On August 5, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, Lipocine, AUG 5, 2021, View Source [SID1234586034]).

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Recent Corporate Highlights

Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
36-week biopsy data from the LiFT clinical study are expected in August 2021
Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
Clinical data from the LiFT clinical study were presented at The International Liver Congress 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021
Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
The U.S. Food and Drug Administration ("FDA") cleared the Company’s Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021
Second Quarter Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $6.8 million, or ($0.08) per diluted share, for the second quarter ended June 30, 2021, compared with a net loss of $6.4 million, or ($0.13) per diluted share, for the second quarter ended June 30, 2020.

Research and development expenses were $1.5 million for the second quarter ended June 30 2021, compared with $2.3 million for the second quarter ended June 30, 2020. The decrease was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a decrease in personnel expense, which was mainly due to a decrease in stock compensation and bonus expense. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $1.5 million for the second quarter ended June 30, 2021, compared with $2.0 million for the second quarter ended June 30, 2020. The decrease in general and administrative was primarily related to a decrease in personnel costs, which was mainly due to a decrease in stock compensation and bonus expense, and a decrease in legal expenses. These decreases were offset by increases in corporate insurance and other general and administrative expenses.

As of June 30, 2021, the Company had $46.6 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.

Six Months Ended June 30, 2021 Financial Results
Lipocine reported a net loss of $10.2 million, or ($0.12) per diluted share, for the six months ended June 30, 2021, compared with a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020.

Research and development expenses were $3.0 million for the six months ended June 30, 2021, compared with $4.8 million for the six months ended June 30, 2020. The decrease in research and development expenses was primarily due to a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 Phase 2 LiFT clinical study in NASH subjects, a decrease in costs associated with TLANDO and a net decrease in personnel expense, which was mainly due to a decrease in stock compensation expense offset by increases in salaries. These decreases were offset by an increase in costs related to LPCN 1154 and LPCN 1107, as well as increases in other R&D expenses.

General and administrative expenses were $3.1 million for the six months ended June 30, 2021, compared with $4.0 million for the six months ended June 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in legal costs and a decrease in personnel costs, mainly due a reduction in stock compensation expense. These decreases were offset by an increase in corporate insurance expenses and an increase in other general and administrative expenses.