OUR NEW PROFILE IS: NASDAQ: CTXR
“Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market
$Cash and cash equivalents of $33.3 million as of June 30, 2023
CTXR) completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA)
Citius Pharmaceuticals to be Added to Russell 3000® and Russell 2000® Indexes
Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial
Download the Investor presentation HERE
Downloads the Fact Sheet HERE
_______________________________
Hello Everyone,
Analyst Target:
H.C. Wainwright analyst Vernon Bernardino’s $4.00 target could mean a potential upside of over 342% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) after bouncing off a low of $.9044 on 9/6/23, according to Barchart.com’s price history. )(33)(52)
Potential FDA Approval For LYMPHIR™ (Denileukin Diftitox):
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has received a Complete Response Letter from the FDA, highlighting the need for enhanced product testing and additional controls. The absence of concerns regarding clinical efficacy and safety data is a significant positive indicator. (55)
Phase 3 Trial:
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).(35)
Biotech Cluster With 70 New FDA Approvals:
The company is headquartered in a hotbed and breeding ground for successful Biotechs, which were responsible for a staggering 70 new FDA dr-ug approvals between 2020 and 2021.(40)
Accelerated Advancement:
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) expanded and accelerated its Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related bloodstream infections (CRBSIs).(35)
Major Index Inclusion:
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s addition to the Russell 3000® and Russell 2000® Indexes not only raises its profile in the market but also reflects the company’s growth potential and commitment to advancing healthcare solutions. (60)
A Wealth of Expertise in Healthcare Vernon Bernardino’s research at H.C. Wainwright focuses on the vast and ever-evolving healthcare sector. His specific areas of therapeutic interest encompass a wide array of medical fields, including vascular diseases, gastrointestinal and autoimmune diseases, infectious diseases, metabolic conditions, and rare diseases. This broad spectrum of expertise showcases his dedication to understanding the diverse and complex facets of the healthcare industry.
A Decade-Plus Journey in Healthcare With over a decade of experience in the healthcare sector, Vernon Bernardino has honed his skills in both sell-side and buy-side equity research. His journey through the industry’s ranks has seen him contribute his insights to several prestigious Wall Street firms. Prior to his tenure at H.C. Wainwright, Mr. Bernardino made significant contributions as a healthcare equity research analyst at multiple renowned firms, including Seaport Global Securities, B. Riley FBR, Rodman & Renshaw LLC, UBS Securities, and Nicholas Applegate Capital Management (now part of Allianz SE). His work has not gone unnoticed; in 2017, he was recognized by TipRanks as one of the Top 150 Wall Street analysts, a testament to his exceptional analytical prowess.
A Trailblazer in Cardiovascular Research Before his illustrious career on Wall Street, Vernon Bernardino made waves as a scientist in the biotechnology and pharmaceutical industry. His research in cardiovascular diseases proved to be groundbreaking, leading to the discovery and development of Zetia, a cholesterol-lowering drug with annual sales exceeding $2 billion. This remarkable achievement underscores his profound impact on the advancement of healthcare solutions that benefit millions of patients worldwide.
A Visionary Entrepreneur Beyond his roles in research and analysis, Mr. Bernardino’s entrepreneurial spirit shines through. He founded Oceros Advisors LP, a strategic healthcare advisory group. This venture allows him to leverage his wealth of knowledge and insights to provide valuable guidance and strategies in the ever-evolving healthcare landscape.
Educational Excellence Vernon Bernardino’s academic background is as impressive as his professional journey. He holds an MBA in Finance from the University of San Diego, reflecting his commitment to a deep understanding of financial aspects within the healthcare industry. Additionally, he earned a BA from Rutgers University, emphasizing his well-rounded education that encompasses various facets of the healthcare sector.
A Positive Outlook on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Vernon Bernardino’s extensive experience and keen insights extend to his assessment of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR). With a thorough analysis of the company’s prospects, he has set a $4.00 target on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR). This target is a testament to his confidence in the company’s future in the healthcare sector. (52)(53)
Non-Hodgkin’s Lymphoma is one of the deadliest forms of cancer.
Targeting your body’s germ-fighting immune system, it invades your body’s lymph nodes. Left unchecked, it can kill more than 1-in-3 of those diagnosed, with over a half-million new cases each year.
