# EDGAR Filing Document

**Accession Number:** 0001535955
**File Stem:** 0001493152-25-027914
**Filing Date:** 2025-12
**Character Count:** 11708
**Document Hash:** f2d008fe4be3f647ae1f1c6d283ae159
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-027914.hdr.sgml**: 20251216

**ACCESSION NUMBER**: 0001493152-25-027914

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20251215

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251216

**DATE AS OF CHANGE**: 20251216

**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:** 251573600

**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):

**December 15, 2025**

![](form8-k_001.jpg)

**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 8.01** | **Other Events.** |

---

On December 16, 2025, the Company issued a press release announcing Lipocine's PPD Phase 3 Study (LPCN 1154) had hit 80% enrollment. 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's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone](ex99-1.htm) |
| 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: | December 16, 2025 | By: | */s/ Mahesh V. Patel* |
|  |  |  | Mahesh V. Patel |
|  |  |  | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone**

● Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026

● Topline results on track for the second quarter of 2026

SALT LAKE CITY, UT, December 15, 2025/PR NEWSWIRE/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026. Following the first DSMB review, the board recommended that the trial continue as planned without modification.

"We are encouraged by the recruiting rate in our Phase 3 study for postpartum depression, which may be indicative of this population's unmet medical need," said Mahesh Patel, CEO of Lipocine. "We extend our deepest gratitude to the patients, their families, and the dedicated clinical teams at the trial sites whose commitment has made this progress possible."

**About the Phase 3 Study**

The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the U.S. Food and Drug Administration (FDA), the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider. Data from this Phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026. For more information, refer to clinicaltrials.gov: NCT06979544.

**About LPCN 1154**

LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. While it is expected that LPCN 1154 could be the first line treatment choice for women with PPD, it may have characteristics that could be particularly appealing to patients with PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.

**About Postpartum Depression and Unmet Needs**

PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery . Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission.

**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 2202 for treatment of treatment resistant depression, 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, including with respect to LPCN 1154, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates, including the impact of LPCN 1154 on the treatment of PPD. 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>