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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):
October
26, 2023
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
October 26, 2023, the Company issued a press release announcing the successful completion of its meeting with the FDA and its plan to
initiate a pivotal registration study for LPCN 1154 targeting postpartum depression. The press release is filed as Exhibits 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: |
October
26, 2023 |
|
By: |
/s/
Mahesh V. Patel |
|
|
|
|
Mahesh
V. Patel |
|
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
Completes Successful Meeting with FDA on LPCN 1154 in Postpartum Depression
|
● |
Lipocine
and FDA agreed on the acceptance criteria for the pivotal study which enables advancement of LPCN 1154 for postpartum depression
(PPD) |
|
|
|
|
● |
Company
on track to initiate dosing in the pivotal study Q1’24 |
SALT
LAKE CITY, October 26, 2023 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System
(CNS) disorders by leveraging its proprietary platform, today announced the completion of a meeting with the FDA and guidance for the
appropriate acceptance criteria for the upcoming LPCN 1154 pivotal study.
PPD
is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12
months after childbirth. LPCN 1154 is targeted to be a differentiated oral option with rapid-onset, robust efficacy, and short treatment
duration as a mono or add-on therapy for patients with unresolved depression symptoms.
Following
positive results from the pilot PK bridge study, Lipocine completed a successful meeting with the U.S. Food and Drug Administration (FDA)
on October 18th with agreement on the following:
|
1) |
Confirmation
of Lipocine’s proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the
approved IV infusion of brexanolone |
|
|
|
|
2) |
The
use of exposure parameters and criteria to assess comparable exposure to IV infusion brexanolone |
Consistent
with the goal to file a New Drug Application (NDA) in 2024, the company anticipates beginning the pivotal study program in Q1’24
with LPCN 1154 “to be marketed” formulation. Top line results from the study are expected by Q2 ‘24.
“We
are thankful for FDA’s guidance and are pleased to reach an agreement on key elements of pivotal study design and other components
required for registration,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “PPD is a serious condition, and we
are developing LPCN 1154 to be a highly effective, oral, fast-acting and short duration treatment option. We believe rapid relief within
3 days will be important for patients and, if approved, LPCN 1154 has the potential to be a differentiated preferred treatment option
for PPD.”
About
LPCN 1154
LPCN
1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression
(PPD). Brexanolone is a bioidentical to naturally occurring neuro active steroid, allopregnanolone, a positive allosteric modulator of
y-aminobutyric acid (GABA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with
severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse
reactions to breastfed infants from exposure to brexanolone.
About
Postpartum Depression and Unmet Needs:
PPD
is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12
months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include
hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia,
sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of
death or suicide. Approximately 500,000 women are affected by PPD annually in the United States and, according to the CDC, an estimated
175,000 women suffer from moderate to severe PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side
effects such as sexual dysfunction and weight gain, and do not demonstrate adequate remission post-acute treatment. The current approved
standard of care is a continuous infusion of intravenous brexanolone which requires inpatient administration and has significant limitations.
About
Lipocine
Lipocine
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop products for CNS disorders. Lipocine has candidates in development as well as candidates for which we are exploring partnering.
Our candidates represent enablement of patient friendly oral delivery options for favorable benefit to risk profile which target large
addressable markets with significant unmet medical needs.
Lipocine
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, an oral prodrug of bioidentical testosterone 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 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, our strategic
plans for developing products to treat CNS disorders, our ability to monetize non-core product candidates, including through entering
into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, 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 to treat CNS disorders, 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, 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) 430-7579
pkelleher@lifesciadvisors.com
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