Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2022)
25 slides from Lipocine's investor presentation, Oct 18, 2022
Slide 1: Lipocine: Enhancing Health
LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-looking statements
f ‘d-looking statement: p ‘to th sic of the ies Litigation Reform Act of 1995 and include statements egarding ct development eff u Tf c ing p : at CNS disorders, our panier to monetize non-core @ product eveloping product c CNS disorders, \ yn able ic rships or other st a Se Tehehipe to monetize our
Slide 3: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase2/POC Pivotal Approved Status LPCN 1154 Pilot PK bridge (Postpartum Depression) study in progress LPCN 1148 Phase 2 POC study in progress (Decompensated Liver Cirrhosis - Secondary Sarcopenia/Hepatic
Slide 4: Unlocking Value Through Partnering
Unlocking Value Through Partnering Assets Available for Partnering Development Candidate (Indication) Pre-Clinical Phase 1 Phase2/POC Pivotal Approved TLANDO® (Testosterone Replacement Therapy) LPCN 1111 (Once Daily Testosterone Replacement Therapy) LPCN 1107 (Prevention of Preterm Birth) LPCN 1144
Slide 5: Summary of LiFT Results
Summary of LiFT Results Positive results support further development of LPCN 1144 e Study population: Men with biopsy-confirmed NASH e Hypogonadal and Eugonadal men e Primary endpoint met — Change in liver fat via MRI-PDFF at Week 12 e Both LPCN 1144 treatment arms met with statistical significance
Slide 6: LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)
LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)*t Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) Study Design Primary Endpoint: Q Biopsy confirmed male NASH subjects with F1-F3 Y Change in hepatic fat fraction via MRI-PDFF (W12) Three-arm, blinded, placebo-controlled Key
Slide 7: LiFT Study: Baseline Characteristics
LiFT Study: Baseline Characteristicst Parameter Placebo reatment A | Treatment B (N=15) (N=15) (N=14) Mean Age (years) 50.5 50.0 54.0 Mean BMI (kg/m?) 36.7 36.5 34.7 Diabetes (%) 53:5) 733 64.3 Hypertension (%) 133) 60.0 Sys Mean ALT (U/L) 49.5 58.7 Bhs} Mean AST (U/L) 35.9) 34.3 30.9 Mean fibrosis
Slide 8: Key Results from LiFT Study
Key Results from LiFT Study Met Liver Fat and NASH Resolution Histology Endpoints Liver Fat Reduction at Week 12 (MRI-PDFF) Placebo (N=19) Treatment A (N=18) Treatment B (N=19) 0.0 -2.0 -1.54 & Ps 2 & Absolute Change (%) 2 5 7.68 p< 0.0001 -9.17 =10:0 p< 0.0001 Ns All Subjects: ITT Dataset, n = 56,
Slide 9: Histological Changes in NASH Components: NASH CRN Scoring
Histological Changes in NASH Components: NASH CRN Scoring Substantial Improvement in All NASH Components from Baseline Steatosis Inflammation Ballooning ue 13% 20% Placebo a 2 1 Grade Worsening 13% [> 13% 1) | Treatment A O9 ® No Change = 2 1 Grade Improvement 21% Treatment B > Lee cnespercmepcemnsm
Slide 10: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction mDosel/Treatment! __—_m Dose2/Treatment2 * p<0.05, *** p< 0.001 vs placebo. NASH Resolution with No Worsening of Fibro: 388 le: be iE mi mi: a: et me: Pa | i 36 Wk 18Mn 52Wk 36 Wk 24Wk Candidate LPCN
Slide 11: Key Non-Histology Marker Results from LiFT Study
Key Non-Histology Marker Results from LiFT Study Liver Enzyme* Reductions and Body Composition Changes Mean Baseline ALT (ul) Placebo (w=19) 49.0 Treatment A (ne18) 53.9 Treatment 8 (n=19} S15 LIPOCIN= ENHANCING HEALTH AST (uf) 35.4 32.4 31.9 Liver Injury Marker Reduction ALT (U/L) Changes Placebo -
Slide 12: Fibrosis Outcomes Across Biopsy Assessment Techniques
Fibrosis Outcomes Across Biopsy Assessment Techniques’ Treatment Effects on Fibrosis Improvement Needs Confirmation in a Larger Study Placebo Treatment A Treatment B Histopathological Assessment Techniques P é ” (N = 15) (N= 15) (N= 14) NASH CRN: Fibrosis Improvement 2 1 Stage with No i Cre 6 (40%)"
Slide 13: Safety Overview of LPCN 1144 Through Week 36
Safety Overview of LPCN 1144 Through Week 36 Well-Tolerated with an Overall Safety Profile Comparable to Placebo ° Frequency and severity of TEAEs in both treatment arms AEs of Interest, n (%) Placebo TreatmentA Treatment B were comparable to placebo + Frequency of SAEs in both treatment arms were c
Slide 14: Treatment Effects in Men
Treatment Effects in Hypogonadal and Eugonadal Men LIPOCIN= ENHANCING H EALTH LPCN 1144 Presentation | 14
Slide 15: Treatment Effects in Men: Baseline Characteristics
Treatment Effects in Hypogonadal and Eugonadal Men Baseline Characteristics t ee LPCN 1144-Treated Mean Age (years) 49.3 54.5 Mean BMI (kg/m?) 32.5* 37.9 Mean ALT (U/L) 64.5 45.6 Mean AST (U/L) 39.2 27.9 Testosterone (ng/dL) 474* 243 Hepatic Fat Fraction % (MRI-PDFF) 19.9 17.2 Mean Fibrosis Stage 1.
