Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2025)
58 slides from Lipocine's investor presentation, May 12, 2025
Slide 1: Corporate Presentation May 2025
Corporate Presentation May 2025 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 candidates and strategic plans an
Slide 3: Lipocine Pipeline
Lipocine Pipeline P2 study completed Devel Cc. i (Ii Pre-Clinical Phase 1 Phase 2 Pivotal Next Steps/Status Phase 3- expected LPON 1154 SSS) palont dosing Q2/25 Postpartum Depression Obesity Management - adjunct to GLP-1 planned Decompensated Liver Cirrhosis Women With Epilepsy wee > empl Prevention
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Aa ; _ ry Drug + EE co | Lip’ral based dosage form = = ee Insoluble drug lipid composition, of GI to. absorption Giliyar et al. Drug Delivery Technology, Jan 2006, Vol 6 No.1 Insoluble drug lipid composition L, Optimal dispersed phaseinGltract => Aqu
Slide 5: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories First and only oral testosterone replacement therapy (TRT) option that does not require dose titration + ey an id . IDATLANDO =ANDS Capsules 25mg G anes wocepsty | 120 caps
Slide 6: Oral Brexanolone for Postpartum Depression (PPD)
Oral Brexanolone for Postpartum Depression (PPD)
Slide 7: 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential as “first line” therapy Brexanolone Mechanism of Acti * Brexanolone is a positive allosteric modulator (PAM) of the GABA, receptor Brexanolone (allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilic: Log P+ 5.0 Poor aqueou
Slide 8: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity Among women reporting PPD symptoms, 64% reported comorbid anxiety symptoms’ « High economic burden ated patients U.S. with PP « Goal of medical intervention is to prevent harm to mother and infant / « Negative impact on family/society « Suicide is a lea
Slide 9: 1154 - Oral Bioidentical NAS for PPD
LPCN 1154 - Oral Bioidentical NAS for PPD Potential for compelling advantages over current therapies Description Administration Onset of Action Treatment Duration Remission Rate at Day 3 LPCN 1154 (BRLIZIO™) Bioidentical NAS Oral Hours* 48 hours Up to 61%* Zuranolone (Zurzuvae®) Synthetic NAS Deriva
Slide 10: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Bridge Study Labeling Studies *Food effect study ¢PK study in PPD Results *Metabolite Positive evaluation Completed Completed Next Step P3 Safety and Efficacy Study Expected patient dosing Q2/25 LIPOCIN= ENHA
Slide 11: 1154 PK Bridge Study Results
LPCN 1154 PK Bridge Study Results LPCN 1154 met standard bioequivalence criteria to lV Brexanolone Comparative Exposure « LPCN 1154 was well tolerated No sedation or somnolence events observed PK GMR (%) 90% CILB 90% Cl UB - Allevents were mild to moderate iZicliicies Testvs. Reference Test vs. Ri T
Slide 12: 1154 Phase 3 Safety and Efficacy Study
LPCN 1154 Phase 3 Safety and Efficacy Study Study design Prospective advantages Brexanolone has established efficacy (IV infusion) LPCN 1154 has demonstrated Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression . Inclusion criteria Endpoints comparable exp
Slide 13: 1154 "Best in Class" Oral Treatment for Depression
LPCN 1154 “Best in Class” Oral Treatment for Depression Key takeaways ¢ Significant market opportunity ¢ Differentiated product attributes addressing unmet needs ¢ Streamlined pathway to NDA submission « PK bridge study: completed with positive results ¢ Phase 3 safety and efficacy study: ongoing *
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Slide 15: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists” Semaglutide: $30 billion sales in the US in 20244 Tirzepatide: $14 billion sales in the US in 20245 v T2DM v Weight management FDA approved indications v Cardiovascular disease v Chronic kidney disease v Sleep apnea As of 2024, around 12 per
Slide 16: Limitations of GLP-1 Use and Unmet Medical Needs
