OUR NEW PROFILE IS: NASDAQ: CTXR
“Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market
CTXR Has Two Extremely Promising Candidates Currently in Phase 3 with the FDA
The Company Just Released Breaking News After the Close Yesterday Regarding a New Study
Download the Investor presentation HERE
Downloads the Fact Sheet HERE
We have another exciting profile for today’s session. This is a company that we have profiled a few times over the years and as of right now it is sitting about 20% or so higher than the last time we brought it to you before the Summer.
Pull up CTXR Immediately.
The company just dropped fresh news after the close yesterday that has yet to be traded on that could be a major catalyst for today’s session, heading into next week.
Looking forward to collaborating with the University of Pittsburgh (@PittTweet) to evaluate #Treg cell depletion with I/ONTAK in combination with pembrolizumab in solid cancer tumors in a Phase 1 investigator-Initiated Trial.
Read more here: https://t.co/3Ujh9LRYLh $CTXR pic.twitter.com/f8fCuiha3q
— Citius Pharma (@CitiusPharma) September 22, 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 five active programs. Three of its 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 its Phase 3 trial and is on track for submission of a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022. Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Citius has announced its intention to spinoff I/ONTAK into standalone oncology-focused publicly traded company. During the second quarter of 2022, Citius initiated a Phase 2b trial of Halo-Lido, potentially the first and only FDA-approved prescription treatment for hemorrhoids; patient enrollment in the trial is expected to be completed by the end of 2022. Citius has two additional pipeline assets in pre-clinical devleopment: a novel proprietary mesenchymal stem cell (i-MSC) treatment for acute respiratory conditions, and Mino-Wrap, for the prevention of infection in tissue expanders and breast implants post mastectomy.
*****BREAKING NEWS RELEASED YESTERDAY AFTER THE CLOSE*****
Citius Pharmaceuticals Announces a Clinical Collaboration with the University of Pittsburgh to Evaluate T-reg Cell Depletion with I/ONTAK (E7777) in Combination with Pembrolizumab in Recurrent or Metastatic Solid Cancer Tumors in a Phase 1 Investigator-Initiated Trial
I/ONTAK plus PD-1 checkpoint inhibitor pembrolizumab to be evaluated in solid tumor patients
University of Pittsburgh dose-ranging study expected to begin in the fourth quarter of 2022
Collaboration marks second investigator-initiated study of I/ONTAK as combination immunotherapy
CRANFORD, N.J., Sept. 22, 2022 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced a collaboration with Dr. Haider Mahdi at the University of Pittsburgh in an investigator-initiated trial to evaluate I/ONTAK (“denileukin diftitox” or “E7777”) in combination with pembrolizumab in the treatment of recurrent or metastatic solid tumors.
“We are honored to support Dr. Mahdi and his team at the University of Pittsburgh in this Phase 1 investigator-initiated study to evaluate I/ONTAK as a combination therapy in the treatment of solid tumors. This study will expand the body of knowledge about I/ONTAK’s unique mechanism-of-action targeting the CD25 component of the IL-2 receptor which is present on both malignant T-cells (T-cell leukemias and lymphomas) and immunosuppressive regulatory T-cells (T-regs),” stated Dr. Myron Czuczman, Chief Medical Officer of Citius. “Preclinical research in a syngeneic solid tumor mouse model shows that E7777 (denileukin diftitox) enhances anti-tumor activity and significantly extends survival benefit of anti-PD-1 therapy. This data provides a positive signal of denileukin diftitox’s potential in the immuno-oncology space. There remains a significant ongoing need for innovative, effective, and well-tolerated treatments for cancer patients with solid tumors, and we are excited that I/ONTAK may provide meaningful antitumor activity in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®),” added Dr. Czuczman.
“Encouraging clinical data emerging in the field of tumor immunotherapy have demonstrated that therapies focused on enhancing T-cell responses against cancer result in a significant survival benefit in patients with advanced malignancies. Overexpression of PD-L1 on tumor cells has been reported to impede anti-tumor immunity, resulting in immune evasion. The interruption of the PD-1:PD-L1 pathway combined with diminishing the suppressive effect by T-regs may represent an attractive strategy for restoring tumor-specific T-cell immunity. This first in human I/ONTAK plus anti-PD-1 combination immunotherapy study is a significant step towards advancing a T-cell-based therapeutic approach to treating solid tumors,” stated Dr. Haider Mahdi, University of Pittsburgh, Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences. Education & Training.
Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN). This Phase 1 dose-finding study to evaluate I/ONTAK prior to tisagenleucel (KYMRIAH®) CAR-T therapy in patients with diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021.
The investigator-initiated trial at UPMC is an open label, Phase I/Ib study to evaluate T-reg cell depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid tumors. The study consists of two parts. Part I is a dose escalation study of four cohorts (3,6,9,12 mcg of I/ONTAK) and is expected to enroll 18-30 patients. Part II is a dose expansion study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of I/ONTAK and pembrolizumab. The study will also investigate the alteration of the immune microenvironment within tumors and peripheral blood. Secondary endpoints include the objective response (complete response plus partial response), progression-free survival, and overall survival.
