CTXR and Mino-Lok Get Positive Feedback From the FDA, We have not had time to confirm this story. So we have included our most recent report here.
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.
Price $.92 per share
CTXR has just released news that has us excited!
The company has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company’s Mino-Lok therapy.
The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market.
Here is why we think the compatibility study is so crucial. The estimated market for Mino-Lok is $1.5 billion. The ability for Mino-Lok® to be labeled for use in all commercially available catheters in the United States, and potentially the rest of the world soon thereafter, gives CTXR access to that entire $1.5 billion market.
The compatibility study is going to happen right alongside the phase III clinical trial.
In our last newsletter we said “We believe the data from the phase III trial may be a major catalyst for the company shares. The phase III trial is expected to conclude this year with interim data possibly coming in the near term.”
CTXR also stated today that the next milestone in the Mino-Lok trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020. Keep in mind the second half of 2020 starts in 27 days. We told you that the efficacy data, through the phase 2B trial, indicated virtually 100% success. We have not heard, nor read, anything to indicate the phase III data may be any different.
CTXR seems to be, in our view, a stock that is chronically undervalued. The market cap is only $40M. Everything we have reported about CTXR indicates the company could absolutely OWN the entire $1.5 billion market for an alternative treatment for infected CVCs.
Consider the CTXR positives:
CTXR has Mino-Lok, a needed product that can reduce deaths, reduce the use of medical assets in hospitals and is in late stage phase III clinical trials. Let’s remember too, Mino-Lok® eliminated 10 strains of the dangerous and increasingly pervasive C. Auris infection in lab testing.
CTXR has its relationship with Novellus, working to create a stem cell treatment for ARDS associated with Covid 19. The potential market for this treatment is not yet measurable.
CTXR has Hydro-Lido, its treatment for hemorrhoids that is also in clinical trials. There is currently no prescription strength treatment for hemorrhoids.
So, the question becomes, what is a company in that position worth? If the company takes their future products to market, they could quickly develop revenues in the hundreds of millions. What price would a company with only 45M shares be worth at that point?
If the company sought an exit to a larger pharma company, what would the price of the shares be? Acquiring companies could look at pro forma revenues and pay a price per share based on those revenues.
We think the real value of CTXR shares could be many multiples of the current price. The 39% insider ownership may indicate the management feels the same way.
We have been looking at CTXR for years and have closely followed the company’s development. All our research indicates CTXR is closer to marketing a product than they ever have been. Things are heating up and getting exciting for Citius Pharma this year!
The Traders News Group
Original report 6/2/20
Data from the Phase III Trial May be a Major Catalyst
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 $.87 per share
Outstanding shares (est.) 45.19M
Float (est.) 22.02M
Insider ownership 39.08%
CTXR released news about its Mino-Lok product last week. The company announced that it 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.
For the benefit of our newest members, Mino-Lok is a proprietary drug compound that CTXR has licensed from the MD Anderson Cancer Center to treat infected Central Venous Catheters (CVC) as an alternative to removing and replacing them.
Let us be clear, Mino-Lok does not treat or cure COVID 19. Rather, it eliminates the need to remove and replace an infected CVC, the current standard of care. To remove and replace an infected CVC requires a procedure that can be time consuming, expensive (estimated at $50K) and carries a risk of morbidity.
Mino-Lok, a combination of three FDA approved compounds, quite simply, gets administered through an IV for two hours a day. And it works. Mino-Lok is in a late stage phase III clinical trial. Data through the phase 2B trial indicated virtually 100% efficacy and we await data from the phase III trial.
We believe the data from the phase III trial may be a major catalyst for the company shares. The phase III trial is expected to conclude this year with interim data possibly coming in the near term.
By providing free access to Mino-Lok, CTXR gives hospitals the ability to divert resources from removing and replacing an infected CVC and reallocating those resources to treating their COVID 19 patients. While the rate of hospitalization for COVID 19 patients has dropped in recent weeks, that number is still staggering and none of us knows if a second wave is coming.
The humanitarian aspect of this effort of free Mino-Lok aside, there’s another reason we are excited about this new development at CTXR. When a company gives away a new product for free, and it’s a great product, the product can become exceedingly popular (think of Microsoft giving away its software in the 1980’s).
CTXR could see its Mino-Lok product being widely used even BEFORE the clinical trial process is completed.
“Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it – particularly in today’s environment,” commented Myron Holubiak, Chief Executive Officer of Citius.
Each year, up to 500,000 CVCs of the 7 million used become infected. 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.
This new Mino-Lok news could develop into a major catalyst for the company shares.
We want to remind you that CTXR is also involved in the treatment of COVID 19. Last month CTXR negotiated a license from Novellus, Inc. to develop their patented treatment for acute respiratory distress syndrome (ARDS).
ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients.
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 ARDS.
MSCs prevent and suppress cytokine storm, believed to be the cause of the severe inflammation of ARDS and now seen in COVID-19 patients.
A treatment similar to the Novellus process, 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 $39 million.
While everyone hears about treatments such as hydroxychloroquine and remdesivir, drugs that may help treat COVID 19, the rate of efficacy attributed to those drugs is limited. The use of stem cell therapy to treat ARDS caused by Covid 19 could become version 2.0 of COVID 19 treatment.
5/19/2020 HC Wainwright Buy $4.00
9/6/2019 Dawson James Buy $7.00
CTXR shares have a 52-week high of $1.50 per share and were trading at $1.30 just one month ago.
We note in the chart below that CTXR shares are trading above their 50 DMA and 200 DMA of $.77 and $.78, respectively. In the past two months the company shares have experienced several price swings and strong trading volumes, creating an environment conducive to realizing potential gains.
Link to Chart: https://stockcharts.com/h-sc/ui?s=CTXR
We will be back with an updated report soon,
The Traders News Group
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