• Over 200 participants fully enrolled across 22 sites in the US
• Trial designed to inform optimal dose and titration schedule of VRB-101 for future clinical development
• Topline results expected by the end of 2026

Verdiva Bio Limited (“Verdiva Bio” or “the Company”) a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and cardiometabolic disorders, today announced the completion of enrollment for its Phase 2b EVOLVE-2 clinical study of VRB-101, a once-weekly oral, cAMP-biased, GLP-1 peptide analog candidate for body weight reduction in people with overweight or obesity. The Company currently expects to report topline data from the study by the end of 2026.

EVOLVE-2 is a randomized, double-blind, placebo-controlled Phase 2b trial with the goal of evaluating the safety, tolerability and efficacy of VRB-101 for body weight reduction. The study enrolled over 200 participants with obesity (BMI of ≥30 kg/m2) or overweight with at least one weight-related comorbidity (BMI of ≥27 kg/m2 and <30 kg/m2) across 22 sites in the United States. It is comprised of five active arms and one placebo arm, with participants being dosed once-weekly orally for 20 weeks. The primary endpoint is mean percentage body weight change from baseline (Study Identifier: NCT07281937).

The trial is designed to provide guidance for the optimal starting and maintenance doses, and titration schedule of VRB-101 in future clinical trials. Assuming positive EVOLVE-2 results, Verdiva Bio currently expects to initiate Phase 3 clinical trials for VRB-101 during 2027.

“Obesity is a multifactorial chronic disease with important health-related complications requiring long-term therapy,” stated Dr. Mohamed Eid, CMO at Verdiva Bio. “Previous studies indicate a promising clinical profile for VRB-101, supported by PK modelling which suggest VRB-101’s ability to achieve drug levels similar to or higher than a once-weekly injectable GLP-1 peptide currently approved in the US and other major markets. VRB-101 appears to have the potential to become a first-in-class once-weekly oral GLP-1 analog for people living with obesity or overweight and weight-related complications.”

About VRB-101

VRB-101 is an oral formulation of ecnoglutide – a cAMP-biased, oral GLP-1 peptide analog – formulated with Verdiva Bio’s clinically validated, proprietary oral delivery technology. PK modelling completed during a Phase 1 trial in Australia suggest that oral VRB-101 may achieve drug levels comparable to, or exceeding, those of the once-weekly injectable GLP-1 peptide analog semaglutide currently approved in the US and other major markets. The Company presented the Phase 1 PK data at the American Diabetes Association (ADA) 85^th Scientific Sessions (LINK). VRB-101 is also being investigated in combination with Verdiva Bio’s potential once-weekly oral amylin analog, VRB-103.

About Verdiva Bio

Verdiva Bio is committed to developing next-generation therapies to help people living with obesity, cardiometabolic disorders, and related complications achieve better outcomes via patient-friendly therapeutic options. Verdiva Bio’s most advanced investigational candidate is VRB-101, an oral GLP-1 peptide analog in clinical development that has exhibited best-in-class efficacy potential in a Phase 1 study in Australia, which also supports the potential for once-weekly dosing. The Company is also developing a portfolio of amylin molecules, including oral and subcutaneous agonists, and other undisclosed programs that offer the potential for enhanced efficacy, improved tolerability, and healthier weight loss. The Verdiva Bio team is harnessing the emerging science in gut-brain biology and leveraging their history of successful drug development to advance novel therapeutic options aiming to transform the lives of millions living with obesity worldwide.

For more information, please visit www.verdivabio.com.

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