false
0001535955
0001535955
2024-01-18
2024-01-18
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
January
18, 2024
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
communication 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
communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communication 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
Entry
into Verity License Agreement
On
January 12, 2024, Lipocine Inc. (the “Company”) entered into a License Agreement (the “License Agreement”) with
Gordon Silver Limited (“GSL”) and Verity Pharmaceuticals, Inc. (“Verity Pharma”), pursuant to which the Company
granted to GSL (an affiliate of Verity Pharma) an exclusive, royalty-bearing, sublicensable right and license to commercialize 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 and Canada. The License Agreement also provides GSL with a license to develop and commercialize TLANDO
XR, the Company’s potential once-daily oral product candidate for testosterone replacement therapy. The Company retains development
and commercialization rights outside of the United States and Canada, and with respect to applications outside of the Field inside or
outside the United States and Canada.
Upon
execution of the License Agreement, GSL agreed to pay the Company a license fee of $11 million with an initial payment of $2.5 million
which was received on signing of the License Agreement, $5 million to be paid on February 1, 2024, $2.5 million to be paid no later than
January 1, 2025, and $1 million to be paid no later than January 1, 2026. The Company is also eligible to receive development and
sales milestone payments of up to $259 million in the aggregate, depending primarily on the achievement of certain sales milestones in
a single calendar year with respect to all products licensed by GSL under the License Agreement. In addition, the Company is eligible
to receive tiered royalty payments at rates ranging from 12% up to 16% of net sales of licensed products in the United States and Canada.
Pursuant
to the terms of the License Agreement, GSL is generally responsible for expenses relating to the development (including the conduct of
any clinical trials) and commercialization of licensed products in the Field in the United States and Canada, while the Company is generally
responsible for expenses relating to development activities outside of the Field and/or the United States and Canada.
The
License Agreement will remain in effect in perpetuity, unless terminated earlier. GSL may generally terminate the License Agreement for
convenience upon a certain number of days’ written notice. Each party has the right to terminate the License Agreement for the
other party’s material breach of its obligations under the License Agreement, subject to cure rights. Either party may terminate
the License Agreement if the other party declares bankruptcy. Upon termination, any license granted by the Company to GSL will terminate
and revert to the Company.
The
License Agreement includes customary representations and warranties on behalf of the Company and Verity as are customarily found in transactions
of this nature, including representations and operative provisions as to the licensed intellectual property, regulatory matters and compliance
with applicable laws. The License Agreement also provides for certain mutual indemnities for breaches of representations, warranties
and covenants.
The
foregoing description of the License Agreement is qualified in its entirety by reference to the full text of the License Agreement, a
copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2023.
The
License Agreement and the above description have been included to provide investors and security holders with information regarding the
terms of the License Agreement. They are not intended to provide any other factual information about the Company or GSL or their respective
subsidiaries or affiliates or stockholders. The representations, warranties and covenants contained in the License Agreement were made
only for purposes of the License Agreement and as of specific dates; were solely for the benefit of the parties to the License Agreement;
and may be subject to limitations agreed upon by the parties, including being qualified by confidential disclosures made by each contracting
party to the other for the purposes of allocating contractual risk between them that differ from those applicable to investors. Investors
should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state
of facts or condition of the Company or GSL or any of their respective subsidiaries, affiliates, businesses or stockholders. Moreover,
information concerning the subject matter of the representations, warranties and covenants may change after the date of the License Agreement,
which subsequent information may or may not be fully reflected in public disclosures or statements by the Company or Verity. Accordingly,
investors should read the representations and warranties in the License Agreement not in isolation but only in conjunction with the other
information about the Company or GSL and their respective subsidiaries that the respective companies include in reports, statements and
other filings made with the U.S. Securities and Exchange Commission.
Item
7.01. Regulation FD Disclosure
On
January 18, 2024, the Company issued a press release announcing the License Agreement. A copy of the press release is attached as Exhibit
99.1 to this Current Report and is incorporated herein by reference.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report and Exhibit 99.1 hereto
are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, or otherwise subject to the liabilities of that Section, nor shall such information or that Exhibit be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended.
