EX-99.2 3 tm2019577d1_ex99-2.htm EXHIBIT 99.2

Exhibit 99.2

IMPACT OF A NEW ORAL TESTOSTERONE UNDECANOATE (TLANDO™) ON BLOOD PRESSURE AND CARDIOVASCULAR RISK Muhammad Shahid; Kongnara Papangkorn , PhD; Nachiappan Chidambaram, PhD; Kilyoung Kim, PhD; Mahesh Patel, PhD; Anthony DelConte, MD; Irwin Goldstein, MD; Martin Miner, MD; Linda Vignozzi , MD; Jed Kaminetsky , MD; Mohit Khera , MD □ Conclusion ▪ TLANDO™ had minimal impact on BP changes. x Decreased SBP and DBP in hypogonadal men with SBP > 140 mmHg at baseline, even though increasing BPs marginally in overall hypogonadal men x Decreased SBP in high CV risk subjects categorized by FRS assessment x Minimal % (1%) of subjects had change or start on anti - hypertensive drug x Marginally increased hematocrit and hemoglobin ▪ TLANDO™ was well tolerated. □ Contact: Kilyoung Kim, kk@lipocine.com , admin@lipocine.com □ Demographics □ Effect of TLANDO™ on BP □ TLANDO™ Lowered SBP in FRS* - based High CV Risk Subjects □ Introduction ▪ Cardiovascular (CV) risk of testosterone replacement therapy (TRT) in chronic use is unclear. ▪ FDA’s recent guidance recommends the study of Ambulatory Blood Pressure Monitoring (ABPM) as it provides precision and accuracy to evaluate the effect of TRT drugs on BP. ▪ Most TRT studies reported an increase in hematocrit, which may be an indicator for potential CV risk. ▪ TLANDO™, a lymphatically delivered oral Testosterone Undecanoate (TU) with fixed dose regimen, is currently under regulatory review. • Demonstrated efficacy with consistent inter - day T levels • Met efficacy in multiple studies regardless of meal fat contents • Well tolerated in +700 subjects up to 52 - week study duration □ Objectives ▪ To assess the effect of TLANDO™ (fixed dose oral TRT) on BPs (especially, Systolic BP (SBP) changes versus cardiovascular (CV) risk categories based on Framingham Risk Score (FRS)) in hypogonadal men □ Methods ▪ ABPM Study (NCT03868059) with TLANDO™ 225mg BID x A 16 - week, multicenter, single arm, 24 - hr ambulatory blood pressure monitoring (ABPM) study in hypogonadal men (n=138) □ Differentiated TLANDO™ Effect ▪ 1% of subjects had a new start or an increase of anti - hypertensive medication during study ▪ Hematocrit and hemoglobin were marginally increased ▪ 4.6% of subjects had hematocrit > 54% at EOS □ TLANDO™ was Well Tolerated ▪ No deaths, no drug - related SAEs, and no MACEs MP45 - 14 Parameter Statistics TLANDO™ (N=138) Age Mean (SD) 53.8 (10.2) Race Asian n (%) 3 (2.2) Black or African American n (%) 25 (18.1) White n (%) 109 (79.0) Other n (%) 1 (0.7) Ethnicity Hispanic or Latino n (%) 35 (25.4) Not Hispanic or Latino n (%) 103 (74.6) Weight (kg) Mean (SD) 104.0 (20.1) BMI (kg/m 2 ) Mean (SD) 33.1 (5.8) ▪ Baseline Serum T 204 ± 88 ng/dL ▪ Comorbidities • Obesity: 30% • Type 2 Diabetes: 24% • Hypertension: 48% • Hypercholesterolemia: 19% • Hyperlipidemia: 17% Androgenic Effect Marker Baseline Change from Baseline Hematocrit, % 44.2 ± 3.2 3.2 ± 3.6 Hemoglobin, g/dL 14.57 ± 1.06 0.87 ± 1.05 ▪ Marginal increase on BP x Full analysis set: N=118 ▪ Lowered BPs in hypogonadal men with SBP>140mmHg at BL CV Risk Category* N 24 - Hr SBP CBL with TLANDO™ Low CV Risk 40  2.6 mmHg Moderate CV Risk 74  4.8 mmHg High CV Risk 4  1.8 mmHg * CV Risk Category based on Framingham Risk Score (FRS), Ref: D’Agostino et al., Circulation 2008 Treatment - Related TEAE > 1% System Organ Class Preferred Term TLANDO™ (N=138) Subjects, n (%) Any Treatment - related TEAE* 14 (10.1) Hematocrit increased 4 (2.9) Hypertension 2 (1.4) Polycythemia 2 (1.4) Gynecomastia 2 (1.4) * All treatment - related Treatment - Emergent Adverse Events (TEAE) are mild or moderate. Exhibit 99.2