Lipocine Announces Financial Results for the 2nd Quarter Ended June 30, 2022.

SALT LAKE CITY: Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Second Quarter Highlights

In June, Lipocine's commercial partner Halozyme launched TLANDO (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism).

In July 2022, Lipocine held an End of Phase 2 meeting with the FDA for LPCN 1144 in NASH. The FDA recommends Lipocine conduct a phase 2 dose ranging study to identify the optimal dose prior to conducting a pivotal study. The FDA agreed to the proposed unique testosterone ester, testosterone dodecanoate, for future clinical studies.

LPCN 1111: Technology transfer for our once-a-day testosterone product candidate was completed. Scale up and manufacturing of registration batches is ongoing.

Lipocine continues to enroll subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete in the second half of 2022.

A type C meeting was held with the FDA to discuss the clinical development path of LPCN 1154, our candidate for postpartum depression ("PPD"). Based on feedback from the meeting, the company plans to initiate a multi-dose proof-of-concept study of LPCN 1154 in the second half of 2022.

The FDA accepted the company's Investigational New Drug Application ("IND") for its neuroactive steroid ("NAS") candidate, LPCN 2101, as a potential treatment for adults with epilepsy. Lipocine plans to initiate a Phase 2 photosensitive epilepsy ("PSE") study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101 in women with epilepsy of childbearing age.

We continue to explore partnering LPCN 1111, LPCN 1144, LPCN 1107 and TLANDO ex-US to third parties.

Second Quarter Ended June 30, 2022 Financial Results

Lipocine reported a net loss of $2.6 million, or ($0.04) per diluted share for the quarter ended June 30, 2022, compared with a net loss of $6.8 million, or ($0.08) per diluted share, in the quarter ended June 30, 2021.

Revenues in the quarter ended June 30, 2022 were $0.5 million related to a non-refundable cash fee...

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