Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2023)
28 slides from Lipocine's investor presentation, Oct 24, 2023
Slide 1: Corporate Presentation October 2023
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 Q4 2023 LPCN 1148: Last Patient Last Visit LPCN 1154: Fast Acting Oral Antidepressant v LPCN 1148: Unique MOA for Management of Cirrhosis Qi 2024 LPCN 2101: Novel MOA for T
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form n 4 Drug Loaded ry = f Zpowe + Be all Ea Carrier cy lipid a Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Superior Oral Bioavailability e.g., TLANDO® composition ‘Section of GI Insoluble drug lipid Enable
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 (e.g. PPD, MDD, TRD): Robust and durable efficacy, fast onset, good tolerability, improved compliance, affordable, and easy access Neu
Slide 6: Lipocine Clinical Development Pipeline
Lipocine Clinical Development Pipeline Development Candidate (Indication) _Pre-Clinical Phase 1 Phase 2/POC Pivotal Approved Status aint ED qe (Postpartum Depression) 1 2024 LPCN 1148 P2 open label (Liver Cirrhosis - Hepatic Encephalopathy; Qi > extension in Secondary Sarcopenia) progress LPCN 2101
Slide 7: LPCN 1154
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/suicide ideation is a significant concern Suicide is a leading
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: LPCN 1154: A New Paradigm in Oral Treatment for PPD
LPCN 1154: A New Paradigm in Oral Treatment for PPD Bioidentical neuroactive steroid Product Candidate Attributes Brexanolone Advantage + Brexanolone is a positive allosteric modulator Men of the GABA, receptor Robust Rapid Relief + Oral for outpatient use + No complications with concomitance antide
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 1vs DR2vs » AEs were similar
Slide 12: LPCN 1154: Streamlined pathway to NDA submission
LPCN 1154 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 multiple dose oral efficacy for NDA submission* allopregnanolone administra
Slide 13: LPCN 1148
LPCN 1148 for the Management of Liver Cirrhosis * Hepatic Encephalopathy (HE) * Secondary Sarcopenia (SS)
Slide 14: A Novel Approach for the Prevention of Overt Hepatic Encephalopathy
A Novel Approach for the Prevention of Overt Hepatic Encephalopathy 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 cli
Slide 15: Overt HE Market Potential with Validated Analog Precedence
Overt HE Market Potential with Validated Analog Precedence US Diagnosed Decompensated Cirrhosis pare Rifa vention of Breakthrough HE | Decompensated Men with Cirrhosis? + Rifaximin (Xifaxan™) is used to prevent episodes (229,000) of HE by stopping the growth of bacteria that I produce toxins that ma
Slide 16: Summary of Current Standard & Unmet Needs in HE
Summary of Current Standard & Unmet Needs in HE Limited options - significant enduring medical need Current Standard of Care Key Unmet Needs Overt HE? a a a ; . Recurrence Low Tolerability + First Line: Lactulose or Lactitol We) Rate * Refractory Patients: IV or Oral Amino Overt HE patients have sig
Slide 17: LPCN 1148: A De-Risked Blockbuster Opportunity
LPCN 1148: A De-Risked Blockbuster Opportunity Product Oral androgen receptor agonist Dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Candidate Attributes Targeted Mechanism of Action Increase muscle mass and Via Improved liver health® and Induce hematopoie
Slide 18: 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 ° at gs + 362 Ba 268 LPCN 1148 | Placebo gE; Timepoint (N=15) (N=10) =, al Baseline (om®/m2) 478 (18) 45.8 (2.3) NIA NS =, —
Slide 19: LPCN 1148 Therapy Resulted in Significantly Fewer HE > Grade 1 Events
LPCN 1148 Therapy Resulted in Significantly Fewer HE > Grade 1 Events Positive clinical outcome achieved* LPCN 1148 Placebo Total Parameter (N=15) (N=14) Total decompensation events 7 10 Total decompensation events > Grade 1 6 10 Hepatic Encephalopathy 3 6 9 HE > Grade 1* 2 6 8 Recurrence of HE > Gr
Slide 20: LPCN 1148 Safety
LPCN 1148 Safety Overall LPCN 1148 was well tolerated LPCN 1148 Placebo Parameter (Ue) (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 Total Hospital Days 54 5 Ty 5 » Administration of LPCN 1148 was well tolerated in this end-stage population, with rat
Slide 21: Study Conclusions
Study Conclusions Study met the primary endpoint - resulted in significantly increased skeletal muscle index — Superior to placebo at Week 24 — Significant improvement from baseline as early as Week 12 Fewer decompensation events with LPCN 1148 treatment — Treatment group had significantly fewer HE
Slide 22: Partnering
Partnering
Slide 23: Unlocking Value Through Partnering
Unlocking Value Through Partnering Why Partnerin Assets for Partnerin' @ Enables focus on CNS opportunities DevelopmentCandidate Indication) Pre-Clinical_ «Phase 1 _—«~Phase2iPOC©—«~Pivotal —=—Approved ji Tames D> @ Candidate advancement (Testosterone Replacement Therapy) Lpon 1111 Oneriynoneeroene
Slide 24: Appendix
Appenc
Slide 25: Brexanolone Safety
Brexanolone Safety* Continuous IV Brexanolone Infusion LPCN 1154 Oral Brexanolone Post-market Experience (as of June 30, 2023) Clinical Study Experience** (n=100): FAERS Database* (n= 207) + LOC 0% + LOC 0% 7 » Somnolence, sedation 0% + IV infusi dministrati lated AEs 9 ~37% —- ° + Dizziness, presyn
Slide 26: Cirrhosis: Complications and Recent Trends
Cirrhosis: Complications and Recent Trends ns iC rends + Decompensation events - hepatic + Occurrence of cirrhosis and related deaths are on the rise encephalopathy, varices, ascites, etc. Complica + In the US between 1999 and 2019, greater than three-fold increase + Compromised liver function, immu
Slide 27: Observed Hematologic Benefits
Observed Hematologic Benefits LPCN 1148 therapy resulted in significant increase in hemoglobin Memestatsin es (N=15) = Change from | V7. placebo Timepoint Baseline Baseline (g/dL) 11.39 (0.75) 13.04 (0.8) N/A NS Week 24 CFB (g/dL) 4.20 (0.33) -0.05 (0.35) 0.001 0.02 LS Mean (SE) 8 LPCN 1148 Placebo
Slide 28: LPCN 1148 Baseline Characteristics
LPCN 1148 Baseline Characteristics Generally well-balanced between treatment arms LPCN 1148 Placebo (N=15) (N=14) Age (years) 58.347.5 58.84+9.5 BMI (kg/m?) 29.2453 29.0486 L3-SMI (cm?/m?) 47.8 47.0 44.8485 MELD Score 15.9437 18.1446 Medical History > 1 Decompensation Event* 14 (93%) 14 (100%) 2 2 D