Lipocine Inc. · NASDAQ:LPCN
Lipocine — H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference (June 2023)
27 slides from Lipocine's conference presentation, Jun 26, 2023
Slide 1: H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference
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 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 Oral Enablement of Brexanolone Lpral based dosage form = - Achieved Relevant Systemic Levels Ego + Fou: = RR untoom in Phase 1 Study T a Aqueous Intestinal Systemic Observed PK Profile Post Oral Administration vatten Barierayer "Wal Chouaton 7 @p_| \
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Neuroactive Steroids (NASs) Significant Unmet Needs in Central Nervous ee ee eer System Disorders (CNS) 9 g 9 Psychiatry Depression Disorders (e.g. PPD, MDD, TRD): Robust and durable efficacy, fast onset, good tolerability, improved compliance, affordable, and
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, (atin Ds) Ce orm LPCN 1148 Phase 2 POC (Liver Cirrhosis - Hepatic Encephalopathy; rT tt si (istsi‘ésCSz topline results, mid Secondary
Slide 7: Unlocking Value Through Partnering
Unlocking Value Through Partnering Why Partnering? Assets for Partnering @ Enables focus on CNS opportunities iv) i) °° i) DevelopmentCandidate (Indication) Pre-Clinical «Phase? —«-~Phase2IPOC——ivotal Approved . TLANDOS——(exUS) Candidate advancement (Testosterone Replacement Therapy) LPON 1111 (Once
Slide 8: LPCN 1154
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 9: 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 10: 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 11: LPCN 1154: Strong Pharmacological Rationale
LPCN 1154 Strong Pharmacological Rationale GABA Receptor Substrates Binding GABA oe 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 channel UPOCINE hips:op
Slide 12: LPCN 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 13: 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 LPCN 1154 was well-tolerated pea All AEs were mild or moderate in severity Vv * v © AEs were similar across trial arms 60 ng 90 ug © — Major
Slide 14: Brexanolone Safety
Brexanolone Safety Continuous IV_Brexanolone infusion Post-market Experience Zulresso REMS: 3-year (March 2022) Assessment Report (n=545)* = Loc 0% - Excessive sedation 1.8% FAERS Database™ (n= 189) — IVinfusion administration related AEs ~39% — Sedation ~3% — Somnolence ~6% LPCN 1154 Oral Brexanolo
Slide 15: LPCN 1154: Streamlined Pathway to NDA Submission
LPCN 1154 Streamlined Pathway to NDA Submission Goal in 2024 Phase 1 Successful single dose study completed Established feasibility of oral administration UPOCIN= “Laboing studies may be needed for NDA submission Pilot PK Bridge Study Positive Topline Results Initiate 4Q 2023 PK Pivotal Study Confir
Slide 16: LPCN 1148 for the Management of Liver Cirrhosis
LPCN 1148 for the Management of Liver Cirrhosis * Hepatic Encephalopathy (HE) * Secondary Sarcopenia (SS)
Slide 17: Hepatic Encephalopathy, a Nervous System Disorder in Cirrhosis
Hepatic Encephalopathy, a Nervous System Disorder in Cirrhosis 100 ition of HE due to Ammonia Buildup 80 ; - - = Decrease in hepatic function | = 60 g a Vv & on ee mocpentisnor HE Dependence on muscle for detoxification | oo | See - Sarcopenia and HE pout 0 Muscle-mass depletion | 0 4 8 12 16 20 24
Slide 18: Liver Cirrhosis Management — Opportunity
Liver Cirrhosis Management — Opportunity 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 waitlist are male
Slide 19: LPCN 1148
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 20: LPCN 1148 - Novel Multi-Modal Mechanism of Action for Liver Cirrhosis
LPCN 1148 - Novel Multi-Modal Mechanism of Action for Liver Cirrhosis Anabolict Increase muscle mass and strength?; Reduce fat mass*; Increase bone density’; Inhibit myostatin’; Improve appetite and nutritional status” Ammonia Detoxific ion Improve liver health; Improve muscle disorders; Antibacteri
Slide 21: LPCN 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 22: LPCN 2101 for Women With Active Epilepsy (WWE)
Slide 23: Women with Epilepsy (WWE) of Childbearing Age
Women with Epilepsy (WWE) of Childbearing Age Treatment Challenges Seizure Control Pre-Pregnancy Pregnancy © Drug-drug ¢ Planned pregnancy Fetal/neonatal toxicity interaction - AED selection * Adherence to AEDs * Unplanned pregnancy 7 " © Lowest effective dose, - Contraception failure monotherapy AE
Slide 24: Women with Epilepsy (WWE) of Childbearing Age - Opportunity
Women with Epilepsy (WWE) of Childbearing Age - Opportunity Prevalence Standard of Care Limitations Unmet Need ~ 900,000 of women of childbearing No drug approved specifically for Seizure control with low/no (CB) suffer from active epilepsy in WWE teratogenic risk ust2 Most approved ASMs have fetal
Slide 25: LPCN 2101
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 26: Exploratory Candidate
Slide 27: 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
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