Lipocine Inc.

Lipocine Inc. is a biopharmaceutical company that uses its own technology platform to create new products for delivering molecules orally that were previously difficult to administer. These delivery technologies aim to improve patient compliance and safety by offering oral treatment options. The company's main development programs focus on oral delivery solutions for drugs that are not easily absorbed by the body. Lipocine has a range of distinct product candidates designed to address significant unmet needs in neurological and psychiatric central nervous system (CNS) disorders, liver disease, and hormone supplementation for both men and women. On January 12, 2024, Lipocine entered into a license agreement with Gordon Silver Limited and Verity Pharmaceuticals, Inc. This agreement grants Verity an exclusive, royalty-bearing, and sublicensable right to commercialize TLANDO for testosterone replacement therapy (TRT) in the U.S. and Canada. TLANDO is an oral treatment for TRT in adult males with conditions related to a deficiency or absence of natural testosterone (primary or hypogonadotropic hypogonadism), and it contains testosterone undecanoate (TU). Verity is also responsible for any post-marketing studies required by the United States Food and Drug Administration (FDA). On January 31, 2024, Lipocine's previous license agreement with Antares Pharma, Inc. was terminated. The transfer of U.S. commercial rights for TLANDO from Antares to Verity for its distribution, marketing, and sale was completed on February 1, 2024. The Verity License Agreement also gives Verity a license to develop and commercialize LPCN 1111 (also known as TLANDO XR), which is the company's potential next-generation, once-daily oral product candidate for testosterone replacement therapy, containing testosterone tridecanoate (TT), in the U.S. and Canada.