SALT LAKE CITY, March 10, 2026 /PRNewswire/ -- Lipocine Inc. $(LPCN)$, a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the full year ended December 31, 2025 and provided a corporate update.
"We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we've made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team's commitment to delivering more effective treatments for patients in need," said Dr Mahesh Patel, Lipocine President and CEO. "We're excited about the near-term milestones ahead and remain committed to advancing our pipeline proficiently."
Neuroactive Steroids (NAS)
LPCN 1154 for Postpartum Depression $(PPD)$
-- Lipocine is developing LPCN 1154, a rapid onset, short treatment duration
oral product candidate comprising the neuroactive steroid brexanolone for
the treatment of postpartum depression.
-- The last patient completed the final study visit (Last Patient/Last
Visit) in a confirmatory Phase 3 safety and efficacy study evaluating
LPCN 1154 as a treatment for PPD in February 2026. The study enrolled 90
patients in total and top line results are expected early in April 2026.
-- If successful, the Phase 3 trial is expected to support a global
registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug
Application (NDA) submission in the U.S. which is expected in mid-2026.
LPCN 2201 for Major Depressive Disorders (MDD)
-- Lipocine is advancing LPCN 2201, a unique oral brexanolone formulation,
as a novel, rapid relief oral treatment option for MDD with the goal of
improving outcomes without the limitations of existing therapies. LPCN
2201 is chemically identical to the endogenous human hormone
allopregnanolone, a positive allosteric modulator of y-aminobutyric acid
(GABAA) receptor.
LPCN 2101 for Epilepsy
-- Lipocine is developing LPCN 2101, a neuroactive steroid GABA positive
allosteric modulator for epilepsy, including drug resistant epilepsy
$(DRE)$ and women with epilepsy (WWE), both of which pose significant
treatment challenges under current standard of care.
-- Two posters related to LPCN 2101 were presented at the 2025 American
Epilepsy Society $(AES)$ Annual Meeting that took place in December
2025 in Atlanta, Georgia.
-- Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating
Neuroactive Steroid (NAS) Anti-seizure Medication $(ASM)$ Candidate
for Women with Epilepsy (WWE)
-- Clinical Pharmacokinetics $(PK)$ and Tolerability of a Novel Oral
GABAA Receptor Positive Allosteric Modulating $(PAM)$ Candidate for
Epilepsy
-- Based on FDA review of the protocol and agreement to proceed, the Company
plans to initiate a Phase 2 proof-of-concept study to evaluate the safety,
tolerability, and efficacy of LPCN 2101, subject to resource
prioritization. Pre-clinical and Phase 1 studies have demonstrated
promising PK results, safety and tolerability.
LPCN 2401 for Obesity Management
-- LPCN 2401 is targeted to be a once daily oral formulation comprising a
proprietary anabolic androgen receptor agonist. It is expected to have a
favorable benefit to risk profile as a non-invasive option for use as an
adjunct to GLP-1 receptor agonist chronic weight management therapies
and/or as a monotherapy post cessation of GLP-1 receptor agonist weight
management therapies with demonstrated benefits to the liver.
-- Pending further regulatory guidance, Lipocine may conduct a
proof-of-concept Phase 2 study for LPCN 2401 in elderly obese and
overweight GLP-1 eligible patients, with possible appropriate body
composition and functional endpoints
-- Lipocine may explore the possibility of partnering LPCN 2401 with a third
party.
TLANDO$(TM)$
-- Lipocine has an exclusive License Agreement with Verity Pharma, entered
into in 2024, under which Verity Pharma has the rights to market TLANDO,
its oral testosterone replacement therapy, in the United States and
Canada, if approved.
-- Also in 2024, Lipocine entered into a distribution and license agreement
with SPC Korea Limited for the development and commercialization of
TLANDO for TRT in South Korea and Lipocine signed an exclusive supply and
distribution agreement with Pharmalink to commercialize TLANDO in the
Gulf Cooperation Council $(GCC)$ countries. In 2025, Lipocine entered into
a license and supply agreement with Aché in Brazil. The Company is
exploring further partnerships for TLANDO outside of North America, South
Korea, the GCC countries and Brazil.
Full year Ended December 31, 2025, Financial Results
As of December 31, 2025, Lipocine had $14.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million as of December 31, 2024.
Lipocine reported a net loss of $9.6 million, or ($1.69) per diluted share, for the year ended December 31, 2025, compared with net income of $8,352, or ($0.00) per diluted share, for the year ended December 31, 2024.
Revenues were $2.0 million during the year ended December 31, 2025, compared to revenue of $11.2 million during the year ended December 31, 2024. Revenue in 2025 primarily consisted of license revenue from the Company's licenses with Verity and Aché of $1.5 million, and royalty revenue from TLANDO sales of $480,000. Revenue in 2024 primarily consisted of $10.9 million in license revenue from licenses with Verity, SPC and Pharmalink and royalty revenue from TLANDO sales of $298,000.
Research and development expenses were $8.6 million and $7.4 million, respectively, for the years ended December 31, 2025 and 2024. The increase in research and development expenses during the year ended December 31, 2025 primarily related to an increase in clinical study costs, in addition to other increases in supplies and research costs and in personnel-related costs.
General and administrative expenses were $3.8 million and $5.0 million, respectively, for the years ended December 31, 2025 and 2024. The decrease in general and administrative expenses during the year ended December 31, 2025 was primarily due to a decrease in business development, strategic advisory services and corporate legal fees, a decrease in estimated franchise taxes, a decrease in other various professional fees, and a decrease in corporate insurance expense, offset by an increase in personnel related expenses, an increase in patent related fees and an increase in other general and administrative expenses.
Interest and investment income was $0.7 million and $1.2 million for the years ended December 31, 2025 and 2024, respectively. The decrease in interest and investment income during the year ended December 31, 2025 was mainly due to declining cash and marketable investment securities balances in 2025 compared to 2024.
As of March 6, 2026, the Company had unrestricted cash, cash equivalents and marketable investment securities of approximately $24.7 million. The higher balance compared with the balance at December 31, 2025 was primarily a result of the sale of shares of common stock by means of an "At the Market ("ATM") Offering" under a sales agreement with A.G.P./Alliance Global Partners ("A.G.P") entered into in April 2024.
For further details on Lipocine's financial results from the year ended December 31, 2025, refer to Form 10K filed with the SEC.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.
Lipocine's development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.
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