First & Only Therapies Faster to Market Upside Potential
CORPORATE OVERVIEW
FACT SHEET JANUARY 2022
Citius Pharmaceuticals, Inc. (Citius) is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a diversified pipeline of anti-infectives in adjunct cancer care,
oncology, stem cell therapy and unique prescription products. Three | of | its | five | pipeline candidates would be the first |
and only prescription treatments in their indications if approved | by | the | FDA. | The Company has two late-stage product |
candidates, Mino-Lok®, an antibiotic lock solution to salvage infected central venous catheters (CVCs) of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), which has completed treatment in its Pivotal Phase 3 trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and
peripheral T-cell lymphoma (PTCL). Through its | subsidiary, NoveCite, Inc., | Citius | is | developing | a | novel | proprietary |
mesenchymal stem cell (i-MSC) | treatment derived from induced | pluripotent | stem | cells | (iPSCs) | for acute | |
respiratory conditions. Citius's | two additional | product candidates are Halo-Lido, | potentially | the | first | and | only |
FDA-approved prescription | treatment | for | hemorrhoids, and Mino-Wrap, potentially | the | first | and | only |
FDA-approved product to prevent infection in tissue expanders and breast implants post mastectomy.
Anticipated 2022 catalysts | ASDAQ: CTXR | |
• Halo-Lido Phase 2b trial start | Share Price | $1.69 (1/4/22) |
• Mino-Lok Phase 3 trial completion | 52-Wk.Range | $1.05-$4.56 |
• I/ONTAK BLA submission | Avg. Vol. | 1.9M |
• NC i-MSC IND filing | Shares O/S | 146.0M (11/30/21) |
• Mino-Wrap IND filing | Market Cap | $246.7M |
INVESTMENT HIGHLIGHTS
Advancing Diversified Pipeline with Five Active Programs
- E7777 "I/ONTAK' (Phase 3): purified reformulation of IL-2 diphtheria toxin fusion protein immunotoxin for CTCL
- Mino-Lok® (Phase 3): potential to be the first and only FDA-approved product to salvage infected central venous catheters (CVCs)
- NCi-MSC: novel stem cell therapy for acute respiratory distress syndrome (ARDS), for which there is no FDA-approved drug therapy available
- Halo-Lido:potential to be the first and only FDA-approved prescription therapy for hemorrhoids
- Mino-Wrap:potential to be the first and only FDA-approved product to prevent infections associated with post mastectomy breast implants
Multi-billion Global Market Opportunities
- CTCL market est. >$300M with larger potential in peripheral T-cell lymphoma (PTCL) and immuno-oncology (I/O)
- Attractive diversified multibillion-dollar opportunities in adjunctive cancer care, infectious and gastrointestinal diseases
- CRBSI and central line-associated bloodstream infection (CLABSI) market total estimated at $1.8B worldwide
- ARDS market large with no approved therapies
- Tissue expander infection prevention market est. $400M worldwide
- Prescription hemorrhoid market est. >$2B US
Seasoned Leadership
- Extensive pharma operational and financial track record
- History of multi-billion $ in successfully completed transactions (pre-Citius)
- Scientific Advisory Board of leading KOLs in infectious disease, pulmonology (ARDS), breast surgery
Strong Financial Platform
- Cash runway into 2023 ($70.1M cash as of 9/30/21)
- Management fully committed with $26.5 million invested by founders
LEADERSHIP
Leonard Mazur, EXECUTIVE CHAIRMAN, DIRECTOR | JayWadekar, SVP, BUSINESS STRATEGY |
Myron Holubiak, PRESIDENT AND CHIEF EXECUTIVE OFFICER | Dr. Alan Lader, VP, CLINICAL OPERATIONS |
Jamie Bartushak, EVP AND CHIEF FINANCIAL OFFICER | PaulSowyrda, VP, PROGRAM DIRECTOR, ONCOLOGY |
Dr. Myron Czuczman, EVP AND CHIEF MEDICAL OFFICER | JohnWestman, VP, PROGRAM MANAGEMENT |
Gary Talarico, EVP, OPERATIONS | Ilanit Allen, VP, INVESTOR RELATIONS |
Kelly Creighton, EVP, CMC |
PIPELINE: FIVE ACTIVE PROGRAMS
I/ONTAK (E7777)
I/ONTAK (E7777) is a novel oncology asset with an attractive near-term revenue opportunity and substantially de-risked path to support commercial success. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK® which was marketed in the U.S. from 2008 to 2014. Subsequent improvements resulted in a version that maintains the same amino acid sequence but features improved purity and bioactivity. I/ONTAK has received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, making it eligible for seven years of market exclusivity post-approval. The last patient in a Pivotal trial of I/ONTAK has been treated, and a biologics license application (BLA) for I/ONTAK's first indication in CTCL is expected to be filed with the FDA in 2022.
MINO-LOK®
In late-stage development, Mino-Lok® is potentially the first and only antibiotic lock solution under investigation to salvage infected central venous catheters (CVCs) causing catheter-related bloodstream infections. Citius believes Mino-Lok® provides a superior alternative to removing and replacing a CVC, leading to a reduction in serious adverse events and cost savings to the healthcare system. A multicenter Phase 3 pivotal superiority trial is currently underway. Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center.
HALO-LIDO
Halo-Lido(CITI-002) is a topical formulation of halobetasol and lidocaine designed to provide anti-inflammatory and anesthetic symptomatic relief to people with hemorrhoids. There are no FDA-approved prescription products on the market to treat hemorrhoids, and Citius's formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States. Citius expects to begin a Phase 2b study of Halo-Lido in 2022.
NCi -MSCs (Stem Cells)
Preclinical activities are underway for Citius's unique, proprietary stem cell therapy for an initial indication in the treatment of Acute Respiratory Distress Syndrome (ARDS). Compared with donor-derived cells that require a continuous supply of new donors, Citius believes its induced mesenchymal stem cellsi( -MSCs), derived from a single clonal induced pluripotent stem cell (iPSC), offer multiple advantages including consistent and scalable manufacturing and a potentially limitless supply. Positive interim results from a proof-of-concept study demonstrate a marked improvement in i-MSC-treated animals over control animals in key clinical parameters. Currently, there is no FDA-approved drug therapy available for ARDS. Citius expects to file an IND in 2022.
Mino-Wrap
Mino-Wrap(CITI-101) is a novel therapeutic designed to significantly reduce the rate of infection in post-mastectomy breast cancer patients that elect to undergo reconstructive breast surgery. This liquefying gel-based wrap provides inflammatory tissue protection and prevents infection in tissue expanders and breast implants post mastectomy. Mino-Wrap, licensed from MD Anderson Cancer Center, has the potential to be the first and only FDA-approved product for this indication. Citius targets filing an IND for Mino-Wrap in 2022.
Citius Pharmaceuticals, Inc.
11 Commerce Drive, First Floor Cranford, NJ 07016 www.citiuspharma.com
Investor Relations Contact
IIanit Allen
- 967-6677x113 ir@citiuspharma.com
Forward-looking Statements: This fact sheet has been prepared by Citius Pharmaceuticals, Inc. (the "Company") for informational purposes only and not for any other purpose. Nothing contained in this fact sheet is, or should be construed as, a recommendation, promise or representation by the Company. Information provided in this fact sheet speaks only as of the date hereof. The Company assumes no obligation to update any statement after the date of this fact sheet as a result of new information, subsequent events or any other circumstances. This fact sheet 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 fact sheet and should not be construed as statements of facts.
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Citius Pharmaceuticals Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 13:57:02 UTC.