CRANFORD, N.J., Dec. 23, 2025 — Citius Oncology, Inc. (Nasdaq: CTOR) reported fiscal 2025 financial results and provided a business update after launching LYMPHIR (denileukin diftitox-cxdl) in the U.S. in December 2025. The company said the launch moves it from a pre-revenue to a revenue-generating stage and is focusing on driving adoption and commercial efficiency.
LYMPHIR, an IL-2 receptor-directed immunotherapy, was approved by the FDA for adults with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma (CTCL) following at least one prior systemic therapy. Citius Oncology has executed distribution agreements with the three leading U.S. pharmaceutical wholesalers to supply hospitals, community oncology practices and infusion centers nationwide.
The company secured access to LYMPHIR in 19 international markets through regional distribution partners under Named Patient Programs, and announced a collaboration with Verix to deploy the Tovana AI platform for commercial targeting, field execution and provider engagement. Citius Oncology also reported promising preliminary results from an investigator-initiated Phase I trial combining pembrolizumab and LYMPHIR in patients with recurrent solid tumors.
Financial highlights for the fiscal year ended Sept. 30, 2025, include cash and cash equivalents of $3.9 million and net loss of $24.8 million, or $0.34 per share, compared with a net loss of $21.1 million, or $0.31 per share, for fiscal 2024. Research and development expenses were $6.4 million, up from $4.9 million a year earlier. General and administrative expenses were $8.8 million versus $8.1 million, and stock-based compensation was $8.3 million compared with $7.5 million in the prior year. The company also received a $1.0 million note payable from parent company Citius Pharmaceuticals, Inc.
Citius Oncology completed $36.0 million in gross proceeds from strategic financings during and after the fiscal year, including a $9.0 million public offering on July 17, 2025; a $9.0 million registered direct offering and private placement on Sept. 10, 2025; and an $18.0 million registered direct offering and private placement on Dec. 10, 2025.
Citius Oncology is the oncology-focused subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR), which owns approximately 78% of the company. Management estimates the initial market opportunity for LYMPHIR exceeds $400 million and said intellectual property and orphan drug protections support its competitive positioning.
The company noted that its statements include forward-looking information subject to risks and uncertainties and referred investors to its SEC filings, including the Form 10-K for the year ended Sept. 30, 2025, filed Dec. 23, 2025, for a detailed description of risk factors.
Investor contact: Ilanit Allen, [email protected], 908-967-6677 x113. Media contact: Greg Salsburg, [email protected].
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