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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):
September
10, 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
September 10, 2026, the Company issued a press release announcing that it is presenting and meeting with investors at the H.C.
Wainwright 28th Annual Global Investor Conference held September 14 – 16, 2026, in New York City, NY. A copy of the
press release is furnished as Exhibit 99.1 to this report to this report and incorporated by reference herein.
| Item
9.01 |
Financial
Statements and Exhibits. |
The
following exhibits are filed with this report:
| Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release announcing Lipocine to Present at the H.C. Wainwright 28th Annual Global Investment Conference |
| |
|
|
| 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: |
September
10, 2026 |
|
By: |
/s/
Mahesh V. Patel |
| |
|
|
|
Mahesh
V. Patel |
| |
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
to Present at the H.C. Wainwright 28th Annual Global Investment Conference
SALT
LAKE CITY, September 10, 2026 — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development
of novel oral therapeutics, today announced that Company management will present and meet with investors at the H.C. Wainwright 28th
Annual Global Investment Conference, to be held in person and virtually September 14-16, 2026.
Presentation
Details
| Date: |
Wednesday, September 16, 2026 |
| Time: |
10am ET |
| Location: |
New York, NY |
Investors
can register for the conference here. Those interested in arranging a one-on-one meeting with Lipocine should contact their H.C.
Wainwright representative.
The live webcast and subsequent replay
of the presentation can be accessed in the “Events” section of Lipocine’s website after the presentation. The webcast
will be archived and available for 90 days following the live event.
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 our products and product
candidates and related efforts with the FDA, including the timing of clinical trials and regulatory submissions, the potential uses and
benefits of our products and product candidates, the commercial potential for our product candidates, and potential strategic partnerships
and other 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:
PJ
Kelleher
Phone:
(617) 430-7579
pkelleher@lifesciadvisors.com