Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-035913

Filed: 2026-08-04

Period: 2026-08-04

CIK: 0001535955

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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):

August 4, 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

2.02

Results

of Operations and Financial Condition.

August 4, 2026, the Company issued a press release announcing financial and operational results for the quarter ended June

30, 2026. A copy of this press release is furnished as Exhibit 99.1 to this report and incorporated by reference herein.

The

information furnished pursuant to this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated

by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth

by specific reference in such filing.

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 Financial Results for the Quarter Ended June 30, 2026

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:

August

4, 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 Financial Results for the Second Quarter Ended June 30, 2026

SALT

LAKE CITY, August 4, 2026 — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of

novel oral therapeutics, today announced financial results for the second quarter ended June 30, 2026 and provided a corporate update.

Recent

Developments and Corporate Update

LPCN

1154 (BRLIZIO™) for Postpartum Depression (PPD)

● On

April 2, 2026, Lipocine reported topline results from its Phase 3 placebo-controlled trial

(N=90) evaluating oral LPCN 1154 (oral brexanolone) for the treatment of PPD. In the full

analysis set, LPCN 1154 did not show a statistically significant reduction from baseline

in HAM-D (Hamilton Depression Rating Scale) total score compared to placebo at hour 60, and

the primary endpoint was not met.

● In

a post hoc analysis, the Company identified anomalies at one high-enrolling site in the Phase

3 trial that raise substantive questions about the validity of that site’s data. Excluding

the outlier site, LPCN 1154 produced a rapid, sustained, and clinically meaningful improvement

in depression symptoms. We believe that these results align with the established antidepressant

profile of intravenous brexanolone and indicate a potential development path for LPCN 1154.

● We

have requested a guidance meeting with the FDA and the meeting is scheduled for the third

quarter of 2026. We have initiated a new placebo controlled clinical trial for PPD to complement

the existing LPCN 1154 clinical database, and to further characterize the efficacy and safety

of LPCN 1154.

● The

LPCN 1154 Phase 3 data in PPD were featured in oral and poster presentations at the 2026

American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, on May 26, 2026, in

Miami, FL.

● On

June 12, 2026, Lipocine hosted a virtual key opinion leader (KOL) event for the investment

community highlighting the unmet needs in PPD and the clinical profile of LPCN 1154. The

event featured presentations by two leading physicians with deep expertise in PPD, Kristina

M. Deligiannidis, MD, and Rakesh Jain, MD, MPH, as well as by company management. A replay

of the event, with slides, can be accessed here.

● Lipocine

continues to explore business partnerships around the development, approval and commercialization

of Brlizio™ (LPCN 1154) for PPD.

LPCN

2201 for Major Depressive Disorder

● In

the aforementioned post hoc analysis of the Phase 3 PPD study, oral brexanolone also demonstrated

that participants with a history of psychiatric conditions showed statistically significant

and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as

hour 12 and sustained through day 30. We plan to submit a protocol for a Phase 2 study to

the FDA, and we may initiate a study to evaluate LPCN 2201 for MDD.

LPCN

2203 for Essential Tremor

● Literature

reports of potential efficacy demonstrated with injectable brexanolone in treating essential

tremor symptoms and with the observed low sedation, dizziness, and GI adverse events in oral

brexanolone, we plan to submit a protocol for a Phase 2 study to the FDA and we may initiate

a study to evaluate LPCN 2203 for essential tremor.

TLANDO

● Lipocine

has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which

Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy,

in the United States and Canada, if approved.

● Lipocine

has entered into additional license, supply and distribution agreements covering development

and commercialization of TLANDO in other counties/ territories including Aché (Brazil),

Pharmalink (GCC countries) and SPC (South Korea). On July 8, 2026, Pharmalink received product

marketing authorization approval for TESTYRA® (TLANDO) in the UAE.

● Lipocine

continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea,

the GCC countries, and Brazil.

Second

Quarter Ended June 30, 2026 Financial Results

of June 30, 2026, Lipocine had $23.3 million of unrestricted cash, cash equivalents, and marketable investment securities, compared to

$14.9 million at December 31, 2025.

Lipocine

reported a net loss of $2.6 million, or ($0.32) per diluted share, for the quarter ended June 30, 2026, compared to a net loss of $2.2

million, or ($0.41) per diluted share, for the quarter ended June 30, 2025.

Royalty

revenue from TLANDO sales were $190,000 during the three months ended June 30, 2026, compared to $123,000 during the three months ended

June 30, 2025. In addition, license revenue of $500,000 was recognized in the three months ended June 30, 2025 and there was no license

revenue in the comparable period of 2026.

Research

and development expenses were $2.0 million and $2.1 million, respectively, for the quarters ended June 30, 2026 and 2025.

General

and administrative expenses were $1.0 million and $0.9 million, respectively, for the quarters ended June 30, 2026 and 2025.

