Citius Pharmaceuticals Inc (CTXR)

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CTXR Running Positive in Phase III Trial


Good day everyone,


We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a company developing new and expanded indications for previously approved pharmaceutical products.


Current price. $1.30 per share

Float (est.). 13.5 million shares


Today we want to focus on the company’s lead product candidate Mino-Lok, as it will likely drive the CTXR market valuation.


Mini-Lok was developed by the MD Anderson cancer center, one of the two top cancer treatment centers in the US. It’ a combination of three FDA approved compounds used to eliminate bacterial infections in central venous catheters (CVC) used in chemo therapy, hemodialysis and other indications.
CTXR has the license to develop the product and bring it to market.


Today, an infected CVC gets removed from the patient and replaced with a new one at a cost of about $50K. Mino-Lok is administered into the infected CVC for two hours per day at a cost of about $1500. There are an estimated 500,000 infected CVCs annually so the savings to the health care system is significant. There have been no adverse events associated with Mino-Lok. The incidence of adverse events (including death) occurs 18% of the time in the remove and replace procedure.


Mino-Lok is patent protected.


Mino-Lok in currently in it Phase III clinical trial. The efficacy rate all the way through the 2B trial is virtually 100%. The P3 trial consists of 700 patients at 32 locations in the US with interim reviews at 40% enrollment and 75% enrollment. The clinical data is being monitored by an independent group of experts and in December, the 40% enrollment data was evaluated with a recommendation to continue the trial. That’s a significant milestone. The next review, at 75% enrollment is due in H1 and will likely be an even larger catalyst for the company shares. FDA approval is anticipated this year.


CTXR estimates the US market for Mino-Lok at $750m annually (500,000 cases at $1,500 per). Double that for the worldwide market. Once the product is FDA approved we will have to think, what is a company with a billion dollar product worth?



But it’s not approved yet, though very close. So, we need to consider, what is CTXR worth today as it’s ¾ of the way through the race? A company with a potential near term catalyst? We don’t know that answer, it’s an answer only big pharma acquisition specialists are likely to know, but we are certain it could be considerably more than the current market cap of $37M.


Let’s remember that top management at CTXR are seasoned professionals at monetizing new pharma technology. They also hold a large position in the company’s shares. They know they have a winner.