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 11, 2015
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 November 11, 2015, Lipocine Inc. issued a press release announcing the presentation of LPCN 1021 clinical data at the 21st Annual Meeting of the Sexual Medicine Society of North America (SMSNA) in Las Vegas, NV. The press release is filed as Exhibit 99.1 and is 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 LPCN 1021 Clinical Data at the 21st Annual Meeting of the Sexual Medicine Society of North America |
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 11, 2015 | By: | /s/ Mahesh V. Patel | |
Mahesh V. Patel | ||||
President and Chief Executive Officer | ||||
Exhibit 99.1
For Immediate Release
LIPOCINE ANNOUNCES PRESENTATION OF LPCN 1021 CLINICAL DATA AT 21st ANNUAL SMSNA MEETING
SALT LAKE CITY (November 11, 2015) – Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced that clinical data for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone ("hypogonadism"), will be presented at the 21st Annual Meeting of the Sexual Medicine Society of North America (SMSNA) in Las Vegas, NV.
Presentation/poster details are as follows:
Title: | Dose Titration and Safety of Oral Testosterone (LPCN 1021) in Hypogonadal Men: Results from the SOAR Study (#030) |
Date: | November 20th |
Time: | 3:15 pm PST (Poster: 3:00 - 4:00 pm PST) |
Presenter: | Mohit Khera, MD |
Associate Professor, | |
Urology | |
Baylor College of Medicine | |
Houston, TX, US | |
Director, Laboratory for Andrology Research | |
Medical Director, Houston Hospital for Specialized Surgery |
Title: | Assessment of Fasting and Varying Meal Fat Content on the Bioavailability of Testosterone from Oral Testosterone Undecanoate (LPCN 1021) in Hypogonadal Men (#036) |
Date: | November 20th | |
Time: | 3:45 pm PST (Poster: 3:00 - 4:00 pm PST) | |
Presenter: | Mohit Khera, MD |
Title: | Efficacy and Pharmacokinetics of Oral Testosterone (LPCN 1021) in Hypogonadal Men (#028) |
Date: | November 20th | |
Time: | 3:05 pm PST (Poster: 3:00 - 4:00 pm PST) | |
Presenter: | Irwin Goldstein, MD | |
Director, San Diego Sexual Medicine | ||
Director, Sexual Medicine, Alvarado Hospital, San Diego, CA | ||
Clinical Professor of Surgery, University of California at San Diego | ||
Editor-in-Chief, Sexual Medicine Reviews | ||
President-Elect, International Society for the Study of Women’s Sexual Health | ||
Editor Emeritus, The Journal of Sexual Medicine | ||
Editor Emeritus, International Journal of Impotence Research |
About LPCN 1021
LPCN 1021 is a twice-a-day, oral testosterone replacement therapy product candidate with three simple oral dosing options that Lipocine expects will overcome the major shortcomings of existing products. The current testosterone market is dominated by topical products that carry FDA "black box" warnings related to inadvertent transfer of testosterone and by injectable products. The IMS Health database shows that an average of half a million prescriptions a month have been dispensed so far in 2015 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. A New Drug Application was filed with the FDA for Lipocine's lead product candidate, LPCN 1021. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing and is targeted for testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, is currently in Phase 1 testing.
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 expectations regarding clinical trials, the potential uses and benefits of Lipocine's product candidates, product development and commercialization efforts and the projected timing 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, 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 Forms 8-K and 10-Q, 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
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