Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (September 2022)
29 slides from Lipocine's investor presentation, Sep 28, 2022
Slide 1: Lipocine: Enhancing Health
LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-looking statements
not being realized, clinical and poy pee {and plans not bing realized, uding the rece ucts, and other risks detailed in ffecnrers “SI Se including, without oe hid rocess inc!
Slide 3: Investment Highlights
Investment Highlights Validated Proprietary Li ral Technology Platform Enabling Effective Oral Delivery Curated Clinical Development Focus LPCN 1154: Fast Acting Oral Antidepressant LPCN 1148: Unique MOA for Management of Cirrhosis LPCN 2101: Novel MOA for Treating Women with Active Epilepsy Explora
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form ep eS) Insoluble drug lipid composition Section of imagoified to ilystrate absorption rug Loaded Cartier Intestinal Systemic Circulation a Aqueous Insoluble drug lipid ‘composition Effective Transfae iepreved Le patina spons
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Endogenous Neuroactive Steroids (NASs) Significant unmet needs in CNS ‘ge and growing CNS market Psychiatry Depression Disorders: Rapid onset antidepressant Neurology Epilepsy: Novel MOA targeting women with active epilepsy (WWE) Movement Disorders: No medicat
Slide 6: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase2/POC Pivotal Approved Status pea t Saas pee (Postpartum Depression) ‘study in progress LPCN 1148 (Decompensated Liver Girhoss- eS Phase 2 POC Secondary Sarcopenia/Hepatic study in progress Encephalop
Slide 7: LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 8: Postpartum Depression (PPD) — A Substantial Opportunity
Postpartum Depression (PPD) — A Substantial Opportunity Market in Need of a Convenient Fast-Acting Oral Antidepressant Standard of Care Limitations Prevalence Unmet Need ~ 1 in 8 women in US Burdensome invasive Convenient non-invasive suffer from PPD after infusion ving birth" Fast-actin: ovingieran
Slide 9: First Oral Brexanolone
LPCN 1154 First Oral Brexanolone Product Candidate Attribute Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising brexanolone Product Candidate Differentiation Non-invasive oral option with rapid onset No IV infusion challenges Potential for outpatient administration
Slide 10: 1154 - Achieved Levels Comparable to 3rd Trimester Pregnancy
LPCN 1154 - Achieved Levels Comparable to 3' Trimester Pregnancy Enablement of Oral Brexanolone (a.k.a. allopregnanolone ) Phase 1 Study of Results + Sequential single dose escalation study in post menopausal women (n=8) with Lip'ral based oral @ mean value observed capsules. High Dose @ Medium Dose
Slide 11: 1154 - Development Status
LPCN 1154 - Development Status Favorable Regulatory Outlook Efficacy can be achieved thru PK bridge to IV infusion brexanolone 505 (b) (2) NDA Validated regulatory pathway LV. Brexanolone approved for PPD fF Phaset Bet Pilot PK Bridge Stucy = ne Planned Pivotal Study Successful single dose study Pil
Slide 12: Slide 12
Slide 13: Liver Cirrhosis Management — Opportunity
Liver Cirrhosis Management — Opportunity Standard of Care Prevalence Limitations Unmet Need ‘Over 2 million cases"; No approved drug for SS: Improve survival! 500k+ with Secondary Sarcopenia quality of life for patients decompensation? (SS) on transplant list 62% on liver transplant Rifaximin for He
Slide 14: Management of Liver Cirrhosis: Secondary Sarcopenia; Hepatic Encephalopathy
LPCN 1148 Management of Liver Cirrhosis: Secondary Sarcopenia; Hepatic Encephalopathy Product Candidate Attribute Androgen receptor agonist Oral dosage form comprising testosterone laurate, a unique prodrug of endogenous testosterone Potential for Orphan Drug Designation Product Candidate Differenti
Slide 15: 1148 - Novel Multi-Modal MOA for Liver Cirrhosis
