Full Press Release Details
Lipocine to Host Virtual KOL Event Highlighting Unmet Needs in Postpartum
Depression and the Clinical Profile of LPCN 1154
webinar to take place on Friday, June 12, 2026 at 11:00 AM Eastern Time
LAKE CITY, Utah, June 4, 2026 - Lipocine Inc. (Nasdaq: LPCN), a specialty pharmaceutical company focused on the development
of novel oral therapeutics, today announced that it will host a virtual Key Opinion Leader (KOL) event on Friday, June 12, 2026 at
11:00 AM Eastern Time. The event will bring together leading physicians with deep expertise in postpartum depression (PPD) to discuss
the continued clinical unmet needs in PPD and the emerging clinical profile of LPCN 1154 (BRLIZIO ), Lipocine's investigational
oral brexanolone, as a potential differentiated treatment option for women with PPD.
presentations will include a review of the current PPD treatment landscape, persistent gaps in care despite recent therapeutic approvals,
and the Phase 3 topline results for LPCN 1154. The KOLs will provide their perspectives on the clinical relevance of the data and how
the findings may inform the potential positioning of LPCN 1154 within the PPD and broader depression treatment paradigms.
management presenting at the event will include Mahesh V. Patel, Ph.D., President and Chief Executive Officer, and Benjamin
Bruno, Ph.D., Vice President of Clinical Development.
Q&A session will follow the formal presentations.
| Date: | Friday, June 12, 2026 |
| Time: | 11:00 AM Eastern Time |
| Format: | Virtual webcast with slides |
| Registration: | Advance registration is required. Click here to register. |
wishing to submit questions in advance of the live Q&A session may do so by emailing questions@lifesciadvisors.com.
replay of the event will be available on the "events" page of the Lipocine corporate website.
M. Deligiannidis, MD received her medical degree from and completed her psychiatry residency and chief residency in psychopharmacology
research at the University of Massachusetts Medical School. Prior to and during medical school she trained in neuroscience research at
the National Institutes of Health (NIH). After residency she completed additional research training in behavioral endocrinology and experimental
therapeutics at the NIH and in multimodal neuroimaging at the Martinos Center for Biomedical Imaging at Mass General Hospital. Dr. Deligiannidis
is the Director of Women's Behavioral Health at Zucker Hillside Hospital, Northwell Health and a Professor of Psychiatry, Molecular
Medicine and Obstetrics and Gynecology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. As a reproductive psychiatrist,
she has expertise in treating women with mood and anxiety disorders linked to the menstrual cycle, perinatal and perimenopausal periods.
Dr. Deligiannidis is a nationally recognized leader in the field of perinatal depression and in novel therapeutics research. Her research
program includes a focus in neurosteroids and hormones, and multimodal neuroimaging. Dr. Deligiannidis's research is supported
by NIH, foundation, donor and industry funding. For the past decade she served as a principal investigator on the series of clinical
trials that led to the FDA approval of two rapid-acting antidepressants for postpartum depression. Dr. Deligiannidis is a current Board
of Directors member and President Elect for the Marc of North America, past Council member of the Society of Biological Psychiatry,
past Board of Directors member for the American Society of Clinical Psychopharmacology and currently is a full member of the American
College of Neuropsychopharmacology. Dr. Deligiannidis also serves as a reviewer on over 20 scientific journals and on Editorial Boards
of national and international journals.
Jain, MD, MPH is a clinical professor in the Department of Psychiatry at the Texas Tech University Health Sciences Center School
of Medicine - Permian Basin in Midland. He is also in private practice in Austin, TX. Dr. Jain attended medical school at the University
of Calcutta in India. He then attended graduate school at The University of Texas Health Science Center at Houston (UTHealth Houston)
School of Public Health, where he was awarded a National Institute/Center for Disease Control Competitive Traineeship. He graduated from
the School of Public Health in 1987 with a masters of public health degree. He served a 3-year residency in psychiatry in the Department
of Psychiatry and Behavioral Sciences at UTHealth Houston McGovern Medical School. He followed that by obtaining further specialty training,
by undergoing a 2-year fellowship in child and adolescent psychiatry. In addition, Dr. Jain completed a postdoctoral fellowship in research
psychiatry at The University of Texas Mental Sciences Institute in Houston. He was awarded the National Research Service Award for the
support of this postdoctoral fellowship. Dr. Jain has been involved with more than 100 research projects studying the effects of medications
on the short- and long-term treatment of depression, anxiety, pain/mood overlap disorders, attention-deficit/hyperactivity disorder,
and psychosis in adult and child/adolescent populations. He is the author of 55 articles published in various journals and magazines,
such as the Journal of Psychiatric Research and The Journal of Clinical Psychiatry, among others, and he has presented more than 25 original
research posters at meetings for various professional societies, including the American Psychological Association, the American College
of Neuropsychopharmacology, the American Academy of Child and Adolescent Psychiatry, and the Psych Congress. He has also coauthored 6
books that range from patient education to cutting-edge neurobiologic findings in psychiatry and mental health. He serves on several
advisory boards that focus on drug development and disease state education. He also recently served as chair of the Psych Congress, held
in Las Vegas, NV, and has served as a member of the Steering Committee for the Psych Congress for several years.
LPCN 1154 (BRLIZIO )
1154 is an investigational oral formulation of brexanolone (allopregnanolone), an endogenous neuroactive steroid and potent positive
allosteric modulator (PAM) of the GABA receptor. LPCN 1154 is designed to deliver bioequivalent systemic exposure to intravenous
brexanolone (ZULRESSO ) via a convenient oral, at-home regimen over 48 hours, without the need for medical monitoring. The drug's
mechanism of action, validated through two FDA-approved therapies (ZULRESSO and ZURZUVAE ), is designed to provide rapid and
sustained antidepressant effects in women with PPD.
a Phase 3 randomized, placebo-controlled trial, LPCN 1154 demonstrated clinically meaningful and statistically significant efficacy across
multiple timepoints in a subgroup analysis excluding an identified epidemiologic outlier site. The drug was well tolerated, with 100%
of participants completing the dosing period and no treatment-related serious adverse events. LPCN 1154 is not yet approved by the FDA.
BRLIZIO is a brand name conditionally approved by the FDA.
Postpartum Depression
depression is a serious and potentially life-threatening condition affecting approximately 1 in 5 women following childbirth. In the
United States, an estimated 600,000 women are diagnosed with PPD annually, yet fewer than half of those diagnosed receive adequate pharmacological
treatment. PPD is associated with significant adverse outcomes for both mother and child, including impaired maternal-infant bonding,
increased risk of suicidal ideation, and long-term effects on child cognitive and behavioral development. Suicide is among the leading
causes of maternal mortality in the first year postpartum. The economic burden of untreated perinatal depression in the U.S. has been
estimated at $14.2 billion annually.
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.
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.
release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not historical facts regarding our development of LPCN 1154 and related
efforts with the FDA, the potential uses and benefits of LPCN 1154 on the treatment of PPD, the commercial potential for LPCN 1154, and
potential strategic opportunities. Investors are cautioned that all such forward-looking statements involve risks and uncertainties,
including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital
to complete the development processes for our product candidates or we may decide to allocate our available capital to other product
candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our assets, safety and efficacy
studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of
a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical
and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval
process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results
and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's
products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports
on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update
or revise publicly any forward-looking statements contained in this release, except as required by law.
further information:
(801) 994-7383, kf@lipocine.com;
(617) 430-7579, pkelleher@lifesciadvisors.com