2 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 the 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, o pinions and beliefs of the Company that are not historical facts. Such forward - looking statements may be identified by words such as “beli eves”, “expects”, “endeavors”, “anticipates”, “intends”, “plans”, “estimates”, “projects”, “should” “objective” and variations of such words a nd similar words. The accuracy of such statements is dependent upon future events, and involves known and unknown risks, uncertainties and other f act ors beyond the Company’s control that may cause actual results to differ materially from what is presented herein. Investors are stron gly encouraged to carefully review the Company’s SEC filings for a listing of the risks that could cause actual results to differ from these for ward looking statements. These forward - looking statements speak only as of the date of this presentation and should not be construed as stat ements of facts.
3 Investment Opportunity Olympic Motto: “ Citius , Altius, Fortius ” (Faster, Higher, Stronger) € Low Risk/ High Reward Strategy • Low development risk … focused on 505(b)2 regulatory pathway products, • avoids unnecessary duplication of studies already performed on previously approved drugs • results in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with high commercial value expected. • Unique indications…little or no competition • Anticipated quick market acceptance (effective, safe and cost - saving/effective solutions) € Successful management team with extensive experience • Approximately $23 million invested privately by founders and $14 million by the public € Multiple near - term milestones and catalysts
4 Unique Pipeline in Progressive Stages € Phase 3: Mino - Lok® • Lead product (Mino - Lok) is a unique antibiotic lock therapy that salvages central lines in bacteremic patients. This is a very serious problem with a clear unmet medical need. We estimate the market to be >$1 billion worldwide. € Phase 2: CITI - 002 (Halo - Lido) • Hydrocortisone/lidocaine completed Phase 2a. New formulation (with halobetasol ) requires animal tox study prior to phase 2b trial. Would be the only FDA approved Rx therapy for hemorrhoids. We estimate the market to be >$1 billion in US. € Pre - Clinical: CITI - 101 (Mino - Wrap) • Unique product that prevents infections associated with breast implants. Preclinical data suggest prolonged protection against colonization by key organisms during time when most susceptible. We estimate the market to be ~$200 million worldwide. € Targeted Acquisitions • Business development activity focused on 505(b)2 products with unique indications.
5 Citius Development Strategy Objectives € Identify drug candidates that can be developed within a 3 - 4 year time horizon with low development risk € Develop products for unique, attractive indications (unmet need/few competitors) € Ensure intellectual property protection for 10 years € Focus on therapeutic areas that are highly influenced by small group of key opinion leaders (KOLs) € Provide cost - effective or cost - saving therapies
Citius Lead Product Minocycline/EDTA/Ethanol Antibiotic Lock Therapy for Salvaging Catheters That Cause Bloodstream Infections Mino - Lok®
7 Central Venous Catheters Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis Central Venous Catheter PICC Hemodialysis
8 Pathogenesis of CRBSI 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. Endogenous: Skin flora Extrinsic: HCW hands; Contaminated field Endogenous: Skin flora Extrinsic: HCW hands From distant Infection (<10%)
9 Bio lm Formation Protects Colonies • 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 Micrograph of Biofilm in Central Venous Catheter
Biofilm Visualizations Post - Removal 10 Glycocalyx under Microscope CVC Dissections Post - Removal
11 The Problem : Removing and Replacing an Infected Catheter in CRBSI is Risky and Costly The Solution : Mino - Lok® to Sterilize and Salvage the Catheter • Central venous catheters (CVCs) are life - saving vascular access ports for patients requiring long term intravenous therapy. • 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. • These infections are associated with 12 - 25% mortality and morbidity, prolonging hospital stay and increasing the cost of care significantly. • Current SOC is to remove and replace the CVC while treating the patient for their blood stream infection with systemic antibiotic(s). • The removal and replacement of the CVC is a risky and costly procedure. • Mino - Lok is the first therapy under investigation that can be used to sterilize and salvage the infected CVC avoiding the complications, discomfort and costs of removal and replacement. • There are no lock solutions under development for treating and salvaging infected CVCs.
