Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (March 2022)
25 slides from Lipocine's investor presentation, Mar 9, 2022
Slide 1: Lipocine: Enhancing Health
LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-looking statements
ig statements are made pursuant to the safe harbor provisions of the y's products and product candidates, FDA’s approval of TLANDO®, the 1148 and LPCN 1154, and IND filing of LPCN 2101 clinical and regulatory matters, all of which involve known and unknown risks and ‘in, or made in connection with,
Slide 3: Innovative Oral Candidates for Neuroendocrine and Metabolic Disorders
Innovative Oral Candidates for Neuroendocrine and Metabolic Disorders PRODUCT (Indication) PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA LPCN 1148 (Decompensated Liver Cirrhosis) LPCN 1144 (Non-Cirrhotic NASH) TLANDO® (Testosterone Replacement Therapy) LPCN 1111 (TLANDO XR) (Once Daily Testosterone Repla
Slide 4: LPCN 1148 for the Management of Liver Cirrhosis
Potential for Orphan Drug Designation & <_ LPCN 1148 for the Management of % ~ Liver Cirrhosis > goa, X Next Step: Complete enrollment P2 study
Slide 5: Liver Cirrhosis in US
Liver Cirrhosis in US Over 2 million cases? ; 500k+ living with decompensated cirrhosis? 62% of those on the liver transplant (LT) waitlist are male? High (~$812,500/transplant) economic burden* 40-70% of cirrhotic men have sarcopenia>® 41. Moon, Clin Gas and Hep, 2019 2. GBD 2017 Cirthosis Collabor
Slide 6: Survival in Cirrhotic Patients with Muscle Disorders
Survival in Cirrhotic Patients with Muscle Disorders Patients with Either Sarcopenia and/or Myosteatosis Had Significantly Worse Survival Survival (%) 100 80 60 40 20 0 ——— _ Log Rank, P<0.001 Log Rank, P<0.001 Log Rank, P<0.001 Log Rank, P<0.001 — No Muscular Abnormalities —— Sarcopenia Sarcopenic
Slide 7: LPCN 1148: Proof of Concept Study
LPCN 1148: Proof of Concept Study Phase 2, Multicenter, Double-Blinded, Placebo-Controlled Study* Study Design Endpoints: * Male subjects with cirrhosis of the liver and sarcopenia + Primary: Change in Skeletal Muscle Index at Week 24 + Stage 1, Weeks 1-24 * Two-arm (1:1 randomization) + Oral LPCN 1
Slide 8: LPCN 1144 for Non-Cirrhotic NASH
Currently No Approved Treatment For NASH LPCN 1144 for Non-Cirrhotic NASH End of phase 2 meciing
Slide 9: Key Results from LiFT Study
Key Results from LiFT Study Met NASH Resolution Histology Endpoint and Fat Reductions NASH Resolution with nr Liver Fat Reduction at Week 12 (MRI-PDFF) seen mendes 1 Placebo (N=19) Treatment A (N=18) Treatment B (N=19) Responders’, n (%) NASH Resolution Set” Safety Set? & Placebo 0 (0%) 0 (0%) 8 Tre
Slide 10: Key Non-Histology Marker Results from LiFT Study
Key Non-Histology Marker Results from LiFT Study Liver Enzyme* Reductions and Body Composition Changes Mean Baseline ALT AST (U/l) (U/L) ee 490 35.4 iar A 539 324 La ® sis 319 LIPOCIN= ENHANCING HEALTH Liver Injury Marker Reduction ALT (U/L) Changes Placebo -e-Treatment A -=-Treatment B Time (week)
Slide 11: Comparison with Other Oral Drug Candidates
Comparison with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction mPlacebo mDose/Treatment 1 ™ Dose/Treatment 2 oer 0% *p<0.05, *** p<0.001 vs placebo 69% 10% con * per NASH Resolution with im Ms “ = . 7 . al 40% ns # 33% No Worsening of Fibrosis ae _ 1 oe ns 19% 19
Slide 12: 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 AEs of Interest, n (%) Placebo TreatmentA Treatment B « Frequency and severity of TEAEs in both treatment arms were comparable to placebo Diarrhea 2 (10.5%) 1 (5.6%) 0 (0%) ¢ Discontinuan
