On November 10, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update (Press release, Lipocine, NOV 10, 2021, View Source [SID1234595156]).

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Third Quarter and Recent Corporate Highlights

Entered into a license agreement with Antares Pharma to commercialize TLANDO in the US
Lipocine to receive up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions
Lipocine is entitled to commercial sales milestone payments of up to $160.0 million and tiered royalties on net sales of TLANDO from mid-teens up to 20%
Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S.
Antares Pharma was also granted an option to license TLANDO XR for development and commercialization in the U.S. for additional licensing fees ($4.0 million), clinical and regulatory milestone payments ($35.0 million), sales milestone payments and royalties (mid-teens up to 20%)
The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to LPCN 1144 for the treatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH")
The FDA has affirmed that the resubmission of the New Drug Application ("NDA") for TLANDO will be a Class 1 resubmission, with a two-month FDA review goal period
The FDA previously granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
The product is not eligible for final approval and marketing in the U.S. until the expiration of the FDA’s Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022
Announced positive topline 36-week results from its Phase 2 proof-of-concept Liver Fat intervention with oral Testosterone ("LiFT") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH
Study met its primary endpoint. At 12 weeks, treatment with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF
Both LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis
Efficacy and safety results from the LiFT study have been accepted for late-breaking presentations at the American Association for the Study of Liver Diseases ("AASLD") The Liver Meeting on November 12-15, 2021
Company intends to meet with the FDA regarding the path forward for an accelerated approval and to discuss Phase 3 study requirements
Third Quarter Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $3.1 million, or ($0.03) per diluted share, for the third quarter ended September 30, 2021, compared with a net loss of $4.3 million, or ($0.07) per diluted share, for the third quarter ended September 30, 2020.

Research and development expenses were $2.4 million for the third quarter ended September 30, 2021, compared with $2.5 million for the third quarter ended September 30, 2020. The decrease for the third quarter of 2021 was primarily due to a decrease in contract research organization expense and outside consulting costs related to our LPCN 1144 LiFT clinical study as well as decrease costs related to TLANDO. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $1.2 million for the third quarter ended September 30, 2021, compared with $1.9 million for the third quarter ended September 30, 2020. The decrease in general and administrative was primarily related to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense.

As of September 30, 2021, the Company had $38.7 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.

Subsequent to the end of the third quarter, the Company received an $11.0 million upfront license fee as part of the licensing agreement with Antares Pharma to commercialize TLANDO.

Nine Months Ended September 30, 2021 Financial Results

Lipocine reported a net loss of $13.3 million, or ($0.15) per diluted share, for the nine months ended September 30, 2021, compared with a net loss of $16.5 million, or ($0.32) per diluted share, for the nine months ended September 30, 2020.

Research and development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $7.3 million for the nine months ended September 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 our LPCN 1144 LiFT clinical study, a decrease in costs related to TLANDO and a decrease in personnel costs primarily related to reduced stock compensation expense. These decreases were offset by increases in costs associated with our LPCN 1154 and LPCN 1148 programs.

General and administrative expenses were $4.3 million for the nine months ended September 30, 2021, compared with $5.9 million for the nine months ended September 30, 2020. The decrease in general and administrative expenses was primarily due to a decrease in our legal costs in 2021 as well as decreased personnel costs primarily related to reduced stock compensation expense. These decreases were offset by an increase in corporate insurance expense.