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):

October 21, 2019

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. ¨

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

Item 8.01 Other Events

The Company will make several presentations at the 20^th Annual Fall Meeting of the Sexual Medicine Society of North America ("SMSNA"), to take place October 24-27^th 2019 in Nashville, TN. The presentations are filed as Exhibit 99.1, Exhibit 99.2, Exhibit 99.3, Exhibit 99.4, Exhibit 99.4 and Exhibit 99.5.

Item 9.01 Financial Statements and Exhibits.

(d)       Exhibits

The following exhibits are filed with this report:

Exhibit No.	Description
99.1	Oral T (TLANDO) Reduces Liver Fat in Men with Liver Fat Slides
99.2	Improved Patient Reported Sexual and Mental Domain Outcomes with Oral Testosterone (TLANDO) Relative to Topical Testosterone in Treated Hypogonadal Men Poster
99.3	Symptomatic Response to TLANDO in Patients that do not Achieve T Cavg > 300 ng/dL Poster
99.4	Paradigm Shifting Beneficial Effects of TLANDO (Oral Testosterone) on Liver Poster

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:	October 21, 2019	By:	/s/ Mahesh V. Patel
			Mahesh V. Patel
			President and Chief Executive Officer

EX-99.1

1 Confidential 1 SMSNA 2019 October 25, 2019 LPCN Oral T (TLANDO) Reduces Liver Fat in Men with Fat Liver Irwin Goldstein, MD University of California at San Diego Exhibit 99.1

2 Confidential Low T is Associated with NAFLD Across the Disease Spectrum Kim et al., BMC Gastroenterol 2012 “Men with low testosterone are at high risk for NAFLD” “Low T levels in cirrhotic men are associated with the mortality or transplantation” Sinclair et al., Liver Transplant 2016 NAFLD Cirrhosis 0 20 40 60 80 100 1 2 3 4 5 Prevalence of NAFLD(%) Testosterone quintile Free T (ng/dL) Free T (ng/dL) NASH Sumida et al., Gastroenterol Hepatol 2015 “Decreasing levels of free T correlated with increased incidence of inflammation, hepatocyte ballooning, NAS, and fibrosis.”

3 Confidential LPCN Oral T Is Not Hepatotoxic TLANDO (Testosterone Undecanoate) vs Methyl Testosterone LPCN Oral T (TLANDO*) is a non - methylated, orally bioavailable prodrug of natural T Testosterone Undecanoate Testosterone 3 Methyl - TLANDO (Oral TU) * TLANDO, LPCN 1144, and LPCN 1021 include the same active pharmaceutical ingredient, API (Testosterone Undecanoate).

4 Confidential TLANDO Clinical Experience More than 700 subjects have been exposed to TLANDO across 14 clinical studies ▪ Two studies involved the assessment of liver health (liver fat changes and liver enzyme changes) Clinical Study # of Subjects Duration of Study Outcome Established SOAR* Trial [Open label active control] N = 315 210 – TLANDO 105 – Topical T 52 weeks ▪ Significant reduction of elevated liver enzymes ▪ Adequate & well tolerated safety profile Liver Fat Study (LFS) [Open label] N = 36 4 months ▪ Significant liver fat reduction ▪ Well tolerated safety profile * SOAR: Study Of Androgen Replacement

5 Confidential LFS: Higher NAFLD Prevalence in Hypogonadal Men † NAFLD identified by MRI - PDFF ≥ 5% in LPCN 1144 Liver Fat Study ‡ Prevalence of NAFLD diagnosed by imaging hepatosteatosis ≥ 5% liver fat in general population ( Younossi et al., J Hepatol 2016) 66% 25% 0% 10% 20% 30% 40% 50% 60% 70% LFS Population† General Population‡ % of NAFLD Patients NAFLD Prevalence

6 Confidential LFS: Substantial Liver Fat Reduction with TLANDO * Responder rate for relative change is % of patients with at least 30% for relative change from baseline. 71% 80% 75% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% BL ≥ 5% BL ≥ 8% BL ≥ 10% % of Responders Responder Rate for Relative Liver Fat % Change* - 33% - 42% - 40% -60% -50% -40% -30% -20% -10% 0% BL ≥ 5% BL ≥ 8% BL ≥ 10% % Liver Fat Changes from BL Mean Relative Liver Fat % Change 16 Wks

7 Confidential LFS: Longitudinal Improvement in Liver Fat with TLANDO ■ NAFLD Free (LF < 5%) ■ NALFD (LF ≥ 5%) NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free 52% 48% Interim (Week 8, N=31) NAFLD Free NAFLD 63% 38% End of Study (Week 16, N=32) NAFLD Free NAFLD * Full Analysis Set (FAS) ~50% of NAFLD Subjects Experienced Resolution at EOS 34% 66% Baseline (N=32)* NAFLD Free NAFLD

