Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (September 2025)
37 slides from Lipocine's investor presentation, Sep 26, 2025
Slide 1: Corporate Presentation September 2025
Corporate Presentation September 2025 LIPOCIN=
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 Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2 Pivotal Next Steps/Status LPeN 1154 CE) Postpartum Depression Obesity Management ~ adjunct to GLP-1 Decompensated Liver Cirrhosis LPeN 210 ED Drug Resistant Epilepsy (ORE) Prevention of Preterm Birth LPEN 2208 Se Essen
Slide 4: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories IMPORTANT SAFENGINEORMATION TLANDO® licensed to Verity Pharma in January 2024 for Berns Naiiciindo cen commercialization in the U.S. $11 million upfront payment to Lipocine
Slide 5: LPCN 1154 (BREXANOLONE) Oral Brexanolone for Postpartum Depression
LPCN 1154 (BRLIZIO™) Oral Brexanolone for Postpartum Depression (PPD) fxizio~ fa brand name conditionally approved by FDA
Slide 6: Postpartum Depression - An Expanding Market Opportunity
High economic burden Goal of medical intervention is to prevent harm to mother and infant Negative impact on family/society Among women reporting PPD symptoms, 64% reported comorbid anxiety symptoms” Suicide is a leading cause of maternal death in the first year following childbirth? - Up to 30% of
Slide 7: 1154 Target Product Profile to Address Unmet Medical Need
LPCN 1154 Target Product Profile to Address Unmet Medical Need Potential for “best in class” 1L therapy option Presynaptic ‘Temi ‘ goon Chemically identical to endogenous allopregnanolone (brexanolone) Rapid Relief Fixed oral solid dosage form ere GAbh ctor No titration or taper required : Ponsmape
Slide 8: 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Overcoming brexanolone oral delivery challenges Brexanolone (allopregnanolone) is a positive allosteric modulator (PAM) of x DrugLoaded ous Fewer = RR uate at_Systomie the GABA, receptor Liprat based Circulation h ro dosage form Insolub
Slide 9: 1154 - Current therapies relative to LPCN 1154
LPCN 1154 - Oral Bioidentical NAS for PPD Current therapies relative to LPCN 1154 SSRIs / SNRIs Zuranolone Brexanolone SSRIs have slow onset, longer treatment duration, and lower response rates. Additionally side effects CiplatialUse || (éubesivile (ERENT) such as sexual dysfunction, changes in slee
Slide 10: PPD is a Life-Threatening Condition with Few Existing Treatment Options
PPD is a Life-Threatening Condition with Few Existing Treatment Options Advantage of Rapid Response/Relief and Short Treatment Duration Maternal depression and suicide can have far-reaching consequences for child development, family function, and the nation’s economy"? Rapid relief benefits Short tr
Slide 11: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Bridge Study Labeling Studies Evaluation Pivotal Study Y Positive Results Y Food effect study © Ongoing P3 Safety and Efficacy VY PK study in PPD Study Y Metabolite evaluation © 1% DSMB update, Q4/25 © Expect
Slide 12: 1154 Dosing Regimen Confirmation Study Results
LPCN 1154 Dosing Regimen Confirmation Study Results LPCN 1154 met standard bioequivalence criteria to IV Brexanolone Comparative Exposure - GMR (%) 90% CILB 90% CIUB LPCN 1154 was well tolerated Parariicter Test vs. Test vs. Test vs. No sedation or somnolence events observed Reference Reference Refe
Slide 13: 1154 Phase 3 Safety and Efficacy Study
LPCN 1154 Phase 3 Safety and Efficacy Study (NCT06979544) Based on FDA feedback - Outpatient setting with no medical monitoring requirement Study design Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression Inclusion criteria Endpoints Rationale for Success
Slide 14: 1154 Opportunities in Other Depression Disorders
LPCN 1154 Opportunities in Other Depression Disorders Adequate and durable remission/response; treat anxiety | Efficacy comorbidity int Unmet Needs in D Mental disorder in reproducti aged women: Approximately 7%-14% of reproductive-aged women suffer from depression and 12%-15% suffer from anxiety 1
