Slide 1: A Late-stage Rare Disease Company Treating Hyperinsulinism
A Late - stage Rare Disease Company Treating Hyperinsulinism Corporate Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward - looking statements regarding our prospective performance and strategies within the meaning of Section 27 A of the Securities Act
Slide 3: A Rare Disease Company Treating Hyperinsulinism
A Rare Disease Company Treating Hyperinsulinism 3 Well - capitalized for execution – $152 million in cash with runway to mid - 2027 Seasoned management team with demonstrated success from early development through commercialization Total $1B+ global market opportunity with additional upside thr
Slide 4: Two Phase 3 Indications Targeting Hyperinsulinism
Two Phase 3 Indications Targeting Hyperinsulinism 4 Milestone Expected Next Milestone Phase 3 Phase 2 Phase 1 IND - Enabling Target Program Q1 2026 FDA Engagement Congenital Hyperinsulinism Ersodetug 2H 2026 Topline data Tumor Hyperinsulinism Ersodetug @2026 Rezolute, Inc. All Rights Reserved.
Slide 5: Ersodetug Treatment for Hyperinsulinism (HI)
Ersodetug Treatment for Hyperinsulinism (HI)
Slide 6: Hypoglycemia as a Result of HI
Hypoglycemia as a Result of HI 6 Rare disease caused by tumors that produce insulin or insulin - like substances such as IGF - 2 Rare pediatric genetic disease characterized by excessive insulin production Congenital HI Tumor HI Ersodetug has been studied in clinical trials and used in real - world
Slide 7: Antibody Designed to Treat All Forms of HI
Antibody Designed to Treat All Forms of HI 7 INSULIN or IGF - 2 GLUCOSE Ersodetug Reduces Insulin Binding & Signaling Ersodetug Increases Available Blood Glucose Reduced Glucose Uptake • Fully human monoclonal antibody with a novel mechanism acting downstream from production source (e.g. pancreas)
Slide 8: Congenital HI
Congenital HI
Slide 9: Disease Background
Disease Background @2026 Rezolute, Inc. All Rights Reserved. 9 • 1 in 22,000 live births in the US 1 , translating to approximately 165 new patients per year • Often presents within first month of life • Most common cause of persistent hypoglycemia in infants and children • Requires constant moni
Slide 10: Inadequate Standard of Care
Inadequate Standard of Care 10 • Diazoxide (DZ) is first line treatment and the only approved medication for hypoglycemia caused by HI • 60% of patients do not respond to DZ • May experience frequent and serious adverse reactions including volume overload, heart failure, and pulmonary hypertension
Slide 11: Therapies in Development
Therapies in Development @2026 Rezolute, Inc. All Rights Reserved. 11 1 Formulation allows for subcutaneous dosing. 2 Phase 2 data supports potential use. SC: subcutaneous. SOC: standard of care. PBH: post - bariatric hypoglycemia. MOA: mechanism of action. Clinical Barriers HI Indication Dosin
Slide 12: Phase 2b RIZE Study Results
Phase 2b RIZE Study Results 12 • 23 participants • Average age ~6.5 (16 participants were between 2 - 6 years of age) • Diverse group across gender and genetics • ~20% average daily time in hypoglycemia and 13 hypoglycemia events per week at baseline • Participants were on standard of care •
Slide 13: The Phase 3 sunRIZE Study
The Phase 3 sunRIZE Study @ 2026 Rezolute, Inc. All Rights Reserved. 13 • Global, multi - center, double - blind, randomized, controlled, safety and efficacy registrational study • Patient population (n=56) • Ages 3 months + who do not have adequate glycemic control with SOC medical management
Slide 14: Phase 3 sunRIZE Study Results Highlights
Phase 3 sunRIZE Study Results Highlights 14 • Study did not meet the primary or key secondary measured glucose endpoints • Up to 45% reduction in events by SMBG in treated groups; not significantly different from placebo (40%) • Reduction in hypoglycemia time by CGM did not reach statistical sign
Slide 15: Baseline Characteristics by Treatment Group
@2026 Rezolute, Inc. All Rights Reserved. 15 Overall [+OLA] (N=63) Placebo (N=17) RZ358 10 mg/kg (N=20) RZ358 5 mg/kg (N=18) Parameter Category 3.4 (3 mo to 15 y) 4.0 (5 mo to 10 y) 3.9 (5 mo to 9 y) 3.4 (1 - 15 y) Age in years, mean (range) 31 (49%) 7 (41%) 10 (50%) 8 (44%) Sex (n, F) 47 (75%) / 16
Slide 16: Preliminary PK: Therapeutic and Age-Comparable Concentrations
P reliminary PK: Therapeutic and Age - Comparable Concentrations @2026 Rezolute, Inc. All Rights Reserved. 16 0 2 4 6 8 10 12 14 16 18 20 22 24 10 100 1000 Study Week R Z 3 5 8 S e r u m C o n c e n t r a t i o n ( μ g / m l ) RZ358_10 mg/kg_DB RZ358_5 mg/kg_DB Ph2 (RIZE) [trough] at effective dose
Slide 17: Increase in Circulating Insulin Consistent With Ph2 (RIZE)
Increase in Circulating Insulin Consistent With Ph2 (RIZE) @2026 Rezolute, Inc. All Rights Reserved. 17 Sensitive Biomarker of Drug Activity -4 -2 0 2 4 6 8 10 12 14 16 18 20 22 24 0 50 100 150 200 250 300 M e a n I n s u l i n C o n c e n t r a t i o n ( μ I U / m l ) Weeks sunRIZE_5 mg/kg_Trough s
Slide 18: Percent Change in Average Weekly Hypoglycemia Events by SMBG
