Corporate Presentation
A Metabolic and Orphan Disease Company
NASDAQ: RZLT
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 Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "prove," "potential," "seek," "strive," "try," or future or conditional verbs such as "predict," "could," "may," "likely," "should," "will," "would," or similar expressions. 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. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC's website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
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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)
- Topline results reported May 2024; met primary endpoints of safety and CST reduction
• Company evaluating strategic next steps for the program
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. CST: central subthreshold thickness. | | 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 | Reported | May 2024 |
Edema (DME) | topline data | ||
EAP: expanded access program | | 4 |
RZ358
Antibody for Hyperinsulinism (HI)
An Antibody Created to Address all Forms of HI
- 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
- Novel mechanism of action by operating downstream from pancreatic insulin over- secretion (usual SOC target)
- 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. | | 6 |
Congenital HI
Pediatric rare genetic disease characterized by dysregulated and excessive insulin production
Congenital HI Disease Background
- 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
- Most common cause of persistent hypoglycemia in infants and children
- Symptoms often not recognized until life-threateningo Risk of coma, death, and other serious complications o 50% of children have neurological deficiencies
- 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 Journey Drives Large Addressable Population
Diagnosis and Treatment Pathway
Disease Duration by Market Segment
~3,500 Diagnosed cHI Patients in US*
Diazoxide Trial
(up to 15 mg/kg/day)
After 5-Day
DZ Trial:
Responsive 40%
(DZR)
Unresponsive
(DZNR)
60%
~70% (980 pts)
Tolerated
Unacceptable
Side Effects
~30% (420 pts)
~75% (1575 pts)
Diffuse
Focal
~25% (525 pts)
>1,500
Addressable
Patient
Population
Focal Disease (surgical)
Partial DZ Responsive Patients
+ Unacceptable Side Effects
Severe, Diffuse Disease,
DZ-Non-Responsive Patients
Age: | 5 | 15 | 25 | 50 | Life |
Average Treatment Duration
HI: hyperinsulinism. DZ: Diazoxide. DZR: Diazoxide Responsive. DZNR: Diazoxide Non-Responsive (kATP channel defect). *Similar numbers in EU | | 10 |
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Rezolute Inc. published this content on 10 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 June 2024 18:17:04 UTC.