Business
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2024 Financial Results and Provides Business Update
Resubmitted LYMPHIR™ Biologics License Application; awaiting PDUFA date Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial CRANFORD, N.J., Feb. 14,
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Resubmitted LYMPHIR™ Biologics License Application; awaiting PDUFA date\nCompleted enrollment in the Mino-Lok® Pivotal Phase 3 trial\nCRANFORD, N.J., Feb. 14, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter 2024 ended December 31, 2023.\nFirst Quarter 2024 Business Highlights and Subsequent Developments\nResubmitted LYMPHIR™ (denileukin diftitox) biologics license application (BLA) to the U.S. Food and Drug Administration (FDA); awaiting Prescription Drug User Fee Act (PDUFA) target date;Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial; topline results anticipated in calendar 2Q 2024;Scheduled end of Phase 2b trial meeting with FDA in calendar 2Q 2024 to discuss next steps in development of Halo-Lido for the treatment of hemorrhoids;Executed definitive agreement to merge our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology, Inc.; transaction is expected to be completed in the first half of 2024; and,Nominated Robert Smith to be elected to the Citius Board of Directors at the upcoming Annual Meeting of Stockholders.Financial Highlights\nCash and cash equivalents of $20.3 million as of December 31, 2023; runway through August 2024;R&D expenses were $2.6 million for the first quarter ended December 31, 2023, compared to $3.4 million for the first quarter ended December 31, 2022;G&A expenses were $3.7 million for the first quarter ended December 31, 2023, compared to $2.6 million for the first quarter ended December 31, 2022;Stock-based compensation expense was $3.1 million for the first quarter ended December 31, 2023, compared to $1.2 million for the first quarter ended December 31, 2022; and,Net loss was $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2023, compared to a net loss of $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022.\"We had a strong first quarter of fiscal 2024 during which we achieved multiple mission critical goals. We are hopeful that topline results from our completed Mino-Lok pivotal Phase 3 trial, which we expect to be available i...