Citius Pharmaceuticals : CTXR Presentation - Winter 2020

Citius Pharmaceuticals, Inc.

Corporate Presentation

Winter 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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Investment Opportunity

	Late Stage	Mid-way through Phase 3; Favorable review received
	Lead Asset	from Futility Analysis by Independent Review Board
	Large Market	Market estimated to be ~$1.5B worldwide; current
	Need	SOC is dangerous and costly
	Expert Team	Management has history of >$1B in pharma M&A;
	to Execute	Scientific Advisors are key KOL's in infectious disease

Olympic Motto: "Citius, Altius, Fortius" (Faster, Higher, Stronger)

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Key Management & Advisors

MANAGEMENT

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 lead commercial activities for many corporate expansions and start-ups, including Reliant Pharma and Ventiv Health
• Directs all commercial disciplines at Citius

SCIENTIFIC ADVISORS

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 execute on commercial preparation, IDSA guidelines, and strategic partnerships

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Unique Pipeline in Progressive Stages

Anticipated activities and dates:

Program	Market	Preclinical	Phase I	Phase II	Phase III
(Worldwide)
Mino-Lok®	> $1.5B	Next milestone: 75% superiority interim analysis (Mar 2020)
Treat CVC Infections

CITI-002 (Halo-Lido)		Next milestone: Phase 2B Initiated
Rx Therapy for	> $2B
(Q3 2020)
Hemorrhoids
CITI-101 (Mino-Wrap)
Prevent Infections	~ $400M	Pre-IND c FDA
Associated with
Breast Implants

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Mino-Lok®

LEAD PRODUCT

Minocycline/EDTA/Ethanol

Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections

Central Venous Catheters

Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis

Central Venous Catheter

PICC

Hemodialysis

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Pathogenesis of CRBSI

Endogenous: Skin flora

Extrinsic: HCW hands

Endogenous: Skin flora

Extrinsic: HCW hands;

Contaminated field

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.

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Biofilm Formation Protects Colonies

Micrograph of Biofilm in Central Venous Catheter

• 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

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THE PROBLEM: CVC's 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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CURRENT IDSA GUIDELINES

Long-term central venous catheter (CVC) - or port (P) - related bacteremia or fungemia

Complicated			Uncomplicated

Tunnel

infection,

port abscess

Remove

CVC/P & treat with antibiotics for 7-10 days

Septic

thrombosis,

endocarditis, osteomyelitis

Remove CVC/P

• treat with antibiotics for 4-6 weeks; 6-8 weeks for osteomyelitis in adults

Coagulase-

negative

staphylococcus

May retain CVC/P

• use systemic antibiotics for 10-

14 days + antibiotic

lock therapy for

10-14 days.

Remove CVC/P if

there is clinical

deterioration persisting or relapsing bacteremia.

Staphylococcus

aureus

Remove the

infected catheter

and then treat with

4-6 weeks of antimicrobial therapy unless the patient has exceptions listed in Recommendation 80.

Enterococcus

May retain CVC/P

• use systemic antibiotic for 7-14 days + antibiotic lock therapy for 7- 14 days.

Remove CVC/P

if there is clinical

deterioration persisting or relapsing bacteremia.

Gram-

negative

bacilli

Remove CVC/P &

treat for 7-14 days for CVC/P salvage, use systemic & antibiotic lock therapy for 10-14 days; if no response, remove CVC/P, rule out endocarditis or suppurative thrombophlebitis, and if not present

Candida spp.

Remove CVC/P

• treat with antifungal

therapy for 14 days after the first negative blood culture.

Mermel L A et al. Clin Infect Dis. 2009:49:2-45

treat with antibiotic

for 10-14 days.

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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)

(80% powered)

Active Arm (n=72)

Mino-Lok® Solution

R

Control Arm (n=72)

Antibiotic Lock

Anticipated median time of 21 days vs. 38 days to achieve significance

Interim Analysis

Performed at 40% for Futility

and 75% for Superiority

Primary End Point

Comparison of "Time to Catheter Failure", TOC = 6 weeks

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Mino-Lok®Time-To-Catheter Failure Trial Design

	100
	90					ALT
		Kaplan-Meier Model
	80			MLT
(%)	70
Survival	60
50
Catheter	40
30
	20
	10
	0
	0	10	20	30	40	50	60

Time (days)

21 vs. 38 Day Difference in Median Number of Catheter Failures

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Phase 3 Futility Analysis Complete (Dec. 2019)

Independent Data Monitoring Committee has recommended to continue the Phase 3 trial with no amendments

Mino-Lok® is Fast Tracked & Priority Reviewed.

Test for Superior Efficacy is Estimated to Occur

Q2 2020.

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Mino-Lok® Development Plan (estimated as of Jan. 2020)

2014

2015

2016

2017

2018

2019

2020

2021

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

Q1

Q2

Q3

Q4

Phase 2

Phase 3 ALT Study

First Patient In

Interim Data

Interim Data

Chemistry and Manufacturing Control

40% Futility

75% Superiority

(CMC) Development

2nd Trial

nd

Pediatric

(if needed)

Registration Manufacturing and Stability

FDA EOP2	FDA CMC	FDA	FDA	INDA
Interim	Review	Submission
Meeting
Meeting	Mtg.	Mtg.

Commercial Preparation

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Regulatory Protection

Granted in

October

2015

• Qualified Infectious Disease Product (QIDP)

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 exclusivity at NDA, combined with Hatch-Waxman.