Slide 16: Treatment Effects in Men: Liver Fat Fraction at Week 12
Treatment Effects in Hypogonadal and Eugonadal Men Absolute Change Liver Fat Fraction at Week 12 Liver Fat Reduction at Week 12 (MRI-PDFF) Eugonadal (n=15) Hypogonadal (n=20) = 0.0! oO ic 9 © -2.5 a Ee 2 50 e 6. Do =| oO f= Oo 75 L2 5 8 8 100 aE LIPOCIN= ENHANCING HEALTH All available data LPCN 1144
Slide 17: Treatment Effects in Men: NASH Resolution with No Worsening of Fibrosis
Treatment Effects in Hypogonadal and Eugonadal Men NASH Resolution with No Worsening of Fibrosis NASH Resolution with No Worsening of Fibrosis* Eugonadal (n=8) Hypogonadal (n=18) 60 NS EN Oo N Oo Responders (%) ot _. 1 NASH resolution is defined per FDA guidance as lobular inflammation score = 0 or
Slide 18: Treatment Effects in Men: NAFLD Activity Score and Components
Treatment Effects in Hypogonadal and Eugonadal Men NAFLD Activity Score and Components % of Subjects with Improvement in Individual NAS Components NS fos] Oo NS Responders (%) aN fo) oO Oo NO oO Steatosis Inflammation Ballooning | Eugonadal (n=10) || Hypogonadal (n=19) LIPOCIN= A responder is define
Slide 19: Treatment Effects in Men: Relative Change in ALT and AST
Treatment Effects in Hypogonadal and Eugonadal Men Relative Change from Baseline in ALT and AST Alanine Aminotransferase Aspartate Aminotransferase (ALT) (AST) Eugonadal (n=13) | Hypogonadal (n=22) Eugonadal (n=13) | Hypogonadal (n=22) 2 © 1 a ' a ite i=) a i) & a a a NS Relative Change from Baselin
Slide 20: Treatment Effects in Men: Changes in Body Composition (DXA)
Treatment Effects in Hypogonadal and Eugonadal Men Changes in Body Composition (DXA) Whole Body Fat Mass Appendicular Lean Mass (Relative Change) (Relative Change) Eugonadal (n=9) Hypogonadal (n=17) Eugonadal (n=9) Hypogonadal (n=17) & 07 z 6 * 2 2 ma -2 a € € £ £ 2 oO oO 2 -4 2 a o i <= OF 6) S) g
Slide 21: Safety Overview of LPCN 1144 Through Week 36
Safety Overview of LPCN 1144 Through Week 36 Well-Tolerated with an Overall Safety Profile Comparable between Hypogonadal and Eugonadal AEs of Interest, n Eugonadal Hypogonadal (%) Placebo (n=15) (n=22) Diarrhea 2 (10.5%) none 1 (5%) Nausea 1 (5.3%) none 1 (5%) Vomiting none none none Pruritus 1 (5.
Slide 22: Open-Label Extension Trial
Open-Label Extension Trial LIPOCIN= LPCN 1144 Presentation | 22
Slide 23: LPCN 1144: NASH Open Label Extension Study
LPCN 1144: NASH Open Label Extension Study Objective & Design Objective: To evaluate the safety and tolerability of extended (up to 72 weeks) treatment with LPCN 1144 in subjects with biopsy confirmed Nonalcoholic Steatohepatitis (NASH) Q Amulticenter study (NCT04685993) to provide LPCN 1144 treatme
Slide 24: Overview of OLE Study Results
Overview of OLE Study Results « Reduction in liver enzymes maintained with increased treatment duration * Liver biopsy — Initial 36 weeks of treatment resulted in NASH resolution and Fibrosis improvement — Longer duration may result in additional fibrosis reduction ¢ As in LiFT, well-tolerated with
Slide 25: LiFT Results Support LPCN 1144 Further Development
LiFT Results Support LPCN 1144 Further Development Met the Primary and Key Secondary Endpoints with Statistical Significance 0h Ow Onw= 05 Met the pre- Changes in liver Treatment effect Open-label Well-tolerated specified fat, key liver and safety extension trial with an overall histological enzymes