Lipocine Inc. · NASDAQ:LPCN
Lipocine — H.C. Wainwright 5th Annual MASH Investor Conference 2024
22 slides from Lipocine's conference presentation, Oct 8, 2024
Slide 1: H.C. Wainwright 5th Annual MASH Investor Conference
October 2024 H.C. Wainwright sth Annual MASH Investor Conference LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategi
Slide 3: Lipocine - Enabling Effective Oral Delivery
Lipocine - Enabling Effective Oral Delivery The Lip’ral platform optimizes GI absorption for faster onset of efficacy Lip’ral based ry AL DrugLoaded dosage form Zhou + (ed Carrier {a == or Aqueous Intestinal Systemic Barrier Layer Wall Circulation Testosterone Esters Lumen Insoluble drug lipid compo
Slide 4: LiFT (Liver Fat Intervention with oral Testosterone)
LiFT (Liver Fat Intervention with oral Testosterone)*tT Phase 2 paired biopsy study in men with MASH (NCT04134091) Study Design Q Biopsy confirmed male MASH subjects with F1-F3 Three-arm, blinded, placebo-controlled = Hypogonadal and eugonadal men enrolled = 1:1:1 randomization Primary Endpoint v Ch
Slide 5: LiFT Study: Baseline characteristics
LiFT Study Baseline characteristics Parameter at TU mono Baseline (N=18) Mean Age (years) 51.3 Mean BMI (kg/m2) 36.9 Diabetes (%) 72.2 Hypertension (%) 66.7 Mean NAFLD 49 Activity Score . 53.4 34.5 57.9 57.9 4.8 53.6 37.3 52.6 68.4 4.7 = ‘Saf LIPOCIN= NASH CRN scoring for NAFLD Activity Score Lipoci
Slide 6: Improvement in Liver Health
Improvement in Liver Health LPCN 1144 - primary endpoint met Liver Fat Reduction at Week 12 (MRI-PDFF)' NASH Resolution with No Worsening of Fibrosis? TU combo TU mono Placebo (N=19) (N=18) (N=19) * i) E 1 2 5 g 60 . a 2 2 ee 3 S 40 So -4 Q £c oO OF 5 oc £2 6 S20 50 7 3 8 < . *$ 0 6 ‘ TU combo TU mo
Slide 7: Improvement in Liver Health: liver injury markers
Improvement in Liver Health LPCN 1144 therapy demonstrated an improvement in liver injury markers Liver Injury Marker Reduction’ ALT AST ALP GGT 5 a 2 0 =) 3 | dl | & 5 Oo 2 $ a 410 $ *$ E p gS * 5 15 s ; ® i$ i= £ 20 5 -25 *$ & TUcombo TU mono Placebo I=" 1. Safetyset. * p< 0.05; vs placebo; $ p <
Slide 8: Safety profile
Safety profile Well-tolerated with no safety signals with up to 72-week exposure Frequency and severity of TEAEs, SAEs with TU arms were comparable to placebo + Asubjects discontinued in placebo due to TEAEs vs. 1 subject total in combined TU treatment arms Gl adverse events (diarrhea, nausea, vomit
Slide 9: 1144: Key Attributes
LPCN 1144: Key Attributes Positive results support further development LPCN 1144 Oral, prodrug of bioidentical hormone Liver Health: Positive findings for MASH resolution Liver Health: Positive reductions in liver injury markers Side effects: Minimal LIPOCIN= Lipocine | October 2024 9
Slide 10: Addressing the role of obesity
LIPOCIN= ENHANC G HEALTH Addressing the role of obesity
Slide 11: Obesity - A Growing Epidemic in US
Obesity - A Growing Epidemic in US Obesity is a major risk factor for the development and progression of MASH Metabolic dysfunction T2DM Peripheral IR 74% | Adipose tissue | tissue | 67% — Proinflammatory cytokines ER stress of patients with MASH meet Oxidative stress — HSC activation criteria for o
Slide 12: Limitations of Incretin Mimetics (GLP-1 Receptor Agonists)
Limitations of Incretin Mimetics (GLP-1 Receptor Agonists) Signi Loss of Lean Mass Change from baseline (kg) WeightLoss FatLoss _ Lean Mass Loss Semaglutide INEngls Moa 2021;384:989-1002 GLP-1 agonist treatment led to 15-21% rapid weight loss with unwanted LBM loss of up to 40% of the total weight l