8 Confidential SOAR: Improved Liver Enzymes Post 52 - Wk TLANDO Treatment 8 - 17.4% - 10.3% - 5.1% - 9.6% -25% -20% -15% -10% -5% 0% ALT AST ALP GGT Mean % Change from BL Mean BL (U/L)* 53.6 32.0 74.0 53.6 * TLANDO patients for ALT > 40 U/L at BL; SOAR (NCT02081300), N=42 N 42 4 6 36 BL 53.6 U/L 59.8 U/L 125.3 U/L 82.2 U/L 52% 50% 67% 31% 0% 10% 20% 30% 40% 50% 60% 70% ALT AST ALP GGT % of Patients Normalized at EOS Normalization † of Biomarkers with TLANDO † ALT, AST, ALP, and GGT normal range upper limit is 40 U/L, 43 U/L, 115 U/L, and 49 U/L, respectively

9 Confidential SOAR: Differentiated TLANDO Effect on Biomarkers Compared to Topical T -8% -6% -4% -2% 0% 2% 4% 6% 8% TLANDO Topical T ALT CBL ALT Changes from Baseline -10% -5% 0% 5% 10% 15% TLANDO Topical T ALP CBL ALP Changes from Baseline P=0.009 -30 -20 -10 0 10 20 30 40 TLANDO Topical T TG CBL (mg/dL) TG Changes from Baseline P=0.02 0 2 4 6 8 10 12 TLANDO Topical T Free T CBL (ng/dL) Free T Changes from Baseline P=0.003 P=0.26

10 Confidential Conclusions ▪ Male hypogonadism is strongly associated with NAFLD. ▪ LPCN Oral T (TLANDO: Testosterone Undecanoate) is well tolerated and not hepatotoxic. – No reported cardiac, hepatic or drug related serious adverse events (SAEs) in more than 700 subjects across 14 clinical trials with exposure up to 52 weeks ▪ Unlike Topical T, TLANDO improved liver enzymes in hypogonadal men. ▪ TLANDO is beneficial on liver health demonstrated by liver enzyme improvement and liver fat reduction.

11 Confidential Acknowledgment ▪ Lipocine Team – Jonathan Baker, PhD; Kilyoung Kim, PhD; Ben Bruno, PharmD, PhD; Nachiappan Chidambaram, PhD; Mahesh V. Patel, PhD ▪ Dr. Somaya Albhaisa , MD – Virginia Commonwealth University, Richmond, VA ▪ Dr. Arun Sanyal , MD – Virginia Commonwealth University, Richmond, VA ▪ Dr. Anthony DelConte, MD – Saint Joseph’s University, Philadelphia, PA

