Rezolute, Inc. Reports Progress on sunRIZE Enrollment and Breakthrough Therapy Designation for Ersodetug in Hypoglycemia Treatment

Rezolute reports on sunRIZE study progress, Breakthrough Therapy Designation for ersodetug, and recent financial results.

Quiver AI Summary

Rezolute, Inc. announced that enrollment for its Phase 3 sunRIZE study on congenital hyperinsulinism (HI) is on track to be completed by May 2025, with topline data expected in December 2025. The U.S. FDA granted Breakthrough Therapy Designation to the company’s therapy, ersodetug, for treating hypoglycemia caused by tumor hyperinsulinism, allowing for expedited discussions with the FDA on regulatory requirements. The upLIFT study for tumor HI is anticipated to begin mid-2025, with topline data expected in late 2026. The company reported a net loss of $18.9 million for the third quarter of fiscal 2025 and closed an offering that raised approximately $97 million, extending its cash runway through mid-2027. Rezolute emphasizes its focus on advancing treatments for all forms of HI with the aim of commercializing ersodetug.

Potential Positives

• FDA grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism, potentially expediting its development and approval process.
• Phase 3 sunRIZE study for congenital hyperinsulinism is on track for timely completion of enrollment, with topline results expected by December 2025.
• Recent appointment of Erik Harris to the Board of Directors brings valuable expertise in rare disease commercialization to aid in potential market readiness.
• Company successfully raised approximately $97 million in an underwritten offering, extending its cash runway to mid-2027 for research and development initiatives.

Potential Negatives

• Net loss increased to $18.9 million for the third quarter of fiscal 2025, compared to a loss of $17.1 million for the same period a year ago, indicating worsening financial performance.
• Cash and cash equivalents decreased significantly from $70.4 million in June 2024 to $14.6 million as of March 31, 2025, raising concerns about the company's financial stability going forward.
• Total stockholders’ equity decreased from $121 million to $82.6 million within less than a year, reflecting a decline in company valuation and shareholder confidence.

FAQ

What is the purpose of the sunRIZE study?

The sunRIZE study aims to evaluate the safety and efficacy of ersodetug for treating congenital hyperinsulinism.

When is the enrollment for the sunRIZE study expected to conclude?

Enrollment for the sunRIZE study is expected to complete in May 2025.

What is the anticipated timeline for topline data release?

The topline data from the sunRIZE study is expected in December 2025.

What designation did the FDA grant for ersodetug?

The FDA granted Breakthrough Therapy Designation to ersodetug for treating hypoglycemia due to tumor hyperinsulinism.

What is the financial status of Rezolute, Inc.?

As of March 31, 2025, Rezolute reported cash and investments totaling $88.4 million.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$RZLT Insider Trading Activity

$RZLT insiders have traded $RZLT stock on the open market 8 times in the past 6 months. Of those trades, 8 have been purchases and 0 have been sales.

Here’s a breakdown of recent trading of $RZLT stock by insiders over the last 6 months:

• DARON EVANS (CFO) has made 5 purchases buying 49,549 shares for an estimated $195,166 and 0 sales.
• WLADIMIR HOGENHUIS has made 2 purchases buying 16,758 shares for an estimated $66,733 and 0 sales.
• NEVAN C ELAM (CEO) purchased 12,302 shares for an estimated $34,999

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

$RZLT Hedge Fund Activity

We have seen 43 institutional investors add shares of $RZLT stock to their portfolio, and 33 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

• FMR LLC added 6,507,718 shares (+inf%) to their portfolio in Q1 2025, for an estimated $18,872,382
• ADAGE CAPITAL PARTNERS GP, L.L.C. added 2,210,038 shares (+699.7%) to their portfolio in Q4 2024, for an estimated $10,829,186
• ALTIUM CAPITAL MANAGEMENT LLC removed 1,390,051 shares (-82.1%) from their portfolio in Q1 2025, for an estimated $4,031,147
• WOODLINE PARTNERS LP added 1,052,002 shares (+2817.1%) to their portfolio in Q4 2024, for an estimated $5,154,809
• SUSQUEHANNA INTERNATIONAL GROUP, LLP added 788,349 shares (+749.0%) to their portfolio in Q4 2024, for an estimated $3,862,910
• VIVO CAPITAL, LLC removed 685,272 shares (-24.5%) from their portfolio in Q1 2025, for an estimated $1,987,288
• GREAT POINT PARTNERS LLC added 621,894 shares (+inf%) to their portfolio in Q4 2024, for an estimated $3,047,280

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

Full Release

sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025

U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism

REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today reported financial results and provided a business update for the three months ended March 31, 2025.

