Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2024)
29 slides from Lipocine's investor presentation, Jan 9, 2024
Slide 1: Lipocine
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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: Investment Highlights and Near-Term Value Events
Investment Highlights Near-Term Value Events Validated Proprietary Lip’ral Technology Platform Enabling Effective Oral Delivery Q1 2024 LPCN 1148: Topline P2 OLE Results LPCN 1154: Fast Acting Oral Antidepressant ¥ LPCN 1148: Unique MOA for Management of Cirrhosis Q2 2024 LPCN 2101: Novel MOA for Tr
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form > Insolul I lipid composition Section of GI ‘magnified to illustrate absorption bbe Lumen - Drug Loaded a Carrier Aqueous Intestinal Systemic Barrier Layer Wall Circulation Insoluble drug lipid composition lL, Optimal disper
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Neuroactive Steroids (NASs) Significant Unmet Needs in Central Nervous System Disorders (CNS) Psychiatry Depression Disorders: Robust and durable efficacy, fast onset, good tolerability, improved compliance, affordable, and easy access Neurology Epilepsy: Nove
Slide 6: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2/POC Pivotal Approved Status (Postpartum Depression) Bay LPCN 1148 P2 open label (nr cmese-reptecnaorasoy, cn ‘Secondary Sarcopenia) progress LPCN 2101 IND cleared for ere Stee EEE Pat Neuroactive S
Slide 7: 1154: Oral Brexanolone for Postpartum Depression (PPD)
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 8: Postpartum Depression (PPD) and Market Potential
Postpartum Depression (PPD) and Market Potential A major depressive disorder within weeks of childbirth The prevalence of adolescent-onset PPD is Estimated patients in the two-folds higher than adult-onset PPD’ U.S. with PPD4 Suicide is a leading cause of maternal death in the first year following c
Slide 9: Limitations of Current Pharmacological Treatment Options for PPD
Limitations of Current Pharmacological Treatment Options for PPD Patients in need of a highly efficacious, fast-acting, and convenient antidepressant SSRIs/SNRIs Injectable Brexanolone Zuranolone (Off label use for PPD indication) (Bioidentical NAS) (NAS derivative) Slow onset of antidepressant acti
Slide 10: 1154: A New Paradigm with Oral Bioidentical NAS for PPD
LPCN 1154: A New Paradigm with Oral Bioidentical NAS for PPD Robust rapid relief with 3 day treatment Target Product Candidate Attributes Bromncineamanace * Brexanolone is a positive allosteric modulator (PAM) of the GABA, receptor + Oral for outpatient use + No complications with concomitance antid
Slide 11: Pilot PK Bridge Study Results
Pilot PK Bridge Study Results Dosing regimen identified for confirmatory PK study Comparative Exposure Safety and Tolerability Ratios (%) of geometric mean » LPCN 1154 was well-tolerated PK LPCN 1154 vs IV brexanolone + AIlAEs were mild or moderate in severity Parameter DR 1 vs DR 2vs » AEs were sim
Slide 12: 1154 Status
LPCN 1154 Status Streamlined pathway to NDA submission goal in 2024 Pilot PK Bridge Study PK Pivotal Study NDA Filing Positive Topline Results Confirmatory trial to establish Expected to be the first oral Established feasibility of multidose oral efficacy for NDA submission* brexanolone administrati
Slide 13: 1148: Management of Liver Cirrhosis
LPCN 1148 Management of Liver Cirrhosis * Overt Hepatic Encephalopathy (OHE) * Secondary Sarcopenia (SS)
Slide 14: Validated Overt HE Market Potential
Validated Overt HE Market Potential 1 ia colloeed alae See Rifaximin for Reduction in Risk of OHE Recurrence + Rifaximin (Xifaxan®) is used to prevent episodes Decompensated Men with Cirrhosis? (229,000) Diagnosed HE? (149,518) Market Size* | > $1B LIPOCINE SeanbLanat 208 Census Intemational Databec
Slide 15: Current Standard of Care & Unmet Needs in OHE
Current Standard of Care & Unmet Needs in OHE Limited options - significant enduring medical need Current Standard of Care Key Unmet Needs 4 @eh Significant Pee a ra . Mortality ecurrence w Tolerability ¢ First Line: Lactulose or Lactitol Rate . Refractory Patients: IV or Oral Amino Overt HE patient
