Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study Histological Analysis Demonstrates Treatment Potential of LPCN 1144 in NASH Both LPCN 1144 treatment ar

LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study

Analysis Demonstrates Treatment Potential of LPCN 1144 in NASH

Call Scheduled for 8:30 a.m. ET today

LAKE CITY, August 25, 2021 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic

and endocrine disorders, today announced positive topline 36-week results from its Phase 2 proof of concept LiFT ("Liver

Fat intervention with oral Testosterone") clinical study, NCT04134091, investigating LPCN 1144 in men

with biopsy-confirmed NASH. Currently, there are no approved treatments for NASH, a leading cause of liver failure and liver transplantation

globally. LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone ("T").

LiFT clinical study, a prospective, multi-center, randomized, double-blind, placebo-controlled, multi-arm, multi-site trial in

the United States, enrolled biopsy-confirmed hypogonadal or eugonadal male NASH subjects with stage F1-F3 fibrosis and a NAFLD Activity

Score 4 for a 36-week treatment period. Subjects with advanced fibrosis (F2-F3) and steatohepatitis (inflammation on liver biopsy)

were also eligible. Subjects were randomized 1:1:1 to one of three arms (Treatment A, a twice daily oral dose of 142 mg testosterone

equivalent; Treatment B, a twice daily oral dose of 142 mg testosterone equivalent formulated with 238 mg of d-alpha tocopherol equivalent;

and the third arm, a twice daily matching placebo).

primary endpoint of the LiFT clinical study was change in hepatic fat fraction via MRI-PDFF post 12 weeks of treatment. Additionally,

key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and/or fibrosis improvement.

The LiFT clinical study was not powered to assess statistical significance of any of the secondary endpoints.

12 weeks, treatments with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF, meeting the pre-specific

primary endpoint of the LiFT clinical study. Statistically significant reduction in liver fat was observed compared to placebo:

up to a mean of 9.2% absolute reduction and a 46.8% relative reduction in liver fat.

biopsies were performed at baseline ("BL") and after 36 weeks of treatment ("EOS"). Prespecified biopsy analyses

include NASH Clinical Research Network ("CRN") scoring as well as a continuous paired ("Paired Technique") and

digital technique ("Digital Technique-Fibronest"). All biopsy analyses were performed on the same slides and the reads for

the three techniques were done independently. Analysis sets included the NASH Resolution Set (all subjects that have BL and EOS biopsy

with NASH at BL [NAS 4 with lobular inflammation score 1 and hepatocyte ballooning score 1 at BL] (n=37)), the Biopsy Set

(all subjects with baseline and EOS biopsies (n=44)), and the Safety Set (all randomized subjects (n=56)).

LPCN 1144 treatment arms met with statistical significance the pre-specified accelerated approval regulatory endpoint of NASH resolution

with no worsening of fibrosis based on NASH CRN scoring. Additionally, both treatment arms showed substantial improvement of the observed

NASH activity in steatosis, inflammation and ballooning.

results are presented in the following table:

NASH CRN Scoring Outcomes1

in NASH defined as improvement in ballooning or inflammation, and no worsening of ballooning or inflammation

p < 0.001 vs placebo

LPCN 1144 treatment arms showed significant improvement in NASH without worsening of fibrosis using Paired Technique, which concurred

with the NASH CRN scoring findings (per Biopsy Set; NASH Improvement responders: Placebo - 13%, Treatment A - 60%, Treatment

B - 57%; NASH Improvement with No Worsening of Fibrosis responders: Placebo - 13%, Treatment A - 60%, Treatment B -

treatment effects on fibrosis improvement need confirmation in a larger study.

fibrosis improvement results are presented in the following table:

Assessment TechniquesX

Fibrosis improvement on paired reads defined as a score of improvement in fibrosis with a score of no worsening of ballooning,

inflammation, or steatosis

For Digital Reads (FibroNest - http://www.fibronest.com), improvement defined as a decrease in parenchymal tissue normalized phenotypic

fibrosis composite score

One subject in placebo is missing NASH CRN fibrosis score and is treated as a non-responder

both treatment arms substantial reductions in markers of liver injury compared to placebo were observed post four weeks of treatment

and were sustained through EOS. Using all available Safety Set data, alanine aminotransferase ("ALT") decreased up to a mean

of 23.4 U/L at EOS from all group mean baseline of 51.5 U/L and aspartate aminotransferase ("AST") decreased up to a mean

of 13.3 U/L at EOS from all group mean baseline of 31.9 U/L.

