Citius Oncology (CTOR) Anticipates Commercial Launch of LYMPHIR in 2025

Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that preparations for the commercial launch of LYMPHIR™, an FDA-approved immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), are nearing completion. The Company believes it is now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization, with all major launch-enabling activities underway. Final preparations are in process for a U.S. launch of LYMPHIR in the second half of 2025.

"We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community," added Mazur.

Manufacturing and Supply Chain Readiness

Citius Oncology has completed commercial-scale manufacturing of LYMPHIR, with packaged and labeled inventory now held at a leading global Contract Development and Manufacturing Organization (CDMO). Sufficient inventory has been manufactured, with a product shelf life of 60 months, to meet projected demand for 12 to 18 months post-launch.

Citius Oncology has executed one and is finalizing other distribution services agreements with multiple top-tier global pharmaceutical logistics partners to support broad access and timely delivery across the United States. These agreements are intended to provide access for CTCL patients so that they may be treated at both major cancer centers and within the community setting.

KOL Engagement

As part of its extensive market research efforts, our team has engaged U.S. Key Opinion Leaders (KOLs) in CTCL and participated in a series of medical congresses and community forums to build awareness and gather insight. Our engagement with the Cutaneous Lymphoma Foundation and similar organizations continues to shape LYMPHIR's patient-centered commercial approach.

A recent Advisory Board convened at the 2024 American Society of Hematology Annual Meeting, composed of leading CTCL experts, provided us with information that informed both launch strategy and refinement of target patient profiles.

Early interest from the clinical community is evident, with 70 institutional oncology centers already signed up via the LYMPHIR™ website (www.lymphirhcp.com).

Commercial & Marketing Activities

The commercial team has developed a targeted launch strategy that leverages a proprietary generative AI model to efficiently and effectively target key accounts. These efforts are designed to amplify the expertise of the commercial organization so that they may have more meaningful interactions with providers, ultimately reaching CTCL patients who would benefit from LYMPHIR more expeditiously.

A comprehensive suite of marketing and educational materials has been developed to support LYMPHIR's introduction. These tools are tailored to providers, patients, and caregivers and include clinical guides, dosing protocols, and disease awareness content.

Market Access Update

LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, assignment of a permanent J-code under HCPCS, and Citius Oncology's continued engagement with payors, positions the product for efficient reimbursement and coverage at launch.

Financing and Strategic Partnerships

The successful capital raise recently completed by Citius Pharma assists with final preparations for LYMPHIR's commercialization, supporting the planned launch of LYMPHIR in the second half of 2025. Concurrently, the Company is actively engaged in strategic partnership discussions, guided by its financial advisor, to expand LYMPHIR's market reach and evaluate potential future development opportunities.

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