Aardvark Therapeutics (NasdaqGS:AARD) Conference Transcript

Aardvark Therapeutics Conference Summary Company Overview - Aardvark Therapeutics is a publicly traded company based in San Diego, founded in 2017, focusing on gut-brain signaling drugs to reduce hunger, with a lead program targeting Prader-Willi syndrome currently in phase three, expecting readout in Q3 2026 [5][39] Core Points and Arguments Obesity and Prader-Willi Syndrome - Aardvark's approach involves oral small molecule drugs that target beta taste receptors in the gut, which are linked to appetite regulation [6][8] - The lead drug, ARD-101, is designed to suppress appetite by triggering hormone release in the intestine, with 99% of the drug remaining in the gut [9][12] - Aardvark's mechanism is considered orthogonal to GLP-1 receptor agonists, which primarily reduce appetite but can lead to nausea and weight rebound upon discontinuation [12][13] Safety Profile - In phase one and two trials, over 70 patients were treated with no significant adverse events beyond grade two, indicating a favorable safety profile [14] Obesity Program and ARD-201 - ARD-201 combines ARD-101 with a DPP-4 inhibitor to prolong the activity of gut hormones, showing promising preclinical results with a 19% body weight loss in 30 days, comparable to high-dose tirzepatide [19][20] - The program aims to provide an "off-ramp" for patients discontinuing GLP-1 receptor agonists, addressing the issue of rapid weight regain [20][28] Clinical Trials - The POWER trial will focus on patients who have lost weight on GLP-1s and aim to maintain that weight loss with ARD-201, expecting readout in the second half of 2026 [28][32] - The STRENGTH trial will evaluate ARD-201 against ARD-201 plus GLP-1, with initiation expected in the first half of 2026 [29][30] Phase Two Data for Prader-Willi Syndrome - Phase two results showed significant reductions in hyperphagia scores, with patients demonstrating behaviors such as leaving food uneaten, indicating potential efficacy [24][25] - The HERO trial for Prader-Willi syndrome is ongoing, with a target enrollment of 90 patients and expected top-line results in Q3 2026 [39][47] Future Directions - Aardvark is exploring additional programs, including a drug derived from a soybean compound that may offer weight loss benefits through a different mechanism, currently seeking partnership opportunities [35][36] Other Important Content - The company plans to expand the age range for the HERO trial to include younger patients, potentially down to age 4, to better represent the target population [44] - Aardvark anticipates a minimum reduction of 6 points in the HQCT score for the HERO trial to demonstrate efficacy, with a robust design to ensure statistical significance [46][47]