LPCN

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

Lipocine Announces Financial Results for the Third Quarter of 2026

SALT

LAKE CITY, November 5, 2026 — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced financial results for the third quarter ended September 30, 2026 and provided a corporate update.

Recent Developments and Corporate Update

LPCN

1154 (BRLIZIO™) for Postpartum Depression (PPD)

In September 2026, Lipocine announced the initiation of the BLOOM (Brexanolone Lifting Outcomes of Moms) study. The Phase 3 placebo-controlled outpatient study is expected to enroll approximately 120 participants with PPD and is designed to generate prospective efficacy and safety evidence to support a potential New Drug Application (NDA) under the 505(b)(2) pathway. Feedback from a recent meeting with the FDA, including the necessity of a positive and well-controlled Phase 3 trial, together with learnings from the prior Phase 3 trial, are incorporated into the BLOOM study design. Further, feedback from the FDA acknowledged that the NDA submission package presented to FDA appears complete to support 505(b)(2) NDA submission with the exception of the need for a single positive and well controlled Phase 3 trial.

●Lipocine continues to explore business partnerships for the development, approval and commercialization of BRLIZIO™ (LPCN 1154).

Other Neuroactive Steroid Programs

●LPCN

2201 for Major Depressive Disorder (MDD): Following planned clinical assessment of unique oral brexanolone formulations, Lipocine plans to submit a Phase 2 protocol to the FDA and may initiate a study of LPCN 2201 in MDD, subject to resource prioritization.

●LPCN

2203 for Essential Tremor (ET): Lipocine has completed oral pharmacokinetic studies of LPCN 2203 and plans to submit a protocol for a proof-of-concept Phase 2 study in essential tremor to the FDA. Any future studies of LPCN 2203 will be subject to resource prioritization.

TLANDO®

●In September 2026, Health Canada approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Verity Pharma, Lipocine’s partner in North America, is planning for launch in Canada in early 2027.

●In July 2026, Lipocine’s distribution partner Pharmalink received product marketing authorization approval in the United Arab Emirates for TESTYRA® (TLANDO). Pharmalink is planning for launch in the UAE in early 2027.

●Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries and Brazil.

Third Quarter Ended September 30, 2026 Financial Results

As of September 30, 2026, Lipocine had $21.5 million of unrestricted cash, cash equivalents and marketable investment securities, compared to $14.9 million at December 31, 2025. As of November 4, 2026, the Company had approximately $28.5 million of unrestricted cash, cash equivalents and marketable investment securities (unaudited).

Lipocine reported a net loss of $0.7 million, or ($0.08) per diluted share, for the quarter ended September 30, 2026, compared to a net loss of $3.2 million, or ($0.59) per diluted share, for the quarter ended September 30, 2025.

Lipocine recognized total revenue of $2.3 million during the quarter ended September 30, 2026, compared to $115,000 during the quarter ended September 30, 2025. Revenue for the third quarter of 2026 consisted of license and collaboration revenue of $2.1 million and royalty revenue from TLANDO sales of $190,000. Revenue for the third quarter of 2025 consisted entirely of royalty revenue from TLANDO sales.

Research and development expenses were $2.1 million and $2.7 million, respectively, for the quarters ended September 30, 2026 and 2025. The decrease primarily reflects lower costs related to the LPCN 2401 study, which was placed on hold in 2025, and lower LPCN 1154 clinical costs in 2026 compared with costs incurred for the prior Phase 3 study during the third quarter of 2025, partially offset by an increase in personnel costs.

General and administrative expenses were $1.1 million and $0.8 million, respectively, for the quarters ended September 30, 2026 and 2025. The increase primarily reflects higher personnel costs and higher legal fees related to protecting the Company’s intellectual property and promoting its corporate strategy.

Interest and investment income was $0.2 million for each of the quarters ended September 30, 2026 and 2025.

Nine Months Ended September 30, 2026 Financial Results

Lipocine reported a net loss of $7.0 million, or ($0.90) per diluted share, for the nine months ended September 30, 2026, compared to a net loss of $7.3 million, or ($1.35) per diluted share, for the nine months ended September 30, 2025.

Lipocine recognized revenue of $2.6 million and $831,000 during the nine months ended September 30

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