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.
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