Item
9.01. Financial Statements and Exhibits
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: |
January
18, 2024 |
|
By: |
/s/
Mahesh V. Patel |
|
|
|
|
Mahesh
V. Patel |
|
|
|
|
President
and Chief Executive Officer |
Exhibit
99.1
Lipocine
and Verity Pharma Enter into License Agreement
for
TLANDO® Franchise in the U.S. and Canada
|
● |
Lipocine
to receive $11 million license fee |
|
● |
Up to $259 million in development
and commercial sales milestones |
|
● |
Tiered
royalties on net sales of licensed products up to 18% |
|
● |
Commercialization of TLANDO
transitions to Verity Pharma effective Feb.1 2024 |
|
● |
Lipocine retains all rights
for territories outside the United States and Canada, and all non-TRT rights globally |
SALT
LAKE CITY, January 18, 2024 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System
(CNS) disorders, Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an
exclusive licensing agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, in Canada. TLANDO
is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does
not require dose titration. The agreement also provides Verity Pharma with the U.S. and Canadian rights to develop and commercialize
LPCN 1111 (TLANDO XR), a next generation, once daily oral product candidate for TRT.
Under
the terms of the agreement, Lipocine will receive from Verity Pharma a license fee of $11 million with an initial payment of $2.5
million which was received on signing of the License Agreement, $5 million to be paid on February 1, 2024, $2.5 million to be paid no
later than January 1, 2025, and $1 million to be paid no later than January 1, 2026. Lipocine will be entitled to receive up to $259
million in development and sales-based commercial milestone payments, as well as tiered royalty payments at rates ranging from
12% up to 18% on net sales of TLANDO franchise products. Under the agreement, Verity Pharma will be responsible for regulatory and marketing
obligations in the U.S. and Canada, and all further development. Lipocine retains all rights to the TLANDO franchise for territories
outside the U.S. and Canada, and all rights to non-TRT indications globally.
“We
are very pleased to enter this license agreement with Verity Pharma. Men’s health is one of Verity Pharma’s areas of focus
and Verity Pharma’s sales force has existing relationships with men’s health prescribers. Verity Pharma is highly motivated
and has the capabilities and expertise to successfully grow the TLANDO franchise without interruption in patient access to TLANDO,”
said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. “This transaction will further enable Lipocine’s
strategy to focus on developing treatments for CNS disorders and to add value to our non-core assets.”
TRT
is a large and growing market with ~8M annual prescriptions in the U.S. and ~650,000 in Canada.
Raymond
James acted as financial advisor to Lipocine on this transaction.
About
TLANDO
TLANDO
is approved by the FDA as a testosterone replacement therapy (“TRT”) in adult males indicated for conditions associated with
a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital
or acquired). It was developed using Lipocine’s proprietary Lip’ral drug delivery technology platform. For more details,
including full prescribing information, refer to tlando.com.
About
TLANDO XR
TLANDO
XR (also known as LPCN 1111) is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (TT) which
uses Lipocine’s proprietary delivery technology to enhance solubility and improve systemic absorption. Lipocine has successfully
completed a Phase 2b dose finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying
the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.
About
Verity Pharma
Verity
Pharma is a specialty pharmaceutical company focused on delivering meaningful solutions to healthcare professionals and their patients.
Verity
Pharma works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant
deliverable. The company is also committed to supporting programs, initiatives, and organizations that help improve health, expand research
opportunities and promote education within the healthcare community. Learn more at www.veritypharma.com.
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, 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 Verity Pharma’s development and
commercialization of TLANDO and TLANDO XR, the amount of the license fee, milestone payments, and royalty payments we will ultimately
receive, Verity Pharma’s ability to grow the TLANDO franchise, 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
v3.23.4
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Lipocine (NASDAQ:LPCN)
過去 株価チャート
から 5 2024 まで 6 2024
Lipocine (NASDAQ:LPCN)
過去 株価チャート
から 6 2023 まで 6 2024