Citius Pharmaceuticals : CTXR Presentation - Summer 2020

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.

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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)

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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

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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

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NoveCite: ARDS in COVID-19

SARS-CoV-2

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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

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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

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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

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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

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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

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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

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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:

1. Shah H., Bosch W., Hellinger W. C., Thompson K. M. (2013). Intravascular catheter-related bloodstream infection. Neurohospitalist 3, 144-151. doi: 10.1177/1941874413476043.
2. 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.
3. 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

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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):

1. McGee DC, Gould MK.. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123-33.
2. 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.
3. Polderman KH, Girbes AJ.. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med 2002;28:1-17.
4. 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

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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.

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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.

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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

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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

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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.

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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.

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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

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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.

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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

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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.

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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

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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

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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

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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

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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

1. 967-6677x105 [e-mail]

NASDAQ: CTXR

38