Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (February 2025)
47 slides from Lipocine's investor presentation, Feb 11, 2025
Slide 1: Corporate Presentation February 2025
Corporate Presentation February 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 and Approved Product
Lipocine Pipeline and Approved Product Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2 Pivotal Status/NextSteps LPCN 1154 Postpartum Depression LPCN 2401 Obesity Management LPCN 1148 Decompensated Liver Cirrhosis Phase 3: safety & efficacy study Initiate POC study as adjunct to GLP-1
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip’ral based dosage form e = Insoluble drug lipid composition, ay, Jan 2006, Vol 8No.1 Insoluble drug lipid composition L, Optimal dispersed phaseinGliract mp Aqueous Effective tranelen across aqueous: barrier WyaE Barrier Layer Drug Loaded Carrier
Slide 5: Oral Brexanolone for Postpartum Depression (PPD)
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 6: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity e High economic burden « Criticalto prevent harm to mother and infant « Negative impact on family/society ¢— Pregnancy in the US* 3.6M jf « Suicide is a leading cause of } maternal death in the first year g——* Postpartum depression® following childbirth
Slide 7: Approved Injectable Brexanolone Product Attributes
Approved Injectable Brexanolone Product Attributes Robust Efficacy Use Li (Bioidentical NAS) itati Logistics of 60-hour IV infusion i age Inpatient administration 1 — ZULRESSO 90 megikg/hour = ZULRESSS Oh eae ~37% of AEs are related to IV infusion administration errors? REMS: Monitoring for excessiv
Slide 8: Approved Neuroactive Steroids for PPD
Approved Neuroactive Steroids for PPD Comparative key attributes Injectable Brexanolone (Zulresso®) Oral Zuranolone (Zurzuvae®) Bioidentical NAS Synthetic NAS derivative 60-hour infusion" 14-day treatment duration4 Terminal half-life: 9 hours? Terminal half-life: 20-25 hré Up to 61% remission post t
Slide 9: 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 Brexanolo: * Brexanolone is a positive allosteric modulator cage (PAM) of the GABA, receptor Brexanolone {allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilio: Log P= 5.0
Slide 10: 1154 Pivotal PK Bridge Study Results
LPCN 1154 Pivotal PK Bridge Study Results Bioequivalence with IV Brexanolone LPCN 1154 was well tolerated Comparative Exposure + No sedation norsomnolence events observed PK GMR (%) 90% CILB 90% Cl UB + Allevents were mild to moderate Ziti) Testvs. Reference Testvs.Reference Test vs. Reference + No
Slide 11: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission Pivotal PK Bridge Study Labeling Studies +Food effect study *PK study in PPD Positive Topline Results *Metabolite evaluation Completed Completed Next Step P3 Safety and Efficacy Study Pending FDA feedback on the
Slide 12: 1154 Safety & Efficacy Study
LPCN 1154 Safety & Efficacy Study mu Planned study design — © Two arm, randomized, blinded, placebo-controlled in women (215 yrs) with postpartum depression Size: Powered based on Zulresso® treatment effect © Dosing regimen: 48 hr treatment consistent with positive pivotal PK bridge © Primary endpoi
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 * Single safety & efficacy study: To be completed Po
Slide 14: Obesity Management
Obesity Management
Slide 15: 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 Target Population {as an adjunct to GLP-1 User) 258 M. Adult US population’ disease, or both? Do you take these drugs primarily to lose weight, orto tr
Slide 16: 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 17: 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 ; Plateauing of Weight Loss/ Less Weight Loss in I d Fracture Risk ae ee Loss of Lean Mass NEreAseS Fracere Re Rebound Weight Gain Diabetics ° Weightloss Fat
Slide 18: 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 19: 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 (96 of ™) (66 of Trunk Mass) : Lean Mass (% of ™M) Appendicular Lean Mass 2 ll % * 4 * 0 og 3 a Fe co) a? G2 4 is) zz S Ri 8 3 4 2 8 4 6 * 3 2 WLPCN 2401
Slide 20: 2401 - Changes in Functional Tests
LPCN 2401 - Changes in Functional Tests Hand Grip Strength Ten Meter Walk Time 8 0 -05 A | - 1S 4 = Baseline Grip Strength (kg) Walk Time (s) LPCN 2401 ea 10.33 mMLPCN2401 mLPCN2401+E Placebo © s ° ny Change from Baseline (5) Change from Baseline (kg) & LPCN 2401+ E 88.5 867 Placebo 82.1 8.60 Data a
Slide 21: 2401: Body Weight Changes During Weeks of Treatment
LPCN 2401: Body Weight Changes During 72 Weeks of Treatment 2 4 Placebo-Controlled Bo l = = ~ 2a 38 ~ ¢ 2 bd a 3 = 2g +4 é So 5 5 os" LPCN 2401 +/-E = 6 ===" | PCN 2401 Oo Placebo 7 = = Placebo to LPCN 2401 8 Time (week) OLE 72 « Participants who took placebo for 36 weeks then switched to LPCN 2401