Slide 13: 2401 Novel Oral Treatment for Obesity and Weight Management
LPCN 2401 Novel Oral Treatment for Obesity and Weight Management Proven potential to improve body composition - quality weight loss with quality fat loss Product Candidate Attributes ¢ Proprietary androgen receptor agonist (ARA) ° Proprietary androgen receptor agonist (ARA) with a-tocopherol Targete
Slide 14: 2401: Potential to Amplify Effects of Incretin Mimetics
LPCN 2401: Potential to Amplify Effects of Incretin Mimetics ARA may increase weight loss through increased expression and activity of GLP1R “> GLP-1 expression increase with ARA2 Non-Diabetic Diabetic ————_, = _—* Androgen Receptor Incretin s = Agonist (ARA) Mimetic 3 z 4. 5 5 § ba 8 3 3 Be 2 Zo Ve
Slide 15: Study in Patients with Obesity and Overweight
Phase 2 Study in Patients with Obesity and Overweight NCT04134091 study design Three-arm, blinded, placebo-controlled trial in male subjects with MASH (n=56) * High prevalence of obesity and weight related comorbid conditions such as dyslipidemia, T2DM, and hypertension ¢ 1:1:1 randomization across
Slide 16: 2401: Significant Improvement in Participants' Body Composition
LPCN 2401: Significant Improvement in Participants’ Body Composition Prespecified endpoints met — increased lean mass and decreased fat mass Body Composition Results Parameter at TU combo TU mono Fat Mass: Lean Mass Ratio Baseline (N=13) 4 Mean Age (years) 53.8 53.2 51.1 2 0 Mean Weight (kg) 107.8 1
Slide 17: 2401 - Significant Improvement in Participants' Body Composition
LPCN 2401 - Significant Improvement in Participants’ Body Composition Prespecified endpoints met — increased lean mass and decreased fat mass EE es Fat Mass Android Fat (% of TM) (% of Fat Mass) Lean Mass (% of TM) Appendicular Lean Mass 5 ‘ x 4 a * A 3 0 a a im 7 O14 QO 2 x SS 3 0 “ * 1 5 2 6 = 7 3
Slide 18: 2401 - Significant Improvement in Bone Health
LPCN 2401 - Significant Improvement in Bone Health Significant increase in bone mass and density Bone Mass Density Bone Mineral Content Femoral Neck T Hip TScore Score 15 * 2 0.15 * 1 on 05 [ 0.05 zo — o | 6 | 8 R05 00s 7 4 0.1 15 0.15 2 0.2 TU TU FB combo ™ mono Placebo Increase in bone mineral con
Slide 19: Testosterone Therapy Reduces Weight
Testosterone Therapy Reduces Weight Continued weight loss after initial slow period 104 oe 5 nd T therapy led to continued weight loss over —D 54 — 11-years in obese men with lower T (N=474)! Qa 2 5 0 ¥y y ¥ y y y , y ' « Weight loss did not plateau, even after 11 years £ 2 54 Included men with low-
Slide 20: 2401 - Potential for Differentiated Benefit to Risk Profile
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile Key takeaways LPCN 2401 Competitive landscape* Oral, QD, prodrug of bioidentical hormone Myostatin /activin receptor modulators (e.g. bimagrumab, apitegromab, taldefgrobep, KER-065, and trevogrumab)*? + Invasive - IV/SC + Moderate to h
Slide 21: 2401 - A New Paradigm in Oral Treatment for Obesity and Weight Management
LPCN 2401 - A New Paradigm in Oral Treatment for Obesity and Weight Management Target benefits to improve body composition Adjunct to GLP-1 agonist treatment Post cessation of GLP-1 agonist treatment —_ Weight loss | L_ Minimize weight __| rebound Amplify fat loss Sustain HbA1c improvement Improve b
Slide 22: LIPOCIN=
LIPOCIN= ENHANCING HEALTH
Lipocine — H.C. Wainwright 5th Annual MASH Investor Conference 2024 on 6ix