We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $1.11 per share
Float (est.) 13.5 million shares
Today’s headline from CTXR:
Citius Achieves 50% Enrollment in Phase 3 Mino-Lok Pivotal Trial
The phase 3 trial for Mino-Lok is designed to compare its efficacy against that of “Standard of Care” antibiotics in the treatment of infected central venous catheters. The results are being evaluated by an Independent Drug Monitoring Committee (DMC).
The trial is designed to release efficacy data at 40% enrollment and 75% enrollment.
The company previously announced that the data from the 40% enrollment analysis was positive and the DMC recommended that the clinical trial continue. We expected as much since all the data through the 2B trial resulted in virtually 100% efficacy.
We’ve said that the Phase 3 clinical trial could yield a catalyst for the company shares when the 75% enrollment results get published in H1 of this year. Today CTXR updated that they’re closer now to that 75% interim analysis data that ever, reaching the 50% level.
Approximately 500,000 central venous catheters of the 7 million used annually in the U.S. become infected and lead to CRBSIs. The current Standard of Care is catheter removal and reinsertion, increasing both patient morbidity risk and costs to the health care system.
Bacterial infections are oftentimes difficult to treat because the bacteria protect itself with a biofilm, keeping antibiotics away. Mino-Lok penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anticlotting properties.
The market potential for an effective antibiotic lock therapy for CVC infections is estimated to be $750+ million per year in the U.S. and approximately $1.5 billion worldwide.
We believe that infected CVCs might just be the beginning of the Mino-Lok potential market. We told you that Mino-Lok was effective against C. auris infection in the lab but C. auris is not a widespread condition with a huge market, yet. We implied that Mino-Lok may be effective against other, more widespread infections such as those that could be associated with coronavirus. We believe that the Mino-Lok combination of compounds may ultimately be effective against a broad range of infections because of the way it works.
We don’t know where CTXR shares are headed but we believe they are undervalued. So, let’s talk about what we DO know.
Biopharma stocks generally rally when advancing to phase 3 clinical trials.
Biopharma stocks generally rally when positive data emerges from clinical studies.
Biopharma stocks generally rally when closing in on a billion-dollar market.
Stocks with low floats, with most of their shares held by insiders and institutions are generally strong.
Not all analysts target prices ($5.50 for CTXR) are accurate, but they generally indicate the direction and potential reach of a company’s share price.
CTXR has all the attributes above but has yet to see the stock price rally we believe they are due. Make no mistake, the rally in CTXR shares may be right around the corner.
The Team
original report below
Could This Be the Hottest Biopharma Stock of 2020?
CTXR’s lead product could be the enemy of infections.
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 $1.09 per share
Float (est.) 13.5 million shares
We began our longer-term coverage of CTXR on December 19th, alerting the company at $.60 per share. During the ensuing 6 weeks, CTXR shares have traded in a range from $.83 per share to $1.40. That price range coupled with an overall trend upward in the share price have created profit opportunities for our members. Congratulations to those realizing gains.
Recent articles mentioning Citius Pharmaceuticals have said:
“Citius Pharmaceuticals is hands down one of the most exciting opportunities we have come across”
"Now that the planet's attention is turned toward infectious disease thanks to the spotting of coronavirus in the United States, the World Health Organization (WHO) took the opportunity to point to another problem: the growing shortage of antibiotics available to fight all pathogens”.
"According to the CDC, over two million infections are caused by antibiotic-resistant bacterial pathogens per year in the country, resulting in around 23,000 deaths."
Mino-Lok is a patented, proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all FDA approved compounds. It is being developed under the FDA's 505(b)(2) pathway for new drug approvals that bring products to market faster and with lower cost than other FDA new drug approval pathways.
Mino-Lok product was developed at the M.D. Anderson Cancer Center. Citius Pharmaceuticals has a worldwide license to the patented technology.
Mino-Lok is in a phase III clinical trial with Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, expected in the first half of 2020. The clinical trial will evaluate the products efficacy in the treatment of Central Venous Catheter infections.
Infected CVC’s may just be the tip of the iceberg for Mino-Lok indications.
Coronavirus, because there is no vaccine, has the potential to sweep the globe. We hope it does not. According to the CDC, 9-45 million cases of influenza happen each year; 140-810 thousand require hospitalization; 12-61 thousand result in death. Influenza deaths mainly occur due to pneumonia. In patients admitted to an ICU with viral pneumonia caused by the flu, 10% will develop bacterial pneumonia.
Last May, 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. More than 1 in 3 patients with invasive C. Auris infection die. C. Auris is an insidious infection because there are many strains of it, and it is highly antibiotic resistant.
ALL 10 STRAINS TREATED WITH MINO-LOK WERE ERADICATED WITHIN AN HOUR
Back then we implied that Mino-Lok may become the best infection treatment, covering a broad spectrum of indications. We still believe that and further, we believe there could be the potential to reduce deaths caused by influenza lung infections.
CTXR has 2 other potential drug candidates. Mino-Wrap (currently under development) to treat infections from breast reconstruction, and Hydro-Lido (in a phase 2a study), a prescription strength hemorrhoid treatment.
Let’s review some indications that CTXR shares may be oversold:
1/24/2020 HC Wainwright Reiterated Rating Buy $4.00 Target
9/6/2019 Dawson James Initiated Coverage Buy $7.00 Target
The float is only 13.5M (est.) shares and the market value is only $34.7M.
Insiders own 42% of the outstanding shares and institutions own 18%
Mino-Lok’s development has never been at a more advanced stage, yet the shares have traded at a much higher price in the past.
We expect that the Topline data results for Mino-Lok could be the catalyst that propels CTXR shares near the analysts target or more. We don’t want you to be the investor lamenting that you could have acquired shares at today’s level.
Note in the chart below, CTXR shares have crossed their 50 DMA and 200 DMA of $.80 and $.92 respectively and trading volumes have increased.
We will be back with updates soon.
The Team
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