or artery.
5. The procedure does not require any change to the tunneling or change in placement of the central line.
6. No anesthesia (general or local) is needed.
7. Standard sterile techniques still apply.
*Mino-Lok™ is not flushed into the venous system.
NASDAQ: CTXR | 20 |
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) |
Neutropenia (<500 ) | 19 | (63) | 36 | (60) |
Microbiologic Eradication | 30 | (100) | 60 | (100) |
- Relapse | 0 | (0) | 3 | (5)*** |
Complications | 0 | (0) | 8 | (13) |
SAEs related to R&R | 0 | (0) | 6 | (10) |
Overall Complication Rate | 0 | (0%) | 11** | (18%) |
*1 polymicrobial patient had Gr+ and Gr - organism cultured; ** 6 patients had >1 complication; ***all 3 CVCs were removed within 1 month.
NASDAQ: CTXR | 21 |
Mino-Lok® Phase 3 Pivotal Trial Design
Multi-center, randomized, open label, blinded assessor, active control superiority study
Adjunct in CLABSI/CRBSI
Patients with
CRBSI/CLABSI
(n~ 144)
Anticipated median time of 21 days vs. 38 days to achieve significance
(80% powered)
Active Arm (n=72)
Mino-Lok® Solution
R
Control Arm (n=72)
Antibiotic Lock
Interim Analysis | Primary End Point |
Futility Performed at 35-40 Events | Comparison of "Time to Catheter |
and 60-70 Events for Superior Efficacy | Failure", TOC = 6 weeks |
NASDAQ: CTXR | 22 |
Mino-Lok® Development Plan (estimated as of May 2020)
2015 | 2016 | 2017 | 2018 | 2020 | 2021 | ||||||||||||||||||||||||||||
2019 | |||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||
Chemistry and Manufacturing | Futility Analysis | Superior Efficacy | |||||||||||||||||||||||||||||||
Control (CMC) Development | |
2nd Trial | |
Pediatric | |
(if needed) |
Registration Manufacturing and Stability
NDA
Submission
FDA | FDA | |||||
FDA EOP2 | ||||||
FDA CMC | Interim | Review | ||||
Meeting | Meeting | Mtg. | Mtg. | |||
Commercial Preparation
NASDAQ: CTXR | 23 |
Market Opportunity
Pursue Directly
>4 million
CLABSI's per
year*
Partnerable
United States | Worldwide | Ex-US |
With modest penetration at conservative pricing, we believe that >$500M peak year U.S. sales is achievable.
Regulatory Updates
DISARM Act is pending in the Senate, which would create a DRG carveout for QIDP products. This would allow for full reimbursement for CMS programs and not be part of the payment bundle.
Reimbursement
Company will apply for NTAP, which was just increased to 75% of list price, which would apply to all QIDP products
Company will apply for transitional pass- through
Pricing
Conservative pricing to allow for rapid market uptake would be ~$1.4k treatment
Pricing should have elasticity upwards, given the alternative, R&R (~$10k)
*DelveInsight "Catheter-Related Blood Stream Infections (CRBSI)-Market Insights, Epidemiology & Market Forecast-2028"
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Intellectual Property
Mino-LokTM is supported by a robust intellectual property portfolio Composition of Matter patentthat provides protection until June 7, 2024. Formulation Patenthas been issued and will add protection through 2036.
Creators | Description of Patent | All U.S. and Foreign Patent |
Applications / Patent Numbers | ||
Antimicrobials in Combination with | • U.S. Patent No.: 7,601,731; | |
Issam Raad, M.D. et | Chelators and Ethanol for the Rapid | • EP Ser. No.: 04754538.9; |
al | Eradication of Micro-organisms Embedded | • CA Ser. No.: 2,528,522; |
in Biofilm (Composition of Matter) | ||
Issam Raad, M.D. | Antimicrobial Catheter Lock / Flush | • Pub.No.: US 2017/051373 A1 |
Joel Rosenblatt, Ph.D. | Solutions with Enhanced Stability | • Global IP: UTFC.P1283WO |
et al | (Formulation) | |
U.S. Patent No. 7,601,731 (Composition of Matter) was filed on June 7, 2004 priority date of Provisional Application No. 60/476,555 of June 6, 2003 and issued on October 13, 2009. The expiration date is June 7, 2024.
