Restoring Balance to Life with Transformative Therapies
January 2022
Forward Looking Statements
Statements in this presentation that are not descriptions of historical facts are forward-looking statements relating to future events, and as such all forward-looking statements are made pursuant to the Securities Litigation Reform Act of 1995. Statements may contain certain forward-looking statements pertaining to future anticipated or projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this presentation that are not statements of historical fact may be considered to be forward-looking statements. Words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements.
These forward-looking statements by their nature are estimates of future results only and involve substantial risks and uncertainties, including but not limited to risks associated with the uncertainty of clinical trial results, future financial results, additional financing requirements, development of new products, successful completion of the Company's proposed restructuring, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed from time to time in our reports filed with the Securities and Exchange Commission.
Our actual results may differ materially from expectations based on the above factors and other factors more fully described in our public filings with the U.S. Securities and Exchange Commission, which can be reviewed at www.sec.gov.
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Targeting Diseases Associated With Chronic Glucose Imbalance
RZ358 for Congenital Hyperinsulinism (HI)
Congenital HI is over-production of insulin resulting in life-threatening hypoglycemia and neurologic damage
RZ358 is an antibody with a unique MOA designed and uniquely suited to treatment hyperinsulinism
Open-labelPhase 2b study, with top-line data expected in 1Q 2022
Orphan designation in US and EU, Pediatric Rare Disease designation
Potential for expanded indications: post bariatric surgery hypoglycemia, insulinoma
RZ402 for Diabetic Macular Edema (DME)
Microvascular complication of diabetes results in breakdown of the blood-retinal barrier and eventual blindness
Potent, selective small molecule kallikrein inhibitor
Oral therapy offering the potential to treat DME earlier and to address the disease at the vascular source
Phase 1 single dose study complete and demonstrated good bioavailability, with drug levels that safely exceeded target efficacious concentrations safely, supporting potential for once daily dosing
Ongoing Phase 1b repeat-dose study, with results expected in 1Q 2022
Potential for expanded indications: diabetic retinopathy, hereditary angioedema, systemic inflammatory syndromes and others
Two clinical stage programs with
transformative therapies targeting diseases of dysglycemia
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Leadership with deep expertise in metabolic drug development
Nevan Charles Elam, JD
Brian Roberts, MD
Michael Covarrubias
Erin O'Boyle
Michael Deperro
Davelyn Eaves Hood, MD
Founder & CEO
Head of Clinical Development
Head of CMC
Head of Clinical Operations
Head of Operations
Scientific & Patient Affairs
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RZ358
A MONOCLONAL ANTIBODY IN
PHASE 2B CLINICAL DEVELOPMENT
FOR CONGENITAL HI
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Rezolute Inc. published this content on 04 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 January 2022 16:58:09 UTC.
Rezolute, Inc. is a clinical-stage biopharmaceutical company, which is developing therapies for metabolic diseases related to chronic glucose imbalance. The Companyâs lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism (HI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas in Phase III. RZ358 is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor in insulin target tissues, such as in the liver, fat and muscle. Its second clinical asset, RZ402, is an oral plasma kallikrein inhibitor (PKI) being developed as a therapy for the chronic treatment of diabetic macular edema (DME) in Phase II. RZ402 is designed to be a once daily oral therapy for the treatment of DME and unlike the anti-VEGF therapies, RZ402 targets the Kallikrein-Kinin System to address inflammation and vascular leakage.
REZOLUTE, INC. 
