8-K

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 20, 2018

 

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))

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 20, 2018, Lipocine Inc. issued a press release announcing the presentation of LPCN 1144 clinical data at Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD in Santa Fe, New Mexico on January 22, 2019. The press release is filed as Exhibit 99.1 and are incorporated herein by reference.

Additionally, the Company will highlight the association of hypogonadism and non-alcoholic fatty liver disease (“NAFLD”) including LPCN 1144 clinical results in which liver fat was assessed via Magnetic Resonance Imaging-Proton Density Fat Fraction (“MRI-PDFF”) in hypogonadal males at the Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD. The abstract is filed as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

(d)       Exhibits

The following exhibits are filed with this report:

Exhibit No.	Description
99.1	Press Release Announcing LPCN 1144 MRI-PDFF Clinical Results Selected for Presentation at Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD
99.2	Abstract Entitled “Hypogonadism is Associated with NAFLD: LPCN 1144 MRI-PDFF Clinical Results”

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 20, 2018	By:	/s/ Mahesh V. Patel
			Mahesh V. Patel
			President and Chief Executive Officer

EX-99.1

Exhibit 99.1

Lipocine Announces LPCN 1144 MRI-PDFF Clinical Results Selected for Presentation at Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD

SALT LAKE CITY, UT, December 20, 2018 – Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, announced today that it has been selected to present LPCN 1144 clinical results as part of the Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD. The presentation will highlight the association of hypogonadism and non-alcoholic fatty liver disease (“NAFLD”) including LPCN 1144 clinical results in which liver fat was assessed via Magnetic Resonance Imaging-Proton Density Fat Fraction (“MRI-PDFF”) in hypogonadal males. The Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD is being held January 20^th – 24^th in Santa Fe, NM.

Presentation Details

Title:	Hypogonadism is Associated with NAFLD: LPCN 1144 MRI-PDFF Clinical Results
Publication Number:	2034
Date:	Tuesday, January 22nd
Location:	Eldorado Hotel & Spa, Santa Fe, New Mexico
Time:	7:30 p.m. – 10:00 pm

"We look forward to sharing LPCN 1144 MRI-PDFF clinical results as part of the Keystone Symposia on Integrated Pathways of Disease in NASH and NAFLD," stated Mahesh Patel, Ph.D., Lipocine's Chairman, President and Chief Executive Officer. "In our study and based on liver fat ≥ 5%, about 70% of hypogonadal patients were identified as having NAFLD suggesting male hypogonadism is an underappreciated comorbidity in NAFLD and NASH,” Dr. Patel further stated.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes four development programs TLANDO, LPCN 1144, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. TLANDO received a Complete Response Letter from the FDA on May 8, 2018. LPCN 1144, an oral prodrug of bioidentical testosterone, is being developed as a treatment of non-alcoholic steatohepatitis ("NASH") and is currently being studied in two proof-of-concept clinical studies. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. 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 Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, including LPCN 1144, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that 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.

CONTACT:

Morgan Brown

Executive Vice President & Chief Financial Officer

Phone: (801) 994-7383

mb@lipocine.com

Investors:

Hans Vitzhum

Phone: (646) 597-6979

hans@lifesciadvisors.com

EX-99.2

Exhibit 99.2

Hypogonadism is Associated with NAFLD: LPCN 1144 MRI-PDFF Clinical Results

Kilyoung Kim¹, Burke Byrne¹, Jonathan Baker¹, Nachiappan Chidambaram¹, Mahesh V. Patel¹, Arun Sanyal², and Michael Charlton³

¹Lipocine Inc., Salt Lake City, UT, USA; ²Virginia Commonwealth University, VA, USA; ³University of Chicago, IL, USA

Male hypogonadism (testosterone, T, level < 300 ng/dL) is an underappreciated comorbidity in non-alcoholic fatty liver disease (NAFLD)/ steatohepatitis (NASH). In addition to the established link between low T levels and facets of the metabolic syndrome (obesity, hypertension, hypertriglyceridemia, and type 2 diabetes), hypogonadism is also associated with NAFLD/NASH in males. Serum levels of free T in male patients with biopsy confirmed NASH have been inversely related with severity of lobular inflammation, ballooning, NAFLD activity and fibrosis.

The aim of this investigation was to evaluate the prevalence of fatty liver in hypogonadal patients, as identified by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF), a non-invasive quantitative biomarker of liver fat content.

In an ongoing prospectively designed open-label, multi-center, single arm ‘Liver Fat Study’ evaluating LPCN 1144 treatment in hypogonadal patients, baseline % liver fat was assessed via MRI-PDFF in a subset of study patients (N=36).

The prevalence of features of the metabolic syndrome was: 81% obese, 58% hypertriglyceridemia, 28% hypertensive, and 17% type 2 diabetes. Body Mass Index (BMI), T level, and liver fat fraction were 34±6 kg/m², 199±61 ng/dL, and 8.8±7.9% (mean±SD), respectively. Based on liver fat ≥ 5%, about 70 % of hypogonadal patients were identified as having NAFLD. Among patients with NAFLD, obesity was the most prevalent comorbidity (88%) with increased prevalence of NAFLD rising to 100% with Class III obesity (BMI ≥ 40 kg/m²). Prevalence of NAFLD in hypogonadal obese patients is ~200% compared with corresponding US obese population (NHANES).

In conclusion, NAFLD is over represented in hypogonadal men. Obesity has the strongest association with NAFLD in the hypogonadal male patients. Based on the established association of male T deficiency with sarcopenia, increased visceral adipose tissue, and insulin resistance, evaluation of hypogonadal status should be considered in NAFLD patients and possibly to assess risk of NAFLD. A detailed, prospective study of the safety and efficacy of androgen therapy on NASH and metabolic endpoints is warranted.