U.S. Patent No. 9,078,441 (Method of Use) was issued on July 14, 2015. The expiration date is June 7, 2024.
There are corresponding patents granted in Europe and Canada (European Patent No. EP 1644024, and Canadian Patent No. 2528522).
U.S. Patent No. 10,086,114 (Formulation/Enhanced Stability) was filed on November 4, 2016 and issued on Oct. 2, 2018. The expiration date is November 4, 2036.
Patent applications for Global IP filed on June 12, 2018 incl. Canada, China, Japan, Korea, European Patent Office.
NASDAQ: CTXR | 25 |
Competitive Landscape
There are no productsbeing developed for treatmentof infected central venous lines.
Company/Source | Product/Components | Status | Features/Weaknesses |
CorMedix | Neutrolin® | Phase III trial in Prevention in | Prevention only |
taurolidine, citrate, | HD; | Anti-infective only being | |
heparin | Available in Europe (CE Mark) | used in prophylaxis | |
No company has United States regulatory approval. CorMedix is focused on development of lock solutions for the prevention of CRBSI in hemodialysis (HD) patients. There are no lock solutions in development for treatingCRBSI patients and salvaging indwelling, infected CVCs. The current standard-of-care is to treat the bacteremia while removing and replacing the CVC usually in a new vascular access site.
NASDAQ: CTXR | 26 |
Mino-Lok® (minocycline/disodium EDTA/ethyl alcohol)
- Treatscatheter-related blood stream infections (CRBSIs).
- Penetratesbiofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anti-clotting properties.
- Salvagescentral venous access in patients highly dependent on central lines and avoids the serious and expensive complications and morbidities associated with catheter removal and reinsertion.
- Expected to be indicatedas adjunctive therapy for the treatment of Catheter-Related Blood Stream Infections (CRBSI) in combination with appropriate systemic antibiotic(s).
- Would have worldwide rights with appx. 16 years of exclusivity at time of launch.
A major step forward in addressing a serious unmet medical need.
NASDAQ: CTXR | 27 |
Mino-Wrap
CITI-101
Minocycline/Rifampin (M/R) Gelatin Film
Bioabsorbable Extended Release Antimicrobial Wrap for the
Prevention of Breast Tissue Expander Infections
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 the TE is removed leading to a delay of lifesaving chemoradiation therapy, and a more complex reconstruction in the future.
- The preventive measures used to decrease the rate of TE infections are (a) systemic perioperative antimicrobial agents, (b) perioperative immersion of the implant or irrigation of the surgical pocket with an antimicrobial solution prior to insertion of the device, and (c) immediate postoperative oral antimicrobials. Except for (a), all of the other preventive modalities are of debatable use.
Armstrong RW. Ann Plast Surg 1989;23:284-8 Francis SH. Plast Reconstr Surg 2009;124:1790-6
Rosenblatt et al. 2015. Novel in situ liquefying antimicrobial wrap for preventing tissue expander infections following breast reconstructive surgeries. J Biomed Mater Res Part B 2015:00B. *Please note that the 12-14%estimate for mean infection rates is an estimate from clinicians and is not a published data point.
NASDAQ: CTXR | 29 |
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-Wrapis a malleable, bioabsorbable, antimicrobial wrap that is placed over the TE in the surgical pocket as a solid film. It swells and liquefies in situ for a specified period of time providing extended protection against infection from the most likely pathogens.
- Mino-Wrapis designed to allow the temporary tissue expander to be inflated without any restrictions, and to prevent infection and biofilm formation on the implant over longer durations than current practice.
- The current standard of care (SOC) appears to be inadequate as the mean infection rate is very high compared to common surgical infection rates.
