Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (December 2024)
45 slides from Lipocine's investor presentation, Dec 13, 2024
Slide 1: Corporate Presentation December 2024
Corporate Presentation December 2024 LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-Looking Statements
Forward-Looking Statements “fe d. i provisions of i ities Litigati: f 1995 and our ability to moneti: product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments, our product ; eas : A f is : an ; a A A eutcoma
Slide 3: Lipocine Pipeline and Approved Product
Lipocine Pipeline and Approved Product Pre-Clinical Phase 1 Phase 2 Pivotal Status/Next Steps LPCN 1154 Postpartum Depression Obesity Management LPCN 2203 Essential Tremor LPCN 2101 Women With Epilepsy 107 Prevention of Preterm Birth LPCN 1148 Decompensated Liver Cirrhosis LPCN 1144 Non-Cirrhotic NA
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip’ral based dosa; A . Drug Loaded ry. Carrier = ige form at Drug + Carrier e == Insoluble dru; lipid composition cI Aqueous Intestinal Systemic Lumen BarrierLayer | Wall Circulation Superior Oral Bioavailability e.g., ANDO® of Gl Insoluble drug lip
Slide 5: LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 6: 1154 Opportunities in Depression Disorders
LPCN 1154 Opportunities in Depression Disorders Prevalence Significant Unmet Needs in Depression Disorders MDD: Per NIMH, in 2020 timated 21.0 : deq 1 diirahl, Ta re aT Usha ectcone > EERE Scscuste sre cre major depressive episode" Rapid Relief Days vs weeks The p l f comorbid anxiety di © Ee u and
Slide 7: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity High economic burden Critical to prevent harm to mother and infant e Negative impact on family/society ¢—e Pregnancy in the US* Suicide is a leading cause of maternal death in the first year following childbirth’ = Postpartum depression® Increased aware
Slide 8: Approved Injectable Brexanolone Product Attributes
Approved Injectable Brexanolone Product Attributes (Bioidentical NAS) Logistics of 60-hour IV infusion sage": . ee a see Placebo Inpatient administration —4— ZULRESSO 90 meg/kg/hour oe 1 — BUIRESSO A maga ~37% of AEs are related to IV infusion 60 n=122 administration errors? & y g stays; providers a
Slide 9: 1154 - First Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - First Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential “first line” product of choice for outpatient use (PAM) of the GABA, receptor Brexanolone (allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilic: Log P ~ 5.0 Poor aqueous solubility: Saq <1.0 g/mL + Ready tou + Fixe
Slide 10: 1154 - Oral Bioidentical NAS for PPD
LPCN 1154 - Oral Bioidentical NAS for PPD Robust rapid relief with 48-hour treatment duration LPCN 1 Targeted Key Attributes* Zuranolone (Zurzuvae®) Bioidentical NAS Synthetic NAS derivative 48-hour treatment duration 14-day treatment duration? Terminal half-life: 9 hours" Terminal half-life: 20-25
Slide 11: 1154 Pivotal Study Results
LPCN 1154 Pivotal Study Results Bioequivalence with IV Brexanolone Comparative Exposure GMR (%) 90% CILB 90% CIUB ° icIcliticiee Testvs.Reference Testvs.Reference Test vs. Reference Cmax 105 92 118 AUCo..0 97 89 107 AUCo+ 89 81 98 * Crougn target also met * Crrougn Of LPCN 1154 geometric mean was hi
Slide 12: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission Pivotal PK Study Labeling Studies Next Step _ . °Food effect study Expected to be Positive Topline *PK study in PPD Sekyin the first oral Results *Metabolite P brexanolone evaluation Completed Completed Q1-25 FD
Slide 13: 1154: Best in Class Oral Treatment for Depression
LPCN 1154: “Best in Class” Oral Treatment for Depression Key takeaways ¢ Differentiated product attributes addressing unmet needs ¢ Streamlined pathway to NDA submission * Positive pivotal study results ¢ Potential to expand for other depression indications LIPOCIN= Lipocine | December 2024 3°
Slide 14: LPCN 2401 Obesity Management
Slide 15: Obesity and Overweight - A Growing Epidemic in US