Six

Months Ended June 30, 2026 Financial Results

Lipocine

reported a net loss of $6.3 million, or ($0.84) per diluted share, for the six months ended June 30, 2026, compared to a net loss of

$4.1 million, or ($0.76) per diluted share, for the six months ended June 30, 2025.

Lipocine

recognized revenue of $309,000 and $717,000 during the six months ended June 30, 2026 and 2025, respectively. Revenue during the six

months ended June 30, 2026 consisted entirely of royalty revenue from TLANDO sales. There was $500,000 of license revenue and $217,000

in royalty revenue during the same period in 2025.

Research

and development expenses were $4.8 million and $3.2 million, respectively, for the six-month periods ended June 30, 2026 and 2025. The

increase was driven primarily by costs related to the LPCN 1154 Phase 3 study and an increase in personnel expense, partially offset

by a decrease in various research and development costs.

General

and administrative expenses were $2.2 million and $2.0 million, respectively, for the six-month periods ended June 30, 2026 and 2025.

The increase was primarily a result of an increase in consulting and professional fees and an increase in various general and administrative

fees.

Interest

and investment income was $0.4 million for each of the six-month periods ended June 30, 2026 and 2025.

For

further detail on Lipocine’s financial results for the three and six months ended June 30, 2026, refer to the Company’s Form

10-Q filed with the SEC.

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 our products and product

candidates and related efforts with the FDA, including 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 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

LIPOCINE

INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

June 30,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 4,979,430

$ 5,205,842

Marketable investment securities

18,287,179

9,724,545

Accrued interest income

101,065

14,189

License fee and royalties receivable

190,099

1,145,390

Prepaid and other current assets

179,004

787,600

Total current assets

23,736,777

16,877,566

Property

and equipment, net of accumulated depreciation of $1,313,541 and $1,284,079 respectively

74,831

104,293

Other assets

23,753

Total assets

$ 23,835,361

$ 17,005,612

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 680,525

$ 971,822

Accrued expenses

1,067,432

1,236,374

Deferred revenue

320,000

Total current liabilities

2,067,957

2,528,196

Total liabilities

2,067,957

2,528,196

Commitments and contingencies

Stockholders’ equity:

Common

stock, par value $0.0001 per share, 75,000,000 shares authorized; 8,244,589 and 6,158,779 issued and 8,244,253 and 6,158,443

outstanding, respectively

9,153

8,944

Additional paid-in capital

237,503,220

223,901,106

Treasury stock at cost, 336 shares

(40,712 )

Accumulated other comprehensive income

(13,401 )

4,445

Accumulated deficit

(215,690,856 )

(209,396,367 )

Total stockholders’ equity

21,767,404

14,477,416

Total liabilities and stockholders’ equity

$ 23,835,361

$ 17,005,612

LIPOCINE

INC. AND SUBSIDIARIES

Condensed

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended June 30,

Six Months Ended June 30,

2026

2025

2026

2025

Revenues:

License revenue

$ -

$ 500,000

$ -

$ 500,000

Royalty revenue

190,099

122,849

309,496

216,713

Total revenues

190,099

622,849

309,496

716,713

Operating expenses:

Research and development

2,041,389

2,136,769

4,805,782

3,198,341

General and administrative

990,956

890,433

2,195,425

2,012,910

Total operating expenses

3,032,345

3,027,202

7,001,207

5,211,251

Operating loss

(2,842,246 )

(2,404,353 )

(6,691,711 )

(4,494,538 )

Other income:

Interest and investment income

219,851

198,637

397,422

424,149

Total other income

219,851

198,637

397,422

424,149

Loss before income tax expense

(2,622,395 )

(2,205,716 )

(6,294,289 )

(4,070,389 )

Income tax expense

(200 )

Net loss attributable to common shareholders

$ (2,622,595 )

$ (2,205,716 )

$ (6,294,489 )

$ (4,070,589 )

Basic loss per share attributable to common stock

$ (0.32 )

$ (0.41 )

$ (0.84 )

$ (0.76 )

Weighted average common shares outstanding, basic

8,216,988

5,351,957

7,509,923

5,350,267

Diluted loss per share attributable to common stock

$ (0.32 )

$ (0.41 )

$ (0.84 )

$ (0.76 )

Weighted average common shares outstanding, diluted

8,216,988

5,351,957

7,509,923

5,350,267

Comprehensive loss:

Net loss

$ (2,622,595 )

$ (2,205,716 )

$ (6,294,489 )

$ (4,070,589 )

Net unrealized loss on marketable investment securities

(6,207 )

(6,764 )

(17,846 )

(10,381 )

Comprehensive loss

$ (2,628,802 )

$ (2,212,480 )

$ (6,312,335 )

$ (4,080,970 )

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Aug. 04, 2026

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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