New cancer immunotherapy LYMPHIR debuts in U.S. with AI-guided rollout

Citius Oncology Reports Fiscal Year 2025 Results and U.S. Launch of LYMPHIR

CRANFORD, N.J., Dec. 23, 2025 — Citius Oncology, Inc. (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), reported financial results for the fiscal year ended September 30, 2025, and provided a business update following the U.S. commercial launch of LYMPHIR in December 2025.

Leonard Mazur, chairman and CEO of Citius Oncology and Citius Pharmaceuticals, said the company has moved from a pre-revenue to a revenue-generating stage and will focus on driving adoption, delivering patient value and maximizing commercial efficiency using AI-driven analytics. He added the company is laying groundwork for international access through distribution partners in Southern Europe and the Middle East.

Business highlights for fiscal 2025 and subsequent developments include the U.S. launch of LYMPHIR (denileukin diftitox-cxdl) for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy; service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to hospitals, community oncology practices and infusion centers; secured access to LYMPHIR in 19 international markets via Named Patient Programs where permitted by local law; a collaboration with Verix to deploy the Tovana AI platform to support U.S. commercialization and provider engagement; and promising preliminary results from an investigator-initiated Phase I trial of pembrolizumab combined with LYMPHIR in patients with recurrent solid tumors.

Financial highlights for the fiscal year ended September 30, 2025: cash and cash equivalents of $3.9 million; $36 million in gross proceeds from strategic financings during and after the fiscal year, including an $18 million concurrent registered direct offering and private placement on December 10, 2025, a $9 million offering on September 10, 2025, and a $9 million public offering on July 17, 2025; and a $1 million note payable received from Citius Pharmaceuticals. Research and development expenses were $6.4 million compared with $4.9 million in fiscal 2024. General and administrative expenses were $8.8 million compared with $8.1 million in fiscal 2024. Stock-based compensation expense was $8.3 million compared with $7.5 million in fiscal 2024. Net loss was $24.8 million, or $0.34 per share, compared with a net loss of $21.1 million, or $0.31 per share, in fiscal 2024.

About Citius Oncology
Citius Oncology is a platform company focused on developing and commercializing targeted oncology therapies. In December 2025 the company launched LYMPHIR, approved by the U.S. Food and Drug Administration for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy. Management estimates the initial market for LYMPHIR exceeds $400 million. The company holds intellectual property and regulatory protections, including orphan drug designation and pending patents for immuno-oncology uses in combination with checkpoint inhibitors. More information is available at www.citiusonc.com.

About Citius Pharmaceuticals
Citius Pharmaceuticals develops and commercializes first-in-class critical care products and owns approximately 78 percent of Citius Oncology. Citius Pharma’s late-stage pipeline includes Mino-Lok, a catheter lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief. A pivotal Phase 3 trial for Mino-Lok met primary and secondary endpoints, and the company is engaged with the FDA on next steps. More information is available at www.citiuspharma.com.

Forward-looking statements in this release are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Risks are described in Citius Oncology’s filings with the U.S. Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended September 30, 2025, filed December 23, 2025.

Investor contact: Ilanit Allen, [email protected], 908-967-6677 ext. 113
Media contact: Greg Salsburg, [email protected]

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