Form 8-K - Current report

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

Exhibit No.		Description
99.1		Press Release announcing Lipocine and Verity Enter into U.S. Licensing Agreement to Commercialize TLANDO

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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

Cover	Jan. 18, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 18, 2024
Entity File Number	001-36357
Entity Registrant Name	LIPOCINE INC.
Entity Central Index Key	0001535955
Entity Tax Identification Number	99-0370688
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	675 Arapeen Drive
Entity Address, Address Line Two	Suite 202
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84108
City Area Code	(801)
Local Phone Number	994-7383
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	LPCN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false