Ankündigung • May 02

Rezolute Inc Announces Oral Presentation Of Results From Phase 3 Sunrize Study Of Ersodetug In Patients With Congenital Hyperinsulinism

Rezolute, Inc. announced that expanded analyses from the Phase 3 sunRIZE study of ersodetug in patients with congenital HI were presented at the Pediatric Endocrine Society (PES) 2026 Annual Meeting. The oral presentation was made by Diva D. De León-Crutchlow, M.D., M.S.C.E., Chief of the Division of Endocrinology and Diabetes, Director of the Congenital Hyperinsulinism Center at Children’s Hospital of Philadelphia, and Principal Investigator of the sunRIZE study. In addition to the previously reported topline results, the presentation included additional results from pre-specified and post-hoc sunRIZE analyses, which the Company believes reiterates evidence of target engagement and highlights the potential therapeutic benefit of ersodetug. As discussed in the presentation, although statistical significance for the secondary endpoint (% time in hypoglycemia by CGM) was not achieved at the Week 24/End of Treatment evaluation window, larger and often nominally statistically significant glycemic improvements were consistently observed throughout the maintenance dosing phase of the study, across time and numerous pre-specified and post-hoc CGM-based endpoints. Summary of Key Additional Data Presented: Average daily percent time in hypoglycemia by CGM: clinically relevant and nominally statistically significant reductions of >50% (Full Analysis Set [FAS]) and ~60-80% (Per Protocol Set [PPS]), compared to placebo across multiple timepoints. Average weekly hypoglycemia events by CGM: clinically relevant and nominally statistically significant reductions of ~50-65% (FAS) and ~50-80% (PPS), compared to placebo across multiple timepoints. Average daily AUC 70 to 180 mg/dL (Exposure to Normoglycemia) by CGM: clinically relevant and nominally statistically significant increases of ~25-50% (FAS and PPS), compared to placebo across multiple timepoints. Average blood glucose (mg/dL) by CGM: clinically relevant and nominally statistically significant increases of ~10-15% (~10-15 mg/dL) in both the FAS and PPS, compared to placebo across multiple timepoints. The Company is also assessing the longer-term efficacy and safety of ersodetug in a real-world setting in an ongoing OLE phase of the study, including the roll-over of placebo participants. Following the conclusion of the randomized and placebo-controlled phase of sunRIZE, all 59 study completers elected to enter the OLE, as previously reported by the Company. Reflecting no change since last reported, 57 participants continue to attend regular study visits at sunRIZE study centers to receive ersodetug in the OLE, now representing a cumulative ersodetug exposure duration in the study ranging from approximately 6 to 24 months. Preliminary OLE observations demonstrate continued glycemic benefit, including a clinically significant change in glycemic control in the rolled-over placebo participants compared to the controlled period of the study. These glycemic benefits have enabled a concurrent significant overall reduction in background SOC therapies (e.g. diazoxide, somatostatin analogs, and/or regular tube feeds), with a significant number of patients now receiving ersodetug as monotherapy. A summary of these same CGM-based study outcomes and preliminary observations from the OLE phase of the study were recently discussed with the U.S. Food and Drug Administration (FDA) as part of the Company’s Type B meeting held on March 17, 2026. The meeting resulted in the agency acknowledging challenges associated with the study primary endpoint (events by finger-stick self-monitored blood glucose [SMBG]), and concluded with the agency requesting that the Company submit the broader study data for the agency’s comprehensive evaluation to inform next steps for the program. The Company’s full data presentation from PES can be found on the Publications and Presentations page of the Rezolute website. The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug. The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment. Although sunRIZE demonstrated reductions from baseline in hypoglycemia events, the study did not meet its primary endpoint, which assessed change in average weekly hypoglycemia events by self-monitored blood glucose (SMBG) compared to placebo. The reductions observed were not statistically significant, which the Company believes was a result of functional unblinding of the SMBG endpoint, leading to divergent and confounding glucose-modifying behaviors between treatment groups, and a pronounced study effect in the placebo arm. Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

