# EDGAR Filing Document

**Accession Number:** 0001535955
**File Stem:** 0001493152-26-009428
**Filing Date:** 2026-3
**Character Count:** 20263
**Document Hash:** 40509108467447800f3617a664fcb67f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-009428.hdr.sgml**: 20260310

**ACCESSION NUMBER**: 0001493152-26-009428

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260310

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260310

**DATE AS OF CHANGE**: 20260310

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Lipocine Inc.
- **CENTRAL INDEX KEY:** 0001535955
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 990370688
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36357
- **FILM NUMBER:** 26737087

**BUSINESS ADDRESS:**
- **STREET 1:** 675 ARAPEEN DRIVE, SUITE 202
- **CITY:** SALT LAKE CITY
- **STATE:** X1
- **ZIP:** 84108
- **BUSINESS PHONE:** 801 994 7383

**MAIL ADDRESS:**
- **STREET 1:** 675 ARAPEEN DRIVE, SUITE 202
- **CITY:** SALT LAKE CITY
- **STATE:** X1
- **ZIP:** 84108

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** MARATHON BAR CORP
- **DATE OF NAME CHANGE:** 20111130

?xml version='1.0' encoding='ASCII'?

**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):

**March 10, 2026**

**LIPOCINE INC.**

(Exact name of registrant as specified in its charter)

Commission File No. 001-36357

Delaware 99-0370688 <br> (State or other jurisdiction of 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:

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| | | |
|:---|:---|:---|
| 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 ☐

If 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.** |

---

On March 10, 2026, the Company issued a press release announcing financial and operational results for the year ended December 31, 2025. 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.** |

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(d) Exhibits

The following exhibits are filed with this report:

<u>Exhibit No.</u> <u>Description</u> <br> 99.1 [Press Release announcing Financial Results for the Year Ended December 31, 2025](ex99-1.htm) <br> 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. | LIPOCINE INC. |
| Date: | March 10, 2026 | By: | */s/ Mahesh V. Patel* |
|  |  |  | Mahesh V. Patel |
|  |  |  | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Lipocine Announces Financial Results for the Full Year Ended December 31, 2025** 

SALT LAKE CITY, March 10, 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 full year ended December 31, 2025 and provided a corporate update.

"We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we've made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team's commitment to delivering more effective treatments for patients in need," said Dr Mahesh Patel, Lipocine President and CEO. "We're excited about the near-term milestones ahead and remain committed to advancing our pipeline proficiently."

<u>Neuroactive Steroids (NAS)</u>

<u>LPCN 1154 for Postpartum Depression (PPD)</u> 

● Lipocine
 is developing LPCN 1154, a rapid onset, short treatment duration oral product candidate comprising
 the neuroactive steroid brexanolone for the treatment of postpartum depression.

● The
 last patient completed the final study visit (Last Patient/Last Visit) in a confirmatory
 Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD in February
 2026. The study enrolled 90 patients in total and top line results are expected early in
 April 2026.

● If
 successful, the Phase 3 trial is expected to support a global registration package for LPCN
 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the U.S. which
 is expected in mid-2026.

<u>LPCN 2201 for Major Depressive Disorders (MDD)</u>

● Lipocine
 is advancing LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral
 treatment option for MDD with the goal of improving outcomes without the limitations of existing
 therapies. LPCN 2201 is chemically identical to the endogenous human hormone allopregnanolone,
 a positive allosteric modulator of y-aminobutyric acid (GABA<sub>A</sub>) receptor.

<u>LPCN 2101 for Epilepsy</u>

● Lipocine
 is developing LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy,
 including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose
 significant treatment challenges under current standard of care.

● Two
 posters related to LPCN 2101 were presented at the <u>2025 American Epilepsy Society (AES) Annual Meeting</u> that took place in December 2025 in Atlanta, Georgia.

