Tillkännagivande • Jun 02

Rezolute, Inc. Provides Positive Interim Data For Its Phase 3 UpLIFT Study Of Ersodetug In Tumor Hyperinsulinism

Rezolute, Inc. provided an interim update on its ongoing open-label Phase 3 study (upLIFT) of ersodetug in tumor HI. With 8 participants enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the Company is midway through enrollment of the planned study sample size of 16 participants. Of the 8 participants enrolled, 6 have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving at least a 50% reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) within the 8-week pivotal treatment phase. Each of these 6 participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug. One of the 8 enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint. The 8th participant was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings reported to date. The Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous (IV) glucose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension. The primary endpoint is the proportion of participants achieving at least a 50% reduction from baseline in IV glucose requirements (glucose infusion rate; GIR). Additional endpoints include the number of participants and time to discontinuation of GIR, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life. Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as variants of IGF-2 that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs. 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 glucose absorption, gastrointestinal incretin hormones, and pancreatic insulin secretion, it has the potential to be universally effective at treating refractory hypoglycemia due to a congenital or any acquired form of HI, including tumor HI (insulinoma, NICTH) or hypoglycemia as a complication of a variety of bariatric or non-bariatric gastrointestinal surgeries.

Tillkännagivande • 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.

Räntetäckningsgrad	n/a
Kontanter	US$120.27m
Eget kapital	US$116.83m
Summa skulder	US$8.63m
Totala tillgångar	US$125.46m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/08/11 04:59
Aktiekurs vid dagens slut	2026/08/11 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/06/30

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Julian Harrison	BTIG
Edward Nash	Canaccord Genuity
Pete Stavropoulos	Cantor Fitzgerald & Co.

Rezolute Balansräkning Hälsa

Finansiell hälsa kriterier kontrolleras 6/6

Viktig information

Nya uppdateringar om finansiell hälsa

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

Forecast to breakeven in 2029

Rezolute, Inc. Highlights Results from Natural History Outcomes Studies and Its Ersodetug Clinical Program in Hyperinsulinism At Annual Meeting of the Endocrine Society

Rezolute, Inc. Provides Positive Interim Data For Its Phase 3 UpLIFT Study Of Ersodetug In Tumor Hyperinsulinism

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