Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (June 2023)
36 slides from Lipocine's investor presentation, Jun 26, 2023
Slide 1: Corporate Presentation June 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements ‘This presentation contains “forward-looking statements" that are mace 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 strateg
Slide 3: Investment Highlights and Near-Term Value Events
Investment Highlights Near-Term Value Events Validated Proprietary Lip’ral Technology Platform Enabling Effective Oral Delivery Mid 2023 LPCN 1148: Phase 2 POC Cirrhosis Study Topline Results Curated Clinical Development Focus LPCN 1154: Fast Acting Oral Antidepressant LPCN 1148: Unique MOA for Mana
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form = Drug Loaded ad = EB oon l a Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation ep Superior Oral Bioavailability e.g., TLANDO® Insoluble drut lipid composition Section of GI Insoluble drug lipid * Enable Effec
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Neuroactive Steroids (NASs) Significant Unmet Needs in Central Nervous Dent logan Gn nen: System Disorders (CNS) a a a Psychiatry Depression Disorders (e.g. PPD, MDD, TRD): Robust and durable efficacy, fast onset, good tolerability, improved compliance, afford
Slide 6: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2/POC. Pivotal Approved Status LPCN 1154 Initiate pivotal study, (oem rete CO) ons LPCN 1148 Phase 2 POC (Liver Cirrhosis - Hepatic Encephalopathy; Qi > topline results, mid ‘Secondary Sarcopenia) 20
Slide 7: Oral Brexanolone for Postpartum Depression (PPD)
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 8: Postpartum Depression (PPD)
Postpartum Depression (PPD) A Major Depressive Disorder Within Weeks of Childbirth » Estimated patients in the U.S. with PPD: ~500K annually’ * The prevalence of adolescent-onset PPD is two-folds higher than adult-onset PPD? » Suicide/suicide ideation, a significant concern: Suicide is a leading cau
Slide 9: Limitations of Current Pharmacological Treatment Modality for PPD
Limitations of Current Pharmacological Treatment Modality for PPD PPD —A Substantial Opportunity SSRIs/SNRIs Injectable Brexanolone (Not approved for PPD indication, off label use) Slow onset of antidepressant action — may take 4-6 weeks" Treatment duration — acute for 6-8 weeks, followed by 4-9 mon
Slide 10: Strong Pharmacological Rationale GABA Receptor Substrates Binding
LPCN 1154 Strong Pharmacological Rationale GABA Receptor Substrates Binding GABA Benzodiazepine, S 6 cone Mechanism of Action Brexanolone is a positive Allosteric Modulator (PAM) of the GABA, receptor Hormonal changes leading to GABA dysfunction are common in depression and pregnancy GABA-gated CI c
Slide 11: 1154: A New Paradigm in Oral Treatment for PPD
LPCN 1154: A New Paradigm in Oral Treatment for PPD Rapid Relief Matters Product Candidate Attributes Brexanolone Efficacy Advantage + Monotherapy or add-on therapy + Convenient oral for outpatient use Brexanolone + Bioidentical to naturally occurring neuroactive steroid, allopregnanolone ‘Symptom r
Slide 12: Pilot PK Bridge Study Results
Pilot PK Bridge Study Results Dosing Regimen Identified for Confirmatory PK Study Comparative Exposure Ratios (%) of geometric mean LPCN 1154 vs IV brexanolone earn DR1ivs DR2vs IV 60 IV 90 pg AUC. Gisx 114% 79% + Showed comparable PK exposure to both efficacious doses of IV Brexanolone (i.e., 60 ug
Slide 13: Brexanolone Safety
Brexanolone Safety Continuous IV_Brexanolone infusion Post-market Experience Zulresso REMS: 3-year (March 2022) Assessment Report (n=545)* = (oe 0% — Excessive sedation 1.8% FAERS Database** (n= 189) — IVinfusion administration related AEs ~39% — Sedation ~3% — Somnolence ~6% LUIPOCIN= LPCN 1154 Ora
Slide 14: Streamlined Pathway to NDA Submission Goal in 2024
LPCN 1154 Streamlined Pathway to NDA Submission Goal in 2024 Phase 1 Successful single dose study completed Established feasibility of oral administration “Labeting studies may be needed for NDA submission Pilot PK Bridge Study Positive Topline Results Initiate 4Q 2023 PK Pivotal Study Confirmatory
Slide 15: 1148 for the Management of Liver Cirrhosis
LPCN 1148 for the Management of Liver Cirrhosis * Hepatic Encephalopathy (HE) * Secondary Sarcopenia (SS)
Slide 16: Hepatic Encephalopathy, a Nervous System Disorder in Cirrhosis
Hepatic Encephalopathy, a Nervous System Disorder in Cirrhosis 100 Precipitation of HE due to Ammonia Buildup 2 8 ] Decrease in hepatic function | Y Dependence on muscle for detoxification | 2 8 Survival (%) & fo-ssn a arcopeniaorHE 7] 502 Sarcopenia and HE J 0-1 , ot Muscle-mass depletion | ff 4 8
Slide 17: Liver Cirrhosis Management — Opportunity
Liver Cirrhosis Management — Opportunity aa = aa gy lot Prevalence Standard of Care Limitations Unmet Need Over 2 million cases*; 500k+ with No approved drug for secondary SS: Improve survival/ quality of life decompensation? ‘sarcopenia (SS) for patients on transplant list 62% on liver transplant w
Slide 18: Management of Liver Cirrhosis: Hepatic Encephalopathy; Secondary Sarcopenia
