Citius Oncology partners with EVERSANA for LYMPHIR commercialization.

Citius Oncology, a subsidiary of Citius Pharmaceuticals, has partnered with EVERSANA for commercialization services to support the US launch of LYMPHIR, a therapy for relapsed or refractory cutaneous T-cell lymphoma. EVERSANA will provide an integrated suite of pre- and post-launch operations services, including medical information, pharmacovigilance, and revenue cycle management. The partnership aims to enhance launch readiness and market entry for LYMPHIR.

Citius Oncology, Inc. (Nasdaq: CTOR), an oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), has finalized an exclusive commercialization agreement with EVERSANA®, a leading provider of global commercialization services. This partnership aims to support the anticipated fourth quarter 2025 U.S. commercialization of LYMPHIR™, Citius Oncology's FDA-approved therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Under the Master Service Agreement, EVERSANA will serve as Citius Oncology's exclusive commercialization partner, providing an integrated suite of pre- and post-launch operations services. These services include medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management. As launch preparations advance, additional commercialization services are expected to be integrated.

This agreement marks a significant milestone in Citius Oncology's pre-commercial strategy, building on the foundational work already completed in preparation for the U.S. launch of LYMPHIR. Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma, stated, "Finalizing our exclusive agreement with EVERSANA is a transformative milestone as we prepare and plan to bring LYMPHIR to market in Q4 2025. This agreement allows us to significantly extend our commercial capabilities by leveraging EVERSANA's best-in-class infrastructure and deep expertise in oncology commercialization."

Greg Skalicky, President of EVERSANA, added, "We are committed to driving oncology commercialization excellence and look forward to continuing our work with Citius Oncology to bring LYMPHIR to market. This agreement reflects our shared mission and vision to deliver innovative cancer treatments to patients who need them."

LYMPHIR was approved by the U.S. Food and Drug Administration in August 2024 and is the only systemic treatment for CTCL that targets the IL-2 receptor on malignant T-cells and T-regs. Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

About LYMPHIR™ (denileukin diftitox-cxdl): LYMPHIR is a targeted immune therapy indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death.

LYMPHIR demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia.

The partnership between Citius Oncology and EVERSANA is expected to enhance launch readiness and market entry for LYMPHIR, supporting a high-quality launch aligned with investor expectations. This collaboration strengthens Citius Oncology's operational readiness, de-risks execution, and enhances its capacity to generate long-term value for shareholders.