Lipocine (NASDAQ: LPCN) discloses 80% enrollment in PPD Phase 3 trial

Rhea-AI Filing Summary

Lipocine Inc. filed a current report to share progress on its clinical development program. On December 16, 2025, the company issued a press release stating that Lipocine’s PPD Phase 3 Study (LPCN 1154) has reached 80% enrollment. This means most of the planned participants for the Phase 3 clinical study have been enrolled, marking a notable step toward completing patient recruitment.

The press release describing this enrollment milestone is furnished as Exhibit 99.1, while a cover page interactive data file is included as Exhibit 104. Lipocine’s common stock, with par value $0.0001 per share, trades on the Nasdaq Stock Market under the symbol LPCN.

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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):

December 15, 2025

LIPOCINE INC.

(Exact name of registrant as specified in its charter)

Commission File No. 001-36357

Delaware		99-0370688
(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:

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
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:	December 16, 2025		By:	/s/ Mahesh V. Patel
				Mahesh V. Patel
				President and Chief Executive Officer

FAQ

What key update does Lipocine (LPCN) report in this 8-K filing?

The company reports that Lipocine’s PPD Phase 3 Study (LPCN 1154) has reached 80% enrollment, as announced in a press release dated December 16, 2025.

What is the enrollment milestone for Lipocine’s (LPCN) PPD Phase 3 Study LPCN 1154?

Lipocine states that its PPD Phase 3 Study (LPCN 1154) has hit 80% enrollment, indicating that most of the trial’s planned participants have been enrolled.

When did Lipocine (LPCN) issue the press release about the Phase 3 study enrollment?

Lipocine issued the press release on December 16, 2025, and this press release is furnished as Exhibit 99.1 to the current report.

Which exhibits are attached to Lipocine’s (LPCN) current report about the PPD Phase 3 Study?

The report includes Exhibit 99.1, a press release on the PPD Phase 3 Study (LPCN 1154) 80% enrollment milestone, and Exhibit 104, a cover page interactive data file embedded in the Inline XBRL document.

On which exchange is Lipocine (LPCN) common stock listed and under what symbol?

Lipocine’s common stock, par value $0.0001 per share, is listed on The Nasdaq Stock Market LLC under the trading symbol LPCN.

What type of event triggers this Lipocine (LPCN) current report?

The report is triggered by Lipocine’s issuance of a press release announcing that its PPD Phase 3 Study (LPCN 1154) has achieved an 80% enrollment milestone.