OUR NEW PROFILE IS: NASDAQ: CTXR
“Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market
$36.9 million in cash and cash equivalents as of December 31, 2022
Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review
Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company
Citius Pharmaceuticals Completes Enrollment in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids
Download the Investor presentation HERE
Downloads the Fact Sheet HERE
Citius Pharmaceuticals Advances Mino-Lok® Phase 3 Trial Achieving 85 of 92 Events to Date
CRANFORD, N.J., April 24, 2023 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has advanced its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Of the 92 events required to complete the trial, the Company estimates that 85 events have been achieved to date. The trial has enrolled 190 patients, of which 16 patients are in active treatment or pending study completion data review, which may result in additional events. The multi-center Mino-Lok® Phase 3 trial continues to recruit patients at 35 clinical trial sites in the U.S. and India.
“We are encouraged by the progress of our Phase 3 Mino-Lok® trial in 2023. Last year, we announced the addition of multiple trial sites in India to expedite trial completion. With an estimated 85 achieved events to date, we believe we are nearing the finish line,” stated Leonard Mazur, Chairman and CEO of Citius.
Mino-Lok® Phase 3 Trial Design
The Mino-Lok® Phase 3 pivotal superiority trial (NCT02901717) is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study 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 blood stream infections (CRBSI/CLABSI) and who meet all 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.
Patients in the Mino-Lok® arm 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.
About Mino-Lok®
Mino-Lok® is an antibiotic lock solution to treat patients with catheter-related blood stream infections that Citius has licensed from The University of Texas MD Anderson Cancer Center. Citius believes Mino-Lok® provides a superior alternative to removing and replacing a central venous catheter (CVC), leading to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok®would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
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Hello Everyone,
I hope that you watched our two profiles last week. Both were strong double digit movers on accelerating interest.
We have another exciting profile that we want to bring to your attention for tomorrow’s session.
This is a company that has had a strong 2023 so far as it climbed up out of the basement and has been on the rampage since the end of March.
Pull up CTXR Immediately.
They are 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.
There are several catalysts in play right now that we need to look at:
Analyst Target:
Dawson James Analyst Jason Kolberts’ $10.00 target could mean potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) right after bouncing off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.(32)(33)
FDA Confirmation:
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has reported that the FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023.(35)
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)
Clinical Collaboration:
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) initiated a clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022.(37)
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023
Financial Results and Provides Business Update.Read the full news release here: https://t.co/SnSHDbJGBr $CTXR #BusinessUpdate pic.twitter.com/OdtznUKWup
— Citius Pharma (@CitiusPharma) February 10, 2023
Citius Pharmaceuticals Completes Enrollment in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids
Topline Results anticipated by the end of Q2 2023
CRANFORD, N.J., April 3, 2023 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR) today announced that the last patient has been enrolled in the Company’s Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoids. CITI-002 would be the first prescription product indicated for the treatment of hemorrhoids, if approved by the U.S. Food and Drug Administration (FDA).
Approximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study (NCT05348200), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. The primary outcome of the study is the change in hemorrhoidal symptoms as reported by the patients following treatment. Efficacy and safety data are recorded by patients utilizing a proprietary mobile-enabled Patient Reported Outcome (ePRO) instrument. The results of the study are anticipated by the end of the second quarter of 2023 and are expected to provide the foundation for development of the Phase 3 study.
“The completion of the Phase 2b enrollment is an important milestone for Citius. We are hopeful that analysis of the study data will support further evaluation of the potential of CITI-002 to provide relief for hemorrhoid patients. We congratulate our clinical management team, our CRO staff and the principal investigators who helped us achieve this milestone in a timely fashion. The study was fully enrolled within one year from initiation. We continue to believe that the global market for a prescription topical treatment for hemorrhoids is large and underserved. Contingent on the trial data, we expect to continue to advance this program to maximize its value,” stated Leonard Mazur, Executive Chairman of Citius.
About Halo-Lido (CITI-002)
CITI-002 is a proprietary topical formulation intended to provide symptomatic relief to individuals suffering from hemorrhoids. Hemorrhoids are a gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Although hemorrhoids are not life-threatening, individual patients often suffer painful symptoms that can limit social activities and have a negative impact on the quality of life. More than half of the U.S. population will experience hemorrhoidal disease at least once in their life. Each year, nearly 10 million patients in the U.S. report symptoms.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Gets $10.00 Target From Dawson James Analyst Jason Kolberts.
Jason Kolberts is no stranger to the biotech and pharmaceutical industries.
He’s actually the Director of Research at Dawson James Securities, Inc.
And for those who don’t know, Dawson James is a full-service boutique investment banking firm focused on emerging growth companies since 2004 and committed to helping clients navigate the healthcare, biotechnology and technology markets. (38)
Jason Kolberts’ career began as a chemist in the pharmaceutical industry and evolved into a product and marketing manager with Schering-Plough in Japan. Upon returning from Japan, Jason joined Salomon Smith Barney, as a research associate which has now evolved into a 20-year career on Wall Street as a leader in the Healthcare space.(38)
Kolberts’ coverage expands across multiple therapeutic areas in biotechnology, specialty pharmaceuticals, and medical devices. As an analyst Jason has developed a high level of expertise in oncology, virology and cell-based medicine such as CAR (Chimeric Antigen Receptor)-T cells and regenerative medicine (stem cells).(38)
Prior to joining Dawson James, Mr. Kolbert spent the prior year as a senior biotechnology analyst at HC Wainwright and spent the previous seven years at the Maxim group, where he was an Executive Managing Director and the Head of Healthcare Research at the firm. During this period Jason and his team covered 80 names across the healthcare vertical. Jason’s Wall Street career began with seven years at Citi Group followed by several years on the buy side as a portfolio manager with the Susquehanna International Group.(38)
One company that seems to have caught the eye of Jason Kolbert is Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).