Limitations of GLP-1 Use and Unmet Medical Needs 2 out of 3 patients on drugs like Wegovy stop within a year’ onal; Lean mass loss i Functionality loss @ Oo and invresse Unmet Medical Needs facture risk . . men * Quality weight/fat loss * Preserve lean mass/functionality Weight/fat @ GLP-1 Use GI re
Slide 17: Drawbacks of Approved GLP-1 Receptor Agonists
Drawbacks of Approved GLP-1 Receptor Agonists Rapid loss of lean mass and functionality in elderly GLP-1 users Low Quality Weight Loss’ Lean Mass Loss! Functionality Loss! Fracture Risk? Weight Loss Fat Loss Lean Mass Loss 2 mSemaglutide i Lean mass. g Placebo B 32% £.) 3 Fat mass 3 Ba 2 a 68% gi Bo
Slide 18: Target Population - Elderly GLP-1 Users, Most Vulnerable Population
Target Population - Elderly GLP-1 Users, Most Vulnerable Population 8 years of expected age-related stair climb power loss in 4 months of GLP-1 use GLP-1 Use Related Decline in Elderly Estimated Elderly GLP-1 Users / Population in the US® — Aged 65+5 GLP-1 User Aged 65+ (~9%)® Pre-existing low lean
Slide 19: 2401 Novel Oral Treatment for Obesity and Weight Management
LPCN 2401 Novel Oral Treatment for Obesity and Weight Management Proven ability 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” * Andro
Slide 20: 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Hypothesized benefits - improve body composition and functionality in weight management Amplify fat loss Preserve lean mass Maintain weight loss Minimize fat regain Preserve functionality Minimize weight rebound ‘Omer nal On GLP-1 GLP-1 On GLP-1
Slide 21: 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Target benefits to improve body composition and functionality LPCN 2401 + GLP-1 agonist treatment LPCN 2401 treatment post GLP-1 cessation Quality weight loss Maintain weight loss 1 1 r 1 r Attenuate functionality loss Maintain/improve functional
Slide 22: 2401 - Clinical Data Show Significant Improvement in Body Composition
LPCN 2401 - Clinical Data Show Significant Improvement in Body Composition Phase 2 results demonstrate increased lean mass and decreased fat mass at Week 20 Lean Mass (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 25 (kg) (kg) 2 * 2 1 * 09 48 6 12 1 0 0 & g gS = 0s = = 3 ; a 09 S 2 -
Slide 23: 2401 - Amplify/Accelerate Fat Loss in Obesity Management
LPCN 2401 - Amplify/Accelerate Fat Loss in Obesity Management Per FDA, weight reduction is a long- term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality’ Excess total body fat increases the risk of death and major comorbidities such as type 2 diabetes, hyperten
Slide 24: 2401 - Body Weight Changes During Weeks of Treatment
LPCN 2401 - Body Weight Changes During 72 Weeks of Treatment 4 Placebo-Controlled L Open Label Extension Change from Baseline (kg) A 5 6 ===" LPCN 2401 +/-E ——— LPCN 2401 7 Placebo <= == Placebo to LPCN 2401 ie} 36 72 Time (weeks) - Participants who received placebo for 36 weeks then switched to LPC
Slide 25: 2401 Safety Data Support Differentiated Product Profile
LPCN 2401 Safety Data Support Differentiated Product Profile Well-tolerated with liver benefits and no safety signals upon 72-week exposure Liver Injury Marker Reduction « POC study in relevant obese and overweight ALT AST ALP GGT s population 3 ° | | | e Frequency and severity of TEAEs with LPCN 24
Slide 26: 2401 Target Attributes Competitive Landscape
LPCN 2401 Target Attributes Competitive Landscape* Oral, QD, prodrug of bioidentical hormone Fat loss amplification + Lower fat mass (preferentially VAT and android fat) Improve/preserve lean mass + Muscle mass, quality, and functionality + Bone health GLP amplification: through genomic and non-geno
Slide 27: 2401 - Regulatory Outlook on Efficacy
LPCN 2401 - Regulatory Outlook on Efficacy Appropriate population and endpoints selection Per FDA Guidance (2025)'?, for efficacy claim related to changes in body composition, trial design should include appropriate choice of population and selection of endpoints that measure how a patient feels, fu
Slide 28: 2401 - Key Takeaways
