Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-021638

Filed: 2026-05-07

Period: 2026-05-07

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):

May

7, 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.

May 7, 2026, the Company issued a press release announcing financial and operational results for the quarter ended March 31, 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 March 31, 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:

May

7, 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

Inc.

Lipocine

Announces Financial Results for the

First

Quarter Ended March 31, 2026

SALT

LAKE CITY, May 07, 2026 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform

to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2026

and provided a corporate update.

Neuroactive

Steroids (NAS)

LPCN

1154 for Postpartum Depression (“PPD”)

●

April 2026, Lipocine announced topline results from its Phase 3 placebo-controlled trial (N=90) evaluating LPCN 1154 (oral brexanolone)

for the treatment of postpartum depression. 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 in the full analysis set and the primary endpoint was not met.

●

The

Phase 3 results showed LPCN 1154 to be well tolerated, demonstrating a differentiated safety profile supportive of outpatient, at-home

use, with no treatment-related serious adverse events, no cases of excessive sedation or loss of consciousness, and no treatment-related

discontinuations.

●

a post hoc analysis of participants with a history of psychiatric conditions (n=54), LPCN 1154 showed statistically significant and

clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30.

●

Based

on these findings, Lipocine has applied for breakthrough therapy and fast track designations for LPCN 1154 in PPD and is awaiting

FDA feedback.

●

The

Company is evaluating all options regarding the potential path forward for LPCN 1154. Such options may include, but are not limited

to, continued development of LPCN 1154, including the potential submission of a validation study protocol in patients with a history

of psychiatric conditions, development of other product candidates, strategic transactions, partnerships, and other opportunities.

●

The

Company intends to complete its full analysis of the Phase 3 trial data and plans to present results at upcoming medical conferences.

For more information on the Phase 3 trial, refer to clinicaltrials.gov: NCT06979544.

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).

●

Lipocine

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

First

Quarter Ended March 31, 2026, Financial Results

of March 31, 2026, Lipocine had $24.7 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 $3.7 million, or ($0.52) per diluted share, for the quarter ended March 31, 2026, compared with a net loss of

$1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025.

The

company recognized royalty revenue from TLANDO sales of $119,000 during the quarter ended March 31, 2026, compared to royalty

revenue of $94,000 during the quarter ended March 31, 2025.

Research

and development expenses were $2.8 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase

in research and development expenses was mainly the result of an increase in costs related to our LPCN 1154 clinical study in 2026.

General

and administrative expenses were $1.2 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase

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

For

further details on Lipocine’s financial results for the quarter ended March 31, 2026, refer to 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 the potential uses and benefits of products

and product candidates, the commercial potential for product candidates, the timing of regulatory reviews and approvals and related procedures,

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

LIPOCINE

INC. AND SUBSIDIARIES

Condensed

Consolidated Balance Sheets

(Unaudited)

March 31,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 5,015,608

$ 5,205,842

Marketable investment securities

19,713,463

9,724,545

Accrued interest income

111,411

14,189

License fee and royalties receivable

119,397

1,145,390

Prepaid and other current assets

285,055

787,600

Total current assets

25,244,934

16,877,566

Property and equipment, net of accumulated depreciation of $1,298,893

and $1,284,079 respectively

89,479

104,293

Other assets

23,753

Total assets

$ 25,358,166

$ 17,005,612

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 1,562,728

$ 971,822

Accrued expenses

645,115

1,236,374

Deferred revenue

320,000

Total current liabilities

2,527,843

2,528,196

Total liabilities

2,527,843

2,528,196

Stockholders’ equity:

Common

stock, par value $0.0001 per share, 75,000,000 shares authorized; 7,475,451 and 6,158,779 issued and 7,475,115 and 6,158,443 outstanding,

respectively

9,076

8,944

Additional paid-in capital

235,937,414

223,901,106

Treasury stock at cost, 336 shares

(40,712 )

Accumulated other comprehensive income

(7,194 )

4,445

Accumulated deficit

(213,068,261 )

(209,396,367 )

Total stockholders’ equity

22,830,323

14,477,416

Total liabilities and stockholders’ equity

$ 25,358,166

$ 17,005,612

LIPOCINE

INC. AND SUBSIDIARIES

Condensed

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended March 31,

2026

2025

Revenues:

Royalty revenue

119,397

93,864

Total revenues

119,397

93,864

Operating expenses:

Research and development

2,764,394

1,061,571

General and administrative

1,204,467

1,122,477

Total operating expenses

3,968,861

2,184,048

Operating loss

(3,849,464 )

(2,090,184 )

Other income:

Interest and investment income

177,570

225,511

Total other income

177,570

225,511

Loss before income tax expense

(3,671,894 )

(1,864,673 )

Income tax expense

(200 )

Net loss attributable to common shareholders Net loss attributable to common shareholders

$ (3,671,894 )

$ (1,864,873 )

Basic loss per share attributable to common stock

$ (0.54 )

$ (0.35 )

Weighted average common shares outstanding, basic

6,795,002

5,348,557

Diluted loss per share attributable to common stock

$ (0.54 )

$ (0.35 )

Weighted average common shares outstanding, diluted

6,795,002

5,348,557

Comprehensive loss:

Net loss

$ (3,671,894 )

$ (1,864,873 )

Net unrealized loss on marketable investment securities

(11,639 )

(3,617 )

Comprehensive loss

$ (3,683,533 )

$ (1,868,490 )

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