Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (September 2021)
29 slides from Lipocine's investor presentation, Sep 13, 2021
Slide 1: Corporate Presentation
LIPOCIN= ENHANCING HEALTH CORPORATE PRESENTATION Exhibit 99.1
Slide 2: a
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Slide 3: Clinical Stage Biopharmaceutical Company
Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders PRODUCT (In n) PRE-CLINICAL PHASE 4 PHASE 2 PHASE 3 NDA Final Approval ® TCANG® Eligibility March (Oral Testosterone for Testosterone Replacement Therapy) Po 28, 2022 fs TLANDO® XR (Long-Acti
Slide 4: TLANDO
ANDO nv
Slide 5: Hypogonadism Affects Approximately Million Men
Hypogonadism Affects Approximately 20 Million Men TLANDO Franchise has the Potential to Drive Market Expansion Diagnosed Untreated 7 ; 19% 67% Hypogonadism Under Treatment in US ay Treatment- experienced Close to 6M men with diagnosed hypogonadism? Undiagnosed 2M men being treated* Hypogonadism 70%
Slide 6: TLANDO: Target Market Strategy
TLANDO®: Target Market Strategy Overview Brand Differentiation TLANDO Drivers * Compelling clinical ¢ Drive naive & switch ¢ Naive patients who are profile patient starts for needle-phobic and ¢ Superior dosing TLANDO® based on its prefer the convenience regimen clinical profile and of an oral agent
Slide 7: TLANDO Market Potential
TLANDO® Market Potential Attributes Particularly Attractive for Topical Switch, and Treatment Naive Patients Overall TRT Market Topical Segment Naive Patient Segment f= \ oe Ee © 33% of “2M patients © ~24% of TRT market ¢ “660K annually * ~1.8M 2020 TRx Monthly TRx (000s) 94% of TRT Patients 85% of
Slide 8: TLANDO Attributes
TLANDO® Attributes* Convenient Oral Route e No inadvertent transference or pulmonary oil micro embolism risks e Single strength and dose TRT without titration requirement e Enables selection of an effective dose at the start of therapy without delay e No “efficacy gap” upon switching from other TRTS
Slide 9: TLANDO XR: An Innovative Opportunity
TLANDO XR: An Innovative Opportunity Next Generation TRT Option TH (Gj Positive Phase 2b study results ' 7 LIPOCIN= ENHANGING HEALTH Corporate Presentation September 2021
Slide 10: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non-Cirrhotic NASH
Slide 11: LPCN 1144: LiFT Phase 2 Paired Biopsy Study
LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)*t Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) Study Design Primary Endpoint: Q Biopsy confirmed male NASH subjects with F1-F3 Y Change in hepatic fat fraction via MRI-PDFF (W12) Three-arm, blinded, placebo-controlled Key
Slide 12: Key Clinical Endpoint Results from LiFT Study
Key Clinical Endpoint Results from LiFT Study Met NASH Resolution Histology Endpoint and Fat ¢« NASH Resolution with No Worsening of Fibrosis’, NASH CRN Scoring [| pete ie ” 2.0 Placebo (N = 11) 0 (0%) g ow 4.0 é Treatment A (N = 13) 6 (46%)* 2 so a 8.0 Treatment B (N = 13) 5 (69%)*** 10.0 * p< 0.05
Slide 13: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates NASH Resolution and Liver Fat Reduction Placebo mDose/Treatment 1m Dose/Treatment 2 en om “ *p<0.05,*** p.<0.001 vspacebo 60% » eK NASH Resolution with a ser vs oo . . . 3 40% ns * 33% No Worsening of Fibrosis 8 sx a 26% 28% ns soe 19% i 19% NS apse 1% 12%
Slide 14: Other Non-Histology Marker Results from LiFT Study
Other Non-Histology Marker Results from LiFT Study Key Liver Enzyme* Reductions and Body Composition Changes * Positive Effects on Body Compositiont + Liver Injury Marker Reduction Relative Change in Appendicular Lean Mass Treatment A Treatment 8 AKT (UA changes go Meebo Nana) (Ne33) (w=13) ae Place
Slide 15: Safety Overview of LPCN 1144 Through Week 36
Safety Overview of LPCN 1144 Through Week 36 Well-Tolerated with an Overall Safety Profile Comparable to Placebo 3 3 AEs of Interest, n Placebo TreatmentA Treatment B * Frequency and severity of TEAEs in both treatment arms (%) (N=19) (N= 18) (N= 18) were comparable to placebo Diarrhea 2 (10.5%) 1 (
