Aardvark Therapeutics (AARD) BofA Securities 2025 Healthcare Conference summary

Clinical program updates

• Ongoing phase III HERO trial in Prader-Willi syndrome with top-line readout expected in early 2026.

• Planned phase II trials for hypothalamic obesity and general obesity, with readouts also anticipated in 2026.

• Over 70 patients dosed with ARD-101 across phase I and II studies, showing only grade 2 adverse events and strong efficacy signals.

• Phase II data in Prader-Willi showed up to 48% reduction in hyperphagia scores for patients matching phase III criteria.

• Multiple clinical endpoints include body composition, inflammatory biomarkers, and ghrelin levels.

Mechanism of action and differentiation

• Drug targets bitter taste receptors in the gut, invoking gut-brain CCK signaling to reduce hunger, distinct from GLP-1's anti-appetite effect.

• Demonstrated reduction in serum ghrelin, unlike GLP-1 therapies which increase ghrelin.

• Approach is complementary to GLP-1, with potential for additive effects and protection from weight regain after GLP-1 discontinuation.

• Drug is 99% gut-restricted, enhancing safety and targeting the gut lumen directly.

Pipeline and future plans

• ARD-201, a fixed-dose combination with a DPP-4 inhibitor, is being advanced for general obesity, showing improved metabolic markers in preclinical and clinical studies.

• EMPOWER study in general obesity will assess additive benefit on top of GLP-1, lean mass preservation, and protection from weight regain.

• Open-label extension and potential randomized withdrawal studies planned for Prader-Willi patients.

• Multiple data readouts expected in 2026 across all major programs.