Lipocine Announces Financial Results for the 3rd Quarter Ended September 30, 2022.

SALT LAKE CITY: Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update.

"During the third quarter we announced a new strategic direction for Lipocine, which involves applying our validated technology to develop differentiated treatments for CNS disorders. Our initial focus is on endogenous neuroactive steroids which have broad applicability in treating various CNS conditions," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "Our most advanced neuroactive steroid ("NAS") candidate is LPCN 1154, which we are developing for the treatment of postpartum depression. We recently initiated a pilot PK bridge study (a prelude to a pivotal study required for NDA filing) and look forward to reporting results of the pilot study in the first half of 2023."

Third Quarter Highlights

Strategic realignment and focus on CNS

In September, Lipocine announced a strategic realignment and forward focus on treating CNS disorders. The Company's initial focus is to advance its pipeline of endogenous neuroactive steroids ("NAS") which have potential to treat various neuropsychiatric conditions.

Lipocine's CNS development portfolio includes LPCN 1154, a fast-acting oral antidepressant for postpartum depression ("PPD") with potential for outpatient use; LPCN 2101, with a novel mechanism of action, for women with epilepsy; and additional undisclosed CNS focused candidates.

The Company is exploring partnering its portfolio of non-core assets (LPCN 1144 for treatment of non-cirrhotic NASH, LPCN 1148 for decompensated liver cirrhosis, LPCN 1107 for prevention of pre-term birth, and LPCN 1111, a once-a-day therapy for TRT), consistent with our strategy designed to diversify risk and potentially create opportunities for non-dilutive financing.

Corporate

Appointed Spyros Papapetropoulos, M.D. Ph.D., as Lead Director and Chairman of the Board. Dr. Papapetropoulos has served on Lipocine's board since April 2022.

Appointed George Nomikos, M.D., Ph.D,. as Chief Medical Officer. Dr. Nomikos is an R&D scientist and psychiatry-trained clinician with extensive academic and industry experience in neuropsychiatric, neurometabolic, neurohormonal, neuromuscular and chronic pain therapeutics.

Third quarter Ended...