NASDAQ: CTXR | 30 |
Mino-WrapDevelopment 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 And Clinical
Concept | Pre-Clinical Studies* | Phase 2 | Phase 3 Study |
Planning | |||
Clinical Study
and Risk
Analysis
Regulatory
Product and CMC
FDA Pre- | |||||||||||
FDA Pre-IND | IND | Orphan | EO Ph2 | ||||||||
Pre-NDA | |||||||||||
IND | drug | ||||||||||
Consultations | Submission | Meeting | |||||||||
Meetings | request | Meeting | NDA | NDA | |||||||
Submission | Approval | |||
Product | ||||
Chemistry and Manufacturing Control (CMC) | ||||
Development and | ||||
Development | ||||
Testing‡ | ||||
-
Pre-ClinicalStudies includes in vitro and in vivo proof of concept studies, animal efficacy, and a 28-dayIND-enabling safety and toxicology study.
‡ Product development and testing includes in vitro testing of prototype physical properties prior to manufacturing scale-up for CMC development.
NASDAQ: CTXR | 31 |
Halo-Lido
CITI-002
Halobetasol/Lidocaine
Prescription Strength Topical for Symptomatic
Hemorrhoid Treatment
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-approved prescription products on the market
- Over 10 million patients admit to symptoms of hemorrhoidal disease and one-third of them seek physician treatment
- OTC hemorrhoid product sales are approximately 20 million units annually
Existing Rx Treatments: "Grandfathered Products"
- Several DESI topical cream formulations containing hydrocortisone and lidocaine are commonly prescribed to treat grade I and II hemorrhoids, but none are FDA-approved
- In 2011, more than 4 million prescriptions were written in the U.S. for hemorrhoidal medications
- Other topical DESI products for hemorrhoids contain hydrocortisone and pramoxine and have annual sales in excess of $80 million
Commonly Used OTC Treatments | Prescription, Non-approvedTreatments |
NASDAQ: CTXR | 33 |
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 formulation containing novel excipientselected for phase 2b study
- Formulation met chemical, physical and stability criteria
- Manufacturing scale-up completed
- Pre-clinicaltoxicology testing in progress, initial results show acceptable profile
- IP evaluation in progress
NASDAQ: CTXR | 34 |
Halo/Lido Development Plan (estimated as of April, 2020)
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
Phase | ||
Product and Formulation Development | VCA | 2b |
Clinical | ||
Study | ||
Pre- | ||
Clinical | ||
Studies | ||
FDA | IND Prep | |
Type C | ||
meeting |
NASDAQ: CTXR | 35 |
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 development pathways
- Multiple staged near-term milestones anticipated
- Highly experienced and successful Management Team, Board of Directors, and Scientific Advisory Board
- Partnership with MD Anderson Cancer Center in developing novel anti-infectives in cancer
- Opportunity to develop a highly differentiated cell therapy, iMSCs, for ARDS
NASDAQ: CTXR | 36 |
Financial Summary (as of 07/08/2020)
Current Cap Table | Shares | % of Fully Diluted | ||
Basic Shares Outstanding | 46,316,298 | 60.5% | ||
Warrants | 27,468,489 | 35.8% | ||
Options | 2,771,838 | 3.6% | ||
Unit Purchase Options | 100,667 | 0.1% | ||
Fully Diluted Shares Outstanding | 76,657,292 | 100% |
Principal Insider and Former Insider
Shareholders (1)
Leonard Mazur | (33.2%) |
Myron Holubiak | (7.5%) |
Reinier Beeuwkes, PhD | (1.3%) |
Geoffrey Clark | (1.3%) |
Stock Price
Current Price | $1.39 |
52 Week High | $1.97 |
52 Week Low | $0.40 |
(1) Beneficial stock ownership as calculated under rules of the Securities Exchange Commission.
NASDAQ: CTXR | 37 |
Citius Pharmaceuticals, Inc.
11 Commerce Drive
First Floor
Cranford, NJ 07016
www.citiuspharma.com
Investor Relations Contact:
Andrew Scott - V.P., Corporate Development
- 967-6677x105 ascott@citiuspharma.com
NASDAQ: CTXR | 38 |
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Citius Pharmaceuticals Inc. published this content on 15 July 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 July 2020 16:40:02 UTC