Rezolute Announces Positive Results from the Phase 3 upLIFT Study in Tumor Hyperinsulinism

Rhea-AI Summary

Rezolute (Nasdaq: RZLT) announced that ersodetug achieved the primary efficacy endpoint in its Phase 3 upLIFT tumor hyperinsulinism study, based on preliminary results. At the November 5 evaluation, 13 of 16 participants met the response criterion of at least a 50% reduction from baseline in intravenous glucose infusion rate; 12 also discontinued intravenous glucose completely. Three participants remained in the pivotal treatment period, including two not yet meeting the response criterion.

The single-arm, open-label study has no comparison group. One participant discontinued early, entered hospice and died from cancer progression; that participant counts as a non-responder. No drug-related safety findings have been attributed to ersodetug to date. Rezolute expects completed-study results, including statistical analysis, by mid-December 2026 and looks forward to FDA discussions in the first quarter of 2027.

6 points · 1 major

PositiveiHow this balance works

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointPrimary endpoint achieved preliminarily: 13 of 16 participants achieved at least a 50% reduction in glucose infusion rate.
• Moderate pointErsodetug has had no attributed drug-related safety findings in the pivotal and extension phases to date.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Rezolute believes both congenital and tumor hyperinsulinism can advance into the approval process in 2027.
• Minor pointIntravenous glucose was completely discontinued in 12 participants.
• Minor point. Forward-looking: it has not happened yet and may not happen.Completed-study results, including primary endpoint statistical analysis, are expected by mid-December 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Rezolute looks forward to FDA discussions in the first quarter of 2027.

Negative

• Moderate pointResults remain preliminary; three participants remain in the pivotal period, including two not yet meeting response criteria.
• Minor pointThe single-arm, open-label study has no comparison group or treatment masking.
• Minor pointOne participant died from cancer progression after early discontinuation and hospice entry, counting as a non-responder.

Key Figures

Responders to date: 13 participants Complete IV glucose discontinuation: 12 participants Minimum responders for statistical significance: At least 9 responders (≥56%) +2 more

Responders to date

13 participants

Preliminary upLIFT results; primary efficacy endpoint

Complete IV glucose discontinuation

12 participants

Among participants meeting the responder criterion

Minimum responders for statistical significance

At least 9 responders (≥56%)

Based on enrollment of 16 participants; final statistical analysis pending

Participants still in pivotal period

3 participants

Two had not yet met the responder criterion

Primary endpoint threshold

At least a 50% reduction from baseline

Glucose infusion rate

Previous Clinical trial Reports

2 past events · Latest: Oct 14

Same Type 2 events

1. Oct 14

   upLIFT enrollment update

   24h Move

   -7.8%

   Enrollment completed; seven of the first eight participants met the responder criterion and discontinued IV glucose.

2. Jun 02

   upLIFT interim data

   24h Move

   +10.8%

   Six of eight participants met the responder criterion and fully discontinued intravenous glucose.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

glucose infusion rate, confidence interval, open-label, allosterically, +1 more

5 terms

glucose infusion rate medical

"reduction from baseline in glucose infusion rate (GIR)"

Glucose infusion rate is the speed at which sugar is delivered into the bloodstream through an IV, usually adjusted for body size and expressed as a rate. Think of it as how fast fuel is poured into an engine: too little or too much can change how the body and drugs behave. Investors should care because this rate affects safety, metabolic responses and trial results for treatments or devices that influence blood sugar, which can change regulatory outcomes and market value.

confidence interval technical

"lower bound of the 95% confidence interval"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

open-label technical

"ongoing open-label Phase 3 upLIFT study"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

allosterically medical

"binds allosterically to the insulin receptor"

By a mechanism called allostery, a molecule binds to one site on a protein and changes the protein’s shape or dynamics so that a different site on the same protein becomes more or less active; saying something acts allosterically means its effect is mediated through that distant-site interaction rather than by directly blocking or activating the primary active site.

monoclonal antibody medical

"a fully human monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

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Primary efficacy endpoint achieved based on preliminary results from a November 5^th data evaluation

Topline results for the completed study, along with additional study details including statistical analysis of the primary endpoint, are expected by mid-December 2026

REDWOOD CITY, Calif., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or the Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced positive results from the ongoing open-label Phase 3 upLIFT study of ersodetug in tumor HI, in which the primary efficacy endpoint has been achieved, based on preliminary results from a November 5^th data evaluation.

