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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
19, 2023
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
On
December 19, 2023, the Company issued a press release announcing that its management will present at the Biotech Showcase and host institutional
investor and partnering meetings at this event and a Corporate Access Event organized by LifeSci Partners. The press release is filed
as Exhibit 99.1 and is incorporated herein by reference.
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: |
December
19, 2023 |
|
By: |
/s/
Mahesh V. Patel |
|
|
|
|
Mahesh
V. Patel |
|
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
to Present at Biotech Showcase 2024
Company
Management Will Also Host Meetings at LifeSci Partners Corporate Access Event
SALT
LAKE CITY, December 19, 2023 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused
on treating Central Nervous System (CNS) disorders, today announced that it will present at the Biotech Showcase and host
institutional investor and partnering meetings at this event and at a Corporate Access Event organized by LifeSci Partners. Both
in-person events will take place January 8 - 10, 2024, in San Francisco, California.
Biotech
Showcase
Date:
|
Monday,
January 8, 2024, 3:00PM PT |
Location: |
Yosemite
A (Ballroom Level), Hilton Hotel Union Square, San Francisco |
Registered
attendees may attend the presentation in-person or view it via webcast through the Biotech Showcase platform. Management will be available
for 1-on-1 meetings on January 8. To schedule a meeting, investors can register on the Biotech Showcase website.
LifeSci
Corporate Access Event
Date:
|
Tuesday,
January 9, 2024, and Wednesday January 10, 2024 |
Location: |
Beacon
Grand Hotel, San Francisco |
Please
click here to register for the conference and schedule a meeting with management via the online system managed by LifeSci Partners.
About
Lipocine
Lipocine
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which
we are exploring partnering. 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 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, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated
cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone
replacement therapy (TRT). 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, the application
of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development
of and filing of a NDA with the FDA for LPCN 1148, 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 to treat CNS disorders, 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.
SOURCE
Lipocine Inc.
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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