Long - term central venous catheter (CVC) – or port (P) – related bacteremia or fungemia Complicated Uncomplicated Tunnel infection, port abscess Septic thrombosis, endocarditis, osteomyelitis Coagulase - negative staphylococcus Staphylococcus aureus Enterococcus Gram - negative bacilli Candida spp. Remove CVC/P & treat with antibiotics for 7 - 10 days Remove CVC/P & treat with antibiotics for 4 - 6 weeks; 6 - 8 weeks for osteomyelitis in adults 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. Remove the infected catheter and then treat with 4 - 6 weeks of antimicrobial therapy unless the patient has exceptions listed in Recommendation 80. 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. CURRENT IDSA GUIDELINES 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 treat with antibiotic for 10 - 14 days. 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 12
13 Current Standard of Care Remove & Replace: Risky, Discomforting, and Costly
14 CVC Insertion Complications Complications include infection, thrombosis, occlusion, and mechanical complications. x Infectious complications are reported to occur in 5% to 26% of patients; x Mechanical complications in 5% to 19%; and, x 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 tr ial. 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 W eek 2017, Infectious Diseases Society of America (IDSA)Oct 04 - 08, 2017
15 (a) Vascular injury following dialysis catheter placement. Initial chest X - ray after reported uneventful place of a tunneled rig ht internal jugular dialysis line in a 67 - year - old female with end - stage renal disease. (b) After initial attempts to access catheter demonstrated t hat fluid was easily flushed, but not aspirated out of the catheter, attempts to change the “malfunctioning” catheter over a wire suggested that t he wire was in the pleural space, and hence the catheter tip was extravascular. (c) Due to concerns of a vascular injury, removal under direct v isu alization was recommended. Following median sternotomy, the intraoperative findings demonstrated the catheter had punctured the confluence of the right subclavian vein as it entered into the superior vena cava. The catheter was in the right pleural space. The pericardial space ha d not been violated. Under direct visualization the catheter was removed and the residual hole was repaired with a pursestring and pledgeted suture. Blood loss was minimal and the postoperative recovery was uneventful. Repeat line placement several days later, under fluoroscopic guidance, wa s uneventful Firstenberg , Michaels, et al. “Central Line Complications.” International Journal of Critical Illness and Injury Science , vol. 5, no. 3, 2015, p. 170., doi:10.4103/2229 - 5151.164940 Examples of Severe Adverse Events Associated with CVC Exchange
16 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.
18 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) 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 a Gram+ and a Gram – organism cultured ** 6 patients had >1 complication
19 Active Arm (n=350) Mino - Lok™ Solution + CVC Salvage + SOC IV Antibiotics for All organisms Control Arm (n=350) Antibiotic Lock + SOC IV Antibiotics for All Organisms [including S.aureus (incl. MRSA ), Gram - , Candida] Patients with CRBSI/CLABSI (n=700) R Mino - Lok® Phase 3 Study Design Multi - center, randomized, open label, blinded assessor, active control superiority study Primary End Point: Proportion of ITT Patients who have Overall Success at TOC week (8) Interim Analysis to be Performed at 50% and 75% Completion.
Mino - Lok Phase 3 End Points Primary End Points: • Proportion of subjects deemed successfully treated at the end of the study period [ Time Frame: 8 weeks ] • Success is defined as any subject who demonstrates eradication of the pathogen, stabilization or improvement in signs and symptoms of the infection, catheter salvage, AND survival at termination of the study. Select Secondary End Points: • Proportion of subjects with a response of Clinical Cure at End of Treatment. [ Time Frame: 8 weeks ] • Clinical Cure is defined as the absence of baseline CRBSI/CLABSI signs/symptoms or, in the Investigator's opinion, improvement of signs/symptoms such that no additional therapy is necessary. • Proportion of subjects in the MITT and CE Populations with a response of microbiological eradication. [ Time Frame: 8 weeks ] • Microbiological Eradication is the demonstration that the bacterial pathogen(s) found at baseline is absent with repeat blood culture. • All - cause mortality [ Time Frame: 14 Days ] • Safety and tolerability profile of subjects as assessed by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations. 20
21 Mino - Lok® Development Plan (as of 02/2019) 2014 2015 2016 2017 2018 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Phase 2 Clinical Study Chemistry and Manufacturing Control (CMC) Development Registration Manufacturing Phase 3 Clinical Study FDA EOP2 Meeting FDA CMC Meeting FDA Interim Mtg. FDA Review Mtg. NDA Submission 2 nd Registration Study (if needed) First Patient In Interim Analysis
22 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 Patent Applications / Patent Numbers Issam Raad , M.D. et al Antimicrobials in Combination with Chelators and Ethanol for the Rapid Eradication of Micro - organisms Embedded in Biofilm (Composition of Matter) • U.S. Patent No.: 7,601,731; • EP Ser. No.: 04754538.9; • CA Ser. No.: 2,528,522; Issam Raad , M.D. Joel Rosenblatt, Ph.D. et al Antimicrobial Catheter Lock / Flush Solutions with Enhanced Stability (Formulation) • Pub.No .: US 2017/051373 A1 • Global IP: UTFC.P1283WO 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. 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.
