Rezolute, Inc. · NASDAQ:RZLT
Rezolute — Investor Presentation (October 2026)
34 slides from Rezolute's investor presentation, October 2026
Slide 1: A Late-stage Ultra-rare Disease Company Treating Refractory Hypoglycemia
A Late-stage Ultra-rare Disease Company Treating Refractory Hypoglycemia 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: An Ultra-rare Disease Company Treating Refractory Hypoglycemia
An Ultra-rare Disease Company Treating Refractory Hypoglycemia RZ358 (ersodetug) Two late-stage Compelling Total $5B+ global Seasoned is an antibody programs evidence that market opportunity management team designed to treat evaluating ersodetug is active with additional with demonstrated refractory
Slide 4: Late-Stage Clinical Programs Targeting Hyperinsulinism
Late-Stage Clinical Programs Targeting Hyperinsulinism IND- Next Milestone Program Target Phase 1 Phase 2 Phase 3 Enabling Milestone Expected Congenital Ersodetug BLA filing 2027 Hyperinsulinism Tumor December Ersodetug Topline data Hyperinsulinism 2026 GI-Surgery Regulatory Ersodetug Hypoglycemia 1
Slide 5: Ersodetug
Ersodetug Treatment for Hyperinsulinism (HI)
Slide 6: Refractory Hypoglycemia as a Result of HI
Refractory 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 GI-Surgery Tumor HI Ultra-rare pediatric genetic Hyperinsulinism mediated by disease characterize
Slide 7: Downstream MOA at Insulin Receptor Addresses any Form of HI
Downstream MOA at Insulin Receptor Addresses any Form 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 b
Slide 8: Congenital HI
Congenital HI
Slide 9: Disease Pathophysiology, Incidence, and Clinical Features
Disease Pathophysiology, Incidence, and Clinical Features • Multiple gene causes of dysregulated insulin production and signaling • 1 in 22,000 live births in the US1, translating to approximately 165 new patients per year • Most common cause of persistent hypoglycemia in infants and children • Of
Slide 10: High Unmet Medical Need with Current Standard of Care
High Unmet Medical Need with Current 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 • Can cause frequent and serious adverse reactions including volume overload, heart failure, and pul
Slide 11: Phase 3 sunRIZE Study Highlights
Phase 3 sunRIZE Study Highlights • Study status • Phase 3 pivotal study completed; open-label extension (OLE) ongoing • 100% roll-over to OLE and very high retention rate • Significant number of patients have stopped other therapies and remain on ersodetug as monotherapy • Efficacy (Pivotal, RCT pe
Slide 12: sunRIZE PK Showed Therapeutic and Age-Comparable Concentrations
sunRIZE PK Showed 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. 12
Slide 13: Decrease in Cleared Insulin Indicates Drug Activity at Insulin Receptor Target
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 14: Study Effect on Unblinded SMBG: Primary Endpoint Not Met
Study Effect on Unblinded SMBG Occurred Early in Dosing: Primary Endpoint Not Met (Change in Avg Weekly Hypo Events by SMBG) 20 Percent Change From Baseline (CFB) Observed Values 0 Mean % CFB 15 -20 Hypoglycemia Events RZ358_5 mg/kg -40 RZ358_10 mg/kg (Mean ± SD) Placebo 10 -60 0 4 8 12 16 20 24 Tim
Slide 15: Secondary Endpoint: Reductions in Time in Hypoglycemia (CGM)
Secondary Endpoint: Clinically Significant Reductions in Time in Hypoglycemia (CGM) not Stat. Sig. at Wk24/EOT • Reductions of >50% compared to placebo with • Not statistically significant at SAP-specified Week nominal statistical significance at the noted timepoints 24/EOT analysis window (-32%; p=
Slide 16: 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 17: Significant Reductions in Average Weekly Hypoglycemia Events by CGM
Significant Reductions in Average Weekly Hypoglycemia Events by CGM in FAS and 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 b
Slide 18: Consistent Glycemic Improvements Across Multiple CGM Outcomes in Maintenance Phase
Consistent and Significant Glycemic Improvements Across Multiple CGM Outcomes in the Maintenance Phase of Dosing (every 4 weeks) LS-Mean (95% CI) Percent Change from Baseline; FAS Population ©2026 Rezolute, Inc. All Rights Reserved. 18
Slide 19: ~2,000 Addressable Congenital HI Patients in the U.S.
