Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2023)
34 slides from Lipocine's investor presentation, Jan 5, 2023
Slide 1: Lipocine - Enhancing Health
LIPOCIN= ENHANCING HEALTH
Slide 2: Forward-looking statements
bor eh jons ofthe Private Secures Ligation Reform Act of 1995 and include statements developing products to treat CNS disorders, our ability to monetize non-core product isorders, our product candidates and related clinical trials, the achievement of milestones ltl of regulatory reviews, outcomes of
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 Management of Cirrhosis LPCN 2101: Novel MOA for Treating Women with Active Epilepsy Explor
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip'ral based dosage form @p eS) Insoluble drug lipid composition Seeton of GI ‘magnified to strate absorption LIPOCIN: tone + lene = ose Gi Aqueous Lumen Barrier Layer Intestinal Systemic Wall Circulation Transfer Improved — ee Optimal dispersed pha
Slide 5: Curated Clinical Development Focus
Curated Clinical Development Focus Oral Endogenous Neuroactive Steroids (NASs) Significant Unmet Needs in Central Nervous System Disorders (CNS) Psychiatry Depression Disorders: Rapid onset antidepressant Neurology Epilepsy: Novel MOA targeting women with active epilepsy (WWE) Movement Disorders: No
Slide 6: Lipocine Clinical Development Pipeline
i) Lipocine Clinical Development Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase 2/POC Pivotal Approved Status pleas EEE, arene (Postpartum Depression) ‘study in progress LPCN 1148 (Decompensated Liver Cintas Ce re ty Secondary Sarcopenia/Hepatic ‘completed Encephalopathy) LPC
Slide 7: LPCN 1154
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 8: Postpartum Depression (PPD) — A Substantial Opportunity
Postpartum Depression (PPD) — A Substantial Opportunity Market in Need of a Convenient Fast-Acting Oral Antidepressant Standard of Care OC Limitations eimet Need ~ 1 in 8 women in US Burdensome invasive Convenient non-invasive suffer from PPD after infusion giving birtht ; ae Fast-acting Inpatient a
Slide 9: LPCN 1154
| LPCN 1154 First Oral Brexanolone GABA Receptor Substrates Binding GABA Product Candidate Atti les cae ae Positive Allosteric Modulator (PAM) of the GABA, receptor Gomak bd Oral dosage form comprising brexanolone, endogenous E om = neurosteroid duct Candidate Differentiati Convenient, non-invasive
Slide 10: LPCN 1154 - Enablement of Oral Brexanolone
LPCN 1154 - Enablement of Oral Brexanolone Achieved Relevant Systemic Levels in Phase 1 Study Sequential single dose escalation study in post-menopausal women (n=8) with Lip’ral based oral capsules. + LC-MS/MS assays of blood samples Z so So Observed PK Profile Post Oral Administration £ © mean valu
Slide 11: LPCN 1154 - Outpatient Use with Monitoring Product Development
LPCN 1154 - Outpatient Use with Monitoring Product Development Favorable Regulatory Outlook Efficacy can be achieved through PK bridge to IV infusion brexanolone 505 (b) (2) NDA Validated regulatory pathway IV brexanolone approved for PPD. CF phaset = Pilot PK Bridge Study — Planned Pivotal Study Su
Slide 12: LPCN 1148 for the Management of Liver Cirrhosis
LPCN 1148 for the Management of Liver Cirrhosis
Slide 13: Liver Cirrhosis Management — Opportunity
| Liver Cirrhosis Management — Opportunity Standard of Care Prevalence pleni iae Unmet Need Over 2 million cases"; No approved drug for 8S: Improve survival/ 500k+ with Secondary Sarcopenia quality of lfe for patients decompensation? (ss) ‘on transplant list 62% on liver transplant I of post- comet
Slide 14: LPCN 1148
LPCN 1148 Management of Liver Cirrhosis: Secondary Sarcopenia; Hepatic Encephalopathy Product Candidate Attributes Androgen receptor agonist Oral dosage form comprising testosterone laurate, a unique prodrug of endogenous testosterone Potential for Orphan Drug Designation Product Candidate Different
Slide 15: LPCN 1148 - Novel Multi-Modal MOA for Liver Cirrhosis
LPCN 1148 - Novel Multi-Modal MOA for Liver Cirrhosis Hepatic Encephalopathy is Associated with Sarcopenia Qranarotc Q Anti-Inflammatory®? | tereae muscle mass andstengtht | ReducelL- 16, and TNFa! Decrease in hepatic function | Reduce fat mass? i | Increase bone density* H a {inhibit myostatn® i =
Slide 16: LPCN 1148 — Potential Beneficial Effects
LPCN 1148 — Potential Beneficial Effects Effects Observed in Subjects with Chronic Liver Disease* Liver (primary organ) Muscle (secondary organ) Injury Marker Reduction Positive Effects on Body Compositiont Relative Changein Appendicular Lean Mass ALT (U/L) Changes ° as) Sree caw ek ’ {a eT aw ta Se
Slide 17: LPCN 1148 - Development Status