23 Regulatory Protection 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. Fast Track Granted (October 2017) € 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; • Priority review to shorten the review process from 10 - 12 months to 6 months; and, • Rolling review which 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.
24 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 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 treating CRBSI 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 . There are no products being developed for treatment of infected central venous lines.
25 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. € Preserves central 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 indicated as adjunctive therapy for the treatment of Catheter - Related Blood Stream Infections (CRBSI) in combination with appropriate systemic antibiotic(s). € Will have worldwide rights with appx. 16 years of exclusivity at time of launch. A major step forward in addressing a serious unmet medical need.
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 (AHRQ). € 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 women in the United States underwent a postmastectomy breast reconstructive procedure. € Only 30% of the time breast reconstruction occurs simultaneously with the mastectomy; most occur weeks after. € Approximately 80% of the time, a breast tissue expander (TE) was chosen over an autologous flap reconstruction. 27
Background: Rate of Infection Post - Mastectomy € As a comparison, the rate of infection following breast augmentation is approximately 2%, while it is as high as 24% for breast reconstructive procedures. Estimated mean is 10%. € Once the TE becomes infected, the patient is hospitalized and the implant is removed leading to a delay in lifesaving chemo - radiation therapy, which can be a devastating consequence for the patient. € The preventive measures used to decrease the rate of TE infections are (a) systemic perioperative antimicrobial agents, (b) 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 28
Mino - Wrap: Thesis € To decrease the high rate of TE infections, Mino - Wrap is a malleable, bioabsorbable, antimicrobial wrap that is placed in the surgical pocket as a solid film. It slowly liquefies in situ for a specified period of time providing extended protection against infection from the most likely pathogens. € Mino - Wrap is designed to allow the temporary tissue expander to be inflated without any restrictions, protect tissue from inflammatory responses, and also prevent infection and biofilm formation on the implant over longer durations than current practice – which are primarily irrigation with an antimicrobial solution. € Mino - Wrap would also be used with breast implants during reconstruction post - TE removal. 29
Mino - Wrap Pre - Clinical Development Summary Four Aspects Have Been Evaluated Preclinically 1. Physical changes over time and durability • Assessed if wrap could retain physical presence in a simulated TE pocket environment • evaluated in patient drain fluid samples following mastectomy and observed over a 1 week duration • Expected bio - absorption time is 2 - 4 weeks 2. Antimicrobial efficacy • MRSA, MRSE, and Pseudomonas aeruginosa clinical isolates were used 1.00E+00 1.00E+01 1.00E+02 1.00E+03 1.00E+04 1.00E+05 1.00E+06 1.00E+07 Day 1 Day 3 Day 7 Day 10 MRSA Recovered CFU/disc 1.00E+00 1.00E+01 1.00E+02 1.00E+03 1.00E+04 1.00E+05 1.00E+06 1.00E+07 Day 1 Day 3 Day 7 Day 10 MRSE Recovered CFU/disc 1.00E+00 1.00E+01 1.00E+02 1.00E+03 1.00E+04 1.00E+05 1.00E+06 1.00E+07 1.00E+08 Day 1 Day 3 Day 7 Day 10 Pseudomonas Recovered CFU/disc Control Wrap p <0.05 M/R Wrap 30
Mino - Wrap Pre - Clinical Development Summary (cont’d) 3. Mammalian cellular cytotoxicity The human fibroblast cell line, HEK - 293T, used for toxicity testing. Gelatin films without antimicrobials, untreated cells and medium were used as controls. 4. Sterilization and stability. Gamma irradiation to 25 kiloGrays ( kGy ) using cobalt 60 source at room temperature. Allows for economical sterilization. 0 20 40 60 80 100 120 Untreated cells Control Wrap M/R Wrap Cell viability (%) 31 Rosenblatt et al. J Biomed Mater Res Part B: Applied Biomaterials, 104B: 369 – 374, 2016
