Lipocine Inc. · NASDAQ:LPCN
Lipocine — H.C. Wainwright 27th Annual Global Investment Conference 2025
25 slides from Lipocine's conference presentation, Sep 5, 2025
Slide 1: H.C. Wainwright 27th Annual Global Investment Conference
LIPOCIN= ENHANCING HEALTH H.C. Wainwright 27* Annual Global Investment Conference September 8-10, 2025
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 es ED * Postpartum Depression Topline results Q2/26 Toes ——== = pon GLP-1 Use Management - adjunct to GLP-1 anitiation| LPCN 1148 ee rasa comp Decompensated Liver Cirrhosis LPEN 201 Gi »D> IND
Slide 4: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories IMPORTANT SAFETY INFORMATION https://www.tlando.com/ Biocon aon BP? ud -ANDO’ Bost care ‘a Yes, TLANDO’ 120 capsules Yc Ss Sp 4 120 capsules 4 is a large TLANDO® licensed t
Slide 5: Oral Brexanolone for Postpartum Depression (PPD)
Oral Brexanolone for Postpartum Depression (PPD) me conditionally approved by FDA
Slide 6: Postpartum Depression (PPD) - An Expanding Market Opportunity
Postpartum Depression (PPD) - An Expanding Market Opportunity Compelling pharmacoeconomic rationale? High economic burden Estimated patients in the U.S. with PPD? Goal of medical intervention is to prevent harm to mother and infant pe Pregnancies in the US* Negative impact on family/society ad Postp
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 Mechanism of Action Target Product Attributes ‘Synaptic GABA Receptor Gereoaaenone a 8B ona sie . . . Presynaptic / y Chemically identical to endogenous allopregnanolone (brexanolone) my “
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 Oral enablement Brexanolone (allopregnanolone) is a positive allosteric modulator (PAM) of the GABA, receptor Molecular Weight: 318.5 g/mol Lipophilic: Log P= 5.0 Poor aqueous
Slide 9: 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 Rapid relief benefits Faster management of depression Reduces the risk of suicidal thoughts and behaviors Lead to fewer hospitalizations Positive outcomes in terms
Slide 10: 1154 - Oral Bioidentical NAS for PPD
LPCN 1154 - Oral Bioidentical NAS for PPD Current therapies relative to LPCN 1154 SSRIs have slow onset, longer treatment duration, and lower response rates. Additionally side effects such as sexual dysfunction, changes in sleep pattern and weight gain are common Zuranolone treatment is associated w
Slide 11: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Dosing Regimen P P P P Confirmation Study Labeling Studies Evaluation Pivotal Study VY Positive Results V Food effect study © Ongoing P3 Safety and Efficacy v PK study in PPD Study VY Metabolite evaluati etab
Slide 12: 1154 Dosing Regimen Confirmation Study Results
LPCN 1154 Dosing Regimen Confirmation Study Results LPCN 1154 met standard bioequivalence criteria to |V Brexanolone Comparative Exposure PK GMR (%) 90% CILB 90% Cl UB LPCN 1154 was well tolerated Parameter Test vs. Test vs. Test vs. No sedation or somnolence events observed f ec af ec af ee . All e
Slide 13: 1154 Phase 3 Safety and Efficacy Study
LPCN 1154 Phase 3 Safety and Efficacy Study 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 Primary endpo
Slide 14: 1154 Opportunities in Other Depression Disorders
LPCN 1154 Opportunities in Other Depression Disorders Significant Unmet Needs in Depression Disorders MDD: Per NIMH, in 2020, an estimated 21.0 million adults (8.4%) in the US had at least one major depressive episode" Prevalence of comorbid anxiety disorder and MDD is as high as 60% TRD: Prevalence
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: GLP-1 Agonist Use Management
: . \ “ ‘Wy GLP-1 Agonist Use Management
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 Tirzepatide: $14 billion sales in the US in 20245 v T2DM v Weight management FDA approved indications Y Cardiovascular disease ¥ Chronic
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 Fat Loss Lean Mass Loss ° 8.6% comaglutide Mean change from Significant weight loss is from lean mass loss in 16 weeks! 32% Lean mass 68% Fat mass The median percentage of total
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 (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 25 4 (kg) (kg) >| 2 1 * 09 1S + 16 12 ~ 14 0 0 g a a 05 4 — zZ 6 a a 0
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 mortality’ Excess total body fat increases the risk of death and major comorbidities such as type 2 diabe
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 ae “ “e eer POC study in relevant obese and overweight population 3° | i Frequency and severity of TEAEs with LPCN 2401 were 7° 5
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 bioidentical hormone Fat loss amplification + Lower fat mas
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 oo a LP EL ESE EPO ES BofA Global Research, Pharmaceutical Scripts/Sales Data Report 21 January 2025 ul IN= POC = Proof
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