Business
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update
$36.9 million in cash and cash equivalents as of December 31, 2022; runway through February 2024 Uptick in patient recruitment for Mino-Lok® Phase 3 trial
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"$36.9 million in cash and cash equivalents as of December 31, 2022; runway through February 2024\nUptick in patient recruitment for Mino-Lok® Phase 3 trial\nHalo-Lido Phase 2b trial nearing completion\nCRANFORD, N.J., Feb. 10, 2023 /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 ended December 31, 2022.\nFiscal Q1 2023 Business Highlights and Subsequent Developments\nI/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023;Mino-Lok® Phase 3 trial progressing with additional enrollment and events in the U.S. and India;Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and,On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane.Financial Highlights \nCash and cash equivalents of $36.9 million as of December 31, 2022;R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021;G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021;Stock-based compensation expense was $1.2 million for the first quarter ended December 31, 2022, compared to $0.9 million for the first quarter ended December 31, 2021; and,Net loss was $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021.\"As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA's decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commer...