What You Need to Know About Citius Pharma (NASDAQ: CTXR)

What You Need to Know About Citius Pharma (NASDAQ: CTXR)

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.


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


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


Privacy Policy and Disclaimer

Your Consent

By using our site, you consent to our online privacy policy and disclaimer.

Do we disclose any information to outside parties?

We hate spam and we do not sell, trade, or otherwise transfer to outside parties your personally identifiable information.

What information do we collect?

We collect information from you when you subscribe to our newsletter or fill out a form. This includes your email address only.

When registering on our site, as appropriate, you may be asked to enter your: e-mail address

What do we use your information for?

When we collect your email it is used for one purpose to send you the free information you requested about small cap stocks. Please read our disclaimer carefully before viewing our emails.

Your information, whether public or private, will not be sold, exchanged, transferred, or given to any other company for any reason whatsoever, other than for the express purpose of delivering the information on small cap stocks that you requested.

We send periodic emails

The email address you provide may be used to send you information, respond to inquiries, and/or other requests or questions.

How do we protect your information?

We implement a variety of security measures to maintain the safety of your personal information when you enter, submit, your email address. We use a secure third party to send email to you.

Because we value your privacy we have taken the necessary precautions to be in compliance with the California Online Privacy Protection Act. We therefore will not distribute your personal information to outside parties without your consent.

Online Privacy Policy Only

This online privacy policy applies only to information collected through our website and not to information collected offline.

Contacting Us

If there are any questions regarding this privacy policy or disclaimer you may contact us using the information below.


Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.

Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.

PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.

Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.

The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.

In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. TNS LLC’s parent company has been compensate.d sixteen thousan.d five hundred dollar.s cas.h via bank wir.e by venado media llc for this week’s coverage of ctxr. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.

TNS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. TNS LLC is not a Broker/Dealer and does not engage in high frequency trading.