Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2023)
27 slides from Lipocine's investor presentation, May 5, 2023
Slide 1: Oral Drug Delivery Corporate Presentation
» Presen iT . 3 PI may 2p2 cave Oral Drug Delivery
Slide 2: Forward-Looking Statements
Forward-Looking Statements ‘This release contains “forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Seourties Litigation Reform Act of 1896 and include statements that are not historical facts regarding our produet development efforts, our strategic pla
Slide 3: Investment Highlights
Investment Highlights Validated Proprietary Lip’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 Explor
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form a Drug Loaded —)- rx = h ee [ a Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Superior Oral Bioavailability Insolul y e.g., TLANDO® lipid composition ‘Section of GI Insoluble drug lipid Enable Effective Or
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Neuroactive Steroids (NASs) Significant Unmet Needs in Central Nervous DEAE ee 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, affordable, a
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 Pilot PK bridge (oops EE Saar LPCN 1148 Phase 2 study ‘Secondary Sarcopenia) ‘completed LPCN 2101 IND cleared for Neuroactive Steroid (ca)
Slide 7: LPCN 1154 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 after Childbirth * One in eight women suffer from PPD‘ with up to 10% being considered severe'? » ~50% of patients are diagnosed and treated in the US? » U.S women with moderate-severe PPD estimated ~175K annually4 » Suicide/suicid
Slide 9: Postpartum Depression (PPD) — A Substantial Opportunity
Postpartum Depression (PPD) — A Substantial Opportunity Limitations of Current Pharmacological Treatment Modality for PPD SSRIs/SNRIs Injectable Brexanolone (Not approved for PPD indication, off label use) (The only FDA approved treatment) Slow onset of action — may take 4-6 weeks" Logistics of burd
Slide 10: Postpartum Depression (PPD) Significant Unmet Needs
Postpartum Depression (PPD) Significant Unmet Needs & Remission and response ® No excessive sedation, no sexual dysfunction and weight gain side effects, no withdrawal side effects upon discontinuation Gs Non-invasive fi) Outpatient/Community setting use ze Improved compliance LIPOCI Days vs weeks.
Slide 11: LPCN 1154 Strong Pharmacological Rationale
LPCN 1154 Strong Pharmacological Rationale Mechanism of Acti Brexanolone is a positive Allosteric Modulator (PAM) of the GABA, receptor Hormonal changes leading to GABA dysfunction is common in depression and pregnancy GABA Receptor Substrates Binding GABA stay Ogun GABA-gated CI- channel
Slide 12: 1154: A Potential Preferred Option for Rapid Relief in PPD
LPCN 1154: A Potential Preferred Option for Rapid Relief in PPD The Days After Childbirth are a Critical Time Period for the Care of Both Mother and Newborn Product Candidate Attributes + Monotherapy or add-on therapy for patients with unresolved symptoms + Convenient oral for outpatient use with no
Slide 13: 1154 - Enablement of Oral Brexanolone
LPCN 1154 - Enablement of Oral Brexanolone Achieved Relevant Systemic Levels in Phase 1 Study Sequential single dose escalation study in post-menopausal women (n=8) with Lip’ral based oral dosage form + LC-MS/MS assays of blood samples Observed PK Profile Post Oral Administration Mean Plasma Concent
Slide 14: LPCN 1154 Development Highlight
LPCN 1154 Development Highlight Favorable Regulatory Outlook Efficacy can be established through PK bridge to IV infusion brexanolone 505(b)(2) NDA Validated Regulatory Pathway IV brexanolone approved for PPD Pilot PK Bridge Study PK Pivotal Study Dosing completed Confirmatory trial to establish Top
Slide 15: LPCN 1148 for the Management of Liver Cirrhosis
LPCN 1148 for the Management of Liver Cirrhosis * Hepatic Encephalopathy (HE) « Secondary Sarcopenia (SS)
Slide 16: Complications in Patients with Cirrhosis
Complications in Patients with Cirrhosis Precipitation of HE due to Ammonia Buildup + Decompensation events - hepatic _ encephalopathy, varices, ascites, etc. | Decrease in hepatic function + Compromised liver function, immunity, and k 7 protein synthesis Dependence on muscle for detoxification + Mu
Slide 17: Liver Cirrhosis Management — Opportunity
Liver Cirrhosis Management — Opportunity Age, Ps ae =) (od 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 tr lant wa
Slide 18: LPCN 1148 Management of Liver Cirrhosis: HE; 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 Anabolict Increase muscle mass and strength?; Reduce fat mass*; Increase bone density"; Inhibit myostatin’; Improve appetite and nutritional status* me) | 2cmoni: on) Improve liver health; Improve muscle disorders; Antibacterial I
Slide 20: 1148 — Potential Beneficial Effects
LPCN 1148 — Potential Beneficial Effects Effects Observed in Subjects with Chronic Liver (primary organ) Injury Marker Reductio1 LPOCIN: # ease Muscle (secondary organ) Positive Effects on Body Composition* AUT (U/L) Changes Relative Change in Appendicular Lean Mass a placebo w=t4) | (Net3) (was) 50
Slide 21: 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: Value Through Partnering of Non-CNS Assets
Slide 23: Unlocking Value Through Partnering
Unlocking Value Through Partnering Why Partnering? Assets for Partnering @ Enables focus on CNS opportunities DevelopmentCandidate Indication) Pre-linical -Phase'1 —-Phase2/POC_—Pivotal:«=«=—Approved i TNC ga ng, § @ Candidate advancement (Testosterone Replacement Therasy) Leen 1111 Onedaiy tetera C
Slide 24: 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 25: LPCN 1111 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 26: LPCN 1107 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 27: LPCN 1144 Novel MOA in Non-Cirrhotic NASH
LPCN 1144 Novel MOA in Non-Cirrhotic NASH duct Candidate Highlights 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 profil