Slide 13: TLANDO
TLAN DO"
Slide 14: TLANDO Market Potential
TLANDO® Market Potential Attributes Particularly Attractive for Topical Switch, and Treatment Naive Patients Overall TRT Market Topical Segment Naive Patient Segment ( ~ | 2018] 2019] 2020 | : 75 * ~24% of TRT market ¢ 33% of ~2M patients 700 a * ~1.8M 2020 TRx ¢ ~660K annually 3 bc0 = «875 & 550 >
Slide 15: TLANDO: Update
TLANDO®: Update Licensed U.S. Rights to Commercialization Partner - Antares Pharma C) Economic Interest C) Launch Potential C) Status Up to $21.0 million in licensing fees Commercial sales milestone payments of up to $160.0 million Tiered royalties on net sales of TLANDO from mid- teens up to 20% Li
Slide 16: LPCN 1111: Next Generation TRT Option
LPCN 1111: Next Generation TRT Option Antares Pharma Has an Option to License LPCN 1111 is clinically differentiated Patients and physicians prefer once a day oral testosterone Positive Phase 2b study results LIPOCIN= ENHANCING HEALTH ' Tech transfer/scale up _ activities on-going Corporate Presenta
Slide 17: PTB, a leading cause of neonatal mortality/morbidity
PTB, a leading cause of neonatal mortality/morbidity LPCN 1107 mleventon of Preterm Birth Next Step: F0od| effect study results;
Slide 18: LPCN 1107: Potential To Be The Standard of Care for Prevention of PTB
LPCN 1107: Potential To Be The Standard of Care for Prevention of PTB Oral Hydroxyprogesterone Caproate (HPC) Convenient dosing , ; 4 No injection site reactions J w | First and only oral enabling technology 7 = - aes Extensive IP coverage -~, 4 « ‘nt s ‘ Orphan drug designated i SS, | LIPOCIN= ENHA
Slide 19: Received IND clearance for Phase 1 study
Received IND clearance for Phase 2 study Food| Effect Study
Slide 20: Postpartum Depression (PPD)
Postpartum Depression (PPD) A Major Depressive Episode Within Weeks of Delivery ~1 in 9 women in US Only 50% (~500,000) of Negative impact on Negative impact on suffer from PPD after patients are currently maternal and infant spouse giving birth diagnosed and treated outcomes in US LIPOCIN= ENHANCIN
Slide 21: LPCN 1154 — Potential Oral Alternative for Post Partum Depression
LPCN 1154 — Potential Oral Alternative for Post Partum Depression Address Limitations of the Current Unmet Medical Needs No hospitalization requirement No facility REMS requirements Provide options for all women: easier access and no hospital logistics issues Provide the required level of privacy fo
Slide 22: No epilepsy drug specifically approved for WWE of childbearing age
No epilepsy drug specifically approved for WWE of childbearing age LPCN 2101 Vomen With Epilepsy Next Step; IND filing
Slide 23: Women with Epilepsy (WWE) of Childbearing Age
Women with Epilepsy (WWE) of Childbearing Age Balance Seizure Control with Specific Concerns ~ 900,000 of childbearing age women suffer from active epilepsy in US Fetal/neonatal toxicity Pregnancy Seizure Control Comorbidities « Adherence to AEDs * Planned pregnancy ¢ Drug-drug ¢ Anxiety * Lowest do
Slide 24: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Expected Timing Complete Enrollment 2Q/3Q 2022 LPCN 1148 inne Topline Primary Endpoint Results 4Q 2022/ Q1 2023 LPCN 1144 Open Label Extension Results Mid 2022 PDUFA Date March 28, 2022 Partner Target Launch 2Q 2022 TLANDO® XR License Option Exercise
Slide 25: Key Financial Metrics
Key Financial Metrics Stock Price, Market Cap, Cash Balance Ticker Symbol Closing Stock Price (3/7/22) Cash Balance (12/31/21) Bank Debt (12/31/21) LIPOCIN=" ENHANCING HEALTH LPCN $1.51/share $46.6 million* $2.3 million Corporate Presentation 2022 25