Business
Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2022 Financial Results and Provides Business Update
$48.0 million in cash and cash equivalents as of June 30, 2022 to support ongoing programs through August 2023 International sites for Mino-Lok® Phase 3 trial
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"$48.0 million in cash and cash equivalents as of June 30, 2022 to support ongoing programs through August 2023 \nInternational sites for Mino-Lok® Phase 3 trial engaged as recruitment accelerates\nI/ONTAK Biologics License Application (BLA) on track for 2H 2022 submission\nCRANFORD, N.J., Aug. 11, 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 third fiscal quarter of 2022 ended June 30, 2022.\nFiscal Q3 2022 Business Highlights and Subsequent Developments\nMino-Lok® Phase 3 trial recruitment approached pre-Covid-19 pace; international trial sites engaged to accelerate trial enrollment; Company reiterates 92 failure events required for trial completion;Halo-Lido Phase 2b trial initiated; enrollment completion anticipated by end of 2022;I/ONTAK (denileukin diftitox) topline results show no new safety signals and are consistent with prior formulation (ONTAK);Pre-BLA meeting held with the FDA for I/ONTAK; biologics license application (BLA) remains on track for submission in the second half of 2022; and,Announced intention to spinoff I/ONTAK into standalone oncology-focused publicly traded company.Financial Highlights\nCash and cash equivalents of $48.0 million as of June 30, 2022;R&D expenses were $4.9 million and $13.8 million for the three and nine months ended June 30, 2022, respectively, compared to $2.2 million and $9.9 million for the three and nine months ended June 30, 2021, respectively;G&A expenses were $3.0 million and $9.0 million for the three and nine months ended June 30, 2022, respectively, compared to $3.4 million and $ 7.4 million for the three and nine months ended June 30, 2021, respectively;Stock-based compensation expense was $1.0 million and $2.9 million for the three and nine months ended June 30, 2022, respectively, compared to $0.4 million and $1.0 million for the three and nine months ended June 30, 2021, respectively; and,Net loss was $8.9 million and $25.6 million, or ($0.06) and ($0.18) per share for the three and nine months ended June 30, 2022, respectively, compared to a net loss of $7.3 million and $19.5 million, or ($0.05) and ($0.20) per share for the three and nine months ended June 30...