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Lipocine Investor Room Lipocine Announces Financial Results for the Third Quarter Ended September 30 , 2021 SALT LAKE CITY , Nov. 10 , 2021 / PRNewswire / -- Lipocine Inc. ( NASDAQ : LPCN ) , a clinical - stage biopharmaceutical company focused on metabolic and endocrine disorders , today announced financial results for the third quarter and nine months ended September 30 , 2021 , and provided a corporate update . Third Quarter and Recent Corporate Highlights • Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US • Lipocine to receive up to $ 21.0 million in licensing fees , including $ 11.0 million payable immediately and $ 10.0 million to be paid in the future subject to certain conditions • Lipocine is entitled to commercial sales milestone payments of up to $ 160.0 million and tiered royalties on net sales of TLANDO from mid - teens up to 20 % • Antares Pharma to undertake all commercialization , post - marketing study obligations , and sourcing of TLANDO in the U.S. • Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ( $ 4.0 million ) , clinical and regulatory milestone payments ( $ 35.0 million ) , sales milestone payments and royalties ( mid - teens up to 20 % ) • The U.S. Food and Drug Administration ( " FDA " ) granted Fast Track Designation to LPCN 1144 for the treatment of non - cirrhotic non - alcoholic steatohepatitis ( " NASH " ) • The FDA has affirmed that the resubmission of the New Drug Application ( " NDA " ) for TLANDO will be a Class 1 resubmission , with a two - month FDA review goal period • The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone : primary hypogonadism ( congenital or acquired ) and hypogonadotropic hypogonadism ( congenital or acquired ) • The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA's Orange Book listed exclusivity period previously granted to Clarus Therapeutics , Inc. with respect to JatenzoⓇ , which expires on March 27 , 2022 • Announced positive topline 36 - week results from its Phase 2 proof - of - concept Liver Fat intervention with oral Testosterone ( " LiFT " ) clinical study , NCT04134091 , investigating LPCN 1144 in men with biopsy - confirmed NASH • Study met its primary endpoint . At 12 weeks , treatment with LPCN 1144 resulted in statistically significant liver fat reduction , assessed by MRI- PDFF • Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis • Efficacy and safety results from the LiFT study have been accepted for late - breaking presentations at the American Association for the Study of Liver Diseases ( " AASLD " ) The Liver MeetingⓇ on November 12-15 , 2021 • Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements Third Quarter Ended September 30 , 2021 Financial Results Lipocine reported a net loss of $ 3.1 million , or ( $ 0.03 ) per diluted share , for the third quarter ended September 30 , 2021 , compared with a net loss of $ 4.3 million , or ( $ 0.07 ) per diluted share , for the third quarter ended September 30 , 2020 . Research and development expenses were $ 2.4 million for the third quarter ended September 30 , 2021 , compared with $ 2.5 million for the third quarter ended September 30 , 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO . These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs . General and administrative expenses were $ 1.2 million for the third quarter ended September 30 , 2021 , compared with $ 1.9 million for the third quarter ended September 30 , 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense . As of September 30 , 2021 , the Company had $ 38.7 million of unrestricted cash , cash equivalents , and marketable investments , compared to $ 19.7 million of unrestricted cash , cash equivalents and marketable investment securities as of December 31 , 2020 . Subsequent to the end of the third quarter , the Company received an $ 11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO . Nine Months Ended September 30 , 2021 Financial Results Lipocine reported a net loss of $ 13.3 million , or ( $ 0.15 ) per diluted share , for the nine months ended September 30 , 2021 , compared with a net loss of $ 16.5 million , or ( $ 0.32 ) per diluted share , for the nine months ended September 30 , 2020 . Research and development expenses were $ 5.4 million for the nine months ended September 30 , 2021 , compared with $ 7.3 million for the nine months ended September 30 , 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study , a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense . These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs . General and administrative expenses were $ 4.3 million for the nine months ended September 30 , 2021 , compared with $ 5.9 million for the nine months ended September 30 , 2020. The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense . These decreases were offset by an increase in corporate insurance expense .