Citius Pharmaceuticals (CTXR) Investor Update summary

Key milestones and strategic updates

• Achieved FDA approval for LYMPHIR, a novel therapy for relapsed/refractory cutaneous T-cell lymphoma (CTCL), with plans to launch within five months and target a $400 million and growing market.

• Completed the spin-off of Citius Oncology into a publicly traded company, retaining 90% ownership to maintain control and financial flexibility while enabling focused growth in oncology.

• Mino-Lok phase III trial met both primary and secondary endpoints, supporting the transition to a commercial-stage company.

LYMPHIR clinical and commercial highlights

• LYMPHIR demonstrated a 36% objective response rate and a 50% clinical benefit rate in heavily pretreated CTCL patients, with rapid time to response and no evidence of cumulative toxicity.

• Safety profile includes a boxed warning for Capillary Leak Syndrome; post-marketing studies will monitor potential visual impairment, but no significant eye toxicity was observed in trials.

• Commercial strategy includes a targeted sales force, proprietary patient identification analytics, and a robust patient support program, with pricing aligned to rare disease peers and anticipated smooth reimbursement.

• Application for a specific J-code will be submitted, with approval expected by April 2025; NCCN guideline inclusion is anticipated within 1–2 months, supporting reimbursement.

Market and operational outlook

• Focused on engaging the concentrated base of 800 key CTCL prescribers at 141 institutions, leveraging KOL relationships and educational campaigns.

• Manufacturing agreements and inventory are in place to support launch and anticipated demand.

• Citius Oncology will operate independently but with shared services and consolidated financials, providing flexibility for future financing and business development.

• Plans to expand LYMPHIR into additional indications such as PTCL and through combination studies with CAR T and PD-1 therapies; business development to broaden the portfolio is under consideration.