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):

November 9, 2020

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 virtual oral presentations at the 21^st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America, Inc. (“SMSNA”) on November 9-15, 2020. The Company’s materials to be included are filed as Exhibits 99.1 and 99.2.

Item 9.01 Financial Statements and Exhibits.

(d)       Exhibits

The following exhibits are filed with this report:

Exhibit No.	Description
99.1	Presentation titled “TLANDO™, Oral Testosterone Replacement Therapy Without Dose Titration Requirement”
99.2	Presentation titled “Is Oral Testosterone a Potential Treatment for COVID-19 in Men?”

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:	November 9, 2020	By:	/s/ Mahesh V. Patel
			Mahesh V. Patel
			President and Chief Executive Officer

EX-99.1

TLANDO™, Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men Anthony DelConte, MD 1,2 ; Nachiappan Chidambaram, PhD 1 ; Kongnara Papangkorn, PhD 1 ; Benjamin J. Bruno, PharmD, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 1 Lipocine Inc., Salt Lake City, UT; 2 Saint Joseph’s University, Philadelphia, PA 1 SMSNA 2020 *Dr. DelConte is a medical director and paid consultant at Lipocine, Inc, ** Drs Chidambaram, Papangkorn, Bruno, Kim, and Patel are employees of Lipocine, Inc Exhibit 99.1

Background • Most marketed testosterone replacement therapy (TRT) products require multiple titration visits to achieve desired eugonadal testosterone (T) levels • Typical titration for TRT takes 3 - 6 months to reach efficacious dose for majority of patients 2

TLANDO* Unique Delivery System Enables Effective Oral TRT Performance □ Not known to produce adverse events that are associated with 17 - methylated testosterone □ Consistent intra & inter - day T restoration* * LPCN 1021 - 14 - 001 Study * LPCN 1021 - 13 - 001 Study: 225mg BID 3 □ Not prone to lower exposure with low fat meal - allows for meal fat flexibility x Avoids abnormal levels post accidental meal fat changes *TLANDO is currently under FDA review for marketing approval

Objective and Study Designs □ The objective was to assess whether TLANDO, to - be - marketed oral TRT option without need for any dose adjustment, can safely and effectively restore testosterone levels in hypogonadal men 4 □ Two P3 studies with TLANDO without dose titration were performed ▪ Study 16 - 002 : A 24 - day, open - label, single - arm, multicenter study with in hypogonadal men (N=95, NCT03242590) ▪ Study 18 - 001 : A 4 - month, open - label, single - arm, multicenter study with in hypogonadal men (N=138, NCT03868059) • 20% of uncontrolled hypertensive patients (SBP > 140 mmHg) were tested Demographics 16 - 002 (N=95) 18 - 001 (N=138) Age, mean ( yrs ) 56.0 53.8 % for ≤ 65 yrs 83.2 87.0 % for > 65 yrs 16.8 13.0 BMI, mean (kg/m 2 ) 32.8 33.1 Baseline T, mean (ng/dL) 202 204

TLANDO Efficacy & Tolerability Daily dose 450mg without requiring dose adjustment □ Efficacy* ▪ 81% (95% CI: 72 – 88%) ▪ Mean T Cavg : 478 ng/dL □ Adverse Events ▪ No death, no drug - related SAEs ▪ Mild to moderate Adverse Reaction ≥ 2% (STUDY 18 - 001) Overall (N=138) n (%) Hematocrit increased/Polycythemia 6 (4.3) Adverse Reaction ≥ 2% (STUDY 16 - 002) Overall (N=95) n (%) Blood prolactin increased 4 (4.2) 5 Nighttime peak Daytime peak * PK measured at efficacy day (Day 24) in Study 16 - 002

Summary & Conclusions □ Safety and efficacy of TLANDO™ (Oral Testosterone Undecanoate) was confirmed □ TLANDO™ is a novel oral TRT option without requiring dose titration □ Start of therapy with the effective dose without delay □ Devoid of accidental T transference and pulmonary oil micro - embolism risks □ No burden of additional dose adjustment visits/invasive samplings □ Potential to improve compliance and persistence rates 6

