Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (April 2025)
54 slides from Lipocine's investor presentation, Apr 3, 2025
Slide 1: Corporate Presentation April 2025
Corporate Presentation April 2025 LIPOCIN=
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “Torward-looking statements" that are made pursuant to the sate harbor provisions of the Private Securities Litigation Reform Act of 1995 and Include statements that are not historical facts regarding our product candidates and strategic plans an
Slide 3: Lipocine Pipeline
Lipocine Pipeline Development Candidate (Indication) Phase1 Phase 2 Pivotal. Next Steps/Status LPon 21 EEE poem LPCN 2101 GD IND cleared for P2. Prevention of Preterm Birth completed Non-cinnatioNASH Lipson |apzeas 8
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform me ep Superior Oral Bioavailability e.g, TLANDO® Insoluble drug Upied composition, Enable Effective Oral Delivery e.g. neuroactive steroids, 17- hydroxyprogesterone caproste Bb
Slide 5: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Approved product utilizing Lip’ral technology First and only oral testosterone replacement therapy (TRT) _*_ TLANDO® licensed to Verity Pharma in January 2024 for option that does not require dose titration commercialize in the U. + $11 mi
Slide 6: LPCN 1154 (BRLIZIO) Oral Brexanolone for Postpartum Depression
Slide 7: 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential as “first line” therapy + Brexanolone is a positive allosteric modulator (PAM) of the GABA, receptor Brexanolone (allopregnanotone) Molecular Weight: 318.5 g/mol peceoe LUpophiti: Log P= 5.0 Poor aqueous solubility: Saq <1. ug
Slide 8: Postpartum Depression (PPD) Market Opportunity
Postpartum Depres: n (PPD) Market Opportu y Among women reporting PPD symptoms, 64% reported comorbid anxiety symptoms” + High economic burden + Critical to prevent harm to mother and infant + Negative impact on family/society + Suicide is a leading cause of maternal death in the first year followin
Slide 9: 1154 - Oral Bioidentical NAS for PPD
LPCN 1154 - Oral Bioidentical NAS for PPD Compelling advantages over current therapies { LPCN 1154 1 SSRIs / SNRIs | Zuranolone (Zurzuvae®) (BRLIZIO™) H ( ) Off-Label Use | 1 Description Bioldenticat NAS synthetic NAS Derivative Synthetic SSRVSNEI Administration rat rat oral Onset of Action Hours* D
Slide 10: 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Bridge Study Labeling Studies +Food effect study Positive Topline +PK study in PPD Results *Metabolite evaluation Completed Completed Next Step P3 Safety and Efficacy Study Expected patient dosing Q2/25 Lipso
Slide 11: 1154 PK Bridge Study Results
LPCN 1154 PK Bridge Study Results LPCN 1154 met standard bioequivalence criteria to IV Brexanolone Comparative Exposure + LPCN 1154 was welltolerated rac GMR (%) 90% CILB 90% C1UB . Testvs. Reference Testvs. Reference Test vs. Reference Coe 105 2 18 . AUC. 7 89 107 AUC. 89 a 98 No sedation nor somno
Slide 12: 1154 Phase 3 Safety and Efficacy Study
LPCN 1154 Phase 3 Safety and Efficacy Study ‘Study design * Two arm, outpatient, randomized, blinded, placebo-controlled in women (215 yrs) with postpartum depression * Size: ~80 women with severe PPD + Dosing regimen: 48 hr treatment + Primary endpoint: HAM-D change from baseline at hour 60 * Addit
Slide 13: 1154: Best in Class Oral Treatment for Depression
LPCN 1154: “Best in Class” Oral Treatment for Depression Key takeaways * Significant market opportunity * Differentiated product attributes addressing unmet needs + Streamlined pathway to NDA submission * PK bridge study: Completed with positive results + Phase 3 safety & efficacy study: ongoing * T
Slide 14: LPCN 2401 Obesity Management
Slide 15: Obesity and Overweight: A Growing Epidemic in US
Obesity and Overweight: A Growing Epidemic in US Increases the risks of heart disease, stroke, type 2 diabetes and certain types of cancer? ~110M adults! 38% of men and 51% of women would be interested in taking a Diabesity population 74% 'y pop prescription drug for weight loss® GLP-1 users in the
Slide 16: Eligible GLP-1 Agonist Users in US for Chronic Weight Management
