Full Press Release Details
Announces Publication in Journal of Endocrinological Investigation Highlighting the Potential of LPCN
1144 in the Treatment of NASH and Hepatic Fibrosis
LAKE CITY, March 4, 2021 -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic
and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144
in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. The results were featured in
a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non-Genomic,
High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation (https://doi.org/10.1007/s40618-021-01522-7).
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, 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 prodrug
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, 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 and related clinical trials, the timing of completion of
clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential
uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without limitation, the risk 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
President & Chief Financial Officer
Phone: (801) 994-7383
Phone: (617) 535-7743