The primary efficacy endpoint in the upLIFT study is the proportion of patients able to achieve at least a 50% reduction from baseline in glucose infusion rate (GIR), a measure of intravenous glucose dependency for underlying hypoglycemia. To achieve statistical significance for the endpoint, the lower bound of the 95% confidence interval for percent of patients responding must exceed 30%, which equates to at least 9 responders (≥56%), based on enrollment of 16 participants. To date, 13 participants have met the responder criterion, including 12 who also achieved a complete discontinuation of IV glucose. Three participants are still in the pivotal period of the study, including two who have not yet met the responder criterion. As previously reported, one participant discontinued the study early and chose to enter home hospice care, and died one week later due to cancer progression. This participant has been classified as a non-responder for purposes of the primary endpoint. Results for the completed study, including statistical analysis of the primary endpoint, are expected by mid-December 2026.

“We are thrilled with this outcome and what it means for individuals living with tumor hyperinsulinism,” said Nevan Charles Elam, Founder and Chief Executive Officer of Rezolute. “Notably, these results substantially mirror the powerful outcomes that we have observed over the last few years in our expanded access program. We believe that we are well positioned to advance both congenital HI and tumor HI into the approval process next year and we look forward to discussions with FDA in the first quarter of 2027.”

The 16 enrolled participants include four with non-islet cell tumors and 12 with insulin-secreting malignant islet cell tumors (insulinomas). Ersodetug has been well-tolerated to date in the pivotal and extension phases of the study, with no drug-related safety findings attributed to ersodetug.

About upLIFT

The upLIFT 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 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 at a reduced dosing frequency in long-term extension. The primary endpoint is the proportion of participants able to achieve at least a 50 percent reduction from baseline in GIR, a measure of intravenous glucose dependency for underlying hypoglycemia. Additional endpoints include the number of participants achieving complete discontinuation of GIR and time to discontinuation, time to discharge from the hospital as applicable, 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.

About Tumor Hyperinsulinism

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 because of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia via the overproduction of insulin. A variety of different NICTs, including hepatocellular carcinoma and soft tissue malignancies (e.g. sarcomas), 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.

About Ersodetug

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 pancreatic insulin or paraneoplastic IGF-2 secretion, and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of HI, including congenital HI, tumor HI (insulinoma, non-islet cell tumors) or bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority. 

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com. 

Forward-Looking Statements

This release, 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," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to the potential safety, efficacy and therapeutic and commercial potential of ersodetug for the treatment of hypoglycemia caused by hyperinsulinism; the timing and final results of the Phase 3 upLIFT study of ersodetug in tumor HI, including our expectation to announce full topline results by mid-December 2026; the Company’s plans and expectations regarding a pre-BLA meeting and the potential submission of one or two Biologics License Applications (BLA) for ersodetug for both of tumor HI and congenital HI in 2027; the potential safety, efficacy and therapeutic potential of ersodetug for treating refractory hypoglycemia caused by any form of HI. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. With respect to congenital hyperinsulinism, although FDA has recommended that the Company file a BLA for review for congenital HI after holding a pre-BLA meeting, there can be no assurance that FDA will agree that the totality of evidence from the sunRIZE program demonstrates a clinically meaningful benefit or is sufficient to support approval of ersodetug for congenital HI. 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 Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’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.

Rezolute Contacts:

Christen Baglaneas
Rezolute, Inc.
1411 Broadway, 16^th Floor
New York, NY 10018
cbaglaneas@rezolutebio.com
508-272-6717

Carrie McKim
Rezolute, Inc.
1411 Broadway, 16^th Floor
New York, NY 10018
cmckim@rezolutebio.com
336-608-9706

FAQ

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What did Rezolute's Phase 3 upLIFT study show for ersodetug?

Preliminary results showed 13 of 16 participants met the primary response criterion: at least a 50% reduction from baseline in intravenous glucose infusion rate. Of these, 12 also discontinued intravenous glucose completely. The evaluation was conducted on November 5, and completed-study results remain pending.

When will Rezolute report completed upLIFT study results?

Rezolute expects completed-study results by mid-December 2026, including additional study details and statistical analysis of the primary endpoint.

What statistical threshold does Rezolute's upLIFT study need to meet?

The lower bound of the 95% confidence interval for the percentage of responding participants must exceed 30%. With 16 participants enrolled, this requires at least 9 responders (≥56%). A responder must achieve at least a 50% reduction from baseline in intravenous glucose infusion rate.

How is ersodetug administered in Rezolute's upLIFT study?

Eligible participants requiring continuous intravenous glucose receive ersodetug 9 mg/kg per week for 8 weeks, added to standard care. After this pivotal treatment period, all participants may receive ersodetug at a reduced dosing frequency in a long-term extension.