Slide 15: 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 Acute rapid relief, short duration, bioidentical Streamlined pathway to NDA submission Dosing regimen confirmed Phase 3 safety & efficacy stud
Slide 16: Obesity Management - adjunct to GLP-1
Obesity Management — adjun to GLP-1 ct
Slide 17: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists'” GLP-1 market trending toward oral once daily dosing Semaglutide: $30 billion sales in the US in 20244 v T2DM Tirzepatide: $14 billion sales in the US in 20245 ¥ Weight management FDA approved indications ¥ Cardiovascular disease ¥ Chronic k
Slide 18: 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 ‘Weight Loss FatLoss Lean Mass Loss Fy sm Semaghtide H Placebo £2 68% a semaghtide Fat mass 3 2 ° Age ® 75 Significant weight loss is from lean The median percentage of total body 43% of el
Slide 19: 2401 Once Daily Oral as An Adjunct to GLP-1 Treatment
LPCN 2401 Once Daily Oral as An Adjunct to GLP-1 Treatment 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” * Androgen re
Slide 20: 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 {ke} Appendicutar Lean Mass (ke) Total Fat Mass Trunk Fat Mass 2s (ke) (kg) 2 1 * 2 ~ 08 15 2 1 » * ° ° S a z g 5 S a", a | 4 é ar is
Slide 21: 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 Fat Mass Loss reduction in excess adiposity (body fat) with a goal of reduced morbidity and ity! mortality on Semaglutide™, Excess total body fat increases the risk of death and major comorbidities
Slide 22: 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 , “ “ “we en POC study in relevant obese and overweight population | | | Frequency and severity of TEAEs with LPCN 2401 were J 5 c
Slide 23: 2401 - Potential for Differentiated Benefit to Risk Profile for Chronic Use
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile for Chronic Use A liver beneficial approach® with no increased risk of adverse cardiovascular outcomes? LPCN 2401 Target Attributes Competitive Landscape* Oral, QD, prodrug of bicidentical hormone Fat loss amplification Lower fat mass
Slide 24: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 25: 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC Phase 2 results in treatment of sarcopenia and OHE in cirrhosis Analogue (Rifaximin) Sales LEP P LEE I SLES 0 lea feseaen rarmacabel SeipsSaes Data apt 21 anu 2025 POC = Proof of concept Lipocine | 2005 25
Slide 26: 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) s zm ef 33% 8 = 20% ro s = S s S 20% 8 3 3. 5 10% 3 ‘Week 2 om 0% SORLPCN 1148 =O Placebo =e Placeboto 1148 iipon 1448 Placebo * ~9% increase in L3-SMI a
Slide 27: 1148 Phase 2 Results - HE Endpoint Met
LPCN 1148 Phase 2 Results - HE Endpoint Met Fewer overt hepatic encephalopathy events Through Week 24 Week 24 to EOS LPCN 1148 switch from placebo N=8 Placebo LPCN 1148 LPCN 1148 Parameter N=14 N=15 N=11 History of HE prior to randomization (n) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent Overt HE (e
Slide 28: 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 LPCN 1148 switch from placebo (Week 24 to EOS) N=8 Placebo LPCN 1148 L
Slide 29: Value Through Partnership
alue Through Pz
Slide 30: 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 Petentiat@ be SOC in provansion of pretermbirth Oral, a Major Contribution to Patient
Slide 31: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate Highlights 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 Oralwith u
Slide 32: Appendix
Append
Slide 33: 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 Odds Ratio, 95% Cl O01 on 10 100 Covert HE (Odds Ratio, 95% Cl Sarcopenia and myosteatosis are associated with inc
Slide 34: 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 35: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption : + Tremor is highly disabling and stigmatizing g—« Estimated prevalence + Stress can aggravate tremor in social setting 2.2 % of population’ + Major impact on activities of daily living leading
Slide 36: 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 84 doses administered across 4 single dose studies to 37 participants No sedation or dizziness AE reported Mean Plasma Concentration Time (h) Lu
Slide 37: 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