Business
Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2024 Financial Results and Provides Business Update
Mino-Lok data analysis on track with topline results anticipated this quarter LYMPHIR biologics license application accepted with PDUFA target action date set
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Mino-Lok data analysis on track with topline results anticipated this quarter\nLYMPHIR biologics license application accepted with PDUFA target action date set for August 13, 2024\nCRANFORD, N.J., May 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 second quarter 2024 ended March 31, 2024.\nSecond Quarter 2024 Business Highlights and Subsequent Developments\nLYMPHIR™ (denileukin diftitox) biologics license application (BLA) accepted by the U.S. Food and Drug Administration (FDA) with August 13, 2024, assigned as Prescription Drug User Fee Act (PDUFA) target action date;Data analysis underway for completed Mino-Lok® Pivotal Phase 3 trial with topline results anticipated in calendar 2Q 2024;Continued engagement with FDA following end of Phase 2b meeting to determine next phase in the development of Halo-Lido for the treatment of hemorrhoids;Merger of our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology, Inc. is progressing and pending review by Securities and Exchange Commission (SEC) and TENK shareholder approval;Robert Smith elected to the Citius Board of Directors at the Annual Meeting of Stockholders; and,Completed $15 million registered direct offering in April 2024 extending the Company's cash runway.Financial Highlights\nCash and cash equivalents of $12.6 million as of March 31, 2024;$15 million in gross proceeds from a registered direct offering on April 30, 2024, extends the Company's cash runway through December 2024;R&D expenses were $3.6 million and $6.2 million for the three and six months ended March 31, 2024, respectively, compared to $4.7 million and $8.2 million for the three and six months ended March 31, 2023, respectively;G&A expenses were $4.3 million and $7.9 million for the three and six months ended March 31, 2024, respectively, compared to $4.8 million and $7.4 million for the three and six months ended March 31, 2023, respectively;Stock-based compensation expense was $3.1 million and $6.1 million for the three and six months ended March 31, 2024, respectively, compared to $1.2 million and $2.4 million for t...