Citius Pharmaceuticals announced Thursday morning that it is making strides in its plan to spin off its oncology asset I/ONTAK into a standalone company. 

The late-stage biopharma said it has engaged investment bank Maxim Group LLC to serve as the financial advisor to the company’s wholly-owned subsidiary Citius Acquisition Corp. as it expects to spin off I/ONTAK.

The company noted that any transactions are subject to the satisfaction of customary conditions, including final approval from the board of directors. Citius confirmed that it will continue to trade under its current Nasdaq ticker CTXR. 

“Citius is committed to maximizing the value of I/ONTAK and advancing our pipeline. Maxim Group has a strong track record of executing strategic and financial transactions in the life science sector, and we look forward to working closely with them to optimize the structure and timing of contemplated I/ONTAK transactions,” Citius CEO Leonard Mazur said in a statement.  

I/ONTAK is a “recombinant fusion protein” that combines the “interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments.” It is intended as a treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL).

The company announced efficacy and safety data from a Phase 3 study for treating CTCL in November and presented it at the American Society of Hematology Annual Meeting in December.

The Food and Drug Administration subsequently accepted Citius’ biologics license application for I/ONTAK and issued a Prescription Drug User Fee Act (PDUFA) target action date of July 28. I/ONTAK has already received orphan drug designation by the FDA for treating CTCL and PTCL.

In its full year fiscal report at the end of December, Mazur said Citius remains committed to establishing a “robust commercial infrastructure” to support the asset’s product launch, if approved by the FDA. He added that the company believes the drug’s value extends “beyond a potential initial indication in persistent or recurrent cutaneous T-cell lymphoma.”

Spinning off I/ONTAK is also expected to provide Citius with additional strategic and financial options to bolster its drug pipeline. Currently, the company is conducting a Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.