On March 9, 2022 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on neuroendocrine and metabolic disorders, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Lipocine, MAR 9, 2022, View Source [SID1234609755]).

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Clinical Program Highlights
LPCN 1148

Initiated a Phase 2 proof-of-concept clinical study evaluating LCPN 1148 for the management of decompensated liver cirrhosis in patients on the transplant waitlist
We currently expect enrollment in the Phase 2 study to be complete by the end of the second or third quarter of 2022 and top-line 24-week results by the end of 2022 or during the first quarter of 2023.
LPCN 1144

In August 2021, Lipocine announced positive topline 36-week results from its Phase 2 proof of concept LiFT ("Liver Fat intervention with oral Testosterone") clinical study investigating LPCN 1144 in men with biopsy-confirmed NASH. Key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and/or fibrosis improvement.
Lipocine held a Type C meeting with the U.S. Food and Drug Administration ("FDA") to discuss the clinical development path for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH"). The FDA suggested a Phase 3 trial with a primary multicomponent surrogate endpoint and indicated a study duration of 72 weeks would be adequate for seeking approval under an accelerated pathway, if successful.
TLANDO

Lipocine entered into a license agreement with Antares Pharma in 2021 to commercialize TLANDO in the U.S.
The FDA accepted a New Drug Application ("NDA") resubmission for TLANDO (testosterone undecanoate) and designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act ("PDUFA").
Neuroactive Steroids

The FDA has cleared an investigational new drug ("IND") application to conduct a Phase 2 proof of concept study of LPCN 1154, an oral endogenous neuroactive steroid ("NAS") product candidate, in postpartum depression.
An IND application is planned to be filed with the FDA in the second quarter of 2022 for LPCN 2101 to conduct and IND opening proof-of-concept study in women with epilepsy of childbearing age.
Year Ended December 31, 2021 Financial Results
Lipocine reported a net loss of $634,399, or ($0.01) per diluted share, for the year ended December 31, 2021, compared with a net loss of $21 million, or ($0.38) per diluted share, in the year ended December 31, 2020.

Lipocine recognized revenue of $16.1 million during the year ended December 31, 2021, compared to no revenue during the year ended December 31, 2020. Revenue in 2021 primarily related to licensing fees, minimum royalties and the sale of finished goods materials we received in accordance with the Antares Licensing Agreement for TLANDO which was signed on October 14, 2021.

Research and development expenses were $7.7 million for the year ended December 31, 2021, compared with $9.7 million for the year ended December 31, 2020. The decrease in research and development expenses during the year ended December 31, 2021 was primarily due a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, as well as decreases in other R&D expenses. These decreases were offset by increases in costs related to LPCN 1154, LPCN 1148 and LPCN 1107.

General and administrative expenses were $5.3 million for the year ended December 31, 2021, compared with $8.2 million for the year ended December 31, 2020. The decrease in general and administrative expenses during the year ended December 31, 2021 was primarily due to decreases in legal costs and personnel costs, offset by an increase in corporate insurance expenses and in other general and administrative expenses.

Lipocine recorded an expense of $4.0 million on litigation settlement during 2021 related to the Global Agreement with Clarus to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies. There was no comparable litigation settlement expense in 2020.

As of December 31, 2021, Lipocine had $44.6 million of unrestricted cash, cash equivalents, and marketable investments, compared to $19.7 million of unrestricted cash, cash equivalents and marketable investment securities as of December 31, 2020.