But one company could be set to change all that…
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, Inc. is a BioPharma Powerhouse Hiding in Plain Sight
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’s Phase 3 Clearance Could Be the Key to Commanding a $1.5 Billion 2 Market:
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)
• Mino-Lok is the first and only therapy under investigation to salvage infected CVCs. In a Phase 2b trial, the Mino-Lok product demonstrated a 100% efficacy rate in salvaging colonized CVCs. • Mino-Lok had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced. • FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036. Currently in a Phase 3 pivotal superiority trial. (14)
Meanwhile, Citius’ “Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market
Citius’ Mino-Wrap could help reduce post-operative infections associated with surgical implants. Its gel-containing film is used primarily to wrap the tissue expander used in breast reconstructive surgeries.
As also noted by CEO Holubiak: (14)
“We believe that this serious condition impacts about 100,000 women in the U.S. and many more in the rest of the world. Mino-Wrap is a bio-absorbable, antimicrobial semi-solid film that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical infections. Once implanted, Mino-Wrap slowly dissolves in situ for a specified period of time, providing extended protection against infection.”
Program Highlights (19)
• Potential to be first and only FDA-approved product to prevent infections associated with post-mastectomy breast implants • Currently in preclinical development • Development in partnership with The University of Texas MD Anderson Cancer Center and support from medical thought leaders
Offering Relief in an $80 Million Hemorrhoids Market
Shockingly, there are no FDA-approved prescription products for hemorrhoids at the moment.(16)
However, that could soon change with Citius’ halobetasol and lidocaine formulations.
Hemorrhoids are an uncomfortable and often recurring condition. However, despite the numerous prescriptions and over the counter (OTC) products commonly used to treat hemorrhoids, none possess the necessary safety and efficacy data generated from rigorously conducted clinical trials.
Citius believes its halobetasol-lidocaine product could one day become that go-to treatment for physicians wanting to provide patients with a therapy demonstrating safety and efficacy.(16)
Program Highlights: (20)
• There are no FDA-approved prescription products on the market for hemorrhoids • Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States • According to IMS, over 25 million units of topical combination prescription products for hemorrhoids are sold in the US
Citius Pharmaceuticals Could Even Help Treat ARDS, Too
• There are about three million cases of Acute Respiratory Distress Syndrome (ARDS) globally, with approximately 200,000 instances just in the U.S.(17) • The health crisis significantly added to the amount of ARDS cases, with death rates among patients on ventilators as high as 50%.(17) • Worse, at the moment, there are no approved treatments for ARDS.(17)
According to Citius CEO Holubiak:
“Currently, there is no FDA-approved drug therapy for ARDS. We plan to submit an IND to the FDA and initiate our Phase 1 study by the end of the second quarter of 2022. Our first-in-human clinical trial is entitled “i-MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [the health predicament]: i-MARCO.” Following the completion of a multi-center Phase 1 pilot study, we would expect to proceed on to a double-blinded, randomized Phase 2/3 trial to demonstrate the safety, efficacy, and multimodal healing capabilities of our i-MSCs in patients with moderate to severe ARDS due to [the health predicament].” (14)
Program Highlights: (21)
• Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS) • i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process • No FDA-approved treatment for ARDS exists today • Preclinical activities are underway
$7.2 Billion in Potential Market Disruption
As you’ve seen today, some of the treatments in Citius Pharmaceuticals’ portfolio go far beyond the definition of “Cutting Edge” …
Mino-Lock could potentially erase the need to operate on those suffering from Catheter-Related Bloodstream Infections (CRBIs), revolutionizing treatment of a $1.5 Billion medical problem overnight. E-7777 could offer a powerful new alternative to those suffering from Non-Hodgkin’s Lymphoma.