Percent Change in Average Weekly Hypoglycemia Events by Self - Monitored Blood Glucose (SMBG) @2026 Rezolute, Inc. All Rights Reserved. 18 0 4 8 12 16 20 24 5 10 15 Time (Week) H y p o g l y c e m i a E v e n t s ( M e a n ± S D ) RZ358_5 mg/kg RZ358_10 mg/kg Placebo -80 -60 -40 -20 0 % Change from
Slide 19: Percent Change in Daily Percent Time in Hypoglycemia by CGM
Percent Change in Average Daily Percent Time in Hypoglycemia by Continuous Glucose Measurement (CGM) @2026 Rezolute, Inc. All Rights Reserved. 19 -60 -40 -20 0 20 40 % Change from BL to Week 24 (Full Analysis Set) % C h a n g e ( L S M e a n ± S E ) p=0.44 p=0.30 -60 -40 -20 0 20 40 60 % Change from
Slide 20: Hypoglycemia Reductions in Ersodetug Groups Appear Pharmacologically Mediated
Hypoglycemia Reductions in Ersodetug Groups Appear Pharmacologically Mediated 20 • Target therapeutic concentrations achieved • Typical biomarker responses occurred • Decline of hypoglycemia was gradual and progressive • Concordant reduction in hypoglycemia by two different measurements (events [
Slide 21: Study Conclusions and Next Steps
Study Conclusions and Next Steps @2026 Rezolute, Inc. All Rights Reserved. 21 • Study/placebo effect observed with primary endpoint (SMBG) • Previous precedent for this observation in this patient population • Glucose - related endpoints in an outpatient study are challenging and likely influenced
Slide 22: Initially Addressable Pediatric Patients in U.S.
22 @2026 Rezolute, Inc. All Rights Reserved. Verified in the claims database 1 • Hypoglycemia + SOC congenital HI medical therapies* 1 Claims database: Forian and Veeva Compass. *SOC = Standard of Care which includes Diazoxide (DZ), Somatostatin Analogs (SSAs), and NTP. There is no s pe cific ICD -
Slide 23: Tumor HI
Tumor HI
Slide 24: Disease Background
Disease Background 24 • Hypoglycemia caused by two distinct tumor types: • Islet Cell Tumors (ICT) • Excessive secretion of insulin • Malignant insulinomas are the most common ICTs that cause hypoglycemia • Non - Islet Cell Tumors (NICT) • Produce and secrete insulin - like substances such as IGF -
Slide 25: Treatment Options and Unmet Need
Treatment Options and Unmet Need 25 • Tumor - directed therapies do not directly treat hypoglycemia • Adequate hypoglycemia management is required prior to initiation of tumor - targeted therapies • Therapies to treat malignant insulinoma are often ineffective or poorly tolerated • Diazoxide (DZ) is
Slide 26: Real-world Patient Benefit in Expanded Access Program of Ersodetug
Real - world Patient Benefit in Expanded Access Program of Ersodetug 26 • Multiple tumor HI patients with severe refractory hypoglycemia • Hospitalized and in life - threatening or hospice - bound condition • Required continuous high volume/concentration intravenous dextrose or nutritional infus
Slide 27: Phase 3: The upLIFT Study
Phase 3: The upLIFT Study 27 • Global, multi - center, single - arm, open - label registrational study • Patient population (n=~16) • Adult ICT and NICT patients with HI who have not achieved adequate hypoglycemia control with SOC therapies • Primary endpoint: number of participants achieving
Slide 28: Malignant Insulinoma Patients Identified in Claims
28 @2026 Rezolute, Inc. All Rights Reserved. Malignant insulinoma patients identified in claims (includes two or more C25.4 or E31.21 + ) ~ 40% patients refractory to surgery and medical management including DZ Initial commercial effort: refractory patient population at nationally recognized cancer
Slide 29: Initially Addressable NICTH Patients in U.S.
29 @2026 Rezolute, Inc. All Rights Reserved. * Analysis identified patients in the Forian and Veeva Compass claims database that matched phase 3 tumor HI clinical inclusion/exclusion criteria. Severe NICTH patients identified in claims* (Tumor Diagnosis + Hypoglycemia + Steroids + Hospitalization) ~
Slide 30: Combined Commercial Opportunity
Combined Commercial Opportunity
Slide 31: Weight-based Dosing Applies to Both Indications
31 • Each vial is 80 mg/mL • Congenital HI maintenance dose: 10 mg/kg • Pediatric patient average weight: ~24 kg • Patients will use 3 vials per infusion • 39 vials per year per patient assuming infusion every four weeks • Tumor HI maintenance dose: 9 mg/kg • Adult patient average weight: ~80 kg • P
Slide 32: Initial Combined U.S. Market Opportunity: 4,500 Patients
32 • Congenital HI Market • Pediatric ultra - rare disease pricing • Lead indication establishes clinical effectiveness and payer access pathway for ersodetug in HI • Addressable market of ~1,500 pediatric patients • Tumor HI Market • Malignant Insulinoma • Immediate opportunity with high awareness
Slide 33: A Rare Disease Company Treating Hyperinsulinism
A Rare Disease Company Treating Hyperinsulinism 33 Well - capitalized for execution – $152 million in cash with runway to mid - 2027 Total $1B+ global market opportunity with additional upside through expansion RZ358 ( ersodetug ) is an antibody designed to treat hypoglycemia caused by all form
Slide 34: Rezolutebio.com
Rezolutebio.com