Rezolute, Inc. · NASDAQ:RZLT
Rezolute — Investor Presentation (May 2026)
38 slides from Rezolute's investor presentation, May 2026
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 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 27A of the Securities Act and S
Slide 3: A Rare Disease Company Treating Hyperinsulinism
A Rare Disease Company Treating Hyperinsulinism RZ358 (ersodetug) is Two rare disease Compelling evidence Total $1B+ global Seasoned an antibody programs evaluating that ersodetug is market opportunity management team designed to treat ersodetug to treat active against with additional with demons
Slide 4: Two Phase 3 Indications Targeting Hyperinsulinism
Two Phase 3 Indications Targeting Hyperinsulinism IND- Next Milestone Program Target Phase 1 Phase 2 Phase 3 Enabling Milestone Expected Congenital Pending FDA Ersodetug 2H 2026 Hyperinsulinism discussions Tumor Ersodetug Topline data 2H 2026 Hyperinsulinism @2026 Rezolute, Inc. All Rights Reserved.
Slide 5: Ersodetug
Ersodetug Treatment for Hyperinsulinism (HI)
Slide 6: Hypoglycemia as a Result of HI
Hypoglycemia as a Result of HI Hypoglycemia o Severe, persistent, life-threatening complication of over activation of the insulin receptor o Lack of effective treatment options Congenital HI Tumor HI Rare pediatric genetic disease Rare disease caused by tumors that characterized by excessive insuli
Slide 7: Antibody Designed to Treat All Forms of HI
Antibody Designed to Treat All Forms of HI • Fully human monoclonal antibody with GLUCOSE a novel mechanism acting downstream INSULIN or IGF-2 from production source (e.g. pancreas) • Allosterically binds to the insulin Ersodetug receptor to counteract excess signaling Increases by insulin or rela
Slide 8: Congenital HI
Congenital HI
Slide 9: Disease Background
Disease Background • 1 in 22,000 live births in the US1, 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 monitoring as serious hypoglycemic lows are often
Slide 10: Inadequate Standard of Care
Inadequate Standard of Care • 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: Phase 2b RIZE Study Results
Phase 2b RIZE Study Results • 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 • Predi
Slide 12: The Phase 3 sunRIZE Study
The Phase 3 sunRIZE Study • 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 • Primary endpoint: change in average number of hypog
Slide 13: Phase 3 sunRIZE Study Results Highlights
Phase 3 sunRIZE Study Results Highlights • 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 significa
Slide 14: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics RZ358 5 mg/kg RZ358 10 mg/kg Placebo Overall [+OLA] Parameter Category (N=18) (N=20) (N=17) (N=63) Age in years, mean (range) 3.4 (1-15 y) 3.9 (5 mo to 9 y) 4.0 (5 mo to 10 y) 3.4 (3 mo to 15 y) Sex (n, F) 8 (44%) 10 (50%) 7 (41%) 31 (49%) Genetics (n,% kATP
Slide 15: Preliminary PK: Therapeutic and Age-Comparable Concentrations
Preliminary PK: Therapeutic and Age-Comparable Concentrations 1000 RZ358 Serum Concentration (μg/ml) 100 RZ358_5 mg/kg_DB Ph2 (RIZE) [trough] RZ358_10 mg/kg_DB at effective doses 10 0 2 4 6 8 10 12 14 16 18 20 22 24 Study Week @2026 Rezolute, Inc. All Rights Reserved. 15
Slide 16: Mean Insulin Concentration
Decrease in Cleared Insulin Indicates Drug Activity at Insulin Receptor Target, and is Comparable to Ph2 RIZE Study Circulating Insulin: Sensitive Biomarker of Drug Activity 300 Mean Insulin Concentration 250 200 (μIU/ml) 150 100 50 0 -4 -2 0 2 4 6 8 10 12 14 16 18 20 22 24 Weeks Dosing (sunRIZE) Do
Slide 17: Hypoglycemia Events
Percent Change in Average Weekly Hypoglycemia Events by Self- Monitored Blood Glucose (SMBG) 20 Percent Change From Baseline (CFB) 0 Mean % CFB Observed Values -20 15 -40 Hypoglycemia Events RZ358_5 mg/k RZ358_10 mg/k (Mean ± SD) Placeb -60 10 0 4 8 12 16 20 24 Time (week) % Change from BL to EOT (W
Slide 18: % Hypoglycemia Time
Percent Change in Average Daily Percent Time in Hypoglycemia by Continuous Glucose Measurement (CGM) Percent Change From Baseline (CFB) 60 40 Mean % CFB Observed Values 20 25 0 RZ358_5 mg/k * # % Hypoglycemia Time RZ358_10 mg/k -20 * Placeb * (Mean ± SD) 20 -40 # * 0 4 8 12 16 20 24 Time (week) 15 #
Slide 19: Time in Hypoglycemia Reductions More Significant in Per Protocol Set
Time in Hypoglycemia Reductions (CGM) More Significant in the Per Protocol Set (PPS)* (n=41) • Reductions of ~60-80% compared to placebo with • Not statistically significant at SAP-specified Week 24/EOT nominal statistical significance at the noted timepoints analysis window (-55%; p=0.18 at 10 mg/k
