Rezolute, Inc. · NASDAQ:RZLT
Rezolute — Investor Presentation (June 2019)
26 slides from Rezolute's investor presentation, Jun 17, 2019
Slide 1: Rezolute Corporate Presentation 3Q 2019
REZOLUTE & Corporate Presentation “= 3Q 2019 TRANSFORMATIVE THERAPIES TARGETING RARE AND METABOLIC DISEASES.
Slide 2: Forward-Looking Statements
Forward-Looking Statements Statements in this presentation that are not descriptions of historical facts are forward-looking statements relating to future events, and as such all forward-looking statements are made pursuant to the Securities Litigation Reform Act of 1995. Statements may contain cert
Slide 3: Rezolute: a Metabolic & Orphan Disease Company
Rezolute: a Metabolic & Orphan Disease Company Antibody for an ultra-orphan indication, Congenital Hyperinsulinism (CHI), potential first in class and best in class therapy Oral Plasma Kallikrein Inhibitor (PKI) for Diabetic Macular Edema (DME) with in vivo pharmacology demonstrating comparable effi
Slide 4: Diversified Pipeline at Multiple Stages of Development
Diversified Pipeline at Multiple Stages of Development Oren Procincal [mane | ptasez | RZ358 Antibody for CHI Phase 2b dosing anticipated 2H'19 RZ402 Oral PKI for DME AB101 Weekly insulin Multiple near-term inflection points anchored by a late-stage orphan program
Slide 5: RZ402
RZ402
Slide 6: Congenital Hyperinsulinism (CHI)
Congenital Hyperinsulinism (CHI) + Ultra-rare disease cucose uc inte lod + Caused by one of 11 known mutations Z x, © sree leading to excessive insulin secretion Most common cause of persistent hypog} fants and child eth sted -— ypoglycemia in infants and children ramamaas A . + Persistent hypoglyce
Slide 7: Observational Study Demonstrates Unmet Need in CHI
Observational Study Demonstrates Unmet Need CH= | Conducted in partnership Continuous Glucose Monitoring (CGM) for Two Weeks: Summary of Results + Blood glucose <70 mg/dl is hypoglycemia + On average, patients had ~3 hours / day (~180 min) of hypoglycemia, even on standard of care (SOC) medications
Slide 8: Potential First and Best in Class Therapy for CHI
Potential First and Best in Class Therapy for CHI RZ358 SE + Fully humanized + Mulipie animal models Safe and welltoleated |» Fully enabled * Utra-orphan monoclonal antibody demonsttedose- |. phase 1and 2stuties Phase beady + Pion reviw voucher + Allosteric mechanism of lependent improvement |" show
Slide 9: Unique Mechanism Attenuates Insulin Effects
Unique Mechanism Attenuates Insulin Effects Pancreatic Beta-Cell Target Cell Insulin Binding Site + Eleven known distinct gene bs KX defects aa aD + Failure to suppress insulin secretion in the setting of hypoglycemia RZ358 Reduced Signaling Allosteric Site + High affinity binding to the insulin rec
Slide 10: Potential to Address Limitations of Standard of Care
Potential to Address Limitations of Standard of Care passe (Grnd Foon) ce © Tergeting & Rinrecontonsions on eciedenendenttorpet: | panscat only Potentially universal treatment Y Genetics-dependent narrow targeting Reversibly counteracts insulin only when insulin is | elevated Marginally effective, i
Slide 11: Phase 1 — Completed Proof of Mechanism
Phase 1 — Completed Proof of Mechanism i “3 [= ” ; ree “ abe Sas aie : =e ii] =aeepe ‘Time (enin) Time (Days) + RZ358 uniformly prevents hypoglycemia following insulin + Single IV doses 0.1 to 9 mg/kg to healthy volunteers administration + Dose-dependent PK with a halflife of 15 days + PK-PD correla
Slide 12: Phase 2a — Completed Proof of Concept
Phase 2a — Completed Proof of Concept Single IV doses of 1 to 9 mg/kg in patients with CHI + Ages = 12 in Europe and 2 18 in the US, + PK comparable with healthy volunteers + Baseline and post-treatment CGM + Up to 70% improvement in patients with baseline hypoglycemia + No hyperglycemia + Effect pe