Obesity and Overweight - A Growing Epidemic in US Increases the risks of heart disease, stroke, type 2 diabetes and certain types of cancer’ ~110M adults4 38% of men and 51% of women diabesity population would be interested in taking a prescription drug for weight loss® 74% GLP-1 users in the US pro
Slide 16: Limitations of Incretin Mimetics (GLP-1 Receptor Agonists)
Limitations of Incretin Mimetics (GLP-1 Receptor Agonists) Significant loss of lean mass and fat/weight/HbA1c rebound potential upon cessation A Plateauing of Weight Loss/ Less Weight Loss in FossorEeaniMass (neko! Pers GEES Rebound Weight Gain ° Weight Loss FatLoss Lean Mass Loss 3 mSemaglutide Set
Slide 17: Unmet Needs in Obesity Management
Unmet Needs in Obesity Management 2 out of 3 people on GLP-1 drugs ( e.g. Wegovy®) discontinue within a year’ - Favorable benefit to risk profile + Superior efficacy + Improved body composition (quality weight loss/quality fat loss) + Improvement in weight-related comorbidities - Better tolerability
Slide 18: 2401 - A New Paradigm in Oral Treatment for Obesity Management
LPCN 2401 - A New Paradigm in Oral Treatment for Obesity Management Target benefits to improve body composition Adjunct to GLP-1 agonist treatment L f GLP-1 agonist treatmen —_ Weight loss | Minimize weight rebound Amplify fat loss Improve bone health LIPOCIN= Lipocine | December 2024 cs
Slide 19: 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, testosterone ester(s), targeted for once-a-day treatment - “LPCN 2401” * And
Slide 20: 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 “> Incretin Androgen Receptor Mimetic Agonist (ARA) Diabetes® P41 GLP-1 Receptor Expression? Receptor Activity’ Non-Diabetic Diabetic : é go 5 . iS 5 3 § 8 2 z
Slide 21: 2401 - Improvement in Body Composition
LPCN 2401 - Improvement in Body Composition Prespecified endpoints met - increased lean mass and decreased fat mass Body Composition Analysis Set’ Body Compo: ion Results . LPCN 2401 LPCN 2401+E Parameter at Baseline ( IN=13) (N=13) Fat Mass:Lean Mass Ratio 4 Mean Age (years) 53.2 53.8 51.1 2 Mean W
Slide 22: 2401 - Improvement in Body Composition
LPCN 2401 - Improvement in Body Composition Prespecified endpoints met - increased lean mass and decreased fat mass Total Fat Mass Trunk Fat Mass (% of TM) (% of Trunk Mass) * *x 4 * 0 og 3 a 4 roa) a 2 a UO a OG 2 19 ro) x 5 Ri [e} a 4 2< 0 a 6 * -3 2 MLPCN 2401 mLPCN2401+E m= Placebo MLPCN 2401 mL
Slide 23: Impact of LPCN 2401, LPCN2401+Vitamin E, and Vitamin E on Fat mass
Impact of LPCN 2401, LPCN2401+Vitamin E, and Vitamin E on Fat mass Fat loss amplification of ARA in conjunction with Vitamin E Total Fat Mass Trunk Fat Mass (% of TM) (% of Trunk Mass) mz 0 L -0.5 1 -1.5 2 -2.5 mLPCN 2401 mLPCN2401+E m Vitamin E 3 mLPCN 2401 mLPCN 2401+E m Vitamin E Placebo adjusted
Slide 24: 2401 - Improvement in Body Composition
LPCN 2401 - Improvement in Body Composition Improvement in bone mass and bone density compared to placebo Bone Mass Density Bone Mineral Content (%) Hip T Score Femoral Neck T Score a wt m3 *,# x 25 Vv a S 25 s) _ 0.2 mod a o a 2 B a _" 0.15 i] 15 sz 3 a (Ut a1 : 8 gv oO & iS) Eos & a | “ — 0 mLPCN
Slide 25: 2401 - Changes in Functional Tests
LPCN 2401 - Changes in Functional Tests Hand Grip Strength 8 0 Bs a g 20 = 4 oO o wo wo 8 © ao oO S 2 g 71 £ & wo 0 o D 2 5-15 8 s 52 7 -4 -2 Baseline Grip Strength (kg) Walk Time (s) LPCN 2401 84.4 10.3: mLPCN 2401 mLPCN2401+E Placebo LPCN 2401+ E 88.5 8.67 Placebo 82.1 8.60 Data are mean (SE) LIPO
Slide 26: 2401 High Quality Fat Loss in Obesity Management
LPCN 2401 High Quality Fat Loss in Obesity Management Strong correlation between fat distribution in central region and obesity related comorbidities Android fat is highly correlated with total visceral fat" Visceral fat is primarily responsible for the risks associated with abdominal fat such as ca
Slide 27: 2401 Differentiated Obesity Management Option
LPCN 2401 Differentiated Obesity Management Option Well-tolerated with liver benefits and no safety signals upon 36-week exposure Liver Injury Marker Reduction ALT AST Change from Baseline (U/L) 0 2 4 6 8 Absolute Change from Baseline (%) -10 LPCN 2401 (N=19) ( ALP LPCN 2401+E (N=18) GGT ° a s -10 .
