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):

May 2, 2016

 

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))

Item 7.01 Regulation FD Disclosures

On May 2, 2016, Lipocine Inc. issued a press release announcing the presentation of TLANDO™ (“LPCN 1021”) clinical data at the 2016 American Urological Association Meeting in San Diego, CA. The press release is filed as Exhibit 99.1 and is incorporated herein by reference. Additionally, the Company submitted two abstracts containing TLANDO clinical data at the 2016 American Urological Association Meeting in San Diego, CA and one abstract at the American Association for Clinical Endocrinologists Annual Meeting in Orlando, FL. The Company’s abstracts are filed as Exhibit 99.2, Exhibit 99.3 and Exhibit 99.4 and are incorporated herein by reference.

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 the Presentation of TLANDO Clinical Data at the 2016 American Urological Association Meeting
99.2	Abstract Concerning Long-term Safety and Tolerability of Oral Testosterone (LPCN 1021) in Hypogonadal Men: Results from the 52-Week Phase 3 Study
99.3	Abstract Concerning Hypogonadal Men with Sexual Function Disorder Benefit from LPCN 1021 (Oral Testosterone) – SOAR (Study of Androgen Replacement) Trial
99.4	Abstract Concerning Hypogonadal Men with Diabetes Benefit from LPCN 1021 (Oral Testosterone)

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:	May 2, 2016	By:	/s/ Mahesh V. Patel
			Mahesh V. Patel
			President and Chief Executive Officer

EX-99.1

EXHIBIT 99.1

For Immediate Release

LIPOCINE ANNOUNCES THE PRESENTATION OF CLINICAL DATA FOR ORAL TESTOSTERONE REPLACEMENT THERAPY PRODUCT CANDIDATE TLANDO™ (“LPCN 1021”) AT THE 2016 AMERICAN UROLOGICAL ASSOCIATION ANNUAL MEETING

SALT LAKE CITY (May 2, 2016) – Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that clinical data for lead candidate TLANDO™ (“LPCN 1021”), will be presented in poster and podium presentations at the 2016 American Urological Association Annual Meeting being held May 6-10 in San Diego, CA. TLANDO is an oral testosterone replacement therapy ("TRT") product candidate being developed for adult males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

Details are as follows:

Title:	Hypogonadal Men with Sexual Function Disorder Benefit from LPCN 1021 (Oral Testosterone) – SOAR (Study of Androgen Replacement) Trial
Abstract No.:	MP76-10
Date/Time:	Monday, May 9, 2016, 3:30 – 5:30 p.m. PT
Location:	San Diego Convention Center, Room 24
Presenter:	Culley C. Carson III, MD
	Rhodes Distinguished Professor, University of North Carolina Department of Urology
	President, American Society for Men's Health
	Congress President, International Society of Men’s Health
Title:	Long-term Safety and Tolerability of Oral Testosterone (LPCN 1021) in Hypogonadal Men:  Results from the 52-Week Phase 3 Study
Abstract No.:	PD50-06
Date/Time:	Tuesday, May 10, 2016, 10:30 a.m. – 12:30 p.m. PT
Location:	San Diego Convention Center, Room 23AB
Presenter:	Mohit Khera, MD
	Associate Professor, Urology, Baylor College of Medicine
	Director, Laboratory for Andrology Research
	Medical Director, Houston Hospital for Specialized Surgery

About TLANDO

TLANDO is a novel twice-a-day oral testosterone replacement therapy product candidate that is designed to help restore normal testosterone levels in hypogonadal men. The safety and efficacy of TLANDO is currently under FDA review. Lipocine expects TLANDO will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA "black box" warning related to inadvertent transfer of testosterone to others. According to the IMS Health database, an average of half a million prescriptions a month have been dispensed in 2016 for TRT.

