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RZ358 Phase 2b (RIZE Study) Topline Data to be Unveiled at Pediatric Endocrine Society Annual Meeting on May 1, 2022

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Rezolute, Inc. (RZLT) announced a late-breaking oral presentation of its Phase 2b RIZE Study data for RZ358 at the Pediatric Endocrine Society Annual Meeting on May 1, 2022. The study focused on congenital hyperinsulinism (HI), evaluating RZ358's safety, tolerability, and glycemic efficacy in patients inadequately controlled by existing therapies. Dr. Paul Thornton will present findings, with the conference call set for 2:30 p.m. ET on the same day. Rezolute aims to disrupt treatment paradigms for metabolic diseases with innovative therapies.

Positive
  • Late-breaking oral presentation of Phase 2b RIZE Study data demonstrates progress in developing RZ358 for congenital hyperinsulinism.
  • Study assesses safety, tolerability, and glycemic efficacy, indicating potential effectiveness of RZ358.
  • Engagement with medical professionals in the presentation boosts credibility and visibility.
Negative
  • Results from the trial are yet to be disclosed, creating uncertainty about the outcomes.
  • Dependence on a single product (RZ358) could pose risks if the data does not support efficacy.

Rezolute to host conference call presentation and discussion of the data on Sunday, May 1 at 2:30 p.m. ET

REDWOOD CITY, Calif., April 26, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced a late-breaking oral presentation of its Phase 2b RIZE Study Topline Data of RZ358 in congenital hyperinsulinism (HI) at the upcoming Pediatric Endocrine Society 2022 Annual Meeting on May 1, 2022.

On behalf of the Company and the study co-authors, Dr. Paul Thornton, a pediatric endocrinologist, and head of the hyperinsulinism center at Cook Children’s Hospital, is scheduled to present results from the Phase 2b, multicenter, global, repeat-dose study of RZ358 in patients with congenital HI. The RIZE study was designed to assess the safety and tolerability, pharmacokinetics, and glycemic efficacy of RZ358 administered bi-monthly for 8 weeks in patients with congenital HI whose hypoglycemia was not adequately controlled on existing standard of care therapies.

Oral Presentation:

Presentation Title: RZ358 in Congenital Hyperinsulinism: Results from a Multi-Center, Global, Phase 2b Study (RIZE)
Presenter: Paul Thornton, M.D.
Session Date and Time: Sunday, May 1, 2022, from 12:00 p.m. – 1:30 p.m. ET
Session Title: Clinical - Endocrinology
Abstract #: 6071
On-Demand Presentation: Available starting on Monday, May 2, 2022, at 11:30 a.m. ET

Conference Call and Webcast Information

Rezolute management will host a conference call at 2:30 p.m. ET on Sunday, May 1, 2022. Analysts and investors are invited to participate in the conference call by dialing (855) 645-1306 from the U.S. and Canada or (442) 268-1087 internationally and using the conference ID 6063004. The live webcast can be accessed on the investor page of Rezolute’s website at ir.rezolutebio.com. A replay of the webcast will be available on Rezolute’s website approximately two hours after the completion of the event and will be archived for up to 90 days.

About Rezolute, Inc.

Rezolute strives to disrupt current treatment paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential to both significantly improve outcomes and reduce the treatment burden for patients, the treating physician, and the healthcare system. Patient, clinician, and advocate voices are integrated in the Company’s drug development process, enabling Rezolute to boldly address a range of severe conditions. Rezolute is steadfast in its mission to create profound, positive, and lasting impact on patients’ lives. The Company’s lead clinical asset, RZ358, is in late-stage development for the treatment of congenital hyperinsulinism, a rare pediatric endocrine disorder. Rezolute is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.com or follow us on Twitter.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute, Inc. 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 the Company, 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. 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.

Investor Contact
Kimberly Minarovich/Carrie McKim
Argot Partners
rezolute@argotpartners.com
212-600-1902

Media Contact
Ingrid Mezo
Canale Communications, Inc.
ingrid.mezo@canalecomm.com
301-473-2881


FAQ

What is Rezolute's RZ358 trial about?

RZ358 is being studied in a Phase 2b trial for treating congenital hyperinsulinism, focusing on safety and glycemic efficacy.

When is the RZ358 Phase 2b study data being presented?

The data will be presented on May 1, 2022, at the Pediatric Endocrine Society Annual Meeting.

What are the next steps for Rezolute after the RZ358 presentation?

Post-presentation, Rezolute will analyze feedback and outcomes to determine further development plans for RZ358.

What is the significance of congenital hyperinsulinism in RZLT's strategy?

Congenital hyperinsulinism is a rare condition, and effective treatment like RZ358 could position Rezolute as a leader in metabolic disease therapies.

Rezolute, Inc.

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