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Tuesday, January 26, 2021

A Closer Look at Citius Pharmaceuticals Inc (OTCMKTS:CTXR)

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Citius Pharmaceuticals Inc (OTCMKTS:CTXR) is a micro-cap stock that’s grabbed hold of the attention of traders during the stock’s recent bounce off of key support in the $0.60-$0.75 ranged. Shares of CTXR have dropped from over $2/share earlier this year. According to our research, the stock is currently being promoted as part of an investor awareness deal, but we are not certain of the terms or the nature of the published information.

The chart shows 10% tacked on to share pricing for the company in the past week. This is emblematic of the stock. CTXR is a stock whose past is littered with sudden rips. What’s more, the company has registered increased average transaction volume recently, with the past month seeing over 10,000% above the average volume levels in play in this stock over the longer term. It pays to take note of this fact given the stock’s relatively small trading float of about 26M shares. One is wise to respect the dynamic this may create — a mechanically driven price squeeze can result from this type of mix of small float and ramping attention from traders.

Citius Pharmaceuticals Inc (OTCMKTS:CTXR) promulgates itself as a specialty pharmaceutical company that develops and commercializes therapeutic products in the United States.

The company offers Suprenza ODT, a phentermine orally disintegrating tablet that is used for the treatment of obesity. Its products also include Hydrocortisone-Lidocaine Cream, which is under phase II of clinical trial for the treatment of hemorrhoids.

The company has a collaboration and license agreement with Alpex Pharma S.A. to develop and commercialize orally disintegrating tablet formulations of pharmaceutical products in United States, Canada, and Mexico. Citius Pharmaceuticals, Inc. was founded in 2007 and is headquartered in Maynard, Massachusetts.

CTXR paints itself as “dedicated to the development and commercialization of critical care products with a focus on anti-infectives, cancer care and unique prescription products using innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements.”

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Currently, CTXR has 2 drugs in late stage development (one product in Phase 3 of FDA approval, and another in Phase 2). Both are potentially strong catalysts for the company over the near term.

The most important factor for this company is the recent initiation of the pivotal Phase 3 clinical trial Mino-Lok, an antibiotic lock solution used to salvage infected central venous catheters and to treat catheter-related bloodstream infections.

Mino-Lok is being developed as an adjunctive therapy for the treatment of catheter-related or central line-associated bloodstream infection. Mino-Lok in combination with appropriate systemic antibiotic is used to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion.

The Phase 3 trial is a multi-center, randomized, double-blind study of 700 subjects. The primary endpoint is the measurement of a significant proportion of subjects having overall success in maintaining the treated CVCs at the test of cure at week 8. Secondary endpoints include the safety and tolerability as described by adverse events, serious adverse events , vital signs, clinical laboratory evaluations, and physical examinations.

Citius has begun recruitment of sites for the trial. This pivotal phase 3 clinical trial is expected to take 2 years to complete. The first patient is expected to be enrolled in early 2017. Medpace, based in Cincinnati, OH, has been designated as the trial management clinical research organization.

Mr. Myron Holubiak, President and CEO stated, “This is a major milestone for Citius as our lead product is entering registration trials. Mino-Lok has the potential to become a standard of care for treating CRBSIs.”

CTXR has a foundation it can build on, now it just needs to execute. Now commanding a market cap of $54.7M, CTXR has a decent store ($1.63M) of cash on the books, with total assets a bit over $23M, which is balanced by an appreciable load ($172.97k) of total accumulated debt. We actually see some interesting potential here despite the current promotional context. The balance sheet is in great shape and the company has two promising drugs already well into FDA processing. Obviously, anything can happen. But this is one to keep an eye on. For continuing coverage on $CTXR and our other hot stock picks, sign up for our free newsletter now and get our next hot stock pick!

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