Lipocine Reports Q2 2024 Financial Results

Lipocine Inc., a biopharmaceutical firm based in Salt Lake City, has announced its financial results for Q2 2024, alongside significant corporate updates. Specializing in the development of therapeutics via effective oral delivery, Lipocine shared progress on several of its key drug candidates.

LPCN 1154 for Postpartum Depression (PPD)

In June 2024, Lipocine revealed encouraging results from a study on LPCN 1154, a treatment aimed at postpartum depression. The treatment showed no sedation or somnolence, making it well-tolerated among participants. The company plans to submit a New Drug Application (NDA) for LPCN 1154 by the end of 2024. LPCN 1154 is designed as a 48-hour oral treatment for postpartum depression, promising to be highly effective, fast-acting, and suitable for outpatient settings.

LPCN 2401 for Chronic Weight Management

April 2024 brought positive outcomes from a Phase 2 study evaluating LPCN 2401 for obesity management. The study indicated that LPCN 2401 significantly improved body composition, increasing lean mass and bone mineral content while reducing fat mass. Adverse effects, including gastrointestinal issues, were comparable to those experienced by the placebo group, and no muscle spasms were reported.

LPCN 2401 could potentially be combined with incretin mimetics, such as GLP-1/GIP agonists, to enhance their insulinotropic actions. This combination could lead to better body composition, quality weight loss, and significant abdominal fat loss, addressing an unmet need in weight management. Additionally, LPCN 2401 could serve as monotherapy after discontinuation of GLP-1 agonists, aiding in weight management and maintaining diabetes remission. Lipocine intends to discuss further development plans with the FDA.

LPCN 1148 for Management of Cirrhosis

In June 2024, Lipocine presented findings from a Phase 2 study on LPCN 1148 for cirrhosis at the European Association for the Study of Liver (EASL) Congress. The study met its primary and hepatic encephalopathy endpoints, showing LPCN 1148 was well-tolerated with adverse events similar to placebo. Lipocine continues to explore partnerships for further development and commercialization of its pipeline candidates.

Financial Results for Q2 2024

Lipocine reported a net loss of $3.1 million, or $0.56 per diluted share, for Q2 2024, compared to a $3.6 million net loss in Q2 2023. Revenues for Q2 2024 were approximately $90,000, stemming from royalty revenue under the Verity license agreement, with no comparable revenue in Q2 2023.

Research and development expenses were $1.9 million for Q2 2024, down from $2.5 million in Q2 2023. This decrease was attributed to reduced expenses in contract research, outside consulting, and personnel, offset by higher costs related to LPCN 1154 clinical studies.

General and administrative expenses were slightly higher at $1.5 million in Q2 2024, compared to $1.4 million in the same period the previous year.

As of June 30, 2024, Lipocine held $22.5 million in unrestricted cash, cash equivalents, and marketable investment securities, up from $22.0 million at the end of 2023.

Six-Month Financial Summary

For the first half of 2024, Lipocine reported a net profit of $0.5 million, or $0.10 per diluted share, a significant improvement from a net loss of $7.4 million for the same period in 2023. Revenues for the six months were $7.7 million, mainly from licensing revenue, compared to $55,000 in the first half of 2023.

Research and development expenses were $4.7 million for the first half of 2024, down from $5.6 million in the same period the previous year, due to decreased costs in various areas, offset by increased expenses for LPCN 1154 and TLANDO-related costs.

General and administrative expenses for the six months ended June 30, 2024, were $3.1 million, up from $2.7 million in the first half of 2023.

Lipocine Inc. remains focused on leveraging its proprietary technology to enhance therapeutic delivery and continues to seek partnerships for its diverse pipeline of drug candidates.

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