Rezolute Reports First Quarter Fiscal 2027 Financial Results and Provides Business Update

FDA recommended a congenital hyperinsulinism application after a pre-application meeting, despite sunRIZE missing its primary endpoint.

Rhea-AI Summary

Rezolute (Nasdaq: RZLT) reported first-quarter fiscal 2027 financial results and completed enrollment in its Phase 3 upLIFT tumor hyperinsulinism study. The company expects topline results by mid-December 2026. Seven of the first eight participants met the primary endpoint responder criterion and discontinued intravenous glucose.

For congenital hyperinsulinism, sunRIZE missed its primary endpoint, although glucose-monitoring endpoints showed improvements. FDA recommended a biologics license application after a pre-application meeting. Rezolute plans to submit for one or potentially both indications in 2027.

For the quarter ended September 30, 2026, net loss widened to $18.487 million from $18.150 million a year earlier; loss per share remained $0.18. Cash, cash equivalents and marketable securities totaled $90.0 million, versus $107.8 million at June 30. Research and development and administrative expenses declined year over year.

9 points · 0 major

MixediHow this balance works

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

1 major · 10 points

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

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Tumor hyperinsulinism upLIFT enrollment is complete; Rezolute expects topline results by mid-December 2026.
• Moderate pointFDA recommended a congenital hyperinsulinism application after a pre-application meeting.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Rezolute plans a biologics license application for one or potentially both indications in 2027.
• Minor pointupLIFT primary endpoint responder criterion was met by 7 of the first 8 participants, who discontinued intravenous glucose.
• Minor pointErsodetug has had no drug-related safety findings reported in upLIFT thus far.

4 minor points

• Minor pointsunRIZE showed clinically relevant improvements across multiple continuous glucose monitoring endpoints in both treatment arms.
• Minor pointsunRIZE’s ongoing extension showed improved glucose-control indicators, including reduced background standard-of-care therapy use.
• Minor pointResearch and development expenses fell to $12.807 million from $13.149 million year over year.
• Minor pointGeneral and administrative expenses fell to $6.578 million from $6.668 million year over year.

Negative

• Major pointsunRIZE missed its primary endpoint: finger-stick hypoglycemia-event reductions were not statistically significant versus placebo.
• Moderate pointCash, cash equivalents and marketable securities fell to $90.0 million from $107.8 million at June 30, 2026.
• Moderate pointQuarterly net loss widened to $18.487 million from $18.150 million; loss per share remained $0.18.
• Minor pointNon-operating income declined to $0.898 million from $1.667 million year over year.
• Minor pointWorking capital fell to $84.370 million from $99.093 million at June 30, 2026.

5 minor points

• Minor pointTotal assets fell to $96.010 million from $112.849 million at June 30, 2026.
• Minor pointStockholders’ equity fell to $85.948 million from $100.687 million at June 30, 2026.
• Minor pointAccumulated deficit increased to $499.929 million from $481.442 million at June 30, 2026.
• Minor pointResearch and development share-based compensation rose to $1.5 million from $1.2 million year over year.
• Minor pointAdministrative share-based compensation rose to $1.8 million from $1.4 million year over year.

Key Figures

upLIFT responders: 7 of 8 participants sunRIZE primary endpoint: Not statistically significant versus placebo Planned BLA submission: 2027 +4 more

upLIFT responders

7 of 8 participants

First half of the Phase 3 study met the primary endpoint responder criterion

sunRIZE primary endpoint

Not statistically significant versus placebo

Reductions in hypoglycemia events measured by finger-stick SMBG

Planned BLA submission

2027

For one or potentially both indications

Cash, cash equivalents and marketable securities

$90.0 million

As of September 30, 2026; compared with $107.8 million as of June 30, 2026

Research and development expenses

$12.8 million

First quarter fiscal 2027; compared with $13.1 million in the year-ago quarter

General and administrative expenses

$6.6 million

First quarter fiscal 2027; compared with $6.7 million in the year-ago quarter

Net loss

$18.5 million

First quarter fiscal 2027; compared with $18.2 million in the year-ago quarter

Previous Earnings Reports

1 past event · Latest: Sep 24

Same Type 1 event

1. Sep 24

   Earnings report

   24h Move

   -1.0%

   upLIFT reported seven of eight responders and six complete IV-glucose discontinuations; enrollment remained underway.

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

Key Terms

single-arm, open label, biologics license agreement, placebo-controlled, +2 more

6 terms

single-arm medical

"a Phase 3, single-arm, open label study"

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

open label medical

"single-arm, open label study in up to 16 hospitalized participants"

Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.

biologics license agreement regulatory

"file for review under a Biologics License Agreement (BLA)"

A biologics license agreement is a contract in which the owner of a biological medicine (such as a vaccine or antibody) gives another company rights to develop, make, or sell that medicine under agreed terms—covering payments, milestones, quality responsibilities and territory. Investors care because these deals determine who collects future sales, who bears development and manufacturing risk, and how revenue and timelines are shared; think of it like a franchise or royalty arrangement that can materially change a company’s cash flow and risk profile.

placebo-controlled medical

"a Phase 3, multicenter, double-blind, randomized, placebo-controlled"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

continuous glucose monitoring medical

"multiple CGM-based hypoglycemia endpoints"

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

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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REDWOOD CITY, Calif., Nov. 05, 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 reported financial results and provided a business update for the first quarter ended September 30, 2026.

