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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):
August
27, 2024
![](https://www.sec.gov/Archives/edgar/data/1535955/000149315224033967/form8-k_002.jpg)
LIPOCINE
INC.
(Exact
name of registrant as specified in its charter)
Commission
File No. 001-36357
Delaware |
|
99-0370688 |
(State
or other jurisdiction |
|
(IRS
Employer |
of
incorporation) |
|
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. ☐
Item
8.01 Other Events
The
Company issued a press release announcing that it is to present at the H.C. Wainwright 26th Annual Global Investor Conference
on September 9, 2024. The press release is filed as Exhibits 99.1.
Item
9.01 Financial Statements and Exhibits.
(d)
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: |
August
27, 2024 |
|
By: |
/s/
Mahesh V. Patel |
|
|
|
|
Mahesh
V. Patel |
|
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
to Present at H.C. Wainwright 26th Annual Global Investment Conference
SALT
LAKE CITY, August 27, 2024— Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform
to augment therapeutics through effective oral delivery, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer,
will present and meet with investors at the H.C. Wainwright 26th Annual Global Investment Conference being held in-person and virtually
on September 9-11, 2024.
Presentation
Details
Time:
|
|
Available
from 7:00 a.m. EDT onwards |
Date: |
|
Monday,
September 9, 2024 |
Webcast
Link: |
|
https://journey.ct.events/view/50f7964c-3a38-4f56-9dfa-454d6c66e39f |
Investors
can register for the conference here. Those interested in arranging a 1x1 meeting with Lipocine should contact their H.C. Wainwright
representative.
About
Lipocine
Lipocine
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products. 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
clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101
for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral
proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin
mimetics, as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug
for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities
for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for chronic
weight management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic
NASH. 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 product development efforts, our strategic
plans for developing products, our ability to monetize product candidates, including through entering into partnering arrangements, our
product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and
completion of regulatory reviews, outcomes of clinical trials of our product candidates, 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, we may not be able to enter into partnerships or other strategic relationships to monetize our
non-core assets, the FDA will 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.
For
further information:
Krista
Fogarty
Phone:
(801) 994-7383
kf@lipocine.com
Investors:
PJ
Kelleher
Phone:
(617) 430-7879
pkelleher@lifesciadvisors.com
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