○ Oral Toxicokinetics of a Bioidentical GABA<sub>A </sub>Receptor Modulating Neuroactive Steroid (NAS) Anti-seizure Medication (ASM) Candidate for Women with Epilepsy (WWE)

○ Clinical Pharmacokinetics (PK) and Tolerability of a Novel Oral GABA<sub>A </sub>Receptor Positive Allosteric Modulating (PAM) Candidate for Epilepsy

● Based
 on FDA review of the protocol and agreement to proceed, the Company plans to initiate a Phase
 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101,
 subject to resource prioritization. Pre-clinical and Phase 1 studies have demonstrated promising
 PK results, safety and tolerability.

<u>LPCN 2401 for Obesity Management</u>

● LPCN
 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen
 receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive
 option for use as an adjunct to GLP-1 receptor agonist chronic weight management therapies
 and/or as a monotherapy post cessation of GLP-1 receptor agonist weight management therapies
 with demonstrated benefits to the liver.

● Pending
 further regulatory guidance, Lipocine may conduct a proof-of-concept Phase 2 study for LPCN
 2401 in elderly obese and overweight GLP-1 eligible patients, with possible appropriate body
 composition and functional endpoints

● Lipocine
 may explore the possibility of partnering LPCN 2401 with a third party.

<u>TLANDO™</u>

● 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.

● Also
 in 2024, Lipocine entered into a distribution and license agreement with SPC Korea Limited
 for the development and commercialization of TLANDO for TRT in South Korea and Lipocine signed
 an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO in
 the Gulf Cooperation Council (GCC) countries. In 2025, Lipocine entered into a license and
 supply agreement with Aché in Brazil. The Company is exploring further partnerships
 for TLANDO outside of North America, South Korea, the GCC countries and Brazil.

**Full year Ended December 31, 2025, Financial Results**

As of December 31, 2025, Lipocine had $14.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million as of December 31, 2024.

Lipocine reported a net loss of $9.6 million, or ($1.69) per diluted share, for the year ended December 31, 2025, compared with net income of $8,352, or ($0.00) per diluted share, for the year ended December 31, 2024.

Revenues were $2.0 million during the year ended December 31, 2025, compared to revenue of $11.2 million during the year ended December 31, 2024. Revenue in 2025 primarily consisted of license revenue from the Company's licenses with Verity and Aché of $1.5 million, and royalty revenue from TLANDO sales of $480,000. Revenue in 2024 primarily consisted of $10.9 million in license revenue from licenses with Verity, SPC and Pharmalink and royalty revenue from TLANDO sales of $298,000.

Research and development expenses were $8.6 million and $7.4 million, respectively, for the years ended December 31, 2025 and 2024. The increase in research and development expenses during the year ended December 31, 2025 primarily related to an increase in clinical study costs, in addition to other increases in supplies and research costs and in personnel-related costs.

General and administrative expenses were $3.8 million and $5.0 million, respectively, for the years ended December 31, 2025 and 2024. The decrease in general and administrative expenses during the year ended December 31, 2025 was primarily due to a decrease in business development, strategic advisory services and corporate legal fees, a decrease in estimated franchise taxes, a decrease in other various professional fees, and a decrease in corporate insurance expense, offset by an increase in personnel related expenses, an increase in patent related fees and an increase in other general and administrative expenses.

Interest and investment income was $0.7 million and $1.2 million for the years ended December 31, 2025 and 2024, respectively. The decrease in interest and investment income during the year ended December 31, 2025 was mainly due to declining cash and marketable investment securities balances in 2025 compared to 2024.

As of March 6, 2026, the Company had unrestricted cash, cash equivalents and marketable investment securities of approximately $24.7 million. The higher balance compared with the balance at December 31, 2025 was primarily a result of the sale of shares of common stock by means of an "At the Market ("ATM") Offering" under a sales agreement with A.G.P./Alliance Global Partners ("A.G.P") entered into in April 2024.

For further details on Lipocine's financial results from the year ended December 31, 2025, refer to Form 10K filed with the SEC.

**About Lipocine**

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 <u>www.lipocine.com</u>.

