Business
Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2023 Financial Results and Provides Business Update
Mino-Lok® Pivotal Phase 3 trial enrollment completed; topline data expected 2Q 2024 LYMPHIR™ BLA resubmission on track for early 2024 CRANFORD, N.J., Jan. 2,
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Mino-Lok® Pivotal Phase 3 trial enrollment completed; topline data expected 2Q 2024\nLYMPHIR™ BLA resubmission on track for early 2024\nCRANFORD, N.J., Jan. 2, 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 full year ended September 30, 2023.\nFiscal Full Year 2023 Business Highlights and Subsequent Developments\nCompleted enrollment in the Mino-Lok® Pivotal Phase 3 trial; topline results anticipated in 2Q 2024;Initiated remediation activities in the second half of 2023 to address comments in the complete response letter (CRL) received from the U.S. Food and Drug Administration (FDA) related to our LYMPHIR biologics license application (BLA); BLA resubmission planned for early 2024;Advanced two investigator-initiated trials to investigate LYMPHIR's potential as an immuno-oncology combination therapy with checkpoint inhibitor pembrolizumab at the University of Pittsburgh Medical Center, and prior to CAR-T therapies at the University of Minnesota, Masonic Cancer Center;Announced publication in the journal Frontiers in Immunology of positive results from a preclinical solid tumor study (liver cancer and colon cancer) of LYMPHIR in combination with anti-PD-1 (to assess the contribution that transient depletion of Tregs has on the anti-tumor activity of checkpoint inhibition);Completed Halo-Lido Phase 2b trial; end of Phase 2 meeting with FDA expected in early 2024;Executed definitive agreement to merge our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENKU) to form publicly listed Citius Oncology, Inc.; and,Raised gross proceeds of $15 million in a registered direct offering in May 2023.Financial Highlights\nCash and cash equivalents of $26.5 million as of September 30, 2023; runway through August 2024;R&D expenses were $14.8 million for the full year ended September 30, 2023, compared to $17.7 million for the full year ended September 30, 2022;G&A expenses were $15.3 million for the full year ended September 30, 2023, compared to $11.8 million for the full year ended September 30, 2022;Stock-based compensation expense was $6.6 million for the full year ended September 30, 2023,...