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Lipocine Announces First Quarter 2020 Financial and Operational Results
SALT LAKE CITY, May 7, 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, May 7, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.\n\n \n \n \n \n \n \n\n \nFirst Quarter and Recent Corporate Highlights\nResubmitted New Drug Application (\"NDA\") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy (\"TRT\") in adult males with hypogonadism The U.S. Food and Drug Administration (\"FDA\") acknowledged receipt of resubmission and established August 28, 2020 as the target Prescription Drug User Fee Act (\"PDUFA\") goal date Received FDA clearance on Investigational New Drug (\"IND\") application for Phase 2 clinical study with LPCN 1148 for the treatment of non-alcoholic steatohepatitis (\"NASH\") in cirrhotic patients Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020 Received 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 First Quarter Ended March 31, 2020 Financial ResultsLipocine reported a net loss of $5.8 million, or ($0.14) per diluted share, for the quarter ended March 31, 2020, compared with a net loss of $3.2 million, or ($0.14) per diluted share, for the quarter ended March 31, 2019.\nResearch and development expenses were $2.5 million for the quarter ended March 31, 2020, compared with $1.9 million for the quarter ended March 31, 2019. The increase in research and development expenses during the three months ended March 31, 2020 was primarily due to increased contract research organization and outside consulting and manufacturing costs for the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $1.7 million, a $50,000 increase in costs for TLANDO XR and a $56,000 increase in personnel expense. These increases were offset by a $1.2 million decrease in costs incurred relating to TLANDO, including the completion of the ABPM study and the filing of the NDA in the first half of 2019 and a $12,000 decrease in contract manufacturing costs for LPCN 1107.\nGeneral and administrative expenses were $2.1 ...