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May 13 , 2021 CITIUS PHARMA 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 equivalents as of March 31 , 2021 to support clinical development and business growth Advanced four pipeline programs , including the Mino - LokⓇ Phase 3 superiority trial despite challenges recruiting subjects due to COVID - 19 CRANFORD , 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 . " 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 . " 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 manufacturing process , and a proof - of - concept and dosing study in a large animal model . As we advance this program , we are mindful that this would be an important