LPCN 1148 Management of Liver Cirrhosis: Hepatic Encephalopathy; Secondary Sarcopenia Product Candidate Attributes Product Candidate Differentiation Androgen receptor agonist Oral dosage form comprising testosterone laurate, a unique prodrug of endogenous testosterone Potential for Orphan Drug Desig
Slide 19: 1148 - Novel Multi-Modal Mechanism of Action for Liver Cirrhosis
LPCN 1148 - Novel Multi-Modal Mechanism of Action for Liver Cirrhosis Increase muscle mass and strength?; Reduce fat mass"; Increase bone density"; Inhibit myostatin’; Improve appetite and nutritional status* Kific Ammonia De ion Improve liver health; Improve muscle disorders; Antibacterial Androgen
Slide 20: 1148 - Development Status
LPCN 1148 - Development Status POC Topline Results Expected in Mid-2023 Endpoints: Phase 2 POC study (NCT04874350) Primary: Change in Skeletal Muscle Index at Week 24 Randomized placebo-controlled study Key Secondary: Overall survival, hospitalization rates in sarcopenic male patients with Change in
Slide 21: Value Through Partnering of Non-CNS Assets
ihre ough Partnering n-CNS Assets
Slide 22: Unlocking Value Through Partnering
Unlocking Value Through Partnering Why Partnering? Assets for Partne @ Enables focus on CNS opportunities DevelopmentCandidate (Indication) Preclinical Phase1_—~Phase2/POC Pivotal ©—=—Approved i aes eet ed @ Candidate advancement (ostestrane Replacement Therapy) Leen init Crear romoergnen Gi i i iii
Slide 23: TLANDO Attributes
TLANDO® Attributes Convenient oral administration + No inadvertent transference or pulmonary oil micro embolism risks + Single strength and dose TRT without titration requirement + Enables selection of an effective dose at the start of therapy without delay + No “efficacy gap” upon switching from ot
Slide 24: Once-A-Day Oral Testosterone Replacement Therapy
LPCN 1111 Once-A-Day Oral Testosterone Replacement Therapy Product Candidate Highlights Oral dosage form comprising testosterone tridecanoate Convenient option for large and growing market Patients and physicians preferred once a day oral testosterone Positive Phase 2 study results “Phase 3 ready”
Slide 25: Potential to be SOC in Prevention of Preterm Birth
LPCN 1107 Potential to be SOC in Prevention of Preterm Birth Product Candidate Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential Strong pharmaco-economic justification Oral, a Major Contribution to Patient Care (MC to PC), including no injection site reaction Compelli
Slide 26: Novel MOA in Non-Cirrhotic NASH
LPCN 1144 Novel MOA in Non-Cirrhotic NASH duct Can ate hlights Oral dosage form comprising testosterone ester No approved drug 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 Y O
Slide 27: 1154
LPCN 1154
Slide 28: 1154: Pilot PK Bridge Study
LPCN 1154: Pilot PK Bridge Study Rationale and Clinical Design FDA agrees with Lipocine's proposal to establish efficacy through a pharmacokinetic (PK) bridge to IV brexanolone An open-label, randomized, three-period, 3-arm partial crossover study to compare the PK of oral LPCN 1154 (brexanolone) an
Slide 29: IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens
IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens WV Brexanolone (ug/kg/hr) IV Brexanolone Dosing Regimen oo 90 yg/kg/hr 60 g/kg/hr 60 30 | ol % 12 16 20 24 28 32 356 40 a4 a8 52 56 60 Hour Change from Baseline in HAM-D Score Over Time Least Squares Msn Change nd of ntusion bs Target Dos
Slide 30: Oral Brexanolone for Depression Disorders
Oral Brexanolone for Depression Disorders A New Paradigm in Oral Treatment for Depression Target attributes: Fast onset, robust efficacy, and durable response » Major Depressive Disorder (MDD) — 21,0 million adults in U.S. (8.4% of all adults) had at least one major depressive episode — Globally, an
Slide 31: Appendix
Appendix
Slide 32: Phase Results Suggest LPCN 1144 Has Favorable Benefit to Risk Profile
Phase 2 Results Suggest LPCN 1144 Has Favorable Benefit to Risk Profile Met the Primary and Key Secondary Endpoints with Statistical Significance yl Ge _ee 02 03 04 \ 05 Met the pre- Changes in liver fat, Treatment effect Open-label Well-tolerated with specified key liver enzymes, and safety extensi
Slide 33: Safety Overview of LPCN 1144 Through Week
Safety Overview of LPCN 1144 Through Week 36 Well-Tolerated with an Overall Safety Profile Comparable to Placebo AEs of Interest,n(%) | Placebo ‘Treatment A . Diarrhea 2 (10.5%) 1 (5.6%) * Frequency and severity of TEAEs were comparable to placebo ( ) ( ) . Nausea 4 (5.3%) 1 (5.6%) * Discontinuance
Slide 34: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction s0oe/Kestent.—_ Dosa/restnett *p-ca0s,*** pcan ve pace NASH Resolution with No Worsening of Fibrosis ts * as -. al OE S Seladelpar | Resmetirom | _Lanifibranor | — Absolute Changes of Liver Fat from
Slide 35: Appendix LPCN 1148
Slide 36: 1148: Management of Decompensated Cirrhosis
LPCN 1148: Management of Decompensated Cirrhosis Arandomized, placebo-controlled phase 2 trial Baseline Characteristics Proportion of Participants Parameter ek eee with Key Decompensation Events ‘Age (years) 58.5484 <65 76% 100 Race/Ethnicity White 83% Black/Af. Am 7% oe 75 Asian 3% 5 ‘American Indi