EX-99.2

] Improved Patient Reported Sexual and Mental Domain Outcomes with Oral Testosterone (TLANDO) Relative to Topical Testosterone in Treated Hypogonadal Men Kilyoung Kim, PhD 1 , Nachiappan Chidambaram, PhD 1 , Kiran Vangara, PhD 1 , Jonathan Baker, PhD 1 , Mahesh V. Patel, PhD 1 , and Anthony DelConte, MD 1,2 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA □ Conclusion ▪ TLANDO (oral TRT) improves mental and sexual health domains greater than topical TRT ▪ Greater improvement in mental and sexual health may be explained in part by higher restoration of free T levels ▪ Free T levels may be more relevant in evaluating the effect of treatment of male hypogonadism ▪ Additional placebo - controlled studies are warranted to further assess PROs with TLANDO Disclosure All authors are employees of Lipocine Inc. □ Results Mean Total T Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) □ Introduction ▪ Male hypogonadism is characterized by symptoms and deficiency in Testosterone (Total Testosterone (TT) levels of <300 ng/dL) • Critical for sexual, cognitive, and body function/development ▪ Free Testosterone ( fT , only 1% to 4% of TT) is Testosterone not bound to protein and available to bind to receptors for androgenic action. Low fT is defined as < 4 ng/dL (Sarkar et al., Gastroenterol 2019) ▪ TLANDO, an oral Testosterone Undecanoate (TU) lymphatically delivered TRT option with good liver tolerability, is currently under regulatory review • Demonstrated efficacy with consistent intra - and inter - day TT levels • Met efficacy in multiple studies regardless of meal fat content • Showed GI tolerability and good safety profile up to 52 - week study duration □ Objectives ▪ To assess key sexual and mental domain related patient reported outcomes following TLANDO treatment compared to topical TRT in hypogonadal men ▪ To examine the role of fT as the key marker to assess treatment effect in TRT □ Methods ▪ Study of Androgen Replacement (SOAR) Trial (NCT02081300): an active controlled (topical T gel), randomized, multi - center 52 - wk study with TLANDO ▪ Patient Reported Outcomes (PRO) assessed via PDQ and SF - 36 survey at BL and EOS ▪ Calculation of fT using serum TT, albumin (ALB), and SHBG ݂ܶ  ݊݃ ݀ܮ ൌ ܶ݋ݐ݈ܽ  ܶ ሺ ݊݃ ݀ܮ ሻ ൈ ͳ ͳ ൅ ܭ ௌு஻ீ כ ܵܪܤܩ ൅ ݊ כ ܭ ஺௅஻ כ ሾ ܣܮܤ ሿ • [SHBG] in nmol/L, K SHBG = 0.6x10 9 /M, n*K ALB = 4x10 4 /M, [ALB] in mol/L using 69,000 Da per g/L Mean ALB Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) Mean SHBG Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) Mean free T Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) TLANDO Greatly Improved TT and fT Levels in Low fT Subjects ▪ TLANDO Safety x No deaths x No drug related SAEs x No MACE • Only 1% subjects having new start or increase in anti - hypertensive medication x No adverse drug reactions in the Hepatobiliary System Organ Class x GI AEs are minimal and comparable to topical T With Similar TT, TLANDO Increased fT Levels Greater Than Topical T Mean Total T Changes from Baseline by free T Baseline Quartiles in a 1 - yr study (SOAR) Mean free T Changes from Baseline by free T Baseline Quartiles in a 1 - yr study (SOAR) Better Mental and Sexual Domains Response with Greater fT Improvement * PRO responders are defined as subjects with positive changes in PRO. Exhibit 99.2

EX-99.3

] Symptomatic Response to TLANDO in Patients That Do Not Achieve T Cavg ≥ 300 ng/dL Nachiappan Chidambaram, PhD 1 ; Jonathan Baker, PhD 1 ; Ben Bruno, PhD, PharmD 1 ; Kiran Vangara, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 ; Anthony DelConte, MD 1,2 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA □ Conclusion ▪ PK - based non - responders (subjects with Cavg < 300 ng/dL) on TLANDO had meaningful symptomatic/androgenic responses with comparable improvements in relative T level increases, symptoms (PROs), and androgen - related biomarkers as compared to PK - based responders (subjects with Cavg ≥ 300 ng/dL). ▪ Monitoring symptoms in addition to T levels can be performed to evaluate the true responders with TLANDO treatment. □ Contact: Dr. Jonathan Baker, jb@lipocine.com □ Results □ Introduction ▪ Current FDA efficacy criteria is based on pharmacokinetics (PK) for treatment of hypogonadism (T Cavg_24hr: 300 - 1100 ng/dL) • At least 75% of patients achieving normal serum T levels with a lower bound of the associated 95% confidence interval being 65% or more ▪ Most marketed testosterone replacement therapy (TRT) products require titration visits to satisfy the FDA PK - based efficacy criteria and may inaccurately categorize the patients as non - responders based on T levels rather than symptoms on the treatment drugs ▪ PK - based dose titration in clinical use may result in some patients being on the “wrong” dose due to titration decision errors based on a single point T measurement □ Objectives ▪ To assess the effect of TLANDO (oral Testosterone Undecanoate) on symptoms in subjects not achieving T Cavg ≥ 300 ng/dL (PK Non - Responders) at week 13 on stable dose □ Methods ▪ Study of Androgen Replacement (SOAR) clinical trial (NCT02081300) : an active controlled (topical T gel) randomized multicenter 52 - wk study with TLANDO ▪ TLANDO arm patients were started on a total daily dose of 450 mg (225 mg BID) • Dose titration, if needed, at Week 4 and Week 8 was based on intensive 24 - hr PK profiles at steady state with the following criteria: x T Cavg < 300 ng/dL were up - titrated to 300mg BID x T Cmax > 1500 ng/dL were down - titrated to 150mg BID • All subjects were maintained on the dose after the second titration for the remainder of the study (Week 8 through week 52) ▪ Patient Reported Outcomes (PRO) were assessed via PDQ and SF - 36 survey at BL and EOS TLANDO Significantly Improved T Levels in Both PK Non - Responders ( Cavg < 300 ng/dL) and PK Responders ( ≥ 300 ng/dL) TLANDO Treatment Met FDA PK - based Efficacy Criteria Mean Total T % Increases from Pre - dose to Cmax (+SEM) Symptoms Improved with TLANDO Treatment Irrespective of Reaching Cavg Efficacy Criteria Comparable Demographic Characteristics for T Cavg < 300 ng/dL (PK Non - Responders) and ≥ 300 ng/dL (PK Responders) with Overall Baseline Demographics Androgenic Biomarker Baseline and Changes from Baseline to End - of - study Baseline and CBLs of androgenic biomarkers were comparable in both groups. Mean Changes of Mental and Sexual Patient Reported Outcomes from Baseline to End - of - study with 95% CI Improvements of mental and sexual health in both PK non - responders and responders were comparable (p>0.05) Increases of Relative T Levels are Comparable in Both Groups Exhibit 99.3