LPCN 2401 - Key Takeaways Compelling opportunity with favorable benefit to risk profile « Addressing huge GLP-1 user market with unmet needs ° Differentiated oral product for use in combination with GLP-1 or post cessation of GLP-1 « Positive Phase 2 results in relevant subjects « Planned clinical s
Slide 29: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 30: 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Sarcopenia in Cirrhosis LIPOCIN= Positive P2 results in sarcopenia FDA granted Fast Track Designation Acceptable endpoints on sarcopenia No competition in development Unique ARA with patent protection through 2044 Overt Hep
Slide 31: Sarcopenia in Cirrhosis
Sarcopenia in Cirrhosis A serious comorbidity Log Rank, P<0.001 * Log Rank, P<0.001 Log Rank, P<0.001 * Log Rank, P<0.001 —— No Muscular Abnormalities Survival (%) & ——— Sarcopenia 204 *« Sarcopenic Obesity * Myosteatosis oy7 Sarcopenic Obesity and Myosteatosis 0 2 4 6 8 10 12 14 16 18 20 22 24 Foll
Slide 32: Overt Hepatic Encephalopathy (OHE) in Cirrhosis
Overt Hepatic Encephalopathy (OHE) in Cirrhosis Presence of both sarcopenia and HE further increases risk of mortality® i i ii Odds Ratio Survival Rate of Patients with Cirrhos' v eK Ci —* 100 . 80 =_ = 0.01 O41 10 100 > 60 Covert HE 2 = 40 a Neither Sarcopenia, nor ads 20 HE . p=0.001 IV, Random, 9
Slide 33: 1148 for the Management of Cirrhosis
LPCN 1148 for the Management of Cirrhosis Product Candidate Attributes Oral androgen receptor agonist; dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Targeted Mechanism of Action Anabolic" Androgenic Ammonia Lowering Stimulates muscle satellite activator,
Slide 34: 1148 Phase 2 Results - Sarcopenia Primary Endpoint Met
LPCN 1148 Phase 2 Results - Sarcopenia Primary Endpoint Met Resolution for sarcopenia and significantly increased skeletal muscle mass index (SMI) 40% 25 q 3 33% = = 30% 3 5 g = i=} 4 ry a Fy 3 20% ® 8 He ° S 10% = 3 3 Week BE} om 0% @=@ 1PCN 1148 @@ Placebo =@=— Placebo to 1148 LPCN 1148 Placebo *
Slide 35: 1148 Phase 2 Results - HE Endpoint Met
LPCN 1148 Phase 2 Results —- HE Endpoint Met Fewer overt hepatic encephalopathy events Parameter History of HE prior to randomization (n) Recurrent Overt HE (events) Time to first recurrent event (days) Through Week 24 Week 24 to EOS LPCN 1148 switch from Placebo LPCN 1148 N=14 N=15 11 (79%) 11 (73%
Slide 36: 1148 Phase 2 Results Safety Data
LPCN 1148 Phase 2 Results Safety Data 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 Placebo LPCN 1148 LPCN 1148 acebo (Week 24 to, Parameter (Through Week
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Slide 38: 1107 for Prevention of Preterm Birth
LPCN 1107 for Prevention of Preterm Birth Product candidate highlights Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential with no approved drug Strong pharmaco-economic justification Potential to be SOC in prevention of preterm birth Oral, a Major Contribution to Patie
Slide 39: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate Oral dosage form comprising testosterone ester Fast Track Designation Compelling P2 biopsy results in the FDA approvable endpoint v Safety support with 72 weeks exposure Mono or adjunct therapy Differentiated profile Y Oral with unique bene
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Slide 41: 1154 Opportunities in Depression Disorders
LPCN 1154 Opportunities in Depression Disorders Significant Unmet Needs in Depression Disorders MDD: Per NIMH, in 2020, an estimated 21.0 & Pete Adequate and durable remission/response; treat million adults (8.4%) in the US had at least one u anxiety comorbidity major depressive episode’ The prevale
Slide 42: Oral Brexanolone - Potential Additional Neuropsychiatric Indications
Oral Brexanolone - Potential Additional Neuropsychiatric Indications qEEG in healthy subjects administered single doses of oral brexanolone Indications Requiring Rapid Onset (e.g. anxiety) Capsule formulations allow for rapid delivery of neuroactive steroids (Tmax 1.5 hours) Alph: Alpha2 etal Beta?
