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Lipocine Announces Second Quarter 2020 Financial and Operational Results
SALT LAKE CITY, Aug. 6, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Aug. 6, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter ended June 30, 2020 and provided a corporate update.\n\n \n \n \n \n \n \n\n \nSecond Quarter and Recent Corporate Highlights\nPresented clinical data on TLANDO™ at the American Urological Association (\"AUA\") Virtual Experience Impact of a New Oral Testosterone Undecanoate on Blood Pressure and Cardiovascular Risk A Novel Oral Testosterone Therapy Restores Testosterone to Eugonadal Levels Without Dose Titration Effects of a New Oral Testosterone Undecanoate (\"TLANDO\") on Liver Announced that the treatment potential of LPCN 1144 was demonstrated in a pre-clinical non-alcoholic steatohepatitis (\"NASH\") and hepatic fibrosis model Received FDA clearance on an Investigational New Drug (\"IND\") application for a Phase 2 clinical study with LPCN 1148 for the treatment of cirrhosis Received a decision from the U.S. Court of Appeals for the Federal Circuit affirming the decision of the United States Patent and Trademark Office (\"USPTO\") in the patent interference case between Lipocine and Clarus Therapeutics Inc. (\"Clarus\") Received decision from Chancery Court of Delaware dismissing the shareholder derivative action filed against Lipocine's board of directorsOngoing Activities and Upcoming Milestones\nTLANDO New Drug Application (\"NDA\") for use in adult males for conditions associated with hypogonadism under review by the U.S. Food and Drug Administration (\"FDA\") with a Prescription Drug User Fee Act (\"PDUFA\") target action date of August 28, 2020 LPCN 1144 Phase 2 LiFT (\"Liver Fat intervention with oral Testosterone\") Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic NASH subjects, has been initiated with enrollment continuing and top-line primary endpoint results expected by the end of 2020 Intellectual property infringement lawsuit against Clarus is on-going, including fact discovery and expert testimony, with the jury trial scheduled for February 2021Second Quarter Ended June 30, 2020 Financial ResultsLipocine reported a net loss of $6.4 million, or ($0.13) per diluted share, for the quarter ended June 30, 2020, compared with a net loss of $3.4 million, or ($0.14) per dilute...