Lipocine Reports Q3 2024 Financial Results

SALT LAKE CITY, Nov. 7, 2024 -- Lipocine Inc., a biopharmaceutical firm leveraging its unique technology platform to enhance therapeutics through effective oral delivery, today reported financial results for the third quarter and nine months ending September 30, 2024, along with a corporate update.

**Neuroactive Steroids**
LPCN 1154, an oral brexanolone, is being advanced as a treatment for postpartum depression (PPD). The aim is for LPCN 1154 to be an efficient, oral, fast-acting, and short-duration treatment. The company has finished labeling studies such as a food effect study and pharmacokinetic profiling in women with PPD and plans to submit a New Drug Application (NDA) for LPCN 1154 by the end of 2024.

In October, Lipocine shared positive outcomes from a quantitative electroencephalogram (qEEG) study in healthy subjects given single doses of LPCN 1154. The findings showed strong central nervous system (CNS) activity of LPCN 1154, with post-dose changes in qEEG that were concentration- and time-dependent. This study confirmed GABAA positive allosteric modulation and supports further development of LPCN 1154 for neuropsychiatric conditions.

**LPCN 2401 for Obesity Management**
LPCN 2401 is an oral formulation consisting of a proprietary anabolic androgen receptor agonist intended for once-daily use. In October, Lipocine held a virtual event with key opinion leaders (KOL) to discuss LPCN 2401. The event showcased positive data from the Phase 2 study, which supports the potential of LPCN 2401 to be used alongside incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post discontinuation of incretin mimetics.

Dr. Frank Greenway of Pennington Biomedical Research Center highlighted the unmet needs and current treatment landscape in obesity management, focusing on fat loss and lean muscle mass preservation for patients on incretin therapies. A poster titled "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring Phase 2 data was presented by Dr. Greenway at ObesityWeek® 2024 in San Antonio, TX. Lipocine plans to discuss the Phase 2 proof-of-concept study design for LPCN 2401 with the FDA and consider expanding to the female population.

**LPCN 1148 for Cirrhosis Management**
Lipocine is investigating LPCN 1148 for managing decompensated cirrhosis and has successfully completed a Phase 2 study that achieved its primary endpoint. The company intends to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148.

**TLANDO®**
In October, Lipocine signed a supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council countries, including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman. In September, the company signed an exclusive distribution and license agreement with SPC Korea to market TLANDO in South Korea. Lipocine is also exploring other opportunities for partnering and development of its remaining pipeline candidates.

**Third Quarter Financial Results**
Lipocine reported a net loss of $2.2 million or $0.44 per diluted share for the third quarter of 2024, compared to a net loss of $6.7 million or $1.27 per diluted share for the same period in 2023. No revenues were recorded during the third quarter of 2024, while the third quarter of 2023 saw a non-cash revenue reversal of $3.1 million related to the termination of the Antares License Agreement.

Research and development expenses were $1.6 million for Q3 2024, down from $2.9 million in Q3 2023, mainly due to reduced TLANDO-related costs and decreased expenses related to the wind-down of the LPCN 1148 study. General and administrative expenses remained steady at $1.0 million for both quarters.

As of September 30, 2024, Lipocine had $19.8 million in unrestricted cash, cash equivalents, and marketable investment securities, compared to $22.0 million at the end of 2023.

**Nine Months Financial Results**
For the nine months ending September 30, 2024, Lipocine reported a net loss of $1.8 million or $0.33 per diluted share, compared to a net loss of $14.1 million or $2.72 per diluted share for the same period in 2023. Revenues for the nine-month period in 2024 were $7.7 million, primarily from the Verity License Agreement and TLANDO royalty revenue, compared to a non-cash revenue reversal and other licensing revenues totaling $55,000 in 2023.

Research and development expenses were $6.3 million for the first nine months of 2024, down from $8.5 million in 2023, due to decreased expenses related to the LPCN 1148 study, TLANDO costs, and other research and development expenses. General administrative expenses increased to $4.1 million in 2024 from $3.8 million in 2023 due to higher business development expenses, corporate legal fees, and director fees, offset by reductions in corporate insurance, professional fees, and travel costs.