On December 23, 2025 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal year ended September 30, 2025.

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"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months."

Fiscal Year 2025 Business Highlights and Subsequent Developments

● Citius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy;

● Citius Pharma drove commercial preparations for LYMPHIR’s launch through its shared management services agreement with Citius Oncology:

- Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.;

- Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.;

- Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand;

- Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines and compendia with a Category 2A recommendation, and a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) to aid in obtaining coverage and reimbursement;

- Partnered to deploy an AI-powered sales and marketing platform to enhance commercial targeting, real-time field execution, and provider engagement; and,

- Contracted with a leading provider of global commercialization services to supply medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management services;

● Raised approximately $61 million in gross proceeds from capital raises:

- Citius Pharma closed $25 million in gross proceeds from strategic financings during and after the fiscal year end; and,

- Citius Oncology closed $36 million in gross proceeds from strategic financings during and after the fiscal year end; and,

● Continued to engage with the FDA on the paths forward for Mino-Lok and Halo-Lido.

Fiscal Year 2025 Financial Highlights

● Cash and cash equivalents of $4.3 million as of September 30, 2025;

● Citius Pharma did not report revenues for the year;

● R&D expenses were $9.2 million for the full year ended September 30, 2025, compared to $11.9 million for the full year ended September 30, 2024;

● G&A expenses were $18.5 million for the full year ended September 30, 2025, compared to $18.2 million for the full year ended September 30, 2024;

● Stock-based compensation expense was $10.8 million for the full year ended September 30, 2025, compared to $11.8 million for the full year ended September 30, 2024; and,

● Net loss was $39.7 million, or ($3.38) per share for the fiscal year ended September 30, 2025 compared to a net loss of $40.2 million, or ($5.97) per share for the full year ended September 30, 2024.

(Press release, Citius Pharmaceuticals, DEC 23, 2025, View Source [SID1234661607])