EX-99.4

] Paradigm Shifting Beneficial Effects of TLANDO (Oral Testosterone) on Liver Mahesh V. Patel, PhD 1 ; Nachiappan Chidambaram, PhD 1 ; Jonathan Baker, PhD 1 ; Kilyoung Kim, PhD 1 ; Anthony DelConte, MD 1,2 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA □ Conclusion ▪ Contrary to hepatotoxic experience with methylated oral T, TLANDO (an innovative lymphatically delivered oral TU) is well tolerated upon prolonged/chronic use ▪ Fatty liver is highly prevalent in hypogonadal males and it warrants a periodic assessment of liver health in hypogonadal men ▪ TLANDO treatment improved liver health as demonstrated by beneficial effects in reductions of elevated liver enzymes and meaningful reductions in abnormally accumulated liver fat. □ Contact: Dr. Jonathan Baker, jb@lipocine.com □ Results – SOAR Trial □ Introduction ▪ 17 - a - methylated Testosterone (e.g., Testred ) indicated as a Testosterone Replacement Therapy (TRT) in males with a deficiency or absence of endogenous Testosterone (hypogonadism) is severely limited in prolonged/chronic use due to liver toxicity inducing liver disease: e.g., peliosis hepatis, hepatic neoplasms, hepatocellular carcinoma cholestatic hepatitis, and jaundice ▪ TLANDO, an oral Testosterone Undecanoate (TU) lymphatically delivered TRT option with good liver tolerability, is currently under regulatory review • Demonstrated efficacy with consistent intra and inter - day TT levels • Met efficacy in multiple studies without regard to meal fat content • Showed GI tolerability and good safety profile up to 52 - week study duration □ Objectives ▪ To evaluate the prolonged use effects of TLANDO (novel oral Testosterone) in male hypogonadal patients ▪ To assess impact of TLANDO treatment on liver health in hypogonadal subjects with Non - Alcoholic Fatty Liver Disease (NAFLD), defined as liver fat of at least 5% □ Methods ▪ To evaluate prolonged use effects of TLANDO: x Study Of Androgen Replacement (SOAR) Trial (NCT02081300): an active controlled (topical T gel) randomized multicenter 52 - wk study with TLANDO treatment arm ▪ To assess liver beneficial effect of TLANDO (225mg BID): x Liver Fat Study (LFS: NCT03868059): a 16 - week open - label, multi - center, single arm study in hypogonadal subjects (N=36) wherein liver fat % was measured by the Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI - PDFF) technique □ Results – Liver Fat Study (LFS) Significant Reduction and Substantial Normalization of Elevated Liver Enzymes Observed with Prolonged TLANDO Treatment Meaningful Reduction of Liver Fat with High Responder Rates * Responder rate for relative change is % of patients with at least 30% for relative change from baseline. Well Tolerated Safety Profile with TLANDO Chronic Use * ALT, AST, ALP, and GGT normal range upper limit is 40 U/L, 43 U/L, 115 U/L, and 49 U/L, respectively □ Results – Liver Fat Study (LFS) ▪ Safety Profile x No adverse drug reactions in the Hepatobiliary System Organ Class x No deaths and no drug related SAEs x No MACE • Only 1% subjects for new start or increase in anti - hypertensive medication † NAFLD identified by MRI - PDFF ≥ 5% in Liver Fat Study ‡ Prevalence of NAFLD diagnosed by imaging hepatosteatosis ≥ 5% liver fat in general population ( Younossi et al, J Hepatol 2016) NAFLD is Overly Prevalent in Hypogonadal Males Higher the BMI, Better the Reduction ~50% Patients Resolved NAFLD with at least 35% Liver Fat Reduction * TLANDO patients for ALT > 40 U/L at BL: N=42 For NAFLD - resolved subjects Exhibit 99.4