Eligible GLP-1 Agonist Users in US for Chronic Weight Management Total GLP-1 users in the U.S. may reach around 9% (30M) of the overall population by 2030” Obesity Prevalence (BMI at or above 30.0) vspopuat All Adults pepunon Co ex ats nd ovewe Population’ obey inaldr obey wth saute ogee? ih ome! Ov
Slide 17: Limitations of Approved GLP-1 Receptor Agonists
Limitations of Approved GLP-1 Receptor Agonists Rapid loss of lean mass in elderly GLP-1 users Gz» eomecial “ «Meine rain annoy tons Fate tints Scenes Fracture ae Q 5 ssonslite fa fh: ky B ceo re p 4 z ge a g dec i 329 i i Sema bs ee s “2 i : 416 ° 2 Age 275, GLP- agonist treatment edto15- ‘Te media
Slide 18: Elderly and/or Sarcopenic GLP-1 User
Elderly and/or Sarcopenic GLP-1 User Vulnerable to accelerated lean mass loss and functional decline with GLP-1 7-8 years of expected age-related stair climb power loss in 4 months of GLP-1 use35 Aging GLP-1 Use Pre-existing low lean mass Muscle strength eclnes by 1.59% > annual between Muscle mass
Slide 19: 2401: Regulatory Stance on Efficacy
LPCN 2401: Regulatory Stance on Efficacy Appropriate population and endpoints selection Per FDA Guidance (2025)', for efficacy claim related to changes in body composition, trial design should include appropriate choice of population and selection of endpoints that measure how a patient feels, funct
Slide 20: 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Target benefits to improve body composition and functionality Target Benefits of LPCN 2401 + GLP-1 agonist = Obesity Management L_ Attenuate _| functionality loss Quality weight loss fatin A Amplify fat loss. More VAT loss Improve bone health Lip
Slide 21: 2401 Novel Oral Treatment for Obesity and Weight Management
LPCN 2401 Novel Oral Treatment for Obesity and Weight Management Proven potential to improve body composition - quality weight loss with quality fat loss Product Candidate Attributes + Proprietary androgen receptor agonist, testosterone ester(s), targeted for once-a-day treatment - “LPCN 2401” + And
Slide 22: Androgen Treatment Improved Body Composition and Functionality
Androgen Treatment Improved Body Composition and Functionality Six months intervention in older men Body Composition Improvement => Improve in functionality Totallean mass Totaltt mass Lag Pres Sanat “ ae Chest Press Strength —=<= 7 seer acon oars tone a 2, ip sg + Boal eciswnzn ceases —— 15 = Loase
Slide 23: 2401 - Significant Improvement in Body Composition
LPCN 2401 - Significant Improvement in Body Composition Prespecified endpoints met - increased lean mass and decreased fat mass at Week 20 Lean Mass (ke) ‘Appendicular Lean Mass (ke) Total Fat Mass ‘Trunk Fat Mass 28 (kg) (kg) * 2 1 ® * os 3 x * ° ° a” | | Z i Z ary 6 & 2 " * 4 ey) * = ts 4 2 MLPCN
Slide 24: 2401 - Amplify/Accelerate Fat Loss in Obesity Management
LPCN 2401 - Amplify/Accelerate Fat Loss in Obesity Management Per FDA, weight reduction is a long-term joni iposi Gren Bren Semaglutide reduction in excess adiposity (body fat) 2401 240146 with a goal of reduced morbidity and rere Total fat massloss(kg)*¥ 3.2 -3.8 32" Excess TBF increases the risk o
Slide 25: 2401 - Body Weight Changes During Weeks of Treatment
LPCN 2401 - Body Weight Changes During 72 Weeks of Treatment 2 + | Placebo-Controlled L OLE g @ £ 3 8 8 o £ £ ‘2 8 § = LPCN 2401 +/-E zs Len 2401 co) Placebo 7 = = Placebo to LPCN 2401 ey , Time (week) + Participants who took placebo for 36 weeks then switched to LPCN 2401 during the 36-week OLE exp
Slide 26: 2401 Safety Data Support Differentiated Product Profile
LPCN 2401 Safety Data Support Differentiated Product Profile Well-tolerated with liver benefits and no safety signals upon 72-week exposure ur oastsC«MPSSC + POC study in relevant obese and overweight Population ] I i] Frequency and severity of TEAEs with LPCN 2401 . rn ‘were comparable to placebo +
Slide 27: 2401 - Potential for Differentiated Benefit to Risk Profile
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile LPCN 2401 Competitive Landscaj ral, 20, prodrug of bioidentical hormone Myostatin /activin receptor modulators (eg. bimagrumab, Fat loss amplification taldefgrobep, KER-065, and trevogrumab)'? "Lower fat mass (preferably VAT and androi
