EX-99.2 3 tm218671d1_ex99-2.htm EXHIBIT 99.2

Exhibit 99.2

Efficacy and Safety of TLANDO 䉼 , An Easy to Prescribe and Use Oral TRT Option Kongnara Papangkorn, PhD 1 ; Kiran Vangara, PhD 1 ; Benjamin J. Bruno, PharmD, PhD 1 ; Kilyoung Kim, PhD 1 ; Nachiappan Chidambaram, PhD 1 ; Anthony DelConte, MD 1,2 ; Mahesh V. Patel, PhD 1 ; Culley C. Carson III, MD 3 ; Irwin Goldstein, MD 4 ; Jed Kaminetsky , MD 5 ; Martin Miner, MD 6 ; Mohit Khera , MD 7 ; Adrian S. Dobs, MD 8 □ Conclusions ▪ TLANDO 䉼 met primary and secondary efficacy endpoints without titration requirement. ▪ TLANDO 䉼 treatment has potential to improve patients’ compliance: • Selection of an effective dose at the start of therapy without a period of “efficacy gap” when switching from other TRTs ▪ With single strength/dose and no titration requirement, TLANDO 䉼 may be easy to prescribe. □ References 1. Axiron ® label (Testosterone topical solution); 2. Xyosted 䉼 label (Testosterone Enanthate injectable); 3. Jatenzo ® SBA (Testosterone Undecanoate oral capsule); 4. Donatucci et al., J Sex Med 2014; 5. Lipocine Physician Quantitative Survey, Jul 2017 □ Contact: Kongnara Papangkorn, kp@lipocine.com □ Results ▪ Primary Endpoint: TLANDO 䉼 Treatment Restored Eugonadal T Levels □ Introduction ▪ Currently, most marketed Testosterone Replacement Therapy (TRT) options are inconvenient and cumbersome to use due to: • Risk of accidental transference to women and children with topicals 1 • Invasiveness, injection site reactions, and risk of pulmonary oil micro - embolism (POME) and/or anaphylaxis with injectables 2 • Require dose titration in majority of patients ▪ Products with dose titration in clinical practice may have high discontinuation rates. 4 ▪ Market research found titration typically takes 3 - 6 months to reach an efficacious dose for majority of patients, a significant barrier in effecting a switch without a period of “efficacy gap”. 5 ▪ TLANDO 䉼 , an oral non - methylated TRT option, is a prodrug of endogenous T, primarily absorbed via the intestinal lymphatic pathway ▪ The objective was to evaluate safety and efficacy of TLANDO 䉼 in hypogonadal men without dose adjustment. □ Methods ▪ Dose Validation Study (NCT03242590) with TLANDO 䉼 x A prospective 24 - day, multicenter, single arm study in hypogonadal men (N=95) x TLANDO 䉼 (225mg BID) without dose adjustment » Primary efficacy endpoint: o At least 75% of subjects with T Cavg in normal range (300 – 1,080 ng/dL) o At least 65% of lower bound for 95% confidence interval » Secondary efficacy endpoints: o ≥ 85% of subjects with T Cmax ≤ 1.5xULN o ≤ 5% of subjects with 1.8xULN ≤ T Cmax ≤ 2.5xULN o No subjects with T Cmax > 2.5xULN □ Secondary Endpoints: TLANDO 䉼 Treatment Had No Excessive T Repletion (> 2.5xULN) □ TLANDO 䉼 was Well Tolerated ▪ No deaths, no drug related SAEs, and no MACE ▪ No reported incidence of depression or suicide ideation ▪ Low (< 2% of subjects) incidence of hematocrit increase ▪ No Hepatic Adverse Events ▪ Low (< 2% of subjects) incidence of gastrointestinal (GI) AEs Demographics Statistics DV Study (N=95) Age, years Mean (SD) 56.0 (8.9) ≤ 65 Yrs n (%) 79 (83.2) > 65 Yrs n (%) 16 (16.8) Race Black or African American n (%) 15 (15.8) White n (%) 77 (81.1) Asian & Others n (%) 3 (3.2) Weight, kg Mean (SD) 103.6 (18.7) BMI, kg/m 2 Mean (SD) 32.8 (5.5) Baseline Total T, ng/dL Mean (SD) 202 (75) T Cavg Responder Criteria Proportion of Subjects post Treatment, % Primary Endpoint Target TLANDO Ρ Results Within Normal Range* ≥ 75 % 80 % Lower Bound of 95% CI** ≥ 65 % 72 % T Cmax Criteria Proportion of Subjects post Treatment, % Secondary Endpoint Target TLANDO Ρ Results ≤ 1.5 x ULN* ≥ 85% 82% Between 1.8xULN and 2.5xULN* ≤ 5% 5% > 2.5xULN* 0% 0% * ULN is 1,080 ng/dL: 1.5xULN = 1,620 ng/dL, 1.8xULN = 1,944 ng/dL, and 2.5xULN = 2,700 ng/dL * Serum total T normal range: 300 to 1080 ng/dL ** A 95%, 2 - sided, binomial confidence interval (CI) surrounding the point estimate was calculated 1 Lipocine Inc., Salt Lake City, UT, USA; 2 Saint Joseph's University, Philadelphia, PA, USA; 3 University OF N CAROLINA SCHL OF Medical, Chapel Hill, NC, USA; 4 University of California at San Diego, San Diego, CA, USA; 5 N YU 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; 8 Johns Hopkins University School of Medicine, Baltimore, MD, USA 3 Exhibit 99.2