EX-99.2

Is Oral Testosterone a Potential Treatment for COVID - 19 in Men? Benjamin J. Bruno, PharmD/PhD 1 ; Kongnara Papangkorn, PhD 1 , Anthony DelConte, MD 1,2 , Nachiappan Chidambaram, PhD 1 , Kilyoung Kim, PhD 1 , Mahesh V. Patel, PhD 1 1 1 Lipocine Inc., Salt Lake City, UT; 2 Saint Joseph’s University, Philadelphia, PA SMSNA 2020 * Drs. Bruno, Papangkorn, Chidambaram, Kim, and Patel are employees of Lipocine Inc. ** Dr. DelConte is a paid consultant to Lipocine Inc. Exhibit 99.2

COVID - 19 Epidemiology Gender Differences on COVID - 19 Infection and Outcomes 2 Sleep Apnea Chemotherapy Injury Age > 65 Hypertension Diabetes CAD COPD Obesity Malignancy Asthma CKD COVID - 19 Hypogonadism 0 10 20 30 40 50 60 70 COVID Cases COVID Deaths % Male Female • Despite being infected at equal rates, men are 2 - 3x more likely to die from COVID - 19 1, 2 • The comorbidities that increase risk for severe COVID - 19 overlap with hypogonadism 3 COVID - 19 Cases and Deaths by Sex

Low T at Hospital Admission Predicts Poor Clinical Outcomes • ~80% of men who die of COVID - 19 have low testosterone at hospital admission 5 • Serum total testosterone level significantly decrease from pre - COVID - 19 levels 6 • Men with lower T are at higher risk for ARDS 4,5,7 and death 4,5,6 0 100 200 300 400 500 600 Asymptomatic IMU ICU Intubation Death Total T (ng/dL) at Hospitalization Care Level/Outcome 3 Adapted from 6 4 7 Testosterone Decreases with Increased Disease Severity

Low T at Hospital Admission Correlates with Markers of Increased Disease Severity • T levels inversely correlate with cytokine storm including levels of: • VEGF • IFN - γ • IL - 2 • IL - 6 • CRP • TNF - α • D - dimer • LDH • Neutrophil count 4 4, 5, 6, 7

COVID - 19 Causes Damage to Testis • SARS - CoV and MERS cause orchitis 9, 14 • Most (but not all 15 ) studies have failed to isolate SARS - CoV - 2 RNA from sperm, testis 10, 11, 12, 13 • Men with COVID - 19 experience elevated LH, decreases in Leydig cell number 8, 8 • Hospitalized COVID - 19 men have decreased sperm count, quality 16 » Intra - testicular T required for spermatogenesis 17 • Men who recover from COVID - 19 may require chronic testosterone replacement 0 50 100 150 200 250 300 Control Not Hospitalized Hospitalized Sperm Count *10^6 Sperm Count % Immotile Adapted from 16 Adapted from 8 5 Effect of Mild - Moderate COVID - 19 on Sperm # of Leydig Cells Decreases in COVID - 19 0 1 2 3 4 5 6 7 8 9 COVID-19 - COVID-19 + Number of Leydig Cells / Tubule Cross - Section 4

Lipocine Oral T: Potential as COVID - 19 Therapy General effects of T therapy in Hypogonadal Men • T therapy improves lung function (COPD) 18 - Rapid, non - genomic relaxation of ASM 23 • T therapy reduces inflammatory markers while promoting T and B - cell production, function 19, 24, 31 -40 -20 0 20 40 % CBL % Change in Inflammatory Markers after 30 Weeks of Therapy in Hypogonadal Men T Placebo CRP IL - 1 β TNF - α Adapted from 19 6 • T therapy improves vascular function 20, 21 • Restoring T to normal range may reestablish coagulative homeostasis 22, 32, 33 Adapted from 18 -1 2 5 8 11 1 % Increase in Hospitalizations 1 - Year Increase in COPD - Associated Hospitalizations No TRT TRT