LET’S TAKE A LOOK AT SOME OF THE INVESTMENT HIGHLIGHTS…….
- E7777 “I/ONTAK’ (Phase 3): purified reformulation of IL-2 diphtheria toxin fusion protein immunotoxin for CTCL
- Mino-Lok® (Phase 3): potential to be thefirst and only FDA-approved product to salvage infected central venous catheters (CVCs)
- Halo-Lido: potential to be thefirst 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
- NC i-MSC: novel stem cell therapy for acute respiratory distress syndrome (ARDS), for which there is no FDA-approved drug therapy availableMulti-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
- Prescription hemorrhoid market est. >$2B US
- ARDS market large with no approved therapies
- Tissue expander infection prevention market est. $400M worldwideSeasoned 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 surgeryStrong Financial Platform
- Cash runway into 2023 ($48.0M cash as of 6/30/22)
- Management fully committed with $26.5 million invested by founders
Flying well under the radar, Citius Pharmaceuticals (NSDQ: CTXR) has quietly acquired the rights to the experimental compound “E-7777,” (27) a direct improvement to a previously FDA-approved medication that directly attacks infected cancer cells inside the human body.
And this new cancer-fighting remedy could be mere months away from its own approval. If and when it hits the market, this new treatment could provide a whole new proven alternative to the harsh side effects of chemotherapy or aggressive radiation treatment.
Directly targeting and attacking infected cells, E-7777 could transform the $5.4 Billion market for Non-Hodgkin’s Lymphoma treatment.
The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline.
Citius Pharmaceuticals United States NASDAQ: (CTXR) is what’s called a “late-stage biopharmaceutical” company, where a highly-experienced management team purchases rights to the most promising new therapies and then either brings them to market or licenses rights to bigger pharma companies like Pfizer or Johnson & Johnson.
It should go without saying that “late-stage” development is the most difficult, most expensive part of the process for any new kind of treatment. Because even after years of investment, research and development, some 2 out of 5 drugs still fail to secure final FDA approval.(30)
But with a “Dream Team” of top industry insiders, Citius is turning the odds in their favor—with two treatments now in Phase 3, and both looking like they will pass.
In addition to E-7777, it’s currently advancing three proprietary product candidates in total:(12).
• Mino-Lok has advanced to Phase 3 clinical studies.
• CITI-101 (Mino-Wrap) is a malleable, bio-absorbable film impregnated with minocycline and rifampin. It is designed to reduce infections associated with the use of breast tissue expanders (TE) used in breast reconstruction surgeries following mastectomies.
• CITI-002 is being developed to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.
We’re going to focus primarily on Mino-Lok here, since it’s Citius Pharmaceuticals’ most promising (and most immediate) potential revenue source.
Mino-Lok is an antibiotic designed to treat patients with catheter-related bloodstream infections (CRBSIs). At present, these infections are treated by removing the catheter and prescribing antibiotics.
This is a costly medical process with potential complications. In fact, studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. (4)
Mino-Lok allows doctors to treat the infection without needing to remove the catheter, avoiding both costs and complications.
North America is projected to account for a major share of the global catheter-related bloodstream infections market during the forecast period due to well-established health care infrastructure. Europe is anticipated to be the second largest market from 2020 to 2030. (31)
This market has very little, if any, competition
But here’s the biggest catalyst for Citrus, the global catheter-related bloodstream infections market is highly consolidated due to the presence of a small number of key players – which means at this time there is very little in the way of competition. (31)
Currently, in Phase 3 pivotal trials, it could be approved in a matter of months … giving Citrus a massive leg up on any competition.
According to CEO Myron Holubiak: (14)
“Data from the Mino-Lok® (M-L) Phase 3 program was reviewed by our independent Data Monitoring Committee (DMC) for safety and efficacy and found to be progressing as planned with no recommended changes to trial design.”
Mino-Lok has reportedly performed well to date: (18)
Leonard MazurExecutive Chairman, Director
Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding and building multiple healthcare companies, and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is also the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC, a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008, and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical companies. From 2005 to 2012, Mr. Mazur co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC, a specialty pharmaceutical company producing prescription dermatological drugs. Earlier, he was the founder and Chief Executive Officer of Genesis Pharmaceuticals, Inc., a dermatological products company that marketed its products through dermatologists’ offices and co-promoted products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company. Mr. Mazur has extensive sales, marketing and business development experience from previous tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc., Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc.
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 served in the U.S. Marine Corps Reserves.
Myron HolubiakPresident and Chief Executive Officer, Director
Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. From 1998 to 2001, Mr. Holubiak served as President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company. As President of Roche, Mr. Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. During his 19-year tenure at Roche Labs, Mr. Holubiak also held multiple sales and marketing roles. Prior to Roche, Mr. Holubiak founded Emron, Inc., a health economics and managed care consulting company, and helped establish the Academy of Managed Care Pharmacy (AMCP). From 2012 to 2016, Mr. Holubiak served as Chairman of the Board of Bioscrip, Inc., a national home infusion company. Since 2010, Mr. Holubiak has served as a member of the Board of Directors of Assembly Biosciences, Inc. and its predecessor, Ventrus Biosciences, Inc., and is a trustee of the Academy of Managed Care Pharmacy Foundation.
