Business
Citius Pharmaceuticals, Inc. Reports Second Fiscal Quarter 2021 Financial Results and Provides General Business Update
Raised gross proceeds of $96.5 million from financing activities during the quarter providing financial runway into 2023 $103.7 million in cash and cash
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Raised gross proceeds of $96.5 million from financing activities during the quarter providing financial runway into 2023\n $103.7 million in cash and cash equivalents as of March 31, 2021 to support clinical development and business growth\n Advanced four pipeline programs, including the Mino-Lok® Phase 3 superiority trial despite challenges recruiting subjects due to COVID-19\n\n\nCRANFORD, N.J., May 13, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR) today reported financial results for the second fiscal quarter of 2021 and provided a general business update.\n\"The Citius team is focused on advancing a growing pipeline of first-in-class treatment options that have the potential to transform the current standards of care for patients around the world. We believe our near-term milestones, including an upcoming meeting with the Drug Monitoring Committee (DMC) for our lead product candidate, Mino-Lok®, will continue to drive momentum. Although COVID-19 slowed enrollment in the Mino-Lok® Phase 3 pivotal superiority trial, we remain on track to meet our milestones for the upcoming DMC meeting, which will clarify our clinical path forward. Our expectation, currently, is that we will file an NDA for Mino-Lok® in 2022, at which time Mino-Lok®'s Fast Track designation would make it eligible for expedited review,\" stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.\n\"In parallel, we continue to advance our other clinical and pre-clinical programs. The U.S. Food and Drug Administration (FDA) guided us in developing a patient reported outcome (PRO) tool as the primary endpoint to assess clinical outcomes and efficacy for Halo-Lido. We have now submitted the PRO for FDA review and are awaiting feedback. Importantly, we remain focused on supporting our pre-clinical programs: a novel stem cell therapy to treat Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients, and Mino-Wrap, an anti-microbial film to prevent infection associated with post-mastectomy breast implants in cancer patients. Preparations are currently underway for in vitro studies for Mino-Wrap. Additionally, based on guidance from the FDA on our proprietary stem cell program, we are engaged in preclinical work, including the creation of an accession cell bank, development of a cGMP...