Slide 28: 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 Fat loss amplification + Lower 1 android f. Improve/preserve Ian mass iscle mass, quality, and functionality + Bone health GLP Gl side effects: mi
Slide 29: Management of Liver Cirrhosis
Management of Liver Cirrhosis J * Overt Hepatic Encephalopathy (OHE) - ¢ Sarcopenia
Slide 30: Cirrhosis is a Large Market with Few Existing Treatment Options
Cirrhosis is a Large Market with Few Existing Treatment Options Significant unmet need in an expansive market US Diagnosed Decompensated Cirrhosis Patients"? ~(382,000) Decompensated Men with Cirrhosis’, ~(229,000} Overt Hepatic Encephalopathy ——— OHE isa sev ate condition where toxit - High recurre
Slide 31: 1148 Management of Cirrhosis
LPCN 1148 Management of Cirrhosis Product Candidate Attributes Anabolic Stimulates muscle satellite activator, FGF22, inhibit myostatin3,increase muscle mass an: strength’, and reduce fat mass® Targeted Mechanism of Action Ammonia Lowering Androgenic Induce hematopoiesis; improve endocrine/sexual dy
Slide 32: 1148 Phase 2 Results - Primary Endpoint Met
LPCN 1148 Phase 2 Results - Primary Endpoint Met A significant increase in L3-SMI L3-SMI Absolute Change from Baseline* L3-SMI Change from Baseline Week 12 Week 24 eH 6 aa im + . —€ 5 = 3.0 BS = 09 22 Q 1 £o o a 5 5? HLPCN 1148 = Placebo -0.6 3 N14 9 15 10 | ven 1143 eee " . 4 jacebo Tim in , epoint
Slide 33: Patients Experienced Improved Myosteatosis
Patients Experienced Improved Myosteatosis Muscle Quality CBL Week 24 Relative Change in Muscle Areas (%) 8 LPCN 1148 Placebo GIMAT BHQM N 1148 therapy - Decrease in intramuscular adipose tissue (IMAT) - Significant increase in high quality muscle (HQM) LIPOCIN= Lipocine | December 2024
Slide 34: Key Secondary Endpoint Met in OHE
Key Secondary Endpoint Met in OHE Significant difference with LPCN 1148 while on HE existing standard of care PCN 1148 switch from icebo Placebo LPCN 1148 LPCN 1148 aa Parameter (Through Week 24) (Through Week 24) (Week 24 to EOS) (Week 24 to EOS) N=14 N=15 N=11 Nes History of HE prior to randomizat
Slide 35: 1148 Phase 2 Results
LPCN 1148 Phase 2 Results Overall LPCN 1148 was well tolerated + Rates and severities of AEs similar to those in Stage 1 with placebo + Fewer participants experienced severe AEs when switched from placebo to LPCN 1148 LPCN 1148 switch from Placebo LPCN 1148 LPCN 1148 lacebo (Week 24 to Parameter (Th
Slide 36: 1148 A Novel Approach for Management of Cirrhosis
LPCN1148 A Novel Approach for Management of Cirrhosis Key takeaways Blockbuster opportunity that medical needs with a strong pharmacoeconomic rationale First in Class MOA Expanded indication potential - non-cirrhotic NASH, prevention of any decompensation event, sarcopenia in end-stage diseases di (
Slide 37: LPCN 2203 Oral NAS for Essential Tremor
Slide 38: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption ’ . Tremor is highly + Majori _—_ 65% in need of 2" line treatment i i drinking, dressing, eating, and / reading (80-85%) - 90 ici * © 20% peak adoption of ET 759 y y $3.6B* . 1. Louis ED, Ottman
Slide 39: 2203 Oral GABA Positive Allosteric Modulator
LPCN 2203 Oral GABA Positive Allosteric Modulator Achieved relevant target levels with good tolerability in Phase 1 studies Typical single dose PK profiles Dose 1 5 84 doses z administered No sedation or dizziness H Dose 2 across 4 AE reported & single dose & studies to 37 Hy f Dose 3 participants 1
Slide 40: LPCN 2101 Women With Epilepsy (WWE)
Slide 41: 2101 - Novel Potential Alternative for Women With Epilepsy (WWE)
LPCN 2101 - Novel Potential Alternative for Women With Epilepsy (WWE) Endogenous Neuroactive Steroid Product Candidate Attribute receptor Product Candidate Differentiation anxiety, Lipocine | December 2024 a
Slide 42: Value Through Partnering
Slide 43: 1107 for Prevention of Preterm Birth
LPCN 1107 for Prevention of Preterm Birth Product candidate highlights ti Oral dosage form comprising 17. aproa’ Strong pharmaco-economic justification Oral, a Major Contribution to Patient Care (MC to Pree Aes f f Accelerated approval pathway and ODD (Orphan Drug Designation) LIPOCIN= Lipocine | De
Slide 44: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate Highlights Fast Track Designation mpelling F v j I Mono or adjunct therapy Differentiated profile v v Potential for and musculoskeletal domain v Weight neutral approach % Responders NASH Resolution with No Fibrosis 60 p< 0.05 oO Placebo (N=
Slide 45: Testosterone Replacement Therapy (TRT) Verity Alliance
Testosterone Replacement Therapy (TRT) Verity Alliance TLANDO® and TLANDO XR (LPCN 1111) TRT market is large and growing with a significant untapped market potential + ~8M annual prescriptions in the U.S. + ~650,000 annual prescriptions in Canada Verity Transaction + $11M license fee for Lipocine; $