Mr. Holubiak received a BS in molecular biology and biophysics from the University of Pittsburgh. He received advanced business training from Harvard Business School and the University of London, as well as advanced training in health economics from the University of York’s Centre for Health Economics.
Jaime BartushakChief Financial Officer
Mr. Bartushak is an experienced finance and operations professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business development, M&A, restructuring, capital formation, and strategic planning expertise. Mr. Bartushak is a founder of Leonard-Meron Biosciences, and, as CFO, was instrumental in obtaining initial investment capital for its start-up in 2014. Earlier, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., and before that, he led the financial efforts for the successful sale of Triax Pharmaceuticals to PreCision Dermatology.
Mr. Bartushak holds a Master of Science and BS from the New Jersey Institute of Technology.
Myron S. Czuczman, MDChief Medical Officer and EVP
Dr. Czuczman is an experienced physician-scientist, academic oncologist, and pharma executive with decades of experience in strategic design, implementation, and oversight for the global development of novel therapeutics for hematologic malignancies. Dr. Czuczman joined Citius from Celgene where he was Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL. In this role, Dr. Czuczman managed a global team of physicians and scientists responsible for cross-functional development of compounds from proof-of-principle to worldwide registration. Prior to his career in pharma, Dr. Czuczman practiced medicine for over two decades at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma Service and head of the Lymphoma Translational Research Laboratory. In addition to his extensive publications record, membership and leadership roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr. Czuczman also attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center.
Dr. Czuczman received his medical degree from the Pennsylvania State University College of Medicine after graduating magna cum laude in biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.
Gary F. TalaricoEVP, Operations
Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently, he was a founder, partner and Executive Vice President of Leonard-Meron Biosciences, Inc.; he 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 a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included tenures as Vice President of Sales for Medicis Pharmaceutical Corporation at its start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.
Jay WadekarSVP, Business Strategy
Mr. Wadekar has been associated with Citius since its inception. Prior to Citius, he lead the clinical program at Ischemix, Inc., a company developing novel therapies for cardiovascular conditions. Mr. Wadekar has more than thirty years of experience in areas of finance, corporate strategy, sales and senior leadership in the healthcare field. Mr. Wadekar has held numerous executive level positions throughout his career in biotechnology and pharmaceutical industries including Chairman and CEO of Able Laboratories, Inc. Most recently he served as a strategic advisor to Camber Pharmaceuticals, Inc. where he was instrumental in building the executive team and establishing Camber’s Sales Operations systems.
Alan Lader, PhDVP, Clinical Operations
Dr. Lader has served as VP, Clinical Operations since March 2016. 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 at scientific meetings. He received his PhD from the 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.
Ilanit AllenVP, Investor Relations
Ms. Allen has more than 20 years of experience in corporate communications, investor relations, strategy and investment banking. Since 2014, Ms. Allen has provided investor relations counsel to more than two dozen private and public life science companies. Previously, she advised executives across a broad spectrum of industries and growth stages, including technology startups and Fortune 500 financial institutions. Ilanit began her career as an investment banking analyst at SG Cowen with a focus on mergers and acquisitions. Ms. Allen holds an MBA from Harvard Business School, a Bachelor of Science degree in Finance from The Wharton School, and a Bachelor of Arts degree in International Relations from the University of Pennsylvania.
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Source 2: https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-highlight-its-phase-3-clinical-trial-product-mino-lok-at-benzinga-biotech-small-cap-conference-on-march-25-301253709.html
Source 3: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093967/
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Source 5: https://www.everydayhealth.com/things-your-doctor-wont-tell-about-hospital-infections/
Source 6: https://www.gurufocus.com/news/697235/citius-announces-united-states-patent-trademark-office-registered-the-companys-minolok-trademark
Source 7: https://www.citiuspharma.com/mino-lok/
Source 8: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
Source 9: https://www.citiuspharma.com/mino-wrap/
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Source 15: https://www.citiuspharma.com/mino-wrap/
Source 16: https://www.citiuspharma.com/halo-lido/
Source 17: https://ir.citiuspharma.com/press-releases/detail/122/citius-pharmaceuticals-signs-an-exclusive-worldwide
Source 18: https://citiuspharma.com/pipeline/mino-lok/default.aspx
Source 19: https://citiuspharma.com/pipeline/mino-wrap/default.aspx
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Source 27: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals#intrinsic-value
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Source 29: https://finance.yahoo.com/quote/CTXR/history?p=CTXR
Source 30: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
Source 31: https://www.biospace.com/article/catheter-related-bloodstream-infections-market-rise-in-prevalence-of-bloodstream-infection-is-projected-to-drive-the-global-market