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 12, 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 present data at the 21st 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 9.01Financial Statements and Exhibits.

 

(d)       Exhibits

 

The following exhibits are filed with this report:

 

Exhibit No. Description

99.1

Abstract titled “TLANDO™, Oral Testosterone Replacement Therapy Without Dose Titration Requirement”

   
99.2 Abstract 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: October 12, 2020   By: /s/ Mahesh V. Patel
        Mahesh V. Patel
        President and Chief Executive Officer
         
         

 

 

Exhibit 99.1

 

TLANDO, Oral Testosterone Replacement Therapy without Dose Titration Requirement

 

Introduction: Most marketed testosterone replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugonadal testosterone (T) levels. For the majority of patients, typical titration of TRT takes 3-6 months with multiple blood draws and titrations (mostly up titrations) to reach an efficacious dose (e.g., ANDROGEL® 1.62 and JATENZO®). The additional dose adjustment visits are burdensome for patients and physicians. Moreover, a major reason for discontinuation is possibly related to inadequate therapeutic response within 3-6 months of therapy. Selection of an efficacious dose from the start of therapy with no potential for titration decision errors remains an unmet need. TLANDOTM (LPCN 1021, testosterone undecanoate) is an easy to use oral TRT option designed to enable effective T replacement in hypogonadal males from the start of therapy without dose titration requirement. The oral, fixed-dose regimen of TLANDOTM may offer additional advantages over most existing TRT options, including absence of accidental transfer risk, absence of application site reactions or need for self-injections, consistent inter-day performance, no additional clinic/pharmacy visits, favorable liver safety profile, and low hematocrit (HCT) increase. TLANDOTM may essentially improve patient adherence and persistence to TRT.

 

Objective: The objective was to assess whether TLANDOTM, an oral fixed-dose regimen TRT option, can safely and effectively restore testosterone levels in hypogonadal men without need for any dose adjustment.

 

Methods: A 24 day, open-label, single-arm, multicenter study with TLANDOTM in hypogonadal men (NCT03242590) was conducted. Subjects (N=95) received 225 mg testosterone undecanoate orally twice a day. At the end of study, blood samples were collected over a 24-hour period for pharmacokinetic analysis. The primary endpoint was the percentage of TLANDO-treated subjects who achieved a 24-hour average serum T concentration (T Cavg) within the eugonadal range of 300 to 1080 ng/dL after 24 days of treatment. Key safety endpoints included incidence of adverse events (AEs), physical examination results, clinical laboratory test results, and changes in HCT and prostate-specific antigen (PSA).

 

Results: 94 subjects completed the study with mean age of 56.0 years, mean BMI of 32.8 kg/m2, and baseline T level 202 ± 75 ng/dL. The vast majority, 81% (95% CI 72% - 88%), of hypogonadal subjects achieved T Cavg within the normal range post ~3 weeks of treatment without requiring dose adjustment. T Cavg and the mean peak serum T concentration were 476 ± 174 ng/dL and 1178 ± 484 ng/dL, respectively. The incidence of treatment emergent adverse events (TEAEs) was 21%. Decrease in lipids was observed (-8.9 mg/dL for triglycerides, and -10.6 mg/dL for total cholesterol). The most frequent TEAEs were blood prolactin increase (6.3%), weight increase (2.1%), headache (2.1%), and musculoskeletal pain (2.1%). Increase in hematocrit (0.9% CBL) and PSA (0.2 μg/L CBL) were observed.

 

 

 

 

Conclusions: Safety and efficacy of TLANDOTM, a clinically easy to use oral TRT without dose titration requirement, was confirmed. TLANDOTM is well suited to improve persistence rates in TRT therapy.

 

Authors: Anthony DelConte*, Nachiappan Chidambaram, Kongnara Papangkorn, Benjamin J. Bruno, Kilyoung Kim, Mahesh V. Patel

 

 

Exhibit 99.2

 

Is Oral Testosterone a Potential Treatment for COVID-19 in Men?

 

Introduction: Over 4 million cases of SARS-CoV-2 infections and more than 150,000 COVID-19 deaths have been recorded in the US alone. While COVID-19 infection rates of men and women are comparable, men are developing severe symptoms and dying at a significant higher rate than women. Men are 2.5x more likely to develop Acute Respiratory Distress Syndrome (ARDS), and 1.5-3x more likely to die from COVID-19 compared to women. Moreover, men with comorbidities commonly associated with lower testosterone are at a greater risk for severe disease and death. This presentation will discuss evidence that men with low testosterone (T) are at an increased risk for poor COVID-19 outcomes and the rationale of using an oral testosterone therapy, for COVID-19.

 

Objective: 1) To summarize recent publication data on the role T plays in the mortality discrepancy between men and women and 2) To evaluate whether LPCN 1149, once a day oral testosterone, is suitable to treat men with COVID-19.

 

Methods: A literature search on the possible mechanisms and clinical evidence concerning T levels in COVID-19 patients was performed.

 

Results: Key clinical evidences suggest that low T levels may play an important role on the clinical outcomes of COVID-19 in men. A recent clinical study investigating T levels in men with COVID-19 found more than 80% of men who died due to COVID-19 had low bioavailable T levels at the time of hospital admission. Those with severe ARDS had acutely depressed total T compared to patients who did not exhibit severe ARDS (total T: 63 ng/dL vs. 202 ng/dL). The mean total T levels for men who required invasive ventilation was 29 ng/dL, whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission. In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 both inpatient and outpatient settings. Oral T can rapidly increase the transiently reduced testosterone. This may prevent unfavorable COVID-19 outcomes through multiple mechanisms of action and its effects on the lung, immune cells, and liver. T therapy has pulmonary effects, including direct, non-transcriptional effects on airway smooth muscle and potentiating the relaxing effect of β2 agonists. In addition, T is known to induce the angiotensin-converting enzyme 2 (ACE2) expression, an important lung protective enzyme, to induce erythrocyte production, to increase hemoglobin and hematocrit, and thereby to improve oxygen carrying capacity. T is a known immunomodulator and exhibits an inhibitory effect on the expression of various cytokines including C-reactive protein, TNF-α, IL-1, and IL-6. Finally, its anabolic effect may prevent the loss of skeletal muscle mass seen in the hospitalized patients, particularly in the presence of low T.

 

 

 

 

Conclusions: Oral testosterone with the goal of achieving physiological T levels should be evaluated in clinical trials of COVID-19, particularly in men who are found to have T deficiency.

 

Authors: Benjamin J. Bruno*, Kongnara Papangkorn, Anthony DelConte, Nachiappan Chidambaram, Kilyoung Kim, Mahesh V. Patel