Combined with a full pipeline of other treatments, Citius Pharmaceuticals could be sitting on top of $5.5 Billion in cumulative pharmaceutical market disruption…
With a full year’s “cash runway” (through December 2023)(43)left to complete critical Research & Development, along with the outrageous profit potential if even one of these treatments makes it to market, Citius Pharmaceuticals (NSDQ:CTXR) is a company that should definitely be on your radar.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is Headquartered in one of the Country’s Hottest Breeding Grounds For for Successful Biotech’s
New Jersey’s biotechnology cluster has grown from a mere 30 companies in the early 1990s to approximately 3,200 establishments in the state today. 46 of those firms are responsible for a staggering 70 new FDA drug approvals between 2020 and 2021, according to the trade association BioNJ.(40)
And several sources indicate that despite recent IPO and capital market challenges, the biotech cluster’s ascension continues.(40)
Debbie Hart, president and CEO of BioNJ, says of the overall US/global biotech community: “The science is advancing by leaps and bounds, and it’s creating lots of opportunities, new companies, and new advances in therapies and treatments.”(40)
“When you look at what happened during the global pandemic – how the industry can really save the world – [it’s] not an understatement. It just speaks to ability and the science.”(40)
New Jersey’s specific biotech juggernaut partly stems from a constellation of cutting-edge advances in cell and gene therapy operating in tandem with a Garden State life sciences ecosystem replete with contract manufacturing and clinical research organizations, as well as specialized accountants, attorneys, and other professionals who serve the industry.(40)
Such a network is particularly important for the biotechnology community given the challenges it faces.(40)
Dean J. Paranicas, president and CEO of the HealthCare Institute of New Jersey (HINJ), details the overall “high-risk profile” for the biopharmaceutical industry: “There’s that challenge of having enough capital to develop your product, being able to get it through the regulatory cycle, and then commercializing [it] and getting it into the marketplace.”(40)
Paranicas additionally explains that New Jersey firms have beneficial opportunities to coordinate with the state’s research institutions as well as with more established companies located here.(40)
Also helping to lubricate the state’s growing industry is New Jersey’s proximity to Wall Street and, separately, a time-zone advantage, which facilitates business communication with locales as diverse as, say, California and the United Kingdom.(40)
In November of 2022, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced it had secured $3.6 million through New Jersey Economic Development Program.(45)
“This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey’s NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application (BLA) for I/ONTAK,” stated Jaime Bartushak, Chief Financial Officer of Citius.(45)
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Receives FDA Complete Response Letter for LYMPHIR™ in Cutaneous T-Cell Lymphoma (56)
The FDA’s response focuses on the need for enhanced product testing and additional controls, which were agreed upon during the market application review process. Notably, the agency’s feedback did not raise any concerns regarding the safety and efficacy clinical data package submitted with the BLA or the proposed prescribing information.
Leonard Mazur, Chairman and CEO of Citius, expressed the company’s gratitude for the FDA’s expedited review and its commitment to meeting the requirements for LYMPHIR’s approval. He stated, “We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make a meaningful difference in their lives.” (56)
LYMPHIR™: A Promising Treatment for CTCL (56) LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. This unique agent specifically targets IL-2 receptors on cell surfaces, leading to the inhibition of protein synthesis within cells. The FDA previously granted orphan drug designation to LYMPHIR in 2011 and 2013 for the treatment of peripheral T-cell lymphoma (PTCL) and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets, excluding Japan and certain parts of Asia.
Understanding Cutaneous T-Cell Lymphoma (CTCL) Cutaneous T-cell lymphoma is a subtype of cutaneous non-Hodgkin lymphoma (NHL) and represents the most prevalent form of cutaneous lymphoma. This condition manifests in various forms, and CTCL is characterized by cancerous T-cells that develop into skin lesions. Consequently, CTCL significantly impacts the quality of life for affected individuals due to severe pain and pruritus. The majority of CTCL cases comprise Mycosis Fungoides (MF) and Sézary Syndrome (SS). The disease progression varies, with some cases progressing slowly over several years, while others reach a highly malignant tumor stage more rapidly, affecting lymph nodes and internal organs.
CTCL predominantly affects men and is typically diagnosed in patients between the ages of 50 and 60. Despite multiple treatment options, including allogeneic stem cell transplantation for a select few, there is currently no curative therapy for advanced CTCL. (56)
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) remains committed to addressing the unmet medical needs of patients with CTCL and is actively working toward the FDA’s requirements for LYMPHIR’s approval, potentially opening new doors for patients battling this challenging disease.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Achieves Milestone in Mino-Lok® Phase 3 Trial (58)
Reaching the 92 Event Milestone Citius Pharmaceuticals has revealed that pending confirmation from an adjudication committee of independent reviewers, it believes to have achieved all 92 events required to complete the Phase 3 Mino-Lok trial. This achievement is paramount as the company moves closer to completing the trial successfully.
