Citius Pharma To Spinoff Late-Stage Oncology Asset Into New Publicly Traded Firm

Citius Pharmaceuticals Inc CTXR plans to form a new company (NewCo) focused on developing and commercializing I/ONTAK. A Phase 3 trial was completed in December 2021, and a biologics license application (BLA) is being planned for submission in the second half of 2022.
The Company's other pipeline assets, including Mino-Lok, would remain at Citius.
Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR.
"As Citius prepares for the commercialization of its two late-stage product candidates, I/ONTAK and Mino-Lok, we believe that the market has not adequately valued the potential of our recent I/ONTAK licensing agreement," stated Leonard Mazur, Chairman, and CEO of Citius.
The transactions are expected to be completed in the second half of the calendar year 2022
I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments.
I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.
ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market.
The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL.
In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for PTCL and CTCL.
Price Action: CTXR shares are down 2.26% at $0.94 on the last check Wednesday.