OUR NEW PROFILE IS: NASDAQ: CTXR
“Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market
$41.7 million in cash and cash equivalents as of September 30, 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
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Hello Everyone,
We have another exciting profile for Monday’s session. This is a company that we have put on you’re radar several times over the years. The last time we looked at this one was back in September when it was sitting below it’s current levels.
Pull up CTXR Immediately.
There is no denying that 2023 has been a good year so far for CTXR. The turnaround started back in late December after it hit low’s and it has been climbing slow and steady ever since. Historically CTXR has made some big multi-week moves and the evidence is right on the chart.
Right now this one is trending green until something gets in it’s way.
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)
Active Chart:
Since bottoming out and hitting its 52-week low of $.77 cents on 12/30/22, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) have climbed to $1.13 for a solid 46.75% move in less than 10 days.(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 Full Year 2022 Financial Results and Provides #BusinessUpdate.
Read the full news release here: https://t.co/asCweu8PSs $CTXR pic.twitter.com/7CpaYjpGuv
— Citius Pharma (@CitiusPharma) December 23, 2022
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)
Listen. Nothing is certain. But look at the Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) weekly chart above and do a little technical analysis using StockCharts.com. You can see the following moving averages:(39)
Weekly average price is: $1.12 (as of 1/13/23)
50-day moving average at $1.18
200-day moving average at $1.28
20-day exponential moving average $1.07 (first line of resistance)
Shares of (CTXR) just trended above its first line of potential resistance at the $1.07 – $1.12 range(39). If (CTXR) is able to push through its 50-day moving average of $1.18… the next line of potential resistance could be its 200-day moving average at $1.28, which, if reached, would represent a potential 28% move as of 1/13/23’s opening price of $1.00.(38)(33) A move back to the 200-day moving average is not certain, but the potential should be noted.
How would that move be possible?
You see, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) could be at the beginning of what’s called a “Descending Triangle Breakout Strategy.”(39)
…And by definition, the “Descending Triangle Breakout Strategy” as the name suggests, involves the anticipation of a breakout from the descending triangle pattern. (41)
The basic premise of using this strategy is to look at volume once you’ve identified the pattern. You can typically observe that volume begins to diminish toward the end of the descending triangle pattern formation. (41)
After bottoming out and hitting its 52-week low of $.77 cents on 12/30/22, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) have climbed to $1.13 for a solid 46.75% move in less than 10 days.(33)
Could this be the beginning of a much larger move?
Shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) would need to climb over 1,198% to reach the $10.00 target set by Dawson James Analyst, Jason Kolberts, from that 52-week low.(32)
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. (Nasdaq: CTXR) Reports Fiscal Full Year 2022 Financial Results, Provides Business Update, Ending the Year with Over $41 Million in Cash.(35)
- $41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023.
- 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.
- I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023.
- Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023.
- Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions.
On December 22, 2022 Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)reported business and financial results for the fiscal full year ended September 30, 2022.
Fiscal Full Year 2022 Business Highlights and Subsequent Developments Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).
FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023.
Advanced Mino-Lok® Phase 3 trial.
Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023.
Initiated 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.
Approved for $3.6 million in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts.
“In 2022, we focused on execution across our key development programs: I/ONTAK, Mino-Lok and Halo-Lido. These efforts, combined with a prudent use of funds, enabled us to meaningfully advance our pipeline. We believe we have sufficient runway through December 2023 to realize additional value-creating milestones, including a potential FDA approval and two anticipated trial completions in the coming calendar year,” stated Leonard Mazur, Chairman and CEO of Citius.(35)
“Our Phase 3 Mino-Lok trial is now significantly closer to completion. While we expected to achieve 92 catheter failure events with 144 patients by the end of 2022, the trial’s observed catheter failure event rate has proven to be lower than anticipated. Consequently, we must continue recruiting patients. By successfully re-engaging with our U.S. trial sites as they recovered from the impact of CVD, we were able to drive patient recruitment. We have now exceeded our targeted enrollment and have achieved 72 of the required catheter failure events, with additional patients under review. To augment our recruitment efforts and continue the positive momentum in enrollment, we expanded the Mino-Lok trial to include sites in India. Once all new trial sites are fully activated, we will have nearly doubled our clinical site footprint. With these additional sites helping to drive incremental enrollment, we anticipate that the 92-event threshold required to complete the trial is achievable in the coming months,” added Mazur.(35)
“During the year, we also completed a Phase 3 trial and submitted a BLA for I/ONTAK, an oncology asset we in-licensed just over a year ago. Upon further discussion with the FDA, the PDUFA target date has been set for July 28, 2023…
We remain committed to establishing a robust commercial infrastructure to support I/ONTAK’s successful product launch, if approved. In the second half of 2022, we also extended our support for a Phase 1 investigator-initiated study of I/ONTAK in combination with pembrolizumab (Keytruda®1) to treat patients with recurrent or metastatic solid tumors…
This study has begun recruiting patients and is the second investigator-initiated trial to explore I/ONTAK’s potential as a combination therapy in much larger immuno-oncology markets…
We continue to believe I/ONTAK’s value extends beyond a potential initial indication in persistent or recurrent cutaneous T-cell lymphoma. Earlier in the year, we announced our intention to spin off I/ONTAK. Given broader market conditions, we continue to evaluate opportunities to further unlock this asset’s value,” continued Mazur.(35)
“In addition to advancing our Phase 3 trials, we initiated a Phase 2b trial for Halo-Lido, our prescription strength topical formulation for hemorrhoids. The trial began enrolling patients with symptomatic Grade II or III hemorrhoids in the second quarter of 2022. Recent recruitment has accelerated and we expect complete trial data available in the second half of 2023,” added Mazur.
“As financial stewards, we continuously evaluate the optimal capital structure for the company. We believe our anticipated catalysts, along with a healthy cash position, provide us with several strategic and financial options with which to continue advancing our pipeline…
This may include the previously announced potential spinoff of I/ONTAK into a standalone oncology company, pending market conditions, and other standalone financing alternatives available to us. We are encouraged by the multiple value-driving catalysts anticipated in calendar 2023, including a potential drug approval and two trial completions, and look forward to extending our positive momentum in the months ahead,” concluded Mazur.(35)
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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