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. TLANDO, an oral testosterone replacement therapy product candidate, demonstrated positive efficacy and safety results in Phase 3 testing and has a New Drug Application under review with the FDA. LPCN 1111, a next-generation oral testosterone replacement therapy product with once-daily dosing, is currently in Phase 2 testing. LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, is currently in Phase 1 testing and has been granted orphan drug designation by the FDA. 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 relating to Lipocine’s common stock, the FDA review process relating to our product candidates and the possible outcome of such process, clinical trials, the potential uses and benefits of our product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA’s review of our NDA for TLANDO, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, the risks related to market conditions for Lipocine’s common stock 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:

John Woolford

Phone: (443) 213-0500

john.woolford@westwicke.com

Media:

Heather Anderson

Phone: (919) 827-5539

handerson@6degreespr.com

EX-99.2

EXHIBIT 99.2

AUA Abstract

Word Count: 2280 characters (not including spaces, but including title) allowed; current draft has 2268 characters.

Long-term Safety and Tolerability of Oral Testosterone (LPCN 1021) in Hypogonadal Men: Results from the 52-Week Phase 3 Study

Mohit Khera, MD¹, Christina Wang, MD², Jed C. Kaminetsky, MD³, Martin M. Miner, MD⁴, Adrian S Dobs, MD, MHS⁵, Nachiappan Chidambaram⁶, Anthony DelConte, MD^6,7, Satish Nachaegari⁶, Mahesh Patel⁶

¹Baylor College of Medicine, Houston, TX, ²Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, ³University Urology Associates, New York, NY, ⁴Brown University and the Miriam Hospital, Providence, RI, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Lipocine, Inc. Salt Lake City, UT, ⁷Saint Joseph’s University, Philadelphia, PA

Introduction: LPCN 1021 is a novel oral testosterone undecanoate (TU) formulation, absorbed primarily via lymphatics bypassing the liver. LPCN 1021 has been shown to be safe and efficacious after 13 weeks in a randomized, active-controlled Phase 3 study.¹ We report long-term safety and tolerability of LPCN 1021 in hypogonadal subjects who continued receiving treatment for up to 52 weeks.

Methods: Hypogonadal patients (serum T levels < 300 ng/dL) were randomized in a 2:1 ratio to LPCN 1021 or T gel 1.62% (active control) and titrated to a successful dose of the assigned treatment. Following a 13-week efficacy phase, subjects continued receiving their assigned study drug for up to 52 weeks. Subjects returned to the clinic at Weeks 26, 39, and 52 for safety assessments and to provide a 3 to 6 hour post dose blood sample. Safety assessments included an evaluation of adverse events (AEs), clinical laboratory tests, and physical examinations.

Results: 210 subjects were randomized to LPCN 1021 and 105 to active control. Eugonadal T levels were restored with LPCN 1021 (Week 13 mean [SD] Cavg of 446 [171] ng/dL) and were reliably maintained throughout 52 weeks. AEs occurred in 67% of LPCN 1021 subjects and 65% of T gel 1.62% subjects. No hepatic, cardiac, or drug-related serious AEs occurred. The most common drug-related AEs (adverse drug reactions, ADRs) for LPCN 1021 and T gel 1.62% were acne (2.9% vs 2.9%, respectively), headache (0.5% vs 3.8%, respectively), weight increase (2.4% vs 0%, respectively), hematocrit increase (1.9% vs 0%, respectively), liver enzyme level increase (1.4% vs 0%, respectively), fatigue (0.5% vs 1.9%, respectively), and hypertension (0.5% vs 1.9%, respectively). All ADRs were mild or moderate in severity. Subjects receiving LPCN 1021 reported few androgenic ADRs with no reports of sleep apnea or oily skin and 1% or fewer subjects reporting peripheral edema and polycythemia. Most lipid parameters (cholesterol, LDL, HDL, and TG) were comparable between treatment groups at Week 52. Other androgenic parameters including hematocrit, hemoglobin, platelet, prothrombin, and PSA showed no significant differences in change from baseline to end of study between treatments.

