Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-014834

Filed: 2026-04-02

Period: 2026-04-02

CIK: 0001535955

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

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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):

April

2, 2026

LIPOCINE

INC.

(Exact

name of registrant as specified in its charter)

Commission

File No. 001-36357

Delaware

99-0370688

(State

or other jurisdiction

incorporation)

(IRS

Employer

Identification

Number)

675

Arapeen Drive, Suite 202

Salt

Lake 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 communications pursuant to Rule 425 under the

Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the

Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b)

under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4©

under the Exchange Act (17 CFR 240.13©(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common Stock, par value $0.0001 per share

LPCN

The 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 ☐

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. ☐

Item 8.01

Other Events.

April 2, 2026, the Company issued a press release announcing topline safety and efficacy results for LPCN 1154 in

patients with postpartum depression. The press release is furnished as Exhibit 99.1

to this report and incorporated by reference herein.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits

The

following exhibits are filed with this report:

Exhibit

No.

Description

99.1

Press

Release announcing Lipocine Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression

104

Cover

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 INC.

Date:

April

2, 2026

By:

/s/ Mahesh

V. Patel

Mahesh V. Patel

President and Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Lipocine

Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression

● In

the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically

significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60

(primary endpoint); the primary endpoint was not met

● In

a post hoc analysis of participants (n=54) who had a history of psychiatric conditions, LPCN

1154 demonstrated nominal statistically significant and clinically meaningful reductions

in HAM-D scores compared to placebo as early as hour 12 and sustained through day 30

● In

the overall population, LPCN 1154 was well tolerated and demonstrated a differentiated safety

profile with no reported adverse event, including somnolence or dizziness, occurring in more

than 5% of the LPCN 1154-treated participants

● The

Company plans to evaluate all available options going forward

SALT

LAKE CITY, UT, April 2, 2026/PR NEWSWIRE/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary

technology platform to develop innovative products with effective oral delivery, today announced topline results from its Phase 3 placebo-controlled

trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design,

refer to clinicaltrials.gov: NCT06979544.

LPCN

1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full

analysis set and the primary was not met. The results showed LPCN 1154 to be well tolerated and demonstrated a favorable safety profile

to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse

events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations

were reported.

a post hoc analysis of participants with a history of psychiatric conditions diagnosed using Mini-International Neuropsychiatric Interview

(MINI, a structured diagnostic interview used to screen for and diagnose psychiatric disorders using DSM/ICD criteria), the Company identified

signals that could indicate a potential development path for LPCN 1154.

Table:

Placebo-Adjusted HAM-D17 Score Change from Baseline

Timepoint

Overall

Population

N=90

History

of Psychiatric

Conditions

Subset N=54

Placebo-Adjusted

Difference

Statistical

Significance

Placebo-Adjusted

Difference

Statistical

Significance

Hour

-3.9

< 0.01

-7.2

< 0.001

Hour

-1.7

NSS

-5.0

< 0.05

Hour

-1.3

NSS

-6.1

< 0.01

Day

-1.2

NSS

-4.2

NSS

Day

-2.3

NSS

-5.3

< 0.05

NSS:

Not Statistically Significant. Mixed model for repeated measures, least squares means placebo-adjusted difference. P-values are nominal

except for Hour 60 Overall Population.

Based

on the results of the post hoc analysis of efficacy among participants with a history of psychiatric condition based on the MINI, the

Company has applied for breakthrough therapy and fast track designations for LPCN 1154 in patients with PPD. While the Company is waiting

for feedback from the FDA on such designations, the Company plans to preserve capital and engage with stakeholders, including investors,

regulators, and advisors, to evaluate all options available to the Company going forward. Such options may include, but are not limited

to, continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product

candidates, strategic transactions, partnerships, and other opportunities.

The

Company intends to complete its full analysis of the trial data in the coming weeks and plans to present the results at upcoming conferences.

The Company thanks patients, investigators, and site staff for their contributions.

About

LPCN 1154

LPCN

1154 is an oral formulation of brexanolone being developed to provide rapid relief of postpartum depression in a convenient, at-home

treatment. It has potential as first line treatment choice for women with PPD. It also has characteristics that could be particularly

beneficial to patients with severe PPD (including those with elevated suicide risk) for whom rapid improvement is a priority. LPCN 1154

is expected to offer a compelling safety profile for breastfeeding mothers.

About

Postpartum 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.

About

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 2202 for treatment of treatment resistant depression,

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.

Forward-Looking

Statements

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 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.

SOURCE

Lipocine Inc.

For

further information:

Krista

Fogarty

Phone:

(801) 994-7383

kf@lipocine.com

Investors:

Kelleher

Phone:

(617) 430-7579

pkelleher@lifesciadvisors.com

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