Tumor HI

• upLIFT, a Phase 3, single-arm, open label study in up to 16 hospitalized participants for the treatment of tumor HI, is ongoing.
  • Enrollment is complete and topline results are expected by mid-December 2026.
• Earlier this year, the Company announced that 7 of the 8 participants enrolled in the first half of the study met the responder criterion for the study’s primary endpoint.
  • Each of these participants also achieved complete discontinuation of intravenous glucose with the administration of ersodetug.
  • Ersodetug has been well-tolerated in the study thus far, with no drug-related safety findings reported.
  • The eighth participant in the first half of the study discontinued study drug shortly after enrollment in favor of pursuing hospice care at home, where they died one week later due to cancer progression. The Company considers this participant as a non-responder, for purposes of the primary endpoint.
    
    

Congenital HI

• In October 2026, the Company provided an update that the U.S. Food and Drug Administration (FDA or the Agency) has reviewed additional study data provided by the Company at the Agency’s request.
• The Agency recommended the Company file for review under a Biologics License Agreement (BLA) for congenital HI after holding a pre-BLA meeting.
  • As previously reported, sunRIZE, a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital HI, demonstrated glycemic improvements, but did not meet the primary endpoint because the reductions in hypoglycemia events by finger-stick self-monitored blood glucose (SMBG) were not statistically significant compared to placebo. However, consistent and clinically relevant improvements in hypoglycemia were observed across multiple CGM-based hypoglycemia endpoints in both treatment arms.
  • The open-label extension (OLE) phase of the sunRIZE study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies.
    
    

Business Update

• On October 29, 2026, the Company participated in a virtual Q&A as part of Guggenheim’s Healthcare Spotlight Series. The discussion focused on commercial outlook and launch strategy for ersodetug. Key highlights include:
  • Potential $5 billion combined market opportunity.
  • Plan to submit a BLA for ersodetug for one or potentially both indications in 2027.
    
    

First Quarter Fiscal 2027 Financial Results

Cash, cash equivalents and investments in marketable securities were $90.0 million as of September 30, 2026, compared with $107.8 million as of June 30, 2026.

Research and development (R&D) expenses were $12.8 million for the first quarter of fiscal 2027, compared with $13.1 million for the same period a year ago. The decrease was primarily due to decreased manufacturing costs for ersodetug and patient affairs costs, partially offset by increased employee-related stock-based compensation expense. R&D expenses include $1.5 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.2 million for the same period a year ago.

General and administrative (G&A) expenses were $6.6 million for the first quarter of fiscal 2027, compared with $6.7 million for the same period a year ago. The decrease was primarily attributable to a decrease in professional fees, partially offset by increased employee-related stock-based compensation expense. G&A expenses include $1.8 million of share-based compensation expense for the first quarter of fiscal 2027, compared with $1.4 million for the same period a year ago.

Net loss was $18.5 million for the first quarter of fiscal 2027 compared with a net loss of $18.2 million for the same period a year ago.

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 hyperinsulinism (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, statements regarding the potential safety, efficacy and therapeutic and commercial potential of ersodetug for the treatment of hypoglycemia caused by hyperinsulinism; the timing and results of the Phase 3 upLIFT study of ersodetug in tumor HI, including our expectation to announce topline results by mid-December 2026; the predictive nature of the CGM data and other findings from the sunRIZE study and its ongoing open-label extension as they relate to the potential efficacy of ersodetug in treating hypoglycemia; the persuasiveness of the additional study data reviewed by FDA and the possibility of FDA agreeing to advance the congenital HI program notwithstanding the lack of statistical significance for the primary endpoint in the sunRIZE study; the Company’s plans and expectations regarding a pre-BLA meeting and the potential submission of a Biologics License Application (BLA) for ersodetug for one or 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; and the commercial outlook and launch strategy for ersodetug, including the potential $5 billion combined market opportunity. 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, 16th Floor
New York, NY 10018
cbaglaneas@rezolutebio.com
508-272-6717

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

Rezolute, Inc.
Condensed Consolidated Financial Statements Data
(in thousands, except per share data)
	Three Months Ended
	September 30,
		2026				2025
Condensed Consolidated Statements of Operations Data:
Operating expenses:
Research and development	$	12,807			$	13,149
General and administrative		6,578				6,668
Total operating expenses		19,385				19,817
Loss from operations		(19,385	)			(19,817	)
Non-operating income, net		898				1,667
Net loss	$	(18,487	)		$	(18,150	)
Basic and diluted net loss per common share	$	(0.18	)		$	(0.18	)
Shares used to compute basic and diluted net loss per common share		104,778				103,423
	September 30,				June 30,
		2026				2026
Condensed Consolidated Balance Sheets Data:
Cash and cash equivalents	$	8,150			$	10,615
Investments in marketable debt securities		81,849				97,186
Working capital		84,370				99,093
Total assets		96,010				112,849
Accumulated deficit		(499,929	)			(481,442	)
Total stockholders’ equity		85,948				100,687

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Rezolute expect upLIFT results, and what have early participants shown?

Rezolute expects topline upLIFT results by mid-December 2026. Enrollment is complete in the Phase 3, single-arm, open-label study in up to 16 hospitalized participants. Seven of the first eight participants met the primary endpoint responder criterion and completely discontinued intravenous glucose.

When does Rezolute plan to submit an ersodetug biologics license application?

Rezolute plans to submit a biologics license application for one or potentially both indications in 2027. For congenital hyperinsulinism, FDA recommended filing for review after a pre-application meeting, following its review of additional study data.

Why was the eighth early participant in Rezolute’s upLIFT study classified as a non-responder?

Rezolute considers the eighth participant a non-responder for the primary endpoint after the participant discontinued study drug shortly after enrollment to pursue hospice care at home. The participant died one week later due to cancer progression. No drug-related safety findings have been reported in the study thus far.