1. Citius Oncology launched LYMPHIR™, targeting relapsed CTCL patients in December 2025. 2. Market for LYMPHIR is estimated to exceed $400 million and growing. 3. Citius raised approximately $61 million from strategic financings post fiscal year. 4. NCCN guidelines included LYMPHIR with a Category 2A recommendation for reimbursement. 5. Citius continues operational growth despite reporting a net loss of $39.7 million.
FAQ
Why Bullish?
LYMPHIR's launch positions CTOR well in a growing market, similar to other successful biopharma launches that boosted stock prices.
How important is it?
The article details significant developments for CTOR that directly relate to its growth potential and revenue streams, showcasing the launch of LYMPHIR and strategic financial maneuvers.
Why Long Term?
The commercial success of LYMPHIR will feed revenue growth, establishing a long-term trajectory for CTOR similar to other biotech firms that capitalized on FDA approvals.
Citius Pharmaceuticals, Inc. Reports Fiscal Year 2025 Financial Results and Business Update
Citius Pharmaceuticals, Inc. (Nasdaq: CTOR), a biopharmaceutical company focused on developing innovative critical care products, has released its financial results and business updates for the fiscal year ending September 30, 2025. A highlight of this period includes the successful launch of LYMPHIR™, an FDA-approved cancer immunotherapy, which began sales in December 2025.
Key Business Developments in Fiscal Year 2025
During fiscal year 2025, Citius Oncology, a subsidiary of Citius Pharma and operating under the symbol CTOR, achieved several milestones:
- Successfully launched LYMPHIR™ (denileukin diftitox-cxdl) in the U.S. for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL).
- Formal agreements established with three major U.S. pharmaceutical wholesalers to facilitate LYMPHIR's nationwide distribution.
- Secured access to LYMPHIR across 19 international markets through named patient programs (NPPs).
- Ensured a production supply of LYMPHIR to meet projected commercial demand for up to 18 months.
- Received a Category 2A recommendation from the National Comprehensive Cancer Network (NCCN) guidelines and a unique Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) to enhance reimbursement efforts.
- Utilized an AI-powered sales and marketing platform to improve engagement with healthcare providers.
- Contracted with a global commercialization services provider for comprehensive support in various operational areas.
Financial Highlights for Fiscal Year 2025
Despite the successful launch of LYMPHIR, Citius Pharma reported the following key financial metrics for the year:
- Cash and Cash Equivalents: $4.3 million as of September 30, 2025.
- Revenue: No revenue reported for the fiscal year.
- R&D Expenses: $9.2 million, a decrease from $11.9 million in 2024.
- G&A Expenses: $18.5 million, slightly up from $18.2 million a year earlier.
- Stock-Based Compensation: $10.8 million, down from $11.8 million in the prior year.
- Net Loss: $39.7 million, or ($3.38) per share, compared to a net loss of $40.2 million, or ($5.97) per share for the fiscal year 2024.
Management Commentary and Future Outlook
Leonard Mazur, Chairman and CEO of Citius Pharma, remarked, “2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for CTCL patients since 2018." He acknowledged the importance of the launch and emphasized a focus on its adoption and further growth opportunities in 2026.
Looking ahead, Citius Pharma plans to engage continuously with the FDA to advance other products like Mino-Lok and explore additional indications for LYMPHIR, all while aiming to strengthen its financial and operational frameworks for sustained growth.
About Citius Oncology and Citius Pharmaceuticals
Citius Oncology, Inc. (Nasdaq: CTOR) is dedicated to the development and commercialization of innovative oncology therapies. The initial market for LYMPHIR is estimated to exceed $400 million, reflecting strong growth potential. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) owns approximately 78% of Citius Oncology and is committed to advancing groundbreaking products to enhance patient care.
Forward-Looking Statements
This news release contains "forward-looking statements" regarding Citius Pharma and Citius Oncology based on management's current expectations. These projections are subject to risks that could significantly affect the companies' operations and stock performance, including funding needs, the success of LYMPHIR’s commercialization, and securing strategic partnerships.