Financial Performance - Citius Oncology reported a net loss of $21.1 million, or ($0.31) per share, for the fiscal year ended September 30, 2024, compared to a net loss of $12.7 million, or ($0.19) per share, for the previous year[9][18]. - Citius Oncology, Inc. reported a net loss of $21,148,747 for fiscal year 2024, compared to a net loss of $12,697,241 in 2023[30]. - The net cash provided by operating activities was $126,353 in 2024, compared to no cash provided in 2023[30]. - The company reported a net cash used in investing activities of $5,000,000 due to license payments[30]. Expenses - Research and Development (R&D) expenses increased to $4.9 million for the full year ended September 30, 2024, up from $4.2 million in the prior year, reflecting activities related to the resubmission of the Biologics License Application for LYMPHIR[4][7]. - General and Administrative (G&A) expenses rose to $8.1 million for the full year ended September 30, 2024, compared to $5.9 million for the previous year, primarily due to pre-commercial and commercial launch activities of LYMPHIR[4][16]. - Stock-based compensation expense was $7.5 million for the full year ended September 30, 2024, significantly higher than $2.0 million for the prior year, attributed to the realization of expenses over a full year[9][17]. - The company recognized stock-based compensation expense of $7,498,817 in 2024, significantly higher than $1,965,500 in 2023[30]. Assets and Liabilities - Citius Oncology's total current assets increased to $10.97 million as of September 30, 2024, compared to $7.73 million in the previous year[21]. - The company’s total liabilities rose to $38.23 million as of September 30, 2024, compared to $22.20 million in the prior year[25]. - Citius Oncology, Inc.'s total assets increased to $84.37 million as of September 30, 2024, compared to $47.73 million in the previous year[24]. Product Development and Approval - LYMPHIR, the company's primary asset, was approved by the FDA for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma, with an estimated initial market exceeding $400 million[19]. - Citius Oncology, Inc. achieved FDA approval for LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL)[36]. - The company supported two investigator-initiated trials for LYMPHIR, exploring its potential as an immuno-oncology combination therapy[2]. - The company expects promising preliminary results from a second investigator trial with CAR-T therapies in 2025, indicating potential for enhanced treatment efficacy[4]. Commercialization Efforts - The company initiated recruitment of a targeted field force with a contract sales organization to support the launch of LYMPHIR[34]. - Citius Oncology, Inc. launched a marketing awareness campaign and engaged with leading CTCL prescribers[34]. - The company applied for a unique J-code within the HCPCS to facilitate accurate reimbursement for LYMPHIR[34]. - Citius secured inclusion of LYMPHIR in the NCCN guidelines, influencing treatment practices and payor reimbursement in the U.S.[34]. - Citius Oncology, Inc. advanced manufacturing, marketing, and sales activities in preparation for the commercial launch of LYMPHIR in the first half of 2025[36].
TenX Keane Acquisition(TENK) - 2024 Q3 - Quarterly Results