Business
Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Financial Results and Provides Business Update
$41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023 Mino-Lok® Phase 3 trial closer to completion with
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"$41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023\nMino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review\nI/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023\nHalo-Lido Phase 2b trial progressed; data readout expected 2H 2023\nMultiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions\nCRANFORD, N.J., Dec. 22, 2022 /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, 2022.\nFiscal Full Year 2022 Business Highlights and Subsequent Developments\nCompleted Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA);FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023;Advanced Mino-Lok® Phase 3 trial:Expanded trial to additional sites in India for an anticipated total of 35 clinical trial locations globally,Enrolled 169 patients to date, exceeding recruitment goal of 144 patients,Observed 72 of 92 required catheter failure events, with 17 patients in active treatment or pending study completion data review (which may contribute additional failure events);Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023;Initiated clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022; and,Approved for $3.6 million in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts.Financial Highlights\nCash and cash equivalents of $41.7 million as of September 30, 2022;R&D expenses were $17.7 million for the full year ended September 30, 2022,...