Corporate Presentation

A Metabolic and Orphan Disease Company

NASDAQ: RZLT

Forward Looking Statements

The information provided herein contain "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These Forward-Looking statements include, but are not limited to, statements regarding the sunRIZE clinical study, the DME RZ402 study, the RIZE study, the ability of RZ358 and RZ402 to become effective treatments, the effectiveness or future effectiveness of RZ358 and RZ402 as treatments, and statements regarding clinical trial timelines for either treatment. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Rezolute's current beliefs, expectations and assumptions regarding the future of its businesses, results of and timing of clinical trials, financial condition and results of operations, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward- looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Rezolute's control. Rezolute's actual results including the timing and results of clinical trials may differ materially from those indicated in the forward- looking statements. Therefore, you should not place undue reliance on any of these forward-looking statements. Important factors that could cause Rezolute's actual results including the timing and results of clinical trials to differ materially from those indicated in the forward-looking statements are discussed or identified in Rezolute's filings made with the U.S. Securities and Exchange Commission. Any forward-looking statements made by Rezolute in this information are based only on information currently available to Rezolute and speak only as of the date on which the statement is made. Rezolute undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise except as required by applicable law.

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Creating Long-term Value By Advancing Transformative Therapies

RZ358: Monoclonal antibody addressing all forms of hyperinsulinism (HI)

  • Congenital HI: Global Phase 3 trial (sunRIZE); topline results expected mid-2025
  • Tumor HI: success in multiple cases under our Expanded Access Program (EAP)

RZ402: Once daily oral therapy in Phase 2 for diabetic macular edema (DME)

  • Potential to change treatment paradigm dominated by eye injections

Topline results expected Q2 2024

Seasoned management team

Demonstrated success from early development through commercialization

Cash runway through Q3 2025

Past topline results for both programs

Strong investor base focused on long-term value

Each program has potential >$1B+ market opportunity

  • Potential upside with expanded indications

EAP: expanded access program.

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3

Pipeline

Program

Target

Status

Preclinical

Phase 1

Phase 2

Phase 3

Congenital Hyperinsulinism (HI)

Currently

Mid-

rarepediatric disease

enrolling

2025

RZ358

Tumor Hyperinsulinism (HI)

EAP Enabled

Alignment with FDA for potential

raredisease

Emergency Use

late-stage clinical study

Authorization

RZ402

Oral PKI for Diabetic Macular

Fully enrolled

2Q 2024

Edema (DME)

EAP: expanded access program

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RZ358

Antibody for Hyperinsulinism (HI)​

An Antibody Created to Address all Forms of HI

  1. RZ358 allosterically binds to the insulin receptor to modulate the signaling effect of ligands such as insulin and other substances to maintain glucose values in a healthy range
  1. Novel mechanism of action by operating downstream from pancreatic insulin over- secretion (usual SOC target)
  1. Administered by IV infusion every 2 to 4 weeks

LIGANDS

GLUCOSE

IncreasesGLUT4

Available Blood

Glucose

RZ358

Reduces

Ligand

Signaling

Reduces

Glucose

Uptake

HI: hyperinsulinism. SOC: standard of care. GLUT4: glucose transporter type 4.

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Congenital HI

Pediatric rare genetic disease characterized by dysregulated and excessive insulin production

Congenital HI Disease Background

  1. 1 in 28,000 live births in the US
    • 25 years of treatment required on average
    • ~3500 cases in the US
    • Often presents within first month of life
  1. Most common cause of persistent hypoglycemia in infants and children
  1. Symptoms often not recognized until life-threateningo Risk of coma, death, and other serious complications o 50% of children have neurological deficiencies
  1. No therapy has been developed and approved for this indication

HI: hyperinsulinism. SOC: standard of care. 1. Banerjee I, et al. Orphanet J Rare Dis. 2022;17(1):61.

Psychosocial and

Carbohydrate

Financial Burden

Supplementation

"Everything I see just

Dependence on

drives home the fact we

nutritional support

will never lead a normal

limits the ability to

life. So many of my hopes

have normal lives,

and dreams for our

especially in social

family and for our little

situations1

one are shattered."1

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Available Treatment Options are Suboptimal

Ineffective in 50% of patients (with KATP mutations) FDA black box for pulmonary hypertension Fluid retention affecting heart/lungs Facial changes and excessive hair growth

Current formulations short-acting Temporary measure for emergent glucose correction Repeated use may deplete liver glucose stores Long-term efficacy is modest

Marginal efficacy, effects wane with repeat dosing Gastrointestinal side effects Risk of NEC, particularly in newborns

Potential interaction with pituitary hormones (growth and thyroid)

Diazoxide Carbohydrate

[Approved] Supplementation

Glucagon Pancreatectomy

[Off label]

Somatostatin Analogues

[Off label]

Frequent, glucose-enriched oral feeds or continuous enteral feeds via NG/GT Multifactorial feeding aversions affect a large proportion of children with cHI

Negative impact on normal daily activities and social interactions

Resection for diffuse disease

Invasive procedure, not done globally

Hypoglycemia may persist for years in up to half of patients

Eventually insulin therapy required

Requires adjuvant medical management, and/or repeat surgery

Resection for focal disease

Limited number of overall cases

Only done at specialized centers

Can be curative for patients

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Congenital HI Treatment Landscape

Diagnosis and Treatment Pathway

~3,500 congenital HI

patients in the US

Diazoxide Trial

Period

(up to 15 mg/kg/day)

HI: hyperinsulinism. DZ: diazoxide.

After 5-Day Treatment:

40%

Responsive

to DZ

Unresponsive

to DZ 60%

~70%

Tolerated

Unacceptable

Side Effects

~30% or 420 pts

~60% or 2100 pts Diffuse

Focal

~40%

RZ358

Addressable

Patient

Population

~2,500

Surgical

Candidates

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Rezolute Inc. published this content on 06 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 March 2024 12:40:24 UTC.