**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 product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, our Phase 3 safety and efficacy study relating to LPCN 1154, including the timing and potential results of the study, the timing of any submission of a NDA for LPCN 1154, and the potential uses and benefits of our product candidates. 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 <u>www.sec.gov</u>. 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

<u>kf@lipocine.com</u>

Investors:

PJ Kelleher

Phone: (617) 430-7579

<u>pkelleher@lifesciadvisors.com</u>

**LIPOCINE INC. AND SUBSIDIARIES**

Consolidated Balance Sheets

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| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2025** | **December 31,**<br>**2024** |
| &nbsp;&nbsp;&nbsp;**Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $5205842 | $6205926 |
| &nbsp;&nbsp;&nbsp;Marketable investment securities | 9724545 | 15427385 |
| &nbsp;&nbsp;&nbsp;Accrued interest income | 14189 | 120447 |
| &nbsp;&nbsp;&nbsp;License fee and royalties receivable | 1145390 | 91405 |
| &nbsp;&nbsp;&nbsp;Prepaid and other current assets | 787600 | 476510 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 16877566 | 22321673 |
| Property and equipment, net of accumulated depreciation of $1,284,079 and $1,223,297, respectively | 104293 | 165075 |
| Other assets | 23753 | 23753 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $17005612 | $22510501 |
| &nbsp;&nbsp;&nbsp;**Liabilities and Stockholders' Equity** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $971822 | $271696 |
| &nbsp;&nbsp;&nbsp;Accrued expenses | 1236374 | 921240 |
| &nbsp;&nbsp;&nbsp;Deferred revenue | 320000 | 320000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 2528196 | 1512936 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 2528196 | 1512936 |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;Common stock, par value $0.0001 per share, 75,000,000 shares authorized; 6,158,779 and 5,348,276 issued and 6,158,443 and 5,347,940 outstanding, respectively | 8944 | 8863 |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 223901106 | 220789138 |
| &nbsp;&nbsp;&nbsp;Treasury stock at cost, 336 shares | (40712) | (40712) |
| &nbsp;&nbsp;&nbsp;Accumulated other comprehensive gain | 4445 | 9138 |
| &nbsp;&nbsp;&nbsp;Accumulated deficit | (209396367) | (199768862) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 14477416 | 20997565 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $17005612 | $22510501 |

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**LIPOCINE INC. AND SUBSIDIARIES**

Consolidated Statements of Operations and Comprehensive Income (Loss)

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| | | |
|:---|:---|:---|
|  | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2025** | **2024** |
| Revenues: |  |  |
| &nbsp;&nbsp;&nbsp;License revenue | $1500000 | $10900000 |
| &nbsp;&nbsp;&nbsp;Royalty revenue | 476677 | 298144 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenues | 1976677 | 11198144 |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | 8583919 | 7351753 |
| &nbsp;&nbsp;&nbsp;General and administrative | 3764137 | 5001426 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 12348056 | 12353179 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating loss | (10371379) | (1155035) |
| Other income: |  |  |
| &nbsp;&nbsp;&nbsp;Interest and investment income | 744074 | 1146902 |
| &nbsp;&nbsp;&nbsp;Unrealized gain on warrant liability | - | 17166 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other income | 744074 | 1164068 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Income (loss) before income tax expense | (9627305) | 9033 |
| Income tax expense | (200) | (681) |
| Net income (loss) | (9627505) | 8352 |
| Basic income (loss) per share attributable to common stock | $(1.77) | $- |
| Weighted average common shares outstanding, basic | 5448871 | 5338957 |
| Diluted income (loss) per share attributable to common stock | $(1.69) | $- |
| Weighted average common shares outstanding, diluted | 5708238 | 5422604 |
| Comprehensive income (loss): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net income (loss) | $(9627505) | $8352 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net unrealized gain (loss) on available-for-sale securities | (4693) | 1879 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Comprehensive gain (loss) | $(9632198) | $10231 |

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