Rezolute, Inc. · NASDAQ:RZLT
Rezolute — Investor Presentation (February 2026)
34 slides from Rezolute's investor presentation, February 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 FDA Ersodetug Q1 2026 Hyperinsulinism Engagement Tumor Ersodetug Topline data 2H 2026 Hyperinsulinism @2026 Rezolute, Inc. All Rights Reserved. 4
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: Decrease in Cleared Insulin Indicates Drug Activity
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: Percent Change in Average Weekly Hypoglycemia Events by SMBG
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: Percent Change in Average Daily Percent Time in Hypoglycemia by CGM
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: 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 20: Study Conclusions and Next Steps
Study Conclusions and Next Steps • 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 influe
Slide 21: ~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 22: Tumor HI
Tumor HI
Slide 23: 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 24: 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 25: 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 26: 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 27: 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 28: ~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 29: ~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 30: Combined Commercial Opportunity
Combined Commercial Opportunity
Slide 31: 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 32: 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 33: 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 34: Rezolutebio.com
€ Rezolutebio.com