Lipocine Announces 2019 Year End Financial and Operational Results

About this update from Lipocine Inc.

[{"type":"text","content":"SALT LAKE CITY, March 13, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, today announced financial results for the year ended December 31, 2019, and provided a corporate update.\n\n \n \n \n \n \n \n\n \nFourth Quarter and Recent Corporate Highlights\nResubmitted the New Drug Application (\"NDA\") in February 2020 for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy (\"TRT\") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The NDA resubmission was made following a Post Action Meeting with the U.S. Food and Drug Administration (\"FDA\") to discuss a potential path forward for TLANDO. The NDA incorporates the reanalysis of existing data based on written feedback from the FDA to address the deficiency from the Complete Response Letter (\"CRL\") received from the FDA in November 2019. The FDA has assigned a Prescription Drug User Fee Act (\"PDUFA\") goal date of August 28, 2020. Continued to actively enroll in the ongoing LPCN 1144 LiFT (\"Liver Fat intervention with oral Testosterone\") Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic non-alcoholic steatohepatitis (\"NASH\") patients. Top-line liver fat reduction data, as measured by MRI-PDFF at 12 weeks, are expected in the second half of 2020, followed by 36-week biopsy data which are expected by the first half of 2021.Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020. Raised $6.0 million in gross process in a public offering of common stock and warrants in November 2019.\"We are pleased that the FDA has assigned a new PDUFA date for TLANDO and are committed to working with the Agency towards the goal of achieving approval of TLANDO,\" said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. \"Based on the recent Post Action Meeting and subsequent written feedback, the FDA has indicated our approach to addressing the deficiency from the most recent CRL appears to be a reasonable path forward. In parallel, we continue to develop LPCN 1144 for the treatment of NASH and look forward to announcing top line liver fat data from the ongoing LiFT clinical study in the second half of 2020.\" \nYear Ended December 3...

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