Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2025)
46 slides from Lipocine's investor presentation, Jan 13, 2025
Slide 1: Corporate Presentation January 2025
Corporate Presentation January 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 development efforts, our strategi
Slide 3: Lipocine Pipeline and Approved Product
Lipocine Pipeline and Approved Product Devel Cc Pre-Clinical Phase 1 Phase 2 Pivotal Status/Next Steps LPoN 1154 ED Postpartum Depression Q1-25 soa CCCs) acjunctto GLP the Obesity Management adjunct to GLP-1 therapy Decompensated Liver Cirrhosis LPGN2101 ED Wo eared Women With Epilepsy Prevention of
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Aa ; _ ryy Drug + Fg co = Lip’ral based dosage form ea = 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 => Aq
Slide 5: LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 6: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity « High economic burden mated patients U.S. with PPD « Critical to prevent harm to mother and infant / « Negative impact on family/society Pregnancy in the US* « Suicide is a leading cause of maternal death in the first year following childbirth" - Upto
Slide 7: Approved Injectable Brexanolone Product Attributes
Approved Injectable Brexanolone Product Attributes (Bioidentical NAS) Logistics of 60-hour IV infusion Target Dosage*: 2 woe . ° ree Placebo Inpatient administration o —— ZULRESSO 90 meg/kg/hour lec 1 i IV Brexanolone Remission Rates 2 2 3 @— ZULRESSO 60 megikg/hour ~37% of AEs are related to IV inf
Slide 8: 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential “first line” product of choice for outpatient use Brexanolone * Brexanolone is a positive allosteric modulator (PAM) of the GABA, receptor Brexanolone (allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilic: Log P+ 5.0 Poo
Slide 9: 1154: Oral Bioidentical NAS for PPD
LPCN 1154: Oral Bioidentical NAS for PPD Robust rapid relief with 48-hour treatment duration LPCN 1154 Targeted Key Attributes Bioidentical NAS 48-hour treatment duration Terminal half-life: 9 hours" Up to 61% remission post treatment (60 hr)? No dosage modifications needed for concomitant drug use’
Slide 10: 1154 Pivotal Study Results
LPCN 1154 Pivotal Study Results Bioequivalence with IV Brexanolone Comparative Exposure « LPCN 1154 was well tolerated PK GMR (%) 90% CILB 90% CIUB lcuiicie Testvs. Reference Test vs. Test vs. « Nosedation nor somnolence events observed Cmax 105 92 118 « All events were mild to moderate No severe or
Slide 11: 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 *PK study in PPD Results *Metabolite Expected to be the first oral Positive Topline brexanolone evaluation Completed Completed Q1-25 FDA Meeting Fol
Slide 12: LPCN 2401 Obesity Management
Slide 13: 2401 - Obesity Management Market Overview
LPCN 2401 - Obesity Management Market Overview Total GLP-1 users in the U.S. may reach around 9% (30M) of the overall population by 20308 Prevalence 258 Mo. asutus popuiston 110 — Obese? (BMI at or above 30.0) 79 M Overweight? (BMI 25.0 to 29.9*) Overweight with related comorbidity 30% Type 2 diabet
Slide 14: Sarcopenic Obesity (SO) and GLP-1 Use
Sarcopenic Obesity (SO) and GLP-1 Use Sarcopenic obesity (SO) is defined as the coexistence of excess fat mass and reduced skeletal muscle mass The causes are multifactorial and can include sedentary lifestyle, hormonal changes, chronic diseases, inflammation, insulin resistance, and nutritional def
Slide 15: Limitations of Incretin Mimetics (GLP-1 Receptor Agonists)
Change from baseline (kg) 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 Loss of Lean Mass Increased Fracture Risk Rebound Weight Gain Diabetics ° WeightLo
Slide 16: 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 17: 2401 - Improvement in Body Composition
LPCN 2401 - Improvement in Body Composition Prespecified endpoints met — increased lean mass and decreased fat mass EE es Total Fat Mass Trunk Fat Mass (% of TM) (% of Trunk Mass) Lean Mass (% of TM) Appendicular Lean Mass 5 2 1 n * 4 * 0 0) g 3 a a f=} 2 a 1S) [=a UO 2 -1 2 UV ex 3 ei [e} a 4 2< °
Slide 18: 2401 - Changes in Functional Tests
LPCN 2401 - Changes in Functional Tests Hand Grip Strength Ten Meter Walk Time 8 0 6 -0.5 4 F 2 -1 0 “15 -2 -4 -2 Baseline Grip Strength (kg) Walk Time (s) LPCN 2401 84.4 10.33 mLPCN 2401 mLPCN2401+E Placebo LPCN 2401+ E 88.5 8.67 Placebo 82.1 8.60 Change from Baseline (kg) Change from Baseline (S)
Slide 19: 2401: Body Weight Changes During Weeks of Treatment Placebo-Controlled OLE
LPCN 2401: Body Weight Changes During 72 Weeks of Treatment 2 1 Placebo-Controlled OLE 3 L = o £ o a Ly a = £ o D 5 omss= LPCN 2401 +/-E = 6 = LPCN 2401 oO Placebo 7 “= == Placebo to LPCN 2401 8 . Time (week) - Participants who took placebo for 36 weeks then switched to LPCN 2401 during the 36-week
