What You Need to Know About Citius Pharma (CTXR)
Good day everyone,
We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $1.39 per share
The recent announcements regarding the Novellus agreement with Citius to develop a stem cell-based treatment for Covid 19 is exciting. Studies are currently being conducted worldwide to test mesenchymal stem cells (MSC) against the respiratory distress caused by the virus.
Mesenchymal stem cells therapy is preferred over other stem cell therapeutic strategies because they are free of ethical and social issues, they have a high proliferation rate and a low invasive nature. Mesenchymal cells can be obtained from various sources, including adipose tissues, dental pulp, bone marrow, umbilical cord, menstrual blood, fetal liver, and Bichat’s fat pad.
MSCs have been proven to be safe in hundreds of studies in the past for other indications. But not all MSCs are created equal as they have different characteristics depending on source material and method of manufacture. Once again. we urge you to watch the video linked below with CEO Myron Holubiak regarding CTXRs involvement with MSCs as part of your due diligence: https://tdameritradenetwork.com/video/rB4AoXL0GEiBcwZknpUIFQ
We hope, as investors, and as humans that CTXR/Novellus produce an effective Covid treatment.
We want to focus for a minute on the CTXR license with the MD Anderson Cancer Center to develop Mino-Lok.
Central venous catheters (CVCs) are used to administer longer term fluid treatment into the body in patients with heart, kidney, and cancer issues among other conditions.
The Mino-Lok product contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties.
In America alone, about 1,370 CVCs get infected every single day. The current standard of care is the removal and replacement of the infected CVC, an expensive, time consuming, and too often deadly procedure. Mino-Lok gets administered through the patients IV, two hours per day for 7-10 days. Mino-Lok aims to become the new standard of care.
The Phase 2B clinical trial consisted of 90 patients in total. Those receiving Mino-Lok yielded an efficacy rate of 100%. The company is currently in its Phase III clinical trial consisting of 700 patients. CTXR announced they were at the 50% enrollment level last November and would advise when they reached the 75% level, expected to occur in the second half of 2020. The phase III study may conclude this year.
As far as we know, the FDA is not evaluating any other alternative treatment for infected CVCs.
The company is providing free access to Mino-Lok® for healthcare providers under an Expanded Access protocol to ease the burden associated with the COVID-19 pandemic. The CTXR CEO stated “We clearly must wait for the results of our clinical trial to fully market Mino-Lok, but we do believe that it can benefit patients and help ease the burden on the health care system. In these challenging times.
Let the paragraph above sink in for a moment. It seems like FDA approval could be a foregone conclusion.
Mino-Lok has FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036. These patent protections are critical. The Mino-Lok patent gives the company virtual exclusivity in the market for another four years. The formulation patent goes another 16 years and that is important because:
Previously, we reported to you about a lab test conducted at the MD Anderson Cancer Center. They treated 10 strains of Candida Auris, a fungus that causes serious infections with Mino-Lok. C. Auris is an insidious infection because there are many strains of it, and it is highly antibiotic resistant.
ALL 10 C. AURIS STRAINS TREATED WITH MINO-LOK WERE ERADICATED WITHIN AN HOUR
While Mino-Lok is in a clinical trial for infected CVCs, the potential applications may be many.
We really like high levels of insider ownership and at CTXR it runs 39%. The insider shares are held mainly by Chairman Leonard Mazur and CEO Myron Holubiak, both veterans in the pharma industry with a history of monetizing pharma companies. Mr. Holubiak is a past president of Roche Laboratories, Inc.
CTXR has a lot going for it as it brings new ideas to the pharma sector under the supervision of pros. There are multiple catalysts that may be coming out in the near term. We think that a market cap under $70M may be inadequate and the shares could trade at multiples of the current price.
The Traders News Group
original report below
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Citius (CTXR) May Be Among the Best Biopharma Value Plays
Multiple near-term catalysts anticipated
Good day everyone,
We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $1.35 per share
Outstanding shares (est.) 45.19M
Float (est.) 24.53M
Insider ownership 39.08%
CTXR shares have been showing gains recently as news about the development of their licensed Novellus stem cell treatment for Covid 19 got more coverage. This is a major development at CTXR. A similar treatment has been used on a limited basis in New York and China with a high rate of success.
On June 26, the FDA acknowledged that the company could apply for fast track designation and provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials. The Company plans to initiate actions on the FDA’s recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP).
Seems like the FDA may be on team Citius as well.
The case for CTXR shares is simple. Their market cap of $55 million seems too low for a company with potential FDA approval just around the corner for a blockbuster product (Mino-Lok) with billion-dollar market estimates, and a prospective Covid 19 treatment on the horizon.
Let’s do a short CTXR review for some of our newer members.
Citius licenses pharma products from non-public entities with the intent to bring them through clinical trials, FDA approval, and finally exploiting the product’s value.
While CTXR has a handful of products in development, we believe that two of them may impact the share price in the near to mid-term. Those two are Mino-Lok, a product licensed from the MD Anderson Cancer Center, and its new stem cell-based treatment for Covid 19 patients licensed from Novellus, Inc.
The CTXR buzz lately has been about the potential Covid 19 treatment. Novellus’s patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating many inflammatory diseases, including Acute Respiratory Distress Syndrome, the main cause of death from Covid 19.
On June 30th, CEO, Myron Holubiak, appeared as a featured guest on TD Ameritrade Network’s “The Watch List” to discuss the stem cell therapy and their work with the FDA. Follow the link to view it: https://tdameritradenetwork.com/video/rB4AoXL0GEiBcwZknpUIFQ
The stem cell treatment for Covid 19 is exciting and the market could be huge. A similar treatment developed by Mesoblast Limited (MESO) was used in March-April as an emergency treatment for COVID 19 patients in New York with ARDS and on a ventilator. The results of the treatment indicated 83% survival (10/12). MESO has a market cap of $1.42 billion, CTXR has a market cap of only $55 million.
Mino-Lok®, a combination of three FDA approved compounds, is used to treat infected Central Venous Catheters (CVCs). Quite simply, Mino-Lok gets administered through an IV for two hours a day. And it works. The company is in a Phase III trial and reached their 50% level of patients treated last fall. The next trial data will be the 75% level of patients treated, scheduled to be completed very soon. Data for the Mino-Lok clinical trials through 2B indicated virtually 100% efficacy.
According to DelveInsight, the potential market size for Mino-Lok® in the global market could reach $1.84 billion in 2028, up from $1.24 billion in 2017.
Mino-Lok has the 75% enrollment data due soon and its likely to cause a change in the company share price when it does. Many followers of CTXR assume the data may be positive.
CEO Myron Holubiak said recently “Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it.” We cannot think of a better accolade for the product.
Mino-Lok has the potential to become THE standard of care for infected central venous catheters.
Both products could have near-term catalysts. Development of the Novellus stem cell treatment may generate a lot of catalysts as it is on a fast development program. Examples could be the beginning of human trials or the release of any efficacy data.
When CTXR releases Phase III data for Mino-Lok, we think the shares will experience significant gains and that data may be coming real soon.
5/19/2020 HC Wainwright Reiterated Rating Buy $4.00
The bottom line on CTXR shares is simple. A market cap of $55 million seems too light for a company so close to product approval with a potential annual market over one billion dollars.
We will be back with a full report soon,
The Traders News Group
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