Lipocine Oral T: Potential as COVID - 19 Therapy • Rapidly restores T levels to normal range • Demonstrates anti – inflammatory and anti – fibrotic effects on the lungs » Including decreasing TNF - α , IL - 6, IL - 8, MCP - 1, and CD68 Days after Oral T Initiation 7 • Reduces elevated liver injury markers 38 • Improves glycemic control • Tested in over 700 subjects with up to 52 - week exposure In clinical trials and preclinical research, Lipocine Oral T: Liver Injury Marker Reduction With Oral T Therapy

Conclusions • Men are more susceptible to severe COVID - 19 and death • Men with COVID - 19 have low T, elevated LH, damaged Leydig cells, and elevated cytokines • T therapy in hypogonadal men improves lung and vascular function, is immunomodulatory, reducing cytokines and promoting B and T cell response • Oral T may improve COVID - 19 outcomes in men by rapidly restoring testosterone to the eugonadal range Future steps • Longitudinally measure testosterone levels in men hospitalized with COVID - 19 • Follow results of trials using antiandrogens to treat COVID - 19: - NCT04446429, NCT04475601, NCT04509999, NCT04374279, NCT04397718 • Interventional trial of testosterone in COVID - 19 8

1. Ng, J et al., COVID - 19 Mortality Rates by Age and Gender: Why is the Disease killing more Men than Women? RGA White Paper 2. Metro.co.uk l Source: Global Health l 50/50 3. CDC.gov 4. Rastrelli, G et al., Low testosterone levels predict clinical adverse outcomes in SARS - CoV - 2 pneumonia patients. Andrology, 2020 . 5. Schroeder, M et al. The majority of male patients with COVID - 19 present low testosterone levels on admission to Intensive Care i n Hamburg, Germany: a retrospective cohort study. medRxiv preprint, 2020. 6. Cayan, S et al., Effect of serum total testosterone and its relationship with other laboratory parameters on the prognosis of coronavirus disease 2019 (COVID - 19) in SARS - CoV - 2 infected male patients: a cohort study. The Aging Male, 2020. 7. Salciccia, S et al., Interplay between Male Testosterone Levels and the Risk for Subsequent Invasive Respiratory Assistance among COVID - 19 Patients at Hospital Admission. Endocrine, 2020. 8. Yang, M et al., Pathological Findings in the Testes of COVID - 19 Patients: Clinical Implications. Eur Uro Foc, 2020. 9. Xu, J et al. Orchitis: a complication of Severe Acute Respiratory Syndrome (SARS). Biol Reprod, 2006. 10. Song, C et al., Absence of 2019 novel coronavirus in semen and testes of COVID - 19 patients. Biol Reprod, 2020. 11. Pan, F et al., No evidence of severe acute respiratory syndrome – coronavirus 2 in semen of males recovering from coronavirus disease 2019. Fertil Steril, 2020. 12. Song, C et al., Detection of 2019 novel coronavirus in semen and testicular biopsy specimen of COVID - 19 patients. medRxiv preprint, 2020. 9 References

13. Guo, L et al., Absence of SARS - CoV - 2 in semen of a COVID - 19 patient cohort. Andrology, 2020. 14. Abobaker, A et al., Does COVID - 19 affect male fertility? World J Urol, 2020. 15. Li, D et al., Clinical Characteristics and Results of Semen Tests Among Men With Coronavirus Disease 2019. Infectious Disease s, 2020. 16. Holtmann, N et al., Assessment of SARS - CoV - 2 in human semen — a cohort study. Fertil Steril, 2020. 17. Walker, W, Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis, 2011. 18. Baillargeon, J et al., Testosterone replacement therapy and hospitalization rates in men with COPD. Chron Resp Dis, 2018 19. Kalinchenko, S et al., Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double - blinded placebo - controlled Moscow study. Clin Endocrin, 2020. 20. Lopes, R et al., Testosterone and Vascular Function in Aging. Front Physiol, 2012. 21. Yaron, M et al. Effect of testosterone replacement therapy on arterial stiffness in older hypogonadal men. Eur J Endocrinol, 200 9. 22. Erem, C et al., Blood coagulation and fibrinolysis in male patient with hypogonadotropic hypogonadism: plasma factor V and fa cto r X activities increase in hypogonadotropic hypogonadism. J Endocrin, 2008. 23. Kouloumenta, V et al., Non - genomic effect of testosterone on airway smooth muscle. Br J Pharmacol, 2006. 24. Vignozzi, L et al., Antiinflammatory effect of androgen receptor activation in human benign prostatic hyperplasia cells. J En doc rin, 2012. 25. Trumble , B et al., Associations between male testosterone and immune function in a pathogenically stressed forager - horticultural population. Am J Phys Anthropol , 2016 10 References