Slide 20: 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 ae = ep oer « POC study in relevant obese and overweight 5 population 3 ° | | | e Frequency and severity of TEAEs with LPCN 2401 3 . : : wer
Slide 21: 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 Post cessation of GLP-1 agonist treatment —_ Weight loss | L_ Minimize weight __| rebound Amplify fat loss fi S Sustain HbA1c Improvement Improve bone he
Slide 22: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 23: 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 OHE is a severe stage of a + Lactulose (Rx laxative) + Fewer driving incidents, ~(382,000) condition where toxins 59% = High recurrence rate falls accumulate in the brain due ~ Poorlytolerat
Slide 24: 1148 Management of Cirrhosis
LPCN 1148 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, FGF2%, i
Slide 25: L3-SMI Change from Baseline Hepatic Encephalopathy
L3-SMI Change from Baseline Hepatic Encephalopathy % CBLL3-SMI LPCN 1148 Phase 2 Results - Primary Endpoint Met Significantly increased SMI and fewer events of overt hepatic encephalopathy i + + ; $ # = I — 5 Through Week 24 Week 24 to EOS LPCN 1148 switch from placebo N=8 Placebo N=14 LPCN 1148 LPC
Slide 26: 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 Placebo LPCN 1148 LPCN 1148 acebo (Week 24 to, Parameter (Through Week 24) (Throug
Slide 27: Through Partnering
ugh Partnering
Slide 28: 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 29: 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
Slide 30: TLANDO Partnerships
TLANDO Partnerships TLANDO® and TLANDO XR (LPCN 1111) TRT market is large and growing with a significant untapped market potential Verity Pharma for TLANDO and TLANDO XR in the U.S. and Canada ~8M annual prescriptions in the U.S. ~650,000 annual prescriptions in Canada $11M license fee for Lipocine;
Slide 31: Tate
Tate
Slide 32: 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 & Adequate and durable remission/response; treat million adults (8.4%) in the US had at least one ee! anxiety comorbidity major depressive episode’ EO) Days vs we
Slide 33: 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) Alpha2 Betal Beta2 Beta3
Slide 34: 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 ¢ Positive pivotal study results ¢ Potential to expand for other depression indications LIPOCIN=
Slide 35: 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 36: 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 ARA? Non-Diabetic Diabetic I § ae 1 = Androgen Receptor Incretin ra 3 | meee | Agonist (ARA) Mimetic Hi ey é £3 8 3 3 S 2 @ Z
Slide 37: 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: LPCN 2401 LPCN 2401+E Parameter at Baseline (N=13) (N=13) Fat Mass:Lean Mass Ratio 4 Mean Age (years) 53.2 53.8 51.1 2 Mean Weight (kg) 111.3
Slide 38: 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) ‘ll 0.5 Fa 0 a So a x a 3 -0.5 z ? 3 3 4 oz -1.5 fe} gs 2, 1S) Oo & 6 g a — mh 7 2.5 8 Mm LPCN 2401 mLPCN2401+E mVi
Slide 39: 2401 - Improvement in Body Composition
LPCN 2401 - Improvement in Body Composition Improvement in bone mass and bone density compared to placebo Bone Mass and Density Bone Mineral Content (%) Hip TScore Femoral Neck T Score 3.5 0.3 = we ma 3 af * 0.25 Vv = SR 25 re] > 0.2 nol 2 © wm ? 4 B = oi 86S so) > 15 ne] 8 a FS a1 : 3 g [ay & Qo x
Slide 40: 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 Visceral fat is primarily responsible for the risks associated with abdominal fat such as cardiovascular, cerebrovascular, metabolic, liver, renal, an
Slide 41: 2401 - Potential for Differentiated Benefit to Risk Profile
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile Key takeaways LP 2401 Oral, QD, prodrug of bioidentical hormone Myostatin /activin receptor modulators (e.g. bimagrumab, Fat loss amplification taldefgrobep, KER-065, and trevogrumab)'? + Lower fat mass (preferably VAT and android fat)
Slide 42: Patients Experienced Improved Myosteatosis
Patients Experienced Improved Myosteatosis Muscle Quality CBL Week 24 quality seen with LPCN 1148 therapy - Decrease in intramuscular adipose tissue (IMAT) - Significant increase in high quality muscle (HQM) Relative Change in Muscle Areas (%) 8 LPCN 1148 Placebo GIMAT BHQM } LOCF. LS Mean (SE); PGI
Slide 43: 1148 A Novel Approach for Management of Cirrhosis
LPCN1148 A Novel Approach for Management of Cirrhosis Key takeaways Blockbuster opportunity that addresses significant unmet medical needs with a strong pharmacoeconomic rationale Targeted to be a “First in Class” product candidate with a novel MOA Protected by patent portfolio Expanded indication p
Slide 44: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption 2.2 % of population’ * Tremor is highly disabling and stigmatizing Estimated|prevalence: * Stress can aggravate tremor in social setting * Majorimpact on activities of daily living leading to une
Slide 45: 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 46: 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