Conclusions: LPCN 1021 was well tolerated and had a favorable safety profile in the long-term management of hypogonadal subjects. Notably, no hepatic safety concerns were identified and gastrointestinal AEs with oral LPCN 1021 were generally comparable to active control.

¹Wang C, et al. Endo Rev. 2015;36(2) Suppl. Abstract OR34-5.

Keywords: Testosterone, clinical trial, hormonal therapy

EX-99.3

EXHIBIT 99.3

AUA abstract

Word Count: 2280 characters (not including spaces, but including title) allowed; current draft has 2261 characters.

Hypogonadal Men with Sexual Function Disorder Benefit from LPCN 1021 (Oral Testosterone) – SOAR (Study of Androgen Replacement) Trial

Culley C. Carson, MD¹, Mohit Khera, MD², Adrian S Dobs, MD, MHS³, Christina Wang, MD⁴, Jed C. Kaminetsky, MD⁵, Irwin Goldstein, MD⁶, Anthony DelConte, MD^7,8, Nachiappan Chidambaram⁸, Satish Nachaegari⁸, Mahesh Patel⁸, Martin M. Miner, MD⁹

¹Department of Urology, University of North Carolina, Chapel Hill, NC,²Baylor College of Medicine, Houston, TX, ³Johns Hopkins University School of Medicine, Baltimore, MD,⁴Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, ⁵University Urology Associates, New York, NY, ⁶Alvarado Hospital, San Diego, CA, ⁷Saint Joseph’s University, Philadelphia, PA, ⁸Lipocine, Inc. Salt Lake City, UT, ⁹Brown University and the Miriam Hospital, Providence, RI

Introduction:  Sexual dysfunction (SD) has been associated with hypogonadism.¹ Testosterone (T) therapy is indicated for treating hypogonadism and related symptoms. However, topical or parenteral T formulations are associated with inadvertent T transference, poor compliance, and superphysiologic T levels in some patients. There is a need for T formulations that improve patient compliance, mitigate transference, and achieve more consistent serum T levels. LPCN 1021 is a novel oral T undecanoate formulation assessed in a Phase 3 (SOAR) trial that may avoid some of the undesirable attributes of non-oral T formulations.

Methods:  SOAR is a randomized, active–controlled, 2-arm, 12-month, open-label, multicenter, dose-titration trial that included 314 hypogonadal (T<300ng/dl on 2 separate days) men between 18 and 80 years old.  Participants were randomized to either LPCN 1021 (n=210) or T gel 1.62% (n=104).  Of the 314 hypogonadal men, 88 (28%) had SD at baseline. Subjects with baseline SD had poorer quality erections (p=0.011) and more difficulty maintaining erections (p=0.017) than hypogonadal subjects without SD. The LPCN 1021 dose could be titrated up (e.g. if T C_ave, _24h <300 mg/dL) or down (e.g. if T C_max was >1500 mg/dL) at Weeks 4 and 8 based on 24 h PK, if required. T gel 1.62% was titrated based on manufacturer’s instruction. Sexual function and mood changes were assessed by the Psychosexual Daily Questionnaire (PDQ) for 7 days preceding visits. Quality of life (QoL) was assessed by the SF-36 questionnaire at Weeks 1 and 52 (end of study).

Results:Hypogonadal subjects with SD were significantly older (p=0.001), and had lower serum estradiol levels (p=0.043); baseline T levels were not significantly different. Sexual desire and activity, which were similar in both groups at baseline, improved to a similar extent in each group. In men with and without SD, LPCN 1021 significantly improved penile rigidity (p<0.001 and p=0.028, respectively) and ability to maintain an erection (p<0.001 and p=0.007, respectively). Non-significant differences were observed for the same with T gel 1.62%. In addition, LPCN 1021 significantly improved depressed mood (p=0.002), mental health (p=0.023) and mental component summary (p=0.008) in hypogonadal subjects with SD.

Conclusions: Twice daily administration of oral LPCN 1021 over 52 weeks improved several parameters of sexual function in hypogonadal men with SD prior to treatment.