Leonard Mazur, Chairman and Chief Executive Officer of Citius, emphasized the significance of this milestone, stating, “This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial. As we complete therapy for patients in active treatment, we will continue to enroll patients in the pipeline and initiate shutdown activities.” (58)
Mino-Lok Phase 3 Trial Design The Phase 3 pivotal superiority trial, registered under NCT02901717, is a multi-center, randomized, open-label, blinded study that aims to assess the efficacy and safety of Mino-Lok (MLT). This innovative antibiotic lock therapy combines minocycline with edetate disodium and is being conducted in the United States and India.
The primary endpoint of the trial is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.
Patients diagnosed with catheter-related bloodstream infections (CRBSI/CLABSI) who meet the necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok therapy or standard-of-care antibiotic lock therapy.
In the Mino-Lok arm, patients receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines. (58)
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Joins the Russell 3000® and Russell 2000® Indexes (60)
Leonard Mazur, Chairman and CEO of Citius, expressed his satisfaction with the news, saying, “We are pleased to be included, once again, in the Russell U.S. Equity Indexes and welcome the enhanced visibility this brings to our diversified late-stage pipeline.” (60)
FTSE Russell, a global leader in index expertise and products, employs a meticulous selection process for its Russell indexes, primarily based on objective market-capitalization rankings and style attributes. Membership in the Russell 2000® Index, a small-cap index that lasts for one year, is predicated on inclusion in the broader Russell 3000® Index. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s stock will also automatically be incorporated into the appropriate growth and value indexes.
The significance of this move extends beyond mere recognition; it signifies Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s growing prominence and potential in the biopharmaceutical sector. With a late-stage pipeline dedicated to the development and commercialization of critical care products, the company’s inclusion in these Russell indexes underscores its commitment to delivering innovative solutions in the healthcare industry.
FTSE Russell’s indexes hold immense weight in the financial world, with institutional and retail investors worldwide relying on their expertise. Currently, approximately $20.1 trillion is benchmarked to FTSE Russell’s indexes, including a substantial $12.1 trillion that is linked to the Russell US Equity Indexes.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s addition to the Russell 3000® and Russell 2000® Indexes not only raises its profile in the market but also reflects the company’s growth potential and commitment to advancing healthcare solutions.
As it continues to make strides in its late-stage pipeline, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) appears poised for a promising future, further solidifying its position in the biopharmaceutical sector. Industry stakeholders will be closely watching the company’s journey as it navigates this significant milestone. (60)
NEWS
MANAGEMENT
Leonard MazurCo-Founder, CEO and Chairman of the Board of Directors
Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable success in founding and building multiple healthcare companies and creating value and returns for investors throughout his five-decade career. Mr. Mazur was the co-founder and Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He was previously the co-founder and Vice Chairman of Akrimax Pharmaceuticals, LLC, which specialized in cardiovascular and general pharmaceutical products. 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. As 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, he successfully negotiated the company’s sale in 2003 to Pierre Fabre, a leading global 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 was born in Ansbach, Germany, and emigrated with his family to the U.S. at an early age. Mr. Mazur served in the U.S. Marine Corps Reserve while studying at Temple University for his undergraduate degree. He earned his MBA from Temple University’s Fox School of Business in 1975. Mr. Mazur is a recipient of the Ellis Island Medal of Honor presented annually to those who immigrated to the United States during the Ellis Island era and have shown an outstanding commitment to serving the United States either professionally, culturally, or civically.
Myron HolubiakCo-Founder, Executive Vice Chairman
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. Mr. Holubiak was the President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company, from 1998 to 2001. As President of Roche, Mr. Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. Before being named President, he held sales and marketing positions at Roche during his 19-year tenure. Earlier, Mr. Holubiak founded Emron, Inc., a health economics and managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP). He was also a director of Bioscrip, Inc., a national home infusion company, serving as its Chairman of the Board from 2012 through 2016. 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 & Chief Business 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.
Kelly Creighton, PhDEVP, Chemistry, Manufacturing and Controls
Kelly joined Citius from Clinipace Worldwide, a leading global contract research organization, where he served as Vice President of Regulatory and Strategic Development. As a senior-level regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products, he has provided comprehensive regulatory strategy assessments, development plans and regulatory dossiers for programs across a wide range of therapeutic areas. As head of a global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Additionally, his substantial product development experience extends to biologics/biosimilars, small molecule, gene and cellular therapies, cancer immunotherapies, live oncolytic biotherapeutics, and microbiome therapies. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU. Additionally, he has performed internal and external quality assurance audits for drug products, drug substance, and tissue and cell therapy products. Kelly earned his BS from New Mexico State University and his MSc and PhD from the University of Nebraska.