Slide 13: 2H '19 Phase 2b Study Overview
2H ‘19 Phase 2b Study Overview + Design: Open-label, repeat-dose study in 4 sequential dosing cohorts + Population: CHI > 2 years old with baseline hypoglycemia (<70 mg/dL for > 2 hours per day by CGMS) + Principal assessments / endpoints: Duration of hypoglycemia measured by CGMS. + Interim Analysi
Slide 14: RZ358 RZ402 AB101
RZ358 RZ402 AB101
Slide 15: Diabetic Macular Edema (DME)
Diabetic Macular Edema (DME) Primary Vision Complication Associated with Diabetes Increased Retinal Vascular Macular Edema Progressive Vision Loss Permeability Seeing of con macula and Blindness Leakage of fd from vascular compartment into the retina Large and growing population ing age adults
Slide 16: Potential Best and First in Class Therapy for DME
Potential Best and First in Class Therapy for DME RZ402 SE Ea | cine | cine | ~~ + Plasma kallikrein | + Suppresses + Pre-IND meeting + Oral dosage inhibitor targeting vascular leakage completed Daily dosing vascular leakage by 90% or more + Clear path towards. Large market + Potent target + Animal
Slide 17: Systemic Administration Reduces Retinal Vascular Leakage
Systemic Administration Reduces Retinal Vascular Leakage Dosing with RZ402 at Onset of Model Dosing with RZ402 after Onset of DME Induction Prevents Formation of DME Reverses DME Efficacy Achieved + Up to 90% reduction in DME Measures Works in both a preventive and Healthy DMEin Zana _—_—RzA02 inter
Slide 18: Exposure-Response Predicts Once Daily Dosing
Exposure-Response Predicts Once Daily Dosing ‘ANIMAL FzA02 DOSE OE: oe bide) | sero Heronsen | Retna Plasma Leakage | 02-0A'mgligtiny | 600% a Diaotes ‘Raina Para Leakage 025-O8mokolay | 49.00% @ Glabsos ——-Hamatoma Expansion 04 motiay o% q Retinal 4 mgkkglday 3 at | tl Lasts moot >e0% 3 — dog 10: m
Slide 19: Common Pathways with Different Routes of Administration
Common Pathways with Different Routes of Administration > Soe Fy PLASMA Sy ms KALLIKREIN if ey RZ402: Once-Daily i \ Oral Therapy ¥ NN Ny ! i-VEGF Therapies: BRADYKININ NEGF pues BiLMonthly > sam Intravitreal Injection | | (current standard of care) PKI efficacy comparable to opps D a injectable ant
Slide 20: RZ358 RZ402
RZ358 Rz402
Slide 21: Potential Best and First in Class Super Long Acting Basal Insulin
Potential Best and First in Class Super Long Acting Basal Insulin AB101 et =e es + Uniform pegylated- + Proof-of-concept in 3 + Phase 1 clinical study + >$20 billion insulin insulin microspheres species presented at dosing initiated in 3Q 17 market enabling controlled and ADA + Data read out + No th
Slide 22: In Vivo Proof of Concept — AB101 Dosing in Diabetic Mini Pigs
In Vivo Proof of Concept —AB101 Dosing in Diabetic Mini Pigs = AM. Glucose as > PM. Glucose 20 + Near-normalization of a “ et pay bape — ‘* both fasting AND ‘© Total Background Dai Se g 4006 ' & post-meal glucose hud 5 y mt E300 58 Reduction and removal § 250 =e of background insulin 3 00 2 * 150" 5
Slide 23: Phase 1 — First-in-Human Study Overview
Phase 1 — First-in-Human Study Overview + Single ascending dose study underway assessing the safety and tolerability, pharmacokinetics, and pharmacodynamics of AB101 in subjects with Type 1 Diabetes Mellitus + Objective is to show a safe, sustained, and relatively peak-less PK-PD profile that enable
Slide 24: Milestones
MILESTONES
Slide 25: Anticipated Near Term Milestones
Anticipated Near Term Milestones = *~ *~ * * = it AB101 Milestones +/-a quarter
Slide 26: Transformative Therapies Targeting Rare and Metabolic Diseases
\ <= he Bo rccne THERAPIES TARGETING DI: ‘Ss RARE AND METABOLIC ~~ wee