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.
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