EX-99.3 4 tm218671d1_ex99-3.htm EXHIBIT 99.3

Exhibit 99.3

] TLANDO, a Novel Oral TRT, Improves Sexual and Mental Domain Outcomes in Hypogonadal Men Benjamin J. Bruno, PharmD, PhD 1 ; Kiran Vangara, PhD 1 ; Kilyoung Kim, PhD 1 ; Kongnara Papangkorn, PhD 1 ; Nachiappan Chidambaram, PhD 1 ; Mahesh V. Patel, PhD 1 ; Anthony DelConte, MD 1,2 ; Culley C. Carson III, MD 3 ; Irwin Goldstein, MD 4 ; Jed Kaminetsky, MD 5 ; Martin Miner, MD 6 ; Mohit Khera, MD 7 1 Lipocine Inc.; 2 Saint Joseph’s University, Philadelphia, PA; 3 University OF N Carolina School of Medical, Chapel Hill, NC, USA; 4 University of California at San Diego, San Diego, CA, USA; 5 NYU Grossman School of Medicine, New York, NY, USA; 6 Men's Health Center The Miriam Hotel, Providence, RI, USA; 7 Baylor College of Medicine, Houston, TX, USA □ Conclusions ▪ Oral T therapy demonstrated improvement in sexual and mental PROs, a significant unmet need in hypogonadal males ▪ Oral T therapy resulted in significantly greater improvement in the mental domain (mental component summary, mental health, and negative mood) than topical T therapy ▪ Differences in fT levels may contribute to observed differences in the PROs ▪ Further placebo - controlled studies are warranted to better elucidate these improvements □ Contact Information ▪ Benjamin J. Bruno: bjb@lipocine.com , admin@lipocine.com □ Results □ Introduction ▪ Male hypogonadism is characterized by symptoms and deficiency in Total Testosterone (TT) levels of <300 ng/dL ▪ Free Testosterone (fT) is the fraction (1 - 4%) of testosterone (T) not protein - bound and available for androgenic receptors ▪ TLANDO 䉼 , an oral non - methylated TRT option, is a prodrug of endogenous T, primarily absorbed via the intestinal lymphatic pathway • Demonstrated efficacy with consistent intra - and inter - day TT levels regardless of meal fat content • Reduced liver fat content and liver injury markers in multiple clinical studies □ Objectives ▪ To assess key patient reported outcomes (PROs) following oral and topical TRT in hypogonadal men □ Methods ▪ Assessments based on Study of Androgen Replacement (SOAR) Trial (NCT02081300): an active controlled (topical T gel), randomized, multi - center 52 - week study (N=315) ▪ Pharmacokinetic parameters were assessed at baseline (BL) and end of study (EOS), and fT levels calculated using Vermeulen equation ▪ PROs were administered at BL and EOS, including Psychosexual Daily Questionnaire (PDQ) and Short Form (SF) - 36 surveys ▪ Safety was assessed at each study visit Oral T Therapy Resulted in Improved Mental/Sexual PRO Responses, Possibly Due to Higher fT * PRO responders are defined as subjects with positive changes in PRO. PROs of Mental/Sexual Domains in Oral T and Topical T Groups Improved Post 52 - week Treatment Baseline Demographics Improvements of mental and sexual health were observed in both PK responders and non - responders and comparable. Effect of TRT should be monitored by symptoms as well as PK levels Observed Improvements in PROs Do Not Appear to Depend on the 300 ng/dL TT Response ▪ No deaths, no drug related SAEs, and no MACE ▪ Only 1% of subjects in this study had new start or increase in anti - hypertensive medication ▪ No reported incidents of depression or suicide ideation ▪ Low incidence of hematocrit increase ▪ No hepatic Adverse Events (AEs) ▪ Low incidence of gastrointestinal (GI) AEs Demographics Oral T Topical T N 210 105 Age, yr, mean (SD) 52.6 (10.2) 54.2 (9.4) Race, n (%) White 172 (81.9) 92 (87.6) Black or African American 32 (15.2) 10 (9.5) Asian 3 (1.4) 3 (2.9) Other 3 (1.4) 0 BMI, kg/m 2 , mean (SD) 30.8 (3.9) 31.0 (3.9) Baseline T, ng/dL, mean (SD) 209 (60.0) 205 (66.7) Oral TU was Well Tolerated in This Study * p < 0.05 vs. Topical * * * Exhibit 99.3