On May 9, 2022 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Lipocine, MAY 9, 2022, View Source [SID1234613881]).
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Program Highlights
●TLANDO was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for hypogonadism and our licensee expects commercial launch in second quarter of 2022
●Lipocine is currently enrolling subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete by the end of the third quarter of 2022
●Lipocine has requested an End of Phase 2 meeting to discuss the Phase 3 study and confirmatory trial design for LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH")
●An open label extension ("OLE") study in non-cirrhotic NASH has been completed and topline results are expected in May 2022
Board Appointments
The company appointed Jill M. Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its board of directors in April 2022
First Quarter Ended March 31, 2022 Financial Results
Lipocine reported a net loss of $3.5 million or ($0.04 per diluted share), for the quarter ended March 31, 2022, compared with a net loss of $3.4 million, or ($0.04) per diluted share, in the quarter ended March 31, 2021.
Research and development expenses were $1.9 million for the quarter ended March 31, 2022, compared with $1.6 million for the quarter ended March 31, 2021. The increase in research and development expenses for the quarter ended March 31, 2022, was a result of increases in contract research organization expenses related to the ongoing Phase 2 clinical study for LPCN 1148, PK and food effect studies for LPCN 1107 and LPCN 1154, manufacturing scale up expenses for LPCN 1111, and an increase in personnel and other R&D expenses. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the LPCN 1144 LiFT Phase 2 clinical study and a decrease in costs related to TLANDO.
General and administrative expenses were $1.2 million for the quarter ended March 31, 2022, compared with $1.5 million for the quarter ended March 31, 2021. The decrease in general and administrative expenses for the quarter ended March 31, 2022, was primarily due to decreases in legal costs, personnel costs and other general and administrative costs. These decreases were offset by increases in professional fees related to various consulting and proxy solicitation services as well as an increase in corporate insurance expenses.
As of March 31, 2022, the company had $42.0 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million as of December 31, 2021.