Cracking the $3.5 Billion

Cancer Crisis

Biotech Breakout Citius Pharmaceuticals’ (NSDQ: CTXR) Phase 3 Results Could Transform the $3.5 Billion Fight Against this Deadly Affliction … and that’s Just the Beginning …

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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,” 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 $3.5 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 …

Latest News

From PRNewswire

April 26, 2022

Citius Pharmaceuticals Enrolls First Patient in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

Primary endpoint is the reduction in hemorrhoidal symptoms

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 the first patient has been enrolled in the Company’s Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids. If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.


The Phase 2b study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. Five cohorts of adults with a clinical diagnosis of symptomatic Goligher’s classification Grade II or Grade III hemorrhoids will be dosed. Approximately 60 patients per cohort are expected to be enrolled, for a total of 300 patients.


From PRNewswire

May 3, 2022

Citius Pharmaceuticals, Inc. Provides Business Update, Highlights Upcoming Milestones

Recent Highlights and Upcoming Milestones

  • Citius anticipates filing a biologics license application (BLA) for I/ONTAK® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;

  • Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;

  • Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;

  • Phase 3 Mino-Lok® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;

  • Mino-Lok Phase 3 trial completion anticipated by end of 2022;

  • Pre-clinical development ongoing for Citius’ Mino-Wrap and induced mesenchymal stem cell programs.

Citius Pharmaceuticals, Inc. (NSDQ: CTXR) 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.


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 …

Here’s How Mino-Lok Could Help With Another $1.5 Billion Medical Crisis:

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. It’s a simple, prescription solution to another $3.5 Billion problem.

Currently, in Phase 3 pivotal trials, it could be approved in a matter of months …

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 Highlights19

  • Potential to be first and only FDA-approved product to prevent infections associated with post-mastectomy breast implants
  • Currently in pre-clinical 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 prescription 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 Highlights20

  • 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 are sold in the US

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Citius Pharmaceuticals (NSDQ: CTXR) 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 Highlights21

• 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

$5.5 Billion in Potential Market Disruption (From a $220 Million Company)

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 over 5 years of “cash runway” 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.

Sources

Source 1: 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

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