Slide 16: 1148: A Blockbuster Opportunity
LPCN 1148: A Blockbuster Opportunity Product Oral androgen receptor agonist Candidate Dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous Attributes hormone Targeted Mechanism of Action Increase muscle mass and Via improved liver health® and Induce hematopoiesis®; Impr
Slide 17: Primary Endpoint Met
Primary Endpoint Met LPCN 1148 therapy resulted in a significant increase in L3-SMI at week 24 L3-SMI Change from Baseline L3-SMI Absolute Change from Baseline Week 12 Week 24 6 tt es ; a6 = oa sa LPCN 1148 | Placebo E: Timepoint (N=18) (N=10) 5, = Baseline (om?im?) 478(18) 45823) c 5” GLPCN 1148 GP
Slide 18: 1148 Efficacy
LPCN 1148 Efficacy Recurrence of Overt HE was decreased with LPCN 1148 LPCN 1148 Placebo Parameter 5) ( 4) Total decompensation events 7 10 Total decompensation events > Grade 1 6 10 Hepatic encephalopathy events 3 6 HE > Grade 1 2* 6 Recurrence of HE > Grade 1 ili 6 Time to first recurrence of HE >
Slide 19: 1148 Efficacy
LPCN 1148 Efficacy LPCN 1148 produced trends in improvement in other secondary end-points Parameter LPCN 1148 Deaths (n) 0 1 Days in hospital (total) 54 17 Length of hospital stay (median, days) 3 5 6 min walk test (feet)* +270 -16 EncephalApp Stroop Test (total time, seconds)* 4.8 413.8 *mean chang
Slide 20: 1148 Safety
LPCN 1148 Safety Overall LPCN 1148 was well tolerated LPCN 1148 Placebo Parameter (N=15) (N=14) # n # n Total AE events 33 8 36 10 Serious AE events 15 5 16 5 Severe AE events 6 4 10 4 * Administration of LPCN 1148 was well tolerated in this end-stage population, with rates and severities of adverse
Slide 21: 1148: A Novel Approach for the Prevention of OHE
LPCN 1148: A Novel Approach for the Prevention of OHE Key takeaways » Blockbuster opportunity that addresses a significant unmet medical needs with a strong pharmacoeconomic rationale » Potential to be a “First in Class” product candidate with a novel MOA » Met primary and relevant clinical endpoint
Slide 22: Partnering Non-Core Assets
| 1 Partnering -Core Assets
Slide 23: Unlocking Value Through Partnering
Unlocking Value Through Partnering Why Partnering? Assets for Partnering @ Enables focus on CNS opportunities Development Candidate Indication) Pre-Clinical_ Phase 1_—-Phase2/POC_———Pivolal Approved TLANDO® Candidate advancement (Testosterone Replacement Therscy) LPoN 1111 {Once Daily Testosterone R
Slide 24: Appendix
Appendix
Slide 25: Brexanolone Safety
Brexanolone Safety* Continuous IV Brexanolone Infusion LPCN 1154 Oral Brexanolone TEAEs Post-Market Experience (as of June 30, 2023) Clinical Study Experience**, N=28, 304 Doses: FAERS Database* (n= 207) -LOC 0% * LOC 0% + Somnolence, sedation 0% + lV infusion administration related AEs ~37% + Dizzi
Slide 26: Cirrhosis: Complications and Recent Trends
Cirrhosis: Complications and Recent Trends Complications Recent Trends + Decompensation events - hepatic * Occurrence of cirrhosis and related deaths are on the rise encephalopathy, varices, ascites, etc. + In the US between 1999 and 2019, greater than three-fold increase + Compromised liver functio
Slide 27: 1148 Study Design
LPCN 1148: * Two-arm (1:1 randomization, N=29) * * Oral LPCN 1148, T dodecanoate vs. Placebo Study Design * Standard of care treatments/therapies allowed * 24-week placebo-controlled * Followed by 28-week open-label extension (OLE) + All subjects receive LPCN 1148 during OLE SCREENING ——————— PEE ST
Slide 28: Baseline Characteristics
LPCN 1148 Baseline Characteristics Generally well-balanced between treatment arms LPCN 1148 Placebo (Se) (N=14) Age (years) 58.347.5 58.8+9.5 BMI (kg/m?) 29.2 45.3 29.0486 L3-SMI (cm’/m?) 47.8 +7.0 44.8485 MELD Score 15.9+3.7 18.1446 Medical History = 1 Decompensation Event* 14 (93%) 14 (100%) 2 2 D
Slide 29: Observed Hematologic Benefits
Observed Hematologic Benefits LPCN 1148 therapy resulted in significant increase in hemoglobin menimattstin upon tia | placeno |————Palue (N=15) (N=14) hange from) 75 placebo Timepoint Baseline Baseline (g/dL) 11.39 (0.75) 13.04 (0.8) NIA NS Week 24 CFB (g/dL) 1.20 (0.33) — -0.05 (0.35) 0.001 0.02 L