Lipocine Inc. · NASDAQ:LPCN
Lipocine — H.C. Wainwright January 2022
23 slides from Lipocine's conference presentation, Jan 4, 2022
Slide 1: Lipocine: Enhancing Health
LIPOCIN= ENHANCING HEALTH
Slide 2: Safe harbor statements
tatements are made pursuant to the safe harbor provisions of the ducts and product candidates, FDA’s approval of TLANDO®, the
Slide 3: Clinical Stage Biopharmaceutical Company
Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders PRODUCT (Indication) PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Final Approval ® TEANDE! Eligibility March 28, (Oral Testosterone for Testosterone Replacement Therapy) 2022 TLANDO® XR (Long-Act
Slide 4: TLANDO®
TLANDO®
Slide 5: 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 r e No “efficacy gap” upon switching from other TR
Slide 6: 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 ‘| ns * ~24% of TRT market ° 33% of “2M patients 700 650 * ~1.8M 2020 TRx ¢ ~660K annually 3 00 = #575 4 &
Slide 7: 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 Targeting 7.6M annual TRx i Tentatively approved Commercial sales Unique attributes: Planned resubmission for final milestone pa
Slide 8: TLANDO XR: Next Generation TRT Option
TLANDO XR: Next Generation TRT Option Licensee Option Execution Required by March 31, 2022 G TLANDO XR is positioned to be the first oral once a day product L ; © _) TLANDo xr is clinically differentiated 7 . Co 7 Tech transfer/scale up ‘7 activities on-going G Patients and physicians prefer once a
Slide 9: Currently No Approved Treatment For NASH
Currently No Approved Treatment For NASH LPCN 1144 2 for Non-Cirrhotic NASH Re Y nl ox! 4 ~~
Slide 10: Key Results from LiFT Study
Key Results from LiFT Study Met NASH Resolution Histology Endpoint and Fat Reductions Liver Fat Reduction at Week 12 (MRI-PDFF) Placebo (N=19) Treatment A (N=18) Treatment B (N=19) ° Ss 2.0 “1.54 z % -4.0 ® 2 5 2 S 2 60 5 3 3 z 8.0 TY p< 0.0001 9.17 ae p<0.0001 Ns All Subjects: ITT Dataset, n = 56,
Slide 11: Histological Changes in NASH Components: NASH CRN Scoring
Histological Changes in NASH Components: NASH CRN Scoring Substantial Improvement in All NASH Components from Baseline Steatosis Inflammation Ballooning -~@06@ e¢ LIPOCIN= Biopsy Set: All subjects with baseline and EOS biopsies H.C. Wainwright January 2022 ENHANCING HEALTH Treatment B aseasoul apes
Slide 12: 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) Placebo ae 49.0 35.4 Treatment A easy 539 324 TreatmentB sis 319 (N=19) LIPOCIN= ENHANCING HEALTH Be Fb bao e Liver Injury Marker Reduction ALT (U/L) Changes Place
Slide 13: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction Placebo mDose/Treatment 1 Dose/Treatment 2 eee * p<0.05,*** p<0,001 vs placebo on ee NASH Resolution with ae ts . | . B46 ns bd No Worsening of Fibrosis im w _ _ sa .” 19% 17% 2% ul = | = Fl es = Ps
Slide 14: 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 15: 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 16: Potential for Orphan Drug Designation
Potential for Orphan Drug Designation - oo! y~ i Ll ee
Slide 17: Liver Cirrhosis in US LPCN 1148: Targeting Unmet Need in Cirrhosis
Liver Cirrhosis in US LPCN 1148: Targeting Unmet Need in Cirrhosis Over 2 million cases ; 500k+ living with decompensated cirrhosis? Event free survival/Improve quality of life for transplant patients * Pre, Post, and the others who optout or are denied 62% of those on the liver transplant (LT) bein
Slide 18: Muscle Disorder in Liver Cirrhosis
Muscle Disorder in Liver Cirrhosis Sarcopenia Associated with Adverse Outcomes A two-fold increase in waitlist mortality/decreased survival Stronger sarcopenia association with waitlist mortality in men Increased risk of further decompensation; increases overt hepatic encephalopathy risk by 2x Highe
Slide 19: Potential Mode Of Action of LPCN 1148
Potential Mode Of Action of LPCN 1148 Multi-Modal Action Myo-augmentation Hepato-effective (mass, quality, function) * Improved ALP, ALT, AST, © Inhibit myostatin | GGT; ¢ Increased protein synthesis * Myo-steotosis reduction ¢ Increase muscle mass and reduce fat mass ¢ Anti-catabolic agent ¢ Slow d
Slide 20: 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 * Stage 1, Weeks 1-24 * Two-arm (1:1 randomization) * Oral LPCN 1
Slide 21: LPCN 1148: P2 POC Study: Key Target Outcomes of Interest
LPCN 1148: P2 POC Study: Key Target Outcomes of Interest Clinical Outcomes Muscle/Functionality Changes © Overall survival ¢ Muscle mass ¢ New Decompensation Events - Sarcopenia - Hepatic encephalopathy ¢ Muscle quality - Ascites - Myosteatosis ¢ Survive to/through transplant ¢ Functional capacity ¢
Slide 22: Upcoming Milestones
Upcoming Milestones Near Term Value Drivers Event Final FDA Approval Partner Target Launch TLANDO® License Option Exercise ® uh aten 24K Food/Phlebotomy Study FDA Meeting LPCN 1144 Open Label Extension Results Complete Enrollment Wess Topline Primary Endpoint Results Food Effect Study Results Beer F
Slide 23: Key Financial Metrics
Key Financial Metrics Stock Price, Market Cap, Cash Balance Ticker Symbol Closing Stock Price (1/3/22) Cash Balance (9/30/21) Bank Debt (9/30/21) * Doesn't include $11M received in October 2022 for the out license of TLANDO to Antares Pharma LIPOCIN= ENHANCING HEALTH LPCN $1.09/share $38.7 million*