“The Phase 3 sunRIZE study in congenital HI is on track to complete enrollment this month and we are poised to start our registrational upLIFT study for tumor HI mid-year,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “Each of our programs received Breakthrough Therapy Designation from FDA this year. We look forward to continued discussions with the agency with a focus on treating hypoglycemia caused by all forms of hyperinsulinism with the goal of advancing our novel therapy towards approval and commercialization.”

Recent Pipeline Progress and Anticipated Milestones

Congenital HI

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  sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study, is ongoing and enrollment is expected to conclude in May 2025.
  
  
  
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    U.S. sites are activated and enrolling patients.
    
  
  
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    Topline results expected in December 2025.
    
  
  
  
  


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  Upon completion of an interim analysis in April 2025, an independent Data Monitoring Committee recommended continuation of the sunRIZE study as planned without an increase to the study sample size.
  
  
  
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    The analysis was intended to evaluate the study for futility or otherwise to inform a potential sample size increase, for purposes of optimizing the study power and statistical confidence in the final analysis outcomes.
    
  
  
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    The Company remains blinded to the results.
    
  
  
  
  

Tumor HI

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  In May 2025, FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for the treatment of hypoglycemia due to tumor HI.
  
  
  
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    BTD was granted based on clinical trial data across the overall HI program and a recognition of the mechanistic applicability to tumor HI, further validated by real-world experience in tumor HI patients who have been successfully treated with ersodetug throughout the U.S. in the Company's Expanded Access Program.
    
  
  
  
  


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  A registrational study for ersodetug in patients with tumor HI, the “upLIFT” study, is anticipated to begin in the middle of 2025 with topline data expected in the second half of 2026.
  
  
  
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    Utilizing BTD, the Company plans to engage further with FDA to discuss the registrational trial, including the necessary data package to support a BLA filing and potential approval for the tumor HI indication.
    
  
  
  
  

Corporate Updates

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  In March 2025, the Company announced the appointment of rare disease commercial leader, Erik Harris, to its Board of Directors.
  
  
  
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    Mr. Harris is an experienced board member and commercial executive with a proven track record in the industry, currently serving as Chief Commercial Officer at Ultragenyx.
    
  
  
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    His insights will be invaluable as the Company advances through clinical development and prepares for potential commercialization.
    
  
  
  
  


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  In April 2025, the Company announced the closing of an underwritten offering raising approximately $97 million.
  
  
  
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    Cash runway extended to middle of 2027.
    
  
  
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    The net proceeds will be used for research and development, general corporate expenses and working capital needs.
    
  
  
  
  

Fiscal Third Quarter Financial Results

Cash, cash equivalents and investments in marketable securities were $88.4 million as of March 31, 2025, compared to $127.1 million as of June 30, 2024.

Research and development expenses were $15.3 million for the third quarter of fiscal 2025, compared with $12.4 million for the same period a year ago, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses, which include employee compensation.

General and administrative expenses were $4.7 million for the third quarter of fiscal 2025, compared with $3.8 million for the same period a year ago, with the increase primarily attributable to professional fees and employee-related expenses as a result of increased headcount.

Net loss was $18.9 million for the third quarter of fiscal 2025 compared with a net loss of $17.1 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 the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

About Rezolute, Inc.

Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital HI and tumor 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 third quarter financial results of Rezolute, the efficacy of ersodetug in the congenital or tumor patient population, the timeline for the completion of enrollment or achieving results in either of our Phase 3 programs and the potential approval and commercialization of ersodetug. 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.

Contacts:

Rezolute, Inc.



Christen Baglaneas



cbaglaneas@rezolutebio.com



508-272-6717

Media



Sarah Lima



Sarah@galvinPR.com



(774) 766-0200

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.