Slide 28: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 29: 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets OHE inci Pamers eae | Posttvep2resuts with sarcopenia ~ r| background SOC. — & — a 3 — » 3 Senne ete 2 Validated regulatory pathway = *° 3 Designation 3 - = 2 = 6 se " £ ____ Acceptable endpoints on ey Acommercially success
Slide 30: Sarcopenia in Cirrhosis
Sarcopenia in Cirrhosis A serious comorbidity Log Ranke Pe.00¢ Log Rank Peo. 100 — No Muscular Abnormalities — sareopenia Sarcopenie Obesity Myosteatosis 0] — + Sarcopenic Obesity and Myostestosis Survival (2%) 0 2 4 6 8 10 12 14 16 18 20 22 2 Follow-up (months) Low muscle mass (sarcopenia) and qui
Slide 31: Overt Hepatic Encephalopathy (OHE) in Cirrhosis
Overt Hepatic Encephalopathy (OHE) in Cirrhosis Presence of both sarcopenia and HE further increases risk of mortality® Survival Rate of Patients v ote Ais iv fonda $25.0 & Covert HE zo a Nether Saropena, nor uur x He aos Random som Clear —Sarcopenia or HE Bandon ° Follow-up (mo) Petaowd 06) a
Slide 32: 1148 for the Management of Cirrhosis
LPCN 1148 for the Management of Cirrhosis Product Candidate Attributes Oral androgen receptor agonist; dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Targeted Mechanism of Action Anabolic’ Androgenic Ammonia Lowering ‘Stimulates muscle satellite ‘activator
Slide 33: 1148 Phase 2 Results - Sarcopenia Primary Endpoint Met
LPCN 1148 Phase 2 Results — Sarcopenia Primary Endpoint Met Resolution for sarcopenia and significantly increased SMI ao = 8 = 33% 5 om 3 20% 5 10% Week & 0% = % mers terete apePmaterome pew rae Mucahe * ~9% increase in L3-SMI at week 24 * 33% of patients had resolution of sarcopenia* at week 24 Sau
Slide 34: 1148 Phase 2 Results - HE Endpoints
LPCN 1148 Phase 2 Results — HE Endp Fewer events of overt hepatic encephalopathy Through Week 24 Week 24 to EOS Placebo LPCN 1148 LPCN 1148 LPCN 1148 switch from = - - placebo N=14 N=15 N=11 re Parameter History of HE prior to randomization tn) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent Overt HE (e
Slide 35: 1148 Phase 2 Results
LPCN 1148 Phase 2 Results Overall LPCN 1148 was well tolerated + Rates and severities of AEs similar to those in Stage 1 with placebo + Fewer participants experienced severe AEs when switched from placebo to LPCN 1148 LPCN 1148 switch from. Placebo LPCN 1148 LPCN 1148 feactno (ee Parameter (tun ce2
Slide 36: Partnering
Partnering
Slide 37: 1107 for Prevention of Preterm Birth
LPCN 1107 for Prevention of Preterm Birth Product candidate highlights Oral dosage form comprising Oral, a Major Contribution to Patient Care (MC to 17-hydroxyprogesterone caproate PC), including no injection site reaction >$2B market potential with no approved drug Compelling efficacy rationale Acc
Slide 38: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate Highlights Oral dosage form comprising testosterone ester Fast Track Designation Competing P2 biopsy results in the FDA approvable endpoint Y Safety support with 72 weeks exposure Mono or adjunct therapy Differentiated profile Y Oralwith un
Slide 39: Appendix
Slide 40: 1154 Opportunities in Depression Disorders
LPCN 1154 Opportunities in Depression Disorders jnticant Unmet Needs in Depression Disorder MDD: Per NIMH, in 2020, an estimated 21.0 6 g ‘Adequate and durable remission/response; treat million adults (8.4%) in the US had at least one anxiety comorbidity major depressive episode? The prevalence of c
Slide 41: Oral Brexanolone - Potential Additional Neuropsychiatric Indications
Oral Brexanolone - Potential Additional Neuropsychiatric Indications EEG in healthy subjects administered single doses of oral brexanolone Indications Requiring Rapid Onset (e.g. anxiety) sajerd | 048 Sony : " Capsule formulations allow for rapid delivery of neuroactive steroids (Tmax 1.5 hours) Obs
Slide 42: 2401: Potential to Amplify Effects of Incretin Mimetics
LPCN 2401: Potential to Amplify Effects of Incretin etics ARA may increase weight loss through increased expression and activity of GLP1R +> GLP expression increase with ARAE Non-Diabetic Diabetic a a elation elative dreoresio Veh ARAa-ARA Veh ARA ARR, Insulin activity Increase with ARA® Non-Diabeti