Alan Lader, PhDSVP, Head of Clinical Operations and Quality Assurance
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.
John WestmanVP, Project Management
John Westman has led commercial efforts—including strategy, sales management, marketing, business development, customer service and strategic partnerships—resulting in improved business results for market-leading and start-up healthcare companies. Prior positions include co-founder and Executive Vice President of Novellus, Inc., General Manager and Vice President of Marketing and Sales for PrecisionMD, NxStage, Fresenius, PharMetrics and Decision Resources Pharmaceutical. John led U.S. and global marketing and sales training at Baxter Healthcare’s Renal division and started his career at Bain Consulting/Baxter consulting firm. John is a Fulbright Scholar who received a B.A. in French and English from Colgate, an M.A. in international relations from the University of Wisconsin, and an MBA in marketing and finance from the Kellogg Graduate School of Management at Northwestern. John is on the faculty at Harvard and Boston College.
Paul SowyrdaVP, Business Development & Market Intelligence
Paul Sowyrda is a seasoned Biopharmaceutical leader and inventor with over 25 years of experience helping to build and lead development stage and commercial companies. He is co-founder of Novellus, Inc. which was sold to Brooklyn ImmunoTherapeutics, Inc. in July 2021, and served as its Executive Vice President. Mr. Sowyrda held previous positions as Vice President of Drug Development at CIBA, and Vice President of Development and Marketing at Dusa Pharmaceuticals, which was acquired by Sun Pharma. Mr. Sowyrda is an inventor and holds more than 15 patents, He has served on the Board of Directors for the Society of Concurrent Product Development and is a member of the American Academy of Dermatology and International Society of Dermatologic Surgery. He earned his B.S. and M.S. from the University of Notre Dame, his MBA from Babson College, and completed the MIT Sloan School of Management Senior Executives Program.
Sincerely,
DISCLAIMER
THIS WEBSITE/NEWSLETTER IS A WHOLLY OWNED SUBSIDIARY OF ONE22 MEDIA, LLC, HEREIN REFERRED TO AS O22, LLC
OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TEN THOUSAND USD FOR A 2 DAY CTXR AWARENESS CAMPAIGN BY A THIRD PARTY, SICA MEDIA, LLC. WE HAVE PREVIOUSLY BEEN COMPENSATED A FEE OF UP TO ONE HUNDRED FIVE THOUSAND USD FOR 7 SEPERATE 2 DAY CTXR AWARENESS CAMPAIGN BY A THIRD PARTY, LEGENDS MEDIA, LLC WHICH HAVE ALL EXPIRED. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: O22 LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD O22, LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. O22 LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND O22, LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD O22, LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.O22, LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. O22, LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND O22, LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS.IN PREPARING THIS PUBLICATION,O22, LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, O22, LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. O22, LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS O22, LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. 022, LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.
SOURCE LIST
https://www.prnewswire.com/news-releases/citius-receives-positive-fda-feedback-on-its-submitted-plan-to-study-catheter-compatibility-for-mino-lok-therapy-301069349.html 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/ Source 4: https://www.citiuspharma.com/opportunity/crbsis/ 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/ Source 10: https://stockcharts.com/h-sc/ui?s=ctxr Source 11: https://www.barchart.com/stocks/quotes/CTXR/opinion Source 12: https://www.citiuspharma.com Source 13: https://d1io3yog0oux5.cloudfront.net/_335875ea4142d81b5406df99d97e4cdf/citiuspharma/db/249/1064/pdf/3.19.2021.WEB.Presentation_Final.pdf Source 14: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf 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 Source 20: https://www.citiuspharma.com/halo-lido/#:~:text=There%20are%20no%20FDA%2Dapproved,hemorrhoids%20in%20the%20United%20States