EX-99.1 2 tm2019577d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

Lipocine Announces Presentations on TLANDO™ at AUA Virtual Experience 2020

SALT LAKE CITY, May 15, 2020 -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced

that clinical data for lead candidate TLANDO™ will be presented at the American Urological Association (“AUA”) Virtual Experience, to take place May 15-17, 2020. TLANDO is an oral testosterone replacement therapy ("TRT") product candidate being developed for adult males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

| 1. | Abstract Number: MP45-14 Title: Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk Presenter: Mohit Khera, MD

Session Type: Poster Session
Session Title: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II

| 2. | Abstract Number: MP45-15 Title: A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration

Presenter: Martin Miner, MD
Session Type: Poster Session
Session Title: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II

| 3. | Abstract Number: PD26-05 Title: Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver

Presenter: Irwin Goldstein, MD
Session Type: Oral Podium Session
Session Title: Sexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I

The abstracts, posters and podium slides are published today on the AUA website.

About Lipocine
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.

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 regarding Lipocine’s product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, risk related to on-going litigation and other risks detailed in Lipocine’s filings with 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 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

(801) 519-4090

mb@lipocine.com

Hans Vitzthum

Phone: (617) 430-7578

hans@lifesciadvisors.com