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Lipocine Investor Room Lipocine Announces Financial Results for the Second Quarter Ended June 30 , 2021 SALT LAKE CITY , Aug. 5 , 2021 / 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 , 2021 , and provided a corporate update . Recent Corporate Highlights • Announced positive topline results from the Phase 2 LiFT ( " Liver Fat intervention with oral Testosterone " ) clinical study , investigating LPCN 1144 in biopsy - confirmed NASH male subjects • 36 - week biopsy data from the LiFT clinical study are expected in August 2021 • Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 • Clinical data from the LiFT clinical study were presented at The International Liver Congress ™ 2021 , the annual meeting of the European Association for the Study of the Liver ( " EASL " ) , Digital Event , which took place June 23-26 , 2021 • Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects • Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects • LPCN 1144 was shown to improve body composition in biopsy - confirmed NASH patients • The U.S. Food and Drug Administration ( " FDA " ) cleared the Company's Investigational New Drug Application ( " IND " ) to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154 , an oral neuro - steroid product candidate , for the treatment of postpartum depression ( " PPD " ) in adults • Top - line results from an ongoing pharmacokinetic ( " PK " ) study to assess dose proportionality are expected in the third quarter of 2021 • Following the PK study , a proof - of - concept study to evaluate the safety , tolerability , and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021 • Entered into a global settlement agreement with Clarus Therapeutics Inc. ( " Clarus " ) to resolve all outstanding claims in the on - going intellectual property litigation between Lipocine and Clarus , as well as the on - going interference proceeding between the two companies • Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA • Expect the first subject will be dosed in the proof - of - concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021 Second Quarter Ended June 30 , 2021 Financial Results Lipocine reported a net loss of $ 6.8 million , or ( $ 0.08 ) per diluted share , for the second quarter ended June 30 , 2021 , compared with a net loss of $ 6.4 million , or ( $ 0.13 ) per diluted share , for the second quarter ended June 30 , 2020 . Research and development expenses were $ 1.5 million for the second quarter ended June 30 2021 , compared with $ 2.3 million for the second quarter ended June 30 , 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects , a decrease in costs associated with TLANDO and a decrease in personnel expense , which was mainly due to a decrease in stock compensation and bonus expense . These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107 , as well as increases in other R & D expenses . General and administrative expenses were $ 1.5 million for the second quarter ended June 30 , 2021 , compared with $ 2.0 million for the second quarter ended June 30 , 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs , which was mainly due to a decrease in stock compensation and bonus expense , and a decrease in legal expenses . These decreases were offset by increases in corporate insurance and other general and administrative expenses . As of June 30 , 2021 , the Company had $ 46.6 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 . Six Months Ended June 30 , 2021 Financial Results Lipocine reported a net loss of $ 10.2 million , or ( $ 0.12 ) per diluted share , for the six months ended June 30 , 2021 , compared with a net loss of $ 12.1 million , or ( $ 0.27 ) per diluted share , for the six months ended June 30 , 2020 . Research and development expenses were $ 3.0 million for the six months ended June 30 , 2021 , compared with $ 4.8 million for the six months ended June 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 the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects , a decrease in costs associated with TLANDO and a net decrease in personnel expense , which was mainly due to a decrease in stock compensation expense offset by increases in salaries . These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107 , as well as increases in other R & D expenses . General and administrative expenses were $ 3.1 million for the six months ended June 30 , 2021 , compared with $ 4.0 million for the six months ended June 30 , 2020. The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs , mainly due a reduction in stock compensation expense . These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses . About Lipocine Inc. Lipocine Inc. is a clinical - stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies . Lipocine's clinical development pipeline includes : TLANDO , LPCN 1144 , TLANDO XR , LPCN 1148 , LPCN 1154 , and LPCN 1107. TLANDO , a novel oral prodrug of testosterone containing testosterone undecanoate , has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone , also known as hypogonadism , in adult males . LPCN 1144 , an oral prodrug of bioidentical testosterone , recently completed a proof - of- concept clinical study demonstrating the potential utility in the treatment of non - cirrhotic NASH . LPCN 1144 is currently being studied in a Phase 2 clinical