Ankündigung • May 03

Rezolute, Inc. Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism

Rezolute, Inc. announced positive results from its Phase 2b RIZE study of RZ358 in patients with congenital hyperinsulinism (HI), which were unveiled in a late-breaking oral presentation at the Pediatric Endocrine Society 2022 Annual Meeting. The study exceeded expectations for correction of hypoglycemia, including a highly significant reduction of ~75% in hypoglycemia events by blood glucometer (BGM) as well as time in hypoglycemia by continuous glucose monitoring (CGM). The RIZE study enrolled a diverse group of congenital HI patients with an average age of 6.5 years, including 16 patients between the ages of 2 and 6 years old, and with substantial continued hypoglycemia despite being on currently available therapies. During a robust screening and baseline run-in period on stable standard of care, the average RIZE study patient was hypoglycemic for 23% of their overall monitored time on a CGM, corroborated by having an average of 16 hypoglycemia events per week by point-of-care blood glucometer. There was also a significant amount of severe hypoglycemia at baseline (defined by glucose values below 50 mg/dL). RZ358 was administered via a thirty-minute intravenous infusion every other week for an 8-week treatment period in four sequential cohorts ranging from 3 to 9 mg/kg. RZ358 led to a better than 50% reduction from baseline in overall (<70 mg/dL) and severe (<50 mg/dL) hypoglycemia events (by BGM) and time in hypoglycemia (by CGM) in the pooled group of patients across all doses. A larger magnitude of improvement of ~75% was seen at the anticipated therapeutic doses of 6 mg/kg and 9 mg/kg. The blood concentrations of RZ358 were highly predictable and dose-proportional, with no apparent impact from factors relevant to this patient population, such as age distribution, food aversions, or gastrointestinal absorption and tolerability. A clear dose and exposure response was observed with RZ358. A safety review committee comprised of three expert investigators in congenital HI met over the course of the study to review and confirm safety prior to dose escalation. RZ358 was generally safe and well-tolerated across the studied dose and age range. There were no adverse drug reactions, study discontinuations, or occurrences of clinically significant hyperglycemia. The observed blood levels of RZ358 were well below levels that were safely tested in long term toxicology studies in non-human primates. There was a high patient response rate to RZ358, as shown by the percentage of patients who achieved improvements in hypoglycemia across different clinically relevant thresholds. Notably, at the top dose, all patients achieved at least a 50% improvement, and all but one patient achieved at least a 75% improvement, indicating that the substantial reductions in hypoglycemia observed on average were nearly universally experienced by the wide variety of congenital HI patients across the study. RIZE is a Phase 2b, multicenter, open label, repeat-dose study, designed to assess the safety and tolerability, pharmacokinetics, and glycemic efficacy of RZ358 administered bi-monthly for 8 weeks in patients with congenital hyperinsulinism whose hypoglycemia was not adequately controlled on standard of care therapies. A total of 23 patients participated in the study in four sequential dosing cohorts ranging from 3 mg/kg to 9 mg/kg. The effects of RZ358 on hypoglycemia were assessed by continuous glucose monitor (hypoglycemia time) and glucometer self-monitored blood glucose (hypoglycemia events). RZ358 is a human monoclonal antibody that binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle. The antibody counteracts the effects of elevated insulin in the body by modifying insulin's binding, signaling, and activity to maintain glucose levels in a normal range. Rezolute believes that RZ358 is ideally suited as a potential therapy for congenital hyperinsulinism (HI) and other conditions characterized by excessive insulin levels. As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating congenital HI, regardless of the causative genetic defect. RZ358 received Orphan Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US.

Zinsdeckungsgrad	n/a
Bargeld	US$120.27m
Eigenkapital	US$116.83m
Gesamtverbindlichkeiten	US$8.63m
Gesamtvermögen	US$125.46m

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/05/24 00:41
Aktienkurs zum Tagesende	2026/05/22 00:00
Gewinne	2026/03/31
Jährliche Einnahmen	2025/06/30

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Julian Harrison	BTIG
Edward Nash	Canaccord Genuity
Pete Stavropoulos	Cantor Fitzgerald & Co.

Rezolute Balance Sheet Health

Finanzielle Gesundheit Kriterienprüfungen 6/6

Wichtige Informationen

Jüngste Berichte zur Finanzlage

Will Rezolute (NASDAQ:RZLT) Spend Its Cash Wisely?

Here's Why We're Not Too Worried About Rezolute's (NASDAQ:RZLT) Cash Burn Situation

Is Rezolute (NASDAQ:RZLT) In A Good Position To Deliver On Growth Plans?

We Think Rezolute (NASDAQ:RZLT) Needs To Drive Business Growth Carefully

Rezolute Receives a Written Notice from the Listing Qualifications Department of Nasdaq Stock Market

Here's Why We're Watching Rezolute's (NASDAQ:RZLT) Cash Burn Situation

Recent updates

Price target increased by 9.8% to US$5.63

Rezolute Inc Announces Oral Presentation Of Results From Phase 3 Sunrize Study Of Ersodetug In Patients With Congenital Hyperinsulinism

Rezolute Inc Provides Update on Congenital Hyperinsulinism Program Following Fda Meeting

Will Rezolute (NASDAQ:RZLT) Spend Its Cash Wisely?

