Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (March 2024)
41 slides from Lipocine's investor presentation, Mar 7, 2024
Slide 1: LIPOCIN=|
LIPOCIN=|
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
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 Hepatic Encephalopathy LPCN 2101: Novel MOA for Treating Women with Active Epilepsy LPCN 22
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form = = | @p Insolul Ms lipid composition (>) Section of GI ‘magnified to illustrate absorption Drug Loaded Carrier Aqueous Intestinal Systemic Barrier Layer Wall Circulation Insoluble drug lipid composition Ll, Optimal disperse
Slide 5: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2/POC. Pivotal Approved Status (Postpartum Depression) 2024 LPCN 1148 Secondary Sarcopenia) LPCN 2101 IND cleared for ieee epee ep ret (Essential Tremor) FDA submission LUPOCI
Slide 6: LPCN 1154
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 7: Postpartum Depression (PPD) and Market Potential
Postpartum Depression (PPD) and Market Potential Dynamic PPD market offers significant opportunity for differentiated LPCN1154 Estimated patients in the U.S. with PPD? Well defined population Suicide is a leading cause of maternal death in the first year following childbirth’ — Up to 30% of women wi
Slide 8: LPCN 1154 - A New Paradigm with Oral Bioidentical NAS for PPD
LPCN 1154 - A New Paradigm with Oral Bioidentical NAS for PPD Patients in need of a highly efficacious, fast-acting, and convenient antidepressant Synthetic NAS derivative 14-day treatment duration Long terminal half-life (20-25 hr) Robust rapid relief with 48-hour treatment duration Upto Up to i il
Slide 9: LPCN 1154: Multidose Dosing Regimen Results
LPCN 1154: Multidose Dosing Regimen Results Positive results confirm 48-hour dosing regimen for the pivotal PK study Comparative Exposure Adverse Reactions of Interest DR1 PEE Ratios (%) of geometric mean PK LPCN 1154 vs IV brexanolone 7 oss of consciousness ° Parameter DR1 vs DR 2vs IV 60 ug* IV 90
Slide 10: LPCN 1154 Status
LPCN 1154 Status Streamlined pathway to NDA submission goal in 2024 Pilot PK Bridge Study Pivotal PK Study NDA Filing Positive Topline Results Confirmatory trial to enable NDA Expected to be the first oral Established feasibility of multidose oral submission* brexanolone administration of LPCN 1154
Slide 11: LPCN 1148
LPCN 1148 Management of Liver Cirrhosis * Overt Hepatic Encephalopathy (OHE) * Secondary Sarcopenia (SS)
Slide 12: Overt HE Market Considerations
Overt HE Market Considerations Blockbuster potential US Diagnosed Decompensated Cirrhosis Patients’ ~(382,000) Decompensated Men with Cirrhosis? ~(229,000) Patients with a History of Overt HE ~(134,100) Market Size* (>$1B) faxi in for Reduction in Risk of OHE Recurrence + Rifaximin (Xifaxan™) is use
Slide 13: 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 Reduction of OHE Recurrence Risk’ ae " Mortality (eames Low Tolerability ¢ First Line: Lactulose or Lactitol Overt HE patients have significant near-term th ave
Slide 14: LPCN 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 15: 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 5 —_ = + 362 Pa 268 LPCN 1148 | Placebo 5g; Timepoint (N=15) (N=10) Ss, ont Baseline (cm?/m?) 47.8 (1.8) 45.8 (2.3) NIA NS =
Slide 16: LPCN 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* i! 6 Time to first recurrence of HE
Slide 17: LPCN 1148 Efficacy
LPCN 1148 Efficacy LPCN 1148 therapy produced trends in improvement in other secondary endpoints 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 13.8 “mean
Slide 18: LPCN 1148 Safety