Conclusion The in vitro preclinical experiments reveal that Mino - Wrap delivers minocycline and rifampin to the silicone surface in an active form • Remains intact at least for 1 week after being submerged in a collagenase - saline solution at 37 ⁰ C, • Is safe and not cytotoxic towards human fibroblasts, • Remains active after gamma radiation sterilization, • Is active against the most common bacterial clinical isolates responsible for TE infections, for at least 10 days. • Mino - Wrap appears to have the characteristics necessary for an advance in the protection of human implants from subsequent infection. Next Steps: Determine Regulatory and Development Pathway 32
Regulatory Pathway Options • 510K • Premarket submission demonstrating Mino - Wrap is at least as safe and effective as another legally marketed device that is not subject to premarket approval. • K142611 - TYRX™ Absorbable Antibacterial Envelope is a fully absorbable antibacterial envelope for cardiac implantable electronic devices, including implantable cardioverter defibrillators and pacemakers. The absorbable surgical mesh envelope two antibiotics — minocycline and rifampin. It is designed to stabilize the device and reduce the risk of infection and infection - related costs. • K041620 - NeuraWrap is an absorbable collagen implant that provides a non - constricting encasement for injured peripheral nerves for protection of the neural environment. • K053655 - Tendon Wrap is an absorbable implant that provides a non - constricting, protective encasement for injured tendons, it is comprised of a porous matrix of cross - linked collagen and glycosaminoglycan. • PMA • Premarket approval (PMA) is the FDA process to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 33 Device - Ctr for Devices & Radiological Health (CDRH) Drug - Center for Drug Eval. & Research (CDER) • Standard drug development and application • CDER evaluates clinical benefit and risk information submitted taking into account any uncertainties that may result from imperfect or incomplete data. Generally, the agency expects two well - designed clinical trials. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties. • Potential for an Orphan Drug Designation • The Orphan Drug Designation (ODD) is designed for safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. • ODD includes incentives including seven - year market exclusivity, tax credits equal a fifteen - year carry - forward and three - year carry - back applied in profitable years, grants for drug development, fast - track approvals, and expanded access to the Investigational New Drug Program. The law was also later amended to waive user fees charged under PDUFA.
Intellectual Property 34 • US Patent filed April 17, 2014 • US Patent Issued Dec. 26, 2017 • If CDER, then apply for Orphan Drug Designation (+7 years) , QIDP (+5 years) Priority Review and Fast Track
Halobetasol /Lidocaine Prescription Strength Topical for Symptomatic Hemorrhoid Treatment Halo - Lido CITI - 002
36 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 - approved Treatments
37 Phase 2a Trial Results - Hydrocortisone/Lidocaine (CITI - 001) In a randomized, double blind study of topical formulations of vehicle and various strengths of components (cream, hydrocortisone, and lidocaine), CITI - 001 showed directional improvement over its components and vehicle*. This study measured improvement in Global Score of Disease Severity from a baseline (2 levels of improvement) Data suggest that CITI - 001 may show quicker and better relief than any of its components in global improvement. Data also suggested that an increase in corticosteroid potency could show greater improvement. 39.10% 56.50% 69.60% 18.50% 37% 40.70% 30.40% 39.10% 69.60% 24.10% 44.80% 55.20% 0% 10% 20% 30% 40% 50% 60% 70% 80% Day 3 Day 8 Day 15 Hydro-Lido 3% Hydro 5% Lido Vehicle Improvement in Global Severity * Study was not powered to show statistical significance; its purpose was to inform future study design.