¹Cunningham GR, et al. J Clin Endocrinol Metab. 2015 Mar;100(3):1146-55.

EX-99.4

EXHIBIT 99.4

Am Assoc Clin Endo: Wang C, Kaminetsky JC, Miner MM, et al. 2016

American Association for Clinical Endocrinologists Annual Meeting, May 25-29, 2016 – Orlando, FL

HYPOGONADAL MEN WITH DIABETES BENEFIT FROM LPCN 1021 (ORAL TESTOSTERONE)

Christina Wang, MD¹, Jed C. Kaminetsky, MD², Martin M. Miner, MD³, Adrian S Dobs, MD, MHS⁴, Anthony DelConte, MD^5,6 Nachiappan Chidambaram⁶, Satish Nachaegari⁶, Mahesh Patel⁶, Mohit Khera, MD⁷

¹Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, ²University Urology Associates, New York, NY, ³Brown University and the Miriam Hospital, Providence, RI, ⁴Johns Hopkins University School of Medicine, Baltimore, MD, ⁵Saint Joseph’s University, Philadelphia, PA, ⁶Lipocine, Inc. Salt Lake City, UT, ⁷Baylor College of Medicine, Houston, TX

Objective: Hypogonadism is more prevalent in men with type 2 diabetes mellitus (DM). Testosterone (T) therapy is indicated for treating hypogonadism and related symptoms. LPCN 1021 is a novel oral T undecanoate formulation that may avoid some undesirable attributes of non-oral T formulations, such as transference or skin irritation. We sought to determine the effect of LPCN 1021 use in hypogonadal men with DM vs those without DM.

Methods: This was a randomized, active–controlled, 2-arm, 12-month, open-label, multicenter, dose-titration trial in hypogonadal (T<300ng/dL on 2 separate days) men between 18 and 80 years old. Subjects were randomized to either LPCN 1021 (n=210) or Androgel 1.62% (n=104). Of 314 hypogonadal men, 82 (26%) reported medical history of DM. The LPCN 1021 dose could be adjusted based on T Cmax and T Cavg levels at weeks 4 and 8, if required. Sexual function and mood changes were assessed by the Psychosexual Daily Questionnaire (PDQ) for 7 days preceding visits. Quality of life (QoL) was assessed by the SF-36 questionnaire at Weeks 1 and 52 (end of study, EOS).

Results: Hypogonadal (HG) men with DM were significantly (p<0.05) older (57 vs 52 years), with higher baseline HbA1c (7.5% vs 5.6%), lower QoL scores (physical functioning, role physical, general health and physical component summary) and lower PDQ scores (sexual desire, sexual pleasure with partner, and erectile function) than HG men without DM. Significant (p<0.05) reduction in sexual hormone binding globulin (22.8 vs 29.8 nmol/L) and HDL (1.1 vs 1.2 mmol/L) occurred post LPCN 1021 therapy (EOS) for HG men with DM vs baseline; significant (p<0.05) improvement in free T level (10.9 vs 5.8 ng/dL) and PDQ parameters (sexual desire and activity, sexual pleasure, erectile function, positive and negative mood) were observed for HG men with DM at EOS vs baseline. Mean T (430 vs 483 ng/dL), DHT (105 vs 117 ng/dL) and estradiol Cavg (26 vs 29 pg/mL) were comparable (p>0.05) between HG men with and without DM at Week 13 (efficacy visit) post LPCN 1021 therapy, respectively. Parameters that showed significant improvements post LPCN 1021 in HG men with DM also showed significant improvements in men without DM.

Discussion: HG men with DM had significantly lower baseline scores for some QoL and sexual function scores vs HG men without DM. HG men with and without DM improved significantly in sexual domains post LPCN 1021, similar to men without DM. T, DHT and E2 levels were comparable post LPCN 1021 between HG men with and without DM.

Conclusion: LPCN 1021 is an effective treatment in HG men with or without DM for restoring serum T levels to the physiological range and relieving some HG symptoms.