Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-042466

Filed: 2026-09-14

Period: 2026-09-14

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):

September

14, 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(c) under the Exchange Act (17 CFR 240.13e-4(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

September 14, 2026, the Company issued a press release announcing the initiation of its BLOOM Phase 3 Study of LPCN 1154 for postpartum

depression. A copy of the press release is furnished as Exhibit 99.1 to this report 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’s Initiation of BLOOM Phase 3 Study of LPCN 1154 for 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:

September

14, 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

Announces Initiation of BLOOM Phase 3 Study of LPCN 1154 for Postpartum Depression

● Study

informed by encouraging exploratory efficacy findings and a favorable safety profile in the

prior Phase 3 trial

● Approximately

120 participants with severe postpartum depression (PPD) planned; first participant dosing expected

in early Q4 2026

● Company

expects existing resources to support BLOOM

SALT

LAKE CITY, September 14, 2026 — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of

novel oral therapeutics, today announced the initiation of BLOOM, a Phase 3 study evaluating LPCN 1154 (oral brexanolone) for PPD. First

participant dosing is expected in early Q4 2026. LPCN 1154 is being developed as a 48-hour, at-home treatment, targeting the need for rapid

symptom relief with a short oral regimen. Lipocine believes this potential profile could address a substantial unmet need in PPD and

represents an important commercial opportunity, subject to successful development and approval.

BLOOM

is designed to complement the existing LPCN 1154 clinical data package and generate prospective efficacy and safety evidence to support

a potential New Drug Application under the 505(b)(2) pathway. The placebo-controlled outpatient study incorporates feedback from a recent

meeting with the U.S. Food and Drug Administration (FDA), together with learnings from the prior Phase 3 trial.

Although the prior Phase 3 trial did not meet its primary endpoint in

the full analysis set, exploratory post hoc analyses identified anomalies concentrated at one high-enrolling site, including an absence

of detectable study drug in blood samples from approximately 40% of LPCN 1154-treated participants at that site. Analyses excluding the

site suggested rapid and sustained improvement in depressive symptoms. These findings are exploratory and are not confirmatory evidence

of efficacy. BLOOM is designed to evaluate LPCN 1154 prospectively with strengthened site and data-quality controls.

The

prior trial also provided encouraging safety and tolerability findings. No treatment-related severe or serious adverse events were reported,

and there were no instances of excessive sedation, loss of consciousness or treatment discontinuation.

“We

believe a treatment that delivers rapid relief through a 48-hour oral course at home could meaningfully change how women and families

manage postpartum depression,” said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. “BLOOM translates

our prior clinical findings and FDA feedback into a study focused on generating the evidence needed to advance LPCN 1154 toward a potential

regulatory submission. Our priorities are rigorous execution, clinically meaningful results and disciplined use of capital as we pursue

this opportunity for patients and shareholders.”

Based

on its current operating plan, Lipocine believes its existing financial and operational resources are sufficient to execute BLOOM. The

Company expects average cash use of approximately $1 million per month during study execution, inclusive of BLOOM-related expenditures.

As of June 30, 2026, Lipocine reported $23.3 million in unrestricted cash, cash equivalents and marketable investment securities. These

expectations are dependent upon study duration, enrollment, costs and other operating requirements and do not imply that existing resources

will fund regulatory approval or commercialization.

About

the BLOOM Study

The

Brexanolone Lifting Outcomes of Moms (BLOOM) study is expected to enroll approximately 120 participants with PPD. It builds on the Company’s

prior Phase 3 trial (NCT06979544) and incorporates the following design and operational measures:

● Consistent

treatment regimen and endpoint: The outpatient study will use the same 48-hour dosing regimen

evaluated in the prior Phase 3 trial with primary efficacy, change from baseline in the 17-item

Hamilton Depression Rating Scale (HAM-D17) total score, assessed at 60 hours post dosing

initiation.

● Site

quality controls: Measures include periodic review of site populations, third-party support

for site selection, geographic diversity, with no selection of sites with significant operational

or data quality concerns, and participation by academic sites.

● Measures

intended to reduce placebo response: The protocol includes fewer rating scales and assessments,

reduced participant contact with site staff, centralized rating for screening and eligibility,

and standardized participant eduction about study procedures and assessments.

● Prespecified

sensitivity analyses: The study includes planned analyses addressing outlier sites and pharmacokinetic

data.

Additional

details about BLOOM will be available on ClinicalTrials.gov.

About

LPCN 1154

LPCN

1154 (proposed brand name BRLIZIO) is an investigational oral formulation of brexanolone, chemically identical to the naturally occurring

neuroactive steroid allopregnanolone, which modulates GABAA receptors. Lipocine is developing LPCN 1154 as a 48-hour, at-home

treatment for PPD, with the goal of rapid relief and a tolerable, practical dosing regimen. LPCN 1154 is not FDA-approved. Its efficacy,

safety, suitability for at-home use and any monitoring or activity restrictions remains subject to clinical evaluation and regulatory

review. No head-to-head trials have established superiority to approved PPD treatments.

About

Postpartum Depression

Postpartum

depression is a serious, potentially life-threatening condition that can impair daily functioning, maternal-infant bonding and family

well-being. Symptoms may include persistent sadness, loss of interest, anxiety and thoughts of self-harm. CDC research found that approximately

1 in 8 women with a recent live birth reported postpartum depressive symptoms. Treatment options include psychotherapy and antidepressants;

zuranolone (ZURZUVAE) is FDA-approved for adults with PPD as a 14-day oral course. Its label includes a boxed warning for driving impairment

and advises avoiding driving for at least 12 hours after each dose. IV brexanolone (ZULRESSO) was discontinued commercially in the United

States, and FDA approval was withdrawn at the sponsor’s request effective April 14, 2025. ACOG’s updated guidance, published

online in 2025 and in its January 2026 journal issue, addresses neuroactive steroid treatment in the postpartum period. There remains

a need for additional effective, well-tolerated, accessible treatments that provide timely relief while fitting the practical demands

of caring for a newborn.

About

Lipocine

is a biopharmaceutical company developing oral therapeutics using its proprietary drug-delivery technology platform. The Company advances

product candidates addressing significant unmet medical needs and explores partnerships to support their development and commercialization.

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.

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 our products and product

candidates and related efforts with the FDA, including the design, planned enrollment, timing and potential outcomes of the BLOOM study;

the sufficiency of existing financial and operational resources to execute the study; expected average monthly cash use, study expenditures

and cash needs; the timing of clinical trials and regulatory submissions, the potential uses and benefits of our products and product

candidates, the commercial potential for our product candidates, and potential strategic partnerships and other 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 an 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, variability

in enrollment and site performance, study costs exceeding current estimates,

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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