38 Phase 2a Trial Results - Positive Directional Improvement Faster Relief at Day 2 * Pruritus Hydro - Lido achieved 88.9% relief at Day 2 compared to any of its components Pain and Discomfort Hydro - Lido achieved 85.7% relief of pain and discomfort at Day 2 compared to any of its components 88.90% 54.50% 77.80% 33.30% Hydro-Lido 3% Hydro 5% Lido Vehicle Day 2 Relief (Pruritus) 85.70% 50.00% 50.00% 50.00% Hydro-Lido 3% Hydro 5% Lido Vehicle Day 2 Relief (Pain and Discomfort) * Study was not powered to show statistical significance; its purpose was to inform future study design.
39 Summary € Addressing attractive diversified multi - billion dollar opportunities – Adjunctive Cancer Care/Infectious Disease, 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
Financial Summary Current Cap Table Sha r es % of Fully Diluted Basic Shares Outstanding 18,520,360 56.0 % Warrants 12,871,623 38.9 % Options 1,601,034 4.8 % Unit Purchase Options 100 , 667 0. 3 % Fully Diluted Shares Outstanding 33,093,684 100% Principal Insider and Former Insider Shareholders (1) (101 Holders of Record) Leonard Mazur ( 48.7 %) Myron Holubiak ( 11.0 % ) Reinier Beeuwkes, PhD ( 2.9 % ) Geoffrey Clark ( 2.9 % ) Stock Price Current Price ( 2 / 18 /1 9 ) $ 1 . 17 52 Week High $3.39 52 Week Low $ 0 . 95 CT XR (1) Beneficial stock ownership as calculated under rules of the Securities Exchange Commission. 40
Management Team Executives, Directors, & Board Members
42 Citius Management Team (Leadership) Leonard Mazur, Director and Chairman of the Board Mr . Mazur is a highly accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building and creating value and returns for the investors . He has been instrumental in launching many brands which have been at the forefront in their respective categories . Mr . Mazur is a founder/co - founder of the following companies : Genesis, Triax , Akrimax, and Rouses Point Pharmaceuticals . He has previously served in Executive Management positions at Medicis Pharmaceuticals, ICN Pharmaceuticals, Knoll Pharma ( divison of BASF) and Cooper Laboratories . Mr . Mazur is a member of the Board of Trustees of Manor College and is a recipient of the Ellis Island Medal of Honor . Mr . Mazur received both his BA and MBA from Temple University and has served in the U . S . Marine Corps Reserves . Myron Holubiak, President & CEO and Director Mr . Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies . He is Co - founder, Director and CEO of Leonard Meron Biosciences, Inc . , and served as CEO until the merger with Citius Pharmaceuticals, Inc . in March 2016 , and then assuming the CEO role for the merged entity, Citius Pharmaceuticals, Inc .. He is the former President of Roche Laboratories, Inc . , a major research based pharmaceutical company . During his tenure as President of Roche, Holubiak transformed Roche Labs into a leading antibiotic and biotechnology company . He was also founder of Emron , Inc . , a pioneering health economics and managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP) . He is a former director and past Chairman of Bioscrip , Inc . , a national home infusion services provider . He is currently a director of bioAffinity , Inc . , and Assembly Biosciences, Inc . He received a BS in the double majors of Molecular Biology and Biophysics with post - graduate work in Biophysics from the U of Pittsburgh ; he received advanced business training from the Harvard Business School, the Amos Tuck School at Dartmouth, and the University of London ; and, advanced training in health economics from the University of York’s Centre for Health Economics .
43 Citius Management Team Jaime Bartushak, CFO Mr . Bartushak is an experienced finance professional for early stage pharmaceutical companies, and has over 20 years of corporate finance, business development, restructuring, and strategic planning experience . Most recently in 2014 , Mr . Bartushak helped lead the sale of PreCision Dermatology to Valeant Pharmaceuticals . Mr . Bartushak is also one of the founders of Leonard - Meron Biosciences and was instrumental in their startup as well as obtaining initial investment capital . Gary F. Talarico, EVP, Operations Mr . Talarico is highly experienced in leading commercial activities for a number of start up companies and corporate expansions . He has directed all of the commercial disciplines including marketing, sales, operations, training, trade and managed markets, and KOL development . Most recently he was partner and Executive Vice President of Leonard Meron Biosciences, and was instrumental in acquiring its lead product . Previously, Mr . Talarico served as Senior Vice President of Triax Pharmaceuticals from its founding to the sale of its assets . Mr . Talarico was also a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals . Before Reliant, he was Executive Vice President of Business Development for Ventiv Health . Mr . Talarico is a graduate of Lewis University .
