Rezolute, Inc. · NASDAQ:RZLT
Rezolute — Investor Presentation (November 2025)
29 slides from Rezolute's investor presentation, November 2025
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 real- Total $1B+ global Seasoned an antibody Phase 3 programs world evidence of market opportunity management team designed to treat evaluating patient benefit with additional with demonstrated hypogl
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 December Ersodetug Topline data Hyperinsulinism 2025 Tumor Ersodetug Topline data 2H 2026 Hyperinsulinism @2025 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 Consequence of multiple forms of HI o Lack of effective treatment options congenital HI tumor HI Rare pediatric genetic disease Rare disease caused by tumors
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: Therapies in Development
Therapies in Development Asset Mechanism Stage Dosing HI Indication Clinical Barriers Insulin receptor IV1, once Congenital, Ersodetug Phase 3 N/A allosteric monthly Tumor, PBH2 modulator •Utility in chronic use unproven; Dasiglucagon Glucagon Continuous Phase 3 Congenital likely need to co
Slide 12: Ongoing Phase 3: The sunRIZE Study
Ongoing Phase 3: The 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
Slide 13: sunRIZE: Patient Demographics
sunRIZE: Patient Demographics • Inclusion criteria • Age: ≥3m-45y • Patients on SOC medications* and/or nutritional supplementation: • ≥2 months of stable treatment • OR had previously discontinued SOC medication due to adverse effects and/or failure to respond • Persistent hypoglycemia • Baseli
Slide 14: 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 15: Substantial Improvement in All Hypoglycemia Metrics
Substantial Improvement in All Hypoglycemia Metrics Pooled 6 and 9 mg/kg dose levels representative of Phase 3 population and dosing Hypoglycemia (<70 mg/dL) Severe Hypoglycemia (<50 mg/dL) Event Rate by BGM (N=15∧) Time by CGM [N=15∧] Event Rate by BGM (N=15∧) Time by CGM [N=15∧] p < 0.0005 p< 0.
Slide 16: Compelling Patient Responses
Compelling Patient Responses Average Daily Time in Hypoglycemia ~40% On Treatment RZ358 6 mg/kg 2-Year-Old on SSA 93% Improvement Average Daily Time in Hypoglycemia ~45% On Treatment RZ358 9 mg/kg 50 40 Hypoglycemia 6-Year-Old; % Time 30 Failed meds, 20 pancreatectomy 10 0 Baseline End of Treatment
Slide 17: ~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 18: Tumor HI
Tumor HI
Slide 19: 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 20: 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 21: 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 22: 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 23: ~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 24: ~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 25: Combined Commercial Opportunity
Combined Commercial Opportunity
Slide 26: 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 27: 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 28: A Rare Disease Company Treating Hyperinsulinism
A Rare Disease Company Treating Hyperinsulinism Mission-driven to RZ358 (ersodetug) is Compelling real- Total $1B+ global improve outcomes an antibody world evidence of market opportunity for individuals with designed to treat patient benefit with additional severe hypoglycemia under the upside t
Slide 29: Rezolutebio.com
€ Rezolutebio.com