Slide 43: 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 #5 GLP-1 expression increase with ARA? Non-Diabetic Diabetic I 5 — ar) 7 Androgen Receptor Incretin rd 3 | eee | Agonist (ARA) Mimetic 5 4 4 S & 3 8 3 3 Se 2
Slide 44: 2401+E - Targeted Mechanisms of Action
LPCN 2401+E - Targeted Mechanisms of Action Obesity is associated with systemic chronic inflammation and oxidative stress Fat ‘OBESE FAT TISSUE NORMAL FATTISSUE 1) ( Z oN ee Androgen °* Induces lipolysist . R * Lowers lipogenesis" Copan * Inhibits expression of adipocytokines (e.g., Agonist leptin,
Slide 45: Summary of Preclinical Results in Diet Induced Model
Summary of Preclinical Results in Diet Induced Model LPCN 2401+E significantly improved oral glucose tolerance test and reduced VAT 12-week study in male rabbit model of metabolic syndrome . Regular Diet (RD control), n=10 High Fat Diet (HFD), n=10 HFD + vehicle, n=7 HFD + LPCN 2401 (TU monotherapy)
Slide 46: Phase 2 Study in Patients with Obesity
Phase 2 Study in Patients with Obesity NCT04134091 study design Three-arm, blinded, placebo-controlled trial in male subjects with metabolic dysfunction associated steatohepatitis (n=56) « High prevalence of obesity and weight related comorbid conditions such as dyslipidemia, T2DM, and hypertension
Slide 47: 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Increased lean mass and decreased fat mass Body Composition Analysis Set’ Body Composition Results (36 Weeks) LPCN 2401 LPCN 2401 +E : i Parameter at Baseline sl Fat Mass: Lean Mass Ratio (N=13) (N=13) 4 Mean Age (years) 53.2 53.8 51.1
Slide 48: 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Increased lean mass and decreased fat mass Fat Mass (36 Weeks) Lean Mass (36 Weeks) Fat Mass Android Fat Lean Mass (% of TM) Appendicular Lean Mass (% of TM) (% of Fat Mass) Visceral Fat ° x Ok a * | | i 2 LJ 0 a 5 a e © & 2 *. 7 4 4 6
Slide 49: 2401+E - Amplify Total Fat and Visceral Fat Loss in Obesity Management
LPCN 2401+E - Amplify Total Fat and Visceral Fat Loss in Obesity Management Visceral fat is primarily responsible for the risks associated with abdominal fat such as cardiovascular, cerebrovascular, metabolic, liver, renal, and joint diseases? Combination of LPCN 2401+E and GLP-1 may amplify VAT los
Slide 50: Presence of Sarcopenia is Associated with Higher Risk of HE
Presence of Sarcopenia is Associated with Higher Risk of HE Muscle key organ for ammonia detoxification in the setting of decompensated cirrhosis Sarcopenia and the Increased Risk of HE Ammonia Metabolism and Trafficking in Liver Cirrhosis? Odds Ratio, 95% Cl Glutaminase Va \ = — ort ——_ Hepatic * E
Slide 51: Rifaximin History and Current Status
Rifaximin History and Current Status * Rifaximin was initially approved in 2004 for the treatment of Travelers Diarrhea ¢ Itwas repurposed and approved by the FDA in March 2010 for the reduction of risk of recurrence of overt hepatic encephalopathy in adult patients ¢ Approved in 2015 for IBS-D * Ri
Slide 52: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Estimated prevalence 2.2 % of population’ 20% peak adoption $3.6B* 1. Louis ED, Ottman R. Tremor Other Hyperkinet Mov (N Y). 2014;4:259 2. Gerbasi etal. Patient experiences in essential tremor: b
Slide 53: 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 84 doses administered No sedation or dizziness across 4 AE reported single dose studies to 37 participants Mean Plasma Concentration Time
Slide 54: 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 Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addres
Slide 55: 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’ 74% of adults age 20 and older are obese or overweight (2017-2018)? ~24M obese elderly, group most vulnerable to losing muscle mass 24 ~110M adults* Diabesity
Slide 56: Eligible GLP-1 Agonist Users in US for Chronic Weight Management
Eligible GLP-1 Agonist Users in US for Chronic Weight Management Total GLP-1 users in the U.S. may reach around 9% (30M) of the overall population by 2030° Obesity Prevalence Overweight Prevalence (BMI 25.0 to 29.9%) (BMI at or above 30.0) a ™ —'~ Adult with Obesity’ Adult with Overweight" 79M 111M
Slide 57: Drawbacks of Approved GLP-1 Receptor Agonists
Drawbacks of Approved GLP-1 Receptor Agonists Rebound weight/fat gain post GLP-1 cessation 07% Bel Nw - 180 -44 2. ES 160 5 a Q- 160 3 ¥ 1 3 # -67 ‘ ¥ ] e Br 3 ° t 140 — { S- 140 = -8) 2 ¥ J i can = Switched to placebo =12 id BS -10- semaglutide run-in ——e 120 4 ” 2-420 & Ss oO J ! fe) £4 2 1 8 2. ©
Slide 58: Androgen Treatment Improved Body Composition and Functionality
Androgen Treatment Improved Body Composition and Functionality Six months intervention in older men Body Composition Improvement Total lean mass Total fat mass +1.2kg Mean CI -2.2(-14, ~3.1), 0001 Mean CL 1.6 (0.8, 2.4), P<0001 -2.1kg Testosterone (N=69) |i Placebo (N= 68) Improved Functionality Leg