EX-99.2 3 tm1920614d1_ex99-2.htm EXHIBIT 99.2

] Improved Patient Reported Sexual and Mental Domain Outcomes with Oral Testosterone (TLANDO) Relative to Topical Testosterone in Treated Hypogonadal Men Kilyoung Kim, PhD 1 , Nachiappan Chidambaram, PhD 1 , Kiran Vangara, PhD 1 , Jonathan Baker, PhD 1 , Mahesh V. Patel, PhD 1 , and Anthony DelConte, MD 1,2 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA □ Conclusion ▪ TLANDO (oral TRT) improves mental and sexual health domains greater than topical TRT ▪ Greater improvement in mental and sexual health may be explained in part by higher restoration of free T levels ▪ Free T levels may be more relevant in evaluating the effect of treatment of male hypogonadism ▪ Additional placebo - controlled studies are warranted to further assess PROs with TLANDO Disclosure All authors are employees of Lipocine Inc. □ Results Mean Total T Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) □ Introduction ▪ Male hypogonadism is characterized by symptoms and deficiency in Testosterone (Total Testosterone (TT) levels of <300 ng/dL) • Critical for sexual, cognitive, and body function/development ▪ Free Testosterone ( fT , only 1% to 4% of TT) is Testosterone not bound to protein and available to bind to receptors for androgenic action. Low fT is defined as < 4 ng/dL (Sarkar et al., Gastroenterol 2019) ▪ TLANDO, an oral Testosterone Undecanoate (TU) lymphatically delivered TRT option with good liver tolerability, is currently under regulatory review • Demonstrated efficacy with consistent intra - and inter - day TT levels • Met efficacy in multiple studies regardless of meal fat content • Showed GI tolerability and good safety profile up to 52 - week study duration □ Objectives ▪ To assess key sexual and mental domain related patient reported outcomes following TLANDO treatment compared to topical TRT in hypogonadal men ▪ To examine the role of fT as the key marker to assess treatment effect in TRT □ Methods ▪ Study of Androgen Replacement (SOAR) Trial (NCT02081300): an active controlled (topical T gel), randomized, multi - center 52 - wk study with TLANDO ▪ Patient Reported Outcomes (PRO) assessed via PDQ and SF - 36 survey at BL and EOS ▪ Calculation of fT using serum TT, albumin (ALB), and SHBG ݂ܶ ݊݃ ݀ܮ ൌ ܶ݋ݐ݈ܽ ܶ ሺ ݊݃ ݀ܮ ሻ ൈ ͳ ͳ ൅ ܭ ௌு஻ீ כ ܵܪܤܩ ൅ ݊ כ ܭ ஺௅஻ כ ሾ ܣܮܤ ሿ • [SHBG] in nmol/L, K SHBG = 0.6x10 9 /M, n*K ALB = 4x10 4 /M, [ALB] in mol/L using 69,000 Da per g/L Mean ALB Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) Mean SHBG Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) Mean free T Conc. at Baseline and End - of - study with TLANDO in a 1 - yr study (SOAR) TLANDO Greatly Improved TT and fT Levels in Low fT Subjects ▪ TLANDO Safety x No deaths x No drug related SAEs x No MACE • Only 1% subjects having new start or increase in anti - hypertensive medication x No adverse drug reactions in the Hepatobiliary System Organ Class x GI AEs are minimal and comparable to topical T With Similar TT, TLANDO Increased fT Levels Greater Than Topical T Mean Total T Changes from Baseline by free T Baseline Quartiles in a 1 - yr study (SOAR) Mean free T Changes from Baseline by free T Baseline Quartiles in a 1 - yr study (SOAR) Better Mental and Sexual Domains Response with Greater fT Improvement * PRO responders are defined as subjects with positive changes in PRO. Exhibit 99.2