LPCN 1148 - Development Status POC Topline Results Expected in Mid-2023 + Phase 2 POC study (NCT04874350) in male ‘hange in Skeletal Muscle Index at Week 24 patients with cirrhosis Key Secondary: Overall survival, hospitalization rates + Randomized placebo-controlled study in ‘Change in number of wa
Slide 18: LPCN 2101 for Women With Active Epilepsy (WWE)
Slide 19: Women with Epilepsy (WWE) of Childbearing Age - Opportunity
Women with Epilepsy (WWE) of Childbearing Age - Opportunity Prevalence Standard of Care Limitations Unmet Need ~ 900,000 of women of childbearing ee approved specifically for Seizure control with low/no (CB) suffer from active epilepsy in teratogenic risk usi2 _— csp ved cca a Address special consid
Slide 20: LPCN 2101
LPCN 2101 Novel Potential Alternative for WWE Product Candidate Attributes Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising an endogenous neuroactive steroid Product Candidate Differentiation Novel MOA specifically addressing WWE unmet needs Active moiety is endo
Slide 21: Value Through Partnering of Non-CNS Assets
Slide 22: Unlocking Value Through Partnering
E] Unlocking Value Through Partnering Why Partnering Assets for Partnering Enables focus on CNS opportunities DevelopmentCandidate(Indication) Pre-Clnical_-Phase1 ——Phase2POC Pivotal ©——Approved Candidate advancement nam inst a) ee) wren ee eet Risk diversification Potential for non-dilutive financi
Slide 23: TLANDO Attributes
TLANDO® Attributes onvenient oral route + No inadvertent transference or pulmonary oil micro embolism risks + Single strength and dose without titrati ‘ement an imy + Enables selection of an effective dose at the start of therapy without delay + No “efficacy gap” upon switching from other TRTs R -)
Slide 24: LPCN 1111
EI] LPCN 1111 Once-A-Day Oral Testosterone Replacement Therapy Product Candidate Highlights Oral dosage form comprising testosterone tridecanoate Convenient option for large and growing market Patients and physicians preferred once a day oral testosterone Positive phase 2 study results “Phase 3 read
Slide 25: LPCN 1107
LPCN 1107 Potential to be SOC in Prevention of Preterm Birth Product Candidate Highlights Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential Strong pharmaco-economic justification Oral, a Major Contribution to Patient Care (MC to PC), including no injection site reacti
Slide 26: LPCN 1144
LPCN 1144 Novel MOA in Non-Cirrhotic NASH Product Candidate Highl Oral dosage form comprising testosterone ester No approved drug Fast Track Designation Compelling P2 biopsy results in the FDA approvable endpoint Y Safety support with 72 weeks exposure Mono or adjunct therapy Differentiated profile
Slide 27: Appendix
Slide 28: Injectable Brexanolone Real World Adverse Events
Injectable Brexanolone Real World Adverse Events FDA Adverse Events Reporting System (FAERS) Public Dashboard * 69 out of 174 cases reported related to: — Product administration error — Product preparation error — Infusion site pain — Device programming error — Device malfunction — Device infusion i
Slide 29: Comparison with Other Oral Drug Candidates
Comparison‘ with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction leDoser/reamenth —mOose2/etment2 * p05," poco vs placebo NASH Resolution with No Worsening of Fibrosis 200 awe Seladelpar | Resmetirom | Lanifibranor Aramchol (wcroassisz2) (wcto2012260) (croso0so70)
Slide 30: 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 Rates 100. 93.4 _ ah = Non-sarcopenia E 142 ~e Sarcopenia Survival (4) g Beof 75 3 ws = 40, 3 zo TIT iT wan en een 3 pee rtowinion) Ss me ane 1 7h tee tas at atta
Slide 31: Cirrhotic Patients with Sarcopenia and Hepatic Encephalopathy (HE)
Cirrhotic Patients with Sarcopenia and Hepatic Encephalopathy(HE) Patients with Sarcopenia and HE had Significantly Worse Survival Rates ebtamine Liver cirrhosis Hepatic Encephalopathy ‘ff ammonia \ Saxgopenia, ae | cael o 100 20 = 6 g : z= 40 - a — Neither Sarcopenia, nor KE 20 | — surcopenia orn f
Slide 32: Mortality and Liver Frailty Index
Mortality and Liver Frailty Index A 0.1 unit change in ALFI per 3 months was associated with a ~2-fold increased risk of death/delisting* 100 1 R t morta ‘ALF per 3 months month 12months 24 months Improved (16%) 08% 12% 73% Stabe (35%) 70% 10% 17.3% ‘Moderate worsening (23%) 8.4% 17.2% 22.6% g Sever
Slide 33: Phase 2 Results Suggest LPCN 1144 Has Favorable Benefit to Risk Profile
Phase 2 Results Suggest LPCN 1144 Has Favorable Benefit to Risk Profile Met the Primary and Key Secondary Endpoints with Statistical Significance -_ 03 04 05 Met the pre- Changes in liver Treatment effect Open-label Well-tolerated specified fat, key liver and safety extension trial with an overall h
Slide 34: 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 —Treatment A +» Frequency and severity of TEAEs were comparable to placebo ‘ 5 i < Diarrhea 2 (10.5%) 1(5.6%) + Discontinuance of study drug due to TEAEs: 4 s