EX-99.3 4 tm1920614d1_ex99-3.htm EXHIBIT 99.3

] Symptomatic Response to TLANDO in Patients That Do Not Achieve T Cavg ≥ 300 ng/dL Nachiappan Chidambaram, PhD 1 ; Jonathan Baker, PhD 1 ; Ben Bruno, PhD, PharmD 1 ; Kiran Vangara, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 ; Anthony DelConte, MD 1,2 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA □ Conclusion ▪ PK - based non - responders (subjects with Cavg < 300 ng/dL) on TLANDO had meaningful symptomatic/androgenic responses with comparable improvements in relative T level increases, symptoms (PROs), and androgen - related biomarkers as compared to PK - based responders (subjects with Cavg ≥ 300 ng/dL). ▪ Monitoring symptoms in addition to T levels can be performed to evaluate the true responders with TLANDO treatment. □ Contact: Dr. Jonathan Baker, jb@lipocine.com □ Results □ Introduction ▪ Current FDA efficacy criteria is based on pharmacokinetics (PK) for treatment of hypogonadism (T Cavg_24hr: 300 - 1100 ng/dL) • At least 75% of patients achieving normal serum T levels with a lower bound of the associated 95% confidence interval being 65% or more ▪ Most marketed testosterone replacement therapy (TRT) products require titration visits to satisfy the FDA PK - based efficacy criteria and may inaccurately categorize the patients as non - responders based on T levels rather than symptoms on the treatment drugs ▪ PK - based dose titration in clinical use may result in some patients being on the “wrong” dose due to titration decision errors based on a single point T measurement □ Objectives ▪ To assess the effect of TLANDO (oral Testosterone Undecanoate) on symptoms in subjects not achieving T Cavg ≥ 300 ng/dL (PK Non - Responders) at week 13 on stable dose □ Methods ▪ Study of Androgen Replacement (SOAR) clinical trial (NCT02081300) : an active controlled (topical T gel) randomized multicenter 52 - wk study with TLANDO ▪ TLANDO arm patients were started on a total daily dose of 450 mg (225 mg BID) • Dose titration, if needed, at Week 4 and Week 8 was based on intensive 24 - hr PK profiles at steady state with the following criteria: x T Cavg < 300 ng/dL were up - titrated to 300mg BID x T Cmax > 1500 ng/dL were down - titrated to 150mg BID • All subjects were maintained on the dose after the second titration for the remainder of the study (Week 8 through week 52) ▪ Patient Reported Outcomes (PRO) were assessed via PDQ and SF - 36 survey at BL and EOS TLANDO Significantly Improved T Levels in Both PK Non - Responders ( Cavg < 300 ng/dL) and PK Responders ( ≥ 300 ng/dL) TLANDO Treatment Met FDA PK - based Efficacy Criteria Mean Total T % Increases from Pre - dose to Cmax (+SEM) Symptoms Improved with TLANDO Treatment Irrespective of Reaching Cavg Efficacy Criteria Comparable Demographic Characteristics for T Cavg < 300 ng/dL (PK Non - Responders) and ≥ 300 ng/dL (PK Responders) with Overall Baseline Demographics Androgenic Biomarker Baseline and Changes from Baseline to End - of - study Baseline and CBLs of androgenic biomarkers were comparable in both groups. Mean Changes of Mental and Sexual Patient Reported Outcomes from Baseline to End - of - study with 95% CI Improvements of mental and sexual health in both PK non - responders and responders were comparable (p>0.05) Increases of Relative T Levels are Comparable in Both Groups Exhibit 99.3