~2,000 Addressable Congenital HI Patients in the U.S. Verified in claims database1 • Hypoglycemia + SOC congenital HI medical therapies* 3,000 Potential market after removing ~40% DZ responsive patients 1,800 Potential market after removing ~5% of patients with 1,650 a surgically curable focal lesio
Slide 20: Market Concentration Enables Targeted Commercial Efforts
Market Concentration Enables Targeted Commercial Efforts High penetration among a small number of treaters and Centers of Excellence HCP CONCENTRATION CENTER CONCENTRATION ~500 HCPs treat 80% of patients 80 centers manage 80% of patients Cumulative unique patient coverage 100% 80% 60% 40% 20% 0% 0 5
Slide 21: Tumor HI
Tumor HI
Slide 22: Pathophysiology and Clinical Presentation
Pathophysiology and Clinical Presentation • Hypoglycemia caused by two distinct tumor categories: • 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 par
Slide 23: High Unmet Medical Need with Current Standard of Care
High Unmet Medical Need with Current Standard of Care • Significant unmet need to directly treat hypoglycemia over the entire course of the patient cancer journey • Therapies to treat hypoglycemia caused by malignant insulinoma are often ineffective or poorly tolerated • Diazoxide (DZ) is the only a
Slide 24: 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 life-threatening or hospice-bound condition • Required continuous high volume / concentration parenteral glucose • Tumor-directed therapies (e.g.
Slide 25: Ongoing Phase 3 (upLIFT) Study
Ongoing Phase 3 (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% r
Slide 26: ~2,500 Addressable Malignant Insulinoma Patients in the U.S.
~2,500 Addressable Malignant Insulinoma Patients in the U.S. Malignant insulinoma patients 6,000 (includes C25.4, hypoglycemia, CGM, supporting symptoms1) Above + surgery or targeted therapy2 + core symptoms3 and repeated 2,500 hospitalization4 Significant market expansion opportunity with increasin
Slide 27: Insulinoma – Concentrated Market with High Disease Awareness
Insulinoma – Concentrated Market with High Disease Awareness High penetration with a small number of treaters at National Cancer Institutes and Academic Medical Centers HCP CONCENTRATION CENTER CONCENTRATION ~1,000 HCPs treat 60% of patients 300 centers manage 60% of patients Cumulative unique patie
Slide 28: ~1,500 Addressable NICTH Patients in the U.S.
~1,500 Addressable NICTH Patients in the U.S. Patients with qualifying tumor1 + in-patient treatment of 6,000 hypoglycemia (“hypo”) or recurrent hypo events Above + hypo treatment2 or ≥ 7 days in-patient/emergency department 1,500 or hypo diagnosis (e.g., insulin, C-peptide, IGF levels) Significant
Slide 29: Strong Foundation for High Penetration and Continued Market Expansion
Strong Foundation for High Penetration and Continued Market Expansion • Insulinoma • Well-understood disease with established guidelines on hypoglycemia management • NANETS (North American Neuroendocrine Tumor Society) and NCF (Neuroendocrine Cancer Foundation) dedicated advocacy groups • Claims ana
Slide 30: Combined Commercial Opportunity in Congenital and Tumor HI Indications
Combined Commercial Opportunity in Congenital and Tumor HI Indications
Slide 31: Payer Research Supports Ultra-Rare Disease Pricing for Tumor HI
Payer Research Supports Ultra-Rare Disease Pricing for Tumor HI • Insulinoma and NICTH indications with a high Tumor HI Payer Mix unmet need and low budgetary impact, supporting ultra-rare disease pricing • Expect to manage ersodetug with a prior 2025 authorization aligned to the label and a step- t
Slide 32: Combined Market Opportunity Exceeds $5 Billion
Ersodetug’s Addressable Patients, Dosing Regimen and Rare-Disease Pricing Enable Combined Market Opportunity that Exceeds $5 Billion Combined U.S. opportunity ~6,000 patients • Congenital HI maintenance dose: 10 mg/kg • Pediatric patient average weight: ~24 kg • Patients will use 3 vials per infusio
Slide 33: An Ultra-rare Disease Company Treating Refractory Hypoglycemia
An Ultra-rare Disease Company Treating Refractory Hypoglycemia Mission-driven to RZ358 (ersodetug) Ersodetug has Total $5B+ global improve outcomes is an antibody been studied in market opportunity for individuals with designed to treat clinical trials and with additional refractory refractory used
Slide 34: Rezolutebio.com
€ Rezolutebio.com