Current Report Filing (8-k)
April 01 2022 - 04:06PM
Edgar (US Regulatory)
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2022-04-01
2022-04-01
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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):
April
1, 2022
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 No.) |
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 (see General Instruction A.2. below):
☐ |
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 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 1.01 Entry into a Material Definitive Agreement.
Amendment
of Antares License Agreement
As
previously disclosed, on October 14, 2021, Lipocine Inc. (the “Company”) entered into a License Agreement (the “License
Agreement”) with Antares Pharma, Inc. (“Antares”), pursuant to which the Company granted to Antares an exclusive, royalty-bearing,
sublicensable right and license to develop and commercialize, upon final approval of TLANDO® from the U.S. Food and Drug Administration
(“FDA”), the Company’s TLANDO product with respect to testosterone replacement therapy in males for conditions associated
with a deficiency or absence of endogenous testosterone, as indicated in NDA No. 208088, treatment of Klinefelter syndrome, and pediatric
indications relating to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous
testosterone (the “Field”), in each case within the United States. The License Agreement also provides Antares with an option,
exercisable on or before March 31, 2022, to license TLANDO XR, the Company’s potential once-daily oral product candidate for testosterone
replacement therapy. The Company retains development and commercialization rights in the rest of the world, and with respect to applications
outside of the Field inside or outside the United States. Antares will also purchase certain existing inventory of licensed products
from the Company, subject to testing and acceptance procedures.
On
April 1, 2022, the Company entered into the First Amendment to the License Agreement (the “Amendment”), pursuant to
which the License Agreement was amended to extend the deadline by which Antares shall exercise its option to license TLANDO XR to
June 30, 2022. Under the amendment, Antares must now exercise its option to license TLANDO XR on or before June 30, 2022. As
consideration for the Company agreeing to enter into the Amendment, Antares agreed to pay to the Company a non-refundable
cash fee of $500,000. The Amendment also reduced the fee initially payable by Antares upon its exercise of its option to license
TLANDO XR from $1,500,000 to $1,000,000.
The
foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which will
be filed as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ending March 31, 2022.
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: |
April
1, 2022 |
|
By: |
/s/
Mahesh V. Patel |
|
|
|
|
Mahesh
V. Patel |
|
|
|
|
President
and Chief Executive Officer |
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