Slide 20: Reduction in Average Weekly Hypoglycemia Events by CGM in FAS & PPS
Reduction in Average Weekly Hypoglycemia Events by CGM in FAS & PPS Populations (Pre-Specified Endpoint) Full Analysis Set (FAS) Per Protocol Set (PPS) 80 120 60 100 80 40 60 20 %CFB %CFB ~50-65% LS-Mean Reductions 40 (one or both dose levels) ~50-80% LS Mean Reductions 0 20 (one or both dose levels
Slide 21: Consistent and Clinically Relevant Glycemic Improvements Across Time and Multiple CGM Outcomes
Consistent and Clinically Relevant Glycemic Improvements Across Time and Multiple CGM Outcomes @2026 Rezolute, Inc. All Rights Reserved. 21
Slide 22: Hypoglycemia Reductions in Ersodetug Groups Appear Pharmacologically Mediated
Hypoglycemia Reductions in Ersodetug Groups Appear Pharmacologically Mediated • Target therapeutic concentrations achieved • Typical biomarker responses occurred • Decline of hypoglycemia was gradual and progressive • Concordant reduction in hypoglycemia by two different measurements (events [SMB
Slide 23: Study Conclusions
Study Conclusions • Study/placebo effect observed with primary endpoint (SMBG) • Previous precedent for this observation in this patient population • Frequent visits and real-time glucose monitoring • Glucose-related endpoints in an outpatient study are challenging and likely influenced by behavio
Slide 24: Program Status and Next Steps
Program Status and Next Steps • Type B meeting with U.S. Food and Drug Administration (FDA) held on March 17, 2026 • Rezolute presented summary results from sunRIZE including: • Information to support Company’s belief that the primary endpoint was confounded as a result of behavioral factors • Evide
Slide 25: ~1,500 Initially Addressable Pediatric Patients in U.S.
~1,500 Initially Addressable Pediatric Patients in U.S. Verified in the claims database1 • Hypoglycemia + SOC congenital HI medical therapies* 3,000 Initial market after removing ~40% DZ responsive patients 1,800 Initial market after removing ~5% patients who have 1,650 had surgery over the previous
Slide 26: Tumor HI
Tumor HI
Slide 27: Disease Background
Disease Background • 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-2 that o
Slide 28: Treatment Options and Unmet Need
Treatment Options and Unmet Need • 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 the on
Slide 29: Real-world Patient Benefit in Expanded Access Program of Ersodetug
Real-world Patient Benefit in Expanded Access Program of Ersodetug • 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 infusion • Tumo
Slide 30: Initial 9 Tumor HI Patient Profiles in Expanded Access Program
Initial 9 Tumor HI Patient Profiles in Expanded Access Program Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8# Patient 9 Gender (M/F) / Age (Years) M / 55 F / 50 F / 50 F / 43 M / 74 M / 62 M / 74 M / 53 M / 24 Neuroendocrine Metastatic Metastatic Metastatic Metasta
Slide 31: Phase 3: The upLIFT Study
Phase 3: The upLIFT Study • 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 ≥50% reductio
Slide 32: ~1,500 Initially Addressable Malignant Insulinoma Patients in U.S.
~1,500 Initially Addressable Malignant Insulinoma Patients in U.S. Malignant insulinoma patients identified in claims 3,000 (includes two or more C25.4 or E31.21+) ~40% patients refractory to surgery and medical management 1,200 including DZ Initial commercial effort: refractory patient population a
Slide 33: ~1,500 Initially Addressable NICTH Patients in U.S.
~1,500 Initially Addressable NICTH Patients in U.S. Severe NICTH patients identified in claims* 6,000 (Tumor Diagnosis + Hypoglycemia + Steroids + Hospitalization) ~40% patients refractory to SOC (tumor-directed and/or steroids) and requiring hospital stays + IV glucose* 2,400 Initial commercial eff
Slide 34: Combined Commercial Opportunity
Combined Commercial Opportunity
Slide 35: Weight-based Dosing Applies to Both Indications
Weight-based Dosing Applies to Both Indications Tumor HI patients require ~3X more vials compared to congenital HI patients • 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 p
Slide 36: Initial Combined U.S. Market Opportunity: 4,500 Patients
Initial Combined U.S. Market Opportunity: 4,500 Patients • 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 Ins
Slide 37: A Rare Disease Company Treating Hyperinsulinism
A Rare Disease Company Treating Hyperinsulinism Mission-driven to RZ358 (ersodetug) is Compelling evidence Total $1B+ global improve outcomes an antibody that ersodetug is market opportunity for individuals with designed to treat active against with additional severe hypoglycemia hypoglycemia in
Slide 38: Rezolutebio.com
€ Rezolutebio.com