Mr. Kolbert has a $10.00 target on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).(32)
This could mean a potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) after a recent bounce off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.(33)
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Has Built a Diversified Pipeline of Therapeutics with a Multi-Billion-Dollar Total Addressable Market.(43)
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
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
“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)
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)
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Announces a Clinical Collaboration with the University of Pittsburgh.(46)
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.(46)
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.
I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.
ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 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, respectively.(46)
In September of 2022, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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.(46)
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.
“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.(46)
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.
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update
$36.9 million in cash and cash equivalents as of December 31, 2022; runway through February 2024
Uptick in patient recruitment for Mino-Lok® Phase 3 trial
Halo-Lido Phase 2b trial nearing completion
CRANFORD, N.J., Feb. 10, 2023 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter ended December 31, 2022.
Fiscal Q1 2023 Business Highlights and Subsequent Developments
- I/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023;
- Mino-Lok® Phase 3 trial progressing with additional enrollment and events in the U.S. and India;
- Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and,
- On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane.
Financial Highlights
- Cash and cash equivalents of $36.9 million as of December 31, 2022;
- R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021;
- G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021;
- Stock-based compensation expense was $1.2 million for the first quarter ended December 31, 2022, compared to $0.9 million for the first quarter ended December 31, 2021; and,
- Net loss was $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021.
“As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA’s decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido trial as it nears completion,” stated Leonard Mazur, Chairman and CEO of Citius.
“In addition to the progress we are making on the clinical front, we continue to strengthen our corporate infrastructure. On February 7, 2023, shareholders approved the nomination of Dennis McGrath to our Board of Directors. We are very fortunate to have a seasoned leader of Dennis’s caliber join our Board. His deep public company, financial and strategic expertise will help guide our path forward. Dennis assumes the Board position formerly held by Dr. William Kane. Since March 2014, Dr. Kane has shared his expertise and insights as a valued member of our Board. We are grateful for his contributions and support through the years. With multiple value-creating catalysts anticipated this year, I look forward to updating shareholders as we work to achieve these milestones,” concluded Mazur.
FIRST QUARTER 2023 FINANCIAL RESULTS:
Liquidity
As of December 31, 2022, the Company had $36.9 million in cash and cash equivalents.
As of December 31, 2022, the Company had 146,211,130 common shares outstanding.
The Company estimates that its available cash resources will be sufficient to fund its operations through February 2024.
Research and Development (R&D) Expenses
R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021. The decrease primarily reflects the completion of the I/ONTAK (E7777) Phase 3 trial and lower Halo-Lido Phase 2b study costs, offset by incremental Mino-Lok Phase 3 trial costs related to the expansion of the trial to include clinical sites outside the U.S.
We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of I/ONTAK and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021. The decrease was primarily due to reduced costs for performance bonuses and investor relations expenses. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the first quarter ended December 31, 2022, stock-based compensation expense was $1.2 million as compared to $0.9 million for the prior year. The increase reflects expenses related to new grants made under the Citius and NoveCite equity incentive plans and new grants made to employees (including new hires), directors and consultants.
Net loss
Net loss was $3.6 million, or ($0.02) per share for the year ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the year ended December 31, 2021. The $5.6 million decrease in the net loss was primarily due to an increase in other income and a decrease in research and development expenses.
Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company
CRANFORD, N.J., March 30, 2023 /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 that Maxim Group LLC will serve as financial advisor to its wholly-owned subsidiary, Citius Acquisition Corp. Inc., in connection with the intended formation of a separate publicly-traded entity to commercialize and grow Citius’ oncology asset, I/ONTAK. The U.S. Food and Drug Administration (FDA) is currently reviewing a biologics license application (BLA) for I/ONTAK and has set a targeted decision date (PDUFA) of July 28, 2023.
“Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline. Maxim Group has a strong track record of executing strategic and financial transactions in the life science sector, and we look forward to working closely with them to optimize the structure and timing of contemplated I/ONTAK transactions,” stated Leonard Mazur, Chairman and CEO of Citius.
Any transactions would be subject to the satisfaction of customary conditions, including final approval from the Citius Board of Directors, regulatory approvals, and SEC filings. Upon closing of the transactions, Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR.
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. There can be no assurance regarding the ultimate timing of proposed transactions or that the transactions will be completed at all.
About Maxim Group LLC
Maxim Group LLC is a full-service investment banking firm headquartered in New York with approximately 240 employees. Maxim Group provides a full array of financial services, including investment banking; private wealth management; and global institutional equity, fixed-income, and derivatives sales and trading, as well as equity research. The investment banking group focuses on middle market and emerging growth companies within the shipping, energy, health care, technology, retail, and business and financial services sectors. The institutional coverage of Maxim Group spans North and South America, Europe, and Asia. Maxim Group LLC is registered as a broker-dealer with the U.S. Securities and Exchange Commission and is a member of the following: Financial Industry Regulatory Authority (FINRA); Municipal Securities Rulemaking Board (MSRB); Securities Insurance Protection Corporation (SIPC); NASDAQ Stock Market and the NYSE Arca, Inc.
NEWS
MANAGEMENT
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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