Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2021)
19 slides from Lipocine's investor presentation, Oct 12, 2021
Slide 1: LPCN 1148 for the Management of Liver Cirrhosis (an End Stage Disease)
LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-looking statements
looking statements are made pursuant to the safe harbor provisions of the cts and product candidates, FDA’s approval of TLANDO®, the 3 and LPCN 1154, clinical and regulatory processes and objectives, known and unknown risks and uncertainties. Actual results may indidates and the Company's capital ne
Slide 3: Clinical Stage Biopharmaceutical Company
Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders Final Approval ® TLANDO Eligibility March (Oral Testosterone for Testosterone Replacement Therapy) 5 28, 2022 [= © TLANDO® XR (Long-Acting Oral Testosterone for Testosterone Next Step: Food E
Slide 4: Summary of LiFT Results
Summary of LiFT Results Study Demonstrates Treatment Potential of LPCN 1144 in NASH e Primary endpoint met — Change in liver fat via MRI-PDFF at Week 12 e Both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no
Slide 5: 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 6: LiFT Study: Baseline Characteristics
LiFT Study: Baseline Characteristics* Parameter Placebo Treatment A Treatment B (N=15) (N=15) (N=14) Mean Age (years) 50.5 50.0 54.0 Mean BMI (kg/m2) 36.7 36.5 34.7 Diabetes (%) 53'3) 733 64.3 Hypertension (%) 1303) 60.0 Byoal Mean ALT (U/L) 49.5 58.7 53.3 Mean AST (U/L) 35.9 34.3 30.9 Mean fibrosis
Slide 7: Key Results from LiFT Study
Key Results from LiFT Study Met NASH Resolution Histology Endpoint and Fat Reductions NASH Resolution with ; eet Liver Fat Reduction at Week 12 (MRI-PDFF) en Sena 1 9 Placebo (N=19) Treatment A (N=18) Treatment B (N=19) Responders’, n (%) NASH Resolution Set” _—_Safety Set* = Placebo 0 (0%) 0 (0%) &
Slide 8: 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 ~- @O6@ ;e6 LIPOCI N= Biopsy Set: All subjects with baseline and EOS biopsies LPCN 1144 Presentation | 8 aseasoul apes TZ asuey) ON aw Treatment B
Slide 9: 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 AST (uy) (UY Placebo (N=19) 49.0 35.4 Treatment A (n-18) 539 324 TreatmentB is a49 (N=19) LIPOCIN= ENHANCING HEALTH SRS EEaoOG Liver Injury Marker Reduction ALT (U/L) Changes Plac
Slide 10: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction ™Placebo mDose/Treatment 1 ™ Dose/Treatment 2 He 05 * p<0.05,"** p<0.001 vs placebo 69% 10% oo i per : 2 NASH Resolution with a” ocx ns = 5 f . Bam * No Worsening of Fibro So os _—" vem ia ts s om eS
Slide 11: Fibrosis Outcomes Across Biopsy Assessment Techniques
Fibrosis Outcomes Across Biopsy Assessment Techniques‘ Treatment Effects on Fibrosis Improvement Needs Confirmation in a Larger Study Histopathological Assessment Techniques Picea Treatment Treatments P e q (N= 15) (N= 15) (N= 14) NASH CRN: Fibrosis Improvement 2 1 Stage with No os\t ° 5 Worsening o
Slide 12: 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 AEs of Interest, n (%) Placebo TreatmentA Treatment B « Frequency and severity of TEAEs in both treatment arms . were comparable to placebo Diarrhea 2 (10.5%) 1 (5.6%) 0 (0%) ¢ Discontinu
Slide 13: LiFT Results Support LPCN 1144 Development for FDA Approval
LiFT Results Support LPCN 1144 Development for FDA Approval Met the Primary and Key Secondary Endpoints with Statistical Significance 01 Statistically significant reduction in liver fat was observed compared to placebo LIPOCIN= ENHANCING HEALTH 02 Met with statistical significance the pre-specified
Slide 14: Slide 14
Slide 15: Liver Cirrhosis in US
Liver Cirrhosis in US Challenges and Opportunities Over 2 million cases? 40-70% of cirrhotic men have sarcopenia®® 1. Moon, Cin Gas ana Hep, 2019 4. Bentley & Philips, Mliman Research Report 2017 — 2. GBD 2017 Cinmhosis Collaboration, Lancet, 2021 ‘5. Sinclair, Ailment Pharmacol Ther, 2016 OCIN 9. S
Slide 16: Sarcopenia in Liver Cirrhosis
Sarcopenia in Liver Cirrhosis Progressive Drop in Testosterone Worsens Sarcopenia A two-fold increase in waitlist mortality/decreased survival Stronger association with waitlist mortality in men Increased risk of hospitalization/prolonged hospitalization Higher risk of hospitalization for hepatic en
Slide 17: LPCN 1148: Proof of Concept Study
LPCN 1148: Proof of Concept Study Phase 2, Multicenter, Double-Blinded, Placebo-Controlled Study* Study Design Endpoints: + Male subjects with cirrhosis of the liver and sarcopenia + Stage 1, Weeks 1-24 * Two-arm (1:1 randomization) * Oral LPCN 1148 or Placebo * Stage 2, Weeks 25-52 + Single arm —LP
Slide 18: LPCN 1148-21-001 POC Study: Outcomes of Interest
LPCN 1148-21-001 POC Study: Outcomes of Interest Clinical Outcomes Sarcopenia/Cachexia © Overall survival ¢ Functional capacity e Anemia status ¢ New Decompensation ¢ LFI, 6MWT, TUG e Albumin Events ¢ Muscle mass/quality 0 ANwanamiia llawells ¢ Hepatic encephalopathy ¢ Sarcopenia * Ascites ¢ Myostea
Slide 19: Next Steps
Next Steps LPCN 1144 for NASH e FDAmeeting e Path forward for Phase 3 study, primary endpoint NASH resolution with no worsening of fibrosis e Seeking recommendations on key elements of Phase 3 design e Treatment arm size e Duration of treatment e Understand current stance regarding digital imaging a