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EX-99.6 - EXHIBIT 99.6 - Lipocine Inc. | tm2019577d1_ex99-6.htm |
EX-99.5 - EXHIBIT 99.5 - Lipocine Inc. | tm2019577d1_ex99-5.htm |
EX-99.4 - EXHIBIT 99.4 - Lipocine Inc. | tm2019577d1_ex99-4.htm |
EX-99.3 - EXHIBIT 99.3 - Lipocine Inc. | tm2019577d1_ex99-3.htm |
EX-99.2 - EXHIBIT 99.2 - Lipocine Inc. | tm2019577d1_ex99-2.htm |
8-K - FORM 8-K - Lipocine Inc. | tm2019577d1_8k.htm |
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