Full Press Release Details
TO CNS AND LIVER PROGRAMS
LAKE CITY, UT, June 14, 2022 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on neuroendocrine and metabolic
disorders, today announced that the United States Patent and Trademark Office (USPTO) has granted US patent 11,337,987 for "Compositions
and Methods for Treating Central Nervous System (CNS) Disorders" and US patent 11,370,811 for "Testosterone Dodecanoate Compositions
and Methods of Preparation and Use".
are pleased to have new patents granted in support of our innovative programs to treat liver and CNS disorders," said Dr. Mahesh
Patel, Chairman, President, and CEO of Lipocine.
Inc. is a biopharmaceutical company focused on neuroendocrine and metabolic 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, has received tentative approval from the FDA for conditions associated with
a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral product of bioidentical testosterone,
recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN
1144 is currently being studied in a Phase 2 clinical study. 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 cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate
product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For
more information. For more information, please visit www.lipocine.com.
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 and
related clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, our
product development efforts, the timing of processes related to intellectual property, and the timing of ongoing litigation. 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, 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.