On August 8, 2022 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Lipocine, AUG 8, 2022, View Source [SID1234617762]).

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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 received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. Antares’ option to license TLANDO XR expired on June 30, 2022 and was not exercised. There was no revenue in the comparable quarter of 2021.

Research and development expenses were $2.9 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The increase in research and development expenses for the quarter ended June 30, 2022, was a result of an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, increases in personnel expenses, and an increase in costs related to LPCN 1111 scale up and LPCN 1107 expenses. These increases were offset by a decrease in contract research organization expenses and outside consulting costs related to the completion of the LiFT Phase 2 clinical study in NASH subjects in 2021, a decrease in costs associated with TLANDO, as well as a decrease in other R&D expenses.

General and administrative expenses were $1.1 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses and personnel costs. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in corporate insurance expenses, and an increase in other general and administrative expenses.

As of June 30, 2022, the company had $37.4 million of unrestricted cash, cash equivalents and marketable investment securities, compared to $46.6 million at December 31, 2021.

Six Months Ended June 30, 2022 Financial Results

Lipocine reported a net loss of $6.1 million, or ($0.07) per diluted share, for the six months ended June 30, 2022, compared with a net loss of $10.2 million, or ($0.12) per diluted share, in the six months ended June 30, 2021.

Revenues in the six months ended June 30, 2022 were $0.5 million related to a non-refundable cash fee received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111, as described above. There was no revenue in the comparable period of 2021.

Research and development expenses for the six months ended June 30, 2022, were $4.8 million compared to $3.0 million for the comparable period in 2021. The increase in research and development expenses was due to an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, an increase related to LPCN 1111 scale up activities, a food effect study in LPCN 1107, and an increase in personnel expenses and other research and development costs. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1144 LiFT Phase 2 clinical study in NASH subjects in 2021, and a decrease in costs associated with TLANDO.

General and administrative expenses for the six months ended June 30, 2022 were $2.4 million compared to $3.1 million for the comparable period in 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses, personnel costs, and other general and administrative expenses. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in various other consulting fees, and an increase in corporate insurance expenses.