effects in appendicular lean mass and whole-body fat mass, an indicator overall tissue quality, based on dual-energy X-ray absorptiometry

scans were noted in both LPCN 1144 treatment arms.

the 36 weeks of treatment, LPCN 1144 was well tolerated with an overall safety profile comparable to placebo. Frequency and severity

of treatment emergent adverse events, TEAEs, in both treatment arms were comparable to placebo. Study drug related TEAEs were mild to

moderate. Four subjects discontinued due to TEAEs in the placebo arm vs one subject in total across the treatment arms. Cardiovascular

events were balanced among groups with hematocrit increases averaging <2% in the treatment arms, no observed thromboembolic events,

and comparable blood pressure changes in both treatment arms to placebo.

were no reported cases of hepatocellular carcinoma or Drug Induced Liver Injury ("DILI"). Weight change from baseline, GI

adverse events and PSA changes were small and comparable among groups. Additionally, no clinically meaningful changes in lipids in treatment

groups were noted compared to placebo, and rates of pedal edema were low and similar in all arms.

all subjects had the option to continue with LPCN 1144 treatment through an open label extension study (NCT04685993). The extension study

will enable the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy.

extent of the LPCN 1144 efficacy results in meeting the NASH resolution regulatory endpoint from the LiFT study are striking with

no adverse safety signal. These data strongly support further development of this differentiated novel approach as a treatment of NASH,"

said Dr. Arun Sanyal, Professor in the Virginia Commonwealth University ("VCU") Department of Internal Medicine and

Education Core Director in the VCU Center for Clinical and Translational Research.

are delighted by the remarkable efficacy results and the overall safety profile of LPCN 1144 in the LiFT study, which we believe

demonstrate the potential for LPCN 1144 to be the "best in class" option for treating NASH with a discerning benefit to risk

profile as required for a chronic therapy," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "Additionally,

the unique benefits of LPCN 1144 in improving body composition may fulfill an unmet medical need. We look forward to meeting with the

FDA regarding the path forward for an accelerated approval and Phase 3 study requirements," said Dr. Patel.

will host a conference call and webcast today at 8:30 a.m. Eastern time to discuss LPCN 1144 Phase 2 LiFT clinical study key secondary

endpoint topline results. To participate in the conference call, please dial 1-877-451-6152 from the U.S. or 1-201-389-0879 from outside

the U.S. In addition, following the completion of the call, a telephone replay will be accessible until September 1, 2021, by dialing

1-844-512-2921 from the U.S. or 1-412-317-6671 from outside the U.S. and entering conference ID #13722634. Those interested in listening

to the conference call live via the internet may do so by using the following link: http://public.viavid.com/index.php?id=146385.

An archive of the webcast will also be available on the webcast page of the Company's website for 90 days.

is a more advanced state of non-alcoholic fatty liver disease ("NAFLD") and can progress to a cirrhotic liver and eventually

hepatocellular carcinoma/liver cancer. Twenty-five to thirty percent of the U.S. population is estimated to suffer from NAFLD. NASH afflicts

three to twelve percent of the U.S. population, which is a substantially large population that lacks effective therapy. Currently, there

are no FDA approved treatments for NASH. Approximately 50% of NASH patients are in adult males and the number of NASH cases is projected

to increase 63% from 16.5 million cases in 2015 to 27.0 million cases in 2030. NAFLD/NASH is becoming more common due to its strong correlation

with obesity and metabolic syndrome, including components of metabolic syndrome such as diabetes, cardiovascular disease and high blood

pressure. In men, especially with comorbidities associated with NAFLD/NASH, testosterone deficiency has been associated with an increased

accumulation of visceral adipose tissue and insulin resistance, which could be factors contributing to NAFLD/NASH.

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, LPCN 1154, 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 Phase 2 clinical study demonstrating the

potential utility in the treatment of non-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 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. LPCN

1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. For more information, please visit www.lipocine.com.

and Forward-Looking Statements

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