44 Citius Management Team Alan Lader, Ph . D . , VP, Clinical Operations Dr . Lader has over 25 years of experience in medical research . Prior to joining Citius, Dr . Lader was the Director of Clinical Operations for Ischemix , Inc . Dr . Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital where he taught Integrated Human Physiology, and was Principal Investigator for NIH funded studies in mechanisms of lung cancer metastasis . Dr . Lader has authored over 20 publications in peer reviewed journals and has presented more than 20 abstracts in scientific meetings . He received his Ph . D . from University of South Carolina School of Medicine . He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University . Andrew Scott, VP, Corporate Development Mr. Scott has 25 years of transactional experience in strategic planning, product identification, asset acquisition and capital markets services. Mr. Scott was an investment banker at Bear Stearns and focused on the life sciences sector before transitioning to the specialty pharma world. Mr. Scott has licensed over 12 technologies, provided capital raising services, restructurings and advised on M&A transactions. He is actively identifying and speaking with key opinion leaders in various therapeutic areas.
45 Citius Board of Directors Dr. William Kane, Director Dr. Kane has served as a Clinical Professor at Duke University Medical Center since 2003. From 2006 to 2009, he served as the Chief Executive Officer of RadarFind Corporation, and from 2002 to 2003, he served as the Interim Chief Medical Officer of Mercy Fitzgerald Hospital. Dr. Kane is currently the chair of the board of directors of Research Triangle Park and was a past member of the board of directors of Pisacano Leadership Foundation and Make - A - Wish Foundation. In addition, he previously served on the Management Advisory Committee of Cornucopia House Cancer Support Center. Dr. Kane received his B.S. in Biology from the University of Scranton and his M.D. with Honors from the Temple University School of Medicine. Howard Safir , Lead Independent Director Mr. Safir has served as a director since April 2014. He previously served as Chairman and Chief Executive Officer of VRI Technologies LLC, a security consulting and law enforcement integrator. From 2001 until 2010, Mr. Safir served as the Chairman and Chief Executive Officer of SafirRosetti , a provider of security and investigation services and a wholly - owned subsidiary of Global Options Group Inc. Mr. Safir currently serves as a director of Implant Sciences Corporation, an explosives device detection company, and LexisNexis Special Services, Inc., a leading provider of information and technology solutions to governments, as well as Verint Systems Inc. During his career, Mr. Safir served as the 39th Police Commissioner of the City of New York, as Associate Director for Operations, U.S. Marshals Service and as Assistant Director of the Drug Enforcement Administration.
46 Citius Board of Directors Suren Dutia, Director Mr. Dutia is a seasoned executive in the healthcare and medical device space. Mr. Dutia has served as Senior Fellow of the Ewing Mario Kauffman Foundation since March 2011 and as Senior Fellow of Skandalaris Center for Entrepreneurial Studies at Washington University, St. Louis since 2013. He has served as a member of the Advisory Board of Center for Digital Transformation, University of California, Irvine since May 2012 and as chairman of the board of directors of AccelPath , LLC since October 2009. Mr. Dutia received his B.S. and M.S. degrees in chemical engineering and B.A. in political science from Washington University, St. Louis. In addition, he obtained an M.B.A. from University of Dallas. Carol Webb, Director From 2000 to 2005, Ms. Webb served as Company Group Chairman of Johnson & Johnson, and from 1987 to 2000 she served in capacities including President, Vice President, Executive Director, Product Management and Senior Product Director of Ortho Biotech. Ms. Webb has worked in various positions at Roche Laboratories from 1972 to 1983. Ms. Webb has extensive experience in the oncology supportive care space and was responsible for the successful development and launch of several successful products, including PROCRIT® ( epoetin alfa). Ms. Webb received her B.S. in Biology from Bowling Green State University. Eugene Holuka, M.D., Director Dr. Eugene Holuka, M.D. is a Diplomate of the American Board of Internal Medicine and Medical Director of the Bay Street Health Care Center. Dr. Holuka is an Adjunct Clinical Professor at the Touro College of Osteopathy, and an attending physician at the Staten Island University Hospital.