Price target increased by 9.1% to US$4.50

Rezolute, Inc. Provides Insights from Its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from Its Expanded Access Program in Tumor Hyperinsulinism

Chief Financial Officer recently bought US$80k worth of stock

Rezolute, Inc. Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism

Price target decreased by 74% to US$4.13

New major risk - Share price stability

Forecast to breakeven in 2028

New minor risk - Profitability

Price target increased by 7.1% to US$15.00

Price target increased by 12% to US$14.89

Here's Why We're Not Too Worried About Rezolute's (NASDAQ:RZLT) Cash Burn Situation

Rezolute, Inc., Annual General Meeting, Nov 19, 2025

No longer forecast to breakeven

Rezolute, Inc. Announces Alignment with FDA on Streamlined Design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism

Rezolute, Inc. Appoints Sunil Karnawat as Chief Commercial Officer, Effective August 18, 2025

Rezolute Announces Presentation of Participant Baseline Data from its Fully Enrolled Phase 3 Study of Ersodetug in Congenital Hyperinsulinism at the Upcoming Annual Meeting of the Endocrine Society (ENDO 2025)

Rezolute, Inc. announced that it has received $4.209995 million in funding

Rezolute Announces Completion of Enrollment in the Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism

Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Tumor Hyperinsulinism

Rezolute, Inc. has filed a Follow-on Equity Offering.

New minor risk - Share price stability

Rezolute, Inc. has completed a Follow-on Equity Offering in the amount of $89.993096 million.

Rezolute, Inc. Announces Positive Recommendation After Independent Interim Analysis of Phase 3 Sunrize Study of Ersodetug in Congenital Hyperinsulinism

Chief Financial Officer recently bought US$58k worth of stock

Rezolute Appoints Erik Harris to Its Board of Directors

Rezolute: Late-Stage Study Targeting Hyperinsulinism

Rezolute, Inc. Provides Update on Its Phase 3 sunRIZE Study of Ersodetug for the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Is Rezolute (NASDAQ:RZLT) In A Good Position To Deliver On Growth Plans?

New major risk - Shareholder dilution

Rezolute Receives Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Chief Financial Officer recently bought US$53k worth of stock

New minor risk - Share price stability

Price target increased by 7.5% to US$12.78

Rezolute, Inc., Annual General Meeting, Dec 05, 2024

Price target increased by 7.2% to US$12.75

Consensus EPS estimates upgraded to US$0.98 loss

Insufficient new directors

Price target increased by 8.1% to US$11.89

New major risk - Shareholder dilution

Rezolute, Inc. Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism

Rezolute, Inc. announced that it expects to receive $6 million in funding

Rezolute, Inc. has completed a Follow-on Equity Offering in the amount of $59.99625 million.

New major risk - Share price stability

Price target increased by 9.4% to US$10.57

Rezolute, Inc. Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)

We Think Rezolute (NASDAQ:RZLT) Needs To Drive Business Growth Carefully

Rezolute, Inc., Annual General Meeting, May 16, 2024

Director recently bought US$70k worth of stock

Rezolute, Inc. Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH)

Chief Financial Officer recently bought US$67k worth of stock

Price target increased by 9.0% to US$8.50

Rezolute, Inc. (NASDAQ:RZLT) Shares Could Be 31% Above Their Intrinsic Value Estimate

Now 29% overvalued after recent price rise

Rezolute, Inc. Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Rezolute, Inc. Appoints Daron Evans as Chief Financial Officer

Rezolute, Inc. Announces Completion of Enrollment in its RZ402 Phase 2 Study in Diabetic Macular Edema

Rezolute Receives a Written Notice from the Listing Qualifications Department of Nasdaq Stock Market

New minor risk - Shareholder dilution

New minor risk - Share price stability

Rezolute Announces Further Evidence of RZ358’s Efficacy in Tumor-Mediated Hyperinsulinism

Rezolute, Inc.'s (NASDAQ:RZLT) Intrinsic Value Is Potentially 65% Above Its Share Price

Here's Why We're Watching Rezolute's (NASDAQ:RZLT) Cash Burn Situation

New major risk - Revenue and earnings growth

Price target decreased by 30% to US$7.80

Rezolute, Inc. Provides an Update on Its Clinical Development Plans for RZ358