Lipocine Reports Q1 2024 Financial Results

Lipocine Inc., a biopharmaceutical company listed on NASDAQ under the symbol LPCN, has announced its financial results for the first quarter ending March 31, 2024, alongside key corporate updates. Here are the highlights:

LPCN 1154 for Postpartum Depression
Lipocine has completed dosing subjects for a pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154, an oral form of brexanolone. The FDA has approved Lipocine's proposal to establish the drug's efficacy via a pivotal PK bridge to an approved IV infusion of brexanolone through a 505(b)(2) NDA filing. Topline results from this pivotal study are expected late in the second quarter of 2024, with a potential NDA filing targeted for the end of the fourth quarter.

LPCN 1148 for Cirrhosis Management
In March 2024, Lipocine shared positive outcomes from a 52-week Phase 2 study of LPCN 1148 in patients with cirrhosis. The study successfully met its primary and secondary endpoints, showing that participants maintained an increase in Skeletal Muscle Index (SMI) over 52 weeks. The treatment was associated with fewer overt hepatic encephalopathy (OHE) events and an extended time to the first recurrent OHE event. Moreover, LPCN 1148 was well-tolerated, with adverse events similar to those experienced by patients on a placebo.

LPCN 2401 for Obesity Management
In April 2024, results from a Phase 2 study evaluating LPCN 2401 for obesity management were announced. Findings showed significant improvements in body composition, including increased lean mass by 4.4% and decreased fat mass by 6.7%. Additionally, the study noted a reduction in android fat by 4.1% and an increase in bone mineral content by 2.8%. The treatment was well-tolerated with adverse events comparable to those of a placebo group. Lipocine sees potential for LPCN 2401 to be used in combination with incretin mimetics or as a monotherapy post-discontinuation.

LPCN 2203 for Essential Tremor
LPCN 2203, an oral GABA Positive Allosteric Modulator, is being developed to provide improved efficacy with fewer side effects such as somnolence and dizziness. Phase 1 studies have shown that LPCN 2203 achieves relevant blood levels with good tolerability and no reported incidences of somnolence, sedation, or dizziness.

TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR)
In January 2024, Lipocine signed an exclusive license agreement with Verity Pharma for the marketing of TLANDO in the United States and, pending approval, in Canada. The agreement includes a license fee of $11 million and potential development and sales milestones up to $259 million, alongside tiered royalty payments ranging from 12% to 18% on net sales in both regions.

Financial Results for Q1 2024
For the first quarter ending March 31, 2024, Lipocine reported a net income of $3.5 million, or $0.66 per diluted share, a significant improvement from a net loss of $3.9 million in the same period last year. Revenue for the first quarter was $7.6 million, primarily driven by licensing income from the Verity Agreement, compared to $0.06 million in the first quarter of 2023. Research and development expenses decreased slightly to $2.8 million, while general and administrative expenses rose to $1.6 million. As of March 31, 2024, the company had $24.6 million in unrestricted cash, cash equivalents, and marketable securities, up from $22.0 million at the end of December 2023.

About Lipocine
Lipocine Inc. specializes in developing oral therapeutics for CNS disorders using its proprietary technology platform. The company has several clinical candidates, including LPCN 1154 for postpartum depression, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, LPCN 2401 for obesity management, and LPCN 1148 for managing liver cirrhosis symptoms. The company's goal is to provide differentiated, patient-friendly oral delivery options that address significant unmet medical needs.

Lipocine continues to explore partnership opportunities for its drug candidates to enhance development and commercialization efforts.

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