EX-99.4 5 tm2019577d1_ex99-4.htm EXHIBIT 99.4

Exhibit 99.4

A NOVEL ORAL TESTOSTERONE (TLANDO™) THERAPY RESTORES TESTOSTERONE TO EUGONADAL LEVELS WITHOUT DOSE TITRATION Anthony DelConte, MD; Nachiappan Chidambaram, PhD; Kongnara Papangkorn , PhD; Benjamin Bruno, PharmD; Kilyoung Kim, PhD; Mahesh Patel, PhD; Martin Miner *, MD; Linda Vignozzi , MD; Jed Kaminetsky , MD; Mohit Khera , MD; and Irwin Goldstein, MD □ Conclusion ▪ TLANDO™ reliably restores T levels to eugonadal range in hypogonadal subjects without need for titration. ▪ The efficacious fixed dose TLANDO™ treatment has potential to improve patients’ compliance. • No additional titration visit, ease to prescribe dosing regimen, and less physician counselling □ References 1. Axiron ® label (Testosterone topical solution); 2. Xyosted ™ label (Testosterone Enanthate injectable); 3. Jatenzo ® label (Testosterone Undecanoate oral capsule); 4. Shackleford et al., J Pharmacol Exp Ther 2003 □ Contact: Kilyoung Kim, kk@lipocine.com , admin@lipocine.com □ Consistent Population in SOAR and DV Studies □ Robust PK Profile Independent of Titration □ Introduction ▪ Most marketed Testosterone Replacement Therapy (TRT) products require multiple titration visits to achieve steady - state eugonadal T levels in hypogonadal men. 1 - 3 ▪ Challenges of single point PK - based dose titration in clinical practice: ▪ TLANDO™ is a novel oral Testosterone Undecanoate (TU) product absorbed via the intestinal lymphatic pathway. 4 • T Pharmacokinetics of TLANDO™, when administered with meal, is consistent independent of low, moderate or high fat amounts. □ Objectives ▪ To evaluate whether TLANDO™ with fixed dose regimen is safe and efficacious in restoring eugonadal T levels in hypogonadal men □ Methods ▪ SOAR Trial (NCT02081300) with titration x A 52 - week, multicenter, open - labelled, active controlled (topical T, N=105) study with TLANDO™ (225mg BID staring dose) in hypogonadal men (N=210) x Titrated to 300mg BID in case of Cavg <300 ng/dL or to 150mg BID in case of Cmax >1500 ng/dL at Week 4 and Week 8 • At Week 3: Pre - titration PK (fixed dose) • At Week 13: Post - titration PK ▪ Dose Validation Study (NCT03242590) with fixed dose regimen x A prospective 24 - day, multicenter, single arm study with fixed dose TLANDO™ (225mg BID) in hypogonadal men (N=95) • To validate if the fixed dose TLANDO™ is efficacious and safe □ TLANDO™ Efficacy with No Need of Titration □ TLANDO is Well Tolerated ▪ No deaths, no drug related SAEs, and no MACE ▪ Only 1% subjects had new start or increase in anti - hypertensive medication ▪ No adverse drug reactions in the Hepatobiliary System Organ ▪ Low incidence of hematocrit increase (erythrocytosis) ▪ GI AEs are minimal and comparable to topical T DE MP45 - 15 Demographics Statistics DV Study (N=95) SOAR Trial (N=210) Age Years (SD) 56.0 (8.9) 52.6 (10.2) Race Black or African American n (%) 15 (15.8) 32 (15.2) White n (%) 77 (81.1) 172 (81.9) Asian & Others n (%) 3 (3.2) 6 (2.8) Weight kg (SD) 103.6 (18.7) 97.1 (15.0) BMI kg/m 2 32.8 (5.5) 30.8 (3.9) Baseline Total T ng/dL (SD) 202 (75) 208 (60) Source: Adheris Health 2017 Measure Target (% of Subjects) DV Study* (N=94) SOAR Trial Pre - Titration (N=192) Post - Titration (N=157) Mean Dose 225mg BID 225mg BID 213mg BID Cavg , ng/dL Normal Range** 474 ( ± 175) 504 ( ± 212) 478 ( ± 196) Cmax , ng/dL 1180 ( ± 514) 1324 ( ±

649) 1256 ( ± 603) % of Subjects with T Cavg in Normal Range ≥ 75% 81% 86% 88% * One subject who withdrew early had no PK data. ** Normal range of T in SOAR Trial is 300 - 1140 ng/dL and in DV Study is 300 - 1080 ng/dL. x Most TRTs Require At Least 1 Titration Visit x 30 - 50% of Patients Discontinued within ~30 days