424B3 1 v388698_424b3.htm RULE 424(B)(3)

Filed Pursuant to Rule 424(b)(3)

Registration No. 333-190897

 

Prospectus Supplement No. 8

(to Prospectus dated April 9, 2014)

 

5,227,631 Shares

LIPOCINE INC.

Common Stock

 

This prospectus supplement supplements the prospectus, dated April 9, 2014 (the “Prospectus”), which forms a part of our Post-Effective Amendment No. 1 to our Registration Statement on Form S-1 (Registration No. 333-190897). This prospectus supplement is being filed to update, amend and supplement the information included or incorporated by reference in the Prospectus with the information contained in our current report on Form 8-K, filed with the Securities and Exchange Commission (the “Commission”) on September 8, 2014 (the “Current Report”). Accordingly, we have attached the Current Report to this prospectus supplement.

 

The Prospectus and this prospectus supplement relate to the sale or other disposition from time to time of up to 5,227,631 shares of our common stock, which are held by the selling stockholders named in the Prospectus. The shares of common stock covered by the Prospectus and this prospectus supplement were previously issued by us in a private placement. We are not selling any common stock under the Prospectus and this prospectus supplement and will not receive any of the proceeds from the sale or other disposition of shares by the selling stockholders.

 

This prospectus supplement should be read in conjunction with the Prospectus. This prospectus supplement updates, amends and supplements the information included or incorporated by reference in the Prospectus and the prospectus supplements dated April 29, 2014, May 13, 2014, May 15, 2014, May 27, 2014, June 11, 2014, July 15, 2015 and August 13, 2014. If there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement.

 

Our common stock is quoted on The NASDAQ Capital Market under the symbol “LPCN”.

 

Investing in our common stock involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page 5 of the Prospectus, and under similar headings in any amendment or supplements to the Prospectus.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the Prospectus or this prospectus supplement. Any representation to the contrary is a criminal offense.

 

The date of this prospectus supplement is September 8, 2014

 
 

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):

September 8, 2014

 

  

 

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 8.01 Other Events

 

On September 8, 2014, Lipocine Inc. issued a press release to report the first patient dosed in a Phase 1 Study in pregnant women of LPCN 1107. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.

 

 

Item 9.01Financial Statements and Exhibits.

 

(d)Exhibits

 

The following exhibits are filed with this report:

 

Exhibit No. Description
99.1 Press Release Announcing First Patient Dosed in a Phase 1 Study in Pregnant Women of LPCN 1107

 

 

 
 

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: September 8, 2014   By: /s/ Mahesh V. Patel
        Mahesh V. Patel
        President and Chief Executive Officer
         

 

 
 

Exhibit 99.1

 


 

 

For Immediate Release

 

Lipocine Announces First Patient Dosed in Phase 1 Study in Pregnant Women of LPCN 1107,

Potentially the First Oral Product for the Prevention of Preterm Birth

 

 

SALT LAKE CITY (September 8, 2014) – Lipocine Inc. (NASDAQ Capital Market: LPCN), a specialty pharmaceutical company, today announced the first patient was dosed in a Phase 1 study in pregnant women of LPCN 1107, the company's oral hydroxyprogesterone caproate (HPC) product candidate. The primary objectives of the study will be to determine safety, tolerability and pharmacokinetics of oral administration of LPCN 1107 in pregnant subjects.

 

"Based on previous clinical testing, we believe that LPCN 1107 has the potential to become the first oral product for prevention of preterm birth. HPC is the only drug approved for prevention of recurrent preterm birth, a leading cause of peri-natal mortality and morbidity worldwide, but it is currently only available in an inconvenient injectable form that may cause pain at the site of injection and requires several visits to the physician during the course of treatment," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look forward to presenting top-line results from this study in 2015."

 

This Phase 1, open-label study will enroll up to eight healthy, pregnant female subjects of child bearing age with a normal pregnancy of 16 to 18 weeks. In period one, subjects will receive two doses of 400 mg oral LPCN 1107, administered 12 hours apart. In period two, subjects will receive two doses of 800 mg oral LPCN 1107, administered 12 hours apart. In period three, subjects will be given 250 mg of HPC via intramuscular injection. There will be a washout period of at least three days between each period. Blood samples will be taken and used to determine the pharmacokinetics for each period.

 

Previously in Phase 1 clinical testing, LPCN 1107 was well tolerated and achieved meaningful drug levels after oral administration in healthy, non-pregnant women.

 

About LPCN 1107

 

LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.

 

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 lead product candidate, LPCN 1021, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth.

 

 

 
 

 

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 includes statements that are not historical facts relating to the potential uses and benefits of Lipocine's product candidates and product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to the receipt of regulatory approvals, the results 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 U.S. Securities and Exchange Commission (the "SEC"), including, without limitation, its Form 10-K and other reports on Form 8-K, all of which can be obtained on the Company's website at www.lipocine.com or 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

Email: mb@lipocine.com

 

John Woolford

Phone: (443) 213-0500

john.woolford@westwicke.com