Update – Institutional research on Citius Pharma just issued by Dawson James Securities. Citius Pharmaceuticals
Positive Phase 3 FDA Trial Results, Low Float Biotech, Trading Below Book Value
Citius Pharma is commercializing critical care drug Mino-Lok.
Citius Announces Positive Outcome of Interim Futility Analysis for its Phase 3 Mino-Lok® Pivotal Trial
“The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and approximately $1.5 billion per year worldwide.”
Good day everyone,
We are updating information on a company we’ve covered before, Citius Pharmaceuticals, Inc. (NASDAQ: CTXR). The company develops Mino-Lok, which is in Phase III clinical trials for the treatment and salvage of infected central venous catheters in patients with catheter related bloodstream infections; Mino Wrap, used in breast reconstruction surgery; and Halo-Lido, a topical formulation of hydrocortisone and lidocaine that is intended for the treatment of hemorrhoids.
Current price $.60 per share
Float (est.) 14 million shares
Book value $ .84 per share
52-week range $.40 to $1.79 per share
Mino-Lok is the lead product at Citius and is a combination of three compounds, already approved by the FDA to treat infected central venous catheters (CVC). Mino-Lok is designed to avoid the standard care of removing and replacing an infected CVC, a costly and oftentimes dangerous procedure.
Mino-Lok was developed by the MD Anderson Cancer Center, one of the top cancer treatment centers in the USA for decades. Citius has a license to develop the product.
Yesterday, the company announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee, an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial.
The positive data from this analysis is a big milestone for CTXR and may act as a catalyst for the company’s shares.
None of the clinical trials, to date, have indicated any adversities. In fact, all clinical trials to date have indicated virtually 100% efficacy.
Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020.
The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and approximately $1.5 billion per year worldwide.
Mino-Wrap (new product for 2019) is a liquefying gel-based wrap containing minocycline and rifampin for reducing tissue expander (TE) infections following breast reconstructive surgeries. Mino-Wrap provides more durable antimicrobial protection of the implant-tissue interface than peri-operative irrigation with antibiotic solutions (the current standard of care). CTXR plans to communicate further developments in the Mino-Wrap program after they secure and have a pre-IND meeting with FDA.
The company recently expanded their relationship with MD Anderson Cancer Center for a worldwide license for Mino-Wrap.
Halo Lido is a formulation of two compounds (already FDA approved) for the treatment of hemorrhoids.
There is no prescription strength medicine for the treatment of hemorrhoids. Recently the company, with advice from the FDA reformulated Halo-Lido based on results from an initial Phase II study. A toxicology study will be initiated by year-end ahead of an expanded Phase II study to start in 2020.
Indicators of a bullish outlook for CTXR shares:
This year the insiders at Citius Pharmaceuticals purchased over four million shares of the company stock at an average price over $1.00 per share. There were no insider sales. In fact, there have been no insider sales in the past two years. The executives at Citius seem to have a bullish outlook for the company.
Two Wall Street analysts have issued ratings and price targets for Citius Pharmaceuticals in the last 12 months. Their average twelve-month price target is $5.00, suggesting that the stock has a possible upside of 747.46%. The high price target for CTXR is $7.00 and the low-price target for CTXR is $3.00. There are currently 2 buy ratings for the stock, resulting in a consensus rating of “Buy.”
CTXR shares are trading at 72% of their book value. A gain just to book value would be 40%.
In September, just three months ago, Citius Pharmaceuticals shares were trading at $1.35 per share. A return to that price level would represent a gain of 225%.
We see many other development stage biotech companies with lofty share prices like TG Therapeutics ($9.85) or Relmada Therapeutics ($43.47), similar in development stage to CTXR, and realize what a bargain Citius shares might be.
One of the more compelling reasons to get in on CTXR shares and Mino-Lok may be HOW the product works. Humans are increasingly encountering infections caused by bacteria that antibiotics aren’t effective against. Part of the reason for that is a biofilm that bacteria forms around itself to keep the antibiotics away. The first thing the Mino-Lok compounds do is dissolve that biofilm.
The implications and potentials of that process are immeasurable.
The Traders News Group
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