On May 8, 2020 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, Lipocine, MAY 8, 2020, View Source [SID1234557403]).

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First Quarter and Recent Corporate Highlights

Resubmitted New Drug Application ("NDA") for TLANDO, the Company’s oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males with hypogonadism
The U.S. Food and Drug Administration ("FDA") acknowledged receipt of resubmission and established August 28, 2020 as the target Prescription Drug User Fee Act ("PDUFA") goal date
Received FDA clearance on Investigational New Drug ("IND") application for Phase 2 clinical study with LPCN 1148 for the treatment of non-alcoholic steatohepatitis ("NASH") in cirrhotic patients
Raised $6.0 million in gross proceeds in a registered direct offering of common stock and warrants in February 2020
Received decision from the U.S. Court of Appeals for the Federal Circuit affirming the decision of the United States Patent and Trademark Office ("USPTO") in the patent interference case between Lipocine and Clarus Therapeutics
First Quarter Ended March 31, 2020 Financial Results
Lipocine reported a net loss of $5.8 million, or ($0.14) per diluted share, for the quarter ended March 31, 2020, compared with a net loss of $3.2 million, or ($0.14) per diluted share, for the quarter ended March 31, 2019.

Research and development expenses were $2.5 million for the quarter ended March 31, 2020, compared with $1.9 million for the quarter ended March 31, 2019. The increase in research and development expenses during the three months ended March 31, 2020 was primarily due to increased contract research organization and outside consulting and manufacturing costs for the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $1.7 million, a $50,000 increase in costs for TLANDO XR and a $56,000 increase in personnel expense. These increases were offset by a $1.2 million decrease in costs incurred relating to TLANDO, including the completion of the ABPM study and the filing of the NDA in the first half of 2019 and a $12,000 decrease in contract manufacturing costs for LPCN 1107.

General and administrative expenses were $2.1 million for the quarter ended March 31, 2020, compared with $1.2 million for the quarter ended March 31, 2019. The increase in general and administrative expenses during the three months ended March 31, 2020 was primarily due to a $1.0 million increase in legal costs associated with the lawsuit filed against Clarus for patent infringement in April 2019 in addition to costs associated with interference cases filed against Clarus, offset by a $59,000 decrease in personnel costs and a $26,000 decrease in administrative travel expenses.

As of March 31, 2020, Lipocine had $15.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally, the Company 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. The Company believes that its existing capital resources will be sufficient to meet its projected operating requirements through at least February 15, 2021.