Business
Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2022 Financial Results and Provides Business Update
Mino-Lok® Phase 3 trial expanded to include sites outside the U.S.; trial enrollment expected to be completed by end of 2022 Topline results of Phase 3 trial
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Mino-Lok® Phase 3 trial expanded to include sites outside the U.S.; trial enrollment expected to be completed by end of 2022\nTopline results of Phase 3 trial in cancer immunotherapy I/ONTAK consistent with prior formulation; BLA submission on track for 2H 2022\n$55.8 million in cash and cash equivalents as of March 31, 2022 and no debt \nCRANFORD, N.J., May 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today reported business and financial results for the second fiscal quarter of 2022 ended March 31, 2022.\nFiscal Q2 2022 Business Highlights and Subsequent Developments\nEngaged global clinical research organization (CRO) to expand Mino-Lok® Phase 3 trial to include additional trial sites outside the U.S.;Reported topline results of Phase 3 trial of I/ONTAK (E7777) with no new safety signals and consistent with prior formulation (ONTAK); biologics license application (BLA) submission on track for the second half of 2022; and,Initiated Halo-Lido Phase 2b trial with first patient dosed in April 2022 and anticipated enrollment completion by end of 2022.Financial Highlights\nCash and cash equivalents of $55.8 million as of March 31, 2022;R&D expenses were $3.5 million and $8.9 million for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the three and six months ended March 31, 2021, respectively;G&A expenses were $3.1 million and $6.0 million for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $ 4.0 million for the three and six months ended March 31, 2021, respectively;Stock-based compensation expense was $1.0 million and $1.9 million for the three and six months ended March 31, 2022, respectively, compared to $0.3 million and $0.6 million for the three and six months ended March 31, 2021, respectively; and,Net loss was $7.6 million and $16.8 million, or ($0.05) and ($0.11) per share for the three and six months ended March 31, 2022, respectively, compared to a net loss of $4.1 million and $12.3 million, or ($0.04) and ($0.16) per share for the three and six months ended March 31, 2021, respectively.\"We continue to make significant progress with our three clinical develo...