47 Citius Scientific Advisory Board Dr. Issam Raad , M.D. Dr. Issam Raad , M.D. is Chair of MD Anderson Cancer Center’s Department of Infectious Diseases and the Endowed Distinguished Professor of Medicine. Dr. Raad is the author of the underlying patents for Mino - Lok. Dr. Raad’s innovations in prevention of bloodstream infections have been endorsed at the highest level (Category 1A) by the Center for Disease Control (CDC). He has been widely hon ored for creative research, compassionate patient care as well as outstanding mentorship and education. In 2015, Dr. Raad received the 2015 SHEA Mentor Scholar Award in recognition of his distinguished record in mentoring, over the last two decades, fellows and jun ior faculty, most of whom have assumed leadership positions as heads of infection control and prevention programs. In 2014, Dr. Raad received the Outstanding “Gerald Bodey Distinguished Professor” Award to honor his accomplishments in advancing the field of infections in cancer . Dr. Mark Rupp, M.D. Dr. Mark Rupp, M.D. is a Professor and Chief of the Division of Infectious Diseases in the Department of Internal Medicine at th e University of Nebraska Medical Center. He is a Past - President of SHEA and is a past - president of ASM Division L (Infection Control/Hospital Epidemiology). Dr Rupp has served as a consultant for the Food and Drug Administration as well as the Centers for Disease Control and Prevention, NIH, and VA. Leonard A. Mermel , D.O. Dr. Mermel DO, ScM , AM (Hon), FACP, FIDSA, FSHEA is Professor of Medicine, Warren Alpert Medical School of Brown University, Adjunct Clinical Professor, University of Rhode Island College of Pharmacy and Medical Director, Dept. of Epidemiology & Infe cti on Control, Rhode Island Hospital. Dr. Mermel was a Technical Expert Panel Member of the Medicare Patient Safety Monitoring System, US Dept. of Health and Human Services. He was the 2005 President of the Society for Healthcare Epidemiology of America (SHEA) a nd the 2014 SHEA Mentor Scholar Award recipient which honors individuals who are recognized for their dedication and excellence in mentoring trainees in infection prevention and control. Dr. Mermel has co - authored US guidelines dealing with prevention and management of intravascular catheter infections and he has authored or co - authored over 300 articles, textbook chapters, and abstracts dealing with infection control and infectious diseases.
48 Citius Scientific Advisory Board Jesse Selber , M.D. Dr. Jesse C. Selber, M.D., MPH, FACS is the Director of Clinical Research and an Associate Professor in the Department of Plastic Surgery at the University of Texas MD Anderson Cancer Center in Houston, Texas. A microvascular reconstructive surgeon, Dr. Selber's research involves head and neck reconstruction, breast reconstruction, microsurgery, abdominal wall reconstruction, microsurgical trai nin g, robotic - assisted reconstructive surgery, and other areas. He also has an active robotic reconstructive surgery practice in which he developed and utilizes four different types of procedures. His work -- especially with regards to robotic - assisted microsurgery -- has allowed him to be invited, to instruct and to perform surgical procedures at various national and international conferences. In addition, Dr. Selber has had over forty articles published in peer - reviewed journals and serves as a reviewer for several journals (i.e. Head and Neck Surgery, Annals of Plastic Surgery, etc.). He holds offices in multiple national plastic surgery societies including the Am erican Society of Reconstructive Microsurgery and the American Society of Plastic Surgeons, and is an Executive Board and Founding member of th e Robotic Assisted Microvascular and Endoscopic Surgery society (RAMSES). George M. Viola, M.D. Dr. George M. Viola, MD, MPH, is Associate Professor, Department of Infectious Diseases, Infection Control and Employee Healt h, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, and Associate Professor, Department of Infe cti ous Diseases, Division of Internal Medicine, Baylor College of Medicine.
49 Corporate Profile Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 908 - 967 - 6767 www.citiuspharma.com IRTH Communications Robert Haag, Managing Director 866 - 976 - 4784 CTXR@irthcommunications.com Media and Investor Relations:
A Guide to the 505(b)(2) Regulatory Pathway • The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many applicants. The pathway was created by the Hatch - Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant. • A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value. 50