On November 10, 2020 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Lipocine, NOV 10, 2020, View Source [SID1234570640]).

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Third Quarter and Recent Corporate Highlights

Completed patient enrollment in the LPCN 1144 Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, a paired-biopsy study in confirmed pre-cirrhotic NASH subjects
Top-line results for change in liver fat data measured by MRI-PDFF (primary endpoint) expected in January 2021 and 36-week biopsy and MRI-PDFF data expected mid-2021
Announced the peer-reviewed publication of LPCN 1144 Liver Fat Study results, "LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease in Hypogonadal Males" in Hepatology Communications
Presented two abstracts at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America ("SMSNA")
A study on the potential use of oral testosterone in COVID-19 highlighted key clinical evidence suggesting that low testosterone levels may play an important role on clinical outcomes
Results from a 24-day, open-label, single-arm, multicenter study confirming the validity of a fixed dose approach to orally administering TLANDO in hypogonadal men without the need for dose titration.
Ongoing Activities and Upcoming Milestones

Presenting results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis ("NASH") features will be presented at The Liver Meeting Digital Experience, hosted by the American Association for the Study of Liver Diseases ("AASLD") on November 13, 2020
Announcing decision from U.S. Food and Drug Administration ("FDA") on the New Drug Application ("NDA") for TLANDO
Third Quarter Ended September 30, 2020 Financial Results
Lipocine reported a net loss of $4.3 million, or ($0.07) per basic and diluted share, for the quarter ended September 30, 2020, compared with a net loss of $3.1 million, or ($0.12) per basic and diluted share, in the quarter ended September 30, 2019.

Research and development expenses were $2.5 million for the quarter ended September 30, 2020, compared with $1.7 million for the quarter ended September 30, 2019. The increase in research and development expenses during the three months ended September 30, 2020 was primarily due to a $280,000 increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $278,000 increase in commercial manufacturing costs related to TLANDO, a $160,000 increase in personnel expense, as well as increases in other R&D expenses of $56,000.

General and administrative expenses were $1.9 million for the quarter ended September 30, 2020, compared with $1.4 million for the quarter ended September 30, 2019. The increase in general and administrative expenses during the three months ended September 30, 2020 was primarily due to a $259,000 increase in legal costs, a $240,000 increase in personnel costs, and a $4,000 increase in other general and administrative expenses. These increases were offset by a $28,000 decrease marketing expense and a $17,000 decrease in administrative travel expenses.

As of September 30, 2020, we had $18.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally, as of September 30, 2020 and December 31, 2019 we had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA.

Nine Months Ended September 30, 2020 Financial Results
Lipocine reported a net loss of $16.5 million, or ($0.32) per basic and diluted share, for the nine months ended September 30, 2020, compared with a net loss of $9.7 million, or ($0.40) per basic and diluted share, for the nine months ended September 30, 2019.

Research and development expenses were $7.3 million for the nine months ended September 30, 2020, compared with $5.6 million for the nine months ended September 30, 2019. The increase in research and development expenses during the nine months ended September 30, 2020 was primarily due to a $2.9 million increase in contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects, a $430,000 increase in personnel expense, and a $50,000 increase in other research and development expenses. These increases were offset by a $1.7 million decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of 2019, a $50,000 decrease in contract manufacturing costs for LPCN 1107, and a $46,000 decrease in costs for TLANDO XR.

General and administrative expenses were $5.9 million for the nine months ended September 30, 2020, compared with $4.0 million for the nine months ended September 30, 2019. The increase in general and administrative expenses during the nine months ended September 30, 2020 was primarily due to a $1.9 million increase in legal costs and a $228,000 increase in personnel costs. These increases were offset by a $77,000 decrease in administrative travel expense, a $68,000 decrease in marketing expense and a $43,000 decrease in other general and administrative expenses.