LPCN 1148 Safety Overall LPCN 1148 was well tolerated LPCN 1148 Parameter (N=15) # 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 events (AEs) s
Slide 19: LPCN1148: A Novel Approach for the Prevention of Overt Hepatic Encephalopathy
LPCN1148: A Novel Approach for the Prevention of Overt Hepatic Encephalopathy and Reversal of Muscle Loss Key takeaways Blockbuster opportunity that addresses a significant unmet medical need with a strong pharmacoeconomic rationale Targeted to be a “First in Class” product candidate with a novel MO
Slide 20: LPCN 2203
LPCN 2203 Oral NAS for Essential Tremor
Slide 21: Essential Tremor (ET)
Essential Tremor (ET) No new drug approved in 50+ years ‘Activities affected by essential tremor of the arms and hands ° Tremor highly disabling and stigmatizing Essential tremor i usually mast noticeable when performing activities Getting dress ° Stress can aggravate tremor in social setting Eating
Slide 22: Essential Tremor Management — Opportunity
Essential Tremor Management — Opportunity Daytime efficacy and improved tolerability remains an unmet need a Prevalence Standard of Care Limitations Unmet Need * ~7 million patients in US* Unfavorable benefit to risk profile® Superior benefit to risk profile . A x. + Most of patients are intolerant
Slide 23: Market Potential and Competitive Development Landscape
Market Potential and Competitive Development Landscape $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Products in Developme! Estimated - prevalence 2.2 % of 0 SAGE-324: Adverse events - somnolence population 68%, dizziness 38%, balance disorder 15%, diplopia 12%, dysarthria 12%, and
Slide 24: LPCN 2203: Oral GABA Positive Allosteric Modulator
LPCN 2203: Oral GABA Positive Allosteric Modulator Achieved relevant target levels with good tolerability in Phase 1 studies Typical single dose PK profiles Dose 1 = 84 doses administered across 4 single i 5 ome dose studies to 36 participants z = No somnolence, sedation, and 2 poses dizziness AE re
Slide 25: Partnering
| ¥ artnering ore Assets
Slide 26: Unlocking Value Through Partnering
Unlocking Value Through Partnering Assets for Partnering @ Enables focus on CNS opportunities ——peiopmencandtisendeston) Pre-lnes! hose -—«PhanezROG ~—«~Pholal:”=«=~«Caled =a ; TLANDO® Ueersetteus © Candidate advancement (ctcmersconernac, mmm: Lpon 1111 wuse Lceedey urements TT oa @ Risk diversifica
Slide 27: TRT Verity Alliance
TRT Verity Alliance TRT market is a large and growing with a significant untapped market potential — ~8M annual prescriptions in the U.S — ~650,000 annual prescriptions in Canada Verity Transaction — Lipocine to receive $11 million license fee — Up to $259 million in development and commercial sales
Slide 28: Appendix
Slide 29: Zulresso (Brexanolone) Post-marketing Safety
Zulresso® (Brexanolone) Post-marketing Safety* IV Brexanolone Infus Post-market Experience (as of December 31, 2023) FAERS Database* (n= 222) * LOC 0% + IV infusion administration related AEs ~37% » Somnolence, sedation ~8% - Dizziness, presyncope, vertigo ~6%
Slide 30: Obstetricians Awareness of PPD is High
Obstetricians Awareness of PPD is High A large majority of OB’s are comfortable making a diagnosis of PPD and prescribing an antidepressant How comfortable are you in making a diagnosis of PPD and prescribing an antidepressant? 2% om 7 || = == bid Inmy abity to makea agnosis inmy aby to make dagnosi
Slide 31: Obstetricians Estimate The Prevalence of PPD To Be >20%
Obstetricians Estimate The Prevalence of PPD To Be >20% Which Is Much Higher Than Previously Estimated* ox wx 1 1% os ox a x 60-80% of my OB patients may ne bbe diagnosed with PPD cteny 08 puerta may be of my 08 peters maybe iy om per diagnosed with PPD diagnosed with PPD diagnosed with PPD diagnose