Slide 43: 2401: Targeted Mechanism of Actions
LPCN 2401: Targeted Mechanism of Actions Obesity is associated with systemic chronic inflammation and oxidative stress Fat Muscle Bone Androgen * Induces lipolysis! + Stimulates muscle satellite activator, * Lowers lipogenesis! FR? + Acts directly on osteoblasts and Receptor innibits expression of a
Slide 44: Importance of Lean Mass (LM) and Consequences of Excess Total Body Fat
Importance of Lean Mass (LM) and Consequences of Excess Total Body Fat Importance of Lean Mass (Fat Free Mass) + Muscle plays a significant rote in metabolic health and disease prevention = High calorie demanc® ‘+ Contributes to physical strength, active lifestyle + Rapid loss of LM has multiple neg
Slide 45: Summary of Preclinical Results in Diet Induced Model
Summary of Preclinical Results in Diet Induced Model LPCN 2401+E significantly improved oral glucose tolerance test and reduced VAT OGTT 12-week study in male rabbit model of 2500 metabolic syndrome _ 2000 z J sso + Regular Diet (RO control), n=10 2 RD Control Emo High Fat Diet (HFD), n=10 8 sao veh
Slide 46: Phase 2 Study in Patients with Obesity
Phase 2 Study in Patients with Obesity NCT04134091 study design Three-arm, blinded, placebo-controlled trial in male subjects with metabolic dysfunction associated steatohepatitis (n=56) + High prevalence of obesity and weight related comorbid conditions such as dyslipidemia, T2DM, and hypertension
Slide 47: 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Prespecified endpoints met - Increased lean mass and decreased fat mass Body Composition Analysis Set* Parameterat 2401+E Baseline (N=13) Mean Age (years) 538 Mean Weight (kg 1078 Mean BM (kg/m?) a7 Fat Mass (DXA) % of 72 totalmass Lean
Slide 48: 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Prespecified endpoints met — Increased lean mass and decreased fat mass Fat Mass (36 Weeks) Lean Mass (36 Weeks) Fat Mass Android Fat Gain EGCG) Uae Lean Mass (% of TM) Appendicular Lean Mass 5 * ‘ * L et | * 2401+E 2401 Mono = Placebo
Slide 49: 2401 - Amplify Total Fat and Visceral Fat Loss in Obesity Management
LPCN 2401 - Amplify Total Fat and Visceral Fat Loss in Obesity Management Visceral fat is primarily responsible for the risks associated with abdominal fat such as cardiovascular, cerebrovascular, metabolic, liver, renal, and joint diseases?> Combination of LPCN 2401 and GLP-1 may amplify VAT loss P
Slide 50: Presence of Sarcopenia is Associated with Higher Risk of HE
Presence of Sarcopenia is Associated with Higher Risk of HE Muscle key organ for ammonia detoxification in the setting of decompensated cirrhosis Sarcopenia and the Increased Risk of HE Ammonia Metabolism and Trafficking in Liver Cirrhosis = = ve had Encephalopathy (Odds Ratio, 95% 61 ral Liver ceho
Slide 51: Rifaximin History and Current Status
Rifaximin History and Current Status * Rifaximin was initially approved in 2004 for the treatment of Travelers Diarrhea * It was repurposed and approved by the FDA in March 2010 for the reduction of risk of recurrence of overt hepatic encephalopathy in adult patients + Approved in 2015 for IBS-D. *
Slide 52: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption + Tremoris highly disabling and stigmatizing Estimatedprevalence stress can aggravate tremor in social sett cowereaauent Stress can aggravate tremor in social setting ‘+ Major impact on activitie
Slide 53: 2203 Oral GABA Positive Allosteric Modulator
LPCN 2203 Oral GABA Positive Allosteric Modulator Achieved relevant target levels with good tolerability in Phase 1 studies eon Plasma Concentration Dose t Typical single dose PK profiles man) 84 doses administered No sedation or dizziness AE reported Lipacine [ap 2008
Slide 54: 2101 - Novel Potential Alternative for Women With Epilepsy (WWE)
LPCN 2101 - Novel Potential Alternative for Women With Epilepsy (WWE) Endogenous Neuroactive Steroid Product Candidate Attribute Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprisinga neuroactive steroid Product Candidate Differentiation Novel MOA specifically address