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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
19, 2026
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(c) under the Exchange Act (17 CFR 240.13e-4(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. ☐
On
May 19, 2026, the Company issued a press release announcing Lipocine’s LPCN 1154 Phase 3 data has been accepted for oral presentation
at the 2026 ASCP Annual Meeting to be held May 26-29, 2026, in Miami, Florida. The press release is furnished as Exhibit 99.1 to this
report and incorporated by reference herein.
| Item
9.01 |
Financial
Statements and Exhibits. |
The
following exhibits are filed with this report:
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
19, 2026 |
By: |
/s/
Mahesh V. Patel |
| |
|
|
Mahesh
V. Patel |
| |
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
Announces LPCN 1154 Phase 3 Data Accepted for Oral Presentation at 2026 ASCP Annual Meeting
SALT
LAKE CITY, May 19, 2026 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology
platform to augment therapeutics through effective oral delivery, today announced that its Phase 3 clinical data for LPCN 1154 have been
selected for oral and poster presentation at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, to
be held May 26–29, 2026, in Miami, FL.
Oral
Presentation details
| Title: |
Novel
Oral Rapid-Acting Neuroactive Steroid for Treatment of Postpartum Depression: A Placebo-Controlled Phase 3 Clinical Trial of LPCN
1154 |
| |
|
| Presenter:
|
Benjamin
Bruno, PhD, Vice President, Clinical Development, Lipocine |
| |
|
| Session: |
Pharmaceutical
Pipeline (Oral Presentation) |
| |
|
| Date: |
Tuesday,
May 26, 2026 |
| |
|
| Time: |
3:20
PM ET |
| |
|
| Location: |
Loews
Miami Beach Hotel, Miami, FL |
The
presentation will highlight results from Lipocine’s Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for
the treatment of postpartum depression (PPD).
Poster
Presentation
| Date: |
Wednesday,
May 27, 2026 |
| |
|
| Time: |
11:45
AM – 1:30 PM ET |
| |
|
| Session: |
Poster
Session 1, Pharmaceutical Pipeline |
| |
|
| Poster
number: |
W98 |
“We
are pleased that our Phase 3 data for LPCN 1154 was selected for an oral presentation at this year’s ASCP meeting, a leading forum
for clinical psychopharmacology research,” said Mahesh V. Patel, Ph.D., President and Chief Executive Officer of Lipocine.
About
LPCN 1154
LPCN
1154, oral brexanolone, a non-SSRI, is chemically identical to the endogenous human hormone allopregnanolone. Brexanolone is a positive
allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 1154 has the potential for rescue therapy for PPD with acute stabilization
of symptoms in hours and no intensive monitoring requirement. LPCN 1154 has demonstrated clinically meaningful improved tolerability
including low CNS depressant side effects, without the risks of disassociation or hallucination of psychedelics, thus potentially enabling
a safe, at-home intervention, preserving the maternal-infant bond.
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 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 LPCN 1154 and related
efforts with the FDA, the potential uses and benefits of LPCN 1154 on the treatment of PPD, the commercial potential for LPCN 1154, 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
[email protected]
Investors:
PJ
Kelleher
Phone:
(617) 430-7579
[email protected]