Granted in

October

2017

• Fast Track Designation

Fast Track expedites review of drugs which treat a serious or life-threatening condition and fills an unmet medical need.

More frequent meetings with FDA to discuss the development plan and ensure collection of appropriate data needed to support approval;

More frequent correspondence with FDA about the design of the clinical trials;

Rolling review allows for completed sections of the New Drug Application (NDA) to be submitted and reviewed by FDA rather than waiting until the entire application is compiled and submitted for review.

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Market Opportunity

Pursue Directly

>1 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)

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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 until 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.

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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 on Mastectomies

• Breast cancer is the most frequent cancer in women worldwide and is increasing particularly in developing countries where the majority of cases are diagnosed in late stages (WHO).
• Mastectomies have increased 36% from 2005 to 2013 in the US (1).
• The incidence of post-mastectomy breast reconstruction, following breast cancer treatment, has been increasing on an annual basis. In 2017, the American Society of Plastic Surgeons reported that over 105,000 womenin the United States underwent a postmastectomy breast reconstructive procedure(2).
• Only 30% of the time breast reconstruction occurs simultaneously with the mastectomy; most occur weeks after (3).
• Approximately 80% of the time, a breast tissue expander(TE) is used in breast reconstructions (4).

Sources:

1. New Data Show Mastectomies Increased 36 Percent From 2005 to 2013. Content last reviewed February 2016. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/news/newsroom/press- releases/2016/mastectomy-sb.html.
2. Liu, Daniel. "New Plastic Surgery Statistics and Breast Reconstruction Trends." American Society of Plastic Surgeons, American Society of Plastic Surgeons, 14 Mar. 2017, https://www.plasticsurgery.org/news/blog/new-plastic-surgery-statistics-and-breast-reconstruction-trends.
3. Miller AM , Steiner CA, Barrett ML, Fingar KR, Elixhauser A. Breast Reconstruction Surgery for Mastectomy in Hospital Inpatient and Ambulatory Settings, 2009-2014. HCUP Statistical Brief #228. October 2017. Agency for Healthcare Research and Quality, Rockville, MD. www.hcup-us.ahrq.gov/reports/statbriefs/sb228-Breast-Reconstruction-For-Mastectomy.pdf.
4. 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:000-000

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Background on Tissue Expanders

A Tissue Expander (TE) serves as a temporary implant that is placed below the pectoralis muscle within the mastectomy space. Once a sufficiently large soft tissue envelope has been created, the TE is replaced by a permanent breast implant (two-stage approach).

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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.

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Mino-Wrap Development Plan (estimated as of Jan. 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 is expected to 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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Phase 2a Trial - Positive Directional Improvement

• Faster Relief at Day 2*

Pruritus

Hydro-Lido achieved 88.9%

relief at Day 2 compared to any

of its components

Day 2 Relief (Pruritus)

88.90%

77.80%

54.50%

33.30%

Pain and Discomfort

Hydro-Lido achieved 85.7% relief of pain and discomfort at Day 2 compared to any of its components

Day 2 Relief (Pain and Discomfort)

85.70%

50.00% 50.00% 50.00%

Hydro-Lido

3% Hydro

5% Lido

Vehicle

Hydro-Lido

3% Hydro

5% Lido

Vehicle

* Study was not powered to show statistical significance; its purpose was to inform future study design.

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Current Status

• Hydro/Lido Trial Results
• • Use more potent steroid, Halobetasol propionate (HBP), and maintain Lidocaine HCl (LH)
• Formulation screen examined a gel and cream
• Ongoing stability tests for new formula (cream and gel)
• Completed Vasoconstriction Assay (VCA) study to determine optimum formulation
• Selected cream (stability, color, consistency and elegance)
• Manufactured scale-up in 2019 (for non-clinical and clinical studies)
• Pre-clinicaltoxicology study required by FDA initiated in January, 2020
• IND Preparation expected to be filed in July 2020
• Phase 2b planning to be initiated in Q3 2020

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Halo/Lido Development Plan (estimated as of Jan. 2020)

2015

2016

2017

2018

2019

2020

2021

Q1

Q2

Q3

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

VCA

FDA	Pre-
Type C	Clinical
meeting	Studies

Phase

2b

Clinical

Study

IND Prep

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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
• 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

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Financial Summary (as of 01.20.2020)

	Current Cap Table	Shares	% of Fully Diluted
	Basic Shares Outstanding	31,348,299	54.6%
	Warrants	23,246,172	40.4%
	Options	2,751,838	4.8%
	Unit Purchase Options	100,667	0.2%
	Fully Diluted Shares Outstanding	57,446,976	100%

	Principal Insider and Former Insider				Stock Price
	Shareholders (1)
	(98 Holders of Record)				Current Price	$1.14
	Leonard Mazur	(47.4%)
			52 Week High	$1.59
	Myron Holubiak	(11.3%)			52 Week Low	$0.40
	Reinier Beeuwkes, PhD	(2.1%)
	Geoffrey Clark	(2.1%)

(1) Beneficial stock ownership as calculated under rules of the Securities Exchange Commission.

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Corporate Profile

Citius Pharmaceuticals, Inc.

11 Commerce Drive

First Floor

Cranford, NJ 07016

908-967-6677

www.citiuspharma.com

Media and Investor Relations:

IRTH Communications

Robert Haag, Managing Director

866-976-4784

[e-mail]

NASDAQ: CTXR

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