Slide 32: Cirrhosis: Complications and Recent Trends
Cirrhosis: Complications and Recent Trends Occurrence of cirrhosis and related deaths are on the rise In the US between 1999 and 2019, greater than three-fold increase in deaths from alcoholic cirrhosis was observed" Hepatitis C virus (HCV) infection remains the leading cause of + Decompensation eve
Slide 33: Hepatic Encephalopathy in Cirrhosis Patients
Hepatic Encephalopathy in Cirrhosis Patients Up to 50% of cirrhosis patients will experience an overt HE episode in their lifetime’ Overt HE is a debilitating, episodic, neurological disorder with a high recurrence rate HE is a major complication of advanced liver disease - patients exhibit global n
Slide 34: Presence of Sarcopenia is Linked with Worse Clinical Outcomes
Presence of Sarcopenia is Linked with Worse Clinical Outcomes Impact of improvement in liver health and body composition “If patients recover a significant amount of liver function and muscle mass from the time they had bouts of overt hepatic encephalopathy, they may well be able to stop standard HE
Slide 35: Presence of Sarcopenia is Linked with Worse Clinical Outcomes
Presence of Sarcopenia is Linked with Worse Clinical Outcomes Higher rates of death and hepatic encephalopathy Log Rak Poot Lap Rak Pe0.01 Leg Rak Ped 01 eg Rank Poot 100 40. aS we | — emreae \ 2 su Bag] mm sarcopenc Obey \ EO] om mrostatosis wercinndse Bg] ~- + sacopenc Obey and yotstons Trae enue
Slide 36: LPCN 1148: Proof of Concept Study
LPCN 1148: Proof of Concept Study 52-Week topline results - Q1 2024 Study Design Endpoints * Male subjects with liver cirrhosis and sarcopenia * Primary: Change in Skeletal Muscle Index (L3 region, L3- awaiting liver transplant SMI) at Week 24 in LPCN 1148 treated participants + Two-arm (1:1 randomi
Slide 37: Baseline Characteristics
Baseline Characteristics Generally well-balanced between treatment arms LPCN 1148 Placebo (N=15) (N=14) Age (years) 58.347.5 BMI (kg/m?) 29.2453 L3-SMI (cm2/m?) 47.8 +7.0 MELD Score 15.943.7 Medical History > 1 Decompensation Event* 14 (93%) 2 2 Decompensation Event 13 (87%) Hepatic Encephalopathy (
Slide 38: LPCN 1148 Improved Myosteatosis
LPCN 1148 Improved Myosteatosis Muscle Quality CBL Week 24 * Substantial Changes in Muscle Quality seen with LPCN 1148 Therapy * Decrease in intramuscular adipose tissue (IMAT) * Significant increase in high quality muscle (HQM) 10 ° Relative Change in Muscle Areas (%) ro) 8 8 1148 Placebo @IMAT BHQ
Slide 39: Observed Hematologic Benefits
Observed Hematologic Benefits LPCN 1148 therapy resulted in significant increase in hemoglobin Hemoglobin LPCN 1148 | Placebo Baseline (g/dL) 11.39(0.75) 13.04 (0.8) NA NS Week 24 CFB (g/dL) 1,30 (0.40) -0.16 (0.23) 0.003 0,005 Mean (SE) : LPCN 1148 | Placebo Anemia Status (N=14) Anemic at baseline
Slide 40: LPCN 1148: PGI-C
LPCN 1148: PGI -C Participants reported significant symptom improvement with LPCN 1148 treatment PGI-C Week 24 Patient Global Impression of Change (PGI-C) Scale % Subjects Responded 1 or 2 Please choose the response below that best P=0.006 describes the overall change in your symptoms Se since you s
Slide 41: ET Patient Journey and Commonly used medications
ET Patient Journey and Commonly used medications First line treatment of propranolol frequently started at PCP 2°4 and 3" line treatments (e.g., primidone, benzodiazepine, gabapentin, topiramate) at general neurologist and movement disorder clinics Patient survey indicates on-going management by PCP