Source 21: https://citiuspharma.com/pipeline/stem-cell-platform/default.aspx Source 22: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/statistics#:~:text=The%20overall%205%2Dyear%20survival,survival%20rate%20is%20around%2063%25. Source 23: https://pubmed.ncbi.nlm.nih.gov/30895415/ Source 24: https://www.nuventra.com/resources/blog/why-do-clinical-trials-fail/#:~:text=This%20means%20that%20around%202,3%20fail%20to%20reach%20approval. Source 25: https://www.google.com/search?rlz=1C1CHBF_enUS977US977&q=NASDAQ:+CTXR&stick=H4sIAAAAAAAAAONgecRowS3w8sc9YSn9SWtOXmPU5OIKzsgvd80rySypFJLmYoOyBKX4uXj10_UNDZOSzSxLDLIzeBax8vg5Brs4BlopOIdEBAEAzts1gUwAAAA&sa=X&ved=2ahUKEwi9i77gz8r0AhV1SzABHY-TBrkQsRV6BAg0EAM&biw=1536&bih=792&dpr=1.25 Source 26: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals/news/we-think-citius-pharmaceuticals-nasdaqctxr-can-afford-to-dri-1 Source 27: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals#intrinsic-value Source 28: https://github.com/SimplyWallSt/Company-Analysis-Model/blob/master/MODEL.markdown#value 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/ Source 32 : https://dawsonjames.com/wp-content/uploads/2022/12/CTXR.12.23.22_-final1.pdf Source 33 : https://www.barchart.com/stocks/quotes/CTXR/price-history/historical Source 34 : https://finance.yahoo.com/news/citius-pharmaceuticals-inc-announces-u-123000919.html Source 35 : https://finance.yahoo.com/news/citius-pharmaceuticals-inc-reports-fiscal-213000115.html Source 36 : https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-accelerate-phase-3-mino-lok-trial-by-expanding-trial-sites-internationally-301541596.html Source 37 : https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-a-clinical-collaboration-with-the-university-of-pittsburgh-to-evaluate-t-reg-cell-depletion-with-iontak-e7777-in-combination-with-pembrolizumab-in-recurrent-or-metastatic-solid-cancer-tumors-in–301631592.html Source 38 : https://dawsonjames.com/wp-content/uploads/2019/06/KolbertDORPRFinal.pdf Source 39 : https://schrts.co/fUAydCuY Source 40 : https://njbmagazine.com/monthly-articles/njs-burgeoning-biotech-industry/ Source 41 : https://www.thebalancemoney.com/triangle-chart-patterns-and-day-trading-strategies-4111224 Source 42 : https://mma.prnewswire.com/media/1593817/Citius_Logo.jpg?p=facebook Source 43 : https://s28.q4cdn.com/169506891/files/doc_presentation/2023/corporate-overview-feb-2023.pdf Source 44 : https://www.marketwatch.com/investing/stock/ctxr?mod=search_symbol Source 45 : https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-secures-3-6-million-through-new-jersey-economic-development-program-301683193.html Source 46 : https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-a-clinical-collaboration-with-the-university-of-pittsburgh-to-evaluate-t-reg-cell-depletion-with-iontak-e7777-in-combination-with-pembrolizumab-in-recurrent-or-metastatic-solid-cancer-tumors-in–301631592.html Source 47 : https://www.pitt.edu/sites/default/files/styles/tier_one_hero/public/2021-07/mission-t1-cl-top-aerial.jpg?h=2c66ef4f&itok=YlGwAwOr Source 48 : https://pbs.twimg.com/media/FmDiCOXXEAEcTfc?format=jpg&name=large Source 49: https://www.adva.com/-/media/adva-main-site/about-us/investors/financial-results/financial-statements/financial-statements.jpg?rev=c7ba9b4d5faa4f73aecf63165df2b1a2 Source 50: https://citiuspharma.com/about/management-team/default.aspx Source 51: https://schrts.co/SsPeThtf Source 52: https://www.tipranks.com/stocks/ctxr/forecast Source 53; https://hcwco.com/services/research/meet-our-analysts/#toggle-id-3 Source 54: https://schrts.co/xGsDHhgH Source 55: https://finance.yahoo.com/news/citius-pharmaceuticals-inc-receives-complete-201600106.html Source 56: https://finance.yahoo.com/news/citius-pharmaceuticals-inc-receives-complete-201600106.html Source 57: https://cloudfront-us-east-2.images.arcpublishing.com/reuters/DDIBUQGRCNLKJE2GUV7AA64E2I.jpg Source 58: https://finance.yahoo.com/news/citius-pharmaceuticals-reaches-92-event-123700846.html Source 59: https://pbs.twimg.com/media/E2KYsauXEAUDrxI.jpg:large Source 60: https://finance.yahoo.com/news/citius-pharmaceuticals-added-russell-3000-123000436.html Source 61: https://media.realvision.com/wp/20220603151313/The-Russell-2000-Index.jpg