Citius Pharmaceuticals, Inc.
(NASDAQ: CTXR)
CORPORATE OVERVIEW MAY 2024
FORWARD-LOOKING STATEMENTS
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 HIGHLIGHTS
1 Diversified Pipeline: Building a Biotech Platform
• LYMPHIR : purified reformulation of IL-2 diphtheria toxin fusion protein for CTCL1 (P3 completed)
- Mino-Lok®: potential to be first and onlyFDA-approved product to salvage infected CVCs causing CLABSI (P3 completed)
- Halo-Lido:potential to be first and onlyFDA-approved Rx therapy for hemorrhoids (P2b completed)
- Attractive Multi-billion $ Global Market Opportunities
- CTCL market est. $300-$400+M with larger potential in PTCL and immuno-oncology (I/O)
- CRBSI/CLABSI market est. >$1.8B worldwide
- Rx hemorrhoid market est. >$2B US
- Healthy Financial Platform
- $12.6M cash as of 3/31/24
- $15 M registered direct offering April 2024
- $26.5 million invested by insiders
- Anticipated Value Driving Catalysts
- Mino-LokPhase 3 trial topline results expected 2Q 2024
- LYMPHIR BLA PDUFA August 13, 2024; 2H 2024 commercialization expected if approved
1. LYMPHIRTM has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed brand name for I/ONTAK (E7777).
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MANAGEMENT TEAM WITH PROVEN TRACK RECORD
LEONARD MAZUR
CHAIRMAN
CEO & CO-FOUNDER
GARY TALARICO
EVP, OPERATIONS
JAY WADEKAR
SVP, BUSINESS STRATEGY
MYRON HOLUBIAK
VICE CHAIRMAN & CO-FOUNDER
KELLY CREIGHTON
EVP, CMC
DR. ALAN LADER
SVP, CLINICAL OPERATIONS
JAIME BARTUSHAK | DR. MYRON CZUCZMAN |
EVP, CFO & CBO | EVP, CHIEF MEDICAL |
OFFICER |
CATHERINE KESSLER | NIK BURLEW |
EVP, REGULATORY AFFAIRS | EVP, QUALITY ASSURANCE |
MIKE MCGUIRE | ILANIT ALLEN |
VP, COMMERCIAL | VP, INVESTOR RELATIONS |
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MINO-LOK
Phase 3 Completed
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MINO-LOK OVERVIEW
Phase 3 Trial topline data anticipated in 2Q 2024
- First and Only antibiotic lock solution in development to sterilize and salvage infected Central Venous Catheters (CVCs) in patients with catheter-related bloodstream infections
- Mino-Lokaddresses the complications, discomfort and cost of CVC removal and replacement
- Positive Phase 2 data indicated strong safety and efficacy signal
- Phase 3 Trial completed: multi-center, randomized, open label, blinded assessor, active control superiority study
- Enrollment completed December 2023; data analysis underway
- 241 patients enrolled; 109 catheter failure events observed
- Clinical sites in US and India
- Primary Endpoint: Comparison of Time to Catheter Failure Event
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MARKET POTENTIAL
High incidence of catheter-related infections support need for effective treatment options
7 Million
Central Venus Catheters (CVCs) used annually in the U.S.*
4 Million
Long-term CVCs
(>1 month) in the U.S.
~500,000
CRBSI/CLABSI infections annually in the U.S.**
12-25%
CRBSI/CLABSI associated mortality & morbidity**
- Shah H., Bosch W., Hellinger W. C., Thompson K. M. (2013). Intravascular catheter-related bloodstream infection. Neurohospitalist 3, 144-151. doi: 10.1177/1941874413476043.
- Antoňáková Němčíková A, Bednárovská E. Catheter-related bloodstream infections: do we know all of it? Klin Onkol. 2017;30(6):405-411. doi: 10.14735/amko2017405.
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CURRENT STANDARD OF CARE IS A POOR OPTION
SOC catheter removal and replacement presents multiple challenges to patients and
caregivers
- Limited availability of other vascular sites
- Infusion therapy interrupted
- Potential for complications
- infectious, thrombotic and mechanical
- 57%-67%of patients experience adverse physical and psychological symptoms from catheter R&R*
- High cost
- ~$10K cost of R&R procedure
- $46K-$65Kcost of CRBSI/CLABSI episode
- 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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POTENTIAL GOLD STANDARD IN CLABSI TREATMENT
Mino-Lok addresses the complications, discomfort and cost of CVC removal and
replacement
- Limited duration IV therapy
5-7DAYS
- Limits disruption of infusion therapy
- Ease of Administration: Locking a catheter is a well-known standard operating procedure
- Not flushed into the venous system
- Lowers risks to patient
- Lower cost alternative: significantly less than removal and replacement
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MINO-LOK PHASE 2B TRIAL RESULTS
Mino-Lok® demonstrated a strong safety and efficacy signal
100% | Effective in salvaging CVCs in all |
patients treated with Mino-Lok | |
100% | Patients treated with Mino-Lok |
all had complete microbiologic | |
eradication with no relapse | |
0% | No SAEs in patients treated with |
Mino-Lok® | |
0% | Complication rate for Mino-Lok |
patients was 0% vs. 18% for |
control arm patients
Mino-Lok Arm | Control Arm | |||
Parameter | % | N | % | |
N | ||||
P atients | 30 | 100% | 60 | 100% |
Cancer Type | ||||
- Hematologic | 20 | 67% | 48 | 80% |
- S olid tumor | 10 | 33% | 12 | 20% |
ICU Admission | 4 | 13% | 4 | 7% |
Mech. Ventilator | 3 | 10% | - | 0% |
Bacteremia | ||||
- Gram+ | 17 | 57%* | 32 | 53% |
- Gram - | 14 | 47%* | 28 | 47% |
Neutropenia (<500 ) | 19 | 63% | 36 | 60% |
Microbiologic E radication | 30 | 100% | 60 | 100% |
- Relapse | - | 0% | 3 | 5%*** |
Complications | - | 0% | 8 | 13% |
S AE s related to R&R | - | 0% | 6 | 10% |
Overall Complication Rate | - | 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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Citius Pharmaceuticals Inc. published this content on 15 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 May 2024 13:57:09 UTC.