LPCN 1148 - Novel Multi-Modal MOA for Liver Cirrhosis Hepatic Encephalopathy is Associated with Sarcopenia Qambate Q Anti-Inflammatory®? Increase muscle mass and strength? Reduce IL-1, 1-6, and TNF-a Precipitation of HE Decrease in hepatic function Reduce fat mass? t : c Increase bone density* Inhib
Slide 16: 1148 — Potential Beneficial Effects
LPCN 1148 — Potential Beneficial Effects Effects Observed in Subjects with Chronic Liver Disease* Liver (primary organ) Injury Marker Reduction ALT (U/L) Changes Tine (st) [AST (U/L) Changes Ek be wswe eee Te (we Muscle (secondary organ) Positive Effects on Body Compositiont Relative Change in Appen
Slide 17: 1148 - Development Status
LPCN 1148 - Development Status POC Topline Results Expected in 1H 2023 Phase 2 POC study (NCT04874350) in male Primary: Change in Skeletal Muscle Index at Week 24 cirrhotic subjects — in progress Multi-center, Key Secondary: randomized, placebo-controlled study in male Overall survival, hospitalizat
Slide 18: LPCN 2101 for Women With Active Epilepsy (WWE)
LPCN 2101 for Women With Active Epilepsy (WWE)
Slide 19: Women with Epilepsy (WWE) of Childbearing Age - Opportunity
Women with Epilepsy (WWE) of Childbearing Age - Opportunity peavalence Standard of Care Limitations Unmet Need ~ 900,000 of women of childbearing No drug approved specifically for Seizure control with lowino (CB) suffer from active epilepsy in WWE teratogenic risk ust? Most approved ASMs have fetal
Slide 20: Novel Potential Alternative for WWE
LPCN 2101 Novel Potential Alternative for WWE Product Candidate Attribute Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addressing WWE unmet needs Active is endogenous to women Pote
Slide 21: 2101 Development Status
LPCN 2101 Development Status IND cleared \ Next Step Phase 2 POC study*
Slide 22: Value Through Partnering of Non-CNS Assets
Slide 23: Unlocking Value Through Partnering
Unlocking Value Through Partnering y Partne Assets Available for Partnering Enables focus on CNS opportunities DevelopmentCandiéte(Indication) Pre-Clineal-—-Phatet_—~PhaseZ/POC——Plvotal_-«—Approved Candidate advancement ae [SEs Risk diversification 7 meen Geos 0 TE : a : (Once Dai Testetoroe Potenti
Slide 24: TLANDO Attributes
TLANDO® Attributes Convenient Oral Route + No inadvertent transference or pulmonary oil micro embolism risks Single strength and dose T without jon requirement + Enables selection of an effective dose at the start of therapy without delay + No “efficacy gap" upon switching from other TRTS + No addit
Slide 25: 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” L
Slide 26: Potential to be SOC in Prevention of Preterm Birth
LPCN 1107 Potential to be SOC in Prevention of Preterm Birth Product Candidate Highlights 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 react
Slide 27: Novel MOA in Non-Cirrhotic NASH
LPCN 1144 Novel MOA in Non-Cirrhotic NASH Product Candidate Highlights Oral dosage form comprising testosterone ester No approved drug Fast Track Designation Compelling P2 Biopsy Results in the FDA approvable endpoint v Safety support with 72 weeks exposure Mono- or adjunct therapy Differentiated pr
Slide 28: Financial Summary
Financial Summary Market Capitalization $43.8M' Debt No outstanding debt Cash $37.4M2 Additional funding Potential for non-dilutive funding through partnerships Research Coverage includes: Cantor Fitzgerald Jennifer Kim Ladenburg Thalmann Matt Kaplan Zacks John Vandermosten UPOCINE” + sesserace ENHA
Slide 29: Investment Highlights
Investment Highlights Validated Proprietary Li ral Technology Platform Enabling Effective Oral Delivery Curated Clinical Development Focus LPCN 1154: Fast Acting Oral Antidepressant LPCN 1148: Unique MOA for Management of Cirrhosis LPCN 2101: Novel MOA for Treating Women with Active Epilepsy Explora