Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-024365

Filed: 2026-05-19

Period: 2026-05-19

CIK: 0001535955

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

GRAPHIC (form8-k_001.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: form8-k.htm · Sequence: 1

false

0001535955

2026-05-19

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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):

May

19, 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

May 19, 2026, the Company issued a press release announcing Lipocine’s LPCN 1154 Phase 3 data has been accepted for oral presentation

at the 2026 ASCP Annual Meeting to be held May 26-29, 2026, in Miami, Florida. 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 LPCN 1154 Phase 3 Data Accepted for Oral Presentation at 2026 ASCP Annual Meeting

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:

May

19, 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 LPCN 1154 Phase 3 Data Accepted for Oral Presentation at 2026 ASCP Annual Meeting

SALT

LAKE CITY, May 19, 2026 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology

platform to augment therapeutics through effective oral delivery, today announced that its Phase 3 clinical data for LPCN 1154 have been

selected for oral and poster presentation at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, to

be held May 26–29, 2026, in Miami, FL.

Oral

Presentation details

Title:

Novel

Oral Rapid-Acting Neuroactive Steroid for Treatment of Postpartum Depression: A Placebo-Controlled Phase 3 Clinical Trial of LPCN

1154

Presenter:

Benjamin

Bruno, PhD, Vice President, Clinical Development, Lipocine

Session:

Pharmaceutical

Pipeline (Oral Presentation)

Date:

Tuesday,

May 26, 2026

Time:

3:20

PM ET

Location:

Loews

Miami Beach Hotel, Miami, FL

The

presentation will highlight results from Lipocine’s Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for

the treatment of postpartum depression (PPD).

Poster

Presentation

Date:

Wednesday,

May 27, 2026

Time:

11:45

AM – 1:30 PM ET

Session:

Poster

Session 1, Pharmaceutical Pipeline

Poster

number:

W98

“We

are pleased that our Phase 3 data for LPCN 1154 was selected for an oral presentation at this year’s ASCP meeting, a leading forum

for clinical psychopharmacology research,” said Mahesh V. Patel, Ph.D., President and Chief Executive Officer of Lipocine.

About

LPCN 1154

LPCN

1154, oral brexanolone, a non-SSRI, is chemically identical to the endogenous human hormone allopregnanolone. Brexanolone is a positive

allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 1154 has the potential for rescue therapy for PPD with acute stabilization

of symptoms in hours and no intensive monitoring requirement. LPCN 1154 has demonstrated clinically meaningful improved tolerability

including low CNS depressant side effects, without the risks of disassociation or hallucination of psychedelics, thus potentially enabling

a safe, at-home intervention, preserving the maternal-infant bond.

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 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 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

GRAPHIC

Filename: form8-k_001.jpg · Sequence: 3

Binary file (4308 bytes)

Download form8-k_001.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.1

Cover

May 19, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

May 19, 2026

Entity File Number

001-36357

Entity Registrant Name

LIPOCINE

INC.

Entity Central Index Key

0001535955

Entity Tax Identification Number

99-0370688

Entity Incorporation, State or Country Code

Entity Address, Address Line One

675

Arapeen Drive

Entity Address, Address Line Two

Suite 202

Entity Address, City or Town

Salt

Lake City

Entity Address, State or Province

Entity Address, Postal Zip Code

84108

City Area Code

(801)

Local Phone Number

994-7383

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common

Stock, par value $0.0001 per share

Trading Symbol

LPCN

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration