Citius Pharmaceuticals Inc (OTCMKTS:CTXR) is about as an exciting as a situation as I have ever seen in small caps. This is an undiscovered runner in the booming biotech field that has really big names behind it and is well funded moving forward.
Currently CTXR has 2 drugs in late stage development (one product in Phase 3 of FDA approval, and another in Phase 2) that could catapult this entire situation into a whole new stratosphere. Everyone knows just how explosive biotechs can be and CTXR with 2 drugs in late stage development is one good press release away from something big!
Citius Pharmaceuticals is a specialty pharmaceutical company 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. CTXR hydrocortisone and lidocaine cream is targeting to become the first FDA approved prescription product to treat hemorrhoids in the U.S.
CTXR has seen significant progress. In February, CTXR reported results from the Phase 2a trial of its Hydrocortisone and Lidocaine Combination Cream in patients with Grade I and II hemorrhoids, and the data suggest that the Hydro-Lido combination may show faster onset of relief of symptoms and reduction in disease severity as compared to its active components or the cream vehicle. Chairman Leonard Mazur said:
“As expected, the data provides a positive directional signal and also indicate early reduction of symptoms. We look forward to submitting these results to the FDA as we move toward commercialization of our product within this $1 billion market with unmet need.”
In April CTXR announced completion of the acquisition of Leonard-Meron Biosciences, Inc. Its leading drug candidate, Mino-Lok™, is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections. Mino-Lok™ is a patent-protected, novel solution containing minocycline, edetate (disodium EDTA), and ethyl alcohol, which act to break down bacterial biofilm, eradicate the bacteria, provide anti-clotting properties to maintain patency, and salvage the indwelling central venous catheter (“CVC”).
Mino-Lok™ is entering phase 3 trials after demonstrating safety in its phase 2b trial conducted at the MD Anderson Cancer Center in Houston. Recently, the U.S. Food and Drug Administration (“FDA”) granted a Qualified Infectious Disease Product (“QIDP”) designation for Mino-Lok™. Receiving QIDP designation means that Mino-Lok™ is now eligible for Fast Track designation, Priority Review, and a five-year extension of market exclusivity.
“Management is excited with the acquisition which has provided us immediate access to Mino-Lok™, a phase 3 ready program in a billion-dollar industry,”
CTXR is well funded moving forward. In March Chairman Leonard Mazur invested $3 million of his own money into the Company in exchange for 5 million restricted shares of CTXR. The company also recently completed a private placement offering of 7.6mm units for net proceeds of $4.1 million. Each unit consists of one share of common stock and one warrant to purchase a share of common stock for $0.60 per share.
Recently, the company appointed Myron Holubiak as the Company’s President and CEO. He was the former President of Roche Laboratories, Inc., a major research-based pharmaceutical company. He said recently:
“We are extremely pleased with the progress that we have made during the previous 12 months. We are confident that we have built a strong platform to realize our goal of becoming an important player in the critical care space and in adjunctive cancer care. We also have the luxury of owning an asset in Hydro-Lido that has the potential to be the first prescription hemorrhoid treatment with evidence of efficacy and safety. We still have a lot of work to do, but we’ve made significant progress towards addressing previously unmet and underserved medical needs. We believe that the commercial opportunities for Mino-Lok™ and Hydro-Lido, combined with current industry towards cost-effective therapies will allow us to create new markets and enhance our shareholder value.”
CTXR management could make some big moves with its recent funding and the depth of its management team. We will be updating Insider Financial as soon as we know more. For the latest updates and analysis on CTXR, sign up below!
Disclosure: We have no position in CTXR and have previously been compensated for a a fee of three thousand dollars by a third party for a 2 day awareness campaign on CTXR.