Slide 16: LiFT Results Support LPCN 1144 Development for FDA Approval
LiFT Results Support LPCN 1144 Development for FDA Approval Met the Primary and Key Secondary Endpoints with Statistical Significance 01 Statistically significant reduction in liver fat was observed compared to placebo LIPOCIN= ENHANCING HEALTH 02 Met with statistical significance the pre-specified
Slide 17: LPCN 1148 for the Management of Liver Cirrhosis
Slide 18: Liver Cirrhosis in US
Liver Cirrhosis in US Challenges and Opportunities Over 2 million cases? ion, Lancet. 2021 LIPOCIN= ENHANCING HEALTH 4. Bentley & Philips, Milman Research Report 2017 5 Sinclar, Ament Pharmacol Ther. 2016 Lai, Am Transplant 2014 Corporate Presentation September 2021 18
Slide 19: Sarcopenia in Liver Cirrhosis
Sarcopenia in Liver Cirrhosis Progressive Drop in Testosterone Worsens Sarcopenia A two-fold increase in waitlist mortality/decreased survival Increased risk of hospitalization/prolonged hospitalization Hepatic encephalopathy is the most potent risk factor Hepatic decompensation Significantly higher
Slide 20: LPCN 1148 for Management of Cirrhosis
LPCN 1148 for Management of Cirrhosis Targeting Unmet Need in Cirrhosis Event free survival/Improve quality of life for transplant patients ¢ Pre, Post, and the others who opt out or are denied a place on the waitlist Improvement of post transplant outcomes/costs ¢ Decreased hospital readmissions ¢
Slide 21: LPCN 1148: Proof of Concept Study
LPCN 1148: Proof of Concept Study Phase 2, Multicenter, Double-Blinded, Placebo-Controlled Study* Endpoints: Primary: Change in Skeletal Muscle Index at Week 24 Study Design + Male subjects with cirrhosis of the liver and sarcopenia + Two-arm (1:1 randomization) + Oral LPCN 1148 or Placebo + To eval
Slide 22: LPCN 1154 Oral Neuro-Steroid for Postpartum Depression
Slide 23: Postpartum Depression (PPD)
Postpartum Depression (PPD) A Major Depressive Episode Within Weeks of Delivery e. ~ 1 in 7 women suffer Only 50% (~400,000) of Negative impact on Negative impact on from PPD after giving patients are currently maternal and infant spouse birth diagnosed and treated outcomes in US LIPOCINE “== ENHANC
Slide 24: LPCN 1154 — Potential Oral Alternative for Post Partum Depression
LPCN 1154 — Potential Oral Alternative for Post Partum Depression Overcome Limitations of the Current Injectable Treatment Y No hospitalization requirement Y No facility REMS requirements ¥Y Opportunity to provide options for all women = Lower cost, easier access, and no hospital logistics issues ¥
Slide 25: LPCN 1154: Clinical Status
LPCN 1154 : Clinical Status Proof of Concept Clinical Studies Received IND clearance for Phase 2 study * PK study Objective: Dose proportionality * Phase 2 — Pilot POC Study Objective: Safety and efficacy in PPD patients Projected 1* patient dosed 4Q 2021 LIPOCIN= ENHANGING HEALTH Corporate Presenta
Slide 26: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1148 First Patient Dosed 4Q 2021 LPCN 1154 First Patient Dosed in Pilot Study 4Q 2021 FDA Meeting 4Q 2021/1Q 2022 cats Open Label Extension Results Mid 2022 Final FDA Approval March 2022 LIPOCIN=" ENHANGING HEALTH Corporate Prese
Slide 27: Key Financial Metrics
Key Financial Metrics Stock Price, Market Cap, Cash Balance Ticker Symbol Closing Stock Price (9/8/21) Cash Balance (6/30/21) Bank Debt (6/30/21) LIPOCIN= ENHANCING HEALTH LPCN $1.22/share $46.6 million $4.0 million Corporate Presentation September 2021 27
Slide 28: Appendix
Slide 29: Oral NASH Drug Candidates
Oral NASH Drug Candidates Non-Histological Efficacy Comparisont LPCN 1144 Obeticholic acid Seladelpar Resmetirom Lanifibranor Aramchol (Treatment B) (25mg QD) (50mg QD) (80£20mg QD) (1200mg QD) (600mg QD) BL 21% 21% 20% -0.1%" Liver Fat Absolute CBL -9% N/A 3% -7% N/A 3.2%" Relative CBL -47 % -13 %