8-K
Lipocine Inc. (LPCN)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of Earliest Event Reported):
June 26, 2025
LIPOCINE
INC.
(Exact name of registrant as specified in its charter)
Commission
File No. 001-36357
| Delaware | 99-0370688 |
|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (IRS<br> Employer<br><br> <br>Identification<br> Number) |
675Arapeen Drive, Suite 202
SaltLake City, Utah 84108
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (801) 994-7383
Former
name or former address, if changed since last report: Not Applicable
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.0001 per share | LPCN | The<br> NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item8.01 Other Events
The Company issued a press release announcing that it has dosed its first patient in its Phase 3 clinical trial for LPCN 1154 in postpartum depression. The press release is filed as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits |
|---|
The following exhibits are filed with this report:
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Press Release announcing Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIPOCINE<br> INC. | |||
|---|---|---|---|
| Date: | June<br> 26, 2025 | By: | /s/ Mahesh V. Patel |
| Mahesh<br> V. Patel | |||
| President<br> and Chief Executive Officer |
Exhibit99.1
LipocineAnnounces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression
Phase3 Top Line Results Expected Q2 2026
SALT LAKE CITY, June 26, 2025 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).
Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider. The Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.
The trial is a two-arm, randomized, blinded study evaluating LPCN 1154 compared to placebo in women aged 15 years and older with severe PPD. The treatment regimen involves a 48-hour dosing period which was informed by the dosing in Lipocine’s successful PK bio-bridge study with injectable brexanolone. The study is being conducted at multiple clinical sites across the U.S.
The primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D), a widely recognized clinical measure of depression severity. Additional secondary endpoints include the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to assess anxiety symptoms, as well as key safety and tolerability measures. The trial size is powered based on the treatment effect observed with the FDA approved injectable brexanolone. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. For more information, refer to ClinicalTrials.gov ID NCT06979544.
“Given the unmet need for rapid relief, this Phase 3 trial is an important step in our development program to bring LPCN 1154 to women suffering from postpartum depression,” said Mahesh Patel, CEO of Lipocine. “By offering a novel bioidentical oral treatment with 48-hour treatment duration and expected robust efficacy, LPCN 1154 is designed to be a differentiated, rapid relief product with the potential to be the standard of care.”
VirtualInvestor Event on LPCN 1154
Lipocine will host a virtual research and development (R&D) investor event to discuss LPCN 1154 on Wednesday, July 9, 2025 at 11:00 AM ET. The event will feature Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who will join company management to discuss the current treatment landscape and unmet needs in PPD. The Company will provide a clinical, regulatory, and development update, including further details on the Phase 3 trial. To register, click here.
AboutLPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.
AboutPostpartum Depression and Unmet Needs
PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission post-acute treatment.
AboutLipocine
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 clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of refractory epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). 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.
Forward-LookingStatements
This 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 product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. 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 non-core 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.
SOURCELipocine Inc.
For further information:
Krista Fogarty
Phone: (801) 994-7383
kf@lipocine.com
Investors:
PJ Kelleher
Phone: (617) 430-7579
pkelleher@lifesciadvisors.com