Lipocine Announces Positive Top-Line Results In Its Phase 3 Study of LPCN 1021 For Oral Testosterone Replacement Therapy

• Met primary efficacy endpoint by successfully restoring testosterone levels to the normal range in 88% of the subjects 
• Lower limit of the 95% confidence interval was 82% 
• 85% of the subjects reached final dose with no more than one dose titration 
• Majority of subjects ended on 225 mg BID 
• Proportion of subjects with maximum serum concentrations generally met FDA pre-specified targets 
• LPCN 1021 treatment was well tolerated with no drug related serious adverse events 

Lipocine Inc. LPCN, a specialty pharmaceutical company, today announced positive top-line efficacy results from its ongoing Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone ("Low T"). Overall, the study demonstrated positive results with respect to the trial's primary efficacy endpoint with no serious adverse events. Lipocine continues to expect to file a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") in the second half of 2015.

"We are extremely pleased with the robustness of the top-line results from this study which are consistent with the existing regulatory paradigm for Testosterone Replacement Therapy ("TRT") product approvals. We believe that LPCN 1021 represents a differentiated TRT for treating hypogonadism in men with the potential to both improve patient compliance and overcome inadvertent testosterone transference risk," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. Dr. Patel further stated, "We look forward to reporting additional safety results from this ongoing study."