Citius Pharma(US:CTXR)2024-08-12 21:25FDA Approval and Product Development - FDA approved LYMPHIR™ for the treatment of cutaneous T-cell lymphoma, marking the first FDA-approved product in the company's portfolio[1][3] - Achieved primary and secondary endpoints in Phase 3 Pivotal Trial of Mino-Lok, designed to salvage central venous catheters in patients with catheter-related bloodstream infections[1] - Citius Oncology is expected to transition from a development stage company to a commercial biopharmaceutical organization following the FDA approval of LYMPHIR[3] Financial Performance and Expenses - Cash and cash equivalents of $17.9 million as of June 30, 2024, with $15 million raised in a registered direct offering extending cash runway through December 2024[2][5] - R&D expenses decreased to $2.8 million for Q3 2024 from $3.8 million in Q3 2023, primarily due to completion of Mino-Lok Phase 3 trial and Halo-Lido Phase 2b trial[6] - G&A expenses increased to $4.8 million for Q3 2024 from $3.7 million in Q3 2023, driven by pre-launch and market research activities for LYMPHIR[8] - Stock-based compensation expense rose to $3.1 million for Q3 2024 from $1.2 million in Q3 2023, primarily due to the Citius Oncology stock plan[9] - Net loss increased to $10.6 million for Q3 2024 from $8.5 million in Q3 2023, driven by higher G&A and stock-based compensation expenses[10] - Total assets decreased from $103.61 million as of September 30, 2023, to $97.09 million as of June 30, 2024[14] - Net loss for the nine months ended June 30, 2024, was $28.35 million, compared to $22.60 million for the same period in 2023[16] - Research and development expenses decreased from $11.94 million for the nine months ended June 30, 2023, to $8.99 million for the same period in 2024[16] - General and administrative expenses increased from $11.13 million for the nine months ended June 30, 2023, to $12.76 million for the same period in 2024[16] - Stock-based compensation expense increased from $3.54 million for the nine months ended June 30, 2023, to $9.20 million for the same period in 2024[16] - Net cash used in operating activities was $22.29 million for the nine months ended June 30, 2024, compared to $22.26 million for the same period in 2023[17] - Net proceeds from registered direct offering were $13.72 million for the nine months ended June 30, 2024[17] - Cash and cash equivalents decreased from $26.48 million as of September 30, 2023, to $17.91 million as of June 30, 2024[14] - In-process research and development remained constant at $59.40 million as of June 30, 2024, and September 30, 2023[14] - Total liabilities decreased from $12.18 million as of September 30, 2023, to $10.81 million as of June 30, 2024[14] Corporate Strategy and Capital Allocation - Completed merger with TenX Keane to form Citius Oncology, Inc., expected to begin trading on Nasdaq under ticker CTOR on August 13, 2024[1] - The company is evaluating opportunities to optimize capital allocation, cash runway, and potential non-dilutive sources of capital for future growth[4]