Slide 22: 2401 Differentiated Obesity Management Option
LPCN 2401 Differentiated Obesity Management Option Well-tolerated with liver benefits and no safety signals upon 36-week exposure 4@ ae Sib ae e POC study in relevant obese and overweight 5 population ° [ | | | Frequency and severity of TEAEs, including diarrhea ‘ 7) and nausea, with LPCN 2401 + Ewe
Slide 23: 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 — Qualitytattoss Quality weight loss Minimize fat regain [_ Weight loss __| [_ Minimize weight _| rebound Ampli
Slide 24: Management of Liver Cirrhosis
Management of Liver Cirrhosis * Overt Hepatic Encephalopathy (OHE) * Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 25: 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 Overt Hepatic Encephalopathy Limitations of Current + OHEiba severe stege ofa + Lactulose (Rx axstive) + Fewer driving incidents, ~(382,000) ‘condition where toxins 59% ~ High recurrencerate
Slide 26: 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, FGF22, i
Slide 27: 1148 Phase 2 Results - Primary Endpoint Met
LPCN 1148 Phase 2 Results - Primary Endpoint Met Significantly increased SMI and fewer events of overt hepatic encephalopathy L3-SMI Change from Baseline Hepatic Encephalopathy Through Week 24 Week 24 to EOS LPCN 1148 switch from placebo Nes Grrr LPCN1148 | LPCN 1148 Parameter N=14 N=15 Neil 96 CBLL
Slide 28: 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 ulate Parameter NCSI (Through We
Slide 29: Value Through Partnering
Value Through Partnering
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 Potential to be SOC in prevention of preterm birth Oral, a Major Contribution to Patie
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 Y Safety support with 72 weeks exposure Mono or adjunct therapy Differentiated profile ¥ Oral with
Slide 32: TLANDO Partnerships
TLANDO Partnerships 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 Pharma for TLANDO and TLANDO XR in the U.S. and Canada $11M license fee for Lipocine;
Slide 33: Appendix
Appendix
Slide 34: 1154 Opportunities in Depression Disorders
LPCN 1154 Opportunities in Depression Disorders n Disorders nmet Needs in Depres: MDD: Per NIMH, in 2020, an estimated 21.0 million adults (8.4%) in the US had at least one major depressive episode! Adequate and durable remission/response; treat anxiety comorbidity Days vs weeks The prevalence of co
Slide 35: 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) 0! Bead Br. Theta s Hz)
Slide 36: 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 + Imp
Slide 37: 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 —— ; z ' —_—— Incretin g H Lee! Mimetico El a4] £ £ é, a, : a 2 Zo Veh ARA o-ARA Veh ARA c-ARA Insu
Slide 38: 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 Compos' LPCN2401 | LPCN2401+E Parameter at Baseline (N=13) (N=13) i FatMass:LeanMass Ratio 4 Mean Age (years) 53.2 53.8 51.1 2 Mean Weight (kg) 111.
Slide 39: 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) 1 05 Zo iz Zo == O44 BF & 6 05 Bg . 3 3 Ba a 2 sg 4 RAs 2 os ° 3 3 2 = 6 ® 7 a 25 8 WLPCN 2401 mLPCN2401+E m Vitami
Slide 40: 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 36 25 0.6 Placebo-Adjusted % CBL Bone Mineral Content (%) HipTScore Femoral NeckTScore ile ov # mLPCN2401 m= LPCN 2401+E 03 Placebo-Adjusted CBL LIPOCIN= 0.05 vs placebo; #
Slide 41: 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 42: 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 fat mass (preferably VAT and android fat) Improve/preserve lean mass + Muscle mass, quality, and functionality + Bone
Slide 43: Patients Experienced Improved Myosteatosis
Patients Experienced Improved Myosteatosis Muscle Quality CBL Week 24 20 poco ccrccr ccc rene a 10 é \ 1 1 £5 | * Substantial changes in muscle ; % & we ‘ quality seen with LPCN 1148 therapy | 2 £38 ' Decrease in intramuscular 4 C < 10 \ adipose tissue (IMAT) 1 2 gy 1 = Significant increase in high
Slide 44: 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 “Firstin Class” product candidate with a novel MOA Protected by patent portfolio Expanded indication po
Slide 45: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Estimated prevalence ? 2.2% of population’ g— Diagnosed 40% g—® 65% inneed of 2" line treatment 20% peak adoption $3.6B* 1. Louls ED, Ottman R. Tremor Other Hyperkinet Mow (NY). 2014;4:259 Tremor
Slide 46: 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 No sedation or dizziness AE reported studies to 37 participants ‘Mean Plasma Concentration Time {h) L
Slide 47: 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