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Citius Oncology, Inc. Reports Fiscal First Quarter 2025 Financial Results and Provides Business Update

Core Insights - Citius Oncology reported business and financial results for the fiscal first quarter ended December 31, 2024, highlighting advancements in bringing LYMPHIR to market and exploring strategic options to maximize shareholder value [1][4]. Business Highlights - The FDA approved LYMPHIR for the treatment of cutaneous T-cell lymphoma (CTCL), making it the only targeted systemic therapy approved for CTCL since 2018, with over 84% of patients in the Phase III trial experiencing skin relief [4]. - The company engaged Jefferies as its exclusive financial advisor to evaluate strategic alternatives, with active discussions ongoing to expedite the market launch of LYMPHIR in the first half of 2025 [5][7]. - Key initiatives for commercial readiness include manufacturing sufficient inventory for launch, securing a new permanent J-code (J9161) effective April 1, 2025, and inclusion in NCCN guidelines [5][7]. Research and Development - Citius Oncology is supporting two investigator-initiated trials to evaluate LYMPHIR's potential as an immuno-oncology combination therapy, with positive interim results shared at the SITC Conference [6][8]. - The University of Minnesota has expanded its Phase I clinical trial to assess LYMPHIR's safety and efficacy prior to CAR-T therapies for B-cell lymphomas [6][8]. Financial Highlights - R&D expenses for the first quarter were $1.3 million, up from $1.2 million in the same quarter of the previous year, primarily due to costs associated with ongoing trials [9]. - G&A expenses increased to $3.3 million from $1.5 million year-over-year, driven by pre-commercial and commercial launch activities for LYMPHIR [10]. - The net loss for the quarter was $6.7 million, or ($0.09) per share, compared to a net loss of $4.7 million, or ($0.07) per share, in the prior year [12].