Citius Pharma Makes Calculated Market Moves with Phase 3 Results Looming for Potential Blockbuster Product

Citius Pharmaceuticals, Inc. is a New Jersey-based, late-stage specialty pharmaceutical company that was launched in 2010. It specializes in developing and commercializing critical care drug products, with a focus on anti-infectives and cancer care.

Citius went public through an initial public offering in September 2014 and started trading on the NASDAQ under the ticker symbol “CTXR”. On February 17th, Citius announced a direct offering for 50,830,566 shares and warranted the purchase of an additional 25,415,283 shares at $1.505 per share.

The aggregate gross proceeds from the offering are estimated to be approximately $76.5 million. In light of the news, Citius’ stock surged and was up 23.8% on Friday. Just last month, the company announced the closing of a private placement offering worth $20.0 Million.

Critical Care Products

At present, Citius is developing three proprietary product candidates:

• CITI-002 (Halo-Lido), a topical formulation of halobetasol, a corticosteroid, and lidocaine to provide anti-inflammatory and anesthetic symptomatic relief to hemorrhoids victims. It is currently gearing up for a Phase IIb trial.
• CITI-101 (Mino-Wrap), a liquefying gel-based wrap containing minocycline and rifampin designed to provide inflammatory tissue protection and prevent infection and biofilm formation in tissue expanders and breast implants post-mastectomy. In December 2020, Citius received a written response and guidance from the USFDA for Mino-Wrap development. Citius expects to file for an IND by the end of this year.
• Mino-Lok, an antibiotic lock solution developed as adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs).

Besides, Citius has also licensed a cellular therapy from Novellus Therapeutics Ltd. to treat acute respiratory distress syndrome (ARDS).

Mino-Lok – A Potential Blockbuster

Among the three products that Citius is developing, Mino-Lok has achieved the most milestones and is currently undergoing Phase 3 evaluations. It has already received the Qualified Infectious Disease Product (“QIDP”) designation providing fast track status, priority review, and additional market exclusivity. If approved, Citius believes that Mino-Lok could enter a $1.5 billion worth market and prove to be a blockbuster without any immediate competition.

The prolonged use of central venous catheters (“CVCs”) results in the colonization of several microbes including pathogens that become antibiotic-resistant. This is dangerous especially for patients with cancer or other serious diseases who are undergoing treatments via catherers. Currently, there are no approved therapies for salvaging those CVCs infected with microbial biofilms. Instead, the standard of care for most CRBSIs is to remove or replace the infected catheters.

In recent times, EDTA and ethanol compounds have been used as alternatives or adjuvants to antibiotics. Mino-Lok, is a proprietary combination of a tetracycline-class of antibiotic, Minocycline along with EDTA and ethanol.

“A typical drug approval contains one drug substance, so for all practical purposes, our team has developed three products. Mino-Lok is unique in many ways, this being one of them,” Citius CEO Myron Holubiak had said previously.

In an in vitro study completed last November, Mino-Lok (30 mg/mL EDTA, 19.5% ethanol, and 1 mg/mL minocycline) was found to be superior to EDTA/Ethanol (30 mg/mL EDTA and 19.5% ethanol) in eradicating Staphylococcus aureus, a notorious pathogen and a leading cause of hospital-acquired infections.

It is currently being evaluated in a Phase 3 trial to evaluate the safety and efficacy in combination with systemic antibiotics in the treatment of CRBSIs. In a letter to shareholders, Citius said that it expects to receive an interim analysis of the pivotal trial and review by the Data Monitoring Committee (DMC) in the second quarter of this year. Once positive results are confirmed, Citius is expected to quickly push for FDA clearance and manufacturing.

Related Article: Vor BioPharma Surpasses $1 Billion Valuation After IPO

References

1. https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-76-5-million-registered-direct-offering-priced-at-the-market-under-nasdaq-rules-301229588.html
2. https://www.sec.gov/Archives/edgar/data/1506251/000121390021009291/ea135617ex99-2_citiuspharma.htm
3. https://www.sec.gov/Archives/edgar/data/1506251/000121390020033152/ea128836ex99-1_citiuspharma.htm
4. https://www.prnewswire.com/news-releases/citius-announces-results-of-study-that-mino-lok-eradicates-s-aureus-biofilm-more-effectively-and-expeditiously-than-components-301180863.html

Author

Rajaneesh K. Gopinath