References 26. Mann, D et al., Neonatal treatment with luteinizing hormone - releasing hormone analogs alters peripheral lymphocyte subsets and cellular and humorally mediated immune responses in juvenile and adult male monkeys. J Clin Endocrinol Metab, 1994. 27. Cain, D and Cidlowski, J, After 62 years of regulating immunity, dexamethasone meets COVID - 19. Nat Rev Immun, 2020. 28. Giagulli, V et al., Worse progression of COVID - 19 in men: Is testosterone a key factor? Andrology, 2020. 29. RECOVERY Collaborative Group, Dexamethasone in Hospitalized Patients with Covid - 19 — Preliminary Report. NEJM, 2020. 30. National Institutes of Health, Coronavirus Disease 2019 (COVID - 19) Treatment Guidelines. NIH.gov. 31. Page, T et al., Effect of medical castration on CD4+CD25+ T cells, CD8+ T cell IFN - γ expression, and NK cells: a physiological role for testosterone and/or its metabolites. Am J Physiol Endocrinol Metab, 2006. 32. Middleton, E et al., Neutrophil extracellular traps contribute to immunothrombosis in COVID - 19 acute respiratory distress syndro me. Blood, 2020. 33. Markman, J et al., Loss of testosterone impairs anti - tumor neutrophil function. Nat Commun, 2020. 34. 2020 Li, F et al. Distinct mechanisms for TMPRSS2 expression explain organ - specific inhibition of SARS - CoV - 2 infection by enzalutamide. bioRxiv preprint, 2020. 35. Baracthian, M et al. No evidence that androgen regulation of pulmonary TMPRSS2 explain sex - discordant COVID - 19 outcomes. bioRxiv preprint. 36. Wang, K et al., Angiotensin Converting Enzyme 2: A Double - Edged Sword. Circulation, 2020. 37. Ma, L et al., Effect of SARS - CoV - 2 infection upon male gonadal function: A single center - based study. medRxiv preprint, 2020. 38. Albhaisi, S et al., LPCN 1144 Resolves NAFLD in Hypogonadal Males. Hepatology Comm, 2020. 11

Appendix 12

Testosterone Normalizes, Dexamethasone Suppresses: Immunomodulation vs Immunosuppression • Dexamethasone suppresses innate and adaptive immune system » Including B cells and CD4+, CD8+ T cells 27 » Greatest benefit for patients with late disease stage 29, 30 » Need to avoid immunosuppression during viral phase? • T is required for proper immune response » Male hypogonadism is associated with impaired T - cell, 31 B - cell, antibody response 26 » T therapy in hypogonadal men curbed innate immune response, cytokines, while promoting T and B - cell production, function 24, 31 » T may inhibit production of clots, hypercoagulation 28, 32, 33 13 The Panel recommends against using dexamethasone for the treatment of COVID - 19 in patients who do not require supplemental oxygen (AI)

What About ACE2 and TMPRSS2? • TMPRSS2 – protease involved in spike priming » Expression known to be driven by androgens in the prostate » Data elsewhere is mixed/ negative » Androgens do NOT increase pulmonary TMPRSS2 expression, and do NOT increase susceptibility to virus in multiple pulmonary models 34, 35 • ACE2 – a double - edged sword 36 » Required for viral entry, but also protects from pulmonary hypertension » Virus may cause internalization of the receptor, leaving less ACE2 to perform its pulmo - protective role » Men are not infected at higher rates than women 1,2 14