Institutional Review Board Approves Amended Protocol To Aardvark Therapeutics' Ongoing Phase 3 HERO Trial Of ARD-101 for Hyperphagia In Individuals With Prader-Willi Syndrome, The amended protocol, submitted to FDA Lowers Minimum Age Of For Participation From 10 to 7 Years Old

This protocol amendment reflects Aardvark's continued focus on reducing barriers to participation and expanding access for those affected by PWS, a rare genetic disorder characterized by chronic hyperphagia. By expanding enrollment to younger children who meet eligibility criteria, the HERO trial may better capture the potential impact of ARD-101 in the PWS population.

"We are very pleased to report this important protocol expansion, which allows us to broaden the patient population for our Phase 3 HERO trial to include children as young as 7 years of age in the U.S.," said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. "Hyperphagia may begin early in life for some individuals with PWS, and it presents a persistent burden for patients and caregivers. Expanding eligibility reflects our commitment to addressing the urgent need in the PWS community for a differentiated therapy and we aim to ensure broad and equitable access."

Dr. Lee added, "Enrollment in HERO is progressing steadily and remains on track to report topline data in the third quarter of 2026. We believe these data will further inform our understanding of ARD-101's potential role as a differentiated therapeutic approach for the treatment of hyperphagia associated with PWS."

About the HERO Trial

The Hunger Elimination or Reduction Objective (HERO) trial (NCT06828861) is a Phase 3 randomized, double-blind, placebo-controlled trial assessing ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS). Aardvark plans to enroll 90 patients in this clinical trial across the U.S., Australia, Canada, the United Kingdom and South Korea. The primary endpoint is change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12. Secondary outcome measures include change in Caregiver Global Impression of Severity (CaGI-S) for hyperphagia in PWS patients and change in Clinical Global Impression of Severity (CGI-S) score for hyperphagia in PWS patients. All participants who complete the 12-week